Anubodh Sunny Varshney

All Publications

• Effectiveness of Virtual Care Team Guided Management of Hospitalized Patients with HFrEF by Ethnicity. Journal of cardiac failure Bertot, J. H., Varshney, A. S., Moscone, A., Claggett, B. L., Miao, Z. M., Akash, M., Pabon, M., Cunningham, J. W., Makuvire, T., Solomon, S. D., Adler, D. S., Vaduganathan, M., Bhatt, A. S. 2024

  Abstract

  IMPLEMENT-HF demonstrated a virtual team-based care strategy was safe and improved prescription of guideline directed medical therapy (GDMT) in hospitalized patients with heart failure and reduced ejection fraction (HFrEF). We evaluated differences in efficacy and safety outcomes by ethnicity in IMPLEMENT-HF.IMPLEMENT-HF evaluated a provider-facing virtual team-based care strategy vs. usual care in hospitalized patients with HFrEF from October 2021 to June 2022. The primary outcome was change in a guideline directed medical therapy (GDMT) optimization score from hospital admission to discharge, with positive changes reflecting net optimization. In this post-hoc analysis, we assessed heterogeneity in treatment effects by ethnicity (Hispanic vs. non-Hispanic). Outcomes included prespecified primary and secondary effectiveness outcomes and adjudicated safety events.Of 808 screened patient admissions, 252 (31%) from 198 unique patients met inclusion criteria. Hispanic patients (n=43) were more likely to have diabetes and end-stage kidney disease than non-Hispanics; 70% spoke Spanish as a primary language. GDMT optimization score was lower among Hispanic vs. non-Hispanic patients (-0.44, 95% CI: -1.88 to 0.99 vs. +1.62, 95% CI: +1.02 to +2.21; p-value of interaction by ethnicity= 0.002). Allocation to the virtual care team intervention vs. usual care increased the proportion of patients experiencing >1 new initiation or dose up-titration among non-Hispanic patients but did not among Hispanic patients (absolute difference non-Hispanic vs. Hispanic: +31% vs. -19%; p-value of interaction = 0.003). Similar trends were seen among individual HF therapy and for the proportion of patients with optimization score >0 (absolute difference non-Hispanic vs. Hispanic: +29% vs. -20%; p-value of interaction = 0.005). Safety outcomes were similar among Hispanic and non-Hispanic patients.A provider-facing, virtual care team guided strategy for HFrEF GDMT optimization was less effective in Hispanic patients. Efforts to identify and reduce bias contributing to this observed difference and more diverse implementation studies are needed.

  View details for DOI 10.1016/j.cardfail.2024.11.018

  View details for PubMedID 39701371

• Dual Coaching of Medical Clerkship Students' History Taking Skills by Volunteer Inpatients at the Bedside and Faculty Physicians on Zoom During the COVID-19 Pandemic. Advances in medical education and practice Patel, K. S., Anderson, R. J., Becker, C. B., Taylor, W. C., Liu, A. F., Varshney, A. S., Ali, N. B., Nath, B. J., Pelletier, S. R., Shields, H. M., Osman, N. Y. 2024; 15: 923-933

  Abstract

  Coaching is a well-described means of providing real-time, actionable feedback to learners. We aimed to determine whether dual coaching from faculty physicians and real inpatients led to an improvement in history-taking skills of clerkship medical students.Expert faculty physicians (on Zoom) directly observed 13 clerkship medical students as they obtained a history from 26 real, hospitalized inpatients (in person), after which students received immediate feedback from both the physician and the patient. De-identified audio-video recordings of all interviews were scored by independent judges using a previously validated clinical rating tool to assess for improvement in history-taking skills between the two interviews. Finally, all participants completed a survey with Likert scale questions and free-text prompts.Students' history-taking skills - specifically in the domains of communication, medical knowledge and professional conduct - on the validated rating tool, as evaluated by the independent judges, did not significantly improve between their first and second patient interviews. However, students rated the dual coaching as overwhelmingly positive (average score of 1.43, with 1 being Excellent and 5 being Poor), with many appreciating the specificity and timeliness of the feedback. Patients also rated the experience very highly (average score of 1.23, with 1 being Excellent and 5 being Poor), noting that they gained new insights into medical training.Students value receiving immediate and specific feedback and real patients enjoy participating in the feedback process. Dual physician-patient coaching is a unique way to incorporate more direct observation into undergraduate medical education curricula.

  View details for DOI 10.2147/AMEP.S472324

  View details for PubMedID 39381803

  View details for PubMedCentralID PMC11460274

• Validating the Association Between Composite Metrics of Guideline-Directed Medical Therapy (GDMT) and Clinical Outcomes for Patients with Heart Failure with Reduced Ejection Fraction (HFrEF). Journal of cardiac failure Steverson, A., Calma, J., Hsiao, S., Sallam, K., Varshney, A. S., Golbus, J. R., Heidenreich, P. A., Sandhu, A. T. 2024

  View details for DOI 10.1016/j.cardfail.2024.08.054

  View details for PubMedID 39357668

• Inpatient Use of Guideline-Directed Medical Therapy During Heart Failure Hospitalizations Among Community-Based Health Systems. JACC. Heart failure Zheng, J., Sandhu, A. T., Bhatt, A. S., Collins, S. P., Flint, K. M., Fonarow, G. C., Fudim, M., Greene, S. J., Heidenreich, P. A., Lala, A., Testani, J. M., Varshney, A. S., Wi, R. S., Ambrosy, A. P. 2024

  Abstract

  Guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains underused. Acute heart failure (HF) hospitalization represents a critical opportunity for rapid initiation of evidence-based medications. However, data on GDMT use at discharge are mostly derived from national quality improvement registries.This study aimed to describe contemporary GDMT use patterns across HF hospitalizations at community-based health systems.The authors identified HF hospitalizations from 2016 to 2022 in a U.S. database aggregating deidentified electronic health record data from more than 30 health systems. In-hospital and discharge rates of GDMT use were reported for eligible HFrEF patients. Factors associated with inpatient GDMT use and predischarge discontinuation were evaluated with the use of multivariable models.A total of 20,387 HF hospitalizations among 13,729 HFrEF patients were identified. Renin-angiotensin system inhibitors, beta-blockers, and mineralocorticoid receptor antagonists were administered during 70%, 86%, and 37% of eligible hospitalizations, respectively. Angiotensin receptor-neprilysin inhibitors and sodium-glucose cotransporter 2 inhibitors were used in 17% and 8% of eligible hospitalizations, respectively. Discharge GDMT rates were low. Triple/quadruple therapy was administered in 26% of hospitalizations, falling to 14% on discharge. Predischarge GDMT discontinuations were associated with inpatient hypotension, hyperkalemia, and worsening renal function, but 43%-57% had no medical contraindications. In adjusted analyses, use of 3 or more GDMT classes was associated with fewer 90-day all-cause deaths and HF readmissions compared with less comprehensive GDMT.Inpatient GDMT use in a national analysis of HF hospitalizations was lower than reported in quality improvement registries. High discontinuation rates emphasize an unmet need for inpatient and postdischarge strategies to optimize GDMT use.

  View details for DOI 10.1016/j.jchf.2024.08.004

  View details for PubMedID 39269395

• Targeted Proteomic Profiling of Cardiogenic Shock in the Cardiac Intensive Care Unit. European heart journal. Acute cardiovascular care Patel, S. M., Lopes, M. S., Morrow, D. A., Bellavia, A., Bhatt, A. S., Butler, K. K., D'Antonio, J., Dunn, M., Fagundes, A. A., Jarolim, P., Marin, E. P., Morton, L., Olenchock, B. O., Senman, B., da Silva, D. S., Varshney, A. S., Bohula, E. A., Berg, D. D. 2024

  Abstract

  We sought to characterize circulating protein biomarkers associated with cardiogenic shock (CS) using highly multiplex proteomic profiling.This analysis employed a cross-sectional case-control study design using a biorepository of patients admitted to a cardiac intensive care unit between 2017-2020. Cases were patients adjudicated to have CS and controls were those presenting for cardiac critical care without shock, including subsets of patients with isolated hypotension or heart failure (HF). The Olink platform was used to analyze 359 biomarkers with Bonferroni correction.The analysis included 239 patients presenting for cardiac critical care (69 cases with CS, 170 non-shock controls). A total of 63 biomarkers (17.7%) were significantly associated with CS after Bonferroni correction compared with all controls. Of these, nine biomarkers remained significantly associated with CS when separately cross-validated in subsets of controls presenting with isolated hypotension and HF: cathepsin D, fibroblast growth factor (FGF)-21 and -23, growth differentiation factor (GDF)-15, insulin-like growth factor binding protein-1, N-terminal pro-B-type natriuretic peptide, osteopontin, oncostatin-M-specific receptor subunit beta (OSMR), and soluble ST2 protein (sST2). Four biomarkers were identified as providing complementary information for CS diagnosis with development of a multi-marker model: sST2, FGF-23, CTSD, and GDF-15.In this pilot study of targeted proteomic profiling in CS, we identified nine biomarkers significantly associated with CS when cross-validated against non-shock controls including those with HF or isolated hypotension, illustrating the potential application of a targeted proteomic approach to identify novel candidates that may support the diagnosis of CS.

  View details for DOI 10.1093/ehjacc/zuae068

  View details for PubMedID 38815149

• Durable Mechanical Circulatory Support: The Spring of Hope or the Winter of Despair? Journal of cardiac failure Varshney, A. S., Teuteberg, J. J. 2024

  View details for DOI 10.1016/j.cardfail.2024.03.015

  View details for PubMedID 38734131

• Sex-Based Differences in the Epidemiology, Clinical Characteristics, and Outcomes Associated with Worsening Heart Failure Events in a Learning Health System. Journal of cardiac failure Leung, C. J., Bhatt, A. S., Go, A. S., Parikh, R. V., Garcia, E. A., Le, K. C., Low, D., Allen, A. R., Fitzpatrick, J. K., Adatya, S., Sax, D. R., Goyal, P., Varshney, A. S., Sandhu, A. T., Gustafson, S. E., Ambrosy, A. P. 2024

  Abstract

  Differences in demographics, risk factors, and clinical characteristics may contribute to variation in men and women in terms of prevalence, clinical setting, and outcomes associated with worsening heart failure (WHF) events.To describe sex-based differences in the epidemiology, clinical characteristics, and outcomes associated with WHF events across clinical settings.We examined adults diagnosed with HF from 2010-2019 within a large, integrated healthcare delivery system. Electronic health record data were accessed for hospitalizations, emergency department (ED) visits/observation stays, and outpatient encounters. WHF was identified using validated natural language processing algorithms and defined as ≥1 symptom, ≥2 objective findings (including ≥1 sign), and ≥1 change in HF-related therapy. Incidence rates and associated outcomes for WHF were compared across care setting by sex.We identified 1,122,368 unique clinical encounters with a diagnosis code for HF, with 124,479 meeting WHF criteria. These WHF encounters existed among 102,116 patients, of which 48,543 (47.5%) were women and 53,573 (52.5%) were men. Women experiencing WHF were older and more likely to have HF with preserved ejection fraction compared to men. The clinical settings of WHF were similar among women and men: hospitalizations (36.8% vs. 37.7%), ED visits or observation stays (11.8% vs. 13.4%), and outpatient encounters (4.4% vs. 4.9%). Women had lower odds of 30-day mortality following an index hospitalization (adjusted odds ratio [aOR] 0.88, 95% confidence interval [CI] 0.83-0.93) or ED visit/observation stay (aOR 0.86, 95% 0.75-0.98) for WHF.Women and men contribute similarly to WHF events across diverse clinical settings despite marked differences in age and left ventricular ejection fraction.

  View details for DOI 10.1016/j.cardfail.2024.01.019

  View details for PubMedID 38697466

• Contemporary Decongestion Strategies in Patients Hospitalized for Heart Failure: A National Community-Based Cohort Study. JACC. Heart failure Zheng, J., Ambrosy, A. P., Bhatt, A. S., Collins, S. P., Flint, K. M., Fonarow, G. C., Fudim, M., Greene, S. J., Lala, A., Testani, J. M., Varshney, A. S., Wi, R. S., Sandhu, A. T. 2024

  Abstract

  Heart failure (HF) is a leading cause of hospitalization in the United States. Decongestion remains a central goal of inpatient management, but contemporary decongestion practices and associated weight loss have not been well characterized nationally.This study aimed to describe contemporary inpatient diuretic practices and clinical predictors of weight loss in patients hospitalized for HF.The authors identified HF hospitalizations from 2015 to 2022 in a U.S. national database aggregating deidentified patient-level electronic health record data across 31 geographically diverse community-based health systems. The authors report patient characteristics and inpatient weight change as a primary indicator of decongestion. Predictors of weight loss were evaluated using multivariable models. Temporal trends in inpatient diuretic practices, including augmented diuresis strategies such as adjunctive thiazides and continuous diuretic infusions, were assessed.The study cohort included 262,673 HF admissions across 165,482 unique patients. The median inpatient weight loss was 5.3 pounds (Q1-Q3: 0.0-12.8 pounds) or 2.4 kg (Q1-Q3: 0.0-5.8 kg). Discharge weight was higher than admission weight in 20% of encounters. An increase of ≥0.3 mg/dL in serum creatinine from admission to inpatient peak occurred in >30% of hospitalizations and was associated with less weight loss. Adjunctive diuretic agents were utilized in <20% of encounters but were associated with greater weight loss.In a large-scale U.S. community-based cohort study of HF hospitalizations, estimated weight loss from inpatient decongestion remains highly variable, with weight gain observed across many admissions. Augmented diuresis strategies were infrequently used. Comparative effectiveness trials are needed to establish optimal strategies for inpatient decongestion for acute HF.

  View details for DOI 10.1016/j.jchf.2024.04.002

  View details for PubMedID 38678466

• CONTEMPORARY DECONGESTION STRATEGIES AND WEIGHT LOSS IN PATIENTS HOSPITALIZED FOR HEART FAILURE: A NATIONAL COMMUNITY-BASED COHORT STUDY Zheng, J., Ambrosy, A. P., Bhatt, A., Collins, S. P., Flint, K. M., Fonarow, G. C., Fudim, M., Greene, S., Lala, A., Testani, J. M., Varshney, A., Wi, R., Sandhu, A. ELSEVIER SCIENCE INC. 2024: 339

  View details for Web of Science ID 001291434300340

• INPATIENT UTILIZATION OF GUIDELINE-DIRECTED MEDICAL THERAPY IN PATIENTS HOSPITALIZED FOR HEART FAILURE AMONG COMMUNITY-BASED HEALTH SYSTEMS Zheng, J., Sandhu, A., Bhatt, A., Collins, S. P., Flint, K. M., Fonarow, G. C., Fudim, M., Greene, S., Lala, A., Testani, J. M., Varshney, A., Wi, R., Ambrosy, A. P. ELSEVIER SCIENCE INC. 2024: 325

  View details for Web of Science ID 001291434300326

• Uptake of sodium-glucose cotransporter-2 inhibitors in hospitalized patients with heart failure: insights from the veterans affairs healthcare system. Journal of cardiac failure Varshney, A. S., Calma, J., Kalwani, N. M., Hsiao, S., Sallam, K., Cao, F., Din, N., Schirmer, J., Bhatt, A. S., Ambrosy, A. P., Heidenreich, P., Sandhu, A. T. 2024

  Abstract

  The use of sodium-glucose cotransporter-2 inhibitor (SGLT2i) in Veteran Affairs (VA) patients hospitalized with heart failure (HF) has not been previously reported.VA electronic health record data were used to identify patients hospitalized for HF (primary or secondary diagnosis) from 01/2019-11/2022. Patients with SGLT2i allergy, advanced/end-stage chronic kidney disease (CKD), or advanced HF therapies were excluded. We identified factors associated with discharge SGLT2i prescription among hospitalizations in 2022. We also compared SGLT2i and angiotensin receptor-neprilysin inhibitor (ARNI) prescription rates. Hospital-level variation in SGLT2i prescription was assessed via the median odds ratio.A total of 69,680 patients were hospitalized for HF; 10.3% were prescribed SGLT2i at discharge (4.4% newly prescribed, 5.9% continued pre-admission therapy). SGLT2i prescription increased over time and was higher in patients with HFrEF and primary HF. Among 15,762 patients hospitalized in 2022, SGLT2i prescription was more likely in patients with diabetes (adjusted odds ratio [aOR] 2.27; 95% confidence interval [CI]: 2.09-2.47) and ischemic heart disease (aOR 1.14; 95% CI: 1.03-1.26). Patients with increased age (aOR 0.77 per 10 years; 95% CI: 0.73-0.80) and lower systolic blood pressure (aOR 0.94 per 10mmHg; 95% CI: 0.92-0.96) were less likely to be prescribed SGLT2i, and SGLT2i prescription was not more likely in patients with CKD (aOR 1.07; 95% CI 0.98-1.16). The adjusted median odds ratio suggested a 1.8-fold variation in the likelihood that similar patients at 2 random VA sites were prescribed SGLT2i (range 0%-21.0%). In patients with EF ≤40%, 30.9% were prescribed SGLT2i while 26.9% were prescribed ARNI (p<0.01).One-tenth of VA patients hospitalized for HF were prescribed SGLT2i at discharge. Opportunities exist to reduce variation in SGLT2i prescription across hospitals and promote use in patients with CKD and older age.

  View details for DOI 10.1016/j.cardfail.2023.12.018

  View details for PubMedID 38281540

• Complications in patients with cardiogenic shock on veno-arterial extracorporeal membrane oxygenation therapy: distribution and relevance. Results from an international, multicentre cohort study. European heart journal. Acute cardiovascular care Beer, B. N., Kellner, C., Goßling, A., Sundermeyer, J., Besch, L., Dettling, A., Kirchhof, P., Blankenberg, S., Bernhardt, A. M., Brunner, S., Colson, P., Eckner, D., Frank, D., Eitel, I., Frey, N., Eden, M., Graf, T., Kupka, D., Landmesser, U., Majunke, N., Maniuc, O., Möbius-Winkler, S., Morrow, D. A., Mourad, M., Noel, C., Nordbeck, P., Orban, M., Pappalardo, F., Patel, S. M., Pauschinger, M., Reichenspurner, H., Schulze, P. C., Schwinger, R. H., Wechsler, A., Skurk, C., Thiele, H., Varshney, A. S., Sag, C. M., Krais, J., Westermann, D., Schrage, B. 2023

  Abstract

  VA-ECMO restores circulation and tissue oxygenation in cardiogenic shock (CS) patients, but can also lead to complications.To quantify VA-ECMO complications and analyse their association with overall survival as well as favourable neurological outcome (CPC 1 + 2).All-comer patients with CS treated with VA-ECMO were retrospectively enrolled from 16 centres in 4 countries (2005-2019). Neurological, bleeding and ischaemic adverse events (AEs) were considered. From these, typical VA-ECMO complications were identified and analysed separately as device-related complications.N = 501. 118 were women (24%), median age was 56.0 years, median lactate 8.1 mmol/l. Acute myocardial infarction caused CS in 289 patients (58%). 30-day mortality was 40% (198/501 patients). At least one device-related complication occurred in 252/486 (52%) patients, neurological AEs in 108/469 (23%), bleeding in 192/480 (40%), ischaemic AEs in 123/478 (26%). The 22% of patients with the most AEs accounted for 50% of all AEs. All types of AEs were associated with a worse prognosis. Aside from neurological ones, all AEs and device-related complications were more likely to occur in women; although prediction of AEs outside of neurological AEs was generally poor.Therapy and device-related complications occur in half of all patients treated with VA-ECMO and are associated with a worse prognosis. They accumulate in some patients, especially in women. Aside from neurological events, identification of patients at risk is difficult, highlighting the need to establish additional quantitative markers of complication risk to guide VA-ECMO treatment in CS.

  View details for DOI 10.1093/ehjacc/zuad129

  View details for PubMedID 37875127

• Heart Failure Medical Therapy Prior to Mitral Transcatheter Edge-to-Edge Repair: The STS/ACC Transcatheter Valve Therapy Registry. European heart journal Varshney, A. S., Shah, M., Vemulapalli, S., Kosinski, A., Bhatt, A. S., Sandhu, A. T., Hirji, S., DeFilippis, E. M., Shah, P. B., Fiuzat, M., O'Gara, P. T., Bhatt, D. L., Kaneko, T., Givertz, M. M., Vaduganathan, M. 2023

  Abstract

  Guideline-directed medical therapy (GDMT) is recommended prior to mitral valve transcatheter edge-to-edge repair (MTEER) in patients with heart failure (HF) and severe functional mitral regurgitation (FMR). Whether MTEER is being performed on the background of optimal GDMT in clinical practice is unknown.Patients with left ventricular ejection fraction (LVEF) < 50% who underwent MTEER for FMR from July 23, 2019 to March 31, 2022 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry were identified. Pre-procedure GDMT utilization was assessed. Cox proportional hazards models were constructed to evaluate associations between pre-MTEER therapy (no/single, double, or triple therapy) and risk of one-year mortality or HF hospitalization (HFH).Among 4,199 patients across 449 sites, beta-blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, mineralocorticoid receptor antagonists, and angiotensin receptor-neprilysin inhibitor were used in 85.1%, 44.4%, 28.6%, and 19.9% prior to MTEER, respectively. Triple therapy was prescribed for 19.2%, double therapy for 38.2%, single therapy for 36.0%, and 6.5% were on no GDMT. Significant center-level variation in the proportion of patients on pre-intervention triple therapy was observed (0-61%; adjusted median odds ratio 1.48 [95% confidence interval (CI) 1.25-3.88]; P < 0.001). In patients eligible for one-year follow-up (n = 2,014; 341 sites), the composite rate of one-year mortality or HFH was lowest in patients prescribed triple therapy (23.1%) compared with double (24.8%), single (35.7%), and no (41.1%) therapy (P < 0.01 comparing across groups). Associations persisted after accounting for relevant clinical characteristics, with lower risk in patients prescribed triple therapy (adjusted hazard ratio [aHR] 0.73, 95% CI 0.55-0.97) and double therapy (aHR 0.69, 95% CI 0.56-0.86) prior to MTEER compared with no/single therapy.Under one-fifth of patients with LVEF <50% who underwent MTEER for FMR in this US nationwide registry were prescribed comprehensive GDMT, with substantial variation across sites. Compared with no/single therapy, triple and double therapy prior to MTEER were independently associated with reduced risk of mortality or HFH one year after intervention.

  View details for DOI 10.1093/eurheartj/ehad584

  View details for PubMedID 37632738

• Virtual Care Team-Guided Therapeutic Optimization During Hospitalization in Patients with Heart Failure: The IMPLEMENT-HF Study. Journal of the American College of Cardiology Bhatt, A. S., Varshney, A. S., Moscone, A., Claggett, B. L., Miao, Z. M., Chatur, S., Lopes, M. S., Ostrominski, J. W., Pabon, M. A., Unlu, O., Wang, X., Bernier, T. D., Buckley, L. F., Cook, B., Eaton, R., Fiene, J., Kanaan, D., Kelly, J., Knowles, D. M., Lupi, K., Matta, L. S., Pimentel, L. Y., Rhoten, M. N., Malloy, R., Ting, C., Chhor, R., Guerin, J. R., Schissel, S. L., Hoa, B., Lio, C. H., Milewski, K., Espinosa, M. E., Liu, Z., McHatton, R., Cunningham, J. W., Jering, K. S., Bertot, J. H., Kaur, G., Ahmad, A., Akash, M., Davoudi, F., Hinrichsen, M. Z., Rabin, D. L., Gordan, P. L., Roberts, D. J., Urma, D., McElrath, E. E., Hinchey, E. D., Choudhry, N. K., Nekoui, M., Solomon, S. D., Adler, D. S., Vaduganathan, M. 2023

  Abstract

  Scalable and safe approaches for heart failure GDMT optimization are needed.We assessed the safety and effectiveness of a virtual care team-guided strategy on GDMT use in hospitalized patients with HFrEF.In a multicenter implementation trial, we allocated 252 hospital encounters in patients with LVEF≤40% to a virtual care team-guided strategy(107 encounters among 83 patients) or usual care(145 encounters among 115 patients) across 3 centers in an integrated health system. In the virtual care team group, clinicians received up to 1 daily GDMT optimization suggestion from a physician-pharmacist team. Primary effectiveness outcome was in-hospital change in GDMT optimization score (+2 initiations, +1 dose uptitrations, -1 dose downtitrations, -2 discontinuations summed across classes). In-hospital safety outcomes were adjudicated by an independent clinical events committee.Among 252 encounters, mean age was 69±14 years, 85(34%) were women, 35(14%) were Black, and 43(17%) were Hispanic. The virtual care team strategy significantly improved GDMT scores vs. usual care (adjusted difference +1.2;95% CI:0.7-1.8;P<0.001). New initiations (44% vs.23%;P=0.001) and intensifications of ≥1 GDMT (50% vs.28%;P=0.001) were higher in the virtual care team group, translating to a number-needed-to-intervene of 5 encounters. Overall, 23(21%) in virtual care team group and 40(28%) in usual care experienced 1 or more safety events(P=0.30). AKI, bradycardia, hypotension, and hyperkalemia were similar between groups.Among patients hospitalized with HFrEF, a virtual care team-guided strategy for GDMT optimization was safe and improved GDMT across multiple hospitals in an integrated health system. Virtual teams represent a centralized, scalable approach to optimize GDMT.

  View details for DOI 10.1016/j.jacc.2023.02.029

  View details for PubMedID 36889612

• Bridging Strategies and Cardiac Replacement Outcomes in Patients with Acute Decompensated Heart Failure-Related Cardiogenic Shock. European journal of heart failure Varshney, A. S., Berg, D. D., Zhou, G., Sinnenberg, L., Hirji, S., DeFilippis, E. M., Mallidi, H. R., Morrow, D. A., Rinewalt, D., Givertz, M. M. 2023

  Abstract

  AIMS: To describe outcomes associated with bridging strategies in patients with acute decompensated heart failure-related cardiogenic shock (ADHF-CS) bridged to durable left ventricular assist device (LVAD) or heart transplant (HTx).METHODS AND RESULTS: Durable LVAD or HTx recipients from 2014 to 2019 with pre-operative ADHF-CS were identified in the Society of Thoracic Surgeons Adult Cardiac Surgery Database and stratified by bridging strategy. The primary outcome was operative or 30-day post-operative mortality. Secondary outcomes included post-operative major bleeding. Exploratory comparisons between bridging strategies and outcomes were performed using overlap weighting with and without covariate adjustment. Among 9783 patients with pre-operative CS, 8777 (89.7%) had ADHF-CS. Medical therapy (N=5013) was the most common bridging strategy, followed by intra-aortic balloon pump (IABP; N=2816), catheter-based temporary mechanical circulatory support (TMCS; N=417), and veno-arterial extracorporeal membrane oxygenation (VA-ECMO; N=465). Mortality was highest in patients bridged with VA-ECMO (22%), followed by catheter-based TMCS (10%), IABP (9%), and medical therapy (7%). Adverse post-operative outcomes were more frequent in LVAD recipients compared with HTx recipients.CONCLUSION: Among patients with ADHF-CS bridged to HTx or durable LVAD, the highest rates of death and adverse events during index hospitalization were observed in those bridged with VA-ECMO, followed by catheter-based TMCS, IABP, and medical therapy. Patients who received durable LVAD had higher rates of post-operative complications compared with HTx recipients. Prospective trials are needed to define optimal bridging strategies in patients with ADHF-CS. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1002/ejhf.2762

  View details for PubMedID 36597721

• Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy. JACC. Heart failure Schrage, B., Sundermeyer, J., Blankenberg, S., Colson, P., Eckner, D., Eden, M., Eitel, I., Frank, D., Frey, N., Graf, T., Kirchhof, P., Kupka, D., Landmesser, U., Linke, A., Majunke, N., Mangner, N., Maniuc, O., Mierke, J., Möbius-Winkler, S., Morrow, D. A., Mourad, M., Nordbeck, P., Orban, M., Pappalardo, F., Patel, S. M., Pauschinger, M., Pazzanese, V., Radakovic, D., Schulze, P. C., Scherer, C., Schwinger, R. H., Skurk, C., Thiele, H., Varshney, A., Wechsler, L., Westermann, D. 2022

  Abstract

  It is currently unclear if active left ventricular (LV) unloading should be used as a primary treatment strategy or as a bailout in patients with cardiogenic shock (CS) treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO).The study sought to evaluate the association between timing of active LV unloading and implantation of VA-ECMO with outcomes of patients with CS.Data from 421 patients with CS treated with VA-ECMO and active LV unloading at 18 tertiary care centers in 4 countries were analyzed. Patients were stratified by timing of device implantation in early vs delayed active LV unloading (defined by implantation before up to 2 hours after VA-ECMO). Adjusted Cox and logistic regression models were fitted to evaluate the association between early active LV unloading and 30-day mortality as well as successful weaning from ventilation.Overall, 310 (73.6%) patients with CS were treated with early active LV unloading. Early active LV unloading was associated with a lower 30-day mortality risk (HR: 0.64; 95% CI: 0.46-0.88) and a higher likelihood of successful weaning from ventilation (OR: 2.17; 95% CI: 1.19-3.93) but not with more complications. Importantly, the relative mortality risk increased and the likelihood of successful weaning from ventilation decreased almost proportionally with the time interval between VA-ECMO implantation and (delayed) initiation of active LV unloading.This exploratory study lends support to the use of early active LV unloading in CS patients on VA-ECMO, although the findings need to be validated in a randomized controlled trial.

  View details for DOI 10.1016/j.jchf.2022.11.005

  View details for PubMedID 36724180

• Investigating the Association Between Telemedicine Use and Timely Follow-Up Care After Acute Cardiovascular Hospital Encounters. JACC advances Tang, M., Holmgren, A. J., McElrath, E. E., Bhatt, A. S., Varshney, A. S., Lee, S. G., Vaduganathan, M., Adler, D. S., Huckman, R. S. 2022; 1 (5): 100156

  Abstract

  Telemedicine use increased dramatically during the COVID-19 pandemic; however, questions remain as to how telemedicine use impacts care.The purpose of this study was to examine the association of increased telemedicine use on rates of timely follow-up and unplanned readmission after acute cardiovascular hospital encounters.We examined hospital encounters for acute coronary syndrome, arrhythmia disorders, heart failure (HF), and valvular heart disease from a large U.S., multisite, integrated academic health system among patients with established cardiovascular care within the system. We evaluated 14-day postdischarge follow-up and 30-day all-cause unplanned readmission rates for encounters from the pandemic "steady state" period from May 24, 2020 through December 31, 2020, when telemedicine use was high and compared them to those of encounters from the week-matched period in 2019 (May 26, 2019, through December 31, 2019), adjusting for patient and encounter characteristics.The study population included 6,026 hospital encounters. In the pandemic steady-state period, 40% of follow-ups after these encounters were conducted via telemedicine vs 0% during the week-matched period in 2019. Overall, 14-day follow-up rates increased from 41.7% to 44.9% (adjusted difference: +2.0 percentage points [pp], 95% CI: -1.1 to +5.1 pp, P = 0.20). HF encounters experienced the largest improvement from 50.1% to 55.5% (adjusted difference: +6.5 pp, 95% CI: +0.5 to +12.4 pp, P = 0.03). Overall 30-day all-cause unplanned readmission rates fell slightly, from 18.3% to 16.9% (adjusted difference -1.6 pp; 95% CI: -4.0 to +0.8 pp, P = 0.20).Increased telemedicine use during the COVID-19 pandemic was associated with earlier follow-ups, particularly after HF encounters. Readmission rates did not increase, suggesting that the shift to telemedicine did not compromise care quality.

  View details for DOI 10.1016/j.jacadv.2022.100156

  View details for PubMedID 36620529

  View details for PubMedCentralID PMC9802537

• Increased Opportunities for Transplantation for Women in the New Heart Allocation System. Journal of cardiac failure Defilippis, E. M., Truby, L. K., Clerkin, K. J., Donald, E., Sinnenberg, L., Varshney, A. S., Cogswell, R., Kittleson, M. M., Haythe, J. H., Givertz, M. M., Hsich, E. M., Agarwal, R., Topkara, V. K., Farr, M. 2022; 28 (7): 1149-1157

  Abstract

  Historically, women have had less access to advanced heart failure therapies, including temporary and permanent mechanical circulatory support and heart transplantation (HT), with worse waitlist and post-transplant survival compared with men. This study evaluated for improvement in sex differences across all phases of HT in the 2018 allocation system.The United Network for Organ Sharing registry was queried to identify adult patients (≥18 years) listed for HT from October 18, 2016, to October 17, 2018 (old allocation), and from October 18, 2018, to October 18, 2020 (new allocation). The outcomes of interest included waitlist survival, pretransplant use of temporary and durable mechanical circulatory support, rates of HT, and post-transplant survival. There were 15,629 patients who were listed for HT and included in this analysis; 7745 (2039 women, 26.3%) in the new and 7875 patients (2074 women, 26.3%) in the old allocation system. When compared with men in the new allocation system, women were more likely to have lower priority United Network for Organ Sharing status at time of transplant, and less likely to be supported by an intra-aortic balloon pump (27.1% vs 32.2%, P < .001), with no difference in the use of venoarterial extracorporeal membrane oxygenation (5.5% vs 6.3%, P = .28). Despite these findings, when transplantation was viewed in the context of risk for death or delisting, the cumulative incidence of transplant within 6 months of listing was higher in women than men in the new allocation system (62.4% vs 54.9%, P < .001) with no differences in post-transplant survival. When comparing women in the old with the new allocation system, the distance traveled for organ procurement was 187.5 ± 207.0 miles vs 272.8 ± 233.7 miles (P < .001).Although the use of temporary mechanical circulatory support in women remains lower than in men in the new allocation system, more women are being transplanted with comparable waitlist and post-transplant outcomes as men. Broader sharing may be making its greatest impact on improving transplant opportunities for women.

  View details for DOI 10.1016/j.cardfail.2022.03.354

  View details for PubMedID 35470056

• The Enabling Potential of Device Therapy for Heart Failure. Journal of cardiac failure Varshney, A. S., Butler, J., Vaduganathan, M. 2022; 28 (7): 1227-1229

  View details for DOI 10.1016/j.cardfail.2022.02.005

  View details for PubMedID 35172221

  View details for PubMedCentralID PMC9288530

• Epidemiology and Management of ST-Segment-Elevation Myocardial Infarction in Patients With COVID-19: A Report From the American Heart Association COVID-19 Cardiovascular Disease Registry. Journal of the American Heart Association Bhatt, A. S., Varshney, A. S., Goodrich, E. L., Gong, J., Ginder, C., Senman, B. C., Johnson, M., Butler, K., Woolley, A. E., de Lemos, J. A., Morrow, D. A., Bohula, E. A. 2022; 11 (9): e024451

  Abstract

  Background Early reports from the COVID-19 pandemic identified coronary thrombosis leading to ST-segment-elevation myocardial infarction (STEMI) as a complication of COVID-19 infection. However, the epidemiology of STEMI in patients with COVID-19 is not well characterized. We sought to determine the incidence, diagnostic and therapeutic approaches, and outcomes in STEMI patients hospitalized for COVID-19. Methods and Results Patients with data on presentation ECG and in-hospital myocardial infarction were identified from January 14, 2020 to November 30, 2020, from 105 sites participating in the American Heart Association COVID-19 Cardiovascular Disease Registry. Patient characteristics, resource use, and clinical outcomes were summarized and compared based on the presence or absence of STEMI. Among 15 621 COVID-19 hospitalizations, 54 (0.35%) patients experienced in-hospital STEMI. Among patients with STEMI, the majority (n=40, 74%) underwent transthoracic echocardiography, but only half (n=27, 50%) underwent coronary angiography. Half of all patients with COVID-19 and STEMI (n=27, 50%) did not undergo any form of primary reperfusion therapy. Rates of all-cause shock (47% versus 14%), cardiac arrest (22% versus 4.8%), new heart failure (17% versus 1.4%), and need for new renal replacement therapy (11% versus 4.3%) were multifold higher in patients with STEMI compared with those without STEMI (P<0.050 for all). Rates of in-hospital death were 41% in patients with STEMI, compared with 16% in those without STEMI (P<0.001). Conclusions STEMI in hospitalized patients with COVID-19 is rare but associated with poor in-hospital outcomes. Rates of coronary angiography and primary reperfusion were low in this population of patients with STEMI and COVID-19. Adaptations of systems of care to ensure timely contemporary treatment for this population are needed.

  View details for DOI 10.1161/JAHA.121.024451

  View details for PubMedID 35470683

  View details for PubMedCentralID PMC9238583

• Epidemiology of Acute Heart Failure in Critically Ill Patients With COVID-19: An Analysis From the Critical Care Cardiology Trials Network. Journal of cardiac failure Berg, D. D., Alviar, C. L., Bhatt, A. S., Baird-Zars, V. M., Barnett, C. F., Daniels, L. B., Defilippis, A. P., Fagundes, A., Katrapati, P., Kenigsberg, B. B., Guo, J., Keller, N., Lopes, M. S., Mody, A., Papolos, A. I., Phreaner, N., Sedighi, R., Sinha, S. S., Toomu, S., Varshney, A. S., Morrow, D. A., Bohula, E. A. 2022; 28 (4): 675-681

  Abstract

  Acute heart failure (HF) is an important complication of coronavirus disease 2019 (COVID-19) and has been hypothesized to relate to inflammatory activation.We evaluated consecutive intensive care unit (ICU) admissions for COVID-19 across 6 centers in the Critical Care Cardiology Trials Network, identifying patients with vs without acute HF. Acute HF was subclassified as de novo vs acute-on-chronic, based on the absence or presence of prior HF. Clinical features, biomarker profiles and outcomes were compared.Of 901 admissions to an ICU due to COVID-19, 80 (8.9%) had acute HF, including 18 (2.0%) with classic cardiogenic shock (CS) and 37 (4.1%) with vasodilatory CS. The majority (n = 45) were de novo HF presentations. Compared to patients without acute HF, those with acute HF had higher cardiac troponin and natriuretic peptide levels and similar inflammatory biomarkers; patients with de novo HF had the highest cardiac troponin levels. Notably, among patients critically ill with COVID-19, illness severity (median Sequential Organ Failure Assessment, 8 [IQR, 5-10] vs 6 [4-9]; P = 0.025) and mortality rates (43.8% vs 32.4%; P = 0.040) were modestly higher in patients with vs those without acute HF.Among patients critically ill with COVID-19, acute HF is distinguished more by biomarkers of myocardial injury and hemodynamic stress than by biomarkers of inflammation.

  View details for DOI 10.1016/j.cardfail.2021.12.020

  View details for PubMedID 35051622

  View details for PubMedCentralID PMC8762923

• Trends and Outcomes of Left Ventricular Assist Device Therapy: JACC Focus Seminar. Journal of the American College of Cardiology Varshney, A. S., DeFilippis, E. M., Cowger, J. A., Netuka, I., Pinney, S. P., Givertz, M. M. 2022; 79 (11): 1092-1107

  Abstract

  As the prevalence of advanced heart failure continues to rise, treatment strategies for select patients include heart transplantation or durable left ventricular assist device (LVAD) support, both of which improve quality of life and extend survival. Recently, the HeartMate 3 has been incorporated into clinical practice, the United Network for Organ Sharing donor heart allocation system was revised, and the management of LVAD-related complications has evolved. Contemporary LVAD recipients have greater preoperative illness severity, but survival is higher and adverse event rates are lower compared with prior eras. This is driven by advances in device design, patient selection, surgical techniques, and long-term management. However, bleeding, infection, neurologic events, and right ventricular failure continue to limit broader implementation of LVAD support. Ongoing efforts to optimize management of patients implanted with current devices and parallel development of next-generation devices are likely to further improve outcomes for patients with advanced heart failure.

  View details for DOI 10.1016/j.jacc.2022.01.017

  View details for PubMedID 35300822

• A Heart Team approach to contemporary device decision-making in heart failure. European journal of heart failure Varshney, A. S., Singh, J. P., Vaduganathan, M. 2022; 24 (3): 562-564

  View details for DOI 10.1002/ejhf.2445

  View details for PubMedID 35118780

  View details for PubMedCentralID PMC8986628

• Relationship Between Myocardial Injury During Index Hospitalization for SARS-CoV-2 Infection and Longer-Term Outcomes. Journal of the American Heart Association Weber, B., Siddiqi, H., Zhou, G., Vieira, J., Kim, A., Rutherford, H., Mitre, X., Feeley, M., Oganezova, K., Varshney, A. S., Bhatt, A. S., Nauffal, V., Atri, D. S., Blankstein, R., Karlson, E. W., Di Carli, M., Baden, L. R., Bhatt, D. L., Woolley, A. E. 2022; 11 (1): e022010

  Abstract

  Background Myocardial injury in patients with COVID-19 is associated with increased mortality during index hospitalization; however, the relationship to long-term sequelae of SARS-CoV-2 is unknown. This study assessed the relationship between myocardial injury (high-sensitivity cardiac troponin T level) during index hospitalization for COVID-19 and longer-term outcomes. Methods and Results This is a prospective cohort of patients who were hospitalized at a single center between March and May 2020 with SARS-CoV-2. Cardiac biomarkers were systematically collected. Outcomes were adjudicated and stratified on the basis of myocardial injury. The study cohort includes 483 patients who had high-sensitivity cardiac troponin T data during their index hospitalization. During index hospitalization, 91 (18.8%) died, 70 (14.4%) had thrombotic complications, and 126 (25.6%) had cardiovascular complications. By 12 months, 107 (22.2%) died. During index hospitalization, 301 (62.3%) had cardiac injury (high-sensitivity cardiac troponin T≧14 ng/L); these patients had 28.6%, 32.2%, and 33.2% mortality during index hospitalization, at 6 months, and at 12 months, respectively, compared with 4.1%, 4.9%, and 4.9% mortality for those with low-level positive troponin and 0%, 0%, and 0% for those with undetectable troponin. Of 392 (81.2%) patients who survived the index hospitalization, 94 (24%) had at least 1 readmission within 12 months, of whom 61 (65%) had myocardial injury during the index hospitalization. Of 377 (96%) patients who were alive and had follow-up after the index hospitalization, 211 (56%) patients had a documented, detailed clinical assessment at 6 months. A total of 78 of 211 (37.0%) had ongoing COVID-19-related symptoms; 34 of 211 (16.1%) had neurocognitive decline, 8 of 211 (3.8%) had increased supplemental oxygen requirements, and 42 of 211 (19.9%) had worsening functional status. Conclusions Myocardial injury during index hospitalization for COVID-19 was associated with increased mortality and may predict who are more likely to have postacute sequelae of COVID-19. Among patients who survived their index hospitalization, the incremental mortality through 12 months was low, even among troponin-positive patients.

  View details for DOI 10.1161/JAHA.121.022010

  View details for PubMedID 34970914

  View details for PubMedCentralID PMC9075193

• Epidemiology of Cardiogenic Shock in Hospitalized Adults With COVID-19: A Report From the American Heart Association COVID-19 Cardiovascular Disease Registry. Circulation. Heart failure Varshney, A. S., Omar, W. A., Goodrich, E. L., Bhatt, A. S., Wolley, A. E., Gong, J., Senman, B. C., Silva, D., Levangie, M. W., Berg, D. D., Yeh, R. W., de Lemos, J. A., Morrow, D. A., Kazi, D. S., Bohula, E. A. 2021; 14 (12): e008477

  View details for DOI 10.1161/CIRCHEARTFAILURE.121.008477

  View details for PubMedID 34789004

  View details for PubMedCentralID PMC8767943

• Contemporary Burden of Primary Versus Secondary Heart Failure Hospitalizations in the United States. The American journal of cardiology Varshney, A. S., Minhas, A. M., Bhatt, A. S., Ambrosy, A. P., Fudim, M., Vaduganathan, M. 2021; 156: 140-142

  View details for DOI 10.1016/j.amjcard.2021.06.036

  View details for PubMedID 34315568

  View details for PubMedCentralID PMC8750211

• Hospitalization of Patients With (But Not for) Heart Failure: An Opportunity for Accelerated Guideline-Directed Medical Therapy Optimization? Journal of cardiac failure Varshney, A. S., Bhatt, A. S., Vaduganathan, M. 2021; 27 (8): 910-912

  View details for DOI 10.1016/j.cardfail.2021.04.004

  View details for PubMedID 34364668

  View details for PubMedCentralID PMC8750052

• Virtual optimization of guideline-directed medical therapy in hospitalized patients with heart failure with reduced ejection fraction: the IMPLEMENT-HF pilot study. European journal of heart failure Bhatt, A. S., Varshney, A. S., Nekoui, M., Moscone, A., Cunningham, J. W., Jering, K. S., Patel, P. N., Sinnenberg, L. E., Bernier, T. D., Buckley, L. F., Cook, B. M., Dempsey, J., Kelly, J., Knowles, D. M., Lupi, K., Malloy, R., Matta, L. S., Rhoten, M. N., Sharma, K., Snyder, C. A., Ting, C., McElrath, E. E., Amato, M. G., Alobaidly, M., Ulbricht, C. E., Choudhry, N. K., Adler, D. S., Vaduganathan, M. 2021; 23 (7): 1191-1201

  Abstract

  Implementation of guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) remains incomplete. Non-cardiovascular hospitalization may present opportunities for GDMT optimization. We assessed the efficacy and durability of a virtual, multidisciplinary 'GDMT Team' on medical therapy prescription for HFrEF.Consecutive hospitalizations in patients with HFrEF (ejection fraction ≤40%) were prospectively identified from 3 February to 1 March 2020 (usual care group) and 2 March to 28 August 2020 (intervention group). Patients with critical illness, de novo heart failure, and systolic blood pressure <90 mmHg in the preceeding 24 hs prior to enrollment were excluded. In the intervention group, a pharmacist-physician GDMT Team provided optimization suggestions to treating teams based on an evidence-based algorithm. The primary outcome was a GDMT optimization score, the sum of positive (+1 for new initiations or up-titrations) and negative therapeutic changes (-1 for discontinuations or down-titrations) at hospital discharge. Serious in-hospital safety events were assessed. Among 278 consecutive encounters with HFrEF, 118 met eligibility criteria; 29 (25%) received usual care and 89 (75%) received the GDMT Team intervention. Among usual care encounters, there were no changes in GDMT prescription during hospitalization. In the intervention group, β-blocker (72% to 88%; P = 0.01), angiotensin receptor-neprilysin inhibitor (6% to 17%; P = 0.03), mineralocorticoid receptor antagonist (16% to 29%; P = 0.05), and triple therapy (9% to 26%; P < 0.01) prescriptions increased during hospitalization. After adjustment for clinically relevant covariates, the GDMT Team was associated with an increase in GDMT optimization score (+0.58; 95% confidence interval +0.09 to +1.07; P = 0.02). There were no serious in-hospital adverse events.Non-cardiovascular hospitalizations are a potentially safe and effective setting for GDMT optimization. A virtual GDMT Team was associated with improved heart failure therapeutic optimization. This implementation strategy warrants testing in a prospective randomized controlled trial.

  View details for DOI 10.1002/ejhf.2163

  View details for PubMedID 33768599

• Spatial relationships among hemodynamic, anatomic, and biochemical plaque characteristics in patients with coronary artery disease. Atherosclerosis Varshney, A. S., Coskun, A. U., Siasos, G., Maynard, C. C., Pu, Z., Croce, K. J., Cefalo, N. V., Cormier, M. A., Fotiadis, D., Stefanou, K., Papafaklis, M. I., Michalis, L., VanOosterhout, S., Mulder, A., Madder, R. D., Stone, P. H. 2021; 320: 98-104

  Abstract

  We aimed to characterize the spatial proximity of plaque destabilizing features local endothelial shear stress (ESS), minimal luminal area (MLA), plaque burden (PB), and near-infrared spectroscopy (NIRS) lipid signal in high- vs. low-risk plaques.Coronary arteries imaged with angiography and NIRS-intravascular ultrasound (IVUS) underwent 3D reconstruction and computational fluid dynamics calculations of local ESS. ESS, PB, MLA, and lipid core burden index (LCBI), for each 3-mm arterial segment were obtained in arteries with large lipid-rich plaque (LRP) vs. arteries with smaller LRP. The locations of the MLA, minimum ESS (minESS), maximum ESS (maxESS), maximum PB (maxPB), and maximum LCBI in a 4-mm segment (maxLCBI4mm) were determined along the length of each plaque.The spatial distributions of minESS, maxESS, maxPB, and maxLCBI4mm, in reference to the MLA, were significantly heterogeneous within and between each variable. The location of maxLCBI4mm was spatially discordant from sites of the MLA (p<0.0001), minESS (p = 0.003), and maxESS (p = 0.003) in arteries with large LRP (maxLCBI4mm ≥ 400) and non-large LRP. Large LRP arteries had higher maxESS (9.31 ± 4.78 vs. 6.32 ± 5.54 Pa; p = 0.023), lower minESS (0.41 ± 0.16 vs. 0.61 ± 0.26 Pa; p = 0.007), smaller MLA (3.54 ± 1.22 vs. 5.14 ± 2.65 mm2; p = 0.002), and larger maxPB (70.64 ± 9.95% vs. 56.70 ± 13.34%, p<0.001) compared with non-large LRP arteries.There is significant spatial heterogeneity of destabilizing plaque features along the course of both large and non-large LRPs. Large LRPs exhibit significantly more abnormal destabilizing plaque features than non-large LRPs. Prospective, longitudinal studies are required to determine which patterns of heterogeneous destabilizing features act synergistically to cause plaque destabilization.

  View details for DOI 10.1016/j.atherosclerosis.2020.12.018

  View details for PubMedID 33468315

  View details for PubMedCentralID PMC8783390

• Characteristics of clinical trials evaluating cardiovascular therapies for Coronavirus Disease 2019 Registered on ClinicalTrials.gov: a cross sectional analysis. American heart journal Varshney, A. S., Wang, D. E., Bhatt, A. S., Blood, A., Sharkawi, M. A., Siddiqi, H. K., Vaduganathan, M., Monteleone, P. P., Patel, M. R., Jones, W. S., Lopes, R. D., Mehra, M. R., Bhatt, D. L., Kochar, A. 2021; 232: 105-115

  Abstract

  Morbidity and mortality associated with COVID-19 has increased exponentially, and patients with cardiovascular (CV) disease are at risk for poor outcomes. Several lines of evidence suggest a potential role for CV therapies in COVID-19 treatment. Characteristics of clinical trials of CV therapies related to COVID-19 registered on ClinicalTrials.gov have not been described.ClinicalTrials.gov was queried on August 7, 2020 for COVID-19 related trials. Studies evaluating established CV drugs, other fibrinolytics (defibrotide), and extracorporeal membrane oxygenation were included. Studies evaluating anti-microbial, convalescent plasma, non-colchicine anti-inflammatory, and other therapies were excluded. Trial characteristics were tabulated from study-specific entries.A total of 2,935 studies related to COVID-19 were registered as of August 7, 2020. Of these, 1,645 were interventional studies, and the final analytic cohort consisted of 114 studies evaluating 10 CV therapeutic categories. Antithrombotics (32.5%; n = 37) were most commonly evaluated, followed by pulmonary vasodilators (14.0%; n = 16), renin-angiotensin-aldosterone system-related therapies (12.3%; n = 14), and colchicine (8.8%; n = 10). Trials evaluating multiple CV therapy categories and CV therapies in combination with non-CV therapies encompassed 4.4% (n = 5) and 9.6% (n = 11) of studies, respectively. Most studies were designed for randomized allocation (87.7%; n = 100), enrollment of less than 1000 participants (86.8%; n = 99), single site implementation (55.3%; n = 63), and had a primary outcome of mortality or a composite including mortality (56.1%; n = 64). Most study populations consisted of patients hospitalized with COVID-19 (81.6%; n = 93). At the time of database query, 28.9% (n = 33) of studies were not yet recruiting and the majority were estimated to be completed after December 2020 (67.8%; n = 78). Most lead sponsors were located in North America (43.9%; n = 50) or Europe (36.0%; n = 41).A minority (7%) of clinical trials related to COVID-19 registered on ClinicalTrials.gov plan to evaluate CV therapies. Of CV therapy studies, most were planned to be single center, enroll less than 1000 inpatients, sponsored by European or North American academic institutions, and estimated to complete after December 2020. Collectively, these findings underscore the need for a network of sites with a platform protocol for rapid evaluation of multiple therapies and generalizability to inform clinical care and health policy for COVID-19 moving forward.

  View details for DOI 10.1016/j.ahj.2020.10.065

  View details for PubMedID 33121978

  View details for PubMedCentralID PMC7586939

• Residual SYNTAX Score After Revascularization in Cardiogenic Shock: When Is Complete Complete? Journal of the American College of Cardiology Kochar, A., Varshney, A. S., Wang, D. E. 2021; 77 (2): 156-158

  View details for DOI 10.1016/j.jacc.2020.11.034

  View details for PubMedID 33446308

  View details for PubMedCentralID PMC8244621

• Recurrent bioprosthetic mitral valve thrombosis treated with anticoagulation. Echocardiography (Mount Kisco, N.Y.) Fernandes, R., Varshney, A. S., Aragam, J. 2020; 37 (12): 2134-2138

  Abstract

  Bioprosthetic valve thrombosis (BPVT) is more common than previously thought and likely underreported. BPVT can be accurately diagnosed with cardiac imaging and treated successfully with anticoagulation, thus preventing reoperation. We hereby report a case of recurrent BPVT in the mitral position successfully treated with anticoagulation along with review of literature.

  View details for DOI 10.1111/echo.14909

  View details for PubMedID 33111368

  View details for PubMedCentralID PMC8749813

• Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study. Circulation Schrage, B., Becher, P. M., Bernhardt, A., Bezerra, H., Blankenberg, S., Brunner, S., Colson, P., Cudemus Deseda, G., Dabboura, S., Eckner, D., Eden, M., Eitel, I., Frank, D., Frey, N., Funamoto, M., Goßling, A., Graf, T., Hagl, C., Kirchhof, P., Kupka, D., Landmesser, U., Lipinski, J., Lopes, M., Majunke, N., Maniuc, O., McGrath, D., Möbius-Winkler, S., Morrow, D. A., Mourad, M., Noel, C., Nordbeck, P., Orban, M., Pappalardo, F., Patel, S. M., Pauschinger, M., Pazzanese, V., Reichenspurner, H., Sandri, M., Schulze, P. C., H G Schwinger, R., Sinning, J. M., Aksoy, A., Skurk, C., Szczanowicz, L., Thiele, H., Tietz, F., Varshney, A., Wechsler, L., Westermann, D. 2020; 142 (22): 2095-2106

  Abstract

  Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality.Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort.Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; P=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%).In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

  View details for DOI 10.1161/CIRCULATIONAHA.120.048792

  View details for PubMedID 33032450

  View details for PubMedCentralID PMC7688081

• Outcomes in the 2018 UNOS donor heart allocation system: A perspective on disparate analyses. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation Varshney, A. S., Hirji, S. A., Givertz, M. M. 2020; 39 (11): 1191-1194

  Abstract

  The United Network for Organ Sharing (UNOS) implemented a revised donor heart allocation system on October 18, 2018 with principle aims to reduce waitlist mortality, enhance geographic organ sharing, and improve organ distribution equity. Five recently published analyses compared outcomes of heart transplant (HT) recipients transplanted under the revised versus previous system. All demonstrated increased pre-transplant temporary mechanical circulatory support use and graft ischemic times under the revised system. However, despite using data from the same UNOS Registry, three analyses demonstrated increased risk of post-transplant mortality under the revised system, while two others found no significant difference in mortality risk. These studies differed in their analytic cohorts, study periods, follow-up duration, and statistical methodologies. Additionally, some may have introduced survivor bias or violated non-informative censoring. Given these variable findings, longer-term outcome assessment is warranted before the HT community can truly understand the impact of the 2018 UNOS system revision on post-transplant outcomes.

  View details for DOI 10.1016/j.healun.2020.08.012

  View details for PubMedID 32950380

  View details for PubMedCentralID PMC8248277

• A Heart Murmur Is Discovered on an Oncology Ward: Extramedullary Acute Myeloid Leukemia. The American journal of medicine Abboud, A., Zamalloa, J. R., Sellars, M., Garza-Mayers, A. C., Varshney, A. S., Osborne, M. T., Chen, Y. E., McAfee, S., DeFilipp, Z. 2020; 133 (9): e457-e459

  View details for DOI 10.1016/j.amjmed.2019.12.034

  View details for PubMedID 32001226

  View details for PubMedCentralID PMC7811184

• Fewer Hospitalizations for Acute Cardiovascular Conditions During the COVID-19 Pandemic. Journal of the American College of Cardiology Bhatt, A. S., Moscone, A., McElrath, E. E., Varshney, A. S., Claggett, B. L., Bhatt, D. L., Januzzi, J. L., Butler, J., Adler, D. S., Solomon, S. D., Vaduganathan, M. 2020; 76 (3): 280-288

  Abstract

  Although patients with cardiovascular disease face excess risks of severe illness with coronavirus disease-2019 (COVID-19), there may be indirect consequences of the pandemic on this high-risk patient segment.This study sought to examine longitudinal trends in hospitalizations for acute cardiovascular conditions across a tertiary care health system.Acute cardiovascular hospitalizations were tracked between January 1, 2019, and March 31, 2020. Daily hospitalization rates were estimated using negative binomial models. Temporal trends in hospitalization rates were compared across the first 3 months of 2020, with the first 3 months of 2019 as a reference.From January 1, 2019, to March 31, 2020, 6,083 patients experienced 7,187 hospitalizations for primary acute cardiovascular reasons. There were 43.4% (95% confidence interval [CI]: 27.4% to 56.0%) fewer estimated daily hospitalizations in March 2020 compared with March 2019 (p < 0.001). The daily rate of hospitalizations did not change throughout 2019 (-0.01% per day [95% CI: -0.04% to +0.02%]; p = 0.50), January 2020 (-0.5% per day [95% CI: -1.6% to +0.5%]; p = 0.31), or February 2020 (+0.7% per day [95% CI: -0.6% to +2.0%]; p = 0.27). There was significant daily decline in hospitalizations in March 2020 (-5.9% per day [95% CI: -7.6% to -4.3%]; p < 0.001). Length of stay was shorter (4.8 days [25th to 75th percentiles: 2.4 to 8.3 days] vs. 6.0 days [25th to 75th percentiles: 3.1 to 9.6 days]; p = 0.003) and in-hospital mortality was not significantly different (6.2% vs. 4.4%; p = 0.30) in March 2020 compared with March 2019.During the first phase of the COVID-19 pandemic, there was a marked decline in acute cardiovascular hospitalizations, and patients who were admitted had shorter lengths of stay. These data substantiate concerns that acute care of cardiovascular conditions may be delayed, deferred, or abbreviated during the COVID-19 pandemic.

  View details for DOI 10.1016/j.jacc.2020.05.038

  View details for PubMedID 32470516

  View details for PubMedCentralID PMC7250561

• Watching for Disease: the Changing Paradigm of Disease Screening in the Age of Consumer Health Devices. Journal of general internal medicine Varshney, A. S., Madias, C., Kakkar, R., Martin, D. T. 2020; 35 (7): 2173-2175

  Abstract

  There has been a recent proliferation of consumer health devices (CHDs) that enable user-initiated screening for a variety of diseases. These devices represent a paradigm shift in the deployment of disease screening, a process that has historically been led by clinicians following the guidance of professional bodies. The detection of AF via CHDs is a contemporary example of this phenomenon and highlights several important implications of the shift of disease screening from clinicians to CHD users. These include responsibility for patient data and outcomes, healthcare costs and access, and an evolution of the patient-provider relationship. However, as CHD technologies mature and become more affordable, they have the potential to detect actionable subclinical disease and improve health. Rather than allow CHDs to enter the marketplace organically with the potential for unintended negative consequences, it is critical that clinical, research, and industry communities proactively collaborate and establish best practices for their use.

  View details for DOI 10.1007/s11606-019-05626-y

  View details for PubMedID 31942673

  View details for PubMedCentralID PMC7352046

• The Early Bird Catches the Worm: Should Severe LVH Be an Indication for Early TAVR? JACC. Cardiovascular interventions Bhatt, D. L., Varshney, A. S. 2020; 13 (11): 1340-1342

  View details for DOI 10.1016/j.jcin.2020.03.019

  View details for PubMedID 32499025

  View details for PubMedCentralID PMC8244622

• Use of Temporary Mechanical Circulatory Support for Management of Cardiogenic Shock Before and After the United Network for Organ Sharing Donor Heart Allocation System Changes. JAMA cardiology Varshney, A. S., Berg, D. D., Katz, J. N., Baird-Zars, V. M., Bohula, E. A., Carnicelli, A. P., Chaudhry, S., Guo, J., Lawler, P. R., Nativi-Nicolau, J., Sinha, S. S., Teuteberg, J. J., van Diepen, S., Morrow, D. A., Critical Care Cardiology Trials Network Investigators 2020

  Abstract

  Importance: The new United Network for Organ Sharing (UNOS) donor heart allocation system gives priority to patients supported with nondischargeable mechanical circulatory support (MCS) devices while awaiting heart transplant. Whether there has been a change in temporary MCS use in cardiac intensive care units (CICUs) since the implementation of this policy is unknown.Objectives: To examine whether the UNOS donor heart allocation system revision in October 2018 was associated with changes in temporary MCS use in CICUs and whether temporary MCS use differed between US transplant centers and US nontransplant centers and Canadian centers.Design, Setting, and Participants: In this cohort study, 14 centers from the Critical Care Cardiology Trials Network (CCCTN), a multicenter network of tertiary CICUs in North America, contributed 2-month snapshots of consecutive medical CICU admissions between September 1, 2017, and September 1, 2018 (prerevision period), and October 1, 2018, and September 1, 2019 (postrevision period). CICUs were classified as US transplant centers (n=7) or other CICUs (US nontransplant centers or Canadian centers; n=7).Exposure: Revision to the UNOS donor heart allocation system.Main Outcomes and Measures: Treatment with temporary MCS (intra-aortic balloon pump, microaxial intracardiac ventricular assist device, percutaneous centrifugal ventricular assist device, venoarterial extracorporeal membrane oxygenation, or surgically implanted, nondischargeable MCS device) during hospital admission.Results: A total of 384 admissions for acute, decompensated, heart failure-related cardiogenic shock (ADHF-CS) were included, among which 248 (64.6%) were to US transplant centers; 126 admissions (51%) were in the prerevision period and 122 (49%) were in the postrevision period. The mean (SD) patient age was 61.2 (14.6) years; 246 patients (64.1%) were male. The proportion of admissions with ADHF-CS managed with temporary MCS at US transplant centers significantly increased from 25.4% (32 of 126 admissions) before to 42.6% (52 of 122 admissions) after the UNOS allocation system changes (P=.004). In other CICUs, the proportion did not significantly change (24.5% [13 of 53 admissions] to 24.1% [20 of 83 admissions]; P=.95). After multivariable adjustment, patients admitted to US transplant centers in the postrevision period were more likely to receive temporary MCS compared with those admitted in the prerevision period (adjusted odds ratio, 2.19; 95% CI, 1.13-4.24; P=.02).Conclusions and Relevance: In the year after implementation of the new UNOS donor heart allocation system, temporary MCS use in patients admitted with ADHF-CS increased in US transplant centers but not in other CICUs. Whether this shift in practice will affect outcomes of patients with ADHF-CS or organ distribution should be evaluated.

  View details for DOI 10.1001/jamacardio.2020.0692

  View details for PubMedID 32293644

• Expanding the Scope of Multimodality Imaging in Durable Mechanical Circulatory Support. JACC. Cardiovascular imaging Almarzooq, Z. I., Varshney, A. S., Vaduganathan, M., Pareek, M., Stewart, G. C., Estep, J. D., Mehra, M. R. 2020; 13 (4): 1069-1081

  Abstract

  An increasing number of patients transition to advanced-stage heart failure refractory to medical therapy. Left ventricular assist systems (LVAS) provide a bridge to candidates awaiting heart transplantation and extended device durability allows permanent implantation referred to as destination therapy. Noninvasive imaging plays a pivotal role in the optimal management of patients implanted with durable mechanical circulatory support (MCS) devices. Several advances require an updated perspective of multi-modality imaging in contemporary LVAS management. First, there has been substantial evolution of devices such as the introduction of the fully magnetically levitated HeartMate 3 pump (Abbott, Abbott Park, Illinois). Second, imaging beyond the device, of the peripheral system, is increasingly recognized as clinically relevant. Third, U.S. Food and Drug Administration recalls have called attention to LVAS complications beyond pump thrombosis that are amenable to imaging-based diagnosis. Fourth, there is increased availability of multimodality imaging, such as computed tomography and positron emission tomography, at many centers across the world. In this review, the authors provide a practical and contemporary approach to multi-modality imaging of current-generation durable MCS devices. As the use of LVAS and other novel MCS devices increases globally, it is critical for clinicians caring for LVAS patients to understand the roles of various imaging modalities in patient evaluation and management.

  View details for DOI 10.1016/j.jcmg.2019.05.035

  View details for PubMedID 31542528

  View details for PubMedCentralID PMC8244625

• Risk stratification of coronary plaques using physiologic characteristics by CCTA: Focus on shear stress. Journal of cardiovascular computed tomography Samady, H., Molony, D. S., Coskun, A. U., Varshney, A. S., De Bruyne, B., Stone, P. H. 2019; 14 (5): 386-393

  Abstract

  The identification of factors determining whether a lesion progresses, destabilizes or becomes quiescent remains a challenge. Wall or endothelial shear stress (WSS or ESS, respectively), the frictional force acting on the lumen wall, is strongly associated with changes in the natural history of lesions. Several clinical intravascular imaging studies have shown a clear link between disturbed flow, typically characterized by low WSS, and plaque growth. In support of these studies, in-vitro experiments of shear stress have identified several mechanisms promoting atherosclerosis. More recently, the relationship between WSS and major adverse cardiac events has been explored. Improvements in coronary computed tomography angiography (CCTA) image resolution and quality has allowed for the calculation of WSS from CT. In this review, we provide an introduction to WSS, highlight important human and animal intravascular-based WSS studies, and discuss CT-based WSS studies to date. Finally, we discuss future directions of CCTA and WSS computation.

  View details for DOI 10.1016/j.jcct.2019.11.012

  View details for PubMedID 31870744

  View details for PubMedCentralID PMC8749833

• What was old is new again: learning from the modern master clinician. The clinical teacher Varshney, A., Braun, D. A., Patel, A. B., Yialamas, M. A. 2019; 16 (3): 274-276

  View details for DOI 10.1111/tct.12919

  View details for PubMedID 30125460

• Left Ventricular Hypertrophy Does Not Affect 1-Year Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC. Cardiovascular interventions Varshney, A. S., Manandhar, P., Vemulapalli, S., Kirtane, A. J., Mathew, V., Shah, B., Lowenstern, A., Kosinski, A. S., Kaneko, T., Thourani, V. H., Bhatt, D. L. 2019; 12 (4): 373-382

  Abstract

  The aim of this study was to evaluate the association between pre-procedural left ventricular hypertrophy (LVH) patterns and clinical outcomes after transcatheter aortic valve replacement (TAVR).The association between pre-procedural LVH pattern and severity and clinical outcomes after TAVR is uncertain.Patients (n = 31,199) across 422 sites who underwent TAVR from November 2011 through June 2016 as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapies) Registry linked with the Centers for Medicare and Medicaid Services database were evaluated by varying LVH patterns, according to sex-specific cutoffs for left ventricular mass index and relative wall thickness. The association between LVH pattern (concentric remodeling, concentric LVH, and eccentric LVH) and outcomes (rates of mortality, myocardial infarction [MI], stroke, new dialysis requirement) at 1-year follow-up were evaluated using multivariate hazard models.There were no significant associations between concentric remodeling (death: adjusted hazard ratio [HR]: 1.03; 95% confidence interval [CI]: 0.93 to 1.15; MI: HR: 1.05; 95% CI: 0.76 to 1.46; stroke: HR: 1.11; 95% CI: 0.89 to 1.39; new dialysis: HR: 0.86; 95% CI: 0.64 to 1.15), concentric LVH (death: HR: 1.04; 95% CI: 0.95 to 1.15; MI: HR: 1.12; 95% CI: 0.82 to 1.52; stroke: HR: 1.14; 95% CI: 0.92 to 1.40; new dialysis: HR: 1.17; 95% CI: 0.90 to 1.52), or eccentric LVH (death: HR: 0.98; 95% CI: 0.87 to 1.10; MI: HR: 1.07; 95% CI: 0.71 to 1.63; stroke: HR: 1.01; 95% CI: 0.78 to 1.32; new dialysis: HR: 1.25; 95% CI: 0.92 to 1.70) and outcomes at 1 year compared with patients without LVH.In a contemporary cohort of patients who underwent TAVR, pre-procedural LVH according to left ventricular mass index and relative wall thickness was not associated with adverse outcomes at 1-year follow-up. TAVR is likely to benefit patients with severe aortic stenosis regardless of the presence of LVH.

  View details for DOI 10.1016/j.jcin.2018.11.013

  View details for PubMedID 30784643

  View details for PubMedCentralID PMC6822896

• Role of local coronary blood flow patterns and shear stress on the development of microvascular and epicardial endothelial dysfunction and coronary plaque. Current opinion in cardiology Siasos, G., Tsigkou, V., Zaromytidou, M., Sara, J. D., Varshney, A., Coskun, A. U., Lerman, A., Stone, P. H. 2018; 33 (6): 638-644

  Abstract

  The natural history of coronary atherosclerosis is complex and atherosclerotic plaques exhibit large morphologic and functional variability within the same individual as well as over time. The purpose of this article is to review the role of blood flow patterns and shear stress on the development of microvascular and epicardial endothelial dysfunction and atherosclerosis progression.Recent breakthroughs in cardiovascular imaging have facilitated in-vivo characterization of the anatomic and functional characteristics of atherosclerotic plaques and have highlighted the role of endothelial shear stress and epicardial and microvascular endothelial dysfunction in the natural history of coronary atherosclerosis.There is an important need to identify individual lesions which may progress to vulnerable plaque in order to provide early therapeutic management. Evaluation of endothelial shear stress, local blood flow patterns, epicardial and microvascular endothelial dysfunction, as well as their complex associations might indicate those patients who have microvascular endothelial dysfunction and increased risk for upstream epicardial endothelial dysfunction and plaque progression. Such high-risk patients could potentially be targeted for more intensive therapeutic strategies to prevent the progression of both microvascular and epicardial atherosclerotic manifestations.

  View details for DOI 10.1097/HCO.0000000000000571

  View details for PubMedID 30303854

• The Simplest Explanation: Pancytopenia. The American journal of medicine Varshney, A., Barkoudah, E. 2018; 131 (9): 1052-1054

  View details for DOI 10.1016/j.amjmed.2018.03.017

  View details for PubMedID 29649461

• Impact of Antithrombotic Regimen on Mortality, Ischemic, and Bleeding Outcomes after Transcatheter Aortic Valve Replacement. Cardiology and therapy Varshney, A., Watson, R. A., Noll, A., Im, K., Rossi, J., Shah, P., Giugliano, R. P. 2018; 7 (1): 71-77

  Abstract

  Optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains unclear. We evaluated the association between antithrombotic regimens and outcomes in TAVR patients.We retrospectively analyzed consecutive patients who underwent TAVR at a single academic center from April 2009 to March 2014. Antithrombotic regimens were classified as single or dual antiplatelet therapy (AP), single antiplatelet plus anticoagulant (SAC), or triple therapy (TT). The primary endpoint was a composite of death, myocardial infarction (MI), stroke, and major bleeding. Adjusted hazard ratios (HRs) were obtained with best subset variable selection methods using bootstrap resampling.Of 246 patients who underwent TAVR, 241 were eligible for analysis with 133, 88, and 20 patients in the AP, SAC, and TT groups, respectively. During a median 2.1-year follow-up, 53.5% had at least one endpoint-the most common was death (68%), followed by major bleeding (23%), stroke (6%), and MI (3%). At 2 years, the composite outcome occurred in 70% of TT, 42% of SAC, and 31% of AP patients. Compared to AP, adjusted HRs for the composite outcome were 2.88 [95% Confidence intervals (CI) (1.61-5.16); p = 0.0004] and 1.66 (95% CI [1.13-2.42]; p = 0.009) in the TT and SAC groups, respectively. Mortality rates at 2 years were 61% in the TT, 32% in the SAC, and 26% in the AP groups (p = 0.005).The risk of the composite outcome of death, MI, stroke, or major bleeding at 2-year follow-up was significantly higher in TAVR patients treated with TT or SAC versus AP, even after multivariate adjustment.

  View details for DOI 10.1007/s40119-018-0111-4

  View details for PubMedID 29779200

  View details for PubMedCentralID PMC5986676

• Examining the applicability of SPRINT in patients with subclinical or established atherothrombotic disease: A REACH registry analysis. International journal of cardiology Varshney, A., Steg, P. G., Elbez, Y., Sorbets, E., Eagle, K. A., Bhatt, D. L. 2017; 243: 95-97

  Abstract

  The optimal blood pressure (BP) target to reduce the risk of cardiovascular (CV) events remains uncertain, especially in patients with coronary artery disease (CAD). Results from the Systolic Blood Pressure Intervention Trial (SPRINT) suggest that targeting a systolic BP<120mmHg decreases the rate of death and CV events in patients with hypertension and increased CV risk. We sought to evaluate the real-world applicability of SPRINT to patients with atherothrombosis.We divided 35,411 hypertensive patients from the REACH registry into SPRINT-eligible and SPRINT-ineligible based on the trial's inclusion and exclusion criteria. We also determined the mean BP and the percentage of patients who had a systolic BP<120mmHg in each group.A total of 11,993 (33.9%) patients were SPRINT-eligible, and 23,418 (66.1%) were SPRINT-ineligible. The most common reason for SPRINT ineligibility was diabetes mellitus (64.7%). Average BP was similar in both groups (139/79mmHg in SPRINT-eligible patients versus 140/79mmHg in SPRINT-ineligible patients). A total of 10.7% of SPRINT-eligible patients and 10.6% of SPRINT-ineligible patients had a systolic BP<120mmHg.Overall, these results indicate that in a large, global registry, most patients with atherothrombosis would not have been eligible for SPRINT and were rarely being treated to a systolic BP<120mmHg. Further dedicated investigation is warranted to determine the optimal BP target in this vulnerable patient population.

  View details for DOI 10.1016/j.ijcard.2017.05.104

  View details for PubMedID 28602550

• Biological Mesh Implants for Abdominal Hernia Repair: US Food and Drug Administration Approval Process and Systematic Review of Its Efficacy. JAMA surgery Huerta, S., Varshney, A., Patel, P. M., Mayo, H. G., Livingston, E. H. 2016; 151 (4): 374-81

  Abstract

  Expensive biological mesh materials are increasingly used to reinforce abdominal wall hernia repairs. The clinical and cost benefit of these materials are unknown.To review the published evidence on the use of biological mesh materials and to examine the US Food and Drug Administration (FDA) approval history for these devices.Search of multiple electronic databases (Ovid, MEDLINE, EMBASE, Cochrane Systematic Reviews, Cochrane Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Cochrane National Health Service Economic Evaluation Database) to identify articles published between 1948 and June 30, 2015, on the use of biological mesh materials used to reinforce abdominal wall hernia repair. Keywords searched included surgical mesh, abdominal hernia, recurrence, infection, fistula, bioprosthesis, biocompatible materials, absorbable implants, dermis, and collagen. The FDA online database for 510(k) clearances was reviewed for all commercially available biological mesh materials. The median national price for mesh materials was established by a benchmarking query through several Integrated Delivery Network and Group Purchasing Organization tools.Of 274 screened articles, 20 met the search criteria. Most were case series that reported results of convenience samples of patients at single institutions with a variety of clinical problems. Only 3 of the 20 were comparative studies. There were no randomized clinical trials. In total, outcomes for 1033 patients were described. Studies varied widely in follow-up time, operative technique, meshes used, and patient selection criteria. Reported outcomes and clinical outcomes, such as fistula formation and infection, were inconsistently reported across studies. Conflicts of interest were not reported in 16 of the 20 studies. Recurrence rates ranged from 0% to 80%. All biological mesh devices were approved by the FDA based on substantial equivalence to a group of nonbiological predicate devices that, on average, were one-third less costly.There is insufficient evidence to determine the extra costs associated with or the clinical efficacy of biological mesh materials for the repair of abdominal wall hernia.

  View details for DOI 10.1001/jamasurg.2015.5234

  View details for PubMedID 26819222