Minang (Mintu) Turakhia

All Publications

• Comparative Effectiveness and Safety of Apixaban and Rivaroxaban in Older Patients with Atrial Fibrillation: A Population-Based Cohort Study. Heart rhythm Shurrab, M., Austin, P. C., Jackevicius, C. A., Tu, K., Qiu, F., Haldenby, O., Middleton, A., Turakhia, M. P., Lopes, R. D., Boden, W. E., Castellucci, L. A., Heidenreich, P. A., Healey, J. S., Ko, D. T. 2024

  Abstract

  There are no clinical trials with head-to-head comparison between the two most commonly used oral anticoagulants (apixaban and rivaroxaban) in patients with atrial fibrillation (AF). The comparative efficacy and safety between these drugs remain unclear, especially among older patients who are at the highest risk for stroke and bleeding.To compare the risk of major bleeding and thromboembolic events with apixaban versus rivaroxaban in older patients with AF.We conducted a population-based, retrospective cohort study of all adult patients (66 years or older) with AF in Ontario, Canada who were treated with apixaban or rivaroxaban between April 1, 2011 and March 31, 2020. The primary safety outcome was major bleeding and the primary efficacy outcome was thromboembolic events. Secondary outcomes included any bleeding. Rates and hazard ratios (HRs) were adjusted for baseline comorbidities with inverse probability of treatment weighting (IPTW).This study included 42,617 patients with AF treated with apixaban and 30,725 patients treated with rivaroxaban. After IPTW using the propensity score, patients in the apixaban and rivaroxaban groups were well balanced for baseline values of demographics, comorbidities and medications; both groups had similar mean age of 77.4 years and 49.9% were female. At one year, the apixaban group had reduced risk for both major bleeding with an absolute risk reduction at one year of 1.1% (2.1% vs 3.2%; HR 0.65 [95% CI, 0.59-0.71]) and any bleeding (8.1% vs 10.9%; HR 0.73 [95% CI, 0.69-0.77]) with no difference in the risk for thromboembolic events (2.2% vs 2.2%; HR 1.02 [95% CI, 0.92-1.13]).Among AF patients, 66 years or older, treatment with apixaban was associated with reduced risk for major bleeding with no difference in risk for thromboembolic events compared with rivaroxaban.

  View details for DOI 10.1016/j.hrthm.2024.06.010

  View details for PubMedID 38878942

• Heart Failure-Related Death in Subjects With Atrial Fibrillation in the United States, 1999 to 2020. Journal of the American Heart Association Zuin, M., Bertini, M., Vitali, F., Turakhia, M., Boriani, G. 2024: e033897

  Abstract

  Population-based data on heart failure (HF)-related death in patients with atrial fibrillation (AF) are lacking. We assessed HF-related death in people with AF in the United States over the past 21 years and examined differences by age, sex, race, ethnicity, urbanization, and census region.Data were extracted from the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research to determine trends in age-adjusted mortality rates per 100 000 people, due to HF-related death among subjects with AF aged ≥15 years. To calculate nationwide annual trends, we assessed the average annual percent change (AAPC) and annual percent change with relative 95% CIs using joinpoint regression. Between 1999 and 2020, 916 685 HF-related deaths (396 205 men and 520 480 women) occurred among US adults having a concomitant AF. The overall age-adjusted mortality rates increased (AAPC: +4.1% [95% CI, 3.8-4.4]; P<0.001), especially after 2011 (annual percent change, +6.8% [95% CI, 6.2-7.4]; P<0.001) in men (AAPC, +4.8% [95% CI, 4.4-5.1]; P<0.001), in White subjects (AAPC: +4.2% [95% CI, 3.9 to 4.6]; P<0.001) and in subjects aged <65 years (AAPC: +7.5% [95% CI, 6.7-8.4]; P<0.001). The higher percentage of deaths were registered in the South (32.8%). During the first year of the COVID-19 pandemic, a significant excess in HF-related deaths among patients with AF aged >65 years was observed.A worrying increase in the HF-related mortality rate among patients with AF has been observed in the United States over the past 2 decades.

  View details for DOI 10.1161/JAHA.123.033897

  View details for PubMedID 38686875

• Wearable Digital Health Technologies for Monitoring in Cardiovascular Medicine. The New England journal of medicine Spatz, E. S., Ginsburg, G. S., Rumsfeld, J. S., Turakhia, M. P. 2024; 390 (4): 346-356

  View details for DOI 10.1056/NEJMra2301903

  View details for PubMedID 38265646

• Design and Implementation of an Electronic Health Record-Integrated Hypertension Management Application. Journal of the American Heart Association Funes Hernandez, M., Babakhanian, M., Chen, T. P., Sarraju, A., Seninger, C., Ravi, V., Azizi, Z., Tooley, J., Chang, T. I., Lu, Y., Downing, N. L., Rodriguez, F., Li, R. C., Sandhu, A. T., Turakhia, M., Bhalla, V., Wang, P. J. 2024; 13 (2): e030884

  Abstract

  High blood pressure affects approximately 116 million adults in the United States. It is the leading risk factor for death and disability across the world. Unfortunately, over the past decade, hypertension control rates have decreased across the United States. Prediction models and clinical studies have shown that reducing clinician inertia alone is sufficient to reach the target of ≥80% blood pressure control. Digital health tools containing evidence-based algorithms that are able to reduce clinician inertia are a good fit for turning the tide in blood pressure control, but careful consideration should be taken in the design process to integrate digital health interventions into the clinical workflow.We describe the development of a provider-facing hypertension management platform. We enumerate key steps of the development process, including needs finding, clinical workflow analysis, treatment algorithm creation, platform design and electronic health record integration. We interviewed and surveyed 5 Stanford clinicians from primary care, cardiology, and their clinical care team members (including nurses, advanced practice providers, medical assistants) to identify needs and break down the steps of clinician workflow analysis. The application design and development stage were aided by a team of approximately 15 specialists in the fields of primary care, hypertension, bioinformatics, and software development.Digital monitoring holds immense potential for revolutionizing chronic disease management. Our team developed a hypertension management platform at an academic medical center to address some of the top barriers to adoption and achieving clinical outcomes. The frameworks and processes described in this article may be used for the development of a diverse range of digital health tools in the cardiovascular space.

  View details for DOI 10.1161/JAHA.123.030884

  View details for PubMedID 38226516

• Prediction of atrial fibrillation from at-home single-lead ECG signals without arrhythmias. NPJ digital medicine Gadaleta, M., Harrington, P., Barnhill, E., Hytopoulos, E., Turakhia, M. P., Steinhubl, S. R., Quer, G. 2023; 6 (1): 229

  Abstract

  Early identification of atrial fibrillation (AF) can reduce the risk of stroke, heart failure, and other serious cardiovascular outcomes. However, paroxysmal AF may not be detected even after a two-week continuous monitoring period. We developed a model to quantify the risk of near-term AF in a two-week period, based on AF-free ECG intervals of up to 24 h from 459,889 patch-based ambulatory single-lead ECG (modified lead II) recordings of up to 14 days. A deep learning model was used to integrate ECG morphology data with demographic and heart rhythm features toward AF prediction. Observing a 1-day AF-free ECG recording, the model with deep learning features produced the most accurate prediction of near-term AF with an area under the curve AUC = 0.80 (95% confidence interval, CI = 0.79-0.81), significantly improving discrimination compared to demographic metrics alone (AUC 0.67; CI = 0.66-0.68). Our model was able to predict incident AF over a two-week time frame with high discrimination, based on AF-free single-lead ECG recordings of various lengths. Application of the model may enable a digital strategy for improving diagnostic capture of AF by risk stratifying individuals with AF-negative ambulatory monitoring for prolonged or recurrent monitoring, potentially leading to more rapid initiation of treatment.

  View details for DOI 10.1038/s41746-023-00966-w

  View details for PubMedID 38087028

  View details for PubMedCentralID 5896911

• Phased target trial design and meta-analysis in a head-to-head treatment comparison Singh, J. P., Wieloch, M., Reynolds, S. L., Blomstrom-Lundqvist, C., Sandhu, A. T., Camm, A., Kabadi, S. M., Pundi, K., Turakhia, M., Boiron, R., Coudert, M., Din, N., Fan, J., Heller, C. G., Leeming, R. C., McKindley, D., Sajedian, R. M., Kowey, P. R. WILEY. 2023: 444

  View details for Web of Science ID 001091511702108

• Validation of a Deep Learning Algorithm for Continuous, Real-Time Detection of Atrial Fibrillation Using a Wrist-Worn Device in an Ambulatory Environment. Journal of the American Heart Association Poh, M. Z., Battisti, A. J., Cheng, L. F., Lin, J., Patwardhan, A., Venkataraman, G. S., Athill, C. A., Patel, N. S., Patel, C. P., Machado, C. E., Ellis, J. T., Crosson, L. A., Tamura, Y., Plowman, R. S., Turakhia, M. P., Ghanbari, H. 2023: e030543

  Abstract

  Background Wearable devices may be useful for identification, quantification and characterization, and management of atrial fibrillation (AF). To date, consumer wrist-worn devices for AF detection using photoplethysmography-based algorithms perform only periodic checks when the user is stationary and are US Food and Drug Administration cleared for prediagnostic uses without intended use for clinical decision-making. There is an unmet need for medical-grade diagnostic wrist-worn devices that provide long-term, continuous AF monitoring. Methods and Results We evaluated the performance of a wrist-worn device with lead-I ECG and continuous photoplethysmography (Verily Study Watch) and photoplethysmography-based convolutional neural network for AF detection and burden estimation in a prospective multicenter study that enrolled 117 patients with paroxysmal AF. A 14-day continuous ECG monitor (Zio XT) served as the reference device to evaluate algorithm sensitivity and specificity for detection of AF in 15-minute intervals. A total of 91 857 intervals were contributed by 111 subjects with evaluable reference and test data (18.3 h/d median watch wear time). The watch was 96.1% sensitive (95% CI, 92.7%-98.0%) and 98.1% specific (95% CI, 97.2%-99.1%) for interval-level AF detection. Photoplethysmography-derived AF burden estimation was highly correlated with the reference device burden (R2=0.986) with a mean difference of 0.8% (95% limits of agreement, -6.6% to 8.2%). Conclusions Continuous monitoring using a photoplethysmography-based convolutional neural network incorporated in a wrist-worn device has clinical-grade performance for AF detection and burden estimation. These findings suggest that monitoring can be performed with wrist-worn wearables for diagnosis and clinical management of AF. Registration Information URL: https://www.clinicaltrials.gov; Unique identifier: NCT04546763.

  View details for DOI 10.1161/JAHA.123.030543

  View details for PubMedID 37750558

• ACC/AHA Hypertension Guidelines and CHA2DS2-VASc Up-Scoring in Patients With Atrial Fibrillation. JAMA network open Pundi, K., Gosch, K. L., Perino, A. C., Jones, P. G., Desai, N. R., Maddox, T. M., Turakhia, M. 2023; 6 (9): e2335722

  View details for DOI 10.1001/jamanetworkopen.2023.35722

  View details for PubMedID 37751209

• The Epidemic and Data-Free Zone of Nonsustained Ventricular Tachycardia: An Unintended Consequence of Digital Monitoring and a Path Forward. Circulation Pundi, K., Marcus, G. M., Turakhia, M. 2023; 148 (10): 805-807

  View details for DOI 10.1161/CIRCULATIONAHA.123.066049

  View details for PubMedID 37669356

• The evolving role of data & amp; safety monitoring boards for real-world clinical trials JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE Bunning, B. J., Hedlin, H., Chen, J. H., Ciolino, J. D., Ferstad, J., Fox, E., Garcia, A., Go, A., Johari, R., Lee, J., Maahs, D. M., Mahaffey, K. W., Opsahl-Ong, K., Perez, M., Rochford, K., Scheinker, D., Spratt, H., Turakhia, M. P., Desai, M. 2023; 7 (1)

  View details for DOI 10.1017/cts.2023.582

  View details for Web of Science ID 001054146900001

• The evolving role of data & safety monitoring boards for real-world clinical trials. Journal of clinical and translational science Bunning, B. J., Hedlin, H., Chen, J. H., Ciolino, J. D., Ferstad, J. O., Fox, E., Garcia, A., Go, A., Johari, R., Lee, J., Maahs, D. M., Mahaffey, K. W., Opsahl-Ong, K., Perez, M., Rochford, K., Scheinker, D., Spratt, H., Turakhia, M. P., Desai, M. 2023; 7 (1): e179

  Abstract

  Clinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor.Three examples of real-world trials that leverage different types of data sources - wearables, medical devices, and electronic health records are described. Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived.Insight and recommendations are given on four topic areas: A. Charge of the DSMB; B. Composition of the DSMB; C. Pre-launch Activities; and D. Post-launch Activities. We recommend stronger and additional focus on data integrity.Clinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. The data, however, present a level of informatic complexity that relies heavily on a robust data science infrastructure. The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials.

  View details for DOI 10.1017/cts.2023.582

  View details for PubMedID 37745930

  View details for PubMedCentralID PMC10514684

• Dronedarone Versus Sotalol in Antiarrhythmic Drug-Naive Veterans With Atrial Fibrillation. Circulation. Arrhythmia and electrophysiology Pundi, K., Fan, J., Kabadi, S., Din, N., Blomström-Lundqvist, C., John Camm, A., Kowey, P., Singh, J. P., Rashkin, J., Wieloch, M., Turakhia, M. P., Sandhu, A. T. 2023: e011893

  Abstract

  Sotalol and dronedarone are both used for maintenance of sinus rhythm for patients with atrial fibrillation. However, while sotalol requires initial monitoring for QT prolongation and proarrhythmia, dronedarone does not. These treatments can be used in comparable patients, but their safety and effectiveness have not been compared head to head. Therefore, we retrospectively evaluated the effectiveness and safety using data from a large health care system.Using Veterans Health Administration data, we identified 11 296 antiarrhythmic drug-naive patients with atrial fibrillation prescribed dronedarone or sotalol in 2012 or later. We excluded patients with prior conduction disease, pacemakers or implantable cardioverter-defibrillators, ventricular arrhythmia, cancer, renal failure, liver disease, or heart failure. We used natural language processing to identify and compare baseline left ventricular ejection fraction between treatment arms. We used 1:1 propensity score matching, based on patient demographics, comorbidities, and medications, and Cox regression to compare strategies. To evaluate residual confounding, we performed falsification analysis with nonplausible outcomes.The matched cohort comprised 6212 patients (3106 dronedarone and 3106 sotalol; mean [±SD] age, 71±10 years; 2.5% female; mean [±SD] CHA2DS2-VASC, 2±1.3). The mean (±SD) left ventricular ejection fraction was 55±11 and 58±10 for dronedarone and sotalol users, correspondingly. Dronedarone, compared with sotalol, did not demonstrate a significant association with risk of cardiovascular hospitalization (hazard ratio, 1.03 [95% CI, 0.88-1.21]) or all-cause mortality (hazard ratio, 0.89 [95% CI, 0.68-1.16]). However, dronedarone was associated with significantly lower risk of ventricular proarrhythmic events (hazard ratio, 0.53 [95% CI, 0.38-0.74]) and symptomatic bradycardia (hazard ratio, 0.56 [95% CI, 0.37-0.87]). The primary findings were stable across sensitivity analyses. Falsification analyses were not significant.Dronedarone, compared with sotalol, was associated with a lower risk of ventricular proarrhythmic events and conduction disorders while having no difference in risk of incident cardiovascular hospitalization and mortality. These observational data provide the basis for prospective efficacy and safety trials.

  View details for DOI 10.1161/CIRCEP.123.011893

  View details for PubMedID 37485722

• Myocardial Infarction Across COVID-19 Pandemic Phases: Insights From the Veterans Health Affairs System. Journal of the American Heart Association Yong, C. M., Graham, L., Beyene, T. J., Sadri, S., Hong, J., Burdon, T., Fearon, W. F., Asch, S. M., Turakhia, M., Heidenreich, P. 2023: e029910

  Abstract

  Background Cardiovascular procedural treatments were deferred at scale during the COVID-19 pandemic, with unclear impact on patients presenting with non-ST-segment-elevation myocardial infarction (NSTEMI). Methods and Results In a retrospective cohort study of all patients diagnosed with NSTEMI in the US Veterans Affairs Healthcare System from January 1, 2019 to October 30, 2022 (n=67 125), procedural treatments and outcomes were compared between the prepandemic period and 6 unique pandemic phases: (1) acute phase, (2) community spread, (3) first peak, (4) post vaccine, (5) second peak, and (6) recovery. Multivariable regression analysis was performed to assess the association between pandemic phases and 30-day mortality. NSTEMI volumes dropped significantly with the pandemic onset (62.7% of prepandemic peak) and did not revert to prepandemic levels in subsequent phases, even after vaccine availability. Percutaneous coronary intervention and coronary artery bypass grafting volumes declined proportionally. Compared with the prepandemic period, patients with NSTEMI experienced higher 30-day mortality during Phases 2 and 3, even after adjustment for COVID-19-positive status, demographics, baseline comorbidities, and receipt of procedural treatment (adjusted odds ratio for Phases 2 and 3 combined, 1.26 [95% CI, 1.13-1.43], P<0.01). Patients receiving Veterans Affairs-paid community care had a higher adjusted risk of 30-day mortality compared with those at Veterans Affairs hospitals across all 6 pandemic phases. Conclusions Higher mortality after NSTEMI occurred during the initial spread and first peak of the pandemic but resolved before the second, higher peak-suggesting effective adaptation of care delivery but a costly delay to implementation. Investigation into the vulnerabilities of the early pandemic spread are vital to informing future resource-constrained practices.

  View details for DOI 10.1161/JAHA.123.029910

  View details for PubMedID 37421288

• Dronedarone versus sotalol in patients with atrial fibrillation: A systematic literature review and network meta-analysis. Clinical cardiology Singh, J. P., Blomstrom-Lundqvist, C., Turakhia, M. P., Camm, A. J., Fazeli, M. S., Kreidieh, B., Crotty, C., Kowey, P. R. 2023

  Abstract

  BACKGROUND: There are limited comparative data on safety and efficacy within commonly used Vaughan-Williams (VW)class III antiarrhythmic drugs (AADs)for maintenance of sinus rhythm in adults with atrial fibrillation (AF).HYPOTHESIS: We hypothesized that dronedarone and sotalol, two commonly prescribed VW class III AADs with class II properties, have different safety and efficacy effects in patients with nonpermanent AF.METHODS: A systematic literature review was conducted searching MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL)up to June 15, 2021 (NCT05279833).Clinical trials and observational studies that evaluated safety and efficacy of dronedarone or sotalol in adults with AF were included. Bayesian random-effects network meta-analysis (NMA)was used to quantify comparative safety and efficacy. Where feasible, we performed sensitivity analyses by including only randomized controlled trials (RCTs).RESULTS: Of 3581 records identified through database searches, 37 unique studies (23 RCTs, 13 observational studies, and 1 nonrandomized trial) were included in the NMA. Dronedarone was associated with a statistically significantly lower risk of all-cause death versus sotalol (hazard ratio [HR]=0.38 [95% credible interval, CrI: 0.19, 0.74]). The association was numerically similar in the sensitivity analysis (HR=0.46 [95% CrI: 0.21, 1.02]). AF recurrence and cardiovascular death results were not significantly different between dronedarone and sotalol in all-studies and sensitivity analyses.CONCLUSION: The NMA findings indicate that, across all clinical trials and observational studies included, dronedarone compared with sotalol was associated with a lower risk of all-cause death, but with no difference in AF recurrence.

  View details for DOI 10.1002/clc.24011

  View details for PubMedID 37025083

• Association of CHA2DS2-VASc and HAS-BLED to Frailty and Frail Outcomes: From the TREAT-AF Study. American heart journal Pundi, K., Perino, A. C., Fan, J., Din, N., Szummer, K., Heidenreich, P., Turakhia, M. P. 2023

  Abstract

  BACKGROUND: Morbidity and mortality associated with high CHA2DS2-VASc and HAS-BLED scores is not specific to atrial fibrillation (AF). Frailty could be an important contributor to this morbidity and mortality while being mechanistically independent from AF. We sought to evaluate the association of stroke and bleeding risk to non-cardiovascular frail events and the association of stroke prevention therapy to outcomes in frail patients with atrial fibrillation.METHODS: Using the TREAT-AF (The Retrospective Evaluation and Assessment of Therapies in AF) study from the Veterans Health Administration, we identified patients with newly diagnosed AF from 2004-2014. Baseline frailty was identified using a previously validated claims-based index requiring ≥2 of 12 ICD-9 diagnoses. Logistic regressions modeled the association between CHA2DS2-VASc and modified HAS-BLED and frailty. Cox proportional hazard regressions were used to evaluate the association between CHA2DS2-VASc and modified HAS-BLED and a composite of non-cardiovascular frail events (fractures, urinary tract infections, bacterial pneumonia, or dehydration). We also evaluated the association of oral anticoagulant (OAC) use with stroke, bleeding, and 1-year mortality in frail patients and non-frail patients.RESULTS: In 213,435 patients (age 70 ± 11; 98% male; CHA2DS2-VASc 2.4±1.7) with AF, 8498 (4%) were frail. CHA2DS2-VASc > 0 and HAS-BLED > 0 were strongly associated with frailty (Odds Ratio [OR] 13.3 (95% CI: 11.6-15.2) for CHA2DS2-VASc 4+ and OR 13.4 (10.2 - 17.5) for HAS-BLED 3+). After adjusting for covariates, CHA2DS2-VASc and HAS-BLED > 0 were associated with higher risk of non-cardiovascular frail events (Hazard Ratio [HR] 2.1 (95% CI: 2.0-2.2) for CHA2DS2-VASc 4+ and HR 1.4 (95% CI: 1.3-1.5) for HAS-BLED 3+). In frail patients, OAC use was associated with significantly lower risk of 1-year mortality (HR 0.82; 95% CI 0.72 - 0.94, p = 0.0031) but did not reach significance for risk of stroke (HR 0.80; 95% CI 0.55 - 1.18, p = 0.26) or major bleeding (HR 1.08; 95% CI 0.93 - 1.25, p = 0.34).CONCLUSION: High CHA2DS2-VASc and HAS-BLED scores are strongly associated with frailty. However, in frail patients, OAC use was associated with reduction in 1-year mortality. For this challenging clinical population with competing risks of frailty and frail events, focused prospective studies are needed to support clinical decision-making. Until then, careful evaluation of frailty should inform shared decision-making.

  View details for DOI 10.1016/j.ahj.2023.03.015

  View details for PubMedID 37024025

• PREVALENCE AND PROGNOSTIC VALUE OF VENTRICULAR TACHYCARDIA ON AMBULATORY ECG MONITORING Pundi, K., Fan, J., Din, N., Sandhu, A., Heidenreich, P. A., Turakhia, M. ELSEVIER SCIENCE INC. 2023: 125

  View details for Web of Science ID 000990866100126

• Contemporary prevalence estimates of undiagnosed and diagnosed atrial fibrillation in the United States. Clinical cardiology Turakhia, M. P., Guo, J. D., Keshishian, A., Delinger, R., Sun, X., Ferri, M., Russ, C., Cato, M., Yuce, H., Hlavacek, P. 2023

  Abstract

  Atrial fibrillation (AF) prevalence estimates vary and have been based on cohorts with clinically established or diagnosed disease. Undiagnosed AF prevalence estimates are less certain as they are based on nongeneralizable convenience samples.Because AF is often asymptomatic, it my remain undiagnosed until the development of complications such as stroke or heart failure. Consequently, the observed prevalence of diagnosed AF from the literature may underestimate total disease burden. We therefore sought to estimate the total prevalence of both diagnosed and undiagnosed AF.We performed a retrospective cohort study from 2012 to 2017 using data from five US medical claims data sets. Undiagnosed AF prevalence was estimated based on the observed incidence of ischemic stroke, systemic embolism (SE), and AF incidence after a stroke/SE. The diagnosed AF cohort included AF patients between Q1 2014 and Q3 2015. The undiagnosed AF cohort were patients with assumed undiagnosed AF in the year before a stroke/SE and who were newly diagnosed with AF in the 3-month poststroke/SE. Stroke/SE incidence was calculated among all AF patients and the ratio of number of undiagnosed AF patients to stroke rate was created. Age- and sex-adjusted estimates were stratified by period of assumed undiagnosed AF before poststroke/SE AF diagnosis (1 or 2 years).The estimated US prevalence of AF (diagnosed and undiagnosed) in Q3 2015 was 5 628 000 cases, of which 591 000 cases (11%) were undiagnosed. The assumed 2-year undiagnosed AF prevalence was 23% (1 531 000) of the total prevalent patients with AF (6 568 000). Undiagnosed (vs. diagnosed) AF patients were older and had higher CHA2DS2-VASc scores. Of undiagnosed AF, 93% had CHA2DS2-VASc ≥2 and met OAC criteria.These contemporary estimates demonstrate the high prevalence of undiagnosed AF in the United States. Undiagnosed AF patients are composed of primarily elderly individuals who if diagnosed, would meet criteria for stroke prevention therapy.

  View details for DOI 10.1002/clc.23983

  View details for PubMedID 36855960

• Research Opportunities in Stroke Prevention for Atrial Fibrillation: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop. Stroke Go, A. S., Al-Khatib, S. M., Desvigne-Nickens, P., Bansal, N., Bushnell, C. D., Fang, M. C., Freeman, J. V., Gage, B. F., Hanke, T., Hylek, E. M., Lopes, R. D., Noseworthy, P. A., Reddy, V. Y., Singer, D. E., Thomas, K. L., True Hills, M., Turakhia, M. P., Zieman, S. J., Cooper, L. S., Benjamin, E. J. 2023; 54 (3): e75-e85

  Abstract

  Atrial fibrillation (AF) is one of the strongest risk factors for ischemic stroke, which is a leading cause of disability and death. Given the aging population, increasing prevalence of AF risk factors, and improved survival in those with cardiovascular disease, the number of individuals affected by AF will continue increasing over time. While multiple proven stroke prevention therapies exist, important questions remain about the optimal approach to stroke prevention at the population and individual patient levels. Our report summarizes the National Heart, Lung, and Blood Institute virtual workshop focused on identifying key research opportunities related to stroke prevention in AF. The workshop reviewed major knowledge gaps and identified targeted research opportunities to advance stroke prevention in AF in the following areas: (1) improving risk stratification tools for stroke and intracranial hemorrhage; (2) addressing challenges with oral anticoagulants; and (3) delineating the optimal roles of percutaneous left atrial appendage occlusion and surgical left atrial appendage closure/excision. This report aims to promote innovative, impactful research that will lead to more personalized, effective use of stroke prevention strategies in people with AF.

  View details for DOI 10.1161/STROKEAHA.121.038273

  View details for PubMedID 36848427

• Associations of Serum and Dialysate Potassium Concentrations With Incident Atrial Fibrillation in a Cohort Study of Older US Persons Initiating Hemodialysis for Kidney Failure. Kidney international reports Hu, A., Liu, S., Montez-Rath, M. E., Khairallah, P., Niu, J., Turakhia, M. P., Chang, T. I., Winkelmayer, W. C. 2023; 8 (2): 305-316

  Abstract

  Introduction: Atrial fibrillation (AF) disproportionally affects persons on maintenance hemodialysis (HD). Associations of serum and dialysate potassium concentrations [K+] with AF incidence are poorly understood.Methods: We conducted a cohort study using Medicare claims merged with clinical data from a dialysis provider to determine whether serum-[K+] and/or dialysate-[K+] independently associated with AF incidence. Persons insured by fee-for-service Medicare aged≥67 years at dialysis initiation and free from diagnosed AF prior to day 120 of dialysis were eligible. Serum-[K+] and dialysate-[K+] were assessed in 30-day intervals and patients were followed-up with for AF incidence in subsequent 30-day intervals.Results: During 2006 to 2011, 15,190 persons (mean age= 76.3 years) initiating HD had no prior AF diagnosis. Mean serum-[K+] was 4.5 mEq/l; dialysate-[K+] was 3 mEq/l in 34% and 2 mEq/l in 52% of patients. Followed-up over 21,907 person-years, 2869 persons had incident AF (incidence/100 person-years, 13.1 [95% confidence interval [CI], 12.6-13.6]). The multivariable-adjusted association of serum-[K+] with incident AF was J-shaped as follows: relative to a serum-[K+] of 4.5 mEq/l, lower serum-[K+] associated with increased AF risk, whereas confidence bands for higher serum-[K+] indicated no association. Dialysis against a dialysate-[K+] of 3 mEq/l versus 2 mEq/l independently associated with a 14% (95% CI, 5%-24%) lower incidence of AF. No effect modification between serum-[K+] and dialysate-[K+] was detected (P= 0.34).Conclusion: Lower serum-[K+] was independently associated with incident AF whereas elevated serum-[K+] was not. The findings support adoption of dialysate solutions with a dialysate-[K+] of 3 mEq/l, regardless of patients' serum-[K+], and elimination of lower dialysate-[K+] solutions from practice. Clinical trials randomizing patients to different dialysate-[K+] are warranted to establish causality.

  View details for DOI 10.1016/j.ekir.2022.11.003

  View details for PubMedID 36815107

• Does Early Detection of Atrial Fibrillation Reduce the Risk of Thromboembolic Events? Rationale and Design of the Heartline Study. American heart journal Gibson, C. M., Steinhubl, S., Lakkireddy, D., Turakhia, M. P., Passman, R., Jones, W. S., Bunch, T. J., Curtis, A. B., Peterson, E. D., Ruskin, J., Saxon, L., Tarino, M., Tarakji, K. G., Marrouche, N., Patel, M., Harxhi, A., Kaul, S., Nikolovski, J., Juan, S., Wildenhaus, K., Damaraju, C. V., Spertus, J. A., Heartline Steering Committee 2023

  Abstract

  BACKGROUND: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown.METHODS: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch Irregular Rhythm Notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naive" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary endpoint is time from randomization to clinical diagnosis of AF, with confirmation by healthcare claims. Key secondary endpoints are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, direct oral anticoagulant medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study.CONCLUSION: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04276441.

  View details for DOI 10.1016/j.ahj.2023.01.004

  View details for PubMedID 36642226

• Warfarin Time in Therapeutic INR Range and Direct Oral Anticoagulant Adherence for Venous Thromboembolism Across the Spectrum of Weight and Body Mass Index: Findings from Veterans Health Administration. Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis Din, N., Fan, J., Schmitt, S., Guo, J. D., Hlavacek, P., Pundi, K., Russ, C., Emir, B., Turakhia, M. P., Perino, A. C. 2023; 29: 10760296231152474

  Abstract

  The evidence of direct oral anticoagulants (DOACs) usage for venous thromboembolism (VTE) in patients at extremes of body weight or mass index is limited. In such situations, warfarin may be more frequently used. We investigated warfarin time in the therapeutic international normalized ratio range (TTR) and DOAC adherence based on the calculated proportion of days covered (PDC) by pill coverage from a DOAC prescription in patients with VTE across all body sizes. Using data from the Veterans Health Administration (VA), we identified first-time patients with VTE between 2013 and 2018 treated with warfarin or DOACs. We analyzed 28,245 patients with warfarin TTR (N=10,167) or DOAC PDC(N=18,078). For warfarin-treated patients after index VTE, mean TTR was lower over shorter treatment durations (TTR 30 vs TTR 180 [mean±SD]: 43.8%±33.5% vs 58.8%±23.5%). Mean TTR over 180 days after VTE was lowest for patients <60 kg (TTR 180 [mean±SD]: <60kg: 49.3%±24.2% vs ≥60 to <100 kg: 57.8%±23.4%; P<.0001). For DOAC-treated patients over 180 days after index VTE, mean PDC was lowest for patients <60 kg (PDC 180 [mean±SD]:<60kg: 76.9%±33.2% vs≥60 to <100 kg: 83.6%±27.7%; P<.0001).Most DOAC-treated patients attained sufficient adherence across the body size spectrum while warfarin-treated patients <60kg were at risk for low TTR.

  View details for DOI 10.1177/10760296231152474

  View details for PubMedID 36694957

• Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared DecisionMaking Pathway Wang, P. J., Lu, Y., Mahaffey, K. W., Lin, A., Morin, D. P., Sears, S. F., Chung, M. K., Russo, A. M., Lin, B., Piccini, J. P., Hills, M. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Shah, R., Newswanger, P., DeSutter, K., Nunes, J., Albert, M. A., Schulman, K., Heidenreich, P. A., Bunch, T. J., Sanders, L., Turakhia, M., Stafford, R. S. LIPPINCOTT WILLIAMS & WILKINS. 2022: E582-E583

  View details for Web of Science ID 000928164500042

• The development of a mobile app-focused deduplication strategy for the Apple Heart Study that informs recommendations for future digital trials. Stat (International Statistical Institute) Garcia, A., Lee, J., Balasubramanian, V., Gardner, R., Gummidipundi, S. E., Hung, G., Ferris, T., Cheung, L., Desai, S., Granger, C. B., Hills, M. T., Kowey, P., Nag, D., Rumsfeld, J. S., Russo, A. M., Stein, J. W., Talati, N., Tsay, D., Mahaffey, K. W., Perez, M. V., Turakhia, M. P., Hedlin, H., Desai, M., Apple Heart Study Investigators 2022; 11 (1): e470

  Abstract

  An app-based clinical trial enrolment process can contribute to duplicated records, carrying data management implications. Our objective was to identify duplicated records in real time in the Apple Heart Study (AHS). We leveraged personal identifiable information (PII) to develop a dissimilarity score (DS) using the Damerau-Levenshtein distance. For computational efficiency, we focused on four types of records at the highest risk of duplication. We used the receiver operating curve (ROC) and resampling methods to derive and validate a decision rule to classify duplicated records. We identified 16,398 (4%) duplicated participants, resulting in 419,297 unique participants out of a total of 438,435 possible. Our decision rule yielded a high positive predictive value (96%) with negligible impact on the trial's original findings. Our findings provide principled solutions for future digital trials. When establishing deduplication procedures for digital trials, we recommend collecting device identifiers in addition to participant identifiers; collecting and ensuring secure access to PII; conducting a pilot study to identify reasons for duplicated records; establishing an initial deduplication algorithm that can be refined; creating a data quality plan that informs refinement; and embedding the initial deduplication algorithm in the enrolment platform to ensure unique enrolment and linkage to previous records.

  View details for DOI 10.1002/sta4.470

  View details for PubMedID 36589778

• Consumer-Led Screening for Atrial Fibrillation: Frontier Review of the AF-SCREEN International Collaboration. Circulation Brandes, A., Stavrakis, S., Freedman, B., Antoniou, S., Boriani, G., Camm, A. J., Chow, C. K., Ding, E., Engdahl, J., Gibson, M. M., Golovchiner, G., Glotzer, T., Guo, Y., Healey, J. S., Hills, M. T., Johnson, L., Lip, G. Y., Lobban, T., Macfarlane, P. W., Marcus, G. M., McManus, D. D., Neubeck, L., Orchard, J., Perez, M. V., Schnabel, R. B., Smyth, B., Steinhubl, S., Turakhia, M. P. 2022; 146 (19): 1461-1474

  Abstract

  The technological evolution and widespread availability of wearables and handheld ECG devices capable of screening for atrial fibrillation (AF), and their promotion directly to consumers, has focused attention of health care professionals and patient organizations on consumer-led AF screening. In this Frontiers review, members of the AF-SCREEN International Collaboration provide a critical appraisal of this rapidly evolving field to increase awareness of the complexities and uncertainties surrounding consumer-led AF screening. Although there are numerous commercially available devices directly marketed to consumers for AF monitoring and identification of unrecognized AF, health care professional-led randomized controlled studies using multiple ECG recordings or continuous ECG monitoring to detect AF have failed to demonstrate a significant reduction in stroke. Although it remains uncertain if consumer-led AF screening reduces stroke, it could increase early diagnosis of AF and facilitate an integrated approach, including appropriate anticoagulation, rate or rhythm management, and risk factor modification to reduce complications. Companies marketing AF screening devices should report the accuracy and performance of their products in high- and low-risk populations and avoid claims about clinical outcomes unless improvement is demonstrated in randomized clinical trials. Generally, the diagnostic yield of AF screening increases with the number, duration, and temporal dispersion of screening sessions, but the prognostic importance may be less than for AF detected by single-time point screening, which is largely permanent, persistent, or high-burden paroxysmal AF. Consumer-initiated ECG recordings suggesting possible AF always require confirmation by a health care professional experienced in ECG reading, whereas suspicion of AF on the basis of photoplethysmography must be confirmed with an ECG. Consumer-led AF screening is unlikely to be cost-effective for stroke prevention in the predominantly young, early adopters of this technology. Studies in older people at higher stroke risk are required to demonstrate both effectiveness and cost-effectiveness. The direct interaction between companies and consumers creates new regulatory gaps in relation to data privacy and the registration of consumer apps and devices. Although several barriers for optimal use of consumer-led screening exist, results of large, ongoing trials, powered to detect clinical outcomes, are required before health care professionals should support widespread adoption of consumer-led AF screening.

  View details for DOI 10.1161/CIRCULATIONAHA.121.058911

  View details for PubMedID 36343103

• A Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. Journal of the American Heart Association Wang, P. J., Lu, Y., Mahaffey, K. W., Lin, A., Morin, D. P., Sears, S. F., Chung, M. K., Russo, A. M., Lin, B., Piccini, J., Hills, M. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Pourshams, I. A., Shah, R., Newswanger, P., DeSutter, K., Nunes, J. C., Albert, M. A., Schulman, K. A., Heidenreich, P. A., Bunch, T. J., Sanders, L. M., Turakhia, M., Verghese, A., Stafford, R. S. 2022: e8009

  Abstract

  Background Oral anticoagulation (OAC) reduces stroke and disability in atrial fibrillation (AF) but is underutilized. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing OAC patient's decisional conflict as compared to usual care. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF SDM Toolkit was developed using patient-centered design with clear health communication principles (e.g. meaningful images, limited text). Available in English and Spanish, the toolkit included the following: 1) a brief animated video; 2) interactive questions with answers; 3) a quiz to check on understanding; 4) a worksheet to be used by the patient during the encounter; and 5) an online guide for clinicians. The study population included English or Spanish speakers with non-valvular AF and a CHA2DS2-VASc stroke score ≥1 for men or ≥2 for women. Participants were randomized in a 1:1 ratio to either Usual Care (UC) or the SDM Toolkit. The primary endpoint was the validated 16-item Decisional Conflict Scale (DCS) at 1 month. Secondary outcomes included DCS at 6 months and the 10-item Decision Regret Scale (DRS) at 1 and 6 months as well as a weighted average of Mann-Whitney U-statistics for both DCS and DRS. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between 12/18/19 and 8/17/22. The mean patient age was 69 ±10years (40% females, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA2DS2-VASc scores ≥3 (M) or ≥4 (F). The primary endpoint at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the two arms (16.4 v 9.4; Mann-Whitney U-statistics=0.550; p-value=0.007). For the secondary endpoint of 1-month DRS, the difference in median scores between arms was 5 points in the direction of less decisional regret (p-value of 0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for DCS (p-value=0.060) and 0 points for DRS (p-value=0.35). Conclusions Implementation of a novel, Shared Decision-Making Toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared to usual care in patients with AF.

  View details for DOI 10.1161/JAHA.122.028562

  View details for PubMedID 36342828

• Association of Race and Ethnicity With Oral Anticoagulation and Associated Outcomes in Patients With Atrial Fibrillation: Findings From the Get With The Guidelines-Atrial Fibrillation Registry. JAMA cardiology Essien, U. R., Chiswell, K., Kaltenbach, L. A., Wang, T. Y., Fonarow, G. C., Thomas, K. L., Turakhia, M. P., Benjamin, E. J., Rodriguez, F., Fang, M. C., Magnani, J. W., Yancy, C. W., Piccini, J. P. 2022

  Abstract

  Oral anticoagulation (OAC) is underprescribed in underrepresented racial and ethnic group individuals with atrial fibrillation (AF). Little is known of how differential OAC prescribing relates to inequities in AF outcomes.To compare OAC use at discharge and AF-related outcomes by race and ethnicity in the Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB) registry.This retrospective cohort analysis used data from the GWTG-AFIB registry, a national quality improvement initiative for hospitalized patients with AF. All registry patients hospitalized with AF from 2014 to 2020 were included in the study. Data were analyzed from November 2021 to July 2022.Self-reported race and ethnicity assessed in GWTG-AFIB registry.The primary outcome was prescription of direct-acting OAC (DOAC) or warfarin at discharge. Secondary outcomes included cumulative 1-year incidence of ischemic stroke, major bleeding, and mortality postdischarge. Outcomes adjusted for patient demographic, clinical, and socioeconomic characteristics as well as hospital factors.Among 69 553 patients hospitalized with AF from 159 sites between 2014 and 2020, 863 (1.2%) were Asian, 5062 (7.3%) were Black, 4058 (5.8%) were Hispanic, and 59 570 (85.6%) were White. Overall, 34 113 (49.1%) were women; the median (IQR) age was 72 (63-80) years, and the median (IQR) CHA2DS2-VASc score (calculated as congestive heart failure, hypertension, age 75 years and older, diabetes, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, and sex category) was 4 (2-5). At discharge, 56 385 patients (81.1%) were prescribed OAC therapy, including 41 760 (74.1%) receiving DOAC. OAC prescription at discharge was lowest in Hispanic patients (3010 [74.2%]), followed by Black patients (3935 [77.7%]) Asian patients (691 [80.1%]), and White patients (48 749 [81.8%]). Black patients were less likely than White patients to be discharged while taking any anticoagulant (adjusted odds ratio, 0.75; 95% CI, 0.68-0.84) and DOACs (adjusted odds ratio, 0.73; 95% CI, 0.65-0.82). In 16 307 individuals with 1-year follow up data, bleeding risks (adjusted hazard ratio [aHR], 2.08; 95% CI, 1.53-2.83), stroke risks (aHR, 2.07; 95% CI, 1.34-3.20), and mortality risks (aHR, 1.22; 95% CI, 1.02-1.47) were higher in Black patients than White patients. Hispanic patients had higher stroke risk (aHR, 2.02; 95% CI, 1.38-2.95) than White patients.In a national registry of hospitalized patients with AF, compared with White patients, Black patients were less likely to be discharged while taking anticoagulant therapy and DOACs in particular. Black and Hispanic patients had higher risk of stroke compared with White patients; Black patients had a higher risk of bleeding and mortality. There is an urgent need for interventions to achieve pharmacoequity in guideline-directed AF management to improve overall outcomes.

  View details for DOI 10.1001/jamacardio.2022.3704

  View details for PubMedID 36287545

• Dronedarone versus sotalol in patients with atrial fibrillation: a systematic literature review and network meta-analysis Kreidieh, B., Singh, J. P., Blomstrom-Lundqvist, C., Turakhia, M. P., Camm, A. J., Fazeli, M. S., Crotty, C., Kowey, P. R. OXFORD UNIV PRESS. 2022: 574

  View details for Web of Science ID 000894947902673

• Machine learned clusters explain heterogeneity in outcomes from map-guided ablation of Atrial Fibrillation results from the large PROspective STanford AF Registry (ProSTAR) Deb, B., Rogers, A. J., Bhatia, N. K., Baykaner, T., Turakhia, M., Clopton, P. L., Chang, H. J., Brodt, C., Narayan, S. M., Wang, P. J., Viswanathan, M. N. OXFORD UNIV PRESS. 2022: 474

  View details for Web of Science ID 000894947902573

• Medical therapy for patients with recent-onset heart failure with reduced ejection fraction during the COVID-19 pandemic: Insights from the Veteran's affairs healthcare system. American heart journal plus : cardiology research and practice Sandhu, A., Zheng, J., Tisdale, R., Kohsaka, S., Turakhia, M. P., Heidenreich, P. 2022: 100210

  Abstract

  This study aims to evaluate trends in guideline-directed medical therapy (GDMT) for patients with recent-onset heart failure with reduced ejection fraction (HFrEF) following the onset of the COVID-19 pandemic using an interrupted time series analysis in the Veteran's Affairs Healthcare System. Among 71,428 patients with recent-onset HFrEF between 1/1/2018 and 2/28/2021, we found the pandemic was not associated with differences in treatment rates for beta-blockers, renin-angiotensin-aldosterone system inhibitors, or mineralocorticoid receptor antagonists; there was a 2.6 % absolute decrease (95 % CI: 0.5 %-4.7 %) in ARNI rates in April 2020; which decreased over the pandemic. Despite the changes to healthcare delivery, the COVID-19 pandemic was associated with minimal changes in GDMT rates among patients with recent-onset HFrEF.

  View details for DOI 10.1016/j.ahjo.2022.100210

  View details for PubMedID 36156887

• Atrial fibrillation bleeding risk and prediction while treated with direct oral anticoagulants in warfarin-naive or warfarin-experienced patients. Clinical cardiology Perino, A. C., Fan, J., Pundi, K., Schmitt, S., Kothari, M., Din, N., Heidenreich, P. A., Turakhia, M. P. 2022

  Abstract

  BACKGROUND: In patients with atrial fibrillation (AF) treated with direct oral anticoagulants (DOAC), bleeding risk scores provide only modest discrimination for major or intracranial bleeding. However, warfarin experience may impact HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (>65 years), Drugs/alcohol concomitantly) score performance in patients evaluated for DOACs, as HAS-BLED was derived and validated in warfarin cohorts.METHODS: We performed a retrospective cohort study of patients prescribed DOAC for AF in the Veterans Health Administration between 2010 and 2017. We determined modified HAS-BLED score discrimination and calibration for bleeding, for patients treated with DOAC, stratified by prior warfarin exposure. We also determined the association betweenDOAC-warfarin-naive status to bleeding (nonintracranial and intracranial) with DOAC-warfarin-experienced patients as reference.RESULTS: The DOAC analysis cohort included 100,492 patients with AF (age [mean±SD]: 72.9±9.6 years; 1.7% female; 90.1% White), of which 26,760 patients (26.6%) and 73,732 patients (73.4%) were warfarin experienced or naive, respectively. HAS-BLED discrimination for bleeds was modest for patients treated with DOAC, regardless of prior warfarin experience (concordancestatistics: 0.53-0.59). For DOAC-warfarin-naive patients, as compared to DOAC-warfarin-experienced patients, adjusted risk of intracranial bleeding was lower, while risk of nonintracranial bleeding was higher (intracranial bleeding propensity adjusted with inverse probability of treatment weights [IPTWs]: hazard ratio [HR]: 0.86, 95% confidence interval [CI]: 0.78-0.95, p=.0040) (nonintracranial bleeding propensity adjusted with IPTW: HR: 1.15, 95% CI: 1.11-1.19, p<.0001).CONCLUSION: Patients' modified HAS-BLED score at the time of DOAC initiation, regardless of prior warfarin use, provided only modest discrimination for intracranial and nonintracranial bleeds. These data argue against maintaining DOAC eligible patients on warfarin therapy regardless of modified HAS-BLED score.

  View details for DOI 10.1002/clc.23887

  View details for PubMedID 35946047

• Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP). NPJ digital medicine Sarraju, A., Seninger, C., Parameswaran, V., Petlura, C., Bazouzi, T., Josan, K., Grewal, U., Viethen, T., Mundl, H., Luithle, J., Basobas, L., Touros, A., Senior, M. J., De Lombaert, K., Mahaffey, K. W., Turakhia, M. P., Dash, R. 2022; 5 (1): 80

  Abstract

  The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

  View details for DOI 10.1038/s41746-022-00622-9

  View details for PubMedID 35764796

• Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. Journal of biopharmaceutical statistics Garcia, A., Balasubramanian, V., Lee, J., Gardner, R., Gummidipundi, S., Hung, G., Ferris, T., Cheung, L., Granger, C., Kowey, P., Rumsfeld, J., Russo, A., Hills, M. T., Talati, N., Nag, D., Stein, J., Tsay, D., Desai, S., Mahaffey, K., Turakhia, M., Perez, M., Hedlin, H., Desai, M. 2022: 1-15

  Abstract

  The digital clinical trial is fast emerging as a pragmatic trial that can improve a trial's design including recruitment and retention, data collection and analytics. To that end, digital platforms such as electronic health records or wearable technologies that enable passive data collection can be leveraged, alleviating burden from the participant and study coordinator. However, there are challenges. For example, many of these data sources not originally intended for research may be noisier than traditionally obtained measures. Further, the secure flow of passively collected data and their integration for analysis is non-trivial. The Apple Heart Study was a prospective, single-arm, site-less digital trial designed to evaluate the ability of an app to detect atrial fibrillation. The study was designed with pragmatic features, such as an app for enrollment, a wearable device (the Apple Watch) for data collection, and electronic surveys for participant-reported outcomes that enabled a high volume of patient enrollment and accompanying data. These elements led to challenges including identifying the number of unique participants, maintaining participant-level linkage of multiple complex data streams, and participant adherence and engagement. Novel solutions were derived that inform future designs with an emphasis on data management. We build upon the excellent framework of the Clinical Trials Transformation Initiative to provide a comprehensive set of guidelines for data management of the digital clinical trial that include an increased role of collaborative data scientists in the design and conduct of the modern digital trial.

  View details for DOI 10.1080/10543406.2022.2080698

  View details for PubMedID 35695137

• Wearables, telemedicine, and artificial intelligence in arrhythmias and heart failure: Proceedings of the European Society of Cardiology: Cardiovascular Round Table. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Leclercq, C., Witt, H., Hindricks, G., Katra, R. P., Albert, D., Belliger, A., Cowie, M. R., Deneke, T., Friedman, P., Haschemi, M., Lobban, T., Lordereau, I., McConnell, M. V., Rapallini, L., Samset, E., Turakhia, M. P., Singh, J. P., Svennberg, E., Wadhwa, M., Weidinger, F. 2022

  Abstract

  Digital technology is now an integral part of medicine. Tools for detecting, screening, diagnosis, and monitoring health-related parameters have improved patient care and enabled individuals to identify issues leading to better management of their own health. Wearable technologies have integrated sensors and can measure physical activity, heart rate and rhythm, and glucose and electrolytes. For individuals at risk, wearables or other devices may be useful for early detection of atrial fibrillation or sub-clinical states of cardiovascular disease, disease management of cardiovascular diseases such as hypertension and heart failure, and lifestyle modification. Health data are available from a multitude of sources, namely clinical, laboratory and imaging data, genetic profiles, wearables, implantable devices, patient-generated measurements, and social and environmental data. Artificial intelligence is needed to efficiently extract value from this constantly increasing volume and variety of data and to help in its interpretation. Indeed, it is not the acquisition of digital information, but rather the smart handling and analysis that is challenging. There are multiple stakeholder groups involved in the development and effective implementation of digital tools. While the needs of these groups may vary, they also have many commonalities, including the following: a desire for data privacy and security; the need for understandable, trustworthy, and transparent systems; standardized processes for regulatory and reimbursement assessments; and better ways of rapidly assessing value.

  View details for DOI 10.1093/europace/euac052

  View details for PubMedID 35640917

• The Increasing Role of Rhythm Control in Patients With Atrial Fibrillation: JACC State-of-the-Art Review. Journal of the American College of Cardiology Camm, A. J., Naccarelli, G. V., Mittal, S., Crijns, H. J., Hohnloser, S. H., Ma, C., Natale, A., Turakhia, M. P., Kirchhof, P. 2022; 79 (19): 1932-1948

  Abstract

  The considerable mortality and morbidity associated with atrial fibrillation (AF) pose a substantial burden on patients and health care services. Although the management of AF historically focused on decreasing AF recurrence, it evolved over time in favor of rate control. Recently, more emphasis has been placed on reducing adverse cardiovascular outcomes using rhythm control, generally by using safe and effective rhythm-control therapies (typically antiarrhythmic drugs and/or AF ablation). Evidence increasingly supports early rhythm control in patients with AF that has not become long-standing, but current clinical practice and guidelines do not yet fully reflect this change. Early rhythm control may effectively reduce irreversible atrial remodeling and prevent AF-related deaths, heart failure, and strokes in high-risk patients. It has the potential to halt progression and potentially save patients from years of symptomatic AF; therefore, it should be offered more widely.

  View details for DOI 10.1016/j.jacc.2022.03.337

  View details for PubMedID 35550691

• THE 2017 ACC/AHA HYPERTENSION GUIDELINES AND CHA2DS2-VASC UP-SCORING IN PATIENTS WITH ATRIAL FIBRILLATION: INSIGHTS FROM THE NCDR (R) PINNACLE (R) REGISTRY Pundi, K., Gosch, K., Din, N., Perino, A., Jones, P. G., Desai, N. R., Maddox, T. M., Turakhia, M. ELSEVIER SCIENCE INC. 2022: 12

  View details for Web of Science ID 000781026600013

• The Gig Economy Worker-A New Social Determinant of Health? JAMA cardiology Rodriguez, F., Sarraju, A., Turakhia, M. P. 1800

  View details for DOI 10.1001/jamacardio.2021.5435

  View details for PubMedID 34985492

• Achievement and Quality Measure Attainment in Patients Hospitalized with Atrial Fibrillation: Results from the Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry. American heart journal Ullal, A. J., Holmes, D. N., Lytle, B. L., Matsouaka, R. A., Sheng, S., Desai, N. R., Curtis, A. B., Fang, M. C., McCabe, P. J., Fonarow, G. C., Russo, A. M., Lewis, W. R., Heidenreich, P. A., Piccini, J. P., Turakhia, M. P., Perino, A. C., On Behalf Of The Gwtg-Afib Working Group 1800

  Abstract

  BACKGROUND: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry.METHODS: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level.RESULTS: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible).CONCLUSION: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

  View details for DOI 10.1016/j.ahj.2021.12.002

  View details for PubMedID 34932998

• Is it time for a consumerized or home-based 12-lead electrocardiogram? Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Tooley, J. E., Turakhia, M. P. 2021

  View details for DOI 10.1093/europace/euab301

  View details for PubMedID 34894220

• Anticoagulation Treatment and Outcomes of Venous Thromboembolism by Weight and Body Mass Index: Insights From the Veterans Health Administration. Circulation. Cardiovascular quality and outcomes Perino, A. C., Fan, J., Schmitt, S., Guo, J. D., Hlavacek, P., Din, N., Kothari, M., Pundi, K., Russ, C., Emir, B., Turakhia, M. P. 2021: CIRCOUTCOMES121008005

  Abstract

  BACKGROUND: Consensus statements have recommended against the use of direct oral anticoagulants (DOACs) in venous thromboembolism (VTE) for patients ≥120 kg and ≥40 kg/m2. We sought to determine use and outcomes of DOACs for VTE across weight and body mass index (BMI).METHODS: We performed a retrospective cohort study of patients with first-time VTE 2013 to 2018 that were treated with DOAC or warfarin in the Veterans Health Administration. The Veterans Health Administration has implemented system-wide guidance for patient selection and shared decision-making for use of DOACs in VTE at extremes of weight. We stratified patients by weight and BMI and assessed (1) association of weight and BMI category to outcomes in those prescribed DOAC; and (2) association of DOAC, as compared to warfarin, to outcomes by weight and BMI categories. Outcomes of interest included major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE.RESULTS: The analysis cohort included 51 871 patients prescribed DOAC or warfarin within 30 days of index VTE diagnosis (age 64.5±13.1 years; 6.0% female; median weight 93.4 kg [25th-75th: 80.5-108.6 kg]). For patients ≥120 kg (N=6934 patients), 38.4% were treated with DOAC, as compared to 45.4% of those ≥60 to <100 kg (N=30 645; P<0.0001). DOAC prescription was not associated with major bleeds, clinically relevant nonmajor bleeds, or recurrent VTE for those in higher weight and BMI categories as compared to those in average weight and BMI categories. DOAC prescription, as compared to warfarin, was not associated with increased recurrent VTE in any weight or BMI category.CONCLUSIONS: Patients ≥120 kg and ≥40 kg/m2 with VTE are frequently prescribed DOAC by the Veterans Health Administration, without an increase in bleeding or recurrent VTE. These findings suggest DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.

  View details for DOI 10.1161/CIRCOUTCOMES.121.008005

  View details for PubMedID 34724801

• Performance of first pacemaker to use smart device app for remote monitoring. Heart rhythm O2 Tarakji, K. G., Zaidi, A. M., Zweibel, S. L., Varma, N., Sears, S. F., Allred, J., Roberts, P. R., Shaik, N. A., Silverstein, J. R., Maher, A., Mittal, S., Patwala, A., Schoenhard, J., Emert, M., Molon, G., Augello, G., Patel, N., Seide, H., Porfilio, A., Maus, B., Di Jorio, S. L., Holloman, K., Natera, A. C., Turakhia, M. P. 2021; 2 (5): 463-471

  Abstract

  Background: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console.Objective: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods.Methods: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless).Results: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber).Conclusion: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM.

  View details for DOI 10.1016/j.hroo.2021.07.008

  View details for PubMedID 34667961

• Utility of device-derived daily activity, a novel digital biomarker, to predict ventricular arrhythmias data from the CERTITUDE registry Kutyifa, V., Rosero, S., Harrel, C., Singh, J., Hicks, J., Chinitz, L., Varma, N., Piccini, J., Turakhia, M. OXFORD UNIV PRESS. 2021: 3073

  View details for Web of Science ID 000720456903374

• Validation of a pandemic-proof, decentralized cardiovascular trial: scalable design produces rapid recruitment, high engagement and protocol adherence in DeTAP (Decentralized Trial in Afib Patients) Josan, K., Touros, A., Petlura, C., Parameswaran, V., Grewal, U., Senior, M., Viethen, T., Mundl, H., Seninger, C., Luithle, J., Mahaffey, K., Turakhia, M., Dash, R. OXFORD UNIV PRESS. 2021: 3177

  View details for Web of Science ID 000720456903478

• It's Time to Rethink (and Retrial) Our Framework for Stroke Prevention in Atrial Fibrillation. JAMA cardiology Turakhia, M. P. 2021

  View details for DOI 10.1001/jamacardio.2021.3709

  View details for PubMedID 34586361

• Feasibility Of An Asynchronous, Semi-Automated Remote Patient Monitoring Blood Pressure Management System Sarraju, A., Babakhanian, M., Szeto, I., Seninger, C., Chang, T., Bhalla, V., Downing, L., Rodriguez, F., Turakhia, M., Wang, P. J. LIPPINCOTT WILLIAMS & WILKINS. 2021

  View details for DOI 10.1161/hyp.78.suppl_1.P120

  View details for Web of Science ID 000714476600150

• Outpatient Prescription Practices in Patients with Atrial Fibrillation (From the NCDR PINNACLE Registry). The American journal of cardiology Hsu, J. C., Reynolds, M. R., Song, Y., Doros, G., Lubitz, S. A., Gehi, A. K., Turakhia, M. P., Maddox, T. M. 2021

  Abstract

  This study sought to evaluate inappropriate prescribing practices in an atrial fibrillation (AF) population, as outlined by the 2016 ACC/AHA Clinical Performance and Quality Measures for Adults with Atrial Fibrillation or Atrial Flutter document. The 2016 AF quality measures document specified medications to avoid in certain AF populations, including aspirin and anticoagulant combination therapy in patients without cardiovascular disease, and non-dihydropyridine calcium channel blockers in patients with reduced ejection fraction. Using data from the NCDR PINNACLE registry, a national outpatient cardiology practice registry, we assessed rates of inappropriate prescription of two types of medications among AF outpatients from 5/1/2008-5/1/2016. Overall rates of inappropriate prescription and variation by practice were calculated. Patient and practice factors associated with inappropriate prescription were assessed in adjusted analyses. A total of 107,759 of 658,250 (16.4%) patients without cardiovascular disease were inappropriately prescribed an antiplatelet and anticoagulant together, and 5,731 of 150,079 (3.8%) patients with reduced ejection fraction were inappropriately prescribed a non-dihydropyridine calcium channel blocker. Overall, 14.8% of AF patients were prescribed medications that were not recommended. Both patient and practice factors were associated with inappropriate prescribing, and the adjusted practice-level median odds ratio for inappropriate prescription was 1.70 (95% CI: 1.61-1.82), indicating a 70% likelihood that 2 random practices would treat identical AF patients differently. In a large registry of AF patients treated in cardiology practices, overall rates of inappropriate prescription practices, as defined by the 2016 AF quality measures, were relatively low, but significant practice variation was present.

  View details for DOI 10.1016/j.amjcard.2021.06.011

  View details for PubMedID 34284863

• Competing Risks, Treatment Switching, and Informative Censoring. JAMA cardiology Thomas, L. E., Turakhia, M. P., Pencina, M. J. 2021

  View details for DOI 10.1001/jamacardio.2021.1239

  View details for PubMedID 34009256

• Smart wearable devices in cardiovascular care: where we are and how to move forward. Nature reviews. Cardiology Bayoumy, K., Gaber, M., Elshafeey, A., Mhaimeed, O., Dineen, E. H., Marvel, F. A., Martin, S. S., Muse, E. D., Turakhia, M. P., Tarakji, K. G., Elshazly, M. B. 2021

  Abstract

  Technological innovations reach deeply into our daily lives and an emerging trend supports the use of commercial smart wearable devices to manage health. In the era of remote, decentralized and increasingly personalized patient care, catalysed by the COVID-19 pandemic, the cardiovascular community must familiarize itself with the wearable technologies on the market and their wide range of clinical applications. In this Review, we highlight the basic engineering principles of common wearable sensors and where they can be error-prone. We also examine the role of these devices in the remote screening and diagnosis of common cardiovascular diseases, such as arrhythmias, and in the management of patients with established cardiovascular conditions, for example, heart failure. To date, challenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice. We present several recommendations to navigate these challenges and propose a simple and practical 'ABCD' guide for clinicians, personalized to their specific practice needs, to accelerate the integration of these devices into the clinical workflow for optimal patient care.

  View details for DOI 10.1038/s41569-021-00522-7

  View details for PubMedID 33664502

• 2021 ISHNE / HRS / EHRA / APHRS Collaborative Statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology / Heart Rhythm Society / European Heart Rhythm Association / Asia Pacific Heart Rhythm Society. European heart journal. Digital health Varma, N., Cygankiewicz, I., Turakhia, M., Heidbuchel, H., Hu, Y., Chen, L. Y., Couderc, J. P., Cronin, E. M., Estep, J. D., Grieten, L., Lane, D. A., Mehra, R., Page, A., Passman, R., Piccini, J., Piotrowicz, E., Piotrowicz, R., Platonov, P. G., Ribeiro, A. L., Rich, R. E., Russo, A. M., Slotwiner, D., Steinberg, J. S., Svennberg, E. 2021; 2 (1): 7-48

  Abstract

  This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology / Heart Rhythm Society / European Heart Rhythm Association / Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.

  View details for DOI 10.1093/ehjdh/ztab001

  View details for PubMedID 36711170

  View details for PubMedCentralID PMC9708018

• 2021 ISHNE/HRS/EHRA/APHRS collaborative statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society JOURNAL OF ARRHYTHMIA Varma, N., Cygankiewicz, I., Turakhia, M., Heidbuchel, H., Hu, Y., Chen, L., Couderc, J., Cronin, E. M., Estep, J. D., Grieten, L., Lane, D. A., Mehra, R., Page, A., Passman, R., Piccini, J., Piotrowicz, E., Piotrowicz, R., Platonov, P. G., Ribeiro, A., Rich, R. E., Russo, A. M., Slotwiner, D., Steinberg, J. S., Svennberg, E. 2021

  View details for DOI 10.1002/joa3.12461

  View details for Web of Science ID 000612833600001

• Research Priorities in Atrial Fibrillation Screening: A Report From a National Heart, Lung, and Blood Institute Virtual Workshop. Circulation Benjamin, E. J., Go, A. S., Desvigne-Nickens, P., Anderson, C. D., Casadei, B., Chen, L. Y., Crijns, H. J., Freedman, B., Hills, M. T., Healey, J. S., Kamel, H., Kim, D., Link, M. S., Lopes, R. D., Lubitz, S. A., McManus, D. D., Noseworthy, P. A., Perez, M. V., Piccini, J. P., Schnabel, R. B., Singer, D. E., Tieleman, R. G., Turakhia, M. P., Van Gelder, I. C., Cooper, L. S., Al-Khatib, S. M. 2021; 143 (4): 372–88

  Abstract

  Clinically recognized atrial fibrillation (AF) is associated with higher risk of complications, including ischemic stroke, cognitive decline, heart failure, myocardial infarction, and death. It is increasingly recognized that AF frequently is undetected until complications such as stroke or heart failure occur. Hence, the public and clinicians have an intense interest in detecting AF earlier. However, the most appropriate strategies to detect undiagnosed AF (sometimes referred to as subclinical AF) and the prognostic and therapeutic implications of AF detected by screening are uncertain. Our report summarizes the National Heart, Lung, and Blood Institute's virtual workshop focused on identifying key research priorities related to AF screening. Global experts reviewed major knowledge gaps and identified critical research priorities in the following areas: (1) role of opportunistic screening; (2) AF as a risk factor, risk marker, or both; (3) relationship between AF burden detected with long-term monitoring and outcomes/treatments; (4) designs of potential randomized trials of systematic AF screening with clinically relevant outcomes; and (5) role of AF screening after ischemic stroke. Our report aims to inform and catalyze AF screening research that will advance innovative, resource-efficient, and clinically relevant studies in diverse populations to improve the diagnosis, management, and prognosis of patients with undiagnosed AF.

  View details for DOI 10.1161/CIRCULATIONAHA.120.047633

  View details for PubMedID 33493033

• Guideline-Concordant Antiarrhythmic Drug Use in the Get With The Guidelines: Atrial Fibrillation Registry. Circulation. Arrhythmia and electrophysiology Field, M. E., Holmes, D. N., Page, R. L., Fonarow, G. C., Matsouaka, R. A., Turakhia, M. P., Lewis, W. R., Piccini, J. P. 2021

  Abstract

  Background - Antiarrhythmic drug (AAD) therapy for atrial fibrillation (AF) can be associated with both proarrhythmic and noncardiovascular toxicities. Practice guidelines recommend tailored AAD therapy for AF based on patient-specific characteristics, such as coronary artery disease and heart failure, to minimize adverse events. However, current prescription patterns for specific AADs and the degree to which these guidelines are followed in practice are unknown. Methods - Patients enrolled in the Get With The Guidelines-AFIB registry with a primary diagnosis of AF discharged on an AAD between 1/2014 and 11/2018 were included. We analyzed rates of prescription of each AAD in several subgroups including those without structural heart disease. We classified AAD use as guideline-concordant or non-guideline concordant based on six criteria derived from the AHA/ACC/HRS AF Guidelines. Guideline concordance for amiodarone was not considered applicable, since its use is not specifically contraindicated in the guidelines for reasons such as structural heart disease or renal function. We analyzed guideline-concordant AAD use by specific patient and hospital characteristics, and regional and temporal trends. Results - Among 21,921 patients from 123 sites, the median age was 69 years, 46% female, and 51% had paroxysmal AF. The most commonly prescribed AAD was amiodarone (38%). Sotalol (23.2%) and dofetilide (19.2%) were each more commonly prescribed than either flecainide (9.8%) or propafenone (4.8%). Overall guideline-concordant AAD prescription at discharge was 84%. Guideline-concordant AAD use by drug was as follows: dofetilide 93%, sotalol 66%, flecainide 68%, propafenone 48%, and dronedarone 80%. There was variability in rate of guideline-concordant AAD use by hospital and geographic region. Conclusions - Amiodarone remains the most commonly prescribed AAD for AF followed by sotalol and dofetilide. Rates of guideline-concordant AAD use were high and there was significant variability by specific drugs, hospitals, and regions, highlighting opportunities for additional quality improvement.

  View details for DOI 10.1161/CIRCEP.120.008961

  View details for PubMedID 33419385

• Patterns of Care for Atrial Fibrillation Before, During, and at Discharge from Hospitalization: From the Get with The Guidelines - Atrial Fibrillation Registry. Circulation. Arrhythmia and electrophysiology Desai, N. R., Sciria, C. T., Zhao, X. n., Piccini, J. P., Turakhia, M. P., Matsouaka, R. n., Fonarow, G. C., Lewis, W. R. 2021

  Abstract

  Background - Atrial fibrillation (AF) is the most common arrhythmia encountered in the hospital. However, contemporary treatment of patients hospitalized with AF, including stroke prevention, switching between these therapies, and rhythm control interventions are not well studied. We aimed to examine trends in inpatient interventions for AF, including switching oral anticoagulation [warfarin to direct oral anticoagulants (DOACs)], cardioversion, catheter ablation, and amiodarone use in hospitalized patients with AF. Methods - Using data from the Get With The Guidelines - AFIB (GWTG-AFIB) registry from the American Heart Association (AHA), we analyzed patterns of medication and procedure use among hospitalized patients with AF from January 3, 2013 to March 28, 2017. To identify significant predictors of switching, multivariable hierarchical regression models were developed with patient baseline characteristics and comorbidities. Results - Among 31,280 patients with AF from 97 participating hospitals, 47.1% were on anticoagulation at presentation (6,695 warfarin, 7,393 DOAC) and the majority were continued at discharge (91.1%). Of those who were not receiving anticoagulation prior to hospitalization, 60.6% started anticoagulation at discharge (25.0% warfarin and 75.0% DOAC). The prevalence of switching from warfarin to DOAC was 4.0% and was more likely with younger age and lower CHA2DS2-VASc. Among 28,143 patients (excluding those discharged from the emergency department or observation status), 32.0% underwent cardioversion (56.1% chemically-assisted and 49.4% electrical), 6.4% AF ablation, and 1.0% left atrial appendage occlusion device implantation. Patients of white race, younger age, and lower CHA2DS2-VASc were significantly more likely to undergo cardioversion or AF ablation, while older patients with higher CHA2DS2-VASc were significantly more likely to be initiated on amiodarone. Conclusions - Despite guideline recommendations prioritizing DOAC therapy, there are relatively low rates of switching from warfarin to DOAC in patients hospitalized with AF. Moreover, there is substantial variation in switching and utilization of rhythm control strategies, highlighting opportunities for performance improvement.

  View details for DOI 10.1161/CIRCEP.120.009003

  View details for PubMedID 33724875

• Cardiovascular Procedural Deferral and Outcomes over COVID-19 Pandemic Phases: A Multi-Center Study. American heart journal Yong, C. M., Spinelli, K. J., Chiu, S. T., Jones, B., Penny, B., Gummidipundi, S., Beach, S., Perino, A., Turakhia, M., Heidenreich, P., Gluckman, T. J. 2021

  Abstract

  The COVID-19 pandemic has disrupted routine cardiovascular care, with unclear impact on procedural deferrals and associated outcomes across diverse patient populations.Cardiovascular procedures performed at 30 hospitals across six Western states in two large, non-profit healthcare systems (Providence St. Joseph Health and Stanford Healthcare) from December 2018-June 2020 were analyzed for changes over time. Risk-adjusted in-hospital mortality was compared across pandemic phases with multivariate logistic regression.Among 36,125 procedures (69% percutaneous coronary intervention, 13% coronary artery bypass graft surgery, 10% transcatheter aortic valve replacement, and 8% surgical aortic valve replacement), weekly volumes changed in two distinct phases after the initial inflection point on February 23, 2020: an initial period of significant deferral (COVID I: March 15 to April 11) followed by recovery (COVID II: April 12 onwards). Compared to pre-COVID, COVID I patients were less likely to be female (p=0.0003), older (p<0.0001), Asian or Black (p=0.02), or Medicare insured (p<0.0001), and COVID I procedures were higher acuity (p<0.0001), but not higher complexity. In COVID II, there was a trend towards more procedural deferral in regions with a higher COVID-19 burden (p=0.05). Compared to pre-COVID, there were no differences in risk-adjusted in-hospital mortality during both COVID phases.Significant decreases in cardiovascular procedural volumes occurred early in the COVID-19 pandemic, with disproportionate impacts by race, gender, and age. These findings should inform our approach to future healthcare disruptions.

  View details for DOI 10.1016/j.ahj.2021.06.011

  View details for PubMedID 34181910

• Direct Oral Anticoagulant Adherence of Patients With Atrial Fibrillation Transitioned from Warfarin. Journal of the American Heart Association Pundi, K. N., Perino, A. C., Fan, J., Schmitt, S., Kothari, M., Szummer, K., Askari, M., Heidenreich, P. A., Turakhia, M. P. 2021: e020904

  Abstract

  Background Reduced time in international normalized ratio therapeutic range (TTR) limits warfarin safety and effectiveness. In patients switched from warfarin to direct oral anticoagulants (DOACs), patient factors associated with low TTR could also increase risk of DOAC nonadherence. We investigated the relationship between warfarin TTR and DOAC adherence in warfarin-treated patients with atrial fibrillation switched to DOAC. Methods and Results Using data from the Veterans Health Administration, we identified patients with atrial fibrillation switched from warfarin to DOAC (switchers) or treated with warfarin alone (non-switchers). Logistic regression was used to evaluate association between warfarin TTR and DOAC adherence. We analyzed 128 605 patients (age, 71±9; 1.6% women; CHA2DS2-VASc 3.5±1.6); 32 377 switchers and 96 228 non-switchers. In 8016 switchers with international normalized ratio data to calculate 180-day TTR before switch, TTR was low (median 0.45; IQR, 0.26-0.64). Patients with TTR <0.5 were more likely to be switched to DOAC (odds ratio [OR],1.68 [95% CI,1.62-1.74], P<0.0001), as were those with TTR <0.6 or TTR <0.7. Proportion of days covered ≥0.8 was achieved by 76% of switchers at 365 days. In low-TTR individuals, proportion of days covered ≥0.8 was achieved by 70%, 72%, and 73% of switchers with TTR <0.5, 0.6, and 0.7, respectively. After multivariable adjustment, TTR <0.5 decreased odds of achieving 365-day proportion of days covered ≥0.8 (OR, 0.49; 0.43-0.57, P<0.0001), with similar relationships for TTR <0.6 and TTR <0.7. In non-switchers with TTR <0.5, long-term TTR remained low. Conclusions In patients with atrial fibrillation switched from warfarin to DOAC, most achieved adequate DOAC adherence despite low pre-switch TTRs. However, TTR trajectories remained low in non-switchers. Patients with low warfarin TTR more consistently achieved treatment targets after switching to DOACs, although adherence-oriented interventions may be beneficial.

  View details for DOI 10.1161/JAHA.121.020904

  View details for PubMedID 34779243

• Evaluation of Quality of Care for US Veterans With Recent-Onset Heart Failure With Reduced Ejection Fraction. JAMA cardiology Sandhu, A. T., Kohsaka, S., Turakhia, M. P., Lewis, E. F., Heidenreich, P. A. 2021

  Abstract

  Multiple guideline-recommended therapies for heart failure with reduced ejection fraction (HFrEF) are available and promoted by performance measures. However, contemporary data on the use of these therapies are limited.To evaluate trends in guideline-directed medical therapy, implantable cardioverter-defibrillator (ICD) use, and risk-adjusted mortality among patients with recent-onset HFrEF.This cohort study analyzed claims and electronic health record data of patients with recent-onset HFrEF diagnosed at US Department of Veterans Affairs (VA) health care system facilities from July 1, 2013, through June 30, 2019. Veterans who had a history of heart transplant or used a ventricular assist device were among the patients who were excluded.Guideline-directed medical therapy (any β-blocker, guideline-recommended β-blocker [bisoprolol, carvedilol, or metoprolol succinate], angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, angiotensin receptor-neprilysin inhibitor, mineralocorticoid receptor antagonist, and hydralazine plus nitrate) and ICD.Treatment rates for guideline-directed medical therapies and ICDs were calculated within 6 months of the index HFrEF date using medication fills, procedural codes for implantation and monitoring, and diagnosis codes. Risk-adjusted mortality was calculated after adjusting for baseline patient characteristics. For both treatment rates and risk-adjusted mortality, we evaluated the change over 3 periods (period 1: July 1, 2013, to June 30, 2015; period 2: July 1, 2015, to June 30, 2017; and period 3: July 1, 2017, to June 30, 2019) and variation across VA facilities.The final cohort comprised 144 074 eligible patients with incident HFrEF that was diagnosed between July 1, 2013, and June 30, 2019. The cohort had a mean (SD) age of 71.0 (11.4) years and was mostly composed of men (140 765 [97.7%]). Overall, changes in medical therapy rates were minimal over time, with the use of a guideline-recommended β-blocker increasing from 64.2% in 2013 to 72.0% in 2019. Rates for mineralocorticoid receptor antagonist therapy increased from 23.9% in 2013 to 26.9% in 2019, and rates for hydralazine plus nitrate therapy remained stable at 24.2% over the study period. Rates for angiotensin receptor-neprilysin inhibitor therapy increased since its introduction in 2015 but only to 22.6% in 2019. Among patients with an ICD indication, early use rates decreased over time. Substantial variation in medical therapy rates persisted across VA facilities. Risk-adjusted mortality decreased over the study period from 19.9% (95% CI, 19.6%-20.2%) in July 1, 2013, to June 30, 2015, to 18.4% (95% CI, 18.0%-18.7%) in July 1, 2017, to June 30, 2019 (OR, 0.96 per additional year; 95% CI, 0.96-0.97).This study found only marginal improvement between 2013 and 2019 in the guideline-recommended therapy and mortality rates among patients with recent-onset HFrEF. New approaches to increase the uptake of evidence-based HFrEF treatment are urgently needed and could lead to larger reductions in mortality.

  View details for DOI 10.1001/jamacardio.2021.4585

  View details for PubMedID 34757380

• Factors indicating intention to vaccinate with a COVID-19 vaccine among older U.S. adults. PloS one Nikolovski, J., Koldijk, M., Weverling, G. J., Spertus, J., Turakhia, M., Saxon, L., Gibson, M., Whang, J., Sarich, T., Zambon, R., Ezeanochie, N., Turgiss, J., Jones, R., Stoddard, J., Burton, P., Navar, A. M. 2021; 16 (5): e0251963

  Abstract

  The success of vaccination efforts to curb the COVID-19 pandemic will require broad public uptake of immunization and highlights the importance of understanding factors associated with willingness to receive a vaccine.U.S. adults aged 65 and older enrolled in the HeartlineTM clinical study were invited to complete a COVID-19 vaccine assessment through the HeartlineTM mobile application between November 6-20, 2020. Factors associated with willingness to receive a COVID-19 vaccine were evaluated using an ordered logistic regression as well as a Random Forest classification algorithm.Among 9,106 study participants, 81.3% (n = 7402) responded and had available demographic data. The majority (91.3%) reported a willingness to be vaccinated. Factors most strongly associated with vaccine willingness were beliefs about the safety and efficacy of COVID-19 vaccines and vaccines in general. Women and Black or African American respondents reported lower willingness to vaccinate. Among those less willing to get vaccinated, 66.2% said that they would talk with their health provider before making a decision. During the study, positive results from the first COVID-19 vaccine outcome study were released; vaccine willingness increased after this report.Even among older adults at high-risk for COVID-19 complications who are participating in a longitudinal clinical study, 1 in 11 reported lack of willingness to receive COVID-19 vaccine in November 2020. Variability in vaccine willingness by gender, race, education, and income suggests the potential for uneven vaccine uptake. Education by health providers directed toward assuaging concerns about vaccine safety and efficacy can help improve vaccine acceptance among those less willing.Clinicaltrials.gov NCT04276441.

  View details for DOI 10.1371/journal.pone.0251963

  View details for PubMedID 34029345

• Combining Clinical and Polygenic Risk Improves Stroke Prediction Among Individuals with Atrial Fibrillation. Circulation. Genomic and precision medicine O'Sullivan, J. W., Shcherbina, A., Justesen, J. M., Turakhia, M., Perez, M., Wand, H., Tcheandjieu, C., Clarke, S. L., Rivas, M. A., Ashley, E. A. 2021

  Abstract

  Background - Atrial fibrillation (AF) is associated with a five-fold increased risk of ischemic stroke. A portion of this risk is heritable, however current risk stratification tools (CHA2DS2-VASc) don't include family history or genetic risk. We hypothesized that we could improve ischemic stroke prediction in patients with AF by incorporating polygenic risk scores (PRS). Methods - Using data from the largest available GWAS in Europeans, we combined over half a million genetic variants to construct a PRS to predict ischemic stroke in patients with AF. We externally validated this PRS in independent data from the UK Biobank, both independently and integrated with clinical risk factors. The integrated PRS and clinical risk factors risk tool had the greatest predictive ability. Results - Compared with the currently recommended risk tool (CHA2DS2-VASc), the integrated tool significantly improved net reclassification (NRI: 2.3% (95%CI: 1.3% to 3.0%)), and fit (χ2 P =0.002). Using this improved tool, >115,000 people with AF would have improved risk classification in the US. Independently, PRS was a significant predictor of ischemic stroke in patients with AF prospectively (Hazard Ratio: 1.13 per 1 SD (95%CI: 1.06 to 1.23)). Lastly, polygenic risk scores were uncorrelated with clinical risk factors (Pearson's correlation coefficient: -0.018). Conclusions - In patients with AF, there appears to be a significant association between PRS and risk of ischemic stroke. The greatest predictive ability was found with the integration of PRS and clinical risk factors, however the prediction of stroke remains challenging.

  View details for DOI 10.1161/CIRCGEN.120.003168

  View details for PubMedID 34029116

• Association of kidney function and atrial fibrillation progression to clinical outcomes in patients with cardiac implantable electronic devices. American heart journal Szummer, K., Perino, A. C., Fan, J., Kothari, M., Turakhia, M. P. 2021

  Abstract

  Kidney function may promote progression of AF.We evaluated the association of kidney function to AF progression and resultant clinical outcomes in patients with cardiac implantable electronic devices (CIED).We performed a retrospective cohort study using national clinical data from the Veterans Health Administration linked to CIED data from the Carelink® remote monitoring data warehouse (Medtronic Inc, Mounds View, MN). All devices had atrial leads and at least 75% of remote monitoring transmission coverage. Patients were included at the date of the first AF episode lasting ≥6 minutes, and followed until the occurrence of persistent AF in the first year, defined as ≥7 consecutive days with continuous AF. We used Cox regression analyses with persistent AF as a time-varying covariate to examine the association to stroke, myocardial infarction, heart failure and death.Of, 10,323 eligible patients, 1,771 had a first CIED-detected AF (mean age 69 ± 10 years, 1.2% female). In the first year 355 (20%) developed persistent AF. Kidney function was not associated with persistent AF after multivariable adjustment including CHA2DS2-VASc variables and prior medications. Only higher age increased the risk (HR: 1.28 per 10 years; 1.07-1.52). Persistent AF was associated to higher risk of heart failure (HR: 2.27; 95% CI: 1.88-2.74) and death (HR: 1.60; 95% CI: 1.30-1.96), but not stroke (HR: 1.28; 95% CI: 0.62-2.62) or myocardial infarction (HR: 1.43; 95% CI: 0.91-2.25).Kidney function was not associated to AF progression, whereas higher age was. Preventing AF progression could reduce the risk of heart failure and death.

  View details for DOI 10.1016/j.ahj.2021.06.002

  View details for PubMedID 34118202

• Sex Differences in Ablation Strategy, Lesion Sets, and Complications of Catheter Ablation for Atrial Fibrillation: An Analysis From the GWTG-AFIB Registry. Circulation. Arrhythmia and electrophysiology Yunus, F. N., Perino, A. C., Holmes, D. N., Matsouaka, R. A., Curtis, A. B., Ellenbogen, K. A., Frankel, D. S., Knight, B. P., Russo, A. M., Lewis, W. R., Piccini, J. P., Turakhia, M. P. 2021: CIRCEP121009790

  Abstract

  When presenting for atrial fibrillation (AF) ablation, women, compared with men, tend to have more nonpulmonary vein triggers and advanced atrial disease. Whether this informs differences in AF ablation strategy is not well described. We aimed to characterize ablation strategy and complications by sex, using the Get With The Guidelines-AF registry.From the Get With The Guidelines-AF registry ablation feature, we included patients who underwent initial AF ablation procedure between January 7, 2016, and December 27, 2019. Patients were stratified based on AF type (paroxysmal versus nonparoxysmal) and sex. We compared patient demographics, ablation strategy, and complications by sex.Among 5356 patients from 31 sites who underwent AF ablation, 1969 were women (36.8%). Women, compared with men, were older (66.8±9.6 versus 63.4±10.6, P<0.0001) and were more likely to have paroxysmal AF (59.4% versus 49.5%, P<0.0001). In women with nonparoxysmal AF, left atrial linear ablation was more frequent (roof line: 53.9% versus 45.3%, P=0.0002; inferior mitral isthmus line: 10.2% versus 7.0%, P=0.01; floor line: 46.1% versus 40.6%, P=0.02) than in men. In multivariable analysis, the association between patient sex and complications from ablation was not statistically significant.In this US wide AF ablation quality improvement registry, women with nonparoxysmal AF were more likely to receive adjunctive lesion sets compared with men. These findings suggest that patient sex may inform ablation strategy in ways that may not be strongly supported by evidence and emphasize the need to clarify optimal ablation strategies by sex.

  View details for DOI 10.1161/CIRCEP.121.009790

  View details for PubMedID 34719235

• 2021 ISHNE/HRS/EHRA/APHRS Collaborative Statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society. Cardiovascular digital health journal Varma, N., Cygankiewicz, I., Turakhia, M. P., Heidbuchel, H., Hu, Y., Chen, L. Y., Couderc, J. P., Cronin, E. M., Estep, J. D., Grieten, L., Lane, D. A., Mehra, R., Page, A., Passman, R., Piccini, J. P., Piotrowicz, E., Piotrowicz, R., Platonov, P. G., Ribeiro, A. L., Rich, R. E., Russo, A. M., Slotwiner, D., Steinberg, J. S., Svennberg, E. 2021; 2 (1): 4-54

  Abstract

  This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.

  View details for DOI 10.1016/j.cvdhj.2020.11.004

  View details for PubMedID 35265889

  View details for PubMedCentralID PMC8890358

• HRS White Paper on Clinical Utilization of Digital Health Technology. Cardiovascular digital health journal Wan, E. Y., Ghanbari, H., Akoum, N., Itzhak Attia, Z., Asirvatham, S. J., Chung, E. H., Dagher, L., Al-Khatib, S. M., Stuart Mendenhall, G., McManus, D. D., Pathak, R. K., Passman, R. S., Peters, N. S., Schwartzman, D. S., Svennberg, E., Tarakji, K. G., Turakhia, M. P., Trela, A., Yarmohammadi, H., Marrouche, N. F. 2021; 2 (4): 196-211

  Abstract

  This collaborative statement from the Digital Health Committee of the Heart Rhythm Society provides everyday clinical scenarios in which wearables may be utilized by patients for cardiovascular health and arrhythmia management. We describe herein the spectrum of wearables that are commercially available for patients, and their benefits, shortcomings and areas for technological improvement. Although wearables for rhythm diagnosis and management have not been examined in large randomized clinical trials, undoubtedly the usage of wearables has quickly escalated in clinical practice. This document is the first of a planned series in which we will update information on wearables as they are revised and released to consumers.

  View details for DOI 10.1016/j.cvdhj.2021.07.001

  View details for PubMedID 35265910

  View details for PubMedCentralID PMC8890053

• Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation. Cardiovascular digital health journal Olivier, C. B., Middleton, S. K., Purington, N., Shashidhar, S., Hereford, J., Mahaffey, K. W., Turakhia, M. P. 2021; 2 (2): 101-108

  Abstract

  We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons learned.SmartGUIDE was an open-label, single-center trial that randomized participants with coronary artery disease who were prescribed a statin and/or P2Y12 inhibitor 1:1 to either usual care or the added use of a mobile app with components of cardiac rehabilitation paired with personal virtual coaching. The primary outcome was medication adherence: proportion of days covered (PDC). The planned sample size was 132. We performed a root cause analysis to evaluate processes from study development to closure.During trial conduct, the technology start-up withdrew the intervention. The study was terminated early with 63 participants randomized and data from 26 available for analysis. The median PDC was high in both groups (intervention group 94%, interquartile range [IQR] 88%-96%; control group: 99%, IQR 95%-100%). Root cause analysis identified factors for not achieving trial objectives: key factors that limited enrollment (inclusion criteria, low penetration of compatible smartphones), participant retention or engagement (poor app product, insufficient technology support), and suboptimal choice of a technology partner (technology start-up's inexperience in health care, poor product design, inadequate fundraising).We identified important and preventable factors leading to trial failure. These factors may be common across digital health trials and may explain prior observations that many such trials are never completed. Careful vetting of technology partners and more pragmatic study designs may prevent these missteps.

  View details for DOI 10.1016/j.cvdhj.2021.01.003

  View details for PubMedID 35265897

  View details for PubMedCentralID PMC8890340

• Patient Characteristics, Care Patterns, and Outcomes of Atrial Fibrillation Associated Hospitalizations in Patients with Chronic Kidney Disease and End-Stage Renal Disease. American heart journal Kumar, N., Xu, H., Garg, N., Pandey, A., Matsouaka, R. A., Field, M. E., Turakhia, M. P., Piccini, J. P., Lewis, W. R., Fonarow, G. C. 2021

  Abstract

  Chronic Kidney Disease (CKD) and end-stage renal disease (ESRD) are associated with poor outcomes in patients with cardiovascular disease. There is a paucity of contemporary data on in-hospital outcomes and care patterns of atrial fibrillation (AF) associated hospitalizations CKD and ESRD.Outcomes and care patterns were evaluated in GWTG-AFIB database (Jan 2013-Dec 2018), including in-hospital mortality, use of a rhythm control strategy, and oral anticoagulation (OAC) prescription at discharge among eligible patients. Generalized logistic regression models with generalized estimating equations were used to ascertain differences in outcomes. Hospital-level variation in OAC prescription and rhythm control was also evaluated.Among 50,154 patients from 105 hospitals the median age was 70 years (interquartile range 61-79) and 47.3% were women. The prevalence of CKD was 36.0% while that of ESRD was 1.6%. Among eligible patients, discharge OAC prescription rates were 93.6% for CKD and 89.1% for ESRD. After adjustment, CKD and ESRD were associated with higher in-hospital mortality (odds ratio [OR] 3.08, 95% confidence interval [CI] 1.57-6.03 for ESRD and OR 2.02, 95% CI 1.52-2.67 for CKD), lower odds of OAC prescription at discharge (OR 0.59, 95% CI 0.44-0.79 for ESRD and OR 0.84, 95% CI 0.75-0.94 for CKD) compared with normal renal function. CKD was associated with lower utilization of rhythm control strategy (OR 0.92, 95% CI 0.87-0.98) with no significant difference between ESRD and normal renal function (OR 1.32, 95% CI 0.79-1.11). There was large hospital-level variation in OAC prescription at discharge (MOR 2.34, 95% CI 2.05-2.76) and utilization of a rhythm control strategy (MOR 2.69, 95% CI 2.34-3.21).CKD/ESRD is associated with higher in-hospital mortality, less frequent rhythm control, and less OAC prescription among patients hospitalized for AF. There is wide hospital-level variation in utilization of a rhythm control strategy and OAC prescription at discharge highlighting potential opportunities to improve care and outcomes for these patients, and better define standards of care in this patient population.

  View details for DOI 10.1016/j.ahj.2021.06.012

  View details for PubMedID 34216572

• 2021 ISHNE/HRS/EHRA/APHRS collaborative statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society. Journal of arrhythmia Varma, N. n., Cygankiewicz, I. n., Turakhia, M. n., Heidbuchel, H. n., Hu, Y. n., Chen, L. Y., Couderc, J. P., Cronin, E. M., Estep, J. D., Grieten, L. n., Lane, D. A., Mehra, R. n., Page, A. n., Passman, R. n., Piccini, J. n., Piotrowicz, E. n., Piotrowicz, R. n., Platonov, P. G., Ribeiro, A. L., Rich, R. E., Russo, A. M., Slotwiner, D. n., Steinberg, J. S., Svennberg, E. n. 2021; 37 (2): 271–319

  Abstract

  This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.

  View details for DOI 10.1002/joa3.12461

  View details for PubMedID 33850572

  View details for PubMedCentralID PMC8022003

• 2021 ISHNE/ HRS/ EHRA/ APHRS collaborative statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society. Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc Varma, N. n., Cygankiewicz, I. n., Turakhia, M. n., Heidbuchel, H. n., Hu, Y. n., Chen, L. Y., Couderc, J. P., Cronin, E. M., Estep, J. D., Grieten, L. n., Lane, D. A., Mehra, R. n., Page, A. n., Passman, R. n., Piccini, J. n., Piotrowicz, E. n., Piotrowicz, R. n., Platonov, P. G., Ribeiro, A. L., Rich, R. E., Russo, A. M., Slotwiner, D. n., Steinberg, J. S., Svennberg, E. n. 2021: e12795

  Abstract

  This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/ Heart Rhythm Society/ European Heart Rhythm Association/ Asia Pacific Heart Rhythm Society describes the current status of mobile health ("mHealth") technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.

  View details for DOI 10.1111/anec.12795

  View details for PubMedID 33513268

• Arrhythmias Other Than Atrial Fibrillation in Those With an Irregular Pulse Detected With a Smartwatch: Findings From the Apple Heart Study. Circulation. Arrhythmia and electrophysiology Perino, A. C., Gummidipundi, S. E., Lee, J., Hedlin, H., Garcia, A., Ferris, T., Balasubramanian, V., Gardner, R. M., Cheung, L., Hung, G., Granger, C. B., Kowey, P., Rumsfeld, J. S., Russo, A. M., True Hills, M., Talati, N., Nag, D., Tsay, D., Desai, S., Desai, M., Mahaffey, K. W., Turakhia, M. P., Perez, M. V. 2021: CIRCEP121010063

  Abstract

  The Apple watch irregular pulse detection algorithm was found to have a positive predictive value of 0.84 for identification of atrial fibrillation (AF). We sought to describe the prevalence of arrhythmias other than AF in those with an irregular pulse detected on a smartwatch.The Apple Heart Study investigated a smartwatch-based irregular pulse notification algorithm to identify AF. For this secondary analysis, we analyzed participants who received an ambulatory ECG patch after index irregular pulse notification. We excluded participants with AF identified on ECG patch and described the prevalence of other arrhythmias on the remaining participant ECG patches. We also reported the proportion of participants self-reporting subsequent AF diagnosis.Among 419 297 participants enrolled in the Apple Heart Study, 450 participant ECG patches were analyzed, with no AF on 297 ECG patches (66%). Non-AF arrhythmias (excluding supraventricular tachycardias <30 beats and pauses <3 seconds) were detected in 119 participants (40.1%) with ECG patches without AF. The most common arrhythmias were frequent PACs (burden ≥1% to <5%, 15.8%; ≥5% to <15%, 8.8%), atrial tachycardia (≥30 beats, 5.4%), frequent PVCs (burden ≥1% to <5%, 6.1%; ≥5% to <15%, 2.7%), and nonsustained ventricular tachycardia (4-7 beats, 6.4%; ≥8 beats, 3.7%). Of 249 participants with no AF detected on ECG patch and patient-reported data available, 76 participants (30.5%) reported subsequent AF diagnosis.In participants with an irregular pulse notification on the Apple Watch and no AF observed on ECG patch, atrial and ventricular arrhythmias, mostly PACs and PVCs, were detected in 40% of participants. Defining optimal care for patients with detection of incidental arrhythmias other than AF is important as AF detection is further investigated, implemented, and refined.

  View details for DOI 10.1161/CIRCEP.121.010063

  View details for PubMedID 34565178

• 2021 ISHNE/HRS/EHRA/APHRS Expert Collaborative Statement on mHealth in Arrhythmia Management: Digital Medical Tools for Heart Rhythm Professionals: From the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society. Circulation. Arrhythmia and electrophysiology Varma, N. n., Cygankiewicz, I. n., Turakhia, M. P., Heidbuchel, H. n., Hu, Y. F., Chen, L. Y., Couderc, J. P., Cronin, E. M., Estep, J. D., Grieten, L. n., Lane, D. A., Mehra, R. n., Page, A. n., Passman, R. n., Piccini, J. P., Piotrowicz, E. n., Piotrowicz, R. n., Platonov, P. G., Ribeiro, A. L., Rich, R. E., Russo, A. M., Slotwiner, D. n., Steinberg, J. S., Svennberg, E. n. 2021: CIRCEP120009204

  Abstract

  This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society describes the current status of mobile health technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mobile health. The promises of predictive analytics but also operational challenges in embedding mobile health into routine clinical care are explored.

  View details for DOI 10.1161/CIRCEP.120.009204

  View details for PubMedID 33573393

• Efficacy of a Centralized, Blended Electronic and Human Intervention to Improve Direct Oral Anticoagulant Adherence: Smartphones to improve rivaroxaban ADHEREnce in Atrial Fibrillation (SmartADHERE) A Randomized Clinical Trial: SmartADHERE rivaroxaban adherence trial. American heart journal Turakhia, M. n., Sundaram, V. n., Smith, S. N., Ding, V. n., Michael Ho, P. n., Kowey, P. R., Piccini, J. P., Foody, J. n., Birmingham, M. n., Ianus, J. n., Rajmane, A. n., Mahaffey, K. W. 2021

  Abstract

  Improving adherence to direct oral anticoagulants (DOAC) is challenging, and simple text messaging reminders have not been effective.SmartADHERE was a randomized trial that tested a personalized digital and human direct oral anticoagulant adherence intervention compared to usual care. Eligibility required age ≥ 18, newly-prescribed (≤ 90 days) rivaroxaban for atrial fibrillation (AF), 1 of 4 at-risk criteria for nonadherence, and a smartphone. The intervention consisted of combination of a medication management smartphone app, daily app-based reminders, adaptive text messaging, and phone-based counseling for severe nonadherence. The primary outcome was the proportion of days covered by rivaroxaban (PDC) at 6 months. There were 25 U.S. sites, all cardiology and electrophysiology outpatient practices, activated for a target sample size of 378, but the study was terminated by the sponsor prior to reaching target enrollment.There were 139 participants (age 65±9.6 years, 30% female, median CHA2DS2-VASc score 3 with IQR 2-4, mean total medication burden 7.7±4.4). DOAC adherence was high in both arms with no difference in the primary outcome (PDC 0.86±0.25 intervention vs 0.88±0.25 control, p=0.62) or in secondary outcomes including PDC ≥ 0.80 and medication persistence. Per protocol analyses had similar results. Because of the high overall PDC, the likelihood to answer the primary hypothesis was only 51% even if target enrollment were achieved. There were no study-related adverse events.The use of a centralized digital and human adherence intervention was feasible across multiple sites. Overall adherence was much higher than expected despite pre-screening for at-risk individuals. SmartADHERE illustrates the challenges of trials of behavioral and technology interventions, where enrollment itself may lead to selection bias or treatment effects. Pragmatic study designs, such as cluster randomization or stepped-wedge implementation, should be considered to improve enrollment and generalizability.

  View details for DOI 10.1016/j.ahj.2021.02.023

  View details for PubMedID 33676886

• Procedure Characteristics and Outcomes of Atrial Fibrillation Ablation Procedures Using Cryoballoon versus Radiofrequency Ablation: A Report from the GWTG-AFIB Registry. Journal of cardiovascular electrophysiology Friedman, D. J., Holmes, D., Curtis, A. B., Ellenbogen, K. A., Frankel, D. S., Knight, B. P., Russo, A. M., Matsouaka, R., Turakhia, M. P., Lewis, W. R., Piccini, J. P. 2020

  Abstract

  INTRODUCTION: CBA is an alternative to RFA for ablation of atrial fibrillation(AF) and real-world comparisons of this strategy are lacking. As such, we sought to compare patient and periprocedural characteristics and outcomes of cryoballoon ablation(CBA) vs. radiofrequency ablation(RFA) in the Get With the Guidelines AFIB Registry.METHODS: Categorical variables were compared via the Chi2 test and continuous variables were compared via the Wilcoxon rank sum test. Adjusted analyses were performed using overlap weighting of propensity scores.RESULTS: A total of 5247(1465 CBA, 3782 RFA) ablation procedures were reported from 33 sites. Those undergoing CBA more often had paroxysmal AF(60.0% vs. 48.8%) and no prior AF ablation(87.5% vs. 73.8%). CHA2 DS2 -VASc scores were similar. Among de novo ablations, most ablations involved intracardiac echocardiography and electroanatomic mapping, but both were less common with CBA(87.3% vs. 93.9%,p<0.0001, and 87.7% vs. 94.6%,p<0.0001, respectively). CBA was associated with shorter procedures(129 vs. 179 min,p<0.0001), increased fluoroscopy use(19 vs. 11min,p<0.0001), and similar ablation times(27 vs. 35min,p=0.15). Non-pulmonary vein ablation was common with CBA: roof line 38.6%, floor line 20.4%, cavotricuspid isthmus 27.7%. RFA was associated with more total complications compared to CBA(5.4% vs. 2.3%,p<0.0001), due to more volume overload and "other" events, although phrenic nerve injury was more common with CBA(0.9 vs 0.1%,p=0.0001). In the adjusted model, any complication was less common among CBA cases(OR 0.45, CI 0.25-0.79,p=0.0056).CONCLUSION: CBA was associated with fewer complications, and shorter procedure times, and greater fluoroscopy times, compared to RFA. Non-pulmonary vein ablation and electroanatomic mapping system use was common with CBA. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1111/jce.14858

  View details for PubMedID 33368764

• Screening and surveillance of atrial fibrillation with continuous vs. intermittent monitoring: a false choice? Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Turakhia, M. P. 2020

  View details for DOI 10.1093/europace/euaa254

  View details for PubMedID 33164056

• Integration of novel monitoring devices with machine learning technology for scalable cardiovascular management. Nature reviews. Cardiology Krittanawong, C., Rogers, A. J., Johnson, K. W., Wang, Z., Turakhia, M. P., Halperin, J. L., Narayan, S. M. 2020

  Abstract

  Ambulatory monitoring is increasingly important for cardiovascular care but is often limited by the unpredictability of cardiovascular events, the intermittent nature of ambulatory monitors and the variable clinical significance of recorded data in patients. Technological advances in computing have led to the introduction of novel physiological biosignals that can increase the frequency at which abnormalities in cardiovascular parameters can be detected, making expert-level, automated diagnosis a reality. However, use of these biosignals for diagnosis also raises numerous concerns related to accuracy and actionability within clinical guidelines, in addition to medico-legal and ethical issues. Analytical methods such as machine learning can potentially increase the accuracy and improve the actionability of device-based diagnoses. Coupled with interoperability of data to widen access to all stakeholders, seamless connectivity (an internet of things) and maintenance of anonymity, this approach could ultimately facilitate near-real-time diagnosis and therapy. These tools are increasingly recognized by regulatory agencies and professional medical societies, but several technical and ethical issues remain. In this Review, we describe the current state of cardiovascular monitoring along the continuum from biosignal acquisition to the identification of novel biosensors and the development of analytical techniques and ultimately to regulatory and ethical issues. Furthermore, we outline new paradigms for cardiovascular monitoring.

  View details for DOI 10.1038/s41569-020-00445-9

  View details for PubMedID 33037325

• Digital Health and the Care of the Arrhythmia Patient; What Every Electrophysiologist Needs to Know. Circulation. Arrhythmia and electrophysiology Tarakji, K. G., Silva, J. N., Chen, L. Y., Turakhia, M. P., Perez, M. V., Attia, Z. I., Passman, R., Boissy, A., Cho, D. J., Majmudar, M., Mehta, N., Wan, E. Y., Chung, M. K. 2020

  Abstract

  The field of cardiac electrophysiology has been on the cutting edge of advanced digital technologies for many years. More recently, medical device development through traditional clinical trials has been supplemented by direct to consumer products with advancement of wearables and healthcare apps. The rapid growth of innovation along with the mega-data generated has created challenges and opportunities. This review summarizes the regulatory landscape, applications to clinical practice, opportunities for virtual clinical trials, the use of artificial intelligence to streamline and interpret data, and integration into the electronic medical records and medical practice. Preparation of the new generation of physicians, guidance and promotion by professional societies, and advancement of research in the interpretation and application of big data and the impact of digital technologies on health outcomes will help to advance the adoption and the future of digital health care.

  View details for DOI 10.1161/CIRCEP.120.007953

  View details for PubMedID 33021815

• Appropriateness of Direct Oral Anticoagulant Dosing in Patients With Atrial Fibrillation: Insights From the Veterans Health Administration JOURNAL OF PHARMACY PRACTICE Leef, G. C., Perino, A. C., Askari, M., Fan, J., Ho, P., Olivier, C. B., Longo, L., Mahaffey, K. W., Turakhia, M. P. 2020; 33 (5): 647–53

  View details for DOI 10.1177/0897190019828270

  View details for Web of Science ID 000584468800012

• Digitizing clinical trials NPJ DIGITAL MEDICINE Inan, O. T., Tenaerts, P., Prindiville, S. A., Reynolds, H. R., Dizon, D. S., Cooper-Arnold, K., Turakhia, M., Pletcher, M. J., Preston, K. L., Krumholz, H. M., Marlin, B. M., Mandl, K. D., Klasnja, P., Spring, B., Iturriaga, E., Campo, R., Desvigne-Nickens, P., Rosenberg, Y., Steinhubl, S. R., Califf, R. M. 2020; 3 (1)

  View details for DOI 10.1038/s41746-020-0302-y

  View details for Web of Science ID 000555457200001

• Digitizing clinical trials. NPJ digital medicine Inan, O. T., Tenaerts, P., Prindiville, S. A., Reynolds, H. R., Dizon, D. S., Cooper-Arnold, K., Turakhia, M., Pletcher, M. J., Preston, K. L., Krumholz, H. M., Marlin, B. M., Mandl, K. D., Klasnja, P., Spring, B., Iturriaga, E., Campo, R., Desvigne-Nickens, P., Rosenberg, Y., Steinhubl, S. R., Califf, R. M. 2020; 3: 101

  Abstract

  Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.

  View details for DOI 10.1038/s41746-020-0302-y

  View details for PubMedID 32821856

  View details for PubMedCentralID PMC7395804

• Procedural Patterns and Safety of Atrial Fibrillation Ablation: Findings from Get with The Guidelines-Atrial Fibrillation. Circulation. Arrhythmia and electrophysiology Loring, Z., Holmes, D. N., Matsouaka, R. A., Curtis, A. B., Day, J. D., Desai, N., Ellenbogen, K. A., Feld, G. K., Fonarow, G. C., Frankel, D. S., Hurwitz, J. L., Knight, B. P., Joglar, J. A., Russo, A. M., Sidhu, M. S., Turakhia, M. P., Lewis, W. R., Piccini, J. P. 2020

  Abstract

  Background - Catheter ablation is an increasingly utilized treatment for symptomatic atrial fibrillation (AF). However, there are limited prospective, nationwide data on patient selection and procedural characteristics. This study describes patient characteristics, techniques, treatment patterns, and safety outcomes of patients undergoing AF ablation. Methods - A total of 3,139 patients undergoing AF ablation between 2016-2018 in the Get With The Guidelines-Atrial Fibrillation registry from 24 US centers were included. Patient demographics, medical history, procedural details and complications were abstracted. Differences between paroxysmal and persistent AF patients were compared using Pearson's Chi-square and Wilcoxon rank-sum tests. Results - Patients undergoing AF ablation were predominantly male (63.9%) and Caucasian (93.2%) with a median age of 65. Hypertension was the most common comorbidity (67.6%) and persistent AF patients had more comorbidities than paroxysmal AF patients. Drug refractory, paroxysmal AF was the most common ablation indication (Class I, 53.6%) followed by drug refractory, persistent AF (Class I, 41.8%). Radiofrequency (RF) ablation with contact force (CF) sensing was the most common ablation modality (70.5%); 23.7% of patients underwent cryoballoon ablation. Pulmonary vein isolation (PVI) was performed in 94.6% of de novo ablations; the most common adjunctive lesions included left atrial roof or posterior/inferior lines, and cavotricuspid isthmus ablation. Complications were uncommon (5.1%), and were life-threatening in 0.7% of cases. Conclusions - More than 98% of AF ablations among participating sites are performed for Class I or Class IIA indications. CF-guided RF ablation is the dominant technique and PVI the principal lesion set. In-hospital complications are uncommon and rarely life-threatening.

  View details for DOI 10.1161/CIRCEP.119.007944

  View details for PubMedID 32703018

• Artificial Intelligence and Machine Learning in Arrhythmias and Cardiac Electrophysiology. Circulation. Arrhythmia and electrophysiology Feeny, A. K., Chung, M. K., Madabhushi, A., Attia, Z. I., Cikes, M., Firouznia, M., Friedman, P. A., Kalscheur, M. M., Kapa, S., Narayan, S. M., Noseworthy, P. A., Passman, R. S., Perez, M. V., Peters, N. S., Piccini, J. P., Tarakji, K. G., Thomas, S. A., Trayanova, N. A., Turakhia, M. P., Wang, P. J. 2020

  Abstract

  Artificial intelligence (AI) and machine learning (ML) in medicine are currently areas of intense exploration, showing potential to automate human tasks and even perform tasks beyond human capabilities. Literacy and understanding of AI/ML methods are becoming increasingly important to researchers and clinicians. The first objective of this review is to provide the novice reader with literacy of AI/ML methods and provide a foundation for how one might conduct an ML study. We provide a technical overview of some of the most commonly used terms, techniques, and challenges in AI/ML studies, with reference to recent studies in cardiac electrophysiology to illustrate key points. The second objective of this review is to use examples from recent literature to discuss how AI and ML are changing clinical practice and research in cardiac electrophysiology, with emphasis on disease detection and diagnosis, prediction of patient outcomes, and novel characterization of disease. The final objective is to highlight important considerations and challenges for appropriate validation, adoption, and deployment of AI technologies into clinical practice.

  View details for DOI 10.1161/CIRCEP.119.007952

  View details for PubMedID 32628863

• Survey of current perspectives on consumer-available digital health devices for detecting atrial fibrillation. Cardiovascular digital health journal Ding, E. Y., Svennberg, E., Wurster, C., Duncker, D., Manninger, M., Lubitz, S. A., Dickson, E., Fitzgibbons, T. P., Akoum, N., Al-Khatib, S. M., Attia, Z. I., Ghanbari, H., Marrouche, N. F., Mendenhall, G. S., Peters, N. S., Tarakji, K. G., Turakhia, M., Wan, E. Y., McManus, D. D. 2020; 1 (1): 21–29

  Abstract

  Background: Many digital health technologies capable of atrial fibrillation (AF) detection are directly available to patients. However, adaptation into clinical practice by heart rhythm healthcare practitioners (HCPs) is unclear.Objective: To examine HCP perspectives on use of commercial technologies for AF detection and management.Methods: We created an electronic survey for HCPs assessing practice demographics and perspectives on digital devices for AF detection and management. The survey was distributed electronically to all members of 3 heart rhythm professional societies.Results: We received 1601 responses out of 73,563 e-mails sent, with 43.6% from cardiac electrophysiologists, 12.8% from fellows, and 11.6% from advanced practice practitioners. Most respondents (62.3%) reported having recommended patient use of a digital device for AF detection. Those who did not had concerns about their accuracy (29.6%), clinical utility of results (22.8%), and integration into electronic health records (19.8%). Results from a 30-second single-lead electrocardiogram were sufficient for 42.7% of HCPs to recommend oral anticoagulation for patients at high risk for stroke. Respondents wanted more data comparing the accuracy of digital devices to conventional devices for AF monitoring (64.9%). A quarter (27.3%) of HCPs had no reservations recommending digital devices for AF detection, and most (53.4%) wanted guidelines from their professional societies providing guidance on their optimal use.Conclusion: Many HCPs have already integrated digital devices into their clinical practice. However, HCPs reported facing challenges when using digital technologies for AF detection, and professional society recommendations on their use are needed.

  View details for DOI 10.1016/j.cvdhj.2020.06.002

  View details for PubMedID 32924024

• HRS white paper on atrial fibrillation centers of excellence: Rationale, considerations, and goals. Heart rhythm Piccini, J. P., Allred, J., Bunch, T. J., Deering, T. F., Di Biase, L., Hussein, A. A., Lewis, W. R., Mittal, S., Natale, A., Osorio, J., Packer, D. L., Ruff, C., Russo, A. M., Sanders, P., Seiler, A., Slotwiner, D., Hills, M. T., Turakhia, M. P., Van Gelder, I. C., Varosy, P. D., Verma, A., Volgman, A. S., Wood, K. A., Deneke, T. 2020

  View details for DOI 10.1016/j.hrthm.2020.04.033

  View details for PubMedID 32387248

• Hydroxychloroquine, Coronavirus Disease 2019, and QT Prolongation. JAMA cardiology Bonow, R. O., Hernandez, A. F., Turakhia, M. 2020

  View details for DOI 10.1001/jamacardio.2020.1782

  View details for PubMedID 32356857

• WARFARIN TIME IN THERAPEUTIC RANGE TRAJECTORIES IN POTENTIAL SWITCHERS TO DIRECT ORAL ANTICOAGULANTS Pundi, K., Perino, A., Fan, J., Schmitt, S., Kothari, M., Szummer, K., Askari, M., Heidenreich, P. A., Turakhia, M. ELSEVIER SCIENCE INC. 2020: 416

  View details for Web of Science ID 000522979100406

• DETERMINANTS OF ATRIAL FIBRILLATION PROGRESSION IN CHRONIC KIDNEY DISEASE PATIENTS WITH CARDIAC IMPLANTABLE ELECTRONIC DEVICES (DATA FROM THE MEDTRONIC CARELINK DATABASE) Szummer, K., Pundi, K., Perino, A., Fan, J., Kothari, M., Turakhia, M. ELSEVIER SCIENCE INC. 2020: 488

  View details for Web of Science ID 000522979100477

• A Smartwatch to Identify Atrial Fibrillation REPLY NEW ENGLAND JOURNAL OF MEDICINE Turakhia, M. P., Desai, M., Perez, M. V. 2020; 382 (10): 975–76

  View details for Web of Science ID 000519214900027

• Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC. Clinical electrophysiology Natale, A. n., Mohanty, S. n., Liu, P. Y., Mittal, S. n., Al-Ahmad, A. n., De Lurgio, D. B., Horton, R. n., Spear, W. n., Bailey, S. n., Bunch, J. n., Musat, D. n., O'Neill, P. n., Compton, S. n., Turakhia, M. P. 2020; 6 (1): 111–24

  Abstract

  This study compared the efficacy and safety of the VASCADE MVP Venous Vascular Closure System (VVCS) device (Cardiva Medical, Santa Clara, California) to manual compression (MC) for closing multiple access sites after catheter-based electrophysiology procedures.The VASCADE MVP VVCS is designed to provide earlier ambulatory hemostasis than MC after catheter-based procedures.The AMBULATE (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore [VASCADE MVP] VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes) trial was a multicenter, randomized trial of device closure versus MC in patients who underwent ablation. Outcomes included time to ambulation (TTA), total post-procedure time (TPPT), time to discharge eligibility (TTDe), time to hemostasis (TTH), 30-day major and minor complications, pain medication usage, and patient-reported outcomes.A total of 204 patients at 13 sites were randomized to the device arm (n = 100; 369 access sites) or the MC arm (n = 104; 382 access sites). Baseline characteristics were similar between groups. Mean TTA, TPPT, TTDe, and TTH were substantially lower in the device arm (respective decreases of 54%, 54%, 52%, and 55%; all p < 0.0001). Opioid use was reduced by 58% (p = 0.001). There were no major access site complications. Incidence of minor complications was 1.0% for the device arm and 2.4% for the MC arm (p = 0.45). Patient satisfaction scores with duration of and comfort during bedrest were 63% and 36% higher in device group (both p < 0.0001). Satisfaction with bedrest pain was 25% higher (p = 0.001) for the device overall, and 40% higher (p = 0.002) for patients with a previous ablation.Use of the closure device for multiple access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe, and opioid use, with increased patient satisfaction and no increase in complications. (A Randomized, Multi-center Trial to Compare Cardiva Mid-Bore VVCS to Manual Compression in Closure of Multiple Femoral Venous Access Sites in 6 - 12 Fr Sheath Sizes [AMBULATE]; NCT03193021).

  View details for DOI 10.1016/j.jacep.2019.08.013

  View details for PubMedID 31971899

• Wearables for arrhythmia care: Challenges and future prospects. Cardiovascular digital health journal Sarraju, A., Turakhia, M. P. 2020; 1 (2): 56-58

  View details for DOI 10.1016/j.cvdhj.2020.09.001

  View details for PubMedID 35265876

  View details for PubMedCentralID PMC8890052

• Sex Differences in Oral Anticoagulation and Outcomes of Stroke and Intracranial Bleeding in Newly Diagnosed Atrial Fibrillation. Journal of the American Heart Association Yong, C. M., Tremmel, J. A., Lansberg, M. G., Fan, J. n., Askari, M. n., Turakhia, M. P. 2020: e015689

  Abstract

  Background Female sex is an independent predictor of stroke in patients with atrial fibrillation (AF). Older data suggest undertreatment with anticoagulation among women compared with men. However, it is unknown if novel therapies and updated guidelines have impacted sex differences in AF treatment and outcomes. Methods and Results We performed a retrospective cohort study of 2.3 million women and men with a new diagnosis of AF and CHA2DS2-VASc ≥2 from Marketscan US commercial claims data from 2008 to 2015 to determine whether women with AF remain undertreated and whether this difference mediates observed differences in outcomes. There were 358 649 patients with newly diagnosed AF (43% women). Compared with men, women were older, with higher CHA2DS2-VASc scores, and higher comorbidity burden (P<0.0001 for all). Oral anticoagulation-eligible women with CHA2DS2-VASc scores ≥2 were more likely to not receive anticoagulation (50.0% women versus 43.9% men). Women, compared with men, had a higher risk of ischemic stroke (adjusted hazard ratio [aHR], 1.27; 95% CI, 1.21-1.32; P<0.0001) and hospitalization (aHR, 1.06; 95% CI, 1.05-1.07, P<0.0001) but had a lower risk of intracranial bleeding (aHR, 0.91; 95% CI, 0.83-0.99, P=0.03). In mediation analysis, nonreceipt of oral anticoagulation partially mediated the observed increased risk of stroke and decreased risk of intracranial bleeding in women. Conclusions In the care of newly diagnosed AF in the United States, women, compared with men, are less likely to receive oral anticoagulation. This appears to mediate the increased risk of both stroke and hospitalization but also appears to mediate lower observed intracranial bleeding risk.

  View details for DOI 10.1161/JAHA.120.015689

  View details for PubMedID 32394763

• Hydroxychloroquine, Coronavirus Disease 2019, and QT Prolongation. JAMA cardiology Bonow, R. O., Hernandez, A. F., Turakhia, M. n. 2020; 5 (9): 986–87

  View details for DOI 10.1001/jamacardio.2020.1782

  View details for PubMedID 32936259

• Factors Associated with Large Improvements in Health-Related Quality of Life in Patients with Atrial Fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. Arrhythmia and electrophysiology Steinberg, B. A., Holmes, D. N., Pieper, K. n., Allen, L. A., Chan, P. S., Ezekowitz, M. D., Freeman, J. V., Fonarow, G. C., Gersh, B. J., Hylek, E. M., Kowey, P. R., Mahaffey, K. W., Naccarelli, G. n., Reiffel, J. n., Singer, D. E., Peterson, E. D., Piccini, J. P. 2020

  Abstract

  Background - Atrial fibrillation (AF) adversely impacts health-related quality of life (hrQoL). While some patients demonstrate improvements in hrQoL, the factors associated with large improvements in hrQoL are not well described. Methods - We assessed factors associated with a 1-year increase in AFEQT of 1 standard deviation (≥18 points; 3x clinically important difference), among outpatients in the ORBIT-AF I registry. Results - Overall, 28% (181/636) of patients had such a hrQoL improvement. Compared with patients not showing large hrQoL improvement, they were of similar age (median 73 vs. 74, p=0.3), equally likely to be female (44% vs. 48%, p=0.3), but more likely to have newly-diagnosed AF at baseline (18% vs. 8%; p=0.0004), prior antiarrhythmic drug use (52% vs. 40%, 0.005), baseline antiarrhythmic drug use (34.8% vs, 26.8%, p=0.045), and more likely to undergo AF-related procedures during follow-up (AF ablation: 6.6% vs. 2.0%, p=0.003; cardioversion:12.2% vs. 5.9% p=0.008). In multivariable analysis, a history of alcohol abuse (adjusted OR 2.41, p=0.01) and increased baseline diastolic BP (adjusted OR 1.23 per 10-point increase and >65 mm Hg, p=0.04) were associated with large improvements in hrQoL at 1 year, whereas patients with prior stroke/TIA, COPD, and PAD were less likely to improve (p<0.05 for each). Conclusions - In this national registry of AF patients, potentially treatable AF risk factors are associated with large hrQoL improvement, whereas less reversible conditions appeared negatively associated with hrQoL improvement. Understanding which patients are most likely to have large hrQoL improvement may facilitate targeting interventions for high-value care that optimizes patient reported outcomes in AF. Clinical Trial Registration - clinicaltrials.gov.; Unique Identifier: NCT01165710.

  View details for DOI 10.1161/CIRCEP.119.007775

  View details for PubMedID 32298144

• Addressing the New Last-Mile Problem in Health Care With Home-Based Complex Diagnostics. JAMA cardiology Turakhia, M. P. 2020

  View details for DOI 10.1001/jamacardio.2020.4379

  View details for PubMedID 32865543

• Accuracy of Smartphone Camera Applications for Detecting Atrial Fibrillation: A Systematic Review and Meta-analysis. JAMA network open O'Sullivan, J. W., Grigg, S. n., Crawford, W. n., Turakhia, M. P., Perez, M. n., Ingelsson, E. n., Wheeler, M. T., Ioannidis, J. P., Ashley, E. A. 2020; 3 (4): e202064

  Abstract

  Atrial fibrillation (AF) affects more than 6 million people in the United States; however, much AF remains undiagnosed. Given that more than 265 million people in the United States own smartphones (>80% of the population), smartphone applications have been proposed for detecting AF, but the accuracy of these applications remains unclear.To determine the accuracy of smartphone camera applications that diagnose AF.MEDLINE and Embase were searched until January 2019 for studies that assessed the accuracy of any smartphone applications that use the smartphone's camera to measure the amplitude and frequency of the user's fingertip pulse to diagnose AF.Bivariate random-effects meta-analyses were constructed to synthesize data. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) of Diagnostic Test Accuracy Studies reporting guideline.Sensitivity and specificity were measured with bivariate random-effects meta-analysis. To simulate the use of these applications as a screening tool, the positive predictive value (PPV) and negative predictive value (NPV) for different population groups (ie, age ≥65 years and age ≥65 years with hypertension) were modeled. Lastly, the association of methodological limitations with outcomes were analyzed with sensitivity analyses and metaregressions.A total of 10 primary diagnostic accuracy studies, with 3852 participants and 4 applications, were included. The oldest studies were published in 2016 (2 studies [20.0%]), while most studies (4 [40.0%]) were published in 2018. The applications analyzed the pulsewave signal for a mean (range) of 2 (1-5) minutes. The meta-analyzed sensitivity and specificity for all applications combined were 94.2% (95% CI, 92.2%-95.7%) and 95.8% (95% CI, 92.4%-97.7%), respectively. The PPV for smartphone camera applications detecting AF in an asymptomatic population aged 65 years and older was between 19.3% (95% CI, 19.2%-19.4%) and 37.5% (95% CI, 37.4%-37.6%), and the NPV was between 99.8% (95% CI, 99.83%-99.84%) and 99.9% (95% CI, 99.94%-99.95%). The PPV and NPV increased for individuals aged 65 years and older with hypertension (PPV, 20.5% [95% CI, 20.4%-20.6%] to 39.2% [95% CI, 39.1%-39.3%]; NPV, 99.8% [95% CI, 99.8%-99.8%] to 99.9% [95% CI, 99.9%-99.9%]). There were methodological limitations in a number of studies that did not appear to be associated with diagnostic performance, but this could not be definitively excluded given the sparsity of the data.In this study, all smartphone camera applications had relatively high sensitivity and specificity. The modeled NPV was high for all analyses, but the PPV was modest, suggesting that using these applications in an asymptomatic population may generate a higher number of false-positive than true-positive results. Future research should address the accuracy of these applications when screening other high-risk population groups, their ability to help monitor chronic AF, and, ultimately, their associations with patient-important outcomes.

  View details for DOI 10.1001/jamanetworkopen.2020.2064

  View details for PubMedID 32242908

• Termination of persistent atrial fibrillation by ablating sites that control large atrial areas. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Bhatia, N. K., Rogers, A. J., Krummen, D. E., Hossainy, S. n., Sauer, W. n., Miller, J. M., Alhusseini, M. I., Peszek, A. n., Armenia, E. n., Baykaner, T. n., Brachmann, J. n., Turakhia, M. P., Clopton, P. n., Wang, P. J., Rappel, W. J., Narayan, S. M. 2020

  Abstract

  Persistent atrial fibrillation (AF) has been explained by multiple mechanisms which, while they conflict, all agree that more disorganized AF is more difficult to treat than organized AF. We hypothesized that persistent AF consists of interacting organized areas which may enlarge, shrink or coalesce, and that patients whose AF areas enlarge by ablation are more likely to respond to therapy.We mapped vectorial propagation in persistent AF using wavefront fields (WFF), constructed from raw unipolar electrograms at 64-pole basket catheters, during ablation until termination (Group 1, N = 20 patients) or cardioversion (Group 2, N = 20 patients). Wavefront field mapping of patients (age 61.1 ± 13.2 years, left atrium 47.1 ± 6.9 mm) at baseline showed 4.6 ± 1.0 organized areas, each separated by disorganization. Ablation of sites that led to termination controlled larger organized area than competing sites (44.1 ± 11.1% vs. 22.4 ± 7.0%, P < 0.001). In Group 1, ablation progressively enlarged unablated areas (rising from 32.2 ± 15.7% to 44.1 ± 11.1% of mapped atrium, P < 0.0001). In Group 2, organized areas did not enlarge but contracted during ablation (23.6 ± 6.3% to 15.2 ± 5.6%, P < 0.0001).Mapping wavefront vectors in persistent AF revealed competing organized areas. Ablation that progressively enlarged remaining areas was acutely successful, and sites where ablation terminated AF were surrounded by large organized areas. Patients in whom large organized areas did not emerge during ablation did not exhibit AF termination. Further studies should define how fibrillatory activity is organized within such areas and whether this approach can guide ablation.

  View details for DOI 10.1093/europace/euaa018

  View details for PubMedID 32243508

• A Smartwatch to Identify Atrial Fibrillation. Reply. The New England journal of medicine Turakhia, M. P., Desai, M. n., Perez, M. V. 2020; 382 (10): 975–76

  View details for DOI 10.1056/NEJMc1916858

  View details for PubMedID 32130828

• Gerotechnology for Older Adults With Cardiovascular Diseases: JACC State-of-the-Art Review. Journal of the American College of Cardiology Krishnaswami, A. n., Beavers, C. n., Dorsch, M. P., Dodson, J. A., Masterson Creber, R. n., Kitsiou, S. n., Goyal, P. n., Maurer, M. S., Wenger, N. K., Croy, D. S., Alexander, K. P., Batsis, J. A., Turakhia, M. P., Forman, D. E., Bernacki, G. M., Kirkpatrick, J. N., Orr, N. M., Peterson, E. D., Rich, M. W., Freeman, A. M., Bhavnani, S. P. 2020; 76 (22): 2650–70

  Abstract

  The growing population of older adults (age ≥65 years) is expected to lead to higher rates of cardiovascular disease. The expansion of digital health (encompassing telehealth, telemedicine, mobile health, and remote patient monitoring), Internet access, and cellular technologies provides an opportunity to enhance patient care and improve health outcomes-opportunities that are particularly relevant during the current coronavirus disease-2019 pandemic. Insufficient dexterity, visual impairment, and cognitive dysfunction, found commonly in older adults should be taken into consideration in the development and utilization of existing technologies. If not implemented strategically and appropriately, these can lead to inequities propagating digital divides among older adults, across disease severities and socioeconomic distributions. A systematic approach, therefore, is needed to study and implement digital health strategies in older adults. This review will focus on current knowledge of the benefits, barriers, and use of digital health in older adults for cardiovascular disease management.

  View details for DOI 10.1016/j.jacc.2020.09.606

  View details for PubMedID 33243384

• Social Media Influence Does Not Reflect Scholarly or Clinical Activity in Real Life. Circulation. Arrhythmia and electrophysiology Zenger, B. n., Swink, J. M., Turner, J. L., Bunch, T. J., Ryan, J. J., Shah, R. U., Turakhia, M. P., Piccini, J. P., Steinberg, B. A. 2020

  Abstract

  Background - Social media has become a major source of communication in medicine. We aimed to understand the relationship between physicians' social media influence and their scholarly and clinical activity. Methods - We identified attending, US electrophysiologists on Twitter. We compared physician Twitter activity to (a) scholarly publication record (h-index) and (b) clinical volume according to CMS. The ratio of observed vs. expected Twitter followers (obs/exp) was calculated based on each scholarly (K-index) and clinical activity. Results - We identified 284 physicians, with mean Twitter age of 5.0 (SD 3.1) years and median 568 followers (25th, 75th: 195, 1146). They had a median 34.5 peer-reviewed papers (25th, 75th: 14, 105), 401 citations (25th, 75th: 102, 1677), and h-index 9 (25th, 75th: 4, 19.8). The median K-index was 0.4 (25th, 75th: 0.15, 1.0), ranging 0.0008 - 29.2. The median EP procedures was 77 (25th, 75th: 0, 160) and E&M visits 264 (25th, 75th: 59, 516) in 2017. The top 1% electrophysiologists for followers accounted for 20% of all followers, 17% of status updates, had a mean h-index of 6 (vs. 15 for others, p=0.3), and accounted for 1% of procedural and E&M volumes. They had a mean K-index of 21 (vs. 0.77 for others, p<0.0001), and clinical obs/exp follower ratio of 17.9 and 18.1 for procedures and E&M (p<0.001 each, vs. others [0.81 for each]). Conclusions - Electrophysiologists are active on Twitter, with modest influence often representative of scholarly and clinical activity. However, the most influential physicians appear to have relatively modest scholarly and clinical activity.

  View details for DOI 10.1161/CIRCEP.120.008847

  View details for PubMedID 33030380

• Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov. JAMA internal medicine Pundi, K. n., Perino, A. C., Harrington, R. A., Krumholz, H. M., Turakhia, M. P. 2020

  View details for DOI 10.1001/jamainternmed.2020.2904

  View details for PubMedID 32730617

• Incidence and outcomes of patients with atrial fibrillation and major bleeding complications: from the TREAT-AF study. Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing Perino, A. C., Kaiser, D. W., Lee, R. J., Fan, J. n., Askari, M. n., Schmitt, S. K., Turakhia, M. P. 2020

  Abstract

  Optimal stroke prevention strategies for patients with atrial fibrillation (AF) who experience a major bleed are poorly defined. We sought to estimate the effectiveness and safety of oral anticoagulation (OAC) represcription after an OAC contraindication.TREAT-AF is a retrospective cohort study of patients with newly diagnosed AF (2004-2012), treated in the Veterans Health Administration. From this cohort, we identified patients with a contraindication to OAC after AF diagnoses, defined as incident intracranial bleeding, non-intracranial bleeding requiring hospitalization, or unrepaired cerebral aneurysm or aortic dissection. We used multivariate Cox proportional hazards to estimate the association of OAC prescription in the 90 days following OAC contraindication to ischemic stroke and rebleeding.Among 167,190 patients with newly diagnosed AF (70 ± 11 years, 1.7% female, CHA2DS2-VASc 2.7 ± 1.7), 19,285 patients (11.5%) had an incident bleed (n = 18,342) or an unrepaired cerebral aneurysm or aortic dissection (n = 943). For OAC-contraindicated patients with a CHA2DS2-VASc ≥2 (N = 16,194), OAC was represcribed in 4075 patients (25%) and was associated with a higher risk of non-intracranial bleeding (HR 1.49; 95% CI 1.37-1.61; p < 0.0001) but no difference in intracranial bleeding. There was a trend toward decreased stroke risk (HR 0.85; 95% CI 0.71-1.02; p 0.09).Development of contraindication to OAC after diagnosis of AF is common (11.5%), with most events requiring hospitalization. OAC reinitiation was associated with non-intracranial bleeding risk, with a trend toward reduced stroke risk. These data suggest that stroke prevention approaches after major bleeding events could be beneficial if bleeding risk can be successfully mitigated.

  View details for DOI 10.1007/s10840-020-00873-0

  View details for PubMedID 32986177

• Apple Watch App Identifies Clinically Important Arrhythmias Other Than Atrial Fibrillation: Results From the Apple Heart Study Perez, M. V., Mahaffey, K., Hedlin, H., Rumsfeld, J. S., Garcia, A., Ferris, T., Balasubramanian, V., Russo, A. M., Rajmane, A., Cheung, L., Hung, G., Lee, J., Kowey, P. R., Talati, N., Nag, D., Gummidipundi, S., Beatty, A. L., Hills, M. T., Desai, S., Granger, C. B., Desai, M., Turakhia, M. LIPPINCOTT WILLIAMS & WILKINS. 2019: E988

  View details for Web of Science ID 000508228600061

• Diagnosing With a Camera From a Distance-Proceed Cautiously and Responsibly. JAMA cardiology Turakhia, M. P. 2019

  View details for DOI 10.1001/jamacardio.2019.4572

  View details for PubMedID 31774448

• Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation. Circulation Marquis-Gravel, G., Roe, M. T., Turakhia, M. P., Boden, W., Temple, R., Sharma, A., Hirshberg, B., Slater, P., Craft, N., Stockbridge, N., McDowell, B., Waldstreicher, J., Bourla, A., Bansilal, S., Wong, J. L., Meunier, C., Kassahun, H., Coran, P., Bataille, L., Patrick-Lake, B., Hirsch, B., Reites, J., Mehta, R., Muse, E. D., Chandross, K. J., Silverstein, J. C., Silcox, C., Overhage, J. M., Califf, R. M., Peterson, E. D. 2019; 140 (17): 1426–36

  Abstract

  The complexity and costs associated with traditional randomized, controlled trials have increased exponentially over time, and now threaten to stifle the development of new drugs and devices. Nevertheless, the growing use of electronic health records, mobile applications, and wearable devices offers significant promise for transforming clinical trials, making them more pragmatic and efficient. However, many challenges must be overcome before these innovations can be implemented routinely in randomized, controlled trial operations. In October of 2018, a diverse stakeholder group convened in Washington, DC, to examine how electronic health record, mobile, and wearable technologies could be applied to clinical trials. The group specifically examined how these technologies might streamline the execution of clinical trial components, delineated innovative trial designs facilitated by technological developments, identified barriers to implementation, and determined the optimal frameworks needed for regulatory oversight. The group concluded that the application of novel technologies to clinical trials provided enormous potential, yet these changes needed to be iterative and facilitated by continuous learning and pilot studies.

  View details for DOI 10.1161/CIRCULATIONAHA.119.040798

  View details for PubMedID 31634011

• Early experience with the first pacemakers to directly connect with smart devices for remote monitoring Tarakji, K., Zweibel, S., Seiler, A., Roberts, P., Shaik, N., Silverstein, J., Patwala, A., Mittal, S., Molon, G., Augello, G., Porfilio, A., Holloman, K., Varma, N., Sears, S., Turakhia, M. OXFORD UNIV PRESS. 2019: 190

  View details for Web of Science ID 000507313003297

• Atrial Fibrillation Burden Signature and Near-Term Prediction of Stroke: A Machine Learning Analysis. Circulation. Cardiovascular quality and outcomes Han, L., Askari, M., Altman, R. B., Schmitt, S. K., Fan, J., Bentley, J. P., Narayan, S. M., Turakhia, M. P. 2019; 12 (10): e005595

  Abstract

  BACKGROUND: Atrial fibrillation (AF) increases the risk of stroke 5-fold and there is rising interest to determine if AF severity or burden can further risk stratify these patients, particularly for near-term events. Using continuous remote monitoring data from cardiac implantable electronic devices, we sought to evaluate if machine learned signatures of AF burden could provide prognostic information on near-term risk of stroke when compared to conventional risk scores.METHODS AND RESULTS: We retrospectively identified Veterans Health Administration serviced patients with cardiac implantable electronic device remote monitoring data and at least one day of device-registered AF. The first 30 days of remote monitoring in nonstroke controls were compared against the past 30 days of remote monitoring before stroke in cases. We trained 3 types of models on our data: (1) convolutional neural networks, (2) random forest, and (3) L1 regularized logistic regression (LASSO). We calculated the CHA2DS2-VASc score for each patient and compared its performance against machine learned indices based on AF burden in separate test cohorts. Finally, we investigated the effect of combining our AF burden models with CHA2DS2-VASc. We identified 3114 nonstroke controls and 71 stroke cases, with no significant differences in baseline characteristics. Random forest performed the best in the test data set (area under the curve [AUC]=0.662) and convolutional neural network in the validation dataset (AUC=0.702), whereas CHA2DS2-VASc had an AUC of 0.5 or less in both data sets. Combining CHA2DS2-VASc with random forest and convolutional neural network yielded a validation AUC of 0.696 and test AUC of 0.634, yielding the highest average AUC on nontraining data.CONCLUSIONS: This proof-of-concept study found that machine learning and ensemble methods that incorporate daily AF burden signature provided incremental prognostic value for risk stratification beyond CHA2DS2-VASc for near-term risk of stroke.

  View details for DOI 10.1161/CIRCOUTCOMES.118.005595

  View details for PubMedID 31610712

• Transparent sharing of digital health data: A call to action HEART RHYTHM Slotwiner, D. J., Tarakji, K. G., Al-Khatib, S. M., Passman, R. S., Saxon, L. A., Peters, N. S., McCall, D. 2019; 16 (9): E95-E106

  View details for DOI 10.1016/j.hrthm.2019.04.042

  View details for Web of Science ID 000483433300001

• Wavefront Field Mapping Reveals a Physiologic Network Between Drivers Where Ablation Terminates Atrial Fibrillation. Circulation. Arrhythmia and electrophysiology Leef, G., Shenasa, F., Bhatia, N. K., Rogers, A. J., Sauer, W., Miller, J. M., Swerdlow, M., Tamboli, M., Alhusseini, M. I., Armenia, E., Baykaner, T., Brachmann, J., Turakhia, M. P., Atienza, F., Rappel, W., Wang, P. J., Narayan, S. M. 2019; 12 (8): e006835

  Abstract

  BACKGROUND: Localized drivers are proposed mechanisms for persistent atrial fibrillation (AF) from optical mapping of human atria and clinical studies of AF, yet are controversial because drivers fluctuate and ablating them may not terminate AF. We used wavefront field mapping to test the hypothesis that AF drivers, if concurrent, may interact to produce fluctuating areas of control to explain their appearance/disappearance and acute impact of ablation.METHODS: We recruited 54 patients from an international registry in whom persistent AF terminated by targeted ablation. Unipolar AF electrograms were analyzed from 64-pole baskets to reconstruct activation times, map propagation vectors each 20 ms, and create nonproprietary phase maps.RESULTS: Each patient (63.6±8.5 years, 29.6% women) showed 4.0±2.1 spatially anchored rotational or focal sites in AF in 3 patterns. First, a single (type I; n=7) or, second, paired chiral-antichiral (type II; n=5) rotational drivers controlled most of the atrial area. Ablation of 1 to 2 large drivers terminated all cases of types I or II AF. Third, interaction of 3 to 5 drivers (type III; n=42) with changing areas of control. Targeted ablation at driver centers terminated AF and required more ablation in types III versus I (P=0.02 in left atrium).CONCLUSIONS: Wavefront field mapping of persistent AF reveals a pathophysiologic network of a small number of spatially anchored rotational and focal sites, which interact, fluctuate, and control varying areas. Future work should define whether AF drivers that control larger atrial areas are attractive targets for ablation.

  View details for DOI 10.1161/CIRCEP.118.006835

  View details for PubMedID 31352796

• Association Between Warfarin Control Metrics and Atrial Fibrillation Outcomes in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. JAMA cardiology Pokorney, S. D., Holmes, D. N., Thomas, L., Fonarow, G. C., Kowey, P. R., Reiffel, J. A., Singer, D. E., Freeman, J. V., Gersh, B. J., Mahaffey, K. W., Hylek, E. M., Naccarelli, G. V., Ezekowitz, M. D., Piccini, J. P., Peterson, E. D., Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators 2019

  Abstract

  Importance: Bleeding and thrombotic events (eg, stroke and systemic embolism) are common in patients with atrial fibrillation (AF) taking warfarin sodium despite a well-established therapeutic range.Objective: To evaluate whether history of therapeutic warfarin control in patients with AF is independently associated with subsequent bleeding or thrombotic events.Design, Setting, and Participants: In this multicenter cohort study of 176 primary care, cardiology, and electrophysiology clinics in the United States, data were obtained during 51 830 visits among 10 137 patients with AF in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry; 5545 patients treated with warfarin were included in the bleeding analysis, and 5635 patients were included in the thrombotic event analysis. Patient follow-up was performed from June 29, 2010, to November 30, 2014. Data analysis was performed from August 4, 2016, to February 15, 2019.Exposures: Multiple measures of warfarin control within the preceding 6 months were analyzed: time in therapeutic range of 2.0 to 3.0, most recent international normalized ratio (INR), percentage of time that a patient had interpolated INR values less than 2.0 or greater than 3.0, INR variance, INR range, and percentage of INR values in therapeutic range.Main Outcomes and Measures: Association of INR measures, alone or in combination, with clinical factors and risk for thrombotic events and bleeding during the subsequent 6 months was assessed post hoc using logistic regression models.Results: A total of 5545 patients (mean [SD] age, 74.5 [9.8] years; 3184 [57.4%] male) with AF were included in the major bleeding analysis and 5635 patients (mean [SD] age, 74.5 [9.8] years; 3236 [57.4%] male) in the thrombotic event analysis. During a median follow-up of 1.5 years (interquartile range, 1.0-2.5 years), there were 339 major bleeds (6.1%) and 51 strokes (0.9%). Multiple metrics of warfarin control were individually associated with subsequent bleeding. After adjustment for clinical bleeding risk, 3 measures-time in therapeutic range (per 1-SD increase ≤55: adjusted odds ratio [aOR], 1.16; 95% CI, 1.02-1.32), variation in INR values (aOR, 1.32; 95% CI, 1.19-1.47), and maximum INR (aOR, 1.20; 95% CI, 1.10-1.31)-remained associated with bleeding risk. Adding INR variance to a clinical risk model slightly increased the C statistic from 0.68 to 0.69 and had a net reclassification improvement index of 0.028 (95% CI, -0.029 to 0.067). No INR measures were associated with subsequent stroke risk.Conclusions and Relevance: Three metrics of prior warfarin control were associated with bleeding risk but only marginally more so than traditional clinical factors. This study did not identify any measures of INR control that were significantly associated with stroke risk.

  View details for DOI 10.1001/jamacardio.2019.1960

  View details for PubMedID 31268487

• Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications EUROPACE Mohanty, S., Trivedi, C., Beheiry, S., Al-Ahmad, A., Horton, R., Della Rocca, D. G., Gianni, C., Gasperetti, A., Abdul-Moheeth, M., Turakhia, M., Natale, A. 2019; 21 (7): 1048–54

  View details for DOI 10.1093/europace/euz004

  View details for Web of Science ID 000493046000012

• Comparison of QT Interval Measurement Methods and Correction Formulas in Atrial Fibrillation AMERICAN JOURNAL OF CARDIOLOGY Tooley, J., Ouyang, D., Hadley, D., Turakhia, M., Wang, P., Ashley, E., Froelicher, V., Perez, M. 2019; 123 (11): 1822–27

  View details for DOI 10.1016/j.amjcard.2019.02.057

  View details for Web of Science ID 000470339900014

• Management of asymptomatic arrhythmias: a European Heart Rhythm Association (EHRA) consensus document, endorsed by the Heart Failure Association (HFA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin America Heart Rhythm Society (LAHRS) EUROPACE Arnar, D. O., Mairesse, G. H., Boriani, G., Calkins, H., Chin, A., Coats, A., Deharo, J., Svendsen, J., Heidbuchel, H., Isa, R., Kalman, J. M., Lane, D. A., Louw, R., Lip, G. H., Maury, P., Potpara, T., Sacher, F., Sanders, P., Varma, N., Fauchier, L., Haugaa, K., Schwartz, P., Sarkozy, A., Sharma, S., Kongsgard, E., Svensson, A., Lenarczyk, R., Volterrani, M., Turakhia, M., Obel, I. P., Abello, M., Swampillai, J., Kalarus, Z., Kudaiberdieva, G., Traykov, V. B., ESC Sci Document Grp 2019; 21 (6): 844-+

  Abstract

  Asymptomatic arrhythmias are frequently encountered in clinical practice. Although studies specifically dedicated to these asymptomatic arrhythmias are lacking, many arrhythmias still require proper diagnostic and prognostic evaluation and treatment to avoid severe consequences, such as stroke or systemic emboli, heart failure, or sudden cardiac death. The present document reviews the evidence, where available, and attempts to reach a consensus, where evidence is insufficient or conflicting.

  View details for DOI 10.1093/europace/euz046

  View details for Web of Science ID 001209676700001

  View details for PubMedID 30882141

• Risk Factors for Symptomatic Atrial Fibrillation-Analysis of an Outpatient Database. Journal of atrial fibrillation Volgman, A. S., Dunn, P., Sundberg, A., Conard, S., Chakravarty, P., Htway, Z., Waldo, A., Albert, C., Turakhia, M. P., Naccarelli, G. V. 2019; 12 (1): 2141

  Abstract

  Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in practice and is the leading cause of debilitating strokes with significant economic burden. It is currently not known whether asymptomatic undiagnosed AF should be treated if detected by various screening methods. Currently, United States guidelines have no recommendations for identifying patients with asymptomatic undiagnosed AF due to lack of evidence. The American Heart Association Center for Health Technology & Innovation undertook a plan to identify tools in 3 phases that may be useful in improving outcomes in patients with undiagnosed AF. In phase I we sought to identify AF risk factors that can be used to develop a risk score to identify high-risk patients using a large commercial insurance dataset. The principal findings of this study show that individuals at high risk for AF are those with advanced age, the presence of heart failure, coronary artery disease, hypertension, metabolic disorders, and hyperlipidemia. Our analysis also found that chronic respiratory failure was a significant risk factor for those over 65 years of age and chronic kidney disease for those less than 65 years of age.

  View details for DOI 10.4022/jafib.2141

  View details for PubMedID 31687065

• Characteristics of Digital Health Studies Registered in ClinicalTrials.gov JAMA INTERNAL MEDICINE Chen, C. E., Harrington, R. A., Desai, S. A., Mahaffey, K. W., Turakhia, M. P. 2019; 179 (6): 838–40

  View details for DOI 10.1016/j.amepre.2007.01.016

  View details for Web of Science ID 000470823400022

• Practice Variation in Anticoagulation Prescription and Outcomes After Device-Detected Atrial Fibrillation Insights From the Veterans Health Administration CIRCULATION Perino, A. C., Fan, J., Askari, M., Heidenreich, P. A., Keung, E., Raitt, M. H., Piccini, J. P., Ziegler, P. D., Turakhia, M. P. 2019; 139 (22): 2502–12

  View details for DOI 10.1161/CIRCULATIONAHA.118.038988

  View details for Web of Science ID 000478903500005

• Comparison of Patient-Reported Care Satisfaction, Quality of Warfarin Therapy, and Outcomes of Atrial Fibrillation: Findings From the ORBIT-AF Registry JOURNAL OF THE AMERICAN HEART ASSOCIATION Perino, A. C., Shrader, P., Turakhia, M. P., Ansell, J. E., Gersh, B. J., Fonarow, G. C., Go, A. S., Kaiser, D. W., Hylek, E. M., Kowey, P. R., Singer, D. E., Thomas, L., Steinberg, B. A., Peterson, E. D., Piccini, J. P., Mahaffey, K. W. 2019; 8 (9)

  View details for DOI 10.1161/JAHA.118.011205

  View details for Web of Science ID 000484574700020

• A novel pacing maneuver to verify the postpacing interval minus the tachycardia cycle length while adjusting for decremental conduction: Using "dual-chamber entrainment" for improved supraventricular tachycardia discrimination HEART RHYTHM Kaiser, D. W., Nasir, J. M., Liem, L., Brodt, C., Motonaga, K. S., Ceresnak, S. R., Turakhia, M. P., Dubin, A. M. 2019; 16 (5): 717–23

  View details for DOI 10.1016/j.hrthm.2018.11.021

  View details for Web of Science ID 000466096200013

• Adherence to Guideline-Directed Stroke Prevention Therapy for Atrial Fibrillation Is Achievable First Results From Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB) CIRCULATION Piccini, J. P., Xu, H., Cox, M., Matsouaka, R. A., Fonarow, G. C., Butler, J., Curtis, A. B., Desai, N., Fang, M., McCabe, P. J., Page, R. L., Turakhia, M., Russo, A. M., Knight, B. P., Sidhu, M., Hurwitz, J. L., Ellenbogen, K. A., Lewis, W. R., Guidelines-AFIB Clinical Working 2019; 139 (12): 1497–1506

  View details for DOI 10.1161/CIRCULATIONAHA.118.035909

  View details for Web of Science ID 000469318300007

• Practice Variation in Anticoagulation Prescription and Outcomes after Device-Detected Atrial Fibrillation: Insights from the Veterans Health Administration. Circulation Perino, A. C., Fan, J., Askari, M., Heidenreich, P. A., Keung, E., Raitt, M. H., Piccini, J. P., Ziegler, P. D., Turakhia, M. P. 2019

  Abstract

  BACKGROUND: Device-detected atrial fibrillation (AF) is associated with increased risk of stroke. However, there are no clearly-defined thresholds of AF burden for which to initiate oral anticoagulation (OAC). We sought to describe OAC prescription practice variation in response to new device-detected AF and the association to outcomes.METHODS: We performed a retrospective cohort study using data from the Veterans Health Administration linked to remote monitoring data that included day-level AF burden. We included patients with cardiac implantable electronic devices (CIED) and remote monitoring from 2011-2014, CHA2DS2-VASc ≥2, and no prior stroke or OAC receipt in the preceding 2 years. We determined the proportion of patients prescribed OAC within 90-days following new device-detected AF across a range of AF thresholds (≥6 minutes to >24 hours), and examined site variation in OAC prescription. We used multivariable Cox proportional hazards regressions to determine the association of OAC prescription with stroke by device-detected AF burden.RESULTS: Among 10,212 patients with CIEDs, 4,570 patients (45%), 3,969 patients (39%), 3,263 patients (32%), and 2,469 patients (24%) had device-detected AF >6 minutes, >1 hour, >6 hours, and >24 hours, respectively. For device-detected AF >1 hour, 1,712 patients met inclusion criteria (72±10 years; 1.5% female; CHA2DS2-VASc 4.0±1.4; HAS-BLED 2.6±1.1). The proportion receiving OAC varied based on device-detected AF burden (≥6 minutes: 272/2,101 (13%); >1 hour: 273/1,712 (16%); >6 hours: 263/1,279 (21%); >24 hours: 224/818 (27%)). Across 52 sites (N=1,329 patients), there was substantial site-level variation in OAC prescription after device-detected AF >1 hour (median: 16%; range: 3%-67%; median odds ratio: 1.56 [95% credible interval 1.49-1.71]). In adjusted models, OAC prescription after device-detected AF >24 hours was associated with reduced stroke risk (HR 0.28, 95% CI 0.10-0.81, p=0.02), although the propensity-adjusted model was significant when AF lasted at least 6 minutes.CONCLUSIONS: Among Veterans with CIEDs, device-detected AF is common. There is large practice variation in 90-day OAC initiation after new device-detected AF with low rates of treatment overall, even for episodes >24 hours. The strongest association of OAC with reduction in stroke was observed after device-detected AF >24 hours. Randomized trials are needed to confirm these observational findings.

  View details for PubMedID 30880434

• Comparison of QT Interval Measurement Methods and Correction Formulas in Atrial Fibrillation. The American journal of cardiology Tooley, J., Ouyang, D., Hadley, D., Turakhia, M., Wang, P., Ashley, E., Froelicher, V., Perez, M. 2019

  Abstract

  Antiarrhythmic drugs used in atrial fibrillation (AF) cause QT prolongation and are associated with torsades de pointes, a deadly ventricular arrhythmia. No consensus exists on the optimal method of QT measurement or correction in AF. Therefore, we compared common methods to measure and correct QT in AF to identify the most accurate approach. We identified patients who had electrocardiograms done at Stanford Hospital (Stanford, California) between January 2014 and October 2016 with conversion from AF to sinus rhythm (SR) within a 24-hour period. QT intervals were determined using different measurement methods and corrected using the Bazett's, Framingham, Fridericia, or Hodges formulas for heart rate (HR). Comparisons were made between QT in a patient's last instance of AF to SR. Computerized measurements were taken from 715 patients. Manual measurements were taken from a 50-patient subset. Bazett's formula produced the longest corrected QT in AF compared with other formulas (p <0.005). Measuring QT as an average over multiple beats resulted in a smaller difference between AF and SR than choosing a single beat. Determining QT from a 5-beat average resulted in a QTc that was 19.0ms higher (interquartile range 0.30 to 43.7) in AF than SR. After correcting for residual effect of HR on QTc, there was not a significant difference between QTc in AF to SR. In conclusion, measuring QT over multiple beats produces a more accurate measurement of QT in AF. Differences between QTc in AF and SR exist because of imperfect HR correction formula and not due to an independent effect of AF.

  View details for PubMedID 30961909

• IMPACT OF PATIENT FRAILTY ON ONE-YEAR MORTALITY ACROSS CHA2DS2-VASC SCORES: FROM THE TREAT-AF STUDY Pundi, K., Perino, A., Fan, J., Askari, M., Heidenreich, P., Turakhia, M. ELSEVIER SCIENCE INC. 2019: 539

  View details for Web of Science ID 000460565900539

• EFFICACY OF A CENTRALIZED, BLENDED ELECTRONIC, AND HUMAN INTERVENTION TO IMPROVE DOAC ADHERENCE: THE SMARTADHERE TRIAL Turakhia, M. P., Sundaram, V., Smith, S., Ding, V., Ho, P., Kowey, P. R., Piccini, J., Foody, J., Birmingham, M., Ianus, J., Rajmane, A., Mahaffey, K. ELSEVIER SCIENCE INC. 2019: 510

  View details for Web of Science ID 000460565900510

• HOW MUCH ATRIAL FIBRILLATION IS TOO MUCH? TREATMENT BENEFIT OF ANTICOAGULATION BASED ON THRESHOLD OF DEVICE-DETECTED AF Perino, A., Fan, J., Askari, M., Heidenreich, P., Keung, E., Piccini, J., Ziegler, P., Turakhia, M. ELSEVIER SCIENCE INC. 2019: 290

  View details for Web of Science ID 000460565900290

• Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices EUROPACE Piccini, J. P., Passman, R., Turakhia, M., Connolly, A. T., Nabutovsky, Y., Varma, N. 2019; 21 (3): 404–13

  View details for DOI 10.1093/europace/euy222

  View details for Web of Science ID 000473744000009

• Dialysis Modality and Incident Atrial Fibrillation in Older Patients With ESRD AMERICAN JOURNAL OF KIDNEY DISEASES Niu, J., Shah, M. K., Perez, J. J., Airy, M., Navaneethan, S. D., Turakhia, M. P., Chang, T. I., Winkelmayer, W. C. 2019; 73 (3): 324–31

  View details for DOI 10.1053/j.ajkd.2018.09.011

  View details for Web of Science ID 000459248200007

• Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network (vol 25, pg 65, 2019) NATURE MEDICINE Hannun, A. Y., Rajpurkar, P., Haghpanahi, M., Tison, G. H., Bourn, C., Turakhia, M. P., Ng, A. Y. 2019; 25 (3): 530

  View details for DOI 10.1038/s41591-019-0359-9

  View details for Web of Science ID 000460643100037

• Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Piccini, J. P., Passman, R., Turakhia, M., Connolly, A. T., Nabutovsky, Y., Varma, N. 2019; 21 (3): 404–13

  Abstract

  AIMS: Atrial fibrillation (AF) is associated with increased mortality, but the temporal relationship between AF burden (AFB) and death among patients with cardiac implanted electronic devices is unknown. We sought to characterize the timing and progression of AFB before death.METHODS AND RESULTS: Using Merlin.netTM remote monitoring (RM) data, we analysed weekly AFB in patients age ≥55 years implanted with dual-chamber pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices whose death was verified in the Social Security Death Index and who had continuous RM from 1year to 4weeks preceding death. Atrial fibrillation burden was defined as amount of time per week atrial rate exceeded a set threshold of 180 b.p.m. Case-crossover analysis was used to compare the AFB at every week to 6 control weeks at the start of the year before death. There were 3131 patients meeting analysis criteria (age at death 76±8years, 70% men). Weekly increase in AFB >6h was associated with increased odds of death, which was greatest at 4 weeks before death [odds ratio (OR) 2.30, 95% confidence interval (CI) 2.09-2.53; P<0.001]. Atrial fibrillation progression week-to-week >24h was associated with the greatest odds of death (OR 12.95, 95% 8.72-19.22; P<0.001). A combination of AFB >6h per week and activity <0.5h per day was associated with an increased odds of death.CONCLUSION: In this large patient cohort, AFB progression accelerated in the weeks leading to death. Continuous monitoring of AFB may help identify device patients who may be at risk for adverse outcomes, including death.

  View details for PubMedID 30462208

• Characteristics of Digital Health Studies Registered in ClinicalTrials.gov. JAMA internal medicine Chen, C. E., Harrington, R. A., Desai, S. A., Mahaffey, K. W., Turakhia, M. P. 2019

  View details for PubMedID 30801617

• Appropriateness of Direct Oral Anticoagulant Dosing in Patients With Atrial Fibrillation: Insights From the Veterans Health Administration. Journal of pharmacy practice Leef, G. C., Perino, A. C., Askari, M., Fan, J., Ho, P. M., Olivier, C. B., Longo, L., Mahaffey, K. W., Turakhia, M. P. 2019: 897190019828270

  Abstract

  BACKGROUND:: Direct oral anticoagulants (DOACs) have strict dosing guidelines, but recent studies indicate that inappropriate dosing is common, particularly in chronic kidney disease (CKD), for which it has been reported to be as high as 43%. Since 2011, the Veterans Health Administration (VA) has implemented anticoagulation management programs for DOACs, generally led by pharmacists, which has previously been shown to improve medication adherence.OBJECTIVE:: We investigated the prevalence of overdosing and underdosing of DOACs in the VA.METHODS:: Using data from the TREAT-AF cohort study (The Retrospective Evaluation and Assessment of Therapies in AF), we identified VA patients with newly diagnosed atrial fibrillation (AF) and receipt of a DOAC between 2003 and 2015. We classified dosing as correct, overdosed, or underdosed based on the Food and Drug Administration-approved dosing criteria.RESULTS:: Of 230 762 patients, 5060 received dabigatran (77.3%) or rivaroxaban (22.7%) within 90 days of AF diagnosis (age 69 [10[ years; CHA2DS2-VASc 1.6 [1.4]), of which 1312 (25.9%) had CKD based on estimated glomerular filtration rate <60. Overall, 93.6% of patients, 83.2% with CKD, received appropriate DOAC dosing. Incorrect dosing increased with worsening renal function.CONCLUSION:: Compared to recent studies of commercial payers and health-care systems, incorrect dosing of DOACs is less common across the VA. Pharmacist-led DOAC management or similar anticoagulation management interventions may reduce the risk of incorrect dosing across health-care systems.

  View details for PubMedID 30791808

• Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology Mohanty, S., Trivedi, C., Beheiry, S., Al-Ahmad, A., Horton, R., Della Rocca, D. G., Gianni, C., Gasperetti, A., Abdul-Moheeth, M., Turakhia, M., Natale, A. 2019

  Abstract

  Aims: Manual compression (MC), widely used to achieve venous access haemostasis, needs prolonged immobilization and extended time-to-haemostasis. Vascular closure devices (VCD) have been reported to have significantly shorter time to haemostasis and ambulation in arterial access-site management. The current study aimed to evaluate the safety and efficacy as well as rate of urinary tract complications in patients receiving MC vs. VCD for venous access-site closure.Methods and results: A total of 803 consecutive patients undergoing catheter ablation or left atrial appendage closure were classified into the VCD (n=304) and the MC (n=499) group, based on the methods used for haemostasis at the venous access site. Foley catheter was used for bladder-emptying in all MC cases and 15 VCD patients. At one site, VCD group patients with experience of MC in prior ablations were asked to describe their overall satisfaction level after comparing the past experience with the present. Haemostasis was achieved effectively in both populations. No VCD cases required >2h bed rest, whereas 7 (1.4%) patients in the MC group needed prolonged immobilization (P=0.04). Significantly higher incidence of access-site haematoma (P=0.004) and urinary complications (P<0.05) were observed in the MC group. Majority of VCD patients (68%) with prior experience of MC for haemostasis expressed satisfaction over the early ambulation and ability to void urine without bladder catheterization.Conclusion: Vascular closure devices provided effective haemostasis, while reducing the access-site complications, ambulation time, and urinary complications.

  View details for PubMedID 30726903

• Real-World Comparison of ClassesICandIII Antiarrhythmic Drugs asan Initial Rhythm Control Strategy inNewly Diagnosed Atrial Fibrillation: From the TREAT-AF Study. JACC. Clinical electrophysiology Kipp, R., Askari, M., Fan, J., Field, M. E., Turakhia, M. P. 2019; 5 (2): 231–41

  Abstract

  OBJECTIVES: In this study the authors investigated effectiveness and safety of an initial treatment strategy with classIC or class III antiarrhythmic drugs (AAD) for newly diagnosed atrial fibrillation (AF) or atrial flutter (AFL).BACKGROUND: There is limited evidence to guide optimal AAD selection for rhythm control in newly diagnosed AF/AFL.METHODS: Using data from TREAT-AF (The Retrospective Evaluation and Assessment of Therapies in AF), the authors performed a retrospective cohort study of patients with AF/AFL from 2004 to 2014 and class IC or class III AAD prescription within 90 days following diagnosis. Patients with prior myocardial infarction, heart failure, or end-stage renal disease were excluded. Inverse probability treatment weighted propensity scores were used to evaluate the association of AAD class on hospitalization and cardiovascular events. To evaluate residual confounding, falsification outcomes were evaluated.RESULTS: A total of 230,762 patients developed newly diagnosed AF/AFL during the study period. Of those, 3,973 patients (1.7%) were prescribed class IC and 6,909 (3.0%) were prescribed class III AAD. Median follow-up was 4.9 years. After inverse probability treatment weighted adjustment, class IC medications were associated with lower risk of hospitalizations for AF/AFL (hazard ratio [HR]: 0.77; 95% confidence interval [CI]: 0.73 to 0.81), cardiovascular disease (HR: 0.78; 95% CI: 0.75 to 0.81), heart failure (HR: 0.70; 95% CI: 0.64 to 0.76), and lower incidence of ischemic stroke (HR:0.74; 95% CI: 0.65 to 0.85). Similar results were found in CHADS2 (Congestive Heart Failure, Hypertension, Age≥75 Years, Diabetes Mellitus, Prior Stroke, Transient Ischemic Attack, or Thromboembolism) 0 or 1 and CHA2DS2-VASc (Congestive Heart Failure, Hypertension, Age≥75 Years, Diabetes Mellitus, Prior Stroke, Transient Ischemic Attack, or Thromboembolism, Vascular Disease, Age 65 to 74 Years, Sex) 0 or 1 subgroups. Falsification analyses for outcomes of urinary tract infection, pneumonia, and hip fracture were generally nonsignificant.CONCLUSIONS: Prescription of class IC AAD as initial treatment for newly diagnosed AF/AFL, compared with prescription of class III AAD, may be associated with lower risk of hospitalization and cardiovascular events.

  View details for PubMedID 30784696

• Real-World Comparison of Classes IC and III Antiarrhythmic Drugs as an Initial Rhythm Control Strategy in Newly Diagnosed Atrial Fibrillation From the TREAT-AF Study JACC-CLINICAL ELECTROPHYSIOLOGY Kipp, R., Askari, M., Fan, J., Field, M. E., Turakhia, M. P. 2019; 5 (2): 231–41

  View details for DOI 10.1016/j.jacep.2018.08.025

  View details for Web of Science ID 000602294500015

• Secular trends in success rate of catheter ablation for atrial fibrillation: The SMASH-AF cohort AMERICAN HEART JOURNAL Perino, A. C., Leef, G. C., Cluckey, A., Yunus, F. N., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2019; 208: 110–19

  View details for DOI 10.1016/j.ahj.2018.10.006

  View details for Web of Science ID 000459125900013

• Adherence to Guideline-Directed Stroke Prevention Therapy for Atrial Fibrillation is Achievable: First Results from Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB). Circulation Piccini, J. P., Xu, H., Cox, M., Matsouaka, R. A., Fonarow, G. C., Butler, J., Curtis, A. B., Desai, N., Fang, M., McCabe, P. J., Page, R. L., Turakhia, M., Russo, A. M., Knight, B. P., Sidhu, M., Hurwitz, J. L., Ellenbogen, K. A., Lewis, W. R., Get With The Guidelines-AFIB Clinical Working Group and Hospitals 2019

  Abstract

  BACKGROUND: Efforts to improve oral anticoagulation (OAC) prescription in patients with atrial fibrillation (AF) have had limited success in improving guideline adherence.METHODS: We evaluated adherence to the ACC/AHA performance measures for OAC in eligible patients with a CHA2DS2-VASc≥2 and trends in prescription over time in the American Heart Association's Get With The Guidelines (GWTG) AFIB registry. Adjusted associations with in-hospital outcomes were also determined. The cohort included 33,235 AF admissions with a CHA2DS2-VASc≥2 enrolled at 115 sites between January 1, 2013 and September 31, 2017.RESULTS: The median age was 73 (65, 81), 52% were female, and the median CHA2DS2-VASc score was 4 (3, 5). At admission 16,206 (59.5%) with a prior diagnosis of AF were on OAC and OAC at admission was associated with a lower adjusted odds of in-hospital ischemic stroke (OR 0.38, 95% CI 0.24-0.59, p<0.0001). At discharge, prescription of OAC in eligible patients (no contraindications) was 93.5% (n=25,499/27,270). In a sensitivity analysis, when excluding only strict contraindications (4.6%, n=1,497/32,806), OAC prescription at discharge was 80.3%. Frequency of OAC was higher in those age ≤75, men, those with heart failure, prior AF ablation, and rhythm control (p<0.0001 for all). OAC use was lowest in Hispanic patients (90.2%, p<0.0001). Prescription of OAC at discharge in eligible patients improved over time from 79.9% to 96.6% (p<0.0001).CONCLUSIONS: Among hospitals participating in the GWTG-AFIB quality improvement program, OAC prescription at discharge in eligible guideline-indicated patients increased significantly and improved consistently over time. These data confirm that high-level adherence to guideline recommended stroke prevention is achievable.

  View details for PubMedID 30700141

• Publisher Correction: Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature medicine Hannun, A. Y., Rajpurkar, P., Haghpanahi, M., Tison, G. H., Bourn, C., Turakhia, M. P., Ng, A. Y. 2019

  Abstract

  In the version of this article originally published, the x axis labels in Fig. 1a were incorrect. The labels originally were 'Specificity,' but should have been '1 - Specificity.' Also, the x axis label in Fig. 2b was incorrect. It was originally 'DNN predicted label,' but should have been 'Average cardiologist label.' The errors have been corrected in the PDF and HTML versions of this article.

  View details for PubMedID 30679787

• Efficacy of Ablation Lesion Sets in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation: Findings From the SMASH - AF Meta-Analysis Study Cohort. Journal of the American Heart Association Cluckey, A., Perino, A. C., Yunus, F. N., Leef, G. C., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2019; 8 (1): e009976

  Abstract

  Background The objective was to explore the efficacy of ablation lesion sets in addition to pulmonary vein isolation ( PVI ) for paroxysmal atrial fibrillation. The optimal strategy for catheter ablation of paroxysmal atrial fibrillation is debated. Methods and Results The SMASH-AF (Systematic Review and Meta-analysis of Ablation Strategy Heterogeneity in Atrial Fibrillation) study cohort includes trials and observational studies identified in PubMed, Scopus, and Cochrane databases from January 1 1990, to August 1, 2016. We included studies reporting single procedure paroxysmal atrial fibrillation ablation success rates. Exclusion criteria included insufficient reporting of outcomes, ablation strategies that were not prespecified and uniform, and a sample size of fewer than 40 patients. We analyzed lesion sets performed in addition to PVI ( PVI plus) using multivariable random-effects meta-regression to control for patient, study, and procedure characteristics. The analysis included 145 total studies with 23263 patients ( PVI- only cohort: 115 studies, 148 treatment arms, 16500 patients; PVI plus cohort: 39 studies; 46 treatment arms, 6763 patients). PVI plus studies, as compared with PVI -only studies, included younger patients (56.7years versus 58.8years, P=0.001), fewer women (27.2% versus 32.0% women, P=0.002), and were more methodologically rigorous with longer follow-up (29.5 versus 17.1months, P 0.004) and more randomization (19.4% versus 11.8%, P<0.001). In multivariable meta-regression, PVI plus studies were associated with improved success (7.6% absolute improvement [95% CI, 2.6-12.5%]; P<0.01, I2=88%), specifically superior vena cava isolation (4 studies, 4 treatment arms, 1392 patients; 15.1% absolute improvement [95%CI, 2.3-27.9%]; P 0.02, I2=87%). However, residual heterogeneity was large. Conclusions Across the paroxysmal atrial fibrillation ablation literature, PVI plus ablation strategies were associated with incremental improvements in success rate. However, large residual heterogeneity complicates evidence synthesis.

  View details for PubMedID 30587059

• Efficacy of Ablation Lesion Sets in Addition to Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation: Findings From the SMASH-AF Meta-Analysis Study Cohort JOURNAL OF THE AMERICAN HEART ASSOCIATION Cluckey, A., Perino, A. C., Yunus, F. N., Leef, G. C., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2019; 8 (1)

  View details for DOI 10.1161/JAHA.118.009976

  View details for Web of Science ID 000455185000012

• Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nature medicine Hannun, A. Y., Rajpurkar, P., Haghpanahi, M., Tison, G. H., Bourn, C., Turakhia, M. P., Ng, A. Y. 2019; 25 (1): 65–69

  Abstract

  Computerized electrocardiogram (ECG) interpretation plays a critical role in the clinical ECG workflow1. Widely available digital ECG data and the algorithmic paradigm of deep learning2 present an opportunity to substantially improve the accuracy and scalability of automated ECG analysis. However, a comprehensive evaluation of an end-to-end deep learning approach for ECG analysis across a wide variety of diagnostic classes has not been previously reported. Here, we develop a deep neural network (DNN) to classify 12 rhythm classes using 91,232 single-lead ECGs from 53,549 patients who used a single-lead ambulatory ECG monitoring device. When validated against an independent test dataset annotated by a consensus committee of board-certified practicing cardiologists, the DNN achieved an average area under the receiver operating characteristic curve (ROC) of 0.97. The average F1 score, which is the harmonic mean of the positive predictive value and sensitivity, for the DNN (0.837) exceeded that of average cardiologists (0.780). With specificity fixed at the average specificity achieved by cardiologists, the sensitivity of the DNN exceeded the average cardiologist sensitivity for all rhythm classes. These findings demonstrate that an end-to-end deep learning approach can classify a broad range of distinct arrhythmias from single-lead ECGs with high diagnostic performance similar to that of cardiologists. If confirmed in clinical settings, this approach could reduce the rate of misdiagnosed computerized ECG interpretations and improve the efficiency of expert human ECG interpretation by accurately triaging or prioritizing the most urgent conditions.

  View details for PubMedID 30617320

• Site Variation and Outcomes for Antithrombotic Therapy in Atrial Fibrillation Patients After Percutaneous Coronary Intervention. Circulation. Cardiovascular interventions Olivier, C. B., Fan, J. n., Askari, M. n., Mahaffey, K. W., Heidenreich, P. A., Perino, A. C., Leef, G. C., Ho, P. M., Harrington, R. A., Turakhia, M. P. 2019; 12 (8): e007604

  Abstract

  Patients with atrial fibrillation (AF) treated with percutaneous coronary intervention (PCI) require multiple antithrombotic therapies. The optimal strategy is debated suggesting increased treatment variation. This study sought to characterize site-level variation in antithrombotic therapies in AF patients after PCI and determine the association with outcomes.Using the retrospective TREAT-AF study (The Retrospective Evaluation and Assessment of Therapies in AF) from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2015 followed by a PCI with a P2Y12-antagonist prescription were identified. Patients were grouped according to the therapy dispensed 7 days before until 30 days after the PCI: oral anticoagulation plus platelet inhibition (OAC+PI) or platelet inhibition only. A combined outcome of death, myocardial infarction, stroke, or major bleeding was assessed 1 year after PCI and Cox regression was performed to estimate hazard ratios.Of 230 762 patients with newly diagnosed AF, 4042 (1.8%) underwent PCI and received a P2Y12-antagonist during the observation period (age, 67±9 years; CHA2DS2-VASc, 2.7±1.7; HAS-BLED, 2.6±1.2). Among these, 47% were prescribed OAC+PI, and 53% platelet inhibition only 7 days before until 30 days after the PCI. Across 63 sites, the use of OAC+PI ranged from 19% to 66%. Prescription of OAC+PI was independently associated with a reduction in the combined outcome of death, myocardial infarction, stroke, or major bleeding compared with platelet inhibition only (adjusted hazard ratio, 0.85; 95% CI, 0.73-0.99; P=0.033).In patients with established AF undergoing PCI, the use of OAC+PI varied substantially across sites in the 30 days post-PCI. Anticoagulation appeared to be underutilized but was associated with improved outcomes. Strategies to promote OAC+PI and minimize site variation may be useful, particularly in light of recent randomized trials.

  View details for DOI 10.1161/CIRCINTERVENTIONS.118.007604

  View details for PubMedID 31416357

• Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study AMERICAN HEART JOURNAL Turakhia, M. P., Desai, M., Hedlin, H., Rajmane, A., Talati, N., Ferris, T., Desai, S., Nag, D., Patel, M., Kowey, P., Rumsfeld, J. S., Russo, A. M., Hills, M., Granger, C. B., Mahaffey, K. W., Perez, M. V. 2019; 207: 66–75

  View details for DOI 10.1016/j.ahj.2018.09.002

  View details for Web of Science ID 000452986300008

• Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network NATURE MEDICINE Hannun, A. Y., Rajpurkar, P., Haghpanahi, M., Tison, G. H., Bourn, C., Turakhia, M. P., Ng, A. Y. 2019; 25 (1): 65-+

  View details for DOI 10.1038/s41591-018-0268-3

  View details for Web of Science ID 000455027700022

• Comparison of Patient-Reported Care Satisfaction, Quality of Warfarin Therapy, and Outcomes of Atrial Fibrillation: Findings From the ORBIT - AF Registry. Journal of the American Heart Association Perino, A. C., Shrader, P. n., Turakhia, M. P., Ansell, J. E., Gersh, B. J., Fonarow, G. C., Go, A. S., Kaiser, D. W., Hylek, E. M., Kowey, P. R., Singer, D. E., Thomas, L. n., Steinberg, B. A., Peterson, E. D., Piccini, J. P., Mahaffey, K. W. 2019; 8 (9): e011205

  Abstract

  Background Patient satisfaction with therapy is an important metric of care quality and has been associated with greater medication persistence. We evaluated the association of patient satisfaction with warfarin therapy to other metrics of anticoagulation care quality and clinical outcomes among patients with atrial fibrillation ( AF ). Methods and Results Using data from the ORBIT - AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry, patients were identified with AF who were taking warfarin and had completed an Anti-Clot Treatment Scale ( ACTS ) questionnaire, a validated metric of patient-reported burden and benefit of oral anticoagulation. Multivariate regressions were used to determine association of ACTS burden and benefit scores with time in therapeutic international normalized ratio range ( TTR ; both ≥75% and ≥60%), warfarin discontinuation, and clinical outcomes (death, stroke, major bleed, and all-cause hospitalization). Among 1514 patients with AF on warfarin therapy (75±10 years; 42% women; CHA 2 DS 2- VAS c 3.9±1.7), those most burdened with warfarin therapy were younger and more likely to be women, have paroxysmal AF , and to be treated with antiarrhythmic drugs. After adjustment for covariates, ACTS burden scores were independent of TTR ( TTR ≥75%: odds ratio, 1.01 [95% CI , 0.99-1.03]; TTR ≥60%: odds ratio, 1.01 [95% CI , 0.98-1.05]), warfarin discontinuation (odds ratio, 0.99; 95% CI , 0.97-1.01), or clinical outcomes. ACTS benefit scores were also not associated with TTR , warfarin discontinuation, or clinical outcomes. Conclusions In a large registry of patients with AF taking warfarin, ACTS scores provided independent information beyond other traditional metrics of oral anticoagulation care quality and identified patient groups at high risk for dissatisfaction with warfarin therapy.

  View details for PubMedID 31023126

• Harmonized outcome measures for use in atrial fibrillation patient registries and clinical practice Endorsed by the Heart Rhythm Society Board of Trustees HEART RHYTHM Calkins, H., Gliklich, R. E., Leavy, M. B., Piccini, J. P., Hsu, J. C., Mohanty, S., Lewis, W., Nazarian, S., Turakhia, M. P. 2019; 16 (1): E3–E16

  View details for DOI 10.1016/j.hrthm.2018.09.021

  View details for Web of Science ID 000454718800003

• Blood Pressure and Incident Atrial Fibrillation in Older Patients Initiating Hemodialysis. Clinical journal of the American Society of Nephrology : CJASN Chang, T. I., Liu, S. n., Airy, M. n., Niu, J. n., Turakhia, M. P., Flythe, J. E., Montez-Rath, M. E., Winkelmayer, W. C. 2019

  Abstract

  We examined the association of predialysis systolic and diastolic BP and intradialytic hypotension with incident atrial fibrillation in older patients initiating hemodialysis.We used the US Renal Data System linked to the records of a large dialysis provider to identify patients aged ≥67 years initiating hemodialysis between January 2006 and October 2011. We examined quarterly average predialysis systolic BP, diastolic BP, and proportion of sessions with intradialytic hypotension (i.e., nadir systolic BP <90 mm Hg). We applied an extended Cox model to compute adjusted hazard ratios (HRs) of each exposure with incident atrial fibrillation.Among 17,003 patients, 3785 developed atrial fibrillation. When comparing predialysis systolic BP to a fixed reference of 140 mm Hg, lower predialysis systolic BP was associated with a higher hazard of atrial fibrillation, whereas higher systolic BP was associated with a lower hazard of atrial fibrillation. When comparing across a range of systolic BP for two hypothetical patients with similar measured covariates, the association varied by mean systolic BP: at systolic BP 190 mm Hg, each 10 mm Hg lower systolic BP was associated with lower atrial fibrillation hazard (HR, 0.94; 95% confidence interval, 0.90 to 1.00), whereas at systolic BP 140 mm Hg, a 10 mm Hg lower systolic BP was associated with a higher atrial fibrillation hazard (HR, 1.12; 95% confidence interval, 1.10 to 1.14). Lower diastolic BP was associated with higher atrial fibrillation hazards. Intradialytic hypotension was weakly associated with atrial fibrillation.In this observational study of older patients initiating hemodialysis, lower predialysis systolic BP and diastolic BP were associated with higher incidence of atrial fibrillation.

  View details for DOI 10.2215/CJN.13511118

  View details for PubMedID 31175104

• Urinary tract infection after catheter ablation of atrial fibrillation. Pacing and clinical electrophysiology : PACE Cluckey, A. n., Perino, A. C., Fan, J. n., Askari, M. n., Nasir, J. n., Marcus, G. M., Baykaner, T. n., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2019

  Abstract

  Urinary tract infection (UTI) is common after surgical procedures and a quality improvement target. For non-surgical procedures such as catheter ablation of atrial fibrillation (AF), UTI risk has not been characterized. We sought to determine incidence and risk factors of UTI after AF ablation and risk variation across sites.Using Marketscan commercial claims databases, we performed a retrospective cohort study of patients that underwent AF ablation from 2007 to 2011. The primary outcome was UTI diagnosis within 30 days after ablation. We performed multivariate analyses to determine risk factors for UTI and risk of sepsis within 30 days after ablation with UTI as the predictor variable. Median odds ratio was used to quantify UTI site variation.Among 21,091 patients (age 59.2±10.9; 29.1% female; CHA2 DS2 -VASc 2.0±1.6), 622 (2.9%) were diagnosed with UTI within 30 days. In multivariate analyses, UTI was independently associated with age, female sex, prior UTI, and general anesthesia (all p < 0.01). UTI diagnosis was associated with a substantial increased risk of sepsis within 30 days (5.0% vs. 0.3%; OR 17.5; 95% CI 10.8 - 28.2; p < 0.0001). Among 416 sites, 211 had at least one UTI. Among these 211 sites, the incidence of post-ablation UTI ranged from 0.7%-26.7% (median: 5.4%; IQR: 3.0%-7.1%; 95th percentile: 14.3%; median odds ratio: 1.45; 95% CI 1.41-1.50).UTI after AF ablation is not uncommon and varies substantially across sites. Consideration of UTI as a quality measure and interventions targeted at high-risk patients or sites warrant consideration. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1111/pace.13738

  View details for PubMedID 31168821

• Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. The New England journal of medicine Perez, M. V., Mahaffey, K. W., Hedlin, H., Rumsfeld, J. S., Garcia, A., Ferris, T., Balasubramanian, V., Russo, A. M., Rajmane, A., Cheung, L., Hung, G., Lee, J., Kowey, P., Talati, N., Nag, D., Gummidipundi, S. E., Beatty, A., Hills, M. T., Desai, S., Granger, C. B., Desai, M., Turakhia, M. P., Apple Heart Study Investigators, Perez, M. V., Turakhia, M. P., Lhamo, K., Smith, S., Berdichesky, M., Sharma, B., Mahaffey, K., Parizo, J., Olivier, C., Nguyen, M., Tallapalli, S., Kaur, R., Gardner, R., Hung, G., Mitchell, D., Olson, G., Datta, S., Gerenrot, D., Wang, X., McCoy, P., Satpathy, B., Jacobsen, H., Makovey, D., Martin, A., Perino, A., O'Brien, C., Gupta, A., Toruno, C., Waydo, S., Brouse, C., Dorfman, D., Stein, J., Huang, J., Patel, M., Fleischer, S., Doll, E., O'Reilly, M., Dedoshka, K., Chou, M., Daniel, H., Crowley, M., Martin, C., Kirby, T., Brumand, M., McCrystale, K., Haggerty, M., Newberger, J., Keen, D., Antall, P., Holbrook, K., Braly, A., Noone, G., Leathers, B., Montrose, A., Kosowsky, J., Lewis, D., Finkelmeier, J. R., Bemis, K., Mahaffey, K. W., Desai, M., Talati, N., Nag, D., Rajmane, A., Desai, S., Caldbeck, D., Cheung, L., Granger, C., Rumsfeld, J., Kowey, P. R., Hills, M. T., Russo, A., Rockhold, F., Albert, C., Alonso, A., Wruck, L., Friday, K., Wheeler, M., Brodt, C., Park, S., Rogers, A., Jones, R., Ouyang, D., Chang, L., Yen, A., Dong, J., Mamic, P., Cheng, P., Shah, R., Lorvidhaya, P. 2019; 381 (20): 1909–17

  Abstract

  BACKGROUND: Optical sensors on wearable devices can detect irregular pulses. The ability of a smartwatch application (app) to identify atrial fibrillation during typical use is unknown.METHODS: Participants without atrial fibrillation (as reported by the participants themselves) used a smartphone (Apple iPhone) app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was initiated and an electrocardiography (ECG) patch was mailed to the participant, to be worn for up to 7 days. Surveys were administered 90 days after notification of the irregular pulse and at the end of the study. The main objectives were to estimate the proportion of notified participants with atrial fibrillation shown on an ECG patch and the positive predictive value of irregular pulse intervals with a targeted confidence interval width of 0.10.RESULTS: We recruited 419,297 participants over 8 months. Over a median of 117 days of monitoring, 2161 participants (0.52%) received notifications of irregular pulse. Among the 450 participants who returned ECG patches containing data that could be analyzed - which had been applied, on average, 13 days after notification - atrial fibrillation was present in 34% (97.5% confidence interval [CI], 29 to 39) overall and in 35% (97.5% CI, 27 to 43) of participants 65 years of age or older. Among participants who were notified of an irregular pulse, the positive predictive value was 0.84 (95% CI, 0.76 to 0.92) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular pulse notification and 0.71 (97.5% CI, 0.69 to 0.74) for observing atrial fibrillation on the ECG simultaneously with a subsequent irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. There were no reports of serious app-related adverse events.CONCLUSIONS: The probability of receiving an irregular pulse notification was low. Among participants who received notification of an irregular pulse, 34% had atrial fibrillation on subsequent ECG patch readings and 84% of notifications were concordant with atrial fibrillation. This siteless (no on-site visits were required for the participants), pragmatic study design provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices. (Funded by Apple; Apple Heart Study ClinicalTrials.gov number, NCT03335800.).

  View details for DOI 10.1056/NEJMoa1901183

  View details for PubMedID 31722151

• Transparent Sharing of Digital Health Data: A Call to Action. Heart rhythm Slotwiner, D. J., Tarakji, K. G., Al-Khatib, S. M., Passman, R. S., Saxon, L. A., Peters, N. S., McCall, D. n., Turakhia, M. P., Schaeffer, J. n., Mendenhall, G. S., Hindricks, G. n., Narayan, S. M., Davenport, E. E., Marrouche, N. F. 2019

  View details for PubMedID 31077802

• Venous Vascular Closure System (VVCS) vs. Manual Compression (MC) for EP Catheter Ablation: The AMBULATE Randomized Trial Natale, A., Al-Ahmad, A., Bailey, S., Bunch, T., Compton, S., De Lurgio, D. B., Horton, R. P., Mittal, S., O'Neill, P., Spear, W., Turakhia, M. P. LIPPINCOTT WILLIAMS & WILKINS. 2018: E769

  View details for Web of Science ID 000453713500036

• Assessment of Procedural Technique and Safety of Atrial Fibrillation Ablation: Data from the AHA/HRS Get With The Guidelines Atrial Fibrillation Registry Piccini, J. P., Liang, L., Matsouaka, R., Curtis, A. B., Day, J. D., Desai, N., Ellenbogen, K., Fang, M., Feld, G., Fonarow, G. C., Frankel, D. S., Hurwitz, J. L., Knight, B. P., Joglar, J., McCabe, P. J., Page, R. L., Russo, A. M., Sheth, K. N., Sidhu, M. S., Turakhia, M., Lewis, W. R. LIPPINCOTT WILLIAMS & WILKINS. 2018: E775

  View details for Web of Science ID 000453713500047

• A Novel Pacing Maneuver to Verify the Post-Pacing Interval Minus the Tachycardia Cycle Length While Adjusting for Decremental Conduction: Using 'Dual Chamber Entrainment' for Improved Supraventricular Tachycardia Discrimination. Heart rhythm Kaiser, D. W., Nasir, J. M., Liem, L. B., Brodt, C., Motonaga, K. S., Ceresnak, S. R., Turakhia, M. P., Dubin, A. M. 2018

  Abstract

  BACKGROUND: The post-pacing interval (PPI) minus the tachycardia cycle length (TCL) is frequently used to investigate tachycardias. However, a variety of issues (e.g. failure to entrain, decremental conduction, and oscillating TCLs) can make interpretation of the PPI-TCL challenging.OBJECTIVES: To investigate a novel maneuver to confirm the PPI-TCL value without using either the ventricular PPI or the TCL interval. To assess the ability of this maneuver to identify decremental conduction and differentiate supraventricular tachycardias.METHODS: We analyzed 77 intracardiac recordings from patients [age 25±20 years, 40 female] who underwent catheter ablation of AVNRT or orthodromic reciprocating tachycardia (ORT) with a concealed pathway. We calculated the PPI-TCL, the AH-corrected PPI-TCL, and estimated the PPI-TCL using "dual chamber entrainment" calculated as: [PPIV-TCL=Stim(AoV)+Stim(VoA)-PPIA].RESULTS: The PPI-TCL calculated by dual chamber entrainment highly correlated with the observed and AH-corrected PPI-TCL [R2=0.79 and 0.96, respectively, p<0.001]. A dual chamber entrainment PPI-TCL value of 80ms correctly differentiated all AVNRT from septal ORT cases, whereas the standard PPI-TCL and AH-corrected PPI-TCL methods were incorrect in 14% and 6% of cases, respectively. Dual chamber entrainment identified 3±10ms of additional decremental conduction beyond AH-prolongation, including four pathways with significant (>10ms) decrement.CONCLUSION: Dual chamber entrainment estimates the PPI-TCL value without using either the ventricular PPI or the TCL interval. This maneuver adjusts for all decremental conduction, including within concealed pathways, where a dual chamber entrainment PPI-TCL value >80ms favors AVNRT over ORT. This maneuver can be used to verify the observed PPI-TCL value in challenging cases.

  View details for PubMedID 30465902

• Dialysis Modality and Incident Atrial Fibrillation in Older Patients With ESRD. American journal of kidney diseases : the official journal of the National Kidney Foundation Niu, J., Shah, M. K., Perez, J. J., Airy, M., Navaneethan, S. D., Turakhia, M. P., Chang, T. I., Winkelmayer, W. C. 2018

  Abstract

  RATIONALE & OBJECTIVE: Atrial fibrillation (AF) is common in patients with kidney failure treated by maintenance dialysis. Whether the incidence of AF differs between patients receiving hemodialysis and peritoneal dialysis is uncertain.STUDY DESIGN: Retrospective cohort study.SETTING & PARTICIPANTS: Using the US Renal Data System, we identified older patients (≥67 years) with Medicare Parts A and B who initiated dialysis therapy (1996-2011) without a diagnosis of AF during the prior 2 years.EXPOSURE: Dialysis modality at incident end-stage renal disease (ESRD) and maintained for at least 90 days.OUTCOME: Patients were followed up for 36 months or less for a new diagnosis of AF.ANALYTICAL APPROACH: Time-to-event analysis usingmultivariable Cox proportional hazards regression to estimate cause-specific HRs whilecensoring at modality switch, kidney transplantation, or death.RESULTS: Overall, 271,722 older patients were eligible; 17,487 (6.9%) were treated with peritoneal dialysis, and 254,235 (93.1%), with hemodialysis, at the onset of ESRD. During 406,225 person-years of follow-up, 69,705 patients had AF newly diagnosed. Because the proportionality assumption was violated, we introduced an interaction term between time (first 90 days vs thereafter) and modality. The AF incidence during the first 90 days was 187/1,000 person-years on peritoneal dialysis therapy and 372/1,000 person-years on hemodialysis therapy. Patients on peritoneal dialysis therapy had an adjusted 39% (95% CI, 34%-43%) lower incidence of AFthan those on hemodialysis therapy. From day91 onward, AF incidence was 140/1,000 person-years with no major difference between modalities.LIMITATIONS: Residual confounding from unobserved differences between exposure groups; ascertainment of AF from billing claims; study of first modality may not generalize to patients switching modalities; uncertain generalizability to younger patients.CONCLUSIONS: Although patients initiating dialysis therapy using peritoneal dialysis had a lower AF incidence during the first 90 days of ESRD, therewas no major difference in AF incidence thereafter. The value of interventions to reduce the early excess AF risk in patients receiving hemodialysismay warrant further study.

  View details for PubMedID 30449517

• Harmonized Outcome Measures for Use in Atrial Fibrillation Patient Registries and Clinical Practice: Endorsed by the Heart Rhythm Society Board of Trustees. Heart rhythm Calkins, H., Gliklich, R. E., Leavy, M. B., Piccini, J. P., Hsu, J. C., Mohanty, S., Lewis, W., Nazarian, S., Turakhia, M. P. 2018

  Abstract

  BACKGROUND: Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization.OBJECTIVES: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice.METHODS: AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings.RESULTS: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements.CONCLUSIONS: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.

  View details for PubMedID 30449519

• CHA2DS2VASC and HAS-BLED Scores Predict Frailty in Non-Valvular Atrial Fibrillation Pundi, K., Perino, A., Fan Jun, Askari, M., Heidenreich, P., Turakhia, M. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619406362

• Atrial Fibrillation Treatment and Outcomes in Pregnancy Yunus, F. N., Askari, M., Fan, J., Perino, A. C., Turakhia, M. P. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619404412

• Comparison of Patient Reported Care Satisfaction, Quality of Warfarin Therapy, and Outcomes of Atrial Fibrillation: Findings From the ORBIT-AF Registry Perino, A. C., Shrader, P., Turakhia, M. P., Ansell, J. E., Gersh, B. J., Fonarow, G. C., Go, A. S., Kaiser, D. W., Hylek, E. M., Kowey, P. R., Singer, D. E., Thomas, L., Steinberg, B. A., Peterson, E. D., Piccini, J. P., Mahaffey, K. W. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619405129

• Estimation of Stroke Outcomes in Atrial Fibrillation Using Continuous Clinical and Implantable Device Data From the Treat-AF Study: A Comparison With CHA2DS2-VASc Score Bentley, J. P., Askari, M., Fan Jun, Heidenreich, P. A., Mahaffey, K. W., Desai, M., Scheinker, D., Turakhia, M. P. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619404424

• Venous Access Site Closure With Vascular Closure Device versus Manual Compression in Patients Undergoing Catheter Ablation or Left Atrial Appendage Occlusion Under Uninterrupted Anticoagulation: A Multi-Center Experience on Efficacy and Complications Mohanty, S., Trivedi, C., Beheiry, S., Ahmad, A., Horton, R., Della Rocca, D., Gianni, C., Gasperetti, A., Abdul-Moheeth, M., Turakhia, M., Natale, A. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619402035

• A Mindfulness Intervention for Paroxysmal Atrial Fibrillation Diminishes Illness Perception, Improves AF Knowledge and Reduces CV Risk Ottoboni, L. K., Turakhia, M., Hecht, F. M., Cataldo, J., Howie-Esquivel, J. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619404341

• Antithrombotic Therapy for Atrial Fibrillation CHEST Guideline and Expert Panel Report CHEST Lip, G. H., Banerjee, A., Boriani, G., Chiang, C., Fargo, R., Freedman, B., Lane, D. A., Ruff, C. T., Turakhia, M., Werring, D., Patel, S., Moores, L. 2018; 154 (5): 1121–1201

  Abstract

  The risk of stroke is heterogeneous across different groups of patients with atrial fibrillation (AF), being dependent on the presence of various stroke risk factors. We provide recommendations for antithrombotic treatment based on net clinical benefit for patients with AF at varying levels of stroke risk and in a number of common clinical scenarios.Systematic literature reviews were conducted to identify relevant articles published from the last formal search perfomed for the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (9th Edition). The overall quality of the evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Graded recommendations and ungraded consensus-based statements were drafted, voted on, and revised until consensus was reached.For patients with AF without valvular heart disease, including those with paroxysmal AF, who are at low risk of stroke (eg, CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 (doubled), diabetes, stroke (doubled)-vascular disease, age 65-74 and sex category (female)] score of 0 in males or 1 in females), we suggest no antithrombotic therapy. The next step is to consider stroke prevention (ie, oral anticoagulation therapy) for patients with 1 or more non-sex CHA2DS2-VASc stroke risk factors. For patients with a single non-sex CHA2DS2-VASc stroke risk factor, we suggest oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel; and for those at high risk of stroke (eg, CHA2DS2-VASc ≥ 2 in males or ≥ 3 in females), we recommend oral anticoagulation rather than no therapy, aspirin, or combination therapy with aspirin and clopidogrel. Where we recommend or suggest in favor of oral anticoagulation, we suggest using a non-vitamin K antagonist oral anticoagulant drug rather than adjusted-dose vitamin K antagonist therapy. With the latter, it is important to aim for good quality anticoagulation control with a time in therapeutic range > 70%. Attention to modifiable bleeding risk factors (eg, uncontrolled BP, labile international normalized ratios, concomitant use of aspirin or nonsteroidal antiinflammatory drugs in an anticoagulated patient, alcohol excess) should be made at each patient contact, and HAS-BLED (hypertension, abnormal renal/liver function [1 point each], stroke, bleeding history or predisposition, labile international normalized ratio, elderly (0.65), drugs/alcohol concomitantly [1 point each]) score used to assess the risk of bleeding where high risk patients (≥ 3) should be reviewed and followed up more frequently.Oral anticoagulation is the optimal choice of antithrombotic therapy for patients with AF with ≥1 non-sex CHA2DS2-VASc stroke risk factor(s).

  View details for PubMedID 30144419

• Secular trends in success rate of catheter ablation for atrial fibrillation: The SMASH-AF cohort. American heart journal Perino, A. C., Leef, G. C., Cluckey, A., Yunus, F. N., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2018

  Abstract

  BACKGROUND: Approaches, tools, and technologies for atrial fibrillation (AF) ablation have evolved significantly since its inception. We sought to characterize secular trends in AF ablation success rates.METHODS: We performed a systematic review and meta-analysis of AF ablation from January 1, 1990, to August 1, 2016, searching PubMed, Scopus, and Cochrane databases. Major exclusion criteria were insufficient outcome reporting and ablation strategies that were not prespecified and uniform. We stratified treatment arms by AF type (paroxysmal AF; nonparoxysmal AF) and analyzed single-procedure outcomes. Multivariate meta-regressions analyzed effects of study, patient, and procedure characteristics on success rate trends. Registered in PROSPERO (CRD42016036549).RESULTS: A total of 180 trials and observational studies with 28,118 patients met inclusion. For paroxysmal AF ablation studies, unadjusted success rate summary estimates ranged from 73.1% in 2003 to 77.1% in 2016, increasing by 0.9%/year (95% CI 0.4%-1.4%; P = .001; I2 = 90%). After controlling for study design and patient demographics, rate of improvement in success rate summary estimate increased (1.6%/year; 95% CI 0.9%-2.2%; P = .001; I2 = 87%). For nonparoxysmal AF ablation studies, unadjusted success rate summary estimates ranged from 70.0% in 2010 to 64.3% in 2016 (1.1%/year; 95% CI -1.3% to 3.5%; P = .37; I2 = 85%), with no improvement in multivariate analyses.CONCLUSIONS: Despite substantial research investment and health care expenditure, improvements in AF ablation success rates have been incremental. Meaningful improvements may require major paradigm or technology changes, and evaluation of clinical outcomes such as mortality and quality of life may prove to be important going forward.

  View details for PubMedID 30502925

• Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. American heart journal Turakhia, M. P., Desai, M., Hedlin, H., Rajmane, A., Talati, N., Ferris, T., Desai, S., Nag, D., Patel, M., Kowey, P., Rumsfeld, J. S., Russo, A. M., Hills, M. T., Granger, C. B., Mahaffey, K. W., Perez, M. V. 2018

  Abstract

  BACKGROUND: Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale.METHODS: The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants.CONCLUSIONS: The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.

  View details for PubMedID 30392584

• Association of Healthcare Plan with atrial fibrillation prescription patterns CLINICAL CARDIOLOGY Chang, A., Askari, M., Fan, J., Heidenreich, P. A., Ho, P., Mahaffey, K. W., Ullal, A., Perino, A., Turakhia, M. P. 2018; 41 (9): 1136–43

  View details for DOI 10.1002/clc.23042

  View details for Web of Science ID 000446429700004

• Initiating anticoagulation with the intention of cardioverting: does drug choice matter? EUROPEAN HEART JOURNAL Mahaffey, K. W., Turakhia, M. P. 2018; 39 (32): 2972–74

  View details for DOI 10.1093/eurheartj/ehy303

  View details for Web of Science ID 000442981500010

• Chronic kidney disease and arrhythmias: highlights from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney international Wanner, C., Herzog, C. A., Turakhia, M. P. 2018; 94 (2): 231-234

  View details for DOI 10.1016/j.kint.2018.05.005

  View details for PubMedID 29935952

• Chronic kidney disease and arrhythmias: highlights from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference KIDNEY INTERNATIONAL Wanner, C., Herzog, C. A., Turakhia, M. P., Conf Steering Comm 2018; 94 (2): 231–34

  View details for DOI 10.1016/j.kint.2018.05.005

  View details for Web of Science ID 000439138700001

• Chronic kidney disease and arrhythmias: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference EUROPEAN HEART JOURNAL Turakhia, M. P., Blankestijn, P. J., Carrero, J., Clase, C. M., Deo, R., Herzog, C. A., Kasner, S. E., Passman, R. S., Pecoits-Filho, R., Reinecke, H., Shroff, G. R., Zareba, W., Cheung, M., Wheeler, D. C., Winkelmayer, W. C., Wanner, C., Conference Participants 2018; 39 (24): 2314-+

  View details for DOI 10.1093/eurheartj/ehy060

  View details for Web of Science ID 000438540200024

• Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Sharma, A., Harrington, R. A., McClellan, M. B., Turakhia, M. P., Eapen, Z. J., Steinhubl, S., Mault, J. R., Majmudar, M. D., Roessig, L., Chandross, K. J., Green, E. M., Patel, B., Hamer, A., Olgin, J., Rumsfeld, J. S., Roe, M. T., Peterson, E. D. 2018; 71 (23): 2680–90

  Abstract

  As we enter the information age of health care, digital health technologies offer significant opportunities to optimize both clinical care delivery and clinical research. Despite their potential, the use of such information technologies in clinical care and research faces major data quality, privacy, and regulatory concerns. In hopes of addressing both the promise and challenges facing digital health technologies in the transformation of health care, we convened a think tank meeting with academic, industry, and regulatory representatives in December 2016 in Washington, DC. In this paper, we summarize the proceedings of the think tank meeting and aim to delineate a framework for appropriately using digital health technologies in healthcare delivery and research.

  View details for PubMedID 29880129

• Mobile Health Advances in Physical Activity, Fitness, and Atrial Fibrillation Moving Hearts JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY McConnell, M. V., Turakhia, M. P., Harrington, R. A., King, A. C., Ashley, E. A. 2018; 71 (23): 2691–2701

  Abstract

  The growing recognition that "health" takes place outside of the hospital and clinic, plus recent advances in mobile and wearable devices, have propelled the field of mobile health (mHealth). Cardiovascular disease and prevention are major opportunities for mHealth, as mobile devices can monitor key physiological signals (e.g., physical activity, heart rate and rhythm) for promoting healthy behaviors, detecting disease, and aid in ongoing care. In this review, the authors provide an update on cardiovascular mHealth by highlighting recent progress and challenges with mobile and wearable devices for assessing and promoting physical activity and fitness, and for monitoring heart rate and rhythm for the detection and management of atrial fibrillation.

  View details for PubMedID 29880130

• Initiating anticoagulation with the intention of cardioverting: does drug choice matter? European heart journal Mahaffey, K. W., Turakhia, M. P. 2018

  View details for PubMedID 29873723

• Improving the prognosis of patients with severely decreased glomerular filtration rate (CKD G4+): conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference KIDNEY INTERNATIONAL Eckardt, K., Bansal, N., Coresh, J., Evans, M., Grams, M. E., Herzog, C. A., James, M. T., Heerspink, H. L., Pollock, C. A., Stevens, P. E., Tamura, M., Tonelli, M. A., Wheeler, D. C., Winkelmayer, W. C., Cheung, M., Hemmelgarn, B. R., Conference Participants 2018; 93 (6): 1281–92

  Abstract

  Patients with severely decreased glomerular filtration rate (GFR) (i.e., chronic kidney disease [CKD] G4+) are at increased risk for kidney failure, cardiovascular disease (CVD) events (including heart failure), and death. However, little is known about the variability of outcomes and optimal therapeutic strategies, including initiation of kidney replacement therapy (KRT). Kidney Disease: Improving Global Outcomes (KDIGO) organized a Controversies Conference with an international expert group in December 2016 to address this gap in knowledge. In collaboration with the CKD Prognosis Consortium (CKD-PC) a global meta-analysis of cohort studies (n = 264,515 individuals with CKD G4+) was conducted to better understand the timing of clinical outcomes in patients with CKD G4+ and risk factors for different outcomes. The results confirmed the prognostic value of traditional CVD risk factors in individuals with severely decreased GFR, although the risk estimates vary for kidney and CVD outcomes. A 2- and 4-year model of the probability and timing of kidney failure requiring KRT was also developed. The implications of these findings for patient management were discussed in the context of published evidence under 4 key themes: management of CKD G4+, diagnostic and therapeutic challenges of heart failure, shared decision-making, and optimization of clinical trials in CKD G4+ patients. Participants concluded that variable prognosis of patients with advanced CKD mandates individualized, risk-based management, factoring in competing risks and patient preferences.

  View details for PubMedID 29656903

• Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY Navara, R., Leef, G., Shenasa, F., Kowalewski, C., Rogers, A. J., Meckler, G., Zaman, J. B., Baykaner, T., Park, S., Turakhia, M. P., Zei, P., Viswanathan, M., Wang, P. J., Narayan, S. M. 2018; 29 (5): 687–95

  View details for DOI 10.1111/jce.13446

  View details for Web of Science ID 000433580000005

• Geographic and racial representation and reported success rates of studies of catheter ablation for atrial fibrillation: Findings from the SMASH-AF meta-analysis study cohort JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY Leef, G. C., Perino, A. C., Cluckey, A., Yunus, F. N., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2018; 29 (5): 747–55

  View details for DOI 10.1111/jce.13439

  View details for Web of Science ID 000433580000013

• Moving From Big Data to Deep Learning-The Case of Atrial Fibrillation JAMA CARDIOLOGY Turakhia, M. P. 2018; 3 (5): 371–72

  View details for PubMedID 29562077

• Estimated prevalence of undiagnosed atrial fibrillation in the United States PLOS ONE Turakhia, M. P., Shafrin, J., Bognar, K., Trocio, J., Abdulsattar, Y., Wiederkehr, D., Goldman, D. P. 2018; 13 (4): e0195088

  Abstract

  As atrial fibrillation (AF) is often asymptomatic, it may remain undiagnosed until or even after development of complications, such as stroke. Consequently the observed prevalence of AF may underestimate total disease burden.To estimate the prevalence of undiagnosed AF in the United States, we performed a retrospective cohort modeling study in working age (18-64) and elderly (≥65) people using commercial and Medicare administrative claims databases. We identified patients in years 2004-2010 with incident AF following an ischemic stroke. Using a back-calculation methodology, we estimated the prevalence of undiagnosed AF as the ratio of the number of post-stroke AF patients and the CHADS2-specific stroke probability for each patient, adjusting for age and gender composition based on United States census data.The estimated prevalence of AF (diagnosed and undiagnosed) was 3,873,900 (95%CI: 3,675,200-4,702,600) elderly and 1,457,100 (95%CI: 1,218,500-1,695,800) working age adults, representing 10.0% and 0.92% of the respective populations. Of these, 698,900 were undiagnosed: 535,400 (95%CI: 331,900-804,400) elderly and 163,500 (95%CI: 17,700-400,000) working age adults, representing 1.3% and 0.09% of the respective populations. Among all undiagnosed cases, 77% had a CHADS2 score ≥1, and 56% had CHADS2 score ≥2.Using a back-calculation approach, we estimate that the total AF prevalence in 2009 was 5.3 million of which 0.7 million (13.1% of AF cases) were undiagnosed. Over half of the modeled population with undiagnosed AF was at moderate to high risk of stroke.

  View details for PubMedID 29649277

• A review of the impact of vascular closure devices and patient preferences in cardiac ablation Huber, C., Thanh Thanh, May-Slater, S., Ballotta, J., Turakhia, M. WILEY. 2018: 676–77

  View details for Web of Science ID 000430109200054

• Cost effectiveness of focal impulse and rotor modulation guided ablation added to pulmonary vein isolation for atrial fibrillation JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY Baykaner, T., Duff, S., Hasegawa, J. T., Mafilios, M. S., Turakhia, M. P. 2018; 29 (4): 526–36

  Abstract

  Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed.We aimed to evaluate the cost effectiveness of FIRM-guided ablation when added to PVI in a mixed AF population.We used a Markov model to estimate the costs, quality-adjusted survival, and cost effectiveness of adding FIRM ablation to PVI. AF recurrence rates were based on 3-year data from the CONFIRM trial. Model inputs for event probabilities and utilities were obtained from literature review. Costs were based on Medicare reimbursement, wholesale acquisition costs, and literature review. Three-year total costs FIRM+PVI versus PVI alone were $27,686 versus $26,924. QALYs were 2.338 versus 2.316, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $34,452 per QALY gained. Most of the cost (65-81%) was related to the index ablation procedure. Lower AF recurrence generated cost offsets of $4,266, primarily due to a reduced need for medications and repeat ablation. Probabilistic sensitivity analysis demonstrated ICER below $100,000/QALY in 74% of simulations.Based on data from the CONFIRM study, the addition of FIRM to PVI does have the potential to be cost-effective due to higher quality-adjusted life years and lower follow-up costs. Value is sensitive to the incremental reduction in AF recurrence, and FIRM may have the greatest economic value in patients with greater AF symptom severity. Results from ongoing randomized trials will provide further clarity.

  View details for PubMedID 29436112

• Digoxin in Atrial Fibrillation? Leave it Out of the Medicine Cabinet JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Turakhia, M. P. 2018; 71 (10): 1075–77

  View details for PubMedID 29519346

• ALTERNATIVE METRICS BY SYSTEMATIC REVIEW INCLUSION STATUS OF STUDIES OF CATHETER ABLATION FOR ATRIAL FIBRILLATION: FINDINGS FROM THE SMASH-AF META-ANALYSIS STUDY COHORT Yunus, F., Leef, G., Cluckey, A., Askari, M., Turakhia, M., Perino, A. ELSEVIER SCIENCE INC. 2018: 342

  View details for DOI 10.1016/S0735-1097(18)30883-0

  View details for Web of Science ID 000429659701192

• Chronic kidney disease and arrhythmias: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. European heart journal Turakhia, M. P., Blankestijn, P. J., Carrero, J., Clase, C. M., Deo, R., Herzog, C. A., Kasner, S. E., Passman, R. S., Pecoits-Filho, R., Reinecke, H., Shroff, G. R., Zareba, W., Cheung, M., Wheeler, D. C., Winkelmayer, W. C., Wanner, C., Conference Participants, Amann, K., Banerjee, D., Bansal, N., Boriani, G., Bunch, J., Chan, C. T., Charytan, D. M., Conen, D., Friedman, A. N., Genovesi, S., Holden, R. M., House, A. A., Jadoul, M., Jardine, A. G., Johnson, D. W., Jun, M., Labriola, L., Mark, P. B., McCullough, P. A., Nolin, T. D., Potpara, T. S., Pun, P. H., Ribeiro, A. L., Rossignol, P., Shen, J. I., Sood, M. M., Tsukamoto, Y., Wang, A. Y., Weir, M. R., Wetmore, J. B., Wranicz, J. K., Yamasaki, H. 2018

  View details for PubMedID 29522134

• Independent mapping methods reveal rotational activation near pulmonary veins where atrial fibrillation terminates before pulmonary vein isolation. Journal of cardiovascular electrophysiology Navara, R., Leef, G., Shenasa, F., Kowalewski, C., Rogers, A. J., Meckler, G., Zaman, J. A., Baykaner, T., Park, S., Turakhia, M. P., Zei, P., Viswanathan, M., Wang, P. J., Narayan, S. M. 2018

  Abstract

  OBJECTIVE: To investigate mechanisms by which atrial fibrillation (AF) may terminate during ablation near the pulmonary veins before the veins are isolated (PVI).INTRODUCTION: It remains unstudied how AF may terminate during ablation before PVs are isolated, or how patients with PV reconnection can be arrhythmia-free. We studied patients in whom PV antral ablation terminated AF before PVI, using two independent mapping methods.METHODS: We studied patients with AF referred for ablation, in whom biatrial contact basket electrograms were studied by both an activation/phase mapping method and by a second validated mapping method reported not to create false rotational activity.RESULTS: In 22 patients (age 60.1 ± 10.4, 36% persistent AF), ablation at sites near the PVs terminated AF (77% to sinus rhythm) prior to PVI. AF propagation revealed rotational (n=20) and focal (n=2) patterns at sites of termination by mapping method 1 and method 2. Both methods showed organized sites that were spatially concordant (P<0.001) with similar stability (P<0.001). Vagal slowing was not observed at sites of AF termination.DISCUSSION: PV antral regions where ablation terminated AF before PVI exhibited rotational and focal activation by two independent mapping methods. These data provide an alternative mechanism for the success of PVI, and may explain AF termination before PVI or lack of arrhythmias despite PV reconnection. Mapping such sites may enable targeted PV lesion sets and improved freedom from AF.

  View details for PubMedID 29377478

• Geographic and racial representation and reported success rates of studies of catheter ablation for atrial fibrillation: Findings from the SMASH-AF meta-analysis study cohort. Journal of cardiovascular electrophysiology Leef, G. C., Perino, A. C., Cluckey, A., Yunus, F. N., Askari, M., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2018

  Abstract

  INTRODUCTION: We performed a systematic review and meta-analysis of geographic and racial representation and reported success rates of studies of catheter ablation for atrial fibrillation (AF).METHODS AND RESULTS: We searched PubMed, Scopus, and Cochrane databases from 1/1/1990 to 8/1/2016 for trials and observational studies reporting AF ablation outcomes. Major exclusion criteria were insufficient reporting of outcomes, non-English language articles, and ablation strategies that were not prespecified and uniform. We described geographic and racial representation and single-procedure ablation success rates by country, controlling for patient demographics and study design characteristics. The analysis cohort included 306 studies (49,227 patients) from 28 countries. Over half of the paroxysmal (PAF) and nonparoxysmal AF (NPAF) treatment arms were conducted in 5 and 3 countries, respectively. Reporting of race or ethnicity demographics and outcomes were rare (1 study, 0.3%) and nonexistent, respectively. Unadjusted success rates by country ranged from 63.5% to 83.0% for PAF studies and 52.7% to 71.6% for NPAF studies, with substantial variation in patient demographics and study design. After controlling for covariates, South Korea and the United States had higher PAF ablation success rates, with large residual heterogeneity. NPAF ablation success rates were statistically similar by country.CONCLUSIONS: Studies of AF ablation have substantial variation in patient demographics, study design, and reported outcomes by country. There is limited geographic representation of trials and observational studies of AF ablation and a paucity of race- or ethnicity-stratified results. Future AF ablation studies and registries should aim to have broad representation by race, geography, and ethnicity to ensure generalizability.

  View details for PubMedID 29364570

• Anticoagulant and antiplatelet therapy choices for patients with atrial fibrillation one year after coronary stenting or acute coronary syndrome EXPERT OPINION ON DRUG SAFETY Olivier, C. B., Turakhia, M. P., Mahaffey, K. W. 2018; 17 (3): 251–58

  Abstract

  Guidelines recommend a combined anticoagulant and antiplatelet approach for patients with atrial fibrillation (AF) after coronary stenting (CS) or acute coronary syndrome (ACS). Finding the optimal balance of reducing ischemic risk and minimizing bleeding risk is challenging. Recent trials have evaluated a variety of regimens for up to one year for AF patients after CS/ACS. Little empiric evidence exists about the best antithrombotic strategy beyond one year. Areas covered: In this review two key areas are covered. First, a summary of the overall risk and benefits of anticoagulant and antiplatelet therapy in patients with AF and CS or ACS is provided. Second, despite limited empiric evidence to guide therapeutic decisions for combined anticoagulant and antiplatelet therapy in patients with AF one year after CS/ACS we provide guidance for shared patient-physician decision making. Expert opinion: The evidence is limited. For all patients with AF and stable CAD (≥1 year after CS or ACS) the risk for thromboembolism, cardiovascular events and bleeding should be assessed individually. For patients with low bleeding risk and high risk for cardiovascular events, antiplatelet therapy might be added to anticoagulant therapy.

  View details for PubMedID 29363352

• Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry. American heart journal Yong, C. M., Liu, Y., Apruzzese, P., Doros, G., Cannon, C. P., Maddox, T. M., Gehi, A., Hsu, J. C., Lubitz, S. A., Virani, S., Turakhia, M. P. 2018; 195: 50-59

  Abstract

  It is poorly understood whether insurance type may be a major contributor to the underuse of oral anticoagulation (OAC) among patients with atrial fibrillation (AF), particularly for novel oral anticoagulants (NOACs).We performed a retrospective cohort registry study of patients with insurance, AF, CHA2DS2-VASc ≥2, and at least one outpatient encounter recorded in the ACC NCDR's PINNACLE Registry between January 1, 2011 and December 31, 2014. We used hierarchical regression, adjusting for patient characteristics and clustering by physician, to evaluate the association of insurance type (Private, Military, Medicare, Medicaid, Other) with receipt of OAC (any OAC, warfarin, or NOAC).In 363,309 patients (age 75±10; 48% female), we found a significant difference in proportions of OAC and NOAC prescription across insurance types (OAC: Military 53%, Private 53%, Medicare 52%, Other 41%, Medicaid 41%, P<.001; NOAC: Military 24%, Private 19%, Medicare 17%, Other 17%, Medicaid 8%, P<.001). After adjustment for patient characteristics and facility, private, Medicaid, and other insurance were independently associated with a lower odds of OAC prescription relative to Medicare, but military insured patients were not significantly different. After adjustment, military and private insurance were independently associated with a higher odds of NOAC prescription relative to Medicare, while Medicaid and other insurance were associated with a lower odds of NOAC prescription.In a contemporary US AF population, there was significant variation of OAC prescription across insurance plans, with the highest among private and Medicare insured patients. These differences may indicate that insurance plan, and its associated pharmacy benefits, affect the pace of diffusion of new therapies.

  View details for DOI 10.1016/j.ahj.2017.08.010

  View details for PubMedID 29224646

• Association of Healthcare Plan with Atrial Fibrillation Prescription Patterns. Clinical cardiology Chang, A. Y., Askari, M. n., Fan, J. n., Heidenreich, P. A., Ho, P. M., Mahaffey, K. W., Ullal, A. J., Perino, A. C., Turakhia, M. P. 2018

  Abstract

  Atrial fibrillation (AF) is treated by many types of physician specialists, including primary care physicians (PCPs). Health plans have different policies for how patients encounter these providers, and these may affect selection of AF treatment strategy.We hypothesized that healthcare plans with PCP-gatekeeping to specialist access may be associated with different pharmacologic treatments for AF.We performed a retrospective cohort study using a commercial pharmaceutical claims database. We utilized logistic regression models to compare odds of prescription of oral anticoagulant (OAC), non-vitamin K-dependent oral anticoagulant (NOAC), rate control, and rhythm control medications used to treat AF between patients with PCP-gated healthcare plans (e.g. HMO, EPO, POS) and patients with non-PCP-gated healthcare plans (e.g. PPO, CHDP, HDHP, Comprehensive) between 2007 and 2012. We also calculated median time to receipt of therapy within 90 days of index AF diagnosis.We found similar odds of OAC prescription at 90 days following new AF diagnosis in patients with PCP-gated plans compared to those with non-PCP-gated plans (OR: OAC 1.01, p=0.84; warfarin 1.05, p=0.08). Relative odds were similar for rate control (1.17, p<0.01) and rhythm control agents (0.93, p=0.03). However, PCP-gated plan patients had slightly lower likelihood of being prescribed NOACs (0.82, p=0.001) than non-gated plan patients. Elapsed time until receipt of medication was similar between PCP-gated and non-gated groups across drug classes.Pharmaceutical claims data do not suggest that PCP-gatekeeping by healthcare plans is a structural barrier to AF therapy, although it was associated with lower use of NOACs.

  View details for PubMedID 30098034

• Patient and facility variation in costs of catheter ablation for atrial fibrillation. Journal of cardiovascular electrophysiology Perino, A. C., Fan, J. n., Schmitt, S. n., Kaiser, D. W., Heidenreich, P. A., Narayan, S. M., Wang, P. J., Chang, A. Y., Turakhia, M. P. 2018

  Abstract

  Cost-effectiveness or value of cardiovascular therapies may be undermined by unwarranted cost variation, particularly for heterogeneous procedures such as catheter ablation for atrial fibrillation (AF). We sought to characterize cost variation of AF ablation in the U.S. health care system and the relationship between cost and outcomes.We performed a retrospective cohort study using data from the MarketScan® commercial claims and Medicare supplemental databases including patients who received an AF ablation from 2007 through 2011. We aggregated encounter cost, reflecting total payments received for the encounter, to the facility level to calculate median facility cost. We classified procedures as outpatient or inpatient and assessed for association between cost and 30-day and one-year outcomes. The analysis cohort included 9,415 AF ablations (59±11 years; 28% female; 52% outpatient) occurring at 327 facilities, with large cost variation across facilities (median: $25,100; 25th percentile: $18,900, 75th percentile: $35,600, 95th percentile: $57,800). Among outpatient procedures, there was reduced health care utilization in higher cost quintiles with reductions in rehospitalization at 30-days (Quintile 1: 16.1%, Quintile 5: 8.8%, p < 0.001) and one-year (Quintile 1: 34.8%, Quintile 5: 25.6%, p < 0.001), which remained significant in multivariate analysis.Although median costs of AF ablation are below amounts used in prior cost-effectiveness studies that demonstrated good value, large facility variation in cost suggests opportunities for cost reduction. However, for outpatient encounters, association of cost to modestly improved outcomes suggests cost containment strategies could have variable effects. This article is protected by copyright. All rights reserved.

  View details for PubMedID 29864193

• Association of insurance type with receipt of oral anticoagulation in insured patients with atrial fibrillation: A report from the American College of Cardiology NCDR PINNACLE registry AMERICAN HEART JOURNAL Yong, C. M., Liu, Y., Apruzzese, P., Doros, G., Cannon, C. P., Maddox, T. M., Gehi, A., Hsu, J. C., Lubitz, S. A., Virani, S., Turakhia, M. P., ACC PINNACLE Investigators 2018; 195: 50–59

  View details for DOI 10.1016/j.ahj.2017.08.010

  View details for Web of Science ID 000417603100004

• REPLY: Improved Outcomes With Cardiology Care in Newly Diagnosed Atrial Fibrillation Is Tachycardia-Induced Cardiomyopathy Underestimated? JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Perino, A. C., Turakhia, M. P. 2017; 70 (21): 2730–31

  View details for DOI 10.1016/j.jacc.2017.09.1090

  View details for Web of Science ID 000416352200020

  View details for PubMedID 29169483

• Pharmacokinetics of Tecarfarin and Warfarin in Patients with Severe Chronic Kidney Disease THROMBOSIS AND HAEMOSTASIS Albrecht, D., Turakhia, M. P., Ries, D., Marbury, T., Smith, W., Dillon, D., Milner, P. G., Midei, M. G. 2017; 117 (11): 2026–33

  Abstract

  Chronic kidney disease (CKD) complicates warfarin anticoagulation partially through its effect on CYP2C9 activity. Tecarfarin, a novel vitamin K antagonist, is not metabolized by CYP2C9. To evaluate the effect of CKD on their metabolism, we measured PK parameters of warfarin and tecarfarin in subjects with and without CKD. CKD subjects with estimated glomerular filtration rate < 30 mL/min not on dialysis (n = 13) were matched to healthy volunteers (HVs) (n = 10). Each subject was randomized to either warfarin 10 mg or tecarfarin 30 mg and was later crossed over to the other drug. PK parameters were measured following each drug. Mean plasma concentrations of (S)-warfarin and (R,S)-warfarin were higher (44 and 27%, respectively) in the subjects with CKD than in the healthy subjects. Both of these values fell outside of the 90% confidence interval of equivalence. For tecarfarin, the difference was less than 15% higher. Elimination half-life (t1/2) increased by 20% for (S)-warfarin and by 8% for (R,S)-warfarin and decreased by 8% for tecarfarin. The mean plasma concentration for tecarfarin's inactive metabolite ATI-5900 increased by approximately eightfold. CKD increased the effect of CYP2C9 genetic variation on (S)-warfarin and (R,S)-warfarin metabolism. Tecarfarin exposure was similar between the HVs and the CKD subjects regardless of CYP2C9 genotype. There were neither serious adverse events (SAEs) nor treatment-emergent adverse events (TEAEs) for any subject in the study. CKD inhibits metabolism of (S)-warfarin and (R,S)-warfarin, but not tecarfarin. The safety of repeated dosing of tecarfarin in CKD patients remains unknown. However, if the PK findings of this single-dose study are present with repeated dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.

  View details for PubMedID 28933798

• Impact of Tachyarrhythmia Detection Rate and Time from Detection to Shock on Outcomes in Nationwide US Practice AMERICAN JOURNAL OF CARDIOLOGY Piccini, J. P., Sanders, P., Shah, R., Roberts, G., Karst, E., Turakhia, M. P. 2017; 120 (8): 1325–31

  Abstract

  Although higher detection rates and delayed detection improve survival in implantable cardioverter defibrillator clinical trials, their effectiveness in clinical practice has limited validation. To evaluate the effectiveness of programming strategies for reducing shocks and mortality, we conducted a nationwide assessment of patients with implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators with linked remote monitoring data. We categorized patients based on the presence or absence of high rate detection and delayed detection: higher rate delayed detection (HRDD), higher rate early detection (HRED), lower rate delayed detection (LRDD), and lower rate early detection (LRED). Cox regression was used to compare mortality and shock-free survival. There were 64,769 patients (age 68 ± 12 years; 27% female; 46% cardiac resynchronization therapy defibrillator; follow-up 1.7 ± 1.1 years). In the first year, 13% of HRDD, 14% of HRED, 18% of LRDD, and 20% in the LRED group experienced a shock. After adjustment, HRDD was associated with lower risk of shock than HRED (hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.89 to 0.98, p = 0.002), LRDD (HR 0.63, 95% CI 0.60 to 0.66, p <0.001), and LRED (HR 0.58, 95% CI 0.55 to 0.61, p <0.001). HRDD was also associated with lower risk of mortality than HRED (adjusted HR 0.80, 95% CI 0.75 to 0.86, p <0.001), LRDD (HR 0.76, 95% CI 0.70 to 0.83, p <0.001), and LRED (HR 0.68, 95% CI 0.62 to 0.73, p <0.001). Similar results were observed in patients with or without a shock in the first 6 months after implant. In conclusion, high rate programming is associated with lower risk of shocks or death compared with delayed detection. Optimal outcomes are observed in patients programmed with both high rate and delayed detection.

  View details for PubMedID 28947249

• Towards a Mechanistic Understanding and Treatment of a Progressive Disease: Atrial Fibrillation. Journal of atrial fibrillation Yang, F., Tiano, J., Mittal, S., Turakhia, M., Jacobowitz, I., Greenberg, Y. 2017; 10 (3): 1627

  Abstract

  Atrial fibrosis appears to be a key factor in the genesis and/or perpetuation of atrial fibrillation (AF). The pathological distribution of atrial fibrosis is geographically consistent with the attachments between the posterior left atrium and the pericardium along the reflections where wall stiffness is increased and structural changes are found. While there is a wide range of complex etiological factors and electrophysiological mechanisms in AF, there is evidence for a common pathophysiological pathway that could account for deliberate substrate formation and progression of AF. Anatomical stresses along the atrium, mediated by the elastic modulus mismatch between atrial tissue and the pericardium, result in inflammatory and fibrotic changes which create the substrate for atrial fibrillation. This may explain the anatomical predominance of pulmonary vein triggers earlier in the development of atrial fibrillation and the increasing involvement of the atrium as the disease progresses. Ablative treatments that address the progressive nature of atrial fibrillation and fibrosis may yield improved success rates.

  View details for PubMedID 29250240

• Screening for atrial fibrillation: a European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulaci<remove>n Cardiaca y Electrofisiologia (SOLAECE) EUROPACE Mairesse, G. H., Moran, P., Van Gelder, I. C., Elsner, C., Rosenqvist, M., Mant, J., Banerjee, A., Gorenek, B., Brachmann, J., Varma, N., de Lima, G., Kalman, J., Claes, N., Lobban, T., Lane, D., Lip, G. H., Boriani, G., Fauchier, L., Jung, W., Savelieva, I., Freedman, B., Chen, S., Isa, R., Turakhia, M., Sapp, J. 2017; 19 (10): 1589–1623

  View details for DOI 10.1093/europace/eux177

  View details for Web of Science ID 000412840300001

  View details for PubMedID 29048522

• Adherence and outcomes to direct oral anticoagulants among patients with atrial fibrillation: findings from the veterans health administration BMC CARDIOVASCULAR DISORDERS Borne, R. T., O'Donnell, C., Turakhia, M. P., Varosy, P. D., Jackevicius, C. A., Marzec, L. N., Masoudi, F. A., Hess, P. L., Maddox, T. M., Ho, P. 2017; 17: 236

  Abstract

  The direct oral anticoagulants (DOACs) reduce the risk of stroke in moderate to high-risk patients with non-valvular atrial fibrillation (AF). Yet, concerns remain regarding its routine use in real world practice. We sought to describe adherence patterns and the association between adherence and outcomes to the DOACs among outpatients with AF.We performed a retrospective cohort study of patients in the VA Healthcare System who initiated pharmacotherapy with dabigatran, rivaroxaban, or apixaban between November 2010 and January 2015 for non-valvular AF with CHA2DS2-VASc score ≥ 2. Adherence was determined using pharmacy refill data and estimated by the proportion of days covered (PDC) over the first year of therapy. Clinical outcomes, including all-cause mortality and stroke, were measured at 6 months and used to assess measures of adherence for each DOAC.A total of 2882 patients were included. Most were prescribed dabigatran (72.7%), compared with rivaroxaban (19.8%) or apixaban (7.5%). The mean PDC was 0.84 ± 0.20 for dabigatran, 0.86 ± 0.18 for rivaroxaban, and 0.89 ± 0.14 for apixaban (p < 0.01). The proportion of non-adherent patients, PDC <0.80, was 27.6% for all and varied according DOAC. Lower adherence to dabigatran was associated with higher risk of mortality and stroke (HR 1.07; 1.03-1.12 per 0.10 decline in PDC).In a real-world VA population being prescribed anticoagulation for AF, more than one quarter had sub-optimal adherence. Lower adherence was associated with a higher risk of mortality and stroke. Efforts identifying non-adherent patients, and targeted adherence interventions are needed to improve outcomes.

  View details for PubMedID 28865440

• Telemedicine for Management of Implantable Defibrillators: Lessons Learned and a Look Toward the Future. Circulation. Arrhythmia and electrophysiology Turakhia, M. P. 2017; 10 (9)

  View details for DOI 10.1161/CIRCEP.117.005728

  View details for PubMedID 28916513

• Early non-persistence with dabigatran and rivaroxaban in patients with atrial fibrillation HEART Jackevicius, C. A., Tsadok, M., Essebag, V., Atzema, C., Eisenberg, M. J., Tu, J. V., Lu, L., Rahme, E., Ho, P., Turakhia, M., Humphries, K. H., Behlouli, H., Zhou, L., Pilote, L. 2017; 103 (17): 1331–38

  Abstract

  Dabigatran and rivaroxaban are novel oral anticoagulants (NOACs) approved for stroke prevention in atrial fibrillation (AF). Although NOACs are more convenient than warfarin, their lack of monitoring may predispose patients to non-persistence. Limited information is available on NOAC non-persistence rates and related clinical outcomes in clinical practice.We conducted a retrospective cohort study using administrative data from Ontario, Canada, from January 1998 to March 2014 of patients with AF who were dispensed dabigatran or rivaroxaban. Non-persistence was defined as a gap in dabigatran or rivaroxaban prescriptions ≥14 days. A multivariable Cox proportional hazards model was used to estimate the primary composite outcome of stroke, transient ischaemic attack (TIA) and mortality associated with non-persistence.The cohort consisted of 15 857 dabigatran (age 80.7±6.7 year) and 10 119 rivaroxaban users (age 77.0±7.1 year) with women comprising 52% of each medication group. At 6 months, 36.4% of patients were non-persistent to dabigatran, while 31.9% of patients were non-persistent to rivaroxaban. Stroke/TIA/death was significantly higher for those non-persistent to dabigatran (HR 1.76 (95% CI 1.60 to 1.94); p<0.0001) or rivaroxaban (HR 1.89 (95% CI 1.64 to 2.19); p<0.0001) compared with those who were persistent. Risk of stroke/TIA was markedly higher in non-persistent patients to dabigatran (HR 3.75 (95% CI 2.59 to 5.43); p<0.0001) and rivaroxaban (HR 6.25 (95% CI 3.37 to 11.58); p<0.0001) than those persistent.NOAC non-persistence rates are high in clinical practice, with approximately one in three patients becoming non-persistent to dabigatran or rivaroxaban within 6 months after drug initiation. Non-persistence with either dabigatran or rivaroxaban is significantly associated with worse clinical outcomes of stroke/TIA/death.

  View details for PubMedID 28286333

• Telemedicine for Management of Implantable Defibrillators Lessons Learned and a Look Toward the Future CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Turakhia, M. P. 2017; 10 (9)

  View details for DOI 10.1161/CIRCEP.117.005728

  View details for Web of Science ID 000411060000019

• Risk and Consequences of Atrial Fibrillation It's in the Jeans, Not the Genes JAMA CARDIOLOGY Turakhia, M. P. 2017; 2 (8): 871

  View details for PubMedID 28678982

• Response by Vaidya et al to Letter Regarding Article, "Burden of Arrhythmia in Pregnancy" CIRCULATION Vaidya, V. R., Arora, S., Patel, N., Badheka, A., Patel, N., Agnihotri, K., Billimoria, Z., Turakhia, M. P., Friedman, P. A., Madhavan, M., Kapa, S., Noseworthy, P. A., Cha, Y., Gersh, B., Asirvatham, S. J., Deshmukh, A. J. 2017; 136 (2): 244–45

  View details for PubMedID 28696274

• Treating Specialty and Outcomes in Newly Diagnosed Atrial Fibrillation From the TREAT-AF Study JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Perino, A. C., Fan, J., Schmitt, S. K., Askari, M., Kaiser, D. W., Deshmukh, A., Heidenreich, P. A., Swan, C., Narayan, S. M., Wang, P. J., Turakhia, M. P. 2017; 70 (1): 78–86

  Abstract

  Atrial fibrillation (AF) occurs in many clinical contexts and is diagnosed and treated by clinicians across many specialties. This approach has resulted in treatment variations.The goal of this study was to evaluate the association between treating specialty and AF outcomes among patients newly diagnosed with AF.Using data from the TREAT-AF (Retrospective Evaluation and Assessment of Therapies in AF) study from the Veterans Health Administration, patients with newly diagnosed, nonvalvular AF between 2004 and 2012 were identified who had at least 1 outpatient encounter with primary care or cardiology within 90 days of the AF diagnosis. Cox proportional hazards regression was used to evaluate the association between treating specialty and AF outcomes.Among 184,161 patients with newly diagnosed AF (age 70 ± 11 years; 1.7% women; CHA2DS2-VASc score 2.6 ± 1.7), 40% received cardiology care and 60% received primary care only. After adjustment for covariates, cardiology care was associated with reductions in stroke (hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.86 to 0.96; p < 0.001) and death (HR: 0.89; 95% CI: 0.88 to 0.91; p < 0.0001) and increases in hospitalizations for AF/supraventricular tachycardia (HR: 1.38; 95% CI: 1.35 to 1.42; p < 0.0001) and myocardial infarction (HR: 1.03; 95% CI: 1.00 to 1.05; p < 0.04). The propensity-matched cohort had similar results. In mediation analysis, oral anticoagulation prescription within 90 days of diagnosis may have mediated reductions in stroke but did not mediate reductions in survival.In patients with newly diagnosed AF, cardiology care was associated with improved outcomes, potentially mediated by early prescription of oral anticoagulation therapy. Although hypothesis-generating, these data warrant serious consideration and study of health care system interventions at the time of new AF diagnosis.

  View details for PubMedID 28662810

• Warfarin utilisation and anticoagulation control in patients with atrial fibrillation and chronic kidney disease HEART Yang, F., Hellyer, J. A., Than, C., Ullal, A. J., Kaiser, D. W., Heidenreich, P. A., Hoang, D. D., Winkelmayer, W. C., Schmitt, S., Frayne, S. M., Phibbs, C. S., Turakhia, M. P. 2017; 103 (11): 818-826

  Abstract

  To evaluate warfarin prescription, quality of international normalised ratio (INR) monitoring and of INR control in patients with atrial fibrillation (AF) and chronic kidney disease (CKD).We performed a retrospective cohort study of patients with newly diagnosed AF in the Veterans Administration (VA) healthcare system. We evaluated anticoagulation prescription, INR monitoring intensity and time in and outside INR therapeutic range (TTR) stratified by CKD.Of 123 188 patients with newly diagnosed AF, use of warfarin decreased with increasing severity of CKD (57.2%-46.4%), although it was higher among patients on dialysis (62.3%). Although INR monitoring intensity was similar across CKD strata, the proportion with TTR≥60% decreased with CKD severity, with only 21% of patients on dialysis achieving TTR≥60%. After multivariate adjustment, the magnitude of TTR reduction increased with CKD severity. Patients on dialysis had the highest time markedly out of range with INR <1.5 or >3.5 (30%); 12% of INR time was >3.5, and low TTR persisted for up to 3 years.There is a wide variation in anticoagulation prescription based on CKD severity. Patients with moderate-to-severe CKD, including dialysis, have substantially reduced TTR, despite comparable INR monitoring intensity. These findings have implications for more intensive warfarin management strategies in CKD or alternative therapies such as direct oral anticoagulants.

  View details for DOI 10.1136/heartjnl-2016-309266

  View details for Web of Science ID 000401028400006

• Screening for Atrial Fibrillation A Report of the AF-SCREEN International Collaboration CIRCULATION Freedman, B., Camm, J., Calkins, H., Healey, J. S., Rosenqvist, M., Wang, J., Albert, C. M., Anderson, C. S., Antoniou, S., Benjamin, E. J., Boriani, G., Brachmann, H., Brachmann, J., Brandes, A., Chao, T., Conen, D., Engdahl, J., Fauchier, L., Fitzmaurice, D. A., Friberg, L., Gersh, B. J., Gladstone, D. J., Glotzer, T. V., Gwynne, K., Hankey, G. J., Harbison, J., Hillis, G. S., Hills, M. T., Kamel, H., Kirchhof, P., Kowey, P. R., Krieger, D., Lee, V. W., Levin, L., Lip, G. Y., Lobban, T., Lowres, N., Mairesse, G. H., Martinez, C., Neubeck, L., Orchard, J., Piccini, J. P., Poppe, K., Potpara, T. S., Puererfellner, H., Rienstra, M., Sandhu, R. K., Schnabel, R. B., Siu, C., Steinhubl, S., Svendsen, J. H., Svennberg, E., Themistoclakis, S., Tieleman, R. G., Turakhia, M. P., Tveit, A., Uittenbogaart, S. B., van Gelder, I. C., Verma, A., Wachter, R., Yan, B. P. 2017; 135 (19): 1851-?

  Abstract

  Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.

  View details for DOI 10.1161/CIRCULATIONAHA.116.026693

  View details for PubMedID 28483832

• Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS(2) to the CHA(2)DS(2)-VASc Score for Thromboembolic Risk Assessment Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Katz, D. F., Maddox, T. M., Turakhia, M., Gehi, A., O'Brien, E. C., Lubitz, S. A., Turchin, A., Doros, G., Lei, L., Varosy, P., Marzec, L., Hsu, J. C. 2017; 10 (5)

  View details for DOI 10.1161/CIRCOUTCOMES.116.003476

  View details for Web of Science ID 000424350200004

• What Explains Atrial Fibrillation Mechanisms at Sites Where Ablation Terminates Persistent Atrial Fibrillation Prior to Pulmonary Vein Isolation? Navara, R., Meckler, G. L., Kowalewski, C. B., Shenasa, F., Baykaner, T., Zaman, U. B., Al-Husseini, M., Hossainy, S., Krummen, D., Brachmann, J., Viswanathan, M., Park, S., Turakhia, M., Wang, P. J., Narayan, S. M. WILEY. 2017: 607

  View details for Web of Science ID 000403296100063

• Long-term electrocardiographic safety monitoring in clinical drug development: A report from the Cardiac Safety Research Consortium AMERICAN HEART JOURNAL Piccini, J. P., Clark, R. L., Kowey, P. R., Mittal, S., Dunnmon, P., Stockbridge, N., Reiffel, J. A., Turakhia, M. P., Ziegler, P. D., Kleiman, R. B., Ismat, F., Sager, P. 2017; 187: 156–69

  Abstract

  This white paper, prepared by members of the Cardiac Safety Research Consortium (CSRC), discusses important issues regarding scientific and clinical aspects of long-term electrocardiographic safety monitoring during clinical drug development. To promote multistakeholder discussion of this topic, a Cardiac Safety Research Consortium-sponsored Think Tank was held on 2 December 2015 at the American College of Cardiology's Heart House in Washington, DC. The goal of the Think Tank was to explore how and under what circumstances new and evolving ambulatory monitoring technologies could be used to improve and streamline drug development. This paper provides a detailed summary of discussions at the Think Tank: it does not represent regulatory guidance.

  View details for PubMedID 28454799

• 2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry ANNALS OF NONINVASIVE ELECTROCARDIOLOGY Steinberg, J. S., Varma, N., Cygankiewicz, I., Aziz, P., Balsam, P., Baranchuk, A., Cantillon, D. J., Dilaveris, P., Dubner, S. J., El-Sherif, N., Krol, J., Kurpesa, M., La Rovere, M., Lobodzinski, S. S., Locati, E. T., Mittal, S., Olshansky, B., Piotrowicz, E., Saxon, L., Stone, P. H., Tereshchenko, L., Turitto, G., Wimmer, N. J., Verrier, R. L., Zareba, W., Piotrowicz, R. 2017; 22 (3)

  Abstract

  Ambulatory ECG (AECG) is very commonly employed in a variety of clinical contexts to detect cardiac arrhythmias and/or arrhythmia patterns which are not readily obtained from the standard ECG. Accurate and timely characterization of arrhythmias is crucial to direct therapies that can have an important impact on diagnosis, prognosis or patient symptom status. The rhythm information derived from the large variety of AECG recording systems can often lead to appropriate and patient-specific medical and interventional management. The details in this document provide background and framework from which to apply AECG techniques in clinical practice, as well as clinical research.

  View details for PubMedID 28480632

• Factors associated with rhythm control treatment decisions in patients with atrial fibrillation-Insights from the NCDR PINNACLE registry AMERICAN HEART JOURNAL Gehi, A. K., Doros, G., Glorioso, T. J., Grunwald, G. K., Hsu, J., Song, Y., Turakhia, M. P., Turchin, A., Virani, S. S., Maddox, T. M. 2017; 187: 88–97

  Abstract

  Decisions to use rhythm control in atrial fibrillation (AF) should generally be dictated by patient factors, such as quality of life, heart failure, and other comorbidities. Whether or not other factors affect decisions about the use of rhythm control, and catheter ablation in particular, is unknown.A cohort of all patients diagnosed with nonvalvular AF were identified from the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence (PINNACLE) AF registry of US outpatient cardiology practices during the study period from May 1, 2008, to December 31, 2014. Overall and practice-specific rates of rhythm control (cardioversion, antiarrhythmic drug therapy, or catheter ablation) were assessed. We assessed patient and practice factors associated with rhythm control and determined the relative contribution of patient, practice, and unmeasured practice factors with its use.Among 511,958 PINNACLE AF patients, 22.3% were treated with rhythm control and 2.9% underwent catheter ablation. Significant practice variation in rhythm control was present (median rate of rhythm control across practices 22.8%, range 0.2%-62.9%). Significant patient factors associated with rhythm control therapy included white (vs nonwhite) race (odds ratio [OR] 2.43, P<.001), private (vs nonprivate) insurance (OR 1.04, P<.001), and whether a patient was seen by an electrophysiologist (OR 1.77, P<.001). In an analysis of the relative contribution of patient, practice, and unmeasured practice factors with rhythm control, the contribution of unmeasured practice factors (95% range OR 0.29-3.44) exceeded that of either patient (95% range OR 0.46-2.30) or practice (95% range OR 0.15-2.77) factors.One in 5 AF patients in the PINNACLE registry received rhythm control, and 1 in 50 received catheter ablation, suggesting that rhythm control may be underused. A variety of measured and unmeasured practice factors unrelated to patient characteristics play a disproportionate role in the use of rhythm control treatment decisions. Understanding the drivers of these decisions may identify inappropriate treatment variation and better inform optimal use of these therapies.

  View details for PubMedID 28454812

• Contemporary Trends in Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Low to Moderate Risk of Stroke After Guideline-Recommended Change in Use of the CHADS2 to the CHA2DS2-VASc Score for Thromboembolic Risk Assessment: Analysis From the National Cardiovascular Data Registry's Outpatient Practice Innovation and Clinical Excellence Atrial Fibrillation Registry. Circulation. Cardiovascular quality and outcomes Katz, D. F., Maddox, T. M., Turakhia, M., Gehi, A., O'Brien, E. C., Lubitz, S. A., Turchin, A., Doros, G., Lei, L., Varosy, P., Marzec, L., Hsu, J. C. 2017; 10 (5)

  Abstract

  Use of the CHA2DS2-VASc score instead of the CHADS2 score for thromboembolic risk stratification and initiation of oral anticoagulation (OAC) was recommended in the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society atrial fibrillation (AF) guidelines. We sought to define the proportion of patients with AF qualifying for and receiving OAC in contemporary practice by applying the CHA2DS2-VASc score to patients with a low CHADS2 score.Among patients with AF enrolled in the American College of Cardiology National Cardiovascular Data Registry's outpatient Practice Innovation and Clinical Excellence registry (2008-2014) CHADS2 score of 0 or 1, we calculated the impact of adoption of the CHA2DS2-VASc score on the proportion of patients with an indication for OAC. We examined trends in prescription of OAC overall, direct OAC (dabigatran/rivaroxaban/apixaban), and multivariable associations between clinical characteristics and OAC use. Of 346 068 patients with AF aged 65±12 years, 61% were men and 65% were white. In total, 24% of those with CHADS2=0 and 81% of those with a CHADS2=1 were reclassified as having a definite indication for OAC (CHA2DS2-VASc score ≥2). OAC use increased from 37% to 48% during the study period, and direct OAC use increased from 5% to 30%. Increasing CHA2DS2-VASc score (odds ratio, 2.07; 95% confidence interval, 1.97-2.19 for score of 4 versus 0) and rhythm control strategy (odds ratio, 1.34; 95% confidence interval, 1.30-1.39) were associated with increased OAC use.Adoption of the CHA2DS2-VASc score reclassifies 64.5% of patients with AF with low CHADS2 scores into a class I indication for OAC prescription. Overall OAC prescription increased between 2011 and 2014.

  View details for DOI 10.1161/CIRCOUTCOMES.116.003476

  View details for PubMedID 28506981

• SECULAR TRENDS IN REPORTED SUCCESS RATES OF CATHETER ABLATION FOR NON-PAROXYSMAL ATRIAL FIBRILLATION: FINDINGS FROM THE SMASH-AF META-ANALYSIS STUDY COHORT Leef, G., Cluckey, A., Yunus, F., Askari, M., Schuit, E., Heidenreich, P., Turakhia, M., Perino, A. ELSEVIER SCIENCE INC. 2017: 451

  View details for Web of Science ID 000397342300452

• SUCCESS RATES BY ABLATION LESION SET OF CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: FINDINGS FROM THE SMASH-AF META-ANALYSIS STUDY COHORT Cluckey, A., Yunus, F., Leef, G., Askari, M., Schuit, E., Heidenreich, P., Turakhia, M., Perino, A. ELSEVIER SCIENCE INC. 2017: 370

  View details for Web of Science ID 000397342300371

• INCLUSION OF WOMEN IN STUDIES OF CATHETER ABLATION FOR ATRIAL FIBRILLATION: FINDINGS FROM THE SMASH-AF META-ANALYSIS STUDY COHORT Yunus, F., Leef, G., Cluckey, A., Askari, M., Schuit, E., Heidenreich, P., Turakhia, M., Perino, A. ELSEVIER SCIENCE INC. 2017: 537

  View details for Web of Science ID 000397342301059

• Burden of Arrhythmia in Pregnancy CIRCULATION Vaidya, V. R., Arora, S., Patel, N., Badheka, A. O., Patel, N., Agnihotri, K., Billimoria, Z., Turakhia, M. P., Friedman, P. A., Madhavan, M., Kapa, S., Noseworthy, P. A., Cha, Y., Gersh, B., Asirvatham, S. J., Deshmukh, A. J. 2017; 135 (6): 619–21

  View details for PubMedID 28154000

• Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Turakhia, M. P., Zweibel, S., Swain, A. L., Mollenkopf, S. A., Reynolds, M. R. 2017; 10 (2)

  Abstract

  In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified.We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different.After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings.

  View details for DOI 10.1161/CIRCOUTCOMES.115.002210

  View details for PubMedID 28196927

• Impact of Baseline Stroke Risk and Bleeding Risk on Warfarin International Normalized Ratio Control in Atrial Fibrillation (from the TREAT-AF Study) AMERICAN JOURNAL OF CARDIOLOGY Hellyer, J. A., Azarbal, F., Than, C. T., Fan, J., Schmitt, S. K., Yang, F., Frayne, S. M., Phibbs, C. S., Yong, C., Heidenreich, P. A., Turakhia, M. P. 2017; 119 (2): 268-274

  Abstract

  Warfarin prevents stroke and prolongs survival in patients with atrial fibrillation and flutter (AF, collectively) but can cause hemorrhage. The time in international normalized ratio (INR) therapeutic range (TTR) mediates stroke reduction and bleeding risk. This study sought to determine the relation between baseline stroke, bleeding risk, and TTR. Using data from The Retrospective Evaluation and Assessment of Therapies in Atrial Fibrillation (TREAT-AF) retrospective cohort study, national Veterans Health Administration records were used to identify patients with newly diagnosed AF from 2003 to 2012 and subsequent initiation of warfarin. Baseline stroke and bleeding risk was determined by calculating CHA2DS2-VASc and HAS-BLED scores, respectively. Main outcomes were first-year and long-term TTR and INR monitoring rate. In 167,190 patients, the proportion of patients with TTR (>65%) decreased across increasing strata of CHA2DS2-VASc and HAS-BLED. After covariate adjustment, odds of achieving TTR >65% were significantly associated with high CHA2DS2-VASc or HAS-BLED score. INR monitoring rate was similar across risk strata. In conclusion, increased baseline stroke and bleeding risk is associated with poor INR control, despite similar rates of INR monitoring. These findings may paradoxically limit warfarin's efficacy and safety in high-risk patients and may explain observed increased bleeding and stroke rates in this cohort.

  View details for DOI 10.1016/j.amjcard.2016.09.045

  View details for PubMedID 27836133

• Atrial Fibrillation Diagnosis Timing, Ambulatory ECG Monitoring Utilization, and Risk of Recurrent Stroke CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Lip, G. Y., Hunter, T. D., Quiroz, M. E., Ziegler, P. D., Turakhia, M. P. 2017; 10 (1)

  Abstract

  The risk of recurrence after an initial ischemic stroke or transient ischemic attack (TIA) may be impacted by undiagnosed atrial fibrillation (AF). We therefore assessed the impact of AF diagnosis and timing on stroke/TIA recurrence rates in a large real-world sample of patients.Using commercial claims data (Truven Health Analytics MarketScan), we performed a retrospective cohort study of patients with an index stroke or TIA event recorded in years 2008 through 2011. Patients were characterized by baseline oral anticoagulation, CHADS2 and CHA2DS2-VASc scores, AF diagnosis and timing with respect to the index stroke, and presence or absence of post-index ambulatory cardiac monitoring. The primary outcome was the recurrence of an ischemic stroke or TIA. Of 179 160 patients (age 67±16.2 years; 53.7% female), the Kaplan-Meier estimate for stroke/TIA recurrence within 1 year was 10.6%. Not having oral anticoagulation prescribed at baseline and having AF first diagnosed >7 days post-stroke (late AF) was highly associated with recurrent stroke/TIA (hazard ratio, 2.0; 95% confidence interval, 1.9-2.1). Among patients with at least 1 year of follow-up, only 2.6% and 9.7% had ambulatory ECG monitoring in the 7 days and 12 months post-stroke, respectively.AF diagnosed after stroke is an important hallmark of recurrent stroke risk. Increasing the low utilization of cardiac monitoring after stroke could identify undiagnosed AF earlier, leading to appropriate oral anticoagulation treatment and a reduction in stroke/TIA recurrence.

  View details for DOI 10.1161/CIRCOUTCOMES.116.002864

  View details for PubMedID 28096204

• Survival After Secondary Prevention Implantable Cardioverter-Defibrillator Placement: An Analysis From the NCDR ICD Registry. JACC. Clinical electrophysiology Katz, D. F., Peterson, P., Borne, R. T., Betz, J., Al-Khatib, S. M., Varosy, P. D., Wang, Y., Hsu, J. C., Hoffmayer, K. S., Kipp, R. T., Hansen, C. M., Turakhia, M. P., Masoudi, F. A. 2017; 3 (1): 20–28

  Abstract

  OBJECTIVES: This study sought to define the characteristics and risks of death of patients receiving a physician-designated secondary prevention implantable cardioverter-defibrillator (ICD) in contemporary clinical practice.BACKGROUND: Data on utilization and outcomes of ICDs for the secondary prevention of sudden cardiac death (SCD) are limited.METHODS: Patients enrolled in the National Cardiovascular Data Registry's (NCDR) ICD Registry from 2006 to 2009 with a physician-designated secondary prevention indication for ICD implantation were identified and linked to the Social Security Death Master File. Those patients with a history either of tachycardic arrest or sustained ventricular tachycardia (SCD/VT) or of syncope without SCD/VT were included. Kaplan-Meier survival analysis was used to assess mortality. Cox proportional hazards survival modeling was used to assess the risk of death in these groups, adjusting for patient characteristics.RESULTS: In the study cohort of 46,685 patients (mean age 66 ± 14 years, 73.5% male, 85% white), 78% had SCD/VT and 22% had syncope. Overall mortality was 10.4% at 1 year and 16.4% at 2 years. Compared with patients having SCD/VT, the adjusted hazard of death at 1 year was lower in the patients having syncope (hazard ratio: 0.89; 95%confidence interval: 0.83 to 0.96) but was not significantly different by 2 years (hazard ratio: 0.96; 95% confidence interval: 0.90 to 1.01).CONCLUSIONS: Nearly 9 of 10 patients receiving a secondary prevention ICD in clinical practice are alive 1 year after implantation. The risk of death varies by indication and is highest among patients who survive SCD or sustained VT inthefirst year after device implantation.

  View details for PubMedID 29759690

• IMPROVEMENT IN QUALITY OF CARE FOR ATRIAL FIBRILLATION IN GET WITH THE GUIDELINES- ATRIAL FIBRILLATION (GWTG-AFIB) Curtis, A. B., Piccini, J. P., Fonarow, G. C., Butler, J., Desai, N., Fang, M., McCabe, P., Page, R. L., Turakhia, M., Lewis, W. KARGER. 2017: 156

  View details for Web of Science ID 000405743600143

• Risk profiles for acute health events after incident atrial fibrillation in patients with end-stage renal disease on hemodialysis. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association Airy, M. n., Chang, T. I., Ding, V. Y., Goldstein, B. A., Bansal, N. n., Niu, J. n., Navaneethan, S. D., Turakhia, M. P., Winkelmayer, W. C. 2017

  Abstract

  Little is known about the cardiovascular risks of incident atrial fibrillation/flutter (AF) in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD).We studied older US patients who newly initiated HD for ESRD (2006-11) and who had not previously been diagnosed with AF, stroke, myocardial infarction (MI) or hip fracture. We used Cox regression with AF as a time-varying covariate, adjusted for socio-demographic characteristics and comorbidities to estimate hazard ratios [HRs (95% confidence intervals)] for the events of ischemic stroke, MI and death. Hip fracture served as a negative control outcome.We identified 85 377 older patients (mean age: 76.5 years) who initiated HD; of these, 14.3% were subsequently diagnosed with AF (14.9% thereof as primary diagnosis) and 49.8% died during follow-up. Incident AF was associated with nine times higher adjusted mortality during the first 30 days [9.2 (8.8-9.6)], 5-fold higher mortality between 31 and 90 days [4.6 (4.3-4.8)] and double the mortality beyond 90 days from first AF diagnosis [2.2 (2.1-2.3)]. Incident AF was similarly associated with higher adjusted risk of ischemic stroke: 2.1 (1.6-2.7) during the first 30 days, 2.5 (2.0-3.0) between 31 and 90 days and 1.5 (1.3-1.7) beyond 90 days. Similar findings were obtained for MI. However, the risk of hip fracture was only marginally increased following AF diagnosis [≤30 days: 1.1 (0.7-1.6); 31-90 days: 1.4 (1.0-1.8); >90 days: 1.2 (1.1-1.4)]. All associations were attenuated and the association with hip fracture was null when incident AF was defined by a primary diagnosis code.AF was strongly associated with increased risks of ischemic stroke, MI and death, with risks highest soon after AF diagnosis but extending beyond 90 days.

  View details for PubMedID 29145634

• Safety and Clinical Outcomes of Catheter Ablation of Atrial Fibrillation in Patients With Chronic Kidney Disease JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY Ullal, A. J., Kaiser, D. W., Fan, J., Schmitt, S. K., Than, C. T., Winkelmayer, W. C., Heidenreich, P. A., Piccini, J. P., Perez, M. V., Wang, P. J., Turakhia, M. P. 2017; 28 (1): 39-48

  Abstract

  Data regarding catheter ablation of atrial fibrillation (AF) in patients with chronic kidney disease (CKD) is limited. We therefore assessed the association of CKD with common safety and clinical outcomes in a nationwide sample of ablation recipients.Using MarketScan(®) Commercial Claims and Medicare Supplemental Databases, we evaluated 30-day safety and 1-year clinical outcomes in patients who underwent a first AF ablation procedure between 2007 and 2011. We calculated frequency of common 30-day complications and calculated frequencies, incidence rates, and Cox proportional hazards for outcomes at 1-year postablation.Of 21,091 patients included, 1,593 (7.6%) had CKD. Patients with CKD were older (64 years vs. 59 years, P < 0.001) with higher CHA2 DS2 -VASc scores (3.2 vs. 1.8, P < 0.001). At 30 days postablation, patients with CKD had similar rates of stroke/TIA (0.13% vs. 0.13%, P = 0.99), perforation/tamponade (3.2% vs. 3.1%, P = 0.83), and vascular complications (2.4% vs. 2.2%, P = 0.59) as patients without CKD, but were more likely to be hospitalized for heart failure (2.1% vs. 0.4%, P < 0.001). In multivariate analysis, there were no significant differences in hazards of AF hospitalization (adjusted HR: 1.02, 95%CI: 0.87-1.20), cardioversion (adjusted HR: 0.99, 95%CI: 0.87-1.12), or repeat AF ablation (adjusted HR: 0.89, 95%CI: 0.76-1.06) at 1 year.Among patients selected for AF ablation, those with and without CKD had similar rates of postprocedural complications although they were more likely to be re-admitted for heart failure. CKD was not independently associated with AF hospitalization, cardioversion, and repeat ablation. These findings can inform clinical decision-making in patients with AF and CKD.

  View details for DOI 10.1111/jce.13118

  View details for Web of Science ID 000393901900004

• Warfarin utilisation and anticoagulation control in patients with atrial fibrillation and chronic kidney disease. Heart Yang, F., Hellyer, J. A., Than, C., Ullal, A. J., Kaiser, D. W., Heidenreich, P. A., Hoang, D. D., Winkelmayer, W. C., Schmitt, S., Frayne, S. M., Phibbs, C. S., Turakhia, M. P. 2016

  Abstract

  To evaluate warfarin prescription, quality of international normalised ratio (INR) monitoring and of INR control in patients with atrial fibrillation (AF) and chronic kidney disease (CKD).We performed a retrospective cohort study of patients with newly diagnosed AF in the Veterans Administration (VA) healthcare system. We evaluated anticoagulation prescription, INR monitoring intensity and time in and outside INR therapeutic range (TTR) stratified by CKD.Of 123 188 patients with newly diagnosed AF, use of warfarin decreased with increasing severity of CKD (57.2%-46.4%), although it was higher among patients on dialysis (62.3%). Although INR monitoring intensity was similar across CKD strata, the proportion with TTR≥60% decreased with CKD severity, with only 21% of patients on dialysis achieving TTR≥60%. After multivariate adjustment, the magnitude of TTR reduction increased with CKD severity. Patients on dialysis had the highest time markedly out of range with INR <1.5 or >3.5 (30%); 12% of INR time was >3.5, and low TTR persisted for up to 3 years.There is a wide variation in anticoagulation prescription based on CKD severity. Patients with moderate-to-severe CKD, including dialysis, have substantially reduced TTR, despite comparable INR monitoring intensity. These findings have implications for more intensive warfarin management strategies in CKD or alternative therapies such as direct oral anticoagulants.

  View details for DOI 10.1136/heartjnl-2016-309266

  View details for PubMedID 27852694

• International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives JOURNAL OF THE AMERICAN HEART ASSOCIATION Hsu, J. C., Akao, M., Abe, M., Anderson, K. L., Avezum, A., Glusenkamp, N., Kohsaka, S., Lane, D. A., Lip, G. H., Ma, C., Masoudi, F. A., Potpara, T. S., Siong, T., Turakhia, M. P., Tse, H., Rumsfeld, J. S., Maddox, T. M. 2016; 5 (11)

  View details for DOI 10.1161/JAHA.116.004037

  View details for Web of Science ID 000390786600025

• Gender Differences in Clinical Outcomes after Catheter Ablation of Atrial Fibrillation. JACC. Clinical electrophysiology Kaiser, D. W., Fan, J., Schmitt, S., Than, C. T., Ullal, A. J., Piccini, J. P., Heidenreich, P. A., Turakhia, M. P. 2016; 2 (6): 703-710

  Abstract

  To explore gender differences in real-world outcomes after catheter ablation of atrial fibrillation (AF).Compared to men, women with AF have greater thromboembolic risk and tend to be more symptomatic. Catheter ablation is generally more effective than antiarrhythmic drug therapy alone. However, there is limited data on the influence of gender on AF ablation outcomes.We analyzed medical claims of 45 million United States patients enrolled in a variety of employee-sponsored and fee-for-service plans. We identified patients who underwent an AF ablation from 2007 to 2011 and evaluated 30-day safety and one-year effectiveness outcomes.Of the 21,091 patients who underwent an AF ablation, 7,460 (29%) were female. Women, compared to men, were older (62±11 vs. 58±11 years), had higher CHADS2 (1.2±1.1 vs. 1.0±1.0), higher CHA2DS2-VASc (2.9±1.5 vs. 1.6±1.4), and higher Charlson comorbidity index scores (1.2±1.3 vs. 1.0±1.2)(p<0.001 for all). Following ablation, women had higher risk of 30-day complications of hemorrhage (2.7 vs. 2.0%,p<0.001) and tamponade (3.8 vs. 2.9%,p<0.001). In multivariable analyses, women were more likely to have a re-hospitalization for AF (adjusted HR 1.12,p=0.009), but less likely to have repeat AF ablation (adjusted HR 0.92,p=0.04) or cardioversion (adjusted HR 0.75,p<0.001).Women have increased hospitalization rates after AF ablation and are more likely to have a procedural complication. Despite the higher rate of hospital admissions for AF after ablation, women were less likely to undergo repeat ablation or cardioversion. These data call for greater examination of barriers and facilitators to sustain rhythm control strategies in women.

  View details for DOI 10.1016/j.jacep.2016.04.014

  View details for PubMedID 29623299

  View details for PubMedCentralID PMC5881580

• Safety and Clinical Outcomes of Catheter Ablation of Atrial Fibrillation in Patients with Chronic Kidney Disease. Journal of cardiovascular electrophysiology Ullal, A. J., Kaiser, D. W., Fan, J., Schmitt, S., Than, C. T., Winkelmayer, W. C., Heidenreich, P. A., Piccini, J. P., Perez, M. V., Wang, P. J., Turakhia, M. P. 2016

  Abstract

  Data regarding catheter ablation of atrial fibrillation (AF) in patients with chronic kidney disease (CKD) is limited. We therefore assessed the association of CKD with common safety and clinical outcomes in a nationwide sample of ablation recipients.Using MarketScan(®) Commercial Claims and Medicare Supplemental Databases, we evaluated 30-day safety and 1-year clinical outcomes in patients who underwent a first AF ablation procedure between 2007 and 2011. We calculated frequency of common 30-day complications and calculated frequencies, incidence rates, and Cox proportional hazards for outcomes at 1-year postablation.Of 21,091 patients included, 1,593 (7.6%) had CKD. Patients with CKD were older (64 years vs. 59 years, P < 0.001) with higher CHA2 DS2 -VASc scores (3.2 vs. 1.8, P < 0.001). At 30 days postablation, patients with CKD had similar rates of stroke/TIA (0.13% vs. 0.13%, P = 0.99), perforation/tamponade (3.2% vs. 3.1%, P = 0.83), and vascular complications (2.4% vs. 2.2%, P = 0.59) as patients without CKD, but were more likely to be hospitalized for heart failure (2.1% vs. 0.4%, P < 0.001). In multivariate analysis, there were no significant differences in hazards of AF hospitalization (adjusted HR: 1.02, 95%CI: 0.87-1.20), cardioversion (adjusted HR: 0.99, 95%CI: 0.87-1.12), or repeat AF ablation (adjusted HR: 0.89, 95%CI: 0.76-1.06) at 1 year.Among patients selected for AF ablation, those with and without CKD had similar rates of postprocedural complications although they were more likely to be re-admitted for heart failure. CKD was not independently associated with AF hospitalization, cardioversion, and repeat ablation. These findings can inform clinical decision-making in patients with AF and CKD.

  View details for DOI 10.1111/jce.13118

  View details for PubMedID 27782345

• Transforming the care of atrial fibrillation with mobile health JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Turakhia, M. P., Kaiser, D. W. 2016; 47 (1): 45-50

  Abstract

  Atrial fibrillation (AF) is a multifaceted and highly variable disease that is often difficult to manage within the traditional health-care model. The conventional model of regular or pre-scheduled appointments with physicians or allied health professionals is poorly suited to the unpredictable and often urgent clinical needs of patients with AF. Mobile health (mHealth) has the potential to dramatically transform the delivery and quality of AF care. In this brief review, we summarize the current limitations and evidence gaps in treating patients with AF. We then describe the current mHealth landscape, changes in telehealth coverage and reimbursement, and recent technological advances of smartphones, mobile applications, and connected wearable devices. We also describe important barriers and challenges, such as clinical management of large volumes of data, application of predictive analytics/machine learning, and the need for high-quality randomized clinical trials.

  View details for DOI 10.1007/s10840-016-0136-3

  View details for PubMedID 27306552

• The Outlook of Digital Health for Cardiovascular Medicine: Challenges but Also Extraordinary Opportunities. JAMA cardiology Turakhia, M. P., Desai, S. A., Harrington, R. A. 2016; 1 (7): 743-744

  View details for DOI 10.1001/jamacardio.2016.2661

  View details for PubMedID 27580275

• Tecarfarin pharmacokinetics and pharmacodynamics-A novel CYP2C9 independent vitamin K antagonist Midei, M., Camm, A. J., Turakhia, M., Druzgala, P., Albrecht, D., Milner, P. OXFORD UNIV PRESS. 2016: 627–28

  View details for Web of Science ID 000383869503087

• Cost-Effectiveness of Cardiac Radiosurgery for Atrial Fibrillation: Implications for Reducing Health Care Morbidity, Utilization, and Costs CUREUS Bhatt, N., Turakhia, M., Fogarty, T. J. 2016; 8 (8): e720

  Abstract

  In the United States (U.S.), atrial fibrillation (AF) is the second-most common cardiovascular condition after hypertension, affecting four million Americans each year. Individuals with AF are three times more likely to be hospitalized over the span of a year when compared to medically matched control groups. The considerably large clinical population of individuals with AF mandates that the cost-effectiveness and efficacy of current treatment regimens for AF have egregious implications for health care spending and public health. Unfortunately, catheter ablation for AF treatment has been shown to make only modest gains in quality-adjusted life years, has yet to demonstrate cost-utility advantages over conventional therapies for AF, and has a reported rate of recurrence for AF that is notably high. Thus, there is a major unmet clinical need for a therapeutic option to treat AF that produces more consistent and efficacious results that are cost-effective. Cardiac radiosurgery as a therapy for AF has the potential to be remarkably cost-effective and produce robust patient outcomes. CyberHeart Inc. has developed the world's first-ever cardiac radiosurgery (CRS) system designed to ablate the heart non-invasively. Procedures that ablate the heart utilizing the Cyberheart CRS system are anticipated to allow higher efficacy and more consistent results than current techniques such as catheter ablation. The aim of this study is to present the current healthcare utilization and expenditures in AF treatment, report the cost-effectiveness of catheter ablation for AF, and project the potential cost-effectiveness of cardiac radiosurgery for the treatment of AF.

  View details for PubMedID 27625906

• Reduced Mortality Associated WithQuadripolar Compared to BipolarLeftVentricular Leads in CardiacResynchronization Therapy. JACC. Clinical electrophysiology Turakhia, M. P., Cao, M., Fischer, A., Nabutovsky, Y., Sloman, L. S., Dalal, N., Gold, M. R. 2016; 2 (4): 426–33

  Abstract

  OBJECTIVES: The study sought to compare survival, lead deactivation, and lead replacement with quadripolar versusbipolar leads using a retrospective cohort of patients with newly implanted cardiac resynchronization therapy (CRT) systems.BACKGROUND: In CRT, quadripolar left ventricular (LV) leads offer alternative pacing sites and vectors not available with bipolar LV leads, which may improve the effectiveness of the therapy.METHODS: Using nationwide data from device implant registration records of a single manufacturer, we identified patients with a de novo cardiac resynchronization therapy with defibrillation (CRT-D) implanted between November 30, 2011, and May 31, 2013. Patients were followed for up to 24 months. The primary predictor was LV lead type (quadripolar Quartet [St. Jude Medical, St. Paul, Minnesota] LV lead or bipolar LV lead). The primary outcome was death and the secondary outcomes were LV lead replacement and deactivation.RESULTS: Among 23,570 patients (69.5 ± 11.1 years of age; 28% female; median follow-up time 1.14 years), 18,406 had quadripolar and 5,164 had bipolar LV leads. The quadripolar and bipolar groups had 5.04 and 6.45 deaths per 100 patient-years, respectively (p< 0.001). After multivariate adjustment, the quadripolar lead was associated with a lower risk of deactivation (hazard ratio [HR]: 0.62; 95% confidence interval [CI]: 0.46 to 0.84; p= 0.002), replacement (HR:0.67; 95% CI: 0.55 to 0.83; p< 0.001), and death (HR: 0.77; 95% CI: 0.69 to 0.86; p< 0.001).CONCLUSIONS: In this observational study of CRT-D devices, use of a quadripolar, compared to a bipolar LV lead, was associated with a reduction in LV lead deactivation, replacement, and mortality.

  View details for PubMedID 29759861

• Defining a Mobile Health Roadmap for Cardiovascular Health and Disease. Journal of the American Heart Association Eapen, Z. J., Turakhia, M. P., McConnell, M. V., Graham, G., Dunn, P., Tiner, C., Rich, C., Harrington, R. A., Peterson, E. D., Wayte, P. 2016; 5 (7)

  View details for DOI 10.1161/JAHA.115.003119

  View details for PubMedID 27405809

• Aspirin Instead of Oral Anticoagulant Prescription in Atrial Fibrillation Patients at Risk for Stroke JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Hsu, J. C., Maddox, T. M., Kennedy, K., Katz, D. F., Marzec, L. N., Lubitz, S. A., Gehi, A. K., Turakhia, M. P., Marcus, G. M. 2016; 67 (25): 2913–23

  Abstract

  Oral anticoagulation (OAC), rather than aspirin, is recommended in patients with atrial fibrillation (AF) at moderate to high risk of stroke.This study sought to examine patient and practice-level factors associated with prescription of aspirin alone compared with OAC in AF patients at intermediate to high stroke risk in real-world cardiology practices.The authors identified 2 cohorts of outpatients with AF and intermediate to high thromboembolic risk (CHADS2 score ≥2 and CHA2DS2-VASc ≥2) enrolled in the American College of Cardiology PINNACLE (Practice Innovation and Clinical Excellence) registry between 2008 and 2012. Using hierarchical modified Poisson regression models adjusted for patient and practice characteristics, the authors examined the prevalence and predictors of aspirin alone versus OAC prescription in AF patients at risk for stroke.Of 210,380 identified patients with CHADS2 score ≥2 on antithrombotic therapy, 80,371 (38.2%) were treated with aspirin alone, and 130,009 (61.8%) were treated with warfarin or non-vitamin K antagonist OACs. In the cohort of 294,642 patients with CHA2DS2-VASc ≥2, 118,398 (40.2%) were treated with aspirin alone, and 176,244 (59.8%) were treated with warfarin or non-vitamin K antagonist OACs. After multivariable adjustment, hypertension, dyslipidemia, coronary artery disease, prior myocardial infarction, unstable and stable angina, recent coronary artery bypass graft, and peripheral arterial disease were associated with prescription of aspirin only, whereas male sex, higher body mass index, prior stroke/transient ischemic attack, prior systemic embolism, and congestive heart failure were associated with more frequent prescription of OAC.In a large, real-world cardiac outpatient population of AF patients with a moderate to high risk of stroke, more than 1 in 3 were treated with aspirin alone without OAC. Specific patient characteristics predicted prescription of aspirin therapy over OAC.

  View details for PubMedID 27339487

• Comparative Effectiveness of Cardiac Resynchronization Therapy Among Patients With Heart Failure and Atrial Fibrillation Findings From the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator Registry CIRCULATION-HEART FAILURE Khazanie, P., Greiner, M. A., Al-Khatib, S. M., Piccini, J. P., Turakhia, M. P., Varosy, P. D., Masoudi, F. A., Curtis, L. H., Hernandez, A. F. 2016; 9 (6)

  Abstract

  Atrial fibrillation is common in patients with heart failure, but outcomes of patients with both conditions who receive cardiac resynchronization therapy with defibrillator (CRT-D) compared with an implantable cardioverter-defibrillator (ICD) alone are unclear.Using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims, we identified 8951 patients with atrial fibrillation who were eligible for CRT-D and underwent first-time device implantation for primary prevention between April 2006 and December 2009. We used Cox proportional hazards models and inverse probability-weighted estimates to compare outcomes with CRT-D versus ICD alone. Cumulative incidence of mortality (744 [33%] for ICD; 1893 [32%] for CRT-D) and readmission (1788 [76%] for ICD; 4611 [76%] for CRT-D) within 3 years and complications within 90 days were similar between groups. After inverse weighting for the probability of receiving CRT-D, risks of mortality (hazard ratio, 0.83; 95% confidence interval, 0.75-0.92), all-cause readmission (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92), and heart failure readmission (hazard ratio, 0.68; 95% confidence interval, 0.62-0.76) were lower with CRT-D compared with ICD alone. There was no significant difference in the 90-day complication rate (hazard ratio, 0.88; 95% confidence interval, 0.60-1.29). We observed hospital-level variation in the use of CRT-D among patients with atrial fibrillation.Among eligible patients with heart failure and atrial fibrillation, CRT-D was associated with lower risks of mortality, all-cause readmission, and heart failure readmission, as well as with a similar risk of complications compared with ICD alone.

  View details for DOI 10.1161/CIRCHEARTFAILURE.115.002324

  View details for PubMedID 27296396

• Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Freeman, J. V., Hutton, D. W., Barnes, G. D., Zhu, R. P., Owens, D. K., Garber, A. M., Go, A. S., Hlatky, M. A., Heidenreich, P. A., Wang, P. J., Al-Ahmad, A., Turakhia, M. P. 2016; 9 (6)

  View details for DOI 10.1161/CIRCEP.115.003407

  View details for Web of Science ID 000378143300006

• Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Freeman, J. V., Hutton, D. W., Barnes, G. D., Zhu, R. P., Owens, D. K., Garber, A. M., Go, A. S., Hlatky, M. A., Heidenreich, P. A., Wang, P. J., Al-Ahmad, A., Turakhia, M. P. 2016; 9 (6)

  Abstract

  Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data.We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation.Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

  View details for DOI 10.1161/CIRCEP.115.003407

  View details for PubMedID 27307517

• Cost-Effectiveness of Implantable Pulmonary Artery Pressure Monitoring in Chronic Heart Failure JACC-HEART FAILURE Sandhu, A. T., Goldhaber-Fiebert, J. D., Owens, D. K., Turakhia, M. P., Kaiser, D. W., Heidenreich, P. A. 2016; 4 (5): 368-375

  Abstract

  This study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure.The CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial.We developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials.CardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost <$100,000 per QALY gained. The cost-effectiveness was most sensitive to the device's durability.In populations similar to that of the CHAMPION trial, the CardioMEMS device is cost-effective if the trial effectiveness is sustained over long periods. Post-marketing surveillance data on durability will further clarify its value.

  View details for DOI 10.1016/j.jchf.2015.12.015

  View details for PubMedID 26874380

• Health Care Utilization and Expenditures Associated With Remote Monitoring in Patients With Implantable Cardiac Devices AMERICAN JOURNAL OF CARDIOLOGY Ladapo, J. A., Turakhia, M. P., Ryan, M. P., Mollenkopf, S. A., Reynolds, M. R. 2016; 117 (9): 1455–62

  Abstract

  Several randomized trials and decision analysis models have found that remote monitoring may reduce health care utilization and expenditures in patients with cardiac implantable electronic devices (CIEDs), compared with in-office monitoring. However, little is known about the generalizability of these findings to unselected populations in clinical practice. To compare health care utilization and expenditures associated with remote monitoring and in-office monitoring in patients with CIEDs, we used Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases. We selected patients newly implanted with an implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy defibrillator (CRT-D), or permanent pacemaker (PPM), in 2009, who had continuous health plan enrollment 2 years after implantation. Generalized linear models and propensity score matching were used to adjust for confounders and estimate differences in health care utilization and expenditures in patients with remote or in-office monitoring. We identified 1,127; 427; and 1,295 pairs of patients with a similar propensity for receiving an ICD, CRT-D, or PPM, respectively. Remotely monitored patients with ICDs experienced fewer emergency department visits resulting in discharge (p = 0.050). Remote monitoring was associated with lower health care expenditures in office visits among patients with PPMs (p = 0.025) and CRT-Ds (p = 0.006) and lower total inpatient and outpatient expenditures in patients with ICDs (p <0.0001). In conclusion, remote monitoring of patients with CIEDs may be associated with reductions in health care utilization and expenditures compared with exclusive in-office care.

  View details for PubMedID 26996767

• Electrocardiographic Early Repolarization A Scientific Statement From the American Heart Association CIRCULATION Patton, K. K., Ellinor, P. T., Ezekowitz, M., Kowey, P., Lubitz, S. A., Perez, M., Piccini, J., Turakhia, M., Wang, P., Viskin, S., Amer Heart Assoc Electrocardiograp, Council Clinical Cardiology, Council Functional Genomics Transl 2016; 133 (15): 1520–29

  View details for DOI 10.1161/CIR.0000000000000388

  View details for Web of Science ID 000373933400012

  View details for PubMedID 27067089

• INCIDENCE AND OUTCOMES OF PATIENTS WITH ATRIAL FIBRILLATION AND MAJOR BLEEDING COMPLICATIONS: FINDINGS FROM THE TREAT-AF STUDY Kaiser, D., Lee, R., Fan, J., Schmitt, S., Turakhia, M. ELSEVIER SCIENCE INC. 2016: 877

  View details for DOI 10.1016/S0735-1097(16)30878-6

  View details for Web of Science ID 000375188701721

• ASSOCIATION OF INSURANCE TYPE WITH RECEIPT OF ORAL ANTICOAGULATION IN ATRIAL FIBRILLATION: AN ANALYSIS OF THE AMERICAN COLLEGE OF CARDIOLOGY NCDR PINNACLE REGISTRY Yong, C. M., Liu, Y., Lei, L., Doros, G., Cannon, C., Maddox, T., Gehi, A., Virani, S., Turakhia, M., ACC PINNACLE Investigators ELSEVIER SCIENCE INC. 2016: 888

  View details for DOI 10.1016/S0735-1097(16)30889-0

  View details for Web of Science ID 000375188701732

• Oral Anticoagulant Therapy Prescription in Patients With Atrial Fibrillation Across the Spectrum of Stroke Risk Insights From the NCDR PINNACLE Registry JAMA CARDIOLOGY Hsu, J. C., Maddox, T. M., Kennedy, K. F., Katz, D. F., Marzec, L. N., Lubitz, S. A., Gehi, A. K., Turakhia, M. P., Marcus, G. M. 2016; 1 (1): 55–62

  Abstract

  Patients with atrial fibrillation (AF) are at a proportionally higher risk of stroke based on accumulation of well-defined risk factors.To examine the extent to which prescription of an oral anticoagulant (OAC) in US cardiology practices increases as the number of stroke risk factors increases.Cross-sectional registry study of outpatients with AF enrolled in the American College of Cardiology National Cardiovascular Data Registry's PINNACLE (Practice Innovation and Clinical Excellence) Registry between January 1, 2008, and December 30, 2012. As a measure of stroke risk, we calculated the CHADS2 score and the CHA2DS2-VASc score for all patients. Using multinomial logistic regression models adjusted for patient, physician, and practice characteristics, we examined the association between increased stroke risk score and prescription of an OAC.The primary outcome was prescription of an OAC with warfarin sodium or a non-vitamin K antagonist OAC.The study cohort comprised 429 417 outpatients with AF. Their mean (SD) age was 71.3 (12.9) years, and 55.8% were male. Prescribed treatment consisted of an OAC (192 600 [44.9%]), aspirin only (111 134 [25.9%]), aspirin plus a thienopyridine (23 454 [5.5%]), or no antithrombotic therapy (102 229 [23.8%]). Each 1-point increase in risk score was associated with increased odds of OAC prescription compared with aspirin-only prescription using the CHADS2 score (adjusted odds ratio, 1.158; 95% CI, 1.144-1.172; P < .001) and the CHA2DS2-VASc score (adjusted odds ratio, 1.163; 95% CI, 1.157-1.169; P < .001). Overall, OAC prescription prevalence did not exceed 50% even in higher-risk patients with a CHADS2 score exceeding 3 or a CHA2DS2-VASc score exceeding 4.In a large quality improvement registry of outpatients with AF, prescription of OAC therapy increased with a higher CHADS2 score and CHA2DS2-VASc score. However, a plateau of OAC prescription was observed, with less than half of high-risk patients receiving an OAC prescription.

  View details for PubMedID 27437655

• The precise timing of tachycardia entrainment is determined by the postpacing interval, the tachycardia cycle length, and the pacing rate: Theoretical insights and practical applications HEART RHYTHM Kaiser, D. W., Hsia, H. H., Dubin, A. M., Liem, L. B., Viswanathan, M. N., Zei, P. C., Wang, P. J., Narayan, S. M., Turakhia, M. P. 2016; 13 (3): 695-703

  Abstract

  Previous observations have reported that the number of pacing stimuli required to entrain a tachycardia varies on the basis of arrhythmia type and location, but a quantitative formulation of the number needed to entrain (NNE) that unifies these observations has not been characterized.We sought to investigate the relationship between the number of pacing stimulations, the tachycardia cycle length (TCL), the overdrive pacing cycle length (PCL), and the postpacing interval (PPI) to accurately estimate the timing of tachycardia entrainment.First, we detailed a mathematical derivation unifying electrophysiological parameters with empirical confirmation in 2 patients undergoing catheter ablation of typical atrial flutter. Second, we validated our formula in 44 patients who underwent various catheter ablation procedures. For accuracy, we corrected for rate-related changes in conduction velocity.We derived the equations NNE = |(PPI - TCL)/(TCL - PCL)| + 1 and Tachycardia advancement = (NNE - 1) × (TCL - PCL) - (PPI - TCL), which state that the NNE and the amount of tachycardia advancement on the first resetting stimulation are determined using regularly measured intracardiac parameters. In the retrospective cohort, the observed PPI - TCL highly correlated with the predicted PPI - TCL (mean difference 5.8 ms; r = 0.97; P < .001), calculated as PPI - TCL = (NNE - 1) × (TCL - PCL) - tachycardia advancement.The number of pacing stimulations required to entrain a reentrant tachycardia is predictable at any PCL after correcting for cycle length-dependent changes in conduction velocity. This relationship unifies established empirically derived diagnostic and mapping criteria for supraventricular tachycardia and ventricular tachycardia. This relationship may help elucidate when antitachycardia pacing episodes are ineffective or proarrhythmic and could potentially serve as a theoretical basis to customize antitachycardia pacing settings for improved safety and effectiveness.

  View details for DOI 10.1016/j.hrthm.2015.11.032

  View details for Web of Science ID 000372367800012

  View details for PubMedCentralID PMC4770895

• Guideline-Directed Medication Use in Patients With Heart Failure With Reduced Ejection Fraction in India: American College of Cardiology's PINNACLE India Quality Improvement Program CLINICAL CARDIOLOGY Pokharel, Y., Wei, J., Hira, R. S., Kalra, A., Shore, S., Kerkar, P. G., Kumar, G., Risch, S., Vicera, V., Oetgen, W. J., Deswal, A., Turakhia, M. P., Glusenkamp, N., Virani, S. S. 2016; 39 (3): 145-149

  Abstract

  Little is known about the use of guideline-directed medical therapy (GDMT) in outpatients with heart failure with reduced left ventricular ejection fraction (HFrEF; ≤40%) in India. Our objective was to understand the use of GDMT in outpatients with HFrEF in India. The Practice Innovation And Clinical Excellence (PINNACLE) India Quality Improvement Program (PIQIP) is a registry for cardiovascular quality improvement in India supported by the American College of Cardiology Foundation. Between January 2008 and September 2014, we evaluated documentation of use of angiotensin-converting enzyme inhibitors (ACEIs)/angiotensin receptor blockers (ARBs) and β-blockers, or both, among outpatients with HFrEF seeking care in 10 centers enrolled in the PIQIP registry. Among 75 639 patients in the PIQIP registry, 34 995 had EF reported, and 15 870 had an EF ≤40%. The mean age was 56 years; 23% were female. Hypertension, diabetes, coronary artery disease, and myocardial infarction were present in 37%, 23%, 27%, and 17%, respectively. Use of ACEIs/ARBs, β-blockers, and both were documented in 33.5%, 34.9%, and 29.6% of patients, respectively. The documentation of GDMT was higher in men, in patients age ≥65 years, and in those with presence of hypertension, diabetes, or coronary artery disease. Documentation of GDMT gradually increased over the study period. Among patients enrolled in the PIQIP registry, about two-thirds of patients with EF ≤40% did not have documented receipt of GDMT. This study is an initial step toward improving adherence to GDMT in India and highlights the feasibility of examining quality of care in HFrEF in a resource-limited setting.

  View details for DOI 10.1002/clc.22519

  View details for PubMedID 26880649

• The precise timing of tachycardia entrainment is determined by the postpacing interval, the tachycardia cycle length, and the pacing rate: Theoretical insights and practical applications. Heart rhythm Kaiser, D. W., Hsia, H. H., Dubin, A. M., Liem, L. B., Viswanathan, M. N., Zei, P. C., Wang, P. J., Narayan, S. M., Turakhia, M. P. 2016; 13 (3): 695-703

  Abstract

  Previous observations have reported that the number of pacing stimuli required to entrain a tachycardia varies on the basis of arrhythmia type and location, but a quantitative formulation of the number needed to entrain (NNE) that unifies these observations has not been characterized.We sought to investigate the relationship between the number of pacing stimulations, the tachycardia cycle length (TCL), the overdrive pacing cycle length (PCL), and the postpacing interval (PPI) to accurately estimate the timing of tachycardia entrainment.First, we detailed a mathematical derivation unifying electrophysiological parameters with empirical confirmation in 2 patients undergoing catheter ablation of typical atrial flutter. Second, we validated our formula in 44 patients who underwent various catheter ablation procedures. For accuracy, we corrected for rate-related changes in conduction velocity.We derived the equations NNE = |(PPI - TCL)/(TCL - PCL)| + 1 and Tachycardia advancement = (NNE - 1) × (TCL - PCL) - (PPI - TCL), which state that the NNE and the amount of tachycardia advancement on the first resetting stimulation are determined using regularly measured intracardiac parameters. In the retrospective cohort, the observed PPI - TCL highly correlated with the predicted PPI - TCL (mean difference 5.8 ms; r = 0.97; P < .001), calculated as PPI - TCL = (NNE - 1) × (TCL - PCL) - tachycardia advancement.The number of pacing stimulations required to entrain a reentrant tachycardia is predictable at any PCL after correcting for cycle length-dependent changes in conduction velocity. This relationship unifies established empirically derived diagnostic and mapping criteria for supraventricular tachycardia and ventricular tachycardia. This relationship may help elucidate when antitachycardia pacing episodes are ineffective or proarrhythmic and could potentially serve as a theoretical basis to customize antitachycardia pacing settings for improved safety and effectiveness.

  View details for DOI 10.1016/j.hrthm.2015.11.032

  View details for PubMedID 26611239

• Stroke Risk Stratification in Atrial Fibrillation: Bridging the Evidence Gaps JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY Turakhia, M. P., Estes, N. 2016; 27 (3): 271–73

  View details for PubMedID 26643150

• Sleep disordered breathing and cardiovascular risk in older patients initiating dialysis in the United States: a retrospective observational study using medicare data BMC NEPHROLOGY Tuohy, C. V., Montez-Rath, M. E., Turakhia, M., Chang, T. I., Winkelman, J. W., Winkelmayer, W. C. 2016; 17

  Abstract

  Sleep disordered breathing (SDB) such as sleep apnea is associated with cardiovascular disease in the general population. However, little is known about the cardiovascular risks of SDB in patients with end-stage renal disease (ESRD).We identified Medicare fee-for-service beneficiaries aged ≥67 years initiating dialysis between 2004 and 2009. Outcomes of interest included all-cause mortality, incident myocardial infarction, ischemic stroke, and atrial fibrillation. We compared patients with and without diagnosed SDB using Cox proportional hazards regression.Between 2004 and 2009, 184,217 older patients developed ESRD, of whom 15,121 (8.2 %) were previously diagnosed with SDB. Patients diagnosed with SDB were younger, more likely to be male and Caucasian, less Medicaid eligible, had more non-Nephrology clinic visits, higher body mass index, and more comorbidity. In analyses adjusting for demographics and BMI, diagnosed SDB was associated with higher risk of death and atrial fibrillation, but not associated with myocardial infarction or ischemic stroke risk. After further adjustment for all baseline characteristics, diagnosed SDB was associated with slightly lower risks of death (hazard ratio [HR]: 0.93, 95 % confidence interval [CI]: 0.91-0.96), myocardial infarction (HR: 0.92, CI: 0.87-0.98), and ischemic stroke (HR: 0.90, 95 % CI: 0.82-0.98), and not associated with atrial fibrillation (HR: 1.02, CI: 0.98-1.07).In older patients initiating dialysis in the U.S., diagnosed SDB was weakly associated with lower risks of death and important cardiovascular outcomes, thus adding to the list of established risk factors that are paradoxically associated with cardiovascular outcomes in the ESRD population.

  View details for DOI 10.1186/s12882-016-0229-3

  View details for Web of Science ID 000369620700001

  View details for PubMedCentralID PMC4748630

• Sleep disordered breathing and cardiovascular risk in older patients initiating dialysis in the United States: a retrospective observational study using medicare data. BMC nephrology Tuohy, C. V., Montez-Rath, M. E., Turakhia, M., Chang, T. I., Winkelman, J. W., Winkelmayer, W. C. 2016; 17: 16

  Abstract

  Sleep disordered breathing (SDB) such as sleep apnea is associated with cardiovascular disease in the general population. However, little is known about the cardiovascular risks of SDB in patients with end-stage renal disease (ESRD).We identified Medicare fee-for-service beneficiaries aged ≥67 years initiating dialysis between 2004 and 2009. Outcomes of interest included all-cause mortality, incident myocardial infarction, ischemic stroke, and atrial fibrillation. We compared patients with and without diagnosed SDB using Cox proportional hazards regression.Between 2004 and 2009, 184,217 older patients developed ESRD, of whom 15,121 (8.2 %) were previously diagnosed with SDB. Patients diagnosed with SDB were younger, more likely to be male and Caucasian, less Medicaid eligible, had more non-Nephrology clinic visits, higher body mass index, and more comorbidity. In analyses adjusting for demographics and BMI, diagnosed SDB was associated with higher risk of death and atrial fibrillation, but not associated with myocardial infarction or ischemic stroke risk. After further adjustment for all baseline characteristics, diagnosed SDB was associated with slightly lower risks of death (hazard ratio [HR]: 0.93, 95 % confidence interval [CI]: 0.91-0.96), myocardial infarction (HR: 0.92, CI: 0.87-0.98), and ischemic stroke (HR: 0.90, 95 % CI: 0.82-0.98), and not associated with atrial fibrillation (HR: 1.02, CI: 0.98-1.07).In older patients initiating dialysis in the U.S., diagnosed SDB was weakly associated with lower risks of death and important cardiovascular outcomes, thus adding to the list of established risk factors that are paradoxically associated with cardiovascular outcomes in the ESRD population.

  View details for DOI 10.1186/s12882-016-0229-3

  View details for PubMedID 26861778

  View details for PubMedCentralID PMC4748630

• Racial Differences in Quality of Anticoagulation Therapy for Atrial Fibrillation (from the TREAT-AF Study) AMERICAN JOURNAL OF CARDIOLOGY Yong, C., Azarbal, F., Abnousi, F., Heidenreich, P. A., Schmitt, S., Fan, J., Than, C. T., Ullal, A. J., Yang, F., Phibbs, C. S., Frayne, S. M., Ho, P. M., Shore, S., Mahaffey, K. W., Turakhia, M. P. 2016; 117 (1): 61-68

  Abstract

  The influence of race on quality of anticoagulation control is not well described. We examined the association between race, international normalized ratio (INR) monitoring intensity, and INR control in warfarin-treated patients with atrial fibrillation (AF). Using data from the Veterans Health Administration (VHA), we performed a retrospective cohort study of 184,161 patients with a new diagnosis of AF/flutter from 2004 to 2012 who received any VHA prescription within 90 days of diagnosis. The primary predictor was race, ascertained from multiple VHA and linked Medicare demographic files. The primary outcome was first-year and long-term time in therapeutic range (TTR) of INR 2.0 to 3.0. Secondary outcomes were INR monitoring intensity and warfarin persistence. Of the 116,021 patients who received warfarin in the cohort, INR monitoring intensity was similar across racial groups. However, TTR was lowest in blacks and highest in whites (first year 0.49 ± 0.23 vs 0.57 ± 0.21, p <0.001; long term 0.52 ± 0.20 vs 0.59 ± 0.18, p <0.001); 64% of whites and 49% of blacks had long-term TTR >55% (p <0.001). After adjusting for site and patient-level covariates, black race was associated with lower first-year and long-term TTRs (4.2% and 4.1% below the conditional mean, relative to whites; p <0.0001 for both). One-year warfarin persistence was slightly lower in blacks compared to whites (58% vs 60%, p <0.0001). In conclusion, in patients with AF anticoagulated with warfarin, differences in INR control are most evident among blacks, underscoring the need to determine if other types of intensive management or warfarin alternatives may be necessary to improve anticoagulation among vulnerable AF populations.

  View details for DOI 10.1016/j.amjcard.2015.09.047

  View details for Web of Science ID 000368048900010

• Gender Differences in Clinical Outcomes After Catheter Ablation of Atrial Fibrillation JACC Clin Electrophysiol Kaiser, D. W., Fan, J., Schmitt, S., Than, C. T., Ullal, A. J., Piccini, J. P., Heidenreich, P. A., Turakhia, M. P. 2016

  View details for DOI 10.1016/j.jacep.2016.04.014

• Racial Differences in Quality of Anticoagulation Therapy for Atrial Fibrillation (from the TREAT-AF Study). The American journal of cardiology Yong, C., Azarbal, F., Abnousi, F., Heidenreich, P. A., Schmitt, S., Fan, J., Than, C. T., Ullal, A. J., Yang, F., Phibbs, C. S., Frayne, S. M., Ho, P. M., Shore, S., Mahaffey, K. W., Turakhia, M. P. 2016; 117 (1): 61-8

  Abstract

  The influence of race on quality of anticoagulation control is not well described. We examined the association between race, international normalized ratio (INR) monitoring intensity, and INR control in warfarin-treated patients with atrial fibrillation (AF). Using data from the Veterans Health Administration (VHA), we performed a retrospective cohort study of 184,161 patients with a new diagnosis of AF/flutter from 2004 to 2012 who received any VHA prescription within 90 days of diagnosis. The primary predictor was race, ascertained from multiple VHA and linked Medicare demographic files. The primary outcome was first-year and long-term time in therapeutic range (TTR) of INR 2.0 to 3.0. Secondary outcomes were INR monitoring intensity and warfarin persistence. Of the 116,021 patients who received warfarin in the cohort, INR monitoring intensity was similar across racial groups. However, TTR was lowest in blacks and highest in whites (first year 0.49 ± 0.23 vs 0.57 ± 0.21, p <0.001; long term 0.52 ± 0.20 vs 0.59 ± 0.18, p <0.001); 64% of whites and 49% of blacks had long-term TTR >55% (p <0.001). After adjusting for site and patient-level covariates, black race was associated with lower first-year and long-term TTRs (4.2% and 4.1% below the conditional mean, relative to whites; p <0.0001 for both). One-year warfarin persistence was slightly lower in blacks compared to whites (58% vs 60%, p <0.0001). In conclusion, in patients with AF anticoagulated with warfarin, differences in INR control are most evident among blacks, underscoring the need to determine if other types of intensive management or warfarin alternatives may be necessary to improve anticoagulation among vulnerable AF populations.

  View details for DOI 10.1016/j.amjcard.2015.09.047

  View details for PubMedID 26552504

• Utilization and Likelihood of Radiologic Diagnostic Imaging in Patients With Implantable Cardiac Defibrillators JOURNAL OF MAGNETIC RESONANCE IMAGING Nazarian, S., Reynolds, M. R., Ryan, M. P., Wolff, S. D., Mollenkopf, S. A., Turakhia, M. P. 2016; 43 (1): 115–27

  Abstract

  To examine imaging utilization in a matched cohort of patients with and without implantable cardioverter defibrillators (ICD) and to project magnetic resonance imaging (MRI) utilization over a 10-year period.The Truven Health MarketScan Commercial claims and Medicare Supplemental health insurance claims data were used to identify patients with continuous health plan enrollment in 2009-2012. Patients with ICDs were identified using ICD-9 and CPT codes, and matched to patients with the same demographic and comorbidity profile, but no record of device implantation. Diagnostic imaging utilization was compared across the matched cohorts, in total, by imaging categories, and in subpopulations of stroke, back pain, and joint pain. MRI use in the nonimplant group over the 4-year period was extrapolated out to 10 years for ICD-indicated patients.A cohort of 18,770 matched patients were identified; average age 65.5 ± 13.38 and 21.9% female. ICD patients had significantly less MRI imaging (0.23 0.70 SD vs. 0.00 0.08 SD, P < 0.0001) than nonimplant patients. Among patients with records of stroke/transient ischemic attack (TIA) (ICD 5%, nonimplant 4%) and accompanying diagnostic imaging, 44% of nonimplant patients underwent MRI vs. 1% of ICD patients (P < 0.0001). Forecast models estimated that 53% to 64% of ICD-eligible patients may require an MRI within 10 years.MRI utilization is lower in ICD patients compared to nonimplant patients, yet the burden of incident stroke/TIA, back, and joint pain suggests an unmet need for MR-conditional devices.

  View details for PubMedID 26118943

  View details for PubMedCentralID PMC4755166

• International Collaborative Partnership for the Study of Atrial Fibrillation (INTERAF): Rationale, Design, and Initial Descriptives. Journal of the American Heart Association Hsu, J. C., Akao, M., Abe, M., Anderson, K. L., Avezum, A., Glusenkamp, N., Kohsaka, S., Lane, D. A., Lip, G. Y., Ma, C., Masoudi, F. A., Potpara, T. S., Siong, T. W., Turakhia, M. P., Tse, H., Rumsfeld, J. S., Maddox, T. M. 2016; 5 (11)

  View details for PubMedID 27806965

• Amiodarone and risk of death in contemporary patients with atrial fibrillation: Findings from The Retrospective Evaluation and Assessment of Therapies in AF study. American heart journal Ullal, A. J., Than, C. T., Fan, J., Schmitt, S., Perino, A. C., Kaiser, D. W., Heidenreich, P. A., Frayne, S. M., Phibbs, C. S., Turakhia, M. P. 2015; 170 (5): 1033-1041 e1

  Abstract

  There are limited data on mortality outcomes associated with use of amiodarone in atrial fibrillation and flutter (AF).We evaluated the association of amiodarone use with mortality in patients with newly diagnosed AF using complete data from the Department of Veterans Affairs national health care system. We included patients seen in an outpatient setting within 90 days of a new diagnosis for nonvalvular AF between Veterans Affairs fiscal years 2004 and 2008. Multivariate analysis and propensity-matched Cox proportional hazards regression were used to evaluate the association of amiodarone use to death.Of 122,465 patients (353,168 person-years of follow-up, age 72.1 ± 10.3 years, 98.4% males), amiodarone was prescribed in 11,655 (9.5%). Cumulative, unadjusted mortality rates were higher for amiodarone recipients than for nonrecipients (87 vs 73 per 1,000 person-years, P < .001). However, in multivariate and propensity-matched survival analyses, there was no significant difference in mortality (multivariate hazard ratio 1.01, 95% CI 0.97-1.05, P = .51, and propensity-matched hazard ratio 1.02, 95% CI 0.97-1.07, P = .45). The hazard of death was not modified by age, sex, heart failure, kidney function, β-blocker use, or warfarin use, but there was evidence of effect modification among patients diagnosed with AF as an inpatient versus outpatient.In a national health care system population of newly diagnosed AF, overall use of amiodarone as an early treatment strategy was not associated with mortality.

  View details for DOI 10.1016/j.ahj.2015.07.023

  View details for PubMedID 26542514

  View details for PubMedCentralID PMC4800972

• Innovative designs of point-of-care comparative effectiveness trials CONTEMPORARY CLINICAL TRIALS Shih, M., Turakhia, M., Lai, T. L. 2015; 45: 61-68

  Abstract

  One of the provisions of the health care reform legislation in 2010 was for funding pragmatic clinical trials or large observational studies for comparing the effectiveness of different approved medical treatments, involving broadly representative patient populations. After reviewing pragmatic clinical trials and the issues and challenges that have made them just a small fraction of comparative effectiveness research (CER), we focus on a recent development that uses point-of-care (POC) clinical trials to address the issue of "knowledge-action gap" in pragmatic CER trials. We give illustrative examples of POC-CER trials and describe a trial that we are currently planning to compare the effectiveness of newly approved oral anticoagulants. We also develop novel stage-wise designs of information-rich POC-CER trials under competitive budget constraints, by using recent advances in adaptive designs and other statistical methodologies.

  View details for DOI 10.1016/j.cct.2015.06.014

  View details for Web of Science ID 000367754700010

  View details for PubMedCentralID PMC4639459

• Anticoagulation in Atrial Fibrillation: Impact of Mental Illness AMERICAN JOURNAL OF MANAGED CARE Schmitt, S. K., Turakhia, M. P., Phibbs, C. S., Moos, R. H., Berlowitz, D., Heidenreich, P., Chiu, V. Y., Go, A. S., Friedman, S. A., Than, C. T., Frayne, S. M. 2015; 21 (11): E609-E617

  Abstract

  To characterize warfarin eligibility and receipt among Veterans Health Administration (VHA) patients with and without mental health conditions (MHCs).Retrospective cohort study.This observational study identified VHA atrial fibrillation (AF) patients with and without MHCs in 2004. We examined unadjusted MHC-related differences in warfarin eligibility and warfarin receipt among warfarin-eligible patients, using logistic regression for any MHC and for specific MHCs (adjusting for sociodemographic and clinical characteristics).Of 125,670 patients with AF, most (96.8%) were warfarin-eligible based on a CHADS2 stroke risk score. High stroke risk and contraindications to anticoagulation were both more common in patients with MHC. Warfarin-eligible patients with MHC were less likely to receive warfarin than those without MHC (adjusted odds ratio [AOR], 0.90; 95% CI, 0.87-0.94). The association between MHC and warfarin receipt among warfarin-eligible patients varied by specific MHC. Patients with anxiety disorders (AOR, 0.86; 95% CI, 0.80-0.93), psychotic disorders (AOR, 0.77; 95% CI, 0.65-0.90), and alcohol use disorders (AOR 0.62, 95% CI 0.54-0.72) were less likely to receive warfarin than patients without these conditions, whereas patients with depressive disorders and posttraumatic stress disorder were no less likely to receive warfarin than patients without these conditions.Compared with patients with AF without MHCs, those with MHCs are less likely to be eligible for warfarin receipt and, among those eligible, are less likely to receive such treatment. Although patients with AF with MHC need careful assessment of bleeding risk, this finding suggests potential missed opportunities for more intensive therapy among some individuals with MHCs.

  View details for Web of Science ID 000379911700003

  View details for PubMedID 26735294

• Innovative designs of point-of-care comparative effectiveness trials. Contemporary clinical trials Shih, M. C., Turakhia, M., Lai, T. L. 2015; 45 (Pt A): 61-8

  Abstract

  One of the provisions of the health care reform legislation in 2010 was for funding pragmatic clinical trials or large observational studies for comparing the effectiveness of different approved medical treatments, involving broadly representative patient populations. After reviewing pragmatic clinical trials and the issues and challenges that have made them just a small fraction of comparative effectiveness research (CER), we focus on a recent development that uses point-of-care (POC) clinical trials to address the issue of "knowledge-action gap" in pragmatic CER trials. We give illustrative examples of POC-CER trials and describe a trial that we are currently planning to compare the effectiveness of newly approved oral anticoagulants. We also develop novel stage-wise designs of information-rich POC-CER trials under competitive budget constraints, by using recent advances in adaptive designs and other statistical methodologies.

  View details for DOI 10.1016/j.cct.2015.06.014

  View details for PubMedID 26099528

  View details for PubMedCentralID PMC4639459

• Amiodarone and risk of death in contemporary patients with atrial fibrillation: Findings from The Retrospective Evaluation and Assessment of Therapies in AF study AMERICAN HEART JOURNAL Ullal, A. J., Than, C. T., Fan, J., Schmitt, S., Perino, A. C., Kaiser, D. W., Heidenreich, P. A., Frayne, S. M., Phibbs, C. S., Turakhia, M. P. 2015; 170 (5): 1033-U231

  Abstract

  There are limited data on mortality outcomes associated with use of amiodarone in atrial fibrillation and flutter (AF).We evaluated the association of amiodarone use with mortality in patients with newly diagnosed AF using complete data from the Department of Veterans Affairs national health care system. We included patients seen in an outpatient setting within 90 days of a new diagnosis for nonvalvular AF between Veterans Affairs fiscal years 2004 and 2008. Multivariate analysis and propensity-matched Cox proportional hazards regression were used to evaluate the association of amiodarone use to death.Of 122,465 patients (353,168 person-years of follow-up, age 72.1 ± 10.3 years, 98.4% males), amiodarone was prescribed in 11,655 (9.5%). Cumulative, unadjusted mortality rates were higher for amiodarone recipients than for nonrecipients (87 vs 73 per 1,000 person-years, P < .001). However, in multivariate and propensity-matched survival analyses, there was no significant difference in mortality (multivariate hazard ratio 1.01, 95% CI 0.97-1.05, P = .51, and propensity-matched hazard ratio 1.02, 95% CI 0.97-1.07, P = .45). The hazard of death was not modified by age, sex, heart failure, kidney function, β-blocker use, or warfarin use, but there was evidence of effect modification among patients diagnosed with AF as an inpatient versus outpatient.In a national health care system population of newly diagnosed AF, overall use of amiodarone as an early treatment strategy was not associated with mortality.

  View details for DOI 10.1016/j.ahj.2015.07.023

  View details for Web of Science ID 000364434600026

  View details for PubMedID 26542514

  View details for PubMedCentralID PMC4800972

• Outcomes After Warfarin Initiation in a Cohort of Hemodialysis Patients With Newly Diagnosed Atrial Fibrillation. American journal of kidney diseases Shen, J. I., Montez-Rath, M. E., Lenihan, C. R., Turakhia, M. P., Chang, T. I., Winkelmayer, W. C. 2015; 66 (4): 677-688

  Abstract

  Although warfarin is indicated to prevent ischemic strokes in most patients with atrial fibrillation (AF), evidence supporting its use in hemodialysis patients is limited. Our aim was to examine outcomes after warfarin therapy initiation, relative to no warfarin use, following incident AF in a large cohort of hemodialysis patients who had comprehensive prescription drug coverage through Medicare Part D.Retrospective observational cohort study.Patients in the US Renal Data System undergoing maintenance hemodialysis who had AF newly diagnosed in 2007 to 2011, with Medicare Part D coverage, who had no recorded history of warfarin use.Warfarin therapy initiation, identified by a filled prescription within 30 days of the AF event.Death, ischemic stroke, hemorrhagic stroke, severe gastrointestinal bleeding, and composite outcomes.HRs estimated by applying Cox regression to an inverse probability of treatment and censoring-weighted cohort.Of 12,284 patients with newly diagnosed AF, 1,838 (15%) initiated warfarin therapy within 30 days; however, ∼70% discontinued its use within 1 year. In intention-to-treat analyses, warfarin use was marginally associated with a reduced risk of ischemic stroke (HR, 0.68; 95% CI, 0.47-0.99), but not with the other outcomes. In as-treated analyses, warfarin use was associated with reduced mortality (HR, 0.84; 95% CI, 0.73-0.97).Short observation period, limited number of nonfatal events, limited generalizability of results to more affluent patients.In hemodialysis patients with incident AF, warfarin use was marginally associated with reduced risk of ischemic stroke, and there was a signal toward reduced mortality in as-treated analyses. These results support clinical equipoise regarding the use of warfarin in hemodialysis patients and underscore the need for randomized trials to fill this evidence gap.

  View details for DOI 10.1053/j.ajkd.2015.05.019

  View details for PubMedID 26162653

• Atrial Fibrillation Burden and Short-Term Risk of Stroke Case-Crossover Analysis of Continuously Recorded Heart Rhythm From Cardiac Electronic Implanted Devices CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Turakhia, M. P., Ziegler, P. D., Schmitt, S. K., Chang, Y., Fan, J., Than, C. T., Keung, E. K., Singer, D. E. 2015; 8 (5): 1040-1047

  Abstract

  The temporal relationship of atrial fibrillation (AF) and stroke risk is controversial. We evaluated this relationship via a case-crossover analysis of ischemic strokes in a large cohort of patients with cardiac implantable electronic devices.We identified 9850 patients with cardiac implantable electronic devices remotely monitored in the Veterans Administration Health Care System between 2002 and 2012. There were 187 patients with acute ischemic stroke and continuous heart rhythm monitoring for 120 days before the stroke (age, 69±8.4 years; 98% with an implantable defibrillator). We compared each patient's daily AF burden in the 30 days before stroke (case period) with their AF burden during days 91 to 120 pre stroke (control period). Defining positive AF burden as ≥5.5 hours of AF on any given day, 156 patients (83%) had no positive AF burden in both periods and, in fact, had little to no AF; 15 (8%) patients had positive AF burden in both periods. Among the discordant (informative) patients, 13 exceeded 5.5 hours of AF in the case period but not in the control period, whereas 3 had positive AF burden in the control but not in the case period (warfarin-adjusted odds ratio for stroke, 4.2; 95% confidence interval, 1.5-13.4). Odds ratio for stroke was highest (17.4; 95% confidence interval, 5.39-73.1) in the 5 days immediately after a qualifying occurrence of AF and decreased toward 1.0 as the period after the AF occurrence increased beyond 30 days.In this population with continuous heart rhythm recording, multiple hours of AF had a strong but transient effect raising stroke risk.

  View details for DOI 10.1161/CIRCEP.114.003057

  View details for PubMedID 26175528

• Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry. Heart rhythm Kaiser, D. W., Tsai, V., Heidenreich, P. A., Goldstein, M. K., Wang, Y., Curtis, J., Turakhia, M. P. 2015; 12 (10): 2086-2093

  Abstract

  Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria.We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs.Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT).Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4).Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance.

  View details for DOI 10.1016/j.hrthm.2015.05.010

  View details for PubMedID 25982720

• Economic Burden of Undiagnosed Nonvalvular Atrial Fibrillation in the United States AMERICAN JOURNAL OF CARDIOLOGY Turakhia, M. P., Shafrin, J., Bognar, K., Goldman, D. P., Mendys, P. M., Abdulsattar, Y., Wiederkehr, D., Trocio, J. 2015; 116 (5): 733-739

  Abstract

  Atrial fibrillation (AF) may be clinically silent and therefore undiagnosed. To date, no estimates of the direct medical cost of undiagnosed AF exist. We estimated the United States (US) incremental cost burden of undiagnosed nonvalvular AF nationally using administrative claims data. To calculate the incremental costs of undiagnosed AF, we compared annual medical costs (in 2014 US Dollars) for patients with AF compared to propensity-matched controls and multiplied this by estimates of undiagnosed AF prevalence derived from the same data sources. The study population included US residents aged ≥18 years with 24 months of continuous enrollment drawn from 2 large administrative claims databases. Mean per capita medical spending for patients with AF aged from 18 to 64 year was $38,861 (95% confidence interval [CI] $35,781 to $41,950) compared to $28,506 (95% CI $28,409 to $28,603) for similar patients without AF (incremental cost difference $10,355, p <0.001); total spending for patients aged ≥65 years with AF was $25,322 (95% CI $25,049 to $25,595) compared to $21,706 (95% CI $21,563 to $21,849) for similar patients without AF (incremental cost difference $3,616, p <0.001). Using estimates of the US prevalence of undiagnosed AF (596,000) drawn from the same data, we estimated that the US incremental cost burden of undiagnosed nonvalvular AF is $3.1 billion (95% CI $2.7 to $3.7 billion). In conclusion, the direct medical costs for patients with undiagnosed AF are greater than patients with similar observable characteristics without AF and strategies to identify and treat patients with undiagnosed AF could lead to sizable reductions in stroke sequelae and associated costs.

  View details for DOI 10.1016/j.amjcard.2015.05.045

  View details for PubMedID 26138378

• A validated risk model for 1-year mortality after primary prevention implantable cardioverter defibrillator placement AMERICAN HEART JOURNAL Heidenreich, P. A., Tsai, V., Curtis, J., Wang, Y., Turakhia, M. P., Masoudi, F. A., Varosy, P. D., Goldstein, M. K. 2015; 170 (2): 281-U119

  Abstract

  We sought to determine survival for patients with heart failure after an implantation of an implantable cardioverter defibrillator (ICD) for primary prevention in the United States and to develop a simple model that would predict mortality risk.Clinical trials have found that patients with heart failure with a 1-year mortality risk near 20% may not benefit from an ICD.We identified patients from the ICD Registry of the National Cardiovascular Disease Registries who underwent ICD implantation for primary prevention from 2007 to 2009. Two risk scores for mortality were developed in 2 cohorts: one limited to those with a B-type natriuretic peptide (BNP) value and a second for all patients. The scores were obtained from derivation datasets and tested in a validation sets using logistic regression models and classification and regression trees.In a primary prevention population with BNP available (18,725) the 6 variables most predictive of 1-year mortality were age ≥75, BNP ≥700 pg/mL, chronic lung disease, dialysis, blood urea nitrogen ≥30 mg/dL, and systolic blood pressure <120 mmHg. Patients with zero risk factors had a 3.3% one-year mortality compared to a 66.7% one-year mortality for those with all 6 risk factors. Those with ≥3 risk factors (24.0% of the population) had a 25.8% one-year mortality. A second score using a larger cohort that did not consider BNP identified similar risk factors.A simple validated risk score can identify patients at high and low risk for death within a year after ICD placement. A large fraction of those currently implanted with an ICD in the United States have a high 1-year mortality and may not benefit from ICD therapy.

  View details for DOI 10.1016/j.ahj.2014.12.013

  View details for Web of Science ID 000360360100015

• Early detection of occult atrial fibrillation and stroke prevention HEART Keach, J. W., Bradley, S. M., Turakhia, M. P., Maddox, T. M. 2015; 101 (14): 1097-1102

  Abstract

  Atrial fibrillation (AF) is a very common arrhythmia and significantly increases stroke risk. This risk can be mitigated with oral anticoagulation, but AF is often asymptomatic, or occult, preventing timely detection and treatment. Accordingly, occult AF may cause stroke before it is clinically diagnosed. Currently, guidelines for the early detection and treatment of occult AF are limited. This review addresses recent advancements in occult AF detection methods, identification of populations at high risk for occult AF, the treatment of occult AF with oral anticoagulation, as well as ongoing trials that may answer critically important questions regarding occult AF screening.

  View details for DOI 10.1136/heartjnl-2015-307588

  View details for PubMedID 25935765

• Individual and Combined Risk Factors for Incident Atrial Fibrillation and Incident Stroke: An Analysis of 3 Million At-Risk US Patients JOURNAL OF THE AMERICAN HEART ASSOCIATION Chyou, J. Y., Hunter, T. D., Mollenkopf, S. A., Turakhia, M. P., Reynolds, M. R. 2015; 4 (7)

  Abstract

  The incremental effects of risk factor combinations for atrial fibrillation (AF) and stroke are incompletely understood. We sought to quantify the risks of incident AF and stroke for combinations of established risk factors in a large US sample.Patients with no evidence of AF or stroke in 2007 were stratified by combinations of the following risk factors: heart failure, hypertension, diabetes, age 65 to 74, age ≥75, coronary artery disease, and chronic kidney disease. Patients with ≥2 of the first 5 or ≥3 of the first 7, classified as "high-risk," and an age-matched sample of patients with fewer risk factors, classified as "low-risk," were followed over 2008-2010 for incident AF and stroke. Annualized incidence rates and risks were quantified for each combination of factors by using Cox regression. Annualized incidence rates for AF, stroke, and both were 3.59%, 3.27%, and 0.62% in 1 851 653 high-risk patients and 1.32%, 1.48%, and 0.18% in 1 156 221 low-risk patients, respectively. Among patients with 1 risk factor, those with age ≥75 had the highest hazards of incident AF and stroke (HR 9.2, 6.9). Among patients with 2 risk factors, those with age ≥75 and heart failure had the highest annualized incidence rates of AF and stroke (10.2%, 5.9%). The combination of age ≥75 and hypertension was prevalent and had the highest incidences of AF and stroke.Adults with combinations of known risk factors are at increased risk of incident AF and stroke, but combinations of risk factors are not always additive.

  View details for DOI 10.1161/JAHA.114.001723

  View details for PubMedID 26206736

• Does Age Influence Cardiac Resynchronization Therapy Use and Outcome? JACC. Heart failure Heidenreich, P. A., Tsai, V., Bao, H., Curtis, J., Goldstein, M., Curtis, L., Hernandez, A., Peterson, P., Turakhia, M. P., Masoudi, F. A. 2015; 3 (6): 497-504

  Abstract

  This study sought to describe the use of CRT-D and its association with survival for older patients.Many patients who receive cardiac resynchronization therapy with defibrillator (CRT-D) in practice are older than those included in clinical trials.We identified patients undergoing ICD implantation in the National Cardiovascular Disease Registry (NCDR) ICD registry from 2006 to 2009, who also met clinical trial criteria for CRT, including left ventricular ejection fraction (LVEF) ≤35%, QRS ≥120 ms, and New York Heart Association (NYHA) functional class III or IV. NCDR registry data were linked to the social security death index to determine the primary outcome of time to death from any cause. We identified 70,854 patients from 1,187 facilities who met prior trial criteria for CRT-D. The mean age of the 58,147 patients receiving CRT-D was 69.4 years with 6.4% of patients age 85 or older. CRT use was 80% or higher among candidates in all age groups. Follow-up was available for 42,285 patients age ≥65 years at 12 months.Receipt of CRT-D was associated with better survival at 1 year (82.1% vs. 77.1%, respectively) and 4 years (54.0% vs. 46.2% , respectively) than in those receiving only an ICD (p < 0.001). The CRT association with improved survival was not different for different age groups (p = 0.86 for interaction).More than 80% of older patients undergoing ICD implantation who were candidates for a CRT-D received the combined device. Mortality in older patients undergoing ICD implantation was high but was lower for those receiving CRT-D.

  View details for DOI 10.1016/j.jchf.2015.01.012

  View details for PubMedID 25982109

• Cardiovascular Disease Performance Measures in the Outpatient Setting in India: Insights From the American College of Cardiology's PINNACLE India Quality Improvement Program (PIQIP) JOURNAL OF THE AMERICAN HEART ASSOCIATION Kalra, A., Pokharel, Y., Hira, R. S., Risch, S., Vicera, V., Li, Q., Kalra, R. N., Kerkar, P. G., Kumar, G., Maddox, T. M., Oetgen, W. J., Glusenkamp, N., Turakhia, M. P., Virani, S. S. 2015; 4 (5)

  Abstract

  India has a growing burden of cardiovascular disease (CVD), yet data on the quality of outpatient care for patients with coronary artery disease, heart failure, and atrial fibrillation in India are very limited. We collected data on performance measures for 68 196 unique patients from 10 Indian cardiology outpatient departments from January 1, 2011, to February 5, 2014, in the American College of Cardiology's PINNACLE (Practice Innovation and Clinical Excellence) India Quality Improvement Program (PIQIP). PIQIP is India's first national outpatient CVD quality-improvement program.In the PIQIP registry, we estimated the prevalence of CVD risk factors (hypertension, diabetes, dyslipidemia, and current tobacco use) and CVD among outpatients. We examined adherence with performance measures established by the American College of Cardiology, the American Heart Association, and the American Medical Association Physician Consortium for Performance Improvement for coronary artery disease, heart failure, and atrial fibrillation. There were a total of 68 196 patients (155 953 patient encounters), with a mean age of 50.6 years (SD 18.2 years). Hypertension was present in 29.7% of patients, followed by diabetes (14.9%), current tobacco use (7.6%), and dyslipidemia (6.5%). Coronary artery disease was present in 14.8%, heart failure was noted in 4.0%, and atrial fibrillation was present in 0.5% of patients. Among eligible patients, the reported use of medications was as follows: aspirin in 48.6%, clopidogrel in 37.1%, and statin-based lipid-lowering therapy in 50.6% of patients with coronary artery disease; RAAS (renin-angiotensin-aldosterone system) antagonist in 61.9% and beta-blockers in 58.1% of patients with heart failure; and oral anticoagulants in 37.0% of patients with atrial fibrillation.This pilot study, initiated to improve outpatient CVD care in India, presents our preliminary results and barriers to data collection and demonstrates that such an initiative is feasible in a resource-limited environment. In addition, we attempted to outline areas for further improvement in outpatient CVD care delivery in India.

  View details for DOI 10.1161/JAHA.115.001910

  View details for PubMedID 25994444

• EVIDENCE OF A GAP IN CARE: UTILIZATION OF RADIOLOGIC DIAGNOSTIC IMAGING IN PATIENTS WITH AND WITHOUT IMPLANTABLE DEFIBRILLATORS Nazarian, S., Reynolds, M. R., Ryan, M. P., Wolff, S. D., Mollenkopf, S., Turakhia, M. P. ELSEVIER SCIENCE INC. 2015: A47

  View details for DOI 10.1016/j.jval.2015.03.279

  View details for Web of Science ID 000354498500250

• Feasibility of Extended Ambulatory Electrocardiogram Monitoring to Identify Silent Atrial Fibrillation in High-risk Patients: The Screening Study for Undiagnosed Atrial Fibrillation (STUDY-AF) CLINICAL CARDIOLOGY Turakhia, M. P., Ullal, A. J., Hoang, D. D., Than, C. T., Miller, J. D., Friday, K. J., Perez, M. V., Freeman, J. V., Wang, P. J., Heidenreich, P. A. 2015; 38 (5): 285-292

  Abstract

  Identification of silent atrial fibrillation (AF) could prevent stroke and other sequelae.Screening for AF using continuous ambulatory electrocardiographic (ECG) monitoring can detect silent AF in asymptomatic in patients with known risk factors.We performed a single-center prospective screening study using a wearable patch-based device that provides up to 2 weeks of continuous ambulatory ECG monitoring (iRhythm Technologies, Inc.). Inclusion criteria were age ≥55 years and ≥2 of the following risk factors: coronary disease, heart failure, hypertension, diabetes, sleep apnea. We excluded patients with prior AF, stroke, transient ischemic attack, implantable pacemaker or defibrillator, or with palpitations or syncope in the prior year.Out of 75 subjects (all male, age 69 ± 8.0 years; ejection fraction 57% ± 8.7%), AF was detected in 4 subjects (5.3%; AF burden 28% ± 48%). Atrial tachycardia (AT) was present in 67% (≥4 beats), 44% (≥8 beats), and 6.7% (≥60 seconds) of subjects. The combined diagnostic yield of sustained AT/AF was 11%. In subjects without sustained AT/AF, 11 (16%) had ≥30 supraventricular ectopic complexes per hour.Outpatient extended ECG screening for asymptomatic AF is feasible, with AF identified in 1 in 20 subjects and sustained AT/AF identified in 1 in 9 subjects, respectively. We also found a high prevalence of asymptomatic AT and frequent supraventricular ectopic complexes, which may be relevant to development of AF or stroke. If confirmed in a larger study, primary screening for AF could have a significant impact on public health.

  View details for DOI 10.1002/clc.22387

  View details for PubMedID 25873476

• Site-level variation in and practices associated with dabigatran adherence. JAMA Shore, S., Ho, P. M., Lambert-Kerzner, A., Glorioso, T. J., Carey, E. P., Cunningham, F., Longo, L., Jackevicius, C., Rose, A., Turakhia, M. P. 2015; 313 (14): 1443-1450

  Abstract

  Unlike warfarin, which requires routine laboratory testing and dose adjustment, target-specific oral anticoagulants like dabigatran do not. However, optimal follow-up infrastructure and modifiable site-level factors associated with improved adherence to dabigatran are unknown.To assess site-level variation in dabigatran adherence and to identify site-level practices associated with higher dabigatran adherence.Mixed-methods study involving retrospective quantitative and cross-sectional qualitative data. A total of 67 Veterans Health Administration sites with 20 or more patients filling dabigatran prescriptions between 2010 and 2012 for nonvalvular atrial fibrillation were sampled (4863 total patients; median, 51 patients per site). Forty-seven pharmacists from 41 eligible sites participated in the qualitative inquiry.Site-level practices identified included appropriate patient selection, pharmacist-driven patient education, and pharmacist-led adverse event and adherence monitoring.Dabigatran adherence (intensity of drug use during therapy) defined by proportion of days covered (ratio of days supplied by prescription to follow-up duration) of 80% or more.The median proportion of patients adherent to dabigatran was 74% (interquartile range [IQR], 66%-80%). After multivariable adjustment, dabigatran adherence across sites varied by a median odds ratio of 1.57. Review of practices across participating sites showed that appropriate patient selection was performed at 31 sites, pharmacist-led education was provided at 30 sites, and pharmacist-led monitoring at 28 sites. The proportion of adherent patients was higher at sites performing appropriate selection (75% vs 69%), education (76% vs 66%), and monitoring (77% vs 65%). Following multivariable adjustment, association between pharmacist-led education and dabigatran adherence was not statistically significant (relative risk [RR], 0.94; 95% CI, 0.83-1.06). Appropriate patient selection (RR, 1.14; 95% CI, 1.05-1.25), and provision of pharmacist-led monitoring (RR, 1.25; 95% CI, 1.11-1.41) were associated with better patient adherence. Additionally, longer duration of monitoring and providing more intensive care to nonadherent patients in collaboration with the clinician improved adherence.Among nonvalvular atrial fibrillation patients treated with dabigatran, there was variability in patient medication adherence across Veterans Health Administration sites. Specific pharmacist-based activities were associated with greater patient adherence to dabigatran.

  View details for DOI 10.1001/jama.2015.2761

  View details for PubMedID 25871670

• Safety of ventricular tachycardia ablation in clinical practice: findings from 9699 hospital discharge records. Circulation. Arrhythmia and electrophysiology Katz, D. F., Turakhia, M. P., Sauer, W. H., Tzou, W. S., Heath, R. R., Zipse, M. M., Aleong, R. G., Varosy, P. D., Kao, D. P. 2015; 8 (2): 362-370

  Abstract

  Outcomes of ventricular tachycardia (VT) ablation have been described in clinical trials and single-center studies. We assessed the safety of VT ablation in clinical practice.Using administrative hospitalization data between 1994 and 2011, we identified hospitalizations with primary diagnosis of VT (International Classification of Diseases-9 Clinical Modification code: 427.1) and cardiac ablation (International Classification of Diseases-9 Clinical Modification code: 37.34). We quantified in-hospital adverse events (AEs), including death, stroke, intracerebral hemorrhage, pericardial complications, hematoma or hemorrhage, blood transfusion, or cardiogenic shock. Secondary outcomes included major AEs (stroke, tamponade, or death) and death. Multivariable mixed effects models identified patient and hospital characteristics associated with AEs. Of 9699 hospitalizations with VT ablations (age, 56.5±17.6; 60.1% men), AEs were reported in 825 (8.5%), major AEs in 295 (3.0%), and death in 110 (1.1%). Heart failure had the strongest association with death (odds ratio, 5.52; 95% confidence interval, 2.97-10.3) and major AE (odds ratio, 2.99; 95% confidence interval, 2.15-4.16). Anemia (odds ratio, 4.84; 95% confidence interval, 3.79-6.19) and unscheduled admission (odds ratio, 1.64; 95% confidence interval, 1.37-1.97) were associated with AEs. During the study period, incidence of AEs increased from 9.2% to 12.8% as did the burden of AE risk factors (0.034 patient/y; P<0.001). Hospital volume >25 cases/y was associated with fewer AEs compared with lower volume centers (6.4% versus 8.8%; P=0.008).VT ablation-associated AE rates in clinical practice are similar to those reported in the literature. Over time rates have increased as have the number of AE risk factors per patient. Ablations done electively and at hospitals with higher procedural volume are associated with lower incidence of AEs.

  View details for DOI 10.1161/CIRCEP.114.002336

  View details for PubMedID 25688143

• Safety of Ventricular Tachycardia Ablation in Clinical Practice Findings from 9699 Hospital Discharge Records CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Katz, D. F., Turakhia, M. P., Sauer, W. H., Tzou, W. S., Heath, R. R., Zipse, M. M., Aleong, R. G., Varosy, P. D., Kao, D. P. 2015; 8 (2): 362-U153

  Abstract

  Outcomes of ventricular tachycardia (VT) ablation have been described in clinical trials and single-center studies. We assessed the safety of VT ablation in clinical practice.Using administrative hospitalization data between 1994 and 2011, we identified hospitalizations with primary diagnosis of VT (International Classification of Diseases-9 Clinical Modification code: 427.1) and cardiac ablation (International Classification of Diseases-9 Clinical Modification code: 37.34). We quantified in-hospital adverse events (AEs), including death, stroke, intracerebral hemorrhage, pericardial complications, hematoma or hemorrhage, blood transfusion, or cardiogenic shock. Secondary outcomes included major AEs (stroke, tamponade, or death) and death. Multivariable mixed effects models identified patient and hospital characteristics associated with AEs. Of 9699 hospitalizations with VT ablations (age, 56.5±17.6; 60.1% men), AEs were reported in 825 (8.5%), major AEs in 295 (3.0%), and death in 110 (1.1%). Heart failure had the strongest association with death (odds ratio, 5.52; 95% confidence interval, 2.97-10.3) and major AE (odds ratio, 2.99; 95% confidence interval, 2.15-4.16). Anemia (odds ratio, 4.84; 95% confidence interval, 3.79-6.19) and unscheduled admission (odds ratio, 1.64; 95% confidence interval, 1.37-1.97) were associated with AEs. During the study period, incidence of AEs increased from 9.2% to 12.8% as did the burden of AE risk factors (0.034 patient/y; P<0.001). Hospital volume >25 cases/y was associated with fewer AEs compared with lower volume centers (6.4% versus 8.8%; P=0.008).VT ablation-associated AE rates in clinical practice are similar to those reported in the literature. Over time rates have increased as have the number of AE risk factors per patient. Ablations done electively and at hospitals with higher procedural volume are associated with lower incidence of AEs.

  View details for DOI 10.1161/CIRCEP.114.002336

  View details for Web of Science ID 000353309100018

  View details for PubMedID 25688143

• ECONOMIC BURDEN OF UNDIAGNOSED NONVALVULAR ATRIAL FIBRILLATION IN THE UNITED STATES Turakhia, M., Shafrin, J., Bognar, K., Trocio, J., Abdulsattar, Y., Wiederkehr, D., Goldman, D. ELSEVIER SCIENCE INC. 2015: A475

  View details for DOI 10.1016/S0735-1097(15)60475-2

  View details for Web of Science ID 000375328800476

• COST VARIATION AND ASSOCIATED OUTCOMES OF CATHETER ABLATION FOR ATRIAL FIBRILLATION Perino, A., Fan, J., Schmitt, S., Chang, A. Y., Kaiser, D., Heidenreich, P., Swan, C., Narayan, S., Wang, P., Turakhia, M. ELSEVIER SCIENCE INC. 2015: A277

  View details for DOI 10.1016/S0735-1097(15)60277-7

  View details for Web of Science ID 000375328800278

• Correlates and outcomes of warfarin initiation in kidney transplant recipients newly diagnosed with atrial fibrillation. Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association Lenihan, C. R., Montez-Rath, M. E., Shen, J. I., Scandling, J. D., Turakhia, M. P., Chang, T. I., Winkelmayer, W. C. 2015; 30 (2): 321-329

  Abstract

  In the kidney transplant population with atrial fibrillation (AF), evidence regarding the effectiveness and safety of warfarin treatment is lacking. We used fee-for-service Medicare claims to identify kidney transplant recipients with newly diagnosed AF from the United States Renal Data System. Warfarin use within 30 days of AF diagnosis was ascertained from Medicare Part D prescription claims (2007-11) or using a validated algorithm (1997-2011). The study end points were (i) the composite of death, stroke or gastrointestinal bleed, (ii) death and (iii) death-censored graft failure. Warfarin user and non-user groups were balanced using inverse probability of treatment weighting and hazard ratios were (HRs) estimated using Cox regression. Among 718 subjects with an indication for anticoagulation, 24% initiated warfarin treatment within 30 days of AF diagnosis. Age was the only independent correlate of warfarin use [odds ratio = 1.02 per year; 95% confidence interval (95% CI) 1.01-1.04]. In the larger cohort of 6492 patients with AF, warfarin use [(23.5%) versus non-use (76.5%)] was associated with small and non-significant reductions in the composite of death, stroke or gastrointestinal bleed (HR = 0.92; 95% CI 0.83-1.02), death (HR = 0.92; 95% CI 0.82-1.02) and death-censored graft failure (HR = 0.90; 95% CI 0.76-1.08). Our study suggests the need for clinical trials of warfarin use in the kidney transplant population with AF.

  View details for DOI 10.1093/ndt/gfu323

  View details for PubMedID 25335507

• Reply: increased mortality by digoxin in patients with atrial fibrillation? Journal of the American College of Cardiology Turakhia, M. P., Heidenreich, P. A. 2015; 65 (2): 221-?

  View details for DOI 10.1016/j.jacc.2014.10.032

  View details for PubMedID 25593068

• Diagnostic yield of extenced cardiac patch monitoring in patients with stroke or TIA FRONTIERS IN NEUROLOGY Tung, C. E., Su, D., Turakhia, M. P., Lansberg, M. G. 2015; 5

  View details for DOI 10.3389/fneur.2014.00266

  View details for Web of Science ID 000363750000001

• Effectiveness of a community screening program for metabolic syndrome and cardiovascular risk factor identification in young South Asians adults. Diabetes & metabolic syndrome Prasad, M., Flowers, E., Mathur, A., Sridhar, V., Molina, C., Turakhia, M. 2015; 9 (1): 38-41

  Abstract

  Metabolic syndrome has been associated with increased risk of cardiovascular disease. We aimed to determine the effectiveness of a community-based screening program in identifying cardiovascular risk factors in healthy young South Asian population.Between 2006 and 2011, 3314 patients of all ages were recruited as a part of a prospective cohort study investigating cardiovascular risk in South Asians. We analyzed 1537 patients between the ages of 18 and 40. Demographic and baseline characteristics including baseline laboratory markers and blood pressures were obtained at initial visit.The total cohort of 1537 patients was 66.5% male, and the mean age was 35±5 years. Among participants who denied a history of hypercholesterolemia, 62% had elevated LDL-C (>100mg/dL), and 8% had markedly elevated LDL-C (>160mg/dL). Overall, diabetes was present in 4%, hypertension was present in 12% and hyperlipidemia was present in 46%. Low HDL-C (50% of men, 52% of women) and elevated triglycerides (44% of men, 18% of women) were the most prevalent components of metabolic syndrome. Metabolic syndrome was present in 14% of men and 8% of women and one-third (30%) of men and one-fifth (19%) of women had at least two component risk factors.This is the largest study to date assessing effectiveness of a community based screening program aiming to identify cardiovascular risk in young South Asians. We note significant modifiable risk at a young age. Such community based interventions can be effective at detecting and managing risk factors early in this vulnerable population.

  View details for DOI 10.1016/j.dsx.2014.04.025

  View details for PubMedID 25470638

• Evaluating the Cost-effectiveness of Catheter Ablation of Atrial Fibrillation. Arrhythmia & electrophysiology review Chang, A. Y., Kaiser, D., Ullal, A., Perino, A. C., Heidenreich, P. A., Turakhia, M. P. 2014; 3 (3): 177-183

  Abstract

  Atrial fibrillation (AF) is one of the most common cardiac conditions treated in primary care and specialty cardiology settings, and is associated with considerable morbidity, mortality and cost. Catheter ablation, typically by electrically isolating the pulmonary veins and surrounding tissue, is more effective at maintaining sinus rhythm than conventional antiarrhythmic drug therapy and is now recommended as first-line therapy. From a value standpoint, the cost-effectiveness of ablation must incorporate the upfront procedural costs and risks with the benefits of longer term improvements in quality of life (QOL) and healthcare utilisation. Here, we present a primer on cost-effectiveness analysis (CEA), review the data on cost-effectiveness of AF ablation and outline key areas for further investigation.

  View details for DOI 10.15420/aer.2014.3.3.177

  View details for PubMedID 26835088

• Get With The Guidelines AFIB: novel quality improvement registry for hospitalized patients with atrial fibrillation. Circulation. Cardiovascular quality and outcomes Lewis, W. R., Piccini, J. P., Turakhia, M. P., Curtis, A. B., Fang, M., Suter, R. E., Page, R. L., Fonarow, G. C. 2014; 7 (5): 770-777

  Abstract

  Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is a cause of stroke, heart failure, and death. Guideline-based treatment can improve outcomes in AF. Unfortunately, adherence to these guidelines is low. Get With The Guidelines is a hospital-based performance initiative, which has been shown to improve adherence over time. Get With The Guidelines-AFIB is a novel quality improvement registry designed to improve adherence to AF guidelines.Hospitals will be recruited by regional American Heart Association staff and key stakeholders. Inpatients or observed patients with AF or atrial flutter will be enrolled. Data collected will include demographic, medical history, and clinical characteristics including laboratory values and treatments. Decision support will guide adherence to achievement and quality measures designed to improve adherence to anticoagulation, heart rate control, safe antiarrhythmic drug use, and patient education and follow-up. Increased adherence to guidelines will be facilitated using rapid-cycle quality improvement, site-specific reporting including national and regional benchmarks and hospital recognition for achievement. Primary analyses will include adherence to American Heart Association/American College of Cardiology performance measures and guidelines. Secondary analyses will include processes of care, risk stratification, treatment of special conditions or populations and use of particular treatment techniques.AF is common clinical problem with significant morbidity and mortality. Get With The Guidelines-AFIB is a national hospital-based AF quality improvement program designed to increase adherence to evidence-based guidelines for AF.

  View details for DOI 10.1161/CIRCOUTCOMES.114.001263

  View details for PubMedID 25185244

• Association between success rate and citation count of studies of radiofrequency catheter ablation for atrial fibrillation: possible evidence of citation bias. Circulation. Cardiovascular quality and outcomes Perino, A. C., Hoang, D. D., Holmes, T. H., Santangeli, P., Heidenreich, P. A., Perez, M. V., Wang, P. J., Turakhia, M. P. 2014; 7 (5): 687-692

  Abstract

  The preferential citation of studies with the highest success rates could exaggerate perceived effectiveness, particularly for treatments with widely varying published success rates such as radiofrequency catheter ablation for atrial fibrillation.We systematically identified observational studies and clinical trials of radiofrequency catheter ablation of atrial fibrillation between 1990 and 2012. Generalized Poisson regression was used to estimate association between study success rate and total citation count, adjusting for sample size, journal impact factor, time since publication, study design, and whether first or last author was a consensus-defined pre-eminent expert. We identified 174 articles meeting our inclusion criteria (36 289 subjects). After adjustment only for time since publication, a 10-point increase above the mean in pooled reported success rates was associated with a 17.8% increase in citation count at 5 years postpublication (95% confidence interval, 7.1-28.4%; P<0.001). After additional adjustment for impact factor, sample size, randomized trial design, and pre-eminent expert authorship, the association remained significant (18.6% increase in citation count; 95% confidence interval, 7.6-29.6%; P<0.0001). In this full model, time since publication, impact factor, and pre-eminent expert authorship were significant covariates, whereas randomized control trial design and study sample size were not.Among studies of radiofrequency catheter ablation of atrial fibrillation, high success rate was independently associated with citation count, which may indicate citation bias. To readers of the literature, radiofrequency catheter ablation of atrial fibrillation could be perceived to be more effective than the data supports. These findings may have implications for a wide variety of novel cardiovascular therapies.

  View details for DOI 10.1161/CIRCOUTCOMES.114.000912

  View details for PubMedID 25205786

• Get With The Guidelines AFIB Novel Quality Improvement Registry for Hospitalized Patients With Atrial Fibrillation CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Lewis, W. R., Piccini, J. P., Turakhia, M. P., Curtis, A. B., Fang, M., Suter, R. E., Page, R. L., Fonarow, G. C. 2014; 7 (5): 770-777

  Abstract

  Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is a cause of stroke, heart failure, and death. Guideline-based treatment can improve outcomes in AF. Unfortunately, adherence to these guidelines is low. Get With The Guidelines is a hospital-based performance initiative, which has been shown to improve adherence over time. Get With The Guidelines-AFIB is a novel quality improvement registry designed to improve adherence to AF guidelines.Hospitals will be recruited by regional American Heart Association staff and key stakeholders. Inpatients or observed patients with AF or atrial flutter will be enrolled. Data collected will include demographic, medical history, and clinical characteristics including laboratory values and treatments. Decision support will guide adherence to achievement and quality measures designed to improve adherence to anticoagulation, heart rate control, safe antiarrhythmic drug use, and patient education and follow-up. Increased adherence to guidelines will be facilitated using rapid-cycle quality improvement, site-specific reporting including national and regional benchmarks and hospital recognition for achievement. Primary analyses will include adherence to American Heart Association/American College of Cardiology performance measures and guidelines. Secondary analyses will include processes of care, risk stratification, treatment of special conditions or populations and use of particular treatment techniques.AF is common clinical problem with significant morbidity and mortality. Get With The Guidelines-AFIB is a national hospital-based AF quality improvement program designed to increase adherence to evidence-based guidelines for AF.

  View details for DOI 10.1161/CIRCOUTCOMES.114.001263

  View details for Web of Science ID 000342365200022

• Association Between Success Rate and Citation Count of Studies of Radiofrequency Catheter Ablation for Atrial Fibrillation Possible Evidence of Citation Bias CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Perino, A. C., Hoang, D. D., Holmes, T. H., Santangeli, P., Heidenreich, P. A., Perez, M. V., Wang, P. J., Turakhia, M. P. 2014; 7 (5): 687-692

  Abstract

  The preferential citation of studies with the highest success rates could exaggerate perceived effectiveness, particularly for treatments with widely varying published success rates such as radiofrequency catheter ablation for atrial fibrillation.We systematically identified observational studies and clinical trials of radiofrequency catheter ablation of atrial fibrillation between 1990 and 2012. Generalized Poisson regression was used to estimate association between study success rate and total citation count, adjusting for sample size, journal impact factor, time since publication, study design, and whether first or last author was a consensus-defined pre-eminent expert. We identified 174 articles meeting our inclusion criteria (36 289 subjects). After adjustment only for time since publication, a 10-point increase above the mean in pooled reported success rates was associated with a 17.8% increase in citation count at 5 years postpublication (95% confidence interval, 7.1-28.4%; P<0.001). After additional adjustment for impact factor, sample size, randomized trial design, and pre-eminent expert authorship, the association remained significant (18.6% increase in citation count; 95% confidence interval, 7.6-29.6%; P<0.0001). In this full model, time since publication, impact factor, and pre-eminent expert authorship were significant covariates, whereas randomized control trial design and study sample size were not.Among studies of radiofrequency catheter ablation of atrial fibrillation, high success rate was independently associated with citation count, which may indicate citation bias. To readers of the literature, radiofrequency catheter ablation of atrial fibrillation could be perceived to be more effective than the data supports. These findings may have implications for a wide variety of novel cardiovascular therapies.

  View details for DOI 10.1161/CIRCOUTCOMES.114.000912

  View details for Web of Science ID 000342365200011

• Increased Mortality Associated With Digoxin in Contemporary Patients With Atrial Fibrillation: Findings From the TREAT-AF Study. Journal of the American College of Cardiology Turakhia, M. P., Santangeli, P., Winkelmayer, W. C., Xu, X., Ullal, A. J., Than, C. T., Schmitt, S., Holmes, T. H., Frayne, S. M., Phibbs, C. S., Yang, F., Hoang, D. D., Ho, P. M., Heidenreich, P. A. 2014; 64 (7): 660-668

  Abstract

  Despite endorsement of digoxin in clinical practice guidelines, there exist limited data on its safety in atrial fibrillation/flutter (AF).The goal of this study was to evaluate the association of digoxin with mortality in AF.Using complete data of the TREAT-AF (The Retrospective Evaluation and Assessment of Therapies in AF) study from the U.S. Department of Veterans Affairs (VA) healthcare system, we identified patients with newly diagnosed, nonvalvular AF seen within 90 days in an outpatient setting between VA fiscal years 2004 and 2008. We used multivariate and propensity-matched Cox proportional hazards to evaluate the association of digoxin use with death. Residual confounding was assessed by sensitivity analysis.Of 122,465 patients with 353,168 person-years of follow-up (age 72.1 ± 10.3 years, 98.4% male), 28,679 (23.4%) patients received digoxin. Cumulative mortality rates were higher for digoxin-treated patients than for untreated patients (95 vs. 67 per 1,000 person-years; p < 0.001). Digoxin use was independently associated with mortality after multivariate adjustment (hazard ratio [HR]: 1.26, 95% confidence interval [CI]: 1.23 to 1.29, p < 0.001) and propensity matching (HR: 1.21, 95% CI: 1.17 to 1.25, p < 0.001), even after adjustment for drug adherence. The risk of death was not modified by age, sex, heart failure, kidney function, or concomitant use of beta-blockers, amiodarone, or warfarin.Digoxin was associated with increased risk of death in patients with newly diagnosed AF, independent of drug adherence, kidney function, cardiovascular comorbidities, and concomitant therapies. These findings challenge current cardiovascular society recommendations on use of digoxin in AF.

  View details for DOI 10.1016/j.jacc.2014.03.060

  View details for PubMedID 25125296

• Adherence to dabigatran therapy and longitudinal patient outcomes: Insights from the Veterans Health Administration AMERICAN HEART JOURNAL Shore, S., Carey, E. P., Turakhia, M. P., Jackevicius, C. A., Cunningham, F., Pilote, L., Bradley, S. M., Maddox, T. M., Grunwald, G. K., Baron, A. E., Rumsfeld, J. S., Varosy, P. D., Schneider, P. M., Marzec, L. N., Ho, P. M. 2014; 167 (6): 810-817

  Abstract

  Dabigatran is a novel oral anti-coagulant (NOAC) that reduces risk of stroke in patients with non-valvular atrial fibrillation (NVAF). It does not require routine monitoring with laboratory testing which may have an adverse impact on adherence. We aimed to describe adherence to dabigatran in the first year after initiation and assess the association between non-adherence to dabigatran and clinical outcomes in a large integrated healthcare system.We studied a national cohort of 5,376 patients with NVAF, initiated on dabigatran between October-2010 and September-2012 at all Veterans Affairs hospitals. Adherence to dabigatran was calculated as proportion of days covered (PDC) and association between PDC and outcomes was assessed using standard regression techniques.Mean age of the study cohort was 71.3 ± 9.7 years; 98.3% were men and mean CHADS2 score was 2.4 ± 1.2 (mean CHA2DS2VASc score 3.2 ± 1.4). Median PDC was 94% (IQR 76%-100%; mean PDC 84% ± 22%) over a median follow-up of 244 days (IQR 140-351). A total of 1,494 (27.8%) patients had a PDC <80% and were classified as non-adherent. After multivariable adjustment, lower adherence was associated with increased risk for combined all-cause mortality and stroke (HR 1.13, 95% CI 1.07-1.19 per 10% decrease in PDC). Adherence to dabigatran was not associated with non-fatal bleeding or myocardial infarction.In the year after initiation, adherence to dabigatran for a majority of patients is very good. However, 28% of patients in our cohort had poor adherence. Furthermore, lower adherence to dabigatran was associated with increased adverse outcomes. Concerted efforts are needed to optimize adherence to NOACs.

  View details for DOI 10.1016/j.ahj.2014.03.023

  View details for PubMedID 24890529

• Relation of Left Atrial Dysfunction to Ischemic Stroke in Patients With Coronary Heart Disease (from the Heart and Soul Study). American journal of cardiology Wong, J. M., Welles, C. C., Azarbal, F., Whooley, M. A., Schiller, N. B., Turakhia, M. P. 2014; 113 (10): 1679-1684

  Abstract

  This study sought to determine whether left atrial (LA) dysfunction independently predicts ischemic stroke. Atrial fibrillation (AF) impairs LA function and is associated with ischemic stroke. However, ischemic stroke frequently occurs in patients without known AF. The direct relation between LA function and risk of ischemic stroke is unknown. We performed transthoracic echocardiography at rest in 983 subjects with stable coronary heart disease. To quantify LA dysfunction, we used the left atrial function index (LAFI), a validated formula incorporating LA volumes at end-atrial systole and diastole. Cox proportional hazards models were used to evaluate the association between LAFI and ischemic stroke or transient ischemic attack (TIA). Over a mean follow-up of 7.1 years, 58 study participants (5.9%) experienced an ischemic stroke or TIA. In patients without known baseline AF or warfarin therapy (n = 893), participants in the lowest quintile of LAFI had >3 times the risk of ischemic stroke or TIA (hazard ratio 3.3, 95% confidence interval 1.1 to 9.7, p = 0.03) compared with those in the highest quintile. For each standard deviation (18.8 U) decrease in LAFI, the hazard of ischemic stroke or TIA increased by 50% (hazard ratio 1.5, 95% confidence interval 1.0 to 2.1, p = 0.04). Among measured echocardiographic indexes of LA function, including LA volume, LAFI was the strongest predictor of ischemic stroke or TIA. In conclusion, LA dysfunction is an independent risk factor for stroke or TIA, even in patients without baseline AF.

  View details for DOI 10.1016/j.amjcard.2014.02.021

  View details for PubMedID 24792737

• Association of CHADS2, CHA2DS2-VASc, and R2CHADS2 Scores With Left Atrial Dysfunction in Patients With Coronary Heart Disease (from the Heart and Soul Study). American journal of cardiology Azarbal, F., Welles, C. C., Wong, J. M., Whooley, M. A., Schiller, N. B., Turakhia, M. P. 2014; 113 (7): 1166-1172

  Abstract

  The predictive ability of the CHADS2 index to stratify stroke risk may be mechanistically linked to severity of left atrial (LA) dysfunction. This study investigated the association between the CHADS2 score and LA function. We performed resting transthoracic echocardiography in 970 patients with stable coronary heart disease and normal ejection fraction and calculated baseline LA functional index (LAFI) using a validated formula: (LA emptying fraction×left ventricular outflow tract velocity time integral)/LA end-systolic volume indexed to body surface area. We performed regression analyses to evaluate the association between risk scores and LAFI. Among 970 subjects, mean CHADS2 was 1.7±1.2. Mean LAFI decreased across tertiles of CHADS2 (42.8±18.1, 37.8±19.1, 36.7±19.4, p<0.001). After adjustment for age, sex, race, systolic blood pressure, hyperlipidemia, myocardial infarction, revascularization, body mass index, smoking, and alcohol use, high CHADS2 remained associated with the lowest quartile of LAFI (odds ratio 2.34, p=0.001). In multivariable analysis of component co-morbidities, heart failure, age, and creatinine clearance<60 ml/min were strongly associated with LA dysfunction. For every point increase in CHADS2, the LAFI decreased by 4.0%. Secondary analyses using CHA2DS2-VASc and R2CHADS2 scores replicated these results. Findings were consistent when excluding patients with baseline atrial fibrillation. In conclusion, CHADS2, CHA2DS2-VASc, and R2CHADS2 scores are associated with LA dysfunction, even in patients without baseline atrial fibrillation. These findings merit further study to determine the role of LA dysfunction in cardioembolic stroke and the value of LAFI for risk stratification.

  View details for DOI 10.1016/j.amjcard.2013.12.028

  View details for PubMedID 24507169

• Warfarin treatment in patients with atrial fibrillation and advanced chronic kidney disease: sins of omission or commission? JAMA Winkelmayer, W. C., Turakhia, M. P. 2014; 311 (9): 913-915

  View details for DOI 10.1001/jama.2014.1781

  View details for PubMedID 24595773

• Phenytoin toxicity unlikely to result in arrhythmias-reply. JAMA internal medicine Johnson, C. J., Turakhia, M. P. 2014; 174 (1): 167-168

  View details for DOI 10.1001/jamainternmed.2013.11168

  View details for PubMedID 24394935

• Regarding "feasibility and safety of same-day discharge after implantable cardioverter defibrillator placement for primary prevention". Pacing and clinical electrophysiology : PACE Turakhia, M. P., Holmes, T. 2014; 37 (1): 131-?

  View details for DOI 10.1111/pace.12273

  View details for PubMedID 24033450

• Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Frontiers in neurology Tung, C. E., Su, D., Turakhia, M. P., Lansberg, M. G. 2014; 5: 266-?

  Abstract

  It is important to evaluate patients with transient ischemic attack (TIA) or stroke for atrial fibrillation (AF) because the detection of AF changes the recommended anti-thrombotic regimen from treatment with an antiplatelet agent to oral anticoagulation. This study describes the diagnostic yield of a patch-based, single-use, and water-resistant 14-day continuous cardiac rhythm monitor (ZIO Patch) in patients with stroke or TIA.We obtained data from the manufacturer and servicer of the ZIO Patch (iRhythm Technologies). Patients who were monitored between January 2012 and June 2013 and whose indication for monitoring was TIA or stroke were included. The duration of monitoring, the number and type of arrhythmias, and the time to first arrhythmia were documented.One thousand one hundred seventy-one monitoring reports were analyzed. The mean monitor wear time was 10.9 days and the median wear time was 13.0 days (interquartile range 7.2-14.0). The median analyzable time relative to the total wear time was 98.7% (IQR 96.0-99.5%). AF was present in 5.0% of all reports. The mean duration before the first episode of paroxysmal AF (PAF) was 1.5 days and the median duration was 0.4 days. 14.3% of first PAF episodes occurred after 48 h. The mean PAF burden was 12.7% of the total monitoring duration.Excellent quality of the recordings and very good patient compliance coupled with a substantial proportion of AF detection beyond the first 48 h of monitoring suggest that the cardiac patch is superior to conventional 48-h Holter monitors for AF detection in patients with stroke or TIA.

  View details for DOI 10.3389/fneur.2014.00266

  View details for PubMedID 25628595

• Adherence and persistence in the use of warfarin after hospital discharge among patients with heart failure and atrial fibrillation. Journal of cardiac failure Eapen, Z. J., Mi, X., Qualls, L. G., Hammill, B. G., Fonarow, G. C., Turakhia, M. P., Heidenreich, P. A., Peterson, E. D., Curtis, L. H., Hernandez, A. F., Al-Khatib, S. M. 2014; 20 (1): 23-30

  Abstract

  Postdischarge adherence and long-term persistence in the use of warfarin among patients with heart failure and atrial fibrillation without contraindications have not been fully described.We identified patients with heart failure and atrial fibrillation who were ≥65 years old, eligible for warfarin, and discharged home from hospitals in the Get With the Guidelines-Heart Failure registry from January 1, 2006, to December 31, 2009. We used linked Medicare prescription drug event data to measure adherence and persistence. The main outcome measures were rates of prescription at discharge, outpatient dispensing, discontinuation, and adherence as measured by the medication possession ratio. We hypothesized that adherence to warfarin would differ according to whether patients received the prescription at discharge. Among 2,691 eligible patients, 1,856 (69.0%) were prescribed warfarin at discharge. Patients prescribed warfarin at discharge had significantly higher prescription fill rates within 90 days (84.5% vs 12.3%; P < .001) and 1 year (91.6% vs 16.8%; P < .001) and significantly higher medication possession ratios (0.78 vs 0.63; P < .001). Among both previous nonusers and existing users, fill rates at 90 days and 1 year and possession ratios were significantly higher among those prescribed warfarin at discharge.One-third of eligible patients with heart failure and atrial fibrillation were not prescribed warfarin at discharge from a heart failure hospitalization, and few started therapy as outpatients. In contrast, most patients who were prescribed warfarin at discharge filled the prescription within 90 days and remained on therapy at 1 year.

  View details for DOI 10.1016/j.cardfail.2013.11.006

  View details for PubMedID 24275703

• Clinical reminders to providers of patients with reduced left ventricular ejection fraction increase defibrillator referral: a randomized trial. Circulation. Heart failure Gupta, A., Gholami, P., Turakhia, M. P., Friday, K., Heidenreich, P. A. 2014; 7 (1): 140-145

  Abstract

  Background- Many patients who are candidates for implantable cardioverter defibrillators (ICDs) are not referred for potential implantation. We sought to determine if a simple provider reminder would increase referrals. Methods and Results- We identified consecutive patients from January 2007 through July 2010 in the VA Palo Alto Health Care System with a left ventricular ejection fraction <35% on echocardiography. Patients were excluded using available administrative data only (no chart review) if they were known to have an ICD, if they were ≥80 years old, or if they did not have a current primary care or cardiology provider within the system. We randomized patients to no intervention or a clinical note to the provider in the medical record. The outcomes were referral for consideration of defibrillator implantation (primary) and documented discussion (secondary). Of 330 patients with left ventricular ejection fraction ≤35%, 128 were known to have an ICD, 85 were no longer followed in the healthcare system, and 28 were ≥80 years old, leaving 89 patients to be randomized. Forty-six patients were randomized to intervention and 43 to control. Eleven of 46 (24%) intervention patients were referred for consideration of ICD implantation during the following 6 months versus 1 of 43 (2%) control patients (P=0.004). Overall, 31 of 46 (67%) intervention patients versus 19 of 43 (44%) control patients had documentation discussing potential candidacy for defibrillators (P=0.05). Conclusions- In patients with low left ventricular ejection fraction, a simple electronic medical record-based intervention directed to their providers improved the rates of referral for ICD implantation. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01217827.

  View details for DOI 10.1161/CIRCHEARTFAILURE.113.000753

  View details for PubMedID 24319096

• Patterns of Adherence to Dabigatran and its Association With Outcomes Shore, S., Carev, E. P., Turakhia, M., Jackevicius, C., Cunnigham, F., Baron, A. E., Grunwald, G. K., Pilote, L., Bradley, S. M., Maddox, T. M., Rumsfeld, J., Varosy, P. D., Ho, P. LIPPINCOTT WILLIAMS & WILKINS. 2013

  View details for Web of Science ID 000332162906195

• Citation Bias Favoring Studies With Higher Success Rates for Catheter Ablation of Atrial Fibrillation Perino, A. C., Hoang, D. D., Holmes, T. H., Santangeli, P., Turakhia, M. P. LIPPINCOTT WILLIAMS & WILKINS. 2013

  View details for Web of Science ID 000332162902012

• Adherence With Dabigatran Therapy in Patients With Atrial Fibrillation Jackevicius, C., Avgil, M., Tu, J., Essebag, V., Eisenberg, M., Atzema, C., Ho, M., Turakhia, M., Lu, L., Behlouli, H., Pilote, L. LIPPINCOTT WILLIAMS & WILKINS. 2013

  View details for Web of Science ID 000332162905109

• Burden, timing, and relationship of cardiovascular hospitalization to mortality among Medicare beneficiaries with newly diagnosed atrial fibrillation. American heart journal Turakhia, M. P., Solomon, M. D., Jhaveri, M., Davis, P., Eber, M. R., Conrad, R., Summers, N., Lakdawalla, D. 2013; 166 (3): 573-580

  Abstract

  Limited data exist on the burden and relationship of cardiovascular (CV) hospitalization to mortality after newly diagnosed with atrial fibrillation (AF).Using a 20% sample of nationwide Medicare Part A and B claims data, we performed a retrospective cohort study of Medicare beneficiaries with newly diagnosed AF (2004-2008). Cox proportional hazards time-varying exposures were used to determine the risk of death among patients with CV hospitalization after AF diagnosis.Of 228,295 patients (mean age 79.6 ± 7.4 years, 56% female), 57% had a CV hospitalization after diagnosis of AF (41% in the first year). The most common primary CV hospitalization diagnoses were AF/supraventricular arrhythmias (21%), heart failure (19%), myocardial infarction (11%), and stroke/transient ischemic attack (7.7%). Incidence rates per 1,000 person-years among patients with and without CV hospitalization were 114 and 87, respectively, for all-cause mortality. After adjustment for covariates and time to CV hospitalization, the hazard of mortality among newly diagnosed AF patients with CV hospitalization, compared with those without CV hospitalization, was higher (hazard ratio 1.22, 95% CI 1.20-1.24).Cardiovascular hospitalization is common in the first year after AF diagnosis. Atrial fibrillation, heart failure, myocardial infarction, and stroke/transient ischemic attack account for half of primary hospitalization diagnosis. Cardiovascular hospitalization is independently associated with mortality, irrespective of time from diagnosis to first hospitalization, and represents a critical inflection point in survival trajectory. These findings highlight the importance of CV hospitalization as a marker of disease progression and poor outcomes. Efforts to clarify the determinants of hospitalization could inform interventions to reduce admissions and improve survival.

  View details for DOI 10.1016/j.ahj.2013.07.003

  View details for PubMedID 24016509

• Diagnostic utility of a novel leadless arrhythmia monitoring device. American journal of cardiology Turakhia, M. P., Hoang, D. D., Zimetbaum, P., Miller, J. D., Froelicher, V. F., Kumar, U. N., Xu, X., Yang, F., Heidenreich, P. A. 2013; 112 (4): 520-524

  Abstract

  Although extending the duration of ambulatory electrocardiographic monitoring beyond 24 to 48 hours can improve the detection of arrhythmias, lead-based (Holter) monitors might be limited by patient compliance and other factors. We, therefore, evaluated compliance, analyzable signal time, interval to arrhythmia detection, and diagnostic yield of the Zio Patch, a novel leadless, electrocardiographic monitoring device in 26,751 consecutive patients. The mean wear time was 7.6 ± 3.6 days, and the median analyzable time was 99% of the total wear time. Among the patients with detected arrhythmias (60.3% of all patients), 29.9% had their first arrhythmia and 51.1% had their first symptom-triggered arrhythmia occur after the initial 48-hour period. Compared with the first 48 hours of monitoring, the overall diagnostic yield was greater when data from the entire Zio Patch wear duration were included for any arrhythmia (62.2% vs 43.9%, p <0.0001) and for any symptomatic arrhythmia (9.7% vs 4.4%, p <0.0001). For paroxysmal atrial fibrillation (AF), the mean interval to the first detection of AF was inversely proportional to the total AF burden, with an increasing proportion occurring after 48 hours (11.2%, 10.5%, 20.8%, and 38.0% for an AF burden of 51% to 75%, 26% to 50%, 1% to 25%, and <1%, respectively). In conclusion, extended monitoring with the Zio Patch for ≤14 days is feasible, with high patient compliance, a high analyzable signal time, and an incremental diagnostic yield beyond 48 hours for all arrhythmia types. These findings could have significant implications for device selection, monitoring duration, and care pathways for arrhythmia evaluation and AF surveillance.

  View details for DOI 10.1016/j.amjcard.2013.04.017

  View details for PubMedID 23672988

• Outcomes after kidney transplantation of patients previously diagnosed with atrial fibrillation. American journal of transplantation Lenihan, C. R., Montez-Rath, M. E., Scandling, J. D., Turakhia, M. P., Winkelmayer, W. C. 2013; 13 (6): 1566-1575

  Abstract

  Little is known about the prevalence and outcomes of patients with atrial fibrillation/flutter (AF) who receive a kidney transplant. We identified all patients who had >1 year of uninterrupted Medicare A+B coverage before receiving their first kidney transplant (1997-2009). The presence of pretransplant AF was ascertained from diagnosis codes in Medicare physician claims. We studied the posttransplant outcomes of death, all-cause graft failure, death-censored graft failure and stroke using multivariable Cox regression. Of 62 706 eligible first kidney transplant recipients studied, 3794 (6.4%) were diagnosed with AF prior to kidney transplant. Over a mean follow up of 4.9 years, 40.6% of AF patients and 24.9% without AF died. All-cause and death-censored graft failure were 46.8% and 16.5%, respectively, in the AF group and 36.4% and 19.5%, respectively, in those without AF. Ischemic stroke occurred in 2.8% of patients with and 1.6% of patients without AF. In patients with AF, multivariable-adjusted hazard ratios (95% confidence intervals) for death, graft failure, death-censored graft failure and ischemic stroke were 1.46 (1.38-1.54), 1.41 (1.34-1.48), 1.26 (1.15-1.37) and 1.36 (1.10-1.68), respectively. Pre-existing AF is associated with poor posttransplant outcomes. Special attention should be paid to AF in pretransplant evaluation, counseling and risk stratification of kidney transplant candidates.

  View details for DOI 10.1111/ajt.12197

  View details for PubMedID 23721555

• Comparative effectiveness of antiarrhythmic drugs on cardiovascular hospitalization and mortality in atrial fibrillation JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH Lakdawalla, D., Turakhia, M. P., Jhaveri, M., Mozaffari, E., Davis, P., Bradley, L., Solomon, M. D. 2013; 2 (3): 301-312

  Abstract

  To assess, through a systematic review, evidence for the effects of antiarrhythmic drugs (AADs) on cardiovascular (CV) hospitalization and mortality.English language articles were identified using MEDLINE, EMBASE and the Cochrane Clinical Trial Registry and were screened for study applicability and methodological quality.Out of 3526 identified studies, 38 were selected for analysis (19 evaluated individual AADs, 13 compared rate- versus rhythm-control strategies, and 6 evaluated multiple AADs but did not report outcomes for individual agents). None of the studies examining individual AADs employed the CV hospitalization end point used in ATHENA (the reference trial). There were no head-to-head comparisons of individual AADs on CV hospitalization. Most high-quality studies used multidrug rate- versus rhythm-control strategies.Assessment of the comparative effectiveness of individual AADs on CV hospitalization and mortality end points is not possible with the current evidence.

  View details for DOI 10.2217/CER.13.19

  View details for Web of Science ID 000319022800018

• IDENTIFICATION OF PATIENTS AT HIGH RISK FOR SUBSEQUENT DEVELOPMENT OF ATRIAL FIBRILLATION OR STROKE USING A CLAIMS DATABASE Reynolds, M. R., Hunter, T. D., Mollenkopf, S. A., Turakhia, M. P. ELSEVIER SCIENCE INC. 2013: A25–A26

  View details for DOI 10.1016/j.jval.2013.03.151

  View details for Web of Science ID 000318916400130

• SLEEP DISORDERED BREATHING AND CARDIOVASCULAR RISK IN OLDER PATIENTS INITIATING DIALYSIS Tuohy, C., Montez-Rath, M. E., Turakhia, M., Chang, T. I., Winkelmayer, W. C. W B SAUNDERS CO-ELSEVIER INC. 2013: A95

  View details for Web of Science ID 000317274900322

• US Health Care Policy and Reform: implications for cardiac electrophysiology JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Turakhia, M. P., Ullal, A. J. 2013; 36 (2): 129-136

  Abstract

  In response to unsustainably rising costs, variable quality and access to health care, and the projected insolvency of vital safety net insurance programs, the federal government has proposed important health policy and regulatory changes in the USA. The US Supreme Court's decision to uphold most of the major provisions of the Affordable Care Act will lead to some of the most sweeping government reforms on entitlements since the creation of Medicare. Furthermore, implementation of new organizational, reimbursement, and health care delivery models will strongly affect the practice of cardiac electrophysiology. In this brief review, we will provide background and context to the problem of rising health care costs and describe salient reforms and their projected impacts on the field and practice of cardiac electrophysiology.

  View details for DOI 10.1007/s10840-012-9773-3

  View details for Web of Science ID 000316749200005

  View details for PubMedID 23397248

• Foreword: health policy and cardiac electrophysiology JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Hlatky, M. A., Reynolds, M., Turakhia, M. 2013; 36 (2): 97-97

  View details for DOI 10.1007/s10840-013-9789-3

  View details for PubMedID 23479090

• Bizarre and Wide QRS After Liver Transplant. JAMA internal medicine Johnson, C. J., Scheinman, M. A., Turakhia, M. P. 2013: 1

  View details for DOI 10.1001/jamainternmed.2013.644a

  View details for PubMedID 23609165

• Differences and trends in stroke prevention anticoagulation in primary care vs cardiology specialty management of new atrial fibrillation: The Retrospective Evaluation and Assessment of Therapies in AF (TREAT-AF) study AMERICAN HEART JOURNAL Turakhia, M. P., Hoang, D. D., Xu, X., Frayne, S., Schmitt, S., Yang, F., Phibbs, C. S., Than, C. T., Wang, P. J., Heidenreich, P. A. 2013; 165 (1): 93-?

  Abstract

  Atrial fibrillation and flutter (AF, collectively) cause stroke. We evaluated whether treating specialty influences warfarin prescription in patients with newly diagnosed AF.In the TREAT-AF study, we used Veterans Health Administration health record and claims data to identify patients with newly diagnosed AF between October 2004 and November 2008 and at least 1 internal medicine/primary care or cardiology outpatient encounter within 90 days after diagnosis. The primary outcome was prescription of warfarin.In 141,642 patients meeting the inclusion criteria, the mean age was 72.3 ± 10.2 years, 1.48% were women, and 25.8% had cardiology outpatient care. Cardiology-treated patients had more comorbidities and higher mean CHADS2 scores (1.8 vs 1.6, P < .0001). Warfarin use was higher in cardiology-treated vs primary care only-treated patients (68.6% vs 48.9%, P < .0001). After covariate and site-level adjustment, cardiology care was significantly associated with warfarin use (odds ratio [OR] 2.05, 95% CI 1.99-2.11). These findings were consistent across a series of adjusted models (OR 2.05-2.20), propensity matching (OR 1.98), and subgroup analyses (OR 1.58-2.11). Warfarin use in primary-care-only patients declined from 2004 to 2008 (51.6%-44.0%, P < .0001), whereas the adjusted odds of warfarin receipt with cardiology care (vs primary care) increased from 2004 to 2008 (1.88-2.24, P < .0001).In patients with newly diagnosed AF, we found large differences in anticoagulation use by treating specialty. A divergent 5-year trend of risk-adjusted warfarin use was observed. Treating specialty influences stroke prevention care and may impact clinical outcomes.

  View details for DOI 10.1016/j.ahj.2012.10.010

  View details for Web of Science ID 000312272900017

  View details for PubMedID 23237139

• Differences and trends in stroke prevention anticoagulation in primary care vs cardiology specialty management of new atrial fibrillation: The Retrospective Evaluation and Assessment of Therapies in AF (TREAT-AF) study. American heart journal Turakhia, M. P., Hoang, D. D., Xu, X., Frayne, S., Schmitt, S., Yang, F., Phibbs, C. S., Than, C. T., Wang, P. J., Heidenreich, P. A. 2013; 165 (1): 93-101 e1

  Abstract

  Atrial fibrillation and flutter (AF, collectively) cause stroke. We evaluated whether treating specialty influences warfarin prescription in patients with newly diagnosed AF.In the TREAT-AF study, we used Veterans Health Administration health record and claims data to identify patients with newly diagnosed AF between October 2004 and November 2008 and at least 1 internal medicine/primary care or cardiology outpatient encounter within 90 days after diagnosis. The primary outcome was prescription of warfarin.In 141,642 patients meeting the inclusion criteria, the mean age was 72.3 ± 10.2 years, 1.48% were women, and 25.8% had cardiology outpatient care. Cardiology-treated patients had more comorbidities and higher mean CHADS2 scores (1.8 vs 1.6, P < .0001). Warfarin use was higher in cardiology-treated vs primary care only-treated patients (68.6% vs 48.9%, P < .0001). After covariate and site-level adjustment, cardiology care was significantly associated with warfarin use (odds ratio [OR] 2.05, 95% CI 1.99-2.11). These findings were consistent across a series of adjusted models (OR 2.05-2.20), propensity matching (OR 1.98), and subgroup analyses (OR 1.58-2.11). Warfarin use in primary-care-only patients declined from 2004 to 2008 (51.6%-44.0%, P < .0001), whereas the adjusted odds of warfarin receipt with cardiology care (vs primary care) increased from 2004 to 2008 (1.88-2.24, P < .0001).In patients with newly diagnosed AF, we found large differences in anticoagulation use by treating specialty. A divergent 5-year trend of risk-adjusted warfarin use was observed. Treating specialty influences stroke prevention care and may impact clinical outcomes.

  View details for DOI 10.1016/j.ahj.2012.10.010

  View details for PubMedID 23237139

• Oral Antithrombotic Agents for the Prevention of Stroke in Nonvalvular Atrial Fibrillation A Science Advisory for Healthcare Professionals From the American Heart Association/American Stroke Association STROKE Furie, K. L., Goldstein, L. B., Albers, G. W., Khatri, P., Neyens, R., Turakhia, M. P., Turan, T. N., Wood, K. A. 2012; 43 (12): 3442-3453

  View details for Web of Science ID 000311497600063

  View details for PubMedID 22858728

• Impact of Baseline Stroke Risk and Bleeding Risk on INR Control among Patients with Atrial Fibrillation on Warfarin: the TREAT-AF Study Turakhia, M. P., Than, C. T., Xu, X., Schmitt, S. K., Yang, F., Frayne, S. M., Phibbs, C. S., Holmes, T. H., Heidenreich, P. A. LIPPINCOTT WILLIAMS & WILKINS. 2012

  View details for Web of Science ID 000208885006200

• Trends in the Incidence of Atrial Fibrillation in Older Patients Initiating Dialysis in the United States CIRCULATION Goldstein, B. A., Arce, C. M., Hlatky, M. A., Turakhia, M., Setoguchi, S., Winkelmayer, W. C. 2012; 126 (19): 2293-?

  Abstract

  One sixth of US dialysis patients 65 years of age have been diagnosed with atrial fibrillation/flutter (AF). Little is known, however, about the incidence of AF in this population.We identified 258 605 older patients (≥67 years of age) with fee-for-service Medicare initiating dialysis in 1995 to 2007, who had not been diagnosed with AF within the previous 2 years. Patients were followed for newly diagnosed AF. Multivariable proportional hazard regression was used to examine temporal trends and associations of race and ethnicity with incident AF. We also studied temporal trends in the mortality and risk of ischemic stroke after new AF. Over 514 395 person-years of follow-up, 76 252 patients experienced incident AF for a crude AF incidence rate of 148/1000 person-years. Incidence of AF increased by 11% (95% confidence interval, 5-16) from 1995 to 2007. Compared with non-Hispanic whites, blacks (-30%), Asians (-19%), Native Americans (-42%), and Hispanics (-29%) all had lower rates of incident AF. Mortality after incident AF decreased by 22% from 1995 to 2008. Even more pronounced reductions were seen for incident ischemic stroke during these years.The incidence of AF is high in older patients initiating dialysis in the United States and has been increasing over the 13 years of study. Mortality declined during that time but remained >50% during the first year after newly diagnosed AF. Because data on warfarin use were not available, we were unable to study whether trends toward better outcomes could be explained by higher rates of oral anticoagulation.

  View details for PubMedID 23032326

• Anticoagulation for atrial fibrillation in patients on dialysis: are the benefits worth the risks? CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION Shen, J. I., Turakhia, M. P., Winkelmayer, W. C. 2012; 21 (6): 600-606

  Abstract

  Atrial fibrillation is common among patients with end-stage renal disease undergoing hemodialysis. Although oral anticoagulation is recommended for stroke prevention in most patients with atrial fibrillation, limited evidence is available to guide treatment in hemodialysis patients with this arrhythmia. We summarize the available evidence on the epidemiology of atrial fibrillation in dialysis patients and review the data on the effectiveness of oral anticoagulation in this population.Atrial fibrillation is increasingly common in patients undergoing chronic hemodialysis, especially among older patients wherein one in six patients is diagnosed with this arrhythmia. Patients with atrial fibrillation experience double the mortality of otherwise similar patients without it. Few hemodialysis patients with atrial fibrillation receive oral anticoagulation, which is consistently associated with excess risks of hemorrhagic stroke. Observational studies did not detect a beneficial association of oral anticoagulation with the risk of ischemic stroke, with some studies describing higher risks of ischemic stroke among warfarin users. New therapeutic options including one oral direct thrombin inhibitor and two oral factor Xa inhibitors have become available, but were not tested in patients with advanced kidney disease.Atrial fibrillation is increasingly common in patients undergoing hemodialysis, yet little is known about the optimal management of these patients. The current evidence does not support net benefits from oral anticoagulation in the dialysis population.

  View details for DOI 10.1097/MNH.0b013e32835856fd

  View details for PubMedID 23079746

• Reply: Ability of microvolt T-wave alternans to modify risk assessment of ventricular tachyarrhythmic events: A meta-analysis AMERICAN HEART JOURNAL Turakhia, M. P., Gupta, A. 2012; 164 (4)

  View details for DOI 10.1016/j.ahj.2012.07.013

  View details for Web of Science ID 000310506000002

• Latency of ECG Displays of Hospital Telemetry Systems A Science Advisory From the American Heart Association CIRCULATION Turakhia, M. P., Estes, N. A., Drew, B. J., Granger, C. B., Wang, P. J., Knight, B. P., Page, R. L. 2012; 126 (13): 1665-1669

  View details for DOI 10.1161/CIR.0b013e31826ae459

  View details for Web of Science ID 000309260600023

  View details for PubMedID 22927339

• Abrupt bradycardia and grouped beating during treadmill testing: A mimic of upper rate behavior HEART RHYTHM Woods, C. E., Friday, K., Wang, P., Turakhia, M. P. 2012; 9 (7): 1165-1167

  View details for DOI 10.1016/j.hrthm.2011.12.020

  View details for PubMedID 22209946

• Incidence and clinical predictors of low defibrillation safety margin at time of implantable defibrillator implantation JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Cheng, Z., Turakhia, M., Lo, R., Gupta, A., Zei, P. C., Hsia, H. H., Al-Ahmad, A., Wang, P. J. 2012; 34 (1): 93-100

  Abstract

  Determination of the defibrillation safety margin (DSM) is the most common method of testing device effectiveness at the time of implantation of implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRTD). Low DSM remains a problem in clinical practice.The purpose of this study is to ascertain the incidence and clinical predictors of low DSM and the treatment strategies for low DSM in ICD or CRTD recipients.Selected ICD or CRTD recipients from January 2006 to May 2008 who underwent DSM test at the time of implantation were included. Low DSM patients were defined as patients who had a DSM within 10 J of the maximum delivered energy of the device. These patients were compared to patients who had DSM > 10 J.This study included 243 patients. Of these, 13 (5.3%) patients had low DSM, and 230 patients had adequate DSM. Patients with low DSM had a high prevalence of amiodarone use (69% vs 13%, p < 0.01), secondary prevention indications (69% vs 30%, p < 0.01), and a trend toward younger age (51 ± 18 vs 58 ± 15 years, p = 0.08). After adjustment for age and sex, amiodarone use was significantly associated with low DSM. All low DSM patients except one obtained adequate DSM after taking additional steps, including discontinuing amiodarone and starting sotalol, RV lead repositioning, adding a subcutaneous array or shock coil, changing single-coil to dual-coil lead, and upgrading to a high output device.The incidence of low DSM patients is low with high-energy devices. Amiodarone use is associated with low DSM, and its discontinuation or substitution with sotalol is one of a variety of available options for low DSM patients.

  View details for DOI 10.1007/s10840-011-9648-z

  View details for Web of Science ID 000303541200013

  View details for PubMedID 22391960

• TRENDS IN THE INCIDENCE OF ATRIAL FIBRILLATION IN OLDER PATIENTS INITIATING DIALYSIS IN THE UNITED STATES 49th Congress of the European-Renal-Association/European-Dialysis-and-Transplant-Association (ERA-EDTA) Goldstein, B., Turakhia, M., Arce, C., Winkelmayer, W. OXFORD UNIV PRESS. 2012: 231–232

  View details for Web of Science ID 000311494700635

• The prognostic value of early repolarization with ST-segment elevation in African Americans HEART RHYTHM Perez, M. V., Uberoi, A., Jain, N. A., Ashley, E., Turakhia, M. P., Froelicher, V. 2012; 9 (4): 558-565

  Abstract

  Increased prevalence of classic early repolarization, defined as ST-segment elevation (STE) in the absence of acute myocardial injury, in African Americans is well established. The prognostic value of this pattern in different ethnicities remains controversial.Measure association between early repolarization and cardiovascular mortality in African Americans.The resting electrocardiograms of 45,829 patients were evaluated at the Palo Alto Veterans Affairs Hospital. Subjects with inpatient status or electrocardiographic evidence of acute myocardial infarction were excluded, leaving 29,281 subjects. ST-segment elevation, defined as an elevation of >0.1 mV at the end of the QRS, was electronically flagged and visually adjudicated by 3 observers blinded to outcomes. An association between ethnicity and early repolarization was measured by using multivariate logistic regression. We analyzed associations between early repolarization and cardiovascular mortality by using the Cox proportional hazards regression analysis.Subjects were 13% women and 13.3% African Americans, with an average age of 55 years and followed for an average of 7.6 years, resulting in 1995 cardiovascular deaths. There were 479 subjects with lateral STE and 185 with inferior STE. After adjustment for age, sex, heart rate, and coronary artery disease, African American ethnicity was associated with lateral or inferior STE (odds ratio 3.1; P = .0001). While lateral or inferior STE in non-African Americans was independently associated with cardiovascular death (hazard ratio 1.6; P = .02), it was not associated with cardiovascular death in African Americans (hazard ratio 0.75; P = .50).Although early repolarization is more prevalent in African Americans, it is not predictive of cardiovascular death in this population and may represent a distinct electrophysiologic phenomenon.

  View details for DOI 10.1016/j.hrthm.2011.11.020

  View details for PubMedID 22094072

• AMIODARONE USE IS NOT ASSOCIATED WITH MORTALITY IN PATIENTS WITH ATRIAL FIBRILLATION AND KIDNEY DYSFUNCTION OR DIALYSIS: THE TREAT-AF STUDY 61st Annual Scientific Session and Expo of the American-College-of-Cardiology (ACC)/Conference on ACC-i2 with TCT Turakhia, M., Yang, F., Xu, X., Winkelmayer, W., Hoang, D., Heidenreich, P. ELSEVIER SCIENCE INC. 2012: E682–E682

  View details for Web of Science ID 000302326700684

• CARDIOVASCULAR HOSPITALIZATION IS A STRONG PREDICTOR OF MORTALITY IN MEDICARE BENEFICIARIES WITH NEWLY DIAGNOSED ATRIAL FIBRILLATION 61st Annual Scientific Session and Expo of the American-College-of-Cardiology (ACC)/Conference on ACC-i2 with TCT Turakhia, M., Solomon, M., Jhaveri, M., Davis, P., Conrad, R., Summers, N., Lakdawalla, D. ELSEVIER SCIENCE INC. 2012: E723–E723

  View details for Web of Science ID 000302326700724

• INTERACTION AMONG DIGOXIN USE, KIDNEY FUNCTION, AND MORTALITY IN PATIENTS WITH ATRIAL FIBRILLATION: THE TREAT-AF STUDY 61st Annual Scientific Session and Expo of the American-College-of-Cardiology (ACC)/Conference on ACC-i2 with TCT Turakhia, M., Yang, F., Xu, X., Winkelmayer, W., Hoang, D., Heidenreich, P. ELSEVIER SCIENCE INC. 2012: E685–E685

  View details for Web of Science ID 000302326700687

• Ability of microvolt T-wave alternans to modify risk assessment of ventricular tachyarrhythmic events: A meta-analysis AMERICAN HEART JOURNAL Gupta, A., Hoang, D. D., Karliner, L., Tice, J. A., Heidenreich, P., Wang, P. J., Turakhia, M. P. 2012; 163 (3): 354-364

  Abstract

  Prior studies have indicated that the magnitude of risk association of microvolt T-wave alternans (MTWA) testing appears to vary with the population studied. We performed a meta-analysis to determine the ability of MTWA to modify risk assessment of ventricular tachyarrhythmic events (VTEs) and sudden cardiac death (SCD) across a series of patient risk profiles using likelihood ratio (LR) testing, a measure of test performance independent of disease prevalence.We identified original research articles published from January 1990 to January 2011 that investigate spectrally derived MTWA. Ventricular tachyarrhythmic event was defined as the total and arrhythmic mortality and nonfatal sustained or implantable cardioverter-defibrillator-treated ventricular tachyarrhythmias. Summary estimates were created for positive and nonnegative MTWA results using a random-effects model and were expressed as positive (LR+) and negative (LR-) LRs.Of 1,534 articles, 20 prospective cohort studies met our inclusion criteria, consisting of 5,945 subjects predominantly with prior myocardial infarction or left ventricular dysfunction. Although there was a modest association between positive MTWA and VTE (relative risk 2.45, 1.58-3.79) and nonnegative MTWA and VTE (3.68, 2.23-6.07), test performance was poor (positive MTWA: LR+ 1.78, LR- 0.43; nonnegative MTWA: LR+ 1.38, LR- 0.56). Subgroup analyses of subjects classified as prior VTE, post-myocardial infarction, SCD-HeFT type, and MADIT-II type had a similar poor test performance. A negative MTWA result would decrease the annualized risk of VTE from 8.85% to 6.37% in MADIT-II-type patients and from 5.91% to 2.60% in SCD-HeFT-type patients.Despite a modest association, results of spectrally derived MTWA testing do not sufficiently modify the risk of VTE to change clinical decisions.

  View details for DOI 10.1016/j.ahj.2011.11.021

  View details for PubMedID 22424005

• Left Atrial Function Predicts Heart Failure Hospitalization in Subjects With Preserved Ejection Fraction and Coronary Heart Disease Longitudinal Data From the Heart and Soul Study JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Welles, C. C., Ku, I. A., Kwan, D. M., Whooley, M. A., Schiller, N. B., Turakhia, M. P. 2012; 59 (7): 673-680

  Abstract

  This study sought to determine whether left atrial (LA) dysfunction predicts heart failure (HF) hospitalization in subjects with preserved baseline ejection fraction (EF).Among patients with preserved EF, factors leading to HF are not fully understood. Cross-sectional studies have demonstrated LA dysfunction at the time of HF, but longitudinal data on antecedent atrial function are lacking.We performed resting transthoracic echocardiography in 855 subjects with coronary heart disease and EF ≥50%. Left atrial functional index (LAFI) was calculated as ([LA emptying fraction × left ventricular outflow tract-velocity time integral] / [indexed LA end-systolic volume]), where LA emptying fraction was defined as (LA end-systolic volume--LA end-diastolic volume) / LA end-systolic volume. We used Cox models to evaluate the association between LAFI and HF hospitalization.Over a median follow-up of 7.9 years, 106 participants (12.4%) were hospitalized for HF. Rates of HF hospitalization were inversely proportional to quartile (Q) of LAFI: Q1, 47 per 1,000 person-years; Q2, 18.3; Q3, 9.6; and Q4, 5.3 (p < 0.001). Each standard deviation decrease in LAFI was associated with a 2.6-fold increased hazard of adverse cardiovascular outcomes (unadjusted hazard ratio: 2.6, 95% confidence interval: 2.1 to 3.3, p < 0.001), and the association persisted even after adjustment for clinical risk factors, N-terminal pro-B-type natriuretic peptide, and a wide range of echocardiographic parameters (adjusted hazard ratio: 1.5, 95% confidence interval: 1.0 to 2.1, p = 0.05).Left atrial dysfunction independently predicts HF hospitalization in subjects with coronary heart disease and preserved baseline EF. The LAFI may be useful for HF risk stratification, and LA dysfunction may be a potential therapeutic target.

  View details for DOI 10.1016/j.jacc.2011.11.012

  View details for Web of Science ID 000300393900008

  View details for PubMedID 22322084

  View details for PubMedCentralID PMC3282121

• Cost-effectiveness of pharmacologic and invasive therapies for stroke prophylaxis in atrial fibrillation JOURNAL OF CARDIOVASCULAR MEDICINE Solomon, M. D., Ullal, A. J., Hoang, D. D., Freeman, J. V., Heidenreich, P., Turakhia, M. P. 2012; 13 (2): 86-96

  Abstract

  Atrial fibrillation is an abnormal heart rhythm characterized by rapid, disorganized activation (fibrillation) of the left and right atria of the heart, and is responsible for 15% of 700,000 strokes in the United States each year. There are multiple pharmacologic and nonpharmacologic therapies used for stroke prevention in atrial fibrillation, including vitamin K antagonists such as warfarin, antiplatelet agents such as aspirin and clopidogrel, and newer agents such as dabigatran, rivaroxaban and apixaban. Nonpharmacologic therapies involve excluding the left atrial appendage from the systemic circulation by surgical ligation or excision, percutaneous ligation, or endovascular implantation of a left atrial occlusion device. Because atrial fibrillation-related stroke is preventable, a comparison of the value of these interventions by cost-effectiveness analysis (CEA) could inform clinical and health policy recommendations. In this article, we review the principles of CEA and identify 11 articles that examine CEA of stroke prophylaxis strategies in atrial fibrillation. Although most studies evaluate aspirin and warfarin across a variety of atrial fibrillation stroke risk profiles, we also review new literature on new pharmacologic therapies such as direct thrombin inhibitors and discuss the potential value of device-based therapies.

  View details for DOI 10.2459/JCM.0b013e32834f23cf

  View details for Web of Science ID 000299652200002

  View details for PubMedID 22193838

• Clinical Reminders to Providers of Patients with Depressed Left Ventricular Ejection Fraction Increase Defibrillator Implantation: A Randomized Trial Scientific Sessions of the American-Heart-Association/Resuscitation Science Symposium Gupta, A., Gholami, P., Turakhia, M., Friday, K., Heidenreich, P. LIPPINCOTT WILLIAMS & WILKINS. 2011

  View details for Web of Science ID 000299738704068

• Early Repolarization in an Ambulatory Clinical Population CIRCULATION Uberoi, A., Jain, N. A., Perez, M., Weinkopff, A., Ashley, E., Hadley, D., Turakhia, M. P., Froelicher, V. 2011; 124 (20): 2208-2214

  Abstract

  The significance of early repolarization, particularly regarding the morphology of the R-wave downslope, has come under question.We evaluated 29 281 resting ambulatory ECGs from the VA Palo Alto Health Care System. With PR interval as the isoelectric line and amplitude criteria ≥0.1 mV, ST-segment elevation is defined at the end of the QRS, J wave as an upward deflection, and slur as a conduction delay on the QRS downstroke. Associations of ST-segment elevation patterns, J waves, and slurs with cardiovascular mortality were analyzed with Cox analysis. With a median follow-up of 7.6 years, there were 1995 cardiac deaths. Of 29 281 subjects, 87% were male (55±14 years) and 13% were female (56±17 years); 13% were black, 6% were Hispanic, and 81% were white or other. Six hundred sixty-four (2.3%) had inferior or lateral ST-segment elevation: 185 (0.6%) in inferior leads and 479 (1.6%) in lateral leads, 163 (0.6%) in both, and 0.4% had global elevation. A total of 4041 ECGs were analyzed with enhanced display, and 583 (14%) had J waves or slurring, which were more prevalent in those with than in those without ST-segment elevation (61% versus 13%; P<0.001). ST-segment elevation occurred more in those with than in those without J waves or slurs (12% versus 1.3%; P<0.001). Except when involving only inferior leads, all components of early repolarization were more common in young individuals, male subjects, blacks, and those with bradycardia. All patterns and components of early repolarization were associated with decreased cardiovascular mortality, but this was not significant after adjustment for age.We found no significant association between any components of early repolarization and cardiac mortality.

  View details for DOI 10.1161/CIRCULATIONAHA.111.047191

  View details for PubMedID 21986288

• JICE goes "social" JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Turakhia, M. P. 2011; 32 (2): 79-80

  Abstract

  Social media is transforming health care. The Journal of Interventional Cardiac Electrophysiology (JICE) has launched its own social media presence and is now on Facebook. JICE will post each issue's table of contents, special articles, online-first publications to allow real-time notifications to JICE's readers and fans of our Facebook page. We encourage you to take the plunge and connect to our Facebook page.

  View details for DOI 10.1007/s10840-011-9621-x

  View details for Web of Science ID 000297556800001

  View details for PubMedID 21972151

• The CHADS(2) score predicts ischemic stroke in the absence of atrial fibrillation among subjects with coronary heart disease: Data from the Heart and Soul Study AMERICAN HEART JOURNAL Welles, C. C., Whooley, M. A., Na, B., Ganz, P., Schiller, N. B., Turakhia, M. P. 2011; 162 (3): 555-561

  Abstract

  We sought to evaluate the prognostic performance of the CHADS(2) score for prediction of ischemic stroke/transient ischemic attack (TIA) in subjects with coronary heart disease (CHD) without atrial fibrillation (AF).In 916 nonanticoagulated outpatients with stable CHD and no AF by baseline electrocardiogram, we calculated CHADS(2) scores (congestive heart failure, hypertension, age ≥75 years, diabetes [1 point each], and prior stroke or TIA [2 points]). The primary outcome was time to ischemic stroke or TIA over a mean follow-up of 6.4 ± 2.3 years.Over 5,821 person-years of follow-up, 40 subjects had an ischemic stroke/TIA (rate 0.69/100 person-years, 95% CI 0.50-0.94). Compared with subjects with low (0-1) CHADS(2) scores, those with intermediate (2-3) and high (4-6) CHADS(2) scores had an increased rate of stroke/TIA, even after adjustment for age, tobacco, antiplatelet therapy, statins, and angiotensin inhibitors (CHADS(2) score 2-3: HR 2.4, 95% CI 1.1-5.3, P = .03; CHADS(2) score 4-6: HR 4.0, 95% CI 1.5-10.6, P = .006). Model discrimination (c-statistic = 0.65) was comparable with CHADS(2) model fit in published AF-only cohorts.The CHADS(2) score predicts ischemic stroke/TIA in subjects with stable CHD and no baseline AF. The event rate in non-AF subjects with high CHADS(2) scores (5-6) was comparable with published rates in AF patients with moderate CHADS(2) scores (1-2), a population known to derive benefit from stroke prevention therapies. These findings should inform efforts to determine whether stroke prevention therapies or screening for silent AF may benefit subjects with stable CHD and high CHADS(2) scores.

  View details for DOI 10.1016/j.ahj.2011.05.023

  View details for Web of Science ID 000294447400022

  View details for PubMedID 21884876

  View details for PubMedCentralID PMC3199107

• Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation ANNALS OF INTERNAL MEDICINE Freeman, J. V., Turakhia, M. P. 2011; 154 (8): 570-571

  View details for Web of Science ID 000289622000024

• THE CHADS2 SCORE PREDICTS ISCHEMIC STROKE IN THE ABSENCE OF ATRIAL FIBRILLATION AMONG PATIENTS WITH CORONARY HEART DISEASE: DATA FROM THE HEART AND SOUL STUDY Welles, C. C., Na, B., Whooley, M. A., Turakhia, M. P. ELSEVIER SCIENCE INC. 2011: E607

  View details for DOI 10.1016/S0735-1097(11)60607-4

  View details for Web of Science ID 000291695100608

• Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation ANNALS OF INTERNAL MEDICINE Freeman, J. V., Zhu, R. P., Owens, D. K., Garber, A. M., Hutton, D. W., Go, A. S., Wang, P. J., Turakhia, M. P. 2011; 154 (1): 1-U129

  Abstract

  Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation (AF) but increases the risk for hemorrhage. Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin.To estimate the quality-adjusted survival, costs, and cost-effectiveness of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF.Markov decision model.The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial and other published studies of anticoagulation. The cost of dabigatran was estimated on the basis of pricing in the United Kingdom.Patients aged 65 years or older with nonvalvular AF and risk factors for stroke (CHADS₂ score ≥1 or equivalent) and no contraindications to anticoagulation.Lifetime.Societal.Warfarin anticoagulation (target international normalized ratio, 2.0 to 3.0); dabigatran, 110 mg twice daily (low dose); and dabigatran, 150 mg twice daily (high dose).Quality-adjusted life-years (QALYs), costs (in 2008 U.S. dollars), and incremental cost-effectiveness ratios.The quality-adjusted life expectancy was 10.28 QALYs with warfarin, 10.70 QALYs with low-dose dabigatran, and 10.84 QALYs with high-dose dabigatran. Total costs were $143 193 for warfarin, $164 576 for low-dose dabigatran, and $168 398 for high-dose dabigatran. The incremental cost-effectiveness ratios compared with warfarin were $51 229 per QALY for low-dose dabigatran and $45 372 per QALY for high-dose dabigatran.The model was sensitive to the cost of dabigatran but was relatively insensitive to other model inputs. The incremental cost-effectiveness ratio increased to $50 000 per QALY at a cost of $13.70 per day for high-dose dabigatran but remained less than $85 000 per QALY over the full range of model inputs evaluated. The cost-effectiveness of high-dose dabigatran improved with increasing risk for stroke and intracranial hemorrhage.Event rates were largely derived from a single randomized clinical trial and extrapolated to a 35-year time frame from clinical trials with approximately 2-year follow-up.In patients aged 65 years or older with nonvalvular AF at increased risk for stroke (CHADS₂ score ≥1 or equivalent), dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States.American Heart Association and Veterans Affairs Health Services Research & Development Service.

  View details for PubMedID 21041570

• Quality of Stroke Prevention Care in Atrial Fibrillation Many Moving Targets CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Turakhia, M. P. 2011; 4 (1): 5-8

  View details for DOI 10.1161/CIRCOUTCOMES.110.959890

  View details for Web of Science ID 000286311700003

  View details for PubMedID 21245458

• Using Restriction to Minimize Bias in Observational Studies JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Turakhia, M. P., Heidenreich, P. A. 2010; 304 (21): 2359-2359

  View details for Web of Science ID 000284763900014

  View details for PubMedID 21119082

• Inappropriate Pacing in a Patient with Managed Ventricular Pacing: What Is the Cause? HEART RHYTHM Perez, M. V., Al-Ahmad, A. A., Wang, P. J., Turakhia, M. P. 2010; 7 (12)

  View details for Web of Science ID 000284875500003

• Sudden Cardiac Death and Implantable Cardioverter-Defibrillators AMERICAN FAMILY PHYSICIAN Turakhia, M. P. 2010; 82 (11): 1357-1366

  Abstract

  Sudden cardiac death is a major public health problem, affecting 500,000 patients in the United States annually. An implantable cardioverter-defibrillator (ICD) can terminate malignant ventricular arrhythmias and has been shown to improve survival in high-risk populations. Although sudden cardiac death is a heterogeneous condition, left ventricular ejection fraction of 35 percent or less remains the single best factor to stratify patients for prophylactic ICD implantation, and randomized trials have shown mortality benefit in this population. Therefore, in patients with heart disease, assessment of ejection fraction remains the most important step to identify patients at risk of sudden cardiac death who would benefit from ICD implantation. Physician understanding of each patient's ICD type, indication, etiology of heart disease, and cardiovascular status is essential for optimal care. If the ICD was placed for secondary prevention, the circumstances relating to the index event should be explored. Evaluation of defibrillator shocks merits careful assessment of the patient's cardiovascular status. Consultation with a subspecialist and interrogation of the ICD can determine if shocks were appropriate or inappropriate and can facilitate management.

  View details for Web of Science ID 000208405500010

• Cardiac Resynchronization Therapy Decreases the Risk of Ventricular Tachyarrhythmias in the MADIT-CRT Trial Wang, P. J., Al-Ahmad, A., Evans, J., Turakhia, M., McNitt, S., Moss, A., Zareba, W. LIPPINCOTT WILLIAMS & WILKINS. 2010

  View details for Web of Science ID 000208231602200

• Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: A Cardiac Safety Research Consortium "Incubator" Think Tank AMERICAN HEART JOURNAL Al-Khatib, S. M., Calkins, H., Eloff, B. C., Kowey, P., Hammill, S. C., Ellenbogen, K. A., Marinac-Dabic, D., Waldo, A. L., Brindis, R. G., Wilbur, D. J., Jackman, W. M., Yaross, M. S., Russo, A. M., Prystowsky, E., Varosy, P. D., Gross, T., Pinnow, E., Turakhia, M. P., Krucoff, M. W. 2010; 160 (4): 619-U249

  Abstract

  Although several randomized clinical trials have demonstrated the safety and efficacy of catheter ablation of atrial fibrillation (AF) in experienced centers, the outcomes of this procedure in routine clinical practice and in patients with persistent and long-standing persistent AF remain uncertain. Brisk adoption of this therapy by physicians with diverse training and experience highlights potential concerns regarding the safety and effectiveness of this procedure. Some of these concerns could be addressed by a national registry of AF ablation procedures such as the Safety of Atrial Fibrillation Ablation Registry Initiative that was initially proposed at a Cardiac Safety Research Consortium Think Tank meeting in April 2009. In January 2010, the Cardiac Safety Research Consortium, in collaboration with the Duke Clinical Research Institute, the US Food and Drug Administration, the American College of Cardiology, and the Heart Rhythm Society, held a follow-up meeting of experts in the field to review the construct and progress to date. Other participants included the National Heart, Lung, and Blood Institute; the Centers for Medicare and Medicaid Services; the Agency for Healthcare Research and Quality; the AdvaMed AF working group; and additional industry representatives. This article summarizes the discussions that occurred at the meeting of the state of the Safety of Atrial Fibrillation Ablation Registry Initiative, the identification of a clear pathway for its implementation, and the exploration of solutions to potential issues in the execution of this registry.

  View details for DOI 10.1016/j.ahj.2010.06.044

  View details for Web of Science ID 000282677300010

  View details for PubMedID 20934554

• Prevalence of Metabolic Syndrome in South Asians Residing in the United States METABOLIC SYNDROME AND RELATED DISORDERS Flowers, E., Molina, C., Mathur, A., Prasad, M., Abrams, L., Sathe, A., Malhotra, D., Basra, R., Malgesini, N., Ratnam, G., Aouizerat, B. E., Turakhia, M. P. 2010; 8 (5): 417-423

  Abstract

  The aim of this study was to define the prevalence of the metabolic syndrome and its component risk factors among individuals of South Asian origin living in the United States.We analyzed baseline data from 1,445 participants enrolled in a cohort study investigating risk factors for cardiovascular disease in South Asians. We defined the metabolic syndrome using the International Diabetes Federation criteria for waist circumference (>90 cm for men; >80 cm, women), triglycerides (>150 mg/dL), high-density lipoprotein cholesterol (HDL-C) (<40 mg/dL (men), < mg/dL (women)), blood pressure (>135/80 mmHg), and fasting glucose (>100 mg/dL).The mean age was 43 +/-10 years, and 30% of participants were women. The prevalence of metabolic syndrome was 27% (31% men vs. 17% women, P < 0.05). Fifty-nine percent of the cohort had high waist circumference (58% men vs. 62% women, P = not significant [N.S.]), 47% had low HDL-C [46% men vs. 48% women (NS)], 19% had elevated triglycerides (23% men vs. 8% women, P < 0.05), 14% had hypertension (16% men vs. 9% women, P < 0.05), and 13% had elevated fasting glucose (18% men vs. 11% women, P < 0.05). The most common metabolic syndrome phenotype is low HDL-C with elevated triglycerides.Although the prevalence of the metabolic syndrome is lower than previous reports of South Asians, the prevalence is still unacceptably high despite the presence of protective demographic factors.

  View details for DOI 10.1089/met.2009.0097

  View details for Web of Science ID 000282809400006

  View details for PubMedID 20939706

• Inappropriate pacing in a patient with managed ventricular pacing: What is the cause? HEART RHYTHM Perez, M. V., Al-Ahmad, A. A., Wang, P. J., Turakhia, M. P. 2010; 7 (9): 1336-1337

  Abstract

  A case of inappropriate atrial pacing in a patient with a pacemaker programmed with Managed Ventricular Pacing (MVP) mode, a proprietary algorithm in Medtronic devices, is presented. The patient was an 84-year-old woman who presented in sinus rhythm with complete atrioventricular block. A dual-chamber pacemaker was implanted and programmed to an MVP pacing mode. After the implant, the patient developed a relatively slow atrial tachyarrhythmia with 2:1 atrioventricular block and inappropriate atrial pacing, followed by a delay in tracking of the atrial tachyarrhythmia. The mechanisms for these behaviors are described.

  View details for DOI 10.1016/j.hrthm.2010.04.028

  View details for PubMedID 20435165

• Predicting Heart Failure Hospitalization and Mortality by Quantitative Echocardiography: Is Body Surface Area the Indexing Method of Choice? The Heart and Soul Study JOURNAL OF THE AMERICAN SOCIETY OF ECHOCARDIOGRAPHY Ristow, B., Ali, S., Na, B., Turakhia, M. P., Whooley, M. A., Schiller, N. B. 2010; 23 (4): 406-413

  Abstract

  Echocardiographic measurements of left ventricular (LV) mass, left atrial (LA) volume, and LV end-systolic volume (ESV) predict heart failure (HF) hospitalization and mortality. Indexing measurements by body size is thought to establish limits of normality among individuals varying in body habitus. The American Society of Echocardiography recommends dividing measurements by body surface area (BSA), but others have advocated alternative indexing methods.Echocardiographic measurements were collected in 1024 ambulatory adults with coronary artery disease. LV mass, LA volume, and LV ESV were calculated using truncated ellipse method and biplane method of disk formulae. Comparison between raw measurements and measurements divided by indexing parameters was made by hazard ratios per standard deviation increase in variable and c-statistics for BSA, BSA(0.43), BSA(1.5), height, height(0.25), height(2), height(2.7), body weight (BW), BW(0.26), body mass index (BMI), and BMI(0.27).Mean LV mass was 192 +/- 57 g, mean LA volume was 65 +/- 24 mL, and mean LV ESV was 41 +/- 26 mL. Average height was 171 +/- 9 cm, average BSA was 1.94 +/- 0.22 m(2), and average BMI was 28.4 +/- 5.3 kg/m(2). At an average follow-up of 5.6 +/- 1.8 years, there were 148 HF hospitalizations, 71 cardiovascular (CV) deaths, and 269 all-cause deaths. There was excellent correlation between raw measurements and those indexed by height (r = 0.98-0.99), and moderate correlation between raw measurements and those indexed by BW (r = 0.73-0.94). C-statistics and hazard ratios per standard deviation increase in indexed variables were similar for HF hospitalization, CV mortality, and all-cause mortality. There were no significant differences among indexing methods in ability to predict outcomes.The choice of indexing method by parameters of BSA, height, BW, and BMI does not affect the clinical usefulness of LV mass, LA volume, and LV ESV in predicting HF hospitalization, CV mortality, or all-cause mortality among ambulatory adults with coronary artery disease. Continued use of BSA to index measurements of LV mass, LA volume, and LV ESV is acceptable.

  View details for DOI 10.1016/j.echo.2010.01.019

  View details for Web of Science ID 000276248600012

  View details for PubMedID 20202792

  View details for PubMedCentralID PMC2886012

• RELATIONSHIP BETWEEN LIPOPROTEIN(A), HOMOCYSTEINE, AND C-REACTIVE PROTEIN AND METABOLIC SYNDROME IN SOUTH ASIAN PATIENTS Divakaruni, M. S., Flowers, E., Molina, C., Mathur, A., Prasad, M., Abrams, L., Sathe, A., Malhotra, D., Basra, R., Ratnam, G., Aouizerat, B. E., Turakhia, M. P. ELSEVIER SCIENCE INC. 2010

  View details for Web of Science ID 001045644800495

• Atrial Mechanical Function Using Left Atrial Pressure Waveform Analysis in Persistent and Paroxysmal Atrial Fibrillation Patients 82nd National Conference and Exhibitions and Scientific Sessions of the American-Heart-Association Cheng, Z., Lo, R., Gupta, A., Perez, M., Zei, P., Hsia, H. H., Turakhia, M., Al-Ahmad, A., Wang, P. J. LIPPINCOTT WILLIAMS & WILKINS. 2009: S628–S628

  View details for Web of Science ID 000271831501532

• Increase in end-systolic volume after exercise independently predicts mortality in patients with coronary heart disease: data from the Heart and Soul Study EUROPEAN HEART JOURNAL Turakhia, M. P., McManus, D. D., Whooley, M. A., Schiller, N. B. 2009; 30 (20): 2478-2484

  Abstract

  The predictive value of changes in global left ventricular (LV) size after exercise has not been studied. Left ventricular end-systolic volume (ESV) is a relatively load-independent echocardiographic marker of contractility that is easily measured. We investigated the role of the change in ESV at rest and after peak exercise on mortality among patients with stable coronary heart disease (CHD).We performed exercise treadmill testing with stress echocardiography in 934 ambulatory subjects with CHD. End-systolic volume was measured immediately before and after exercise using 2D echocardiography. We defined ESV reversal as an increase in ESV after exercise, and we examined the association of ESV reversal with all-cause mortality during a median follow-up of 3.92 years. Of the 934 participants, 199 (21%) had ESV reversal. At the end of follow-up, mortality was higher among participants with ESV reversal than those without (26 vs. 11%; P < 0.001). After adjustment for clinical covariates, ESV reversal remained predictive of all-cause mortality (HR 2.0; 95% CI 1.4-2.9; P = 0.001). The association of ESV reversal with mortality also persisted after adjustment for exercise-induced wall-motion abnormalities (HR 1.7; 95% CI 1.1-2.3, P = 0.006). To determine if the effect of ESV reversal was independent from other echocardiographic measurements, we created a separate model adjusting for resting LV ejection fraction, ESV, end-diastolic volume, and LV mass. End-systolic volume reversal was the only significant predictor of mortality in this model (HR 2.1, 95% CI 1.4-3.0, P < 0.001).End-systolic volume reversal is a novel parameter that independently predicts mortality in patients with CHD undergoing exercise treadmill echocardiography, even after adjustment for a wide range of clinical, echocardiographic, and treadmill exercise variables. Because measurement of ESV is simple, reproducible, and requires no additional imaging views, identification of ESV reversal during exercise echocardiography can provide useful complementary information for risk stratification.

  View details for DOI 10.1093/eurheartj/ehp270

  View details for PubMedID 19578167

• "Low ejection fraction prophylaxis" with implantable defibrillators in the elderly: Call for a randomized trial? HEART RHYTHM Turakhia, M. P., Wang, P. J. 2009; 6 (8): 1144-1145

  View details for DOI 10.1016/j.hrthm.2009.04.031

  View details for Web of Science ID 000268867700006

  View details for PubMedID 19632625

• Polymorphic Ventricular Tachycardia? JOURNAL OF HOSPITAL MEDICINE Davis, E., Hoffmayer, K., Turakhia, M., Goldschlager, N. 2009; 4 (2): 140-141

  View details for DOI 10.1002/jhm.419

  View details for Web of Science ID 000263807400010

  View details for PubMedID 19219929

• Rates and severity of perforation from implantable cardioverter-defibrillator leads: A 4-year study JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY Turakhia, M., Prasad, M., Olgin, J., Badhwar, N., Tseng, Z. H., Lee, R., Marcus, G. M., Lee, B. K. 2009; 24 (1): 47-52

  Abstract

  Although recent case reports and one small single-year observational study report a substantially increased rate of perforation with the St. Jude Riata series defibrillator lead, these results have not been externally validated.From 2004 to 2007, 593 implantable cardioverter-defibrillator (ICD) implants were performed by six faculty and 13 fellows at four University of California, San Francisco, CA, USA and affiliate hospitals. An electronic medical records system was systematically searched to identify clinically significant cases of ICD lead dislodgment or perforation. Of 307 (56%) St. Jude leads (all Riata series 6.3- and 7.3-French leads), 188 (29%) Medtronic leads (including 99 Sprint Fidelis 6.6 French leads), and 98 (15%) Guidant/Boston Scientific leads, there were three perforations in 593 cases (0.51%). One perforation occurred with a Medtronic Sprint Fidelis 6949 lead (0.53%), and two with a St. Jude Riata 1581 lead (0.65%). There were no statistically significant differences in perforation or dislodgement rates between manufacturers or lead models (p = NS for all). In both cases of perforation with the St. Jude Riata leads, the lead tip perforated through the pericardium into the pleural space.In our 4-year series of ICD implants, perforation and dislodgement rates were low, similar across all lead makes and models, and well below published and accepted complication rates. Our findings contradict previously-reported higher rates of perforation with the Riata lead. Registry and product performance reports should also classify complications by severity and outcome to provide a more complete assessment of product safety.

  View details for DOI 10.1007/s10840-008-9308-0

  View details for Web of Science ID 000262987700008

  View details for PubMedID 18855128

• Wolff-Parkinson-White syndrome: where is the pathway? Indian pacing and electrophysiology journal Turakhia, M. P., Scheinman, M., Badhwar, N. 2009; 9 (2): 130-133

  Abstract

  A 31-year old male presented with atrial fibrillation and ventricular preexcitation that was positive in leads V1-V4, negative in lead II, and positive in lead AVR. The patient was cardioverted and invasive electrophysiologic study was performed. Based on the ECG findings, the coronary sinus and its branches were interrogated during orthodromic atrioventricular reentrant tachycardia. The earliest local activation was seen in the true coronary sinus lumen at the bifurcation of the posterolateral branch. Radiofrequency energy application at this area led to loss of preexcitation. When localizing left septal and posterior accessory pathways, ventricular preexcitation that is both negative in II and positive in AVR has been shown in previous studies to be highly sensitive and specific for a subepicardial location. Therefore, investigation of the coronary sinus and its branches may allow for effective ablation without the need for left ventricular access.

  View details for PubMedID 19308285

• Impact of Remote Magnetic Catheter Navigation on Ablation Fluoroscopy and Procedure Time PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY Kim, A. M., Turakhia, M., Lu, J., Badhwar, N., Lee, B. K., Lee, R. J., Marcus, G. M., Tseng, Z. H., Scheinman, M., Olgin, J. E. 2008; 31 (11): 1399-1404

  Abstract

  Remote magnetic catheter navigation (RCN) is gaining acceptance in clinical cardiac electrophysiology, but details regarding how RCN affects procedure execution are not well characterized.From January 1, 2005, to November 30, 2007, 721 cases were retrospectively analyzed and compared. Of these, 127 used RCN and 594 used manual catheter navigation (MCN). Data including procedure time, fluoroscopy time, ablation catheter, procedural success, and complications were extracted from our procedure database and compared between RCN and MCN.RCN use significantly decreased fluoroscopy time for atrial fibrillation (AF) ablation (-29 minutes, P < 0.001), atrioventricular nodal reentrant tachycardia ablation (-14 minutes, P < 0.001), and atrioventricular reentrant tachycardia ablation (-18 minutes, P = 0.045). While RCN significantly increased mean procedure time for AF (+36 minutes, P = 0.003) and atypical atrial flutter cases (+116 minutes, P = 0.016), RCN AF procedure time diminished with increasing number of cases performed. Two cases of tamponade occurred during AF ablation using MCN (2.2%, 2 of 91 cases). No tamponade occurred during all 75 AF ablations with RCN.RCN can reduce fluoroscopy time and may reduce complications during catheter ablation. While it may increase total procedure duration, procedure times decrease with increasing operator experience. (PACE 2008; 31:1399-1404).

  View details for DOI 10.1111/j.1540-8159.2008.01202.x

  View details for Web of Science ID 000262203600005

  View details for PubMedID 18950296

• Prognostic Significance of Increased Left Ventricular Mass Index to Mortality and Sudden Death in Patients With Stable Coronary Heart Disease (from the Heart and Soul Study) AMERICAN JOURNAL OF CARDIOLOGY Turakhia, M. P., Schiller, N. B., Whooley, M. A. 2008; 102 (9): 1131-1135

  Abstract

  Data are limited about the significance of left ventricular (LV) hypertrophy or mass in patients with coronary heart disease (CHD), particularly in the setting of normal ejection fraction (EF). The association of LV mass index with all-cause mortality and sudden death in a cohort with CHD was evaluated. Using transthoracic echocardiography, LV mass normalized to body surface area was measured in 1,016 subjects with stable CHD. Cox proportional hazards models were used to examine the association of LV mass index and LV hypertrophy (LV mass index >95 g/m(2) in women and >115 in men) with time to death and time to sudden or arrhythmic death. Mean LV mass index was 101 +/- 27 g/m(2) in men and 88 +/- 23 in women. During a mean follow-up of 3.55 years, there were 146 deaths and 34 sudden or arrhythmic deaths. Total mortality was higher in subjects with LV hypertrophy (25% vs 11%, p <0.001), as was mortality from sudden or arrhythmic death (6.7% vs 2.2%, p = 0.001). After adjustment for age, gender, cardiovascular risk factors, and medical therapy, LV hypertrophy was associated with both all-cause mortality (hazard ratio 2.0, p <0.001) and sudden or arrhythmic death (hazard ratio 3.1, p = 0.003). Findings were similar in the subgroup with EF > or =55% (mortality hazard ratio 1.8, p = 0.02; sudden and arrhythmic death hazard ratio 3.1, p = 0.02). Analyzed as a continuous variable, every 20-unit increase in LV mass index increased the adjusted hazard of death by 22% (p = 0.001) and adjusted hazard of sudden or arrhythmic death by 40% (p = 0.004). In conclusion, in patients with stable CHD, increased LV mass index was independently associated with all-cause mortality and sudden or arrhythmic death, even in subjects with normal EF.

  View details for DOI 10.1016/j.amjcard.2008.06.030

  View details for Web of Science ID 000261007500003

  View details for PubMedID 18940278

  View details for PubMedCentralID PMC2583450

• Impact of advanced age on survival in patients with implantable cardioverter defibrillators EUROPACE Pellegrini, C. N., Lee, K., Olgin, J. E., Turakhia, M. P., Tseng, Z. H., Lee, R., Badhwar, N., Lee, B., Varosy, P. D. 2008; 10 (11): 1296-1301

  Abstract

  Given the selectivity of clinical trial patients and meager representation of elderly in the major implantable cardioverter defibrillator (ICD) randomized trials (<25%), whether such data apply to elderly patients overall is unclear. The purpose of our study is to understand the influence of age on mortality after ICD implantation.We performed a retrospective cohort study of 502 consecutive patients receiving ICDs from 1993 to 2003 at a single university hospital. The primary predictor was patient age, categorized as <65, 65-75, and >75 years at ICD implantation. The primary outcome was time to death. Mean follow-up was 4 years. Median survival after ICD implantation was 5.3 years among subjects >75 years, less than half that of the youngest group. After adjusting for potential confounders, compared with subjects <65 years of age, patients >75 years [hazard ratio (HR), 4.7; 95% confidence interval (CI), 2.8-7.9; P < 0.001] and those 65-75 years (HR, 2.8; 95% CI, 1.7-4.8; P < 0.001) were at greater risk of death. Increased age was associated with higher total, cardiac, and non-cardiac mortality (all P

  View details for DOI 10.1093/europace/eun253

  View details for Web of Science ID 000260556300009

  View details for PubMedID 18818212

  View details for PubMedCentralID PMC2721725

• The Irritable Heart JOURNAL OF HOSPITAL MEDICINE Turakhia, M. P., Grubb, B. P., Gregoratos, G. 2008; 3 (5): 423-429

  View details for DOI 10.1002/jhm.344

  View details for Web of Science ID 000260690300010

  View details for PubMedID 18951396

• Knowledge and attitudes of primary care physicians in the management of patients at risk for cardiovascular events BMC FAMILY PRACTICE Doroodchi, H., Abdolrasulnia, M., Foster, J. A., Foster, E., Turakhia, M. P., Skelding, K. A., Sagar, K., Casebeer, L. L. 2008; 9

  Abstract

  Adherence to clinical practice guidelines for management of cardiovascular disease (CVD) is suboptimal. The purposes of this study were to identify practice patterns and barriers among U.S. general internists and family physicians in regard to cardiovascular risk management, and examine the association between physician characteristics and cardiovascular risk management.A case vignette survey focused on cardiovascular disease risk management was distributed to a random sample of 12,000 U.S. family physicians and general internists between November and December 2006.Responses from a total of 888 practicing primary care physicians who see 60 patients per week were used for analysis. In an asymptomatic patient at low risk for cardiovascular event, 28% of family physicians and 37% of general internists made guideline-based preventive choices for no antiplatelet therapy (p < .01). In a patient at high risk for cardiovascular event, 59% of family physicians and 56% of general internists identified the guideline-based goal for serum fasting LDL level (< 100 mg/dl). Guideline adherence was inversely related to years in practice and volume of patients seen. Cost of medications (87.7%), adherence to medications (74.1%), adequate time for counseling (55.7%), patient education tools (47.1%), knowledge and skills to recommend dietary changes (47.8%) and facilitate patient adherence (52.0%) were cited as significant barriers to CVD risk management.Despite the benefits demonstrated for managing cardiovascular risks, gaps remain in primary care practitioners' management of risks according to guideline recommendations. Innovative educational approaches that address barriers may facilitate the implementation of guideline-based recommendations in CVD risk management.

  View details for DOI 10.1186/1471-2296-9-42

  View details for Web of Science ID 000257836800001

  View details for PubMedID 18611255

  View details for PubMedCentralID PMC2474612

• Sudden cardiac death: Epidemiology, mechanisms, and therapy CURRENT PROBLEMS IN CARDIOLOGY Turakhia, M., Tseng, Z. H. 2007; 32 (9): 501-546

  Abstract

  Sudden cardiac death is a major public health problem affecting 500,000 patients annually in the United States alone. The major risk factor for sudden cardiac death is the presence of coronary artery disease, usually in the setting of reduced ejection fraction. Globally, the incidence is expected to rise sharply as the prevalence of coronary artery disease and heart failure continue to increase. However, sudden cardiac death is a heterogeneous condition and may be caused by acute ischemia, structural defects, myocardial scar, and/or genetic mutations. Sudden death may occur even in a grossly normal heart. Beta-blockers can reduce the risk of sudden cardiac death, while implantable cardioverter defibrillators are effective at terminating malignant arrhythmias. Ejection fraction remains the major criterion to stratify patients for defibrillator implantation but this strategy alone is insensitive and nonspecific. Novel clinical, electrophysiologic, and genetic markers have been identified that may increase precision in patient selection for primary prevention therapy. This review discusses the epidemiology, mechanisms, etiologies, therapies, treatment guidelines, and future directions in the management of sudden cardiac death.

  View details for DOI 10.1016/j.cpcardiol.2007.05.002

  View details for Web of Science ID 000249579000002

  View details for PubMedID 17723906

• Impact of renal function on survival in patients with implantable cardioverter-defibrillators PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY Turakhia, M. P., Varosy, P. D., Lee, K., Tseng, Z. H., Lee, R., Badhwar, N., Scheinman, M., Lee, B. K., Olgin, J. E. 2007; 30 (3): 377-384

  Abstract

  Although chronic renal insufficiency (CRI) is associated with increased cardiac and noncardiac mortality, there is limited data on the relationship between CRI and survival in patients with implantable cardioverter-defibrillators (ICDs), particularly across a wide range of renal function.We studied 507 consecutive patients receiving first-time ICDs from 1993-2003 at a single center. Preimplant serum creatinine measurements were used to determine glomerular filtration rate (GFR) and stage of chronic kidney disease (CKD). The primary outcome was time to death.During a mean follow-up of 4 years, all-cause mortality through completion of follow-up increased stepwise by GFR stage (I: 16%, II: 20%, III: 35%; IV: 40%; V: 50%; P < 0.001 for trend). After multivariate adjustment, CRI was independently associated with death (HR = 1.7, P = 0.02), as were a serum creatinine >or=2.0 mg/dL (HR 2.5, P = 0.003) and the presence of end-stage renal disease (HR 6.8; P < 0.001). For every 10-unit decrease in GFR, the adjusted hazard of death increased 12% (P = 0.04).The presence of CRI prior to implant is independently associated with increased mortality in patients receiving ICDs. The risk is proportional to the degree of renal dysfunction and is apparent even when GFR is only mildly reduced. Differences in mortality are observed within the first year of implant, and patients on dialysis are at highest risk. Because randomized trials of ICDs have not included large numbers of patients with moderate or severe renal disease, our findings may have important implications in prognosis and case selection of patients who otherwise meet current indications for ICD implantation.

  View details for Web of Science ID 000244886500011

  View details for PubMedID 17367357

• Association of platelet count with residual thrombus in the myocardial infarct-related coronary artery among patients treated with fibrinolytic therapy for ST-segment elevation acute myocardial infarction AMERICAN JOURNAL OF CARDIOLOGY Turakhia, M. P., Murphy, S. A., Pinto, T. L., Antman, E. M., Giugliano, R. P., Cannon, C. P., Braunwald, E., Gibson, C. M. 2004; 94 (11): 1406-1410

  Abstract

  A higher platelet count is independently associated with the presence of residual thrombus in the infarct-related artery after administration of fibrinolytic therapy, even after multivariate adjustment.

  View details for DOI 10.1016/j.amjcard.2004.08.015

  View details for Web of Science ID 000225529600009

  View details for PubMedID 15566912

• Sequential risk stratification using TIMI risk score and TIMI flow grade among patients treated with fibrinolytic therapy for ST-segment elevation acute myocardial infarction AMERICAN JOURNAL OF CARDIOLOGY Karmpaliotis, D., Turakhia, M. P., Kirtane, A., Murphy, S. A., Kosmidou, I., Morrow, D. A., Giugliano, R. P., Cannon, C. P., Antman, E. M., Braunwald, E., Gibson, C. M. 2004; 94 (9): 1113-1117

  Abstract

  In the setting of ST-segment elevation myocardial infarction (STEMI), the Thrombolysis In Myocardial Infarction (TIMI) risk score (TRS) and indexes of epicardial and myocardial perfusion are associated with mortality. The association between TRS at presentation and angiographic indexes of epicardial and myocardial perfusion after reperfusion therapy has not been investigated. We hypothesized that TRS, TIMI flow grade (TFG), and TIMI myocardial perfusion grade (TMPG) would provide independent prognostic information and that angiographic indexes of poor flow and perfusion would be associated with a higher TRS. TRS and angiographic data were evaluated in 3,801 patients from the TIMI 4, 10A, 10B, 14, 20, 23, and 24 trials. Within each TRS stratum (TRS 0 to 2, 3 to 4, >/=5), 30-day mortality increased stepwise among patients with impaired TFG at 60 minutes after fibrinolytic administration. In a multivariate model adjusting for the TRS strata, impaired TMPG (0/1) was independently associated with higher mortality (odds ratio 2.28, p = 0.018). In a multivariate model adjusting for the TFG and infarct location, the likelihood of impaired TMPG (0/1) was greater among intermediate-risk (TRS 3 to 4) and high-risk (TRS >/=5) patients than among low-risk (TRS 0 to 2) patients (odds ratio 1.43, p = 0.019 and 1.50, p = 0.055, respectively). Thus, impaired epicardial flow and myocardial perfusion are independently associated with increased 30-day mortality among patients identified by TRS as high risk, although there is no synergism between either TFG or TMPG and TRS. High TRS at presentation is associated with abnormal myocardial perfusion, even after adjusting for possible confounders.

  View details for DOI 10.1016/j.amjcard.2004.07.075

  View details for Web of Science ID 000224837500002

  View details for PubMedID 15518603

• Association of the Fibonacci Cascade with the distribution of coronary artery lesions responsible for ST-segment elevation myocardial infarction AMERICAN JOURNAL OF CARDIOLOGY Gibson, C. M., Gibson, W. J., Murphy, S. A., Marble, S. J., McCabe, C. H., Turakhia, M. P., Kirtane, A. J., Karha, J., Aroesty, J. M., Giugliano, R. P., Antman, E. M. 2003; 92 (5): 595-597

  Abstract

  This is the first study to demonstrate the appearance of the Fibonacci Cascade within the distribution of coronary artery lesions in the human heart. The propensity for this ratio to appear in nature may also be because this ratio optimizes the efficiency of packing structures in a limited space in such a way that wasted space is minimized and the supply of energy or nutrients is optimized.

  View details for DOI 10.1016/S0002-9149(03)00731-8

  View details for Web of Science ID 000185060700020

  View details for PubMedID 12943884

• Isoflurane alters shivering patterns and reduces maximum shivering intensity ANESTHESIOLOGY Ikeda, T., Kim, J. S., Sessler, D. I., Negishi, C., Turakhia, M., Jeffrey, R. 1998; 88 (4): 866-873

  Abstract

  Shivering can be characterized by its threshold (triggering core temperature), gain (incremental intensity increase with further core hypothermia), and maximum response intensity. Isoflurane produces a clonic muscular activity that is not a component of normal shivering. To the extent that clonic activity is superimposed on normal thermoregulatory shivering, the gain of shivering might be increased during isoflurane anesthesia. Conversely, volatile anesthetics decrease systemic oxygen consumption and peripherally inhibit skeletal muscle strength, which might limit maximum intensity despite central activation. The purpose of the present study was, therefore, to evaluate the effect of isoflurane shivering patterns and the gain and maximum intensity of shivering.Ten volunteers were each studied in two separate protocols: (1) control (no drug) and (2) 0.7% end-tidal isoflurane. On each day, the mean skin temperature was maintained at 31 degrees C. Core temperature was then reduced by infusion of cold fluid until shivering intensity no longer increased. The core temperature triggering the initial increase in oxygen consumption defined the shivering threshold. The gain of shivering was defined by the slope of the core temperature versus oxygen consumption regression. Pectoralis and quadriceps electromyography was used to evaluate anesthetic-induced facilitation of clonic (5-7 Hz) muscular activity.Isoflurane significantly decreased the shivering threshold from 36.4 +/- 0.3 to 34.2 +/- 0.8 degrees C. The increase in oxygen consumption was linear on the control day and was followed by sustained high-intensity activity. During isoflurane administration, shivering was characterized by bursts of intense shivering separated by quiescent periods. Isoflurane significantly increased the gain of shivering (as calculated from the initial increase), from -684 +/- 266 to -1483 +/- 752 ml x min(-1) x degrees C(-1). However, isoflurane significantly decreased the maximum intensity of shivering, from 706 +/- 144 to 489 +/- 80 ml/min. Relative electromyographic power in frequencies associated with clonus increased significantly when the volunteers were given isoflurane.These data indicate that isoflurane anesthesia markedly changes the overall pattern of shivering during progressive hypothermia from a linear increase to an unusual saw-tooth pattern. They further suggest that clonic muscular activity combines with shivering to increase the initial gain of shivering during isoflurane anesthesia, but that isoflurane peripherally inhibits the maximum expression of shivering.

  View details for Web of Science ID 000073024700004

  View details for PubMedID 9579493

• Meperidine and alfentanil do not reduce the gain or maximum intensity of shivering ANESTHESIOLOGY Ikeda, T., Sessler, D. I., Tayefeh, F., Negishi, C., Turakhia, M., Marder, D., Bjorksten, A. R., Larson, M. D. 1998; 88 (4): 858-865

  Abstract

  Thermoregulatory shivering can be characterized by its threshold (triggering core temperature), gain (incremental intensity increase with further core temperature deviation), and maximum intensity. Meperidine (a combined mu- and kappa-agonist) treats shivering better than equianalgesic doses of pure mu-opioid agonists. Meperidine's special antishivering action is mediated, at least in part, by a disproportionate decrease in the shivering threshold. That is, meperidine decreases the shivering threshold twice as much as the vasoconstriction threshold, whereas alfentanil (a pure mu-agonist) decreases the vasoconstriction and shivering thresholds comparably. However, reductions in the gain or maximum shivering intensity might also contribute to the clinical efficacy of meperidine. Accordingly, we tested the hypothesis that meperidine reduces the gain and maximum intensity of shivering much more than alfentanil does.Ten volunteers were each studied on three separate days: (1) control (no drug); (2) a target total plasma meperidine concentration of 1.2 microg/ml; and (3) a target plasma alfentanil concentration of 0.2 microg/ml. Skin temperatures were maintained near 31 degrees C, and core temperatures were decreased by central-venous infusion of cold lactated Ringer's solution until maximum shivering intensity was observed. Shivering was evaluated using oxygen consumption and electromyography. A sustained increase in oxygen consumption identified the shivering threshold. The gain of shivering was calculated as the slope of the oxygen consumption versus core temperature regression, and as the slope of electromyographic intensity versus core temperature regression.Meperidine and alfentanil administration significantly decreased the shivering thresholds. However, neither meperidine nor alfentanil reduced the gain of shivering, as determined by either oxygen consumption or electromyography. Opioid administration also failed to significantly decrease the maximum intensity of shivering.The authors could not confirm the hypothesis that meperidine reduces the gain or maximum intensity of shivering more than alfentanil does. These results suggest that meperidine's special antishivering effect is primarily mediated by a disproportionate reduction in the shivering threshold.

  View details for Web of Science ID 000073024700003

  View details for PubMedID 9579492

• Epidural anesthesia reduces and gain and maximum intensity of shivering ANESTHESIOLOGY Kim, J. S., Ikeda, T., Sessler, D. I., Turakhia, M., Jeffrey, R. 1998; 88 (4): 851-857

  Abstract

  Shivering can be characterized by its threshold (triggering core temperature), gain (incremental intensity increase), and maximum intensity. The gain of shivering might be preserved during epidural or spinal anesthesia if control mechanisms compensate for lower-body paralysis by augmenting the activity of upper-body muscles. Conversely, gain will be reduced approximately by half if the thermoregulatory system fails to compensate. Similarly, appropriate regulatory feedback might maintain maximum shivering intensity during regional anesthesia. Accordingly, the gain and maximum intensity of shivering during epidural anesthesia were determined.Seven volunteers participated on two randomly ordered study days. On one day (control), no anesthesia was administered; on the other, epidural anesthesia was maintained at a T8 sensory level. Shivering, at a mean skin temperature near 33 degrees C, was provoked by central-venous infusion of cold fluid; core cooling continued until shivering intensity no longer increased. Shivering was evaluated by systemic oxygen consumption and electromyography of two upper-body and two lower-body muscles. The core temperature triggering an increase in oxygen consumption identified the shivering threshold. The slopes of the oxygen consumption versus core temperature and electromyographic intensity versus core temperature regressions identified systemic and regional shivering gains, respectively.The shivering threshold was reduced by epidural anesthesia by approximately 0.4 degrees C, from 36.7 +/- 0.6 to 36.3 +/- 0.5 degrees C (means +/- SD; P < 0.05). Systemic gain, as determined by oxygen consumption, was reduced from -581 +/- 186 to -215 +/- 154 ml x min(-1) x degrees C(-1) (P < 0.01). Lower-body gain, as determined electromyographically, was essentially obliterated by paralysis during epidural anesthesia, decreasing from -0.73 +/- 0.85 to -0.04 +/- 0.06 intensity units/degrees C (P < 0.01). However, upper-body gain had no compensatory increase: -1.3 +/- 1.1 units/degrees C control versus 2.0 +/- 2.1 units/degrees C epidural. Maximum oxygen consumption was decreased by one third during epidural anesthesia: 607 +/- 82 versus 412 +/- 50 ml/min (P < 0.05).These results confirm that regional anesthesia reduces the shivering threshold. Epidural anesthesia reduced the gain of shivering by 63% because upper-body muscles failed to compensate for lower-body paralysis. The thermoregulatory system thus fails to recognize that regional anesthesia reduces metabolic heat production, instead responding as if lower-body muscular activity remained intact.

  View details for Web of Science ID 000073024700002

  View details for PubMedID 9579491

• Postanesthetic vasoconstriction slows peripheral-to-core transfer of cutaneous heat, thereby isolating the core thermal compartment ANESTHESIA AND ANALGESIA Plattner, O., Ikeda, T., Sessler, D. I., Christensen, R., Turakhia, M. 1997; 85 (4): 899-906

  Abstract

  Forced-air warming during anesthesia increases core temperature comparably with and without thermoregulatory vasoconstriction. In contrast, postoperative forced-air warming may be no more effective than passive insulation. Nonthermoregulatory anesthesia-induced vasodilation may thus influence heat transfer. We compared postanesthetic core rewarming rates in volunteers given cotton blankets or forced air. Additionally, we compared increases in peripheral and core heat contents in the postanesthetic period with data previously acquired during anesthesia to determine how much vasomotion alters intercompartmental heat transfer. Six men were anesthetized and cooled passively until their core temperatures reached 34 degrees C. Anesthesia was then discontinued, and shivering was prevented by giving meperidine. On one day, the volunteers were covered with warmed blankets for 2 h; on the other, volunteers were warmed with forced air. Peripheral tissue heat contents were determined from intramuscular and skin thermocouples. Predicted changes in core temperature were calculated assuming that increases in body heat content were evenly distributed. Predicted changes were thus those that would be expected if vasomotor activity did not impair peripheral-to-core transfer of applied heat. These results were compared with those obtained previously in a similar study of anesthetized volunteers. Body heat content increased 159 +/- 35 kcal (mean +/- SD) more during forced-air than during blanket warming (P < 0.001). Both peripheral and core temperatures increased significantly faster during active warming: 3.3 +/- 0.7 degrees C and 1.1 +/- 0.4 degrees C, respectively. Nonetheless, predicted core temperature increase during forced-air warming exceeded the actual temperature increase by 0.8 +/- 0.3 degree C (P < 0.001). Vasoconstriction thus isolated core tissues from heat applied to the periphery, with the result that core heat content increased 32 +/- 12 kcal less than expected after 2 h of forced-air warming (P < 0.001). In contrast, predicted and actual core temperatures differed only slightly in the anesthetized volunteers previously studied. In contrast to four previous studies, our results indicate that forced-air warming increases core temperature faster than warm blankets. Postanesthetic vasoconstriction nonetheless impeded peripheral-to-core heat transfer, with the result that core temperatures in the two groups differed less than might be expected based on systemic heat balance estimates. Implications: Comparing intercompartmental heat flow in our previous and current studies suggests that anesthetic-induced vasodilation influences intercompartmental heat transfer and distribution of body heat more than thermoregulatory shunt vasomotion.

  View details for Web of Science ID A1997XY23200034

  View details for PubMedID 9322477

• Rapid core-to-peripheral tissue heat transfer during cutaneous cooling ANESTHESIA AND ANALGESIA Plattner, O., Xiong, J. Y., Sessler, D. I., Schmied, H., Christensen, R., Turakhia, M., Dechert, M., Clough, D. 1996; 82 (5): 925-930

  Abstract

  Perioperative thermal manipulations are usually directed at the skin surface because methods of directly warming the core are invasive or ineffective. However, inadequate heat flow between peripheral and core compartments will decrease the rate at which core temperature changes. We therefore determined whether core hypothermia is delayed after initiation of surface cooling. Six volunteers were anesthetized with propofol and midazolam, and maintained under three layers of passive insulation for 2.5-4 h. Subsequently, the skin surface was cooled using forced air, 1000 L/min, at 10 degrees C. Isoflurane was added as necessary to maintain arteriovenous shunt vasodilation. Overall heat balance was determined from the difference between cutaneous heat loss (thermal flux transducers) and metabolic heat production (oxygen consumption). Average arm and leg (peripheral) tissue temperatures were determined from 19 intramuscular needle thermocouples, 10 skin temperatures, and "deep" foot temperature. Overall body heat content decreased approximately 234 kcal during 2.5 h of active cooling. Core temperature, which was nearly constant before active cooling, decreased approximately 1.3 degrees C/h. There was no delay between initiation of active cooling and the decrease in core temperature. Furthermore, peripheral (arm and leg) and core (trunk and head) tissue heat contents decreased at virtually the same rates: approximately 50 kcal/h and approximately 47 kcal/h, respectively. These data indicate that there is little restriction of heat flow between peripheral and core tissues in vasodilated, anesthetized subjects.

  View details for Web of Science ID A1996UH19500006

  View details for PubMedID 8610900