Dr. Anubodh Sunny Varshney is an Advanced Heart Failure, Transplant Cardiology, and Mechanical Circulatory Support Fellow at Stanford University. Sunny engages in outcomes and epidemiology research related to cardiogenic shock, mechanical circulatory support, advanced heart failure, and the interactions between drug and device therapies in patients with heart failure. He earned a BS in biomedical engineering (cum laude) at Washington University in St. Louis and MD from The University of Texas Southwestern Medical School, where he graduated 1st in his class. He completed residency in Internal Medicine and fellowship in Cardiovascular Medicine at Brigham & Women's Hospital/Harvard Medical School, including an NIH T32 research fellowship and a year as the Daniel Pierce Family Fellow in Advanced Heart Disease.
Sunny also has experience advising multiple medical device, drug, and digital health start-ups and currently serves as an Advisor to Broadview Ventures, a philanthropically-funded venture fund that invests in early-stage companies developing drug and device therapies that have the potential to change standard of care for patients with cardiovascular disease, cardiovascular risk factors, or stroke.
After fellowship, Sunny plans to pursue a career as a clinical advanced heart failure cardiologist, outcomes researcher, and venture advisor. He intends to combine insights from clinical care and outcomes research to identify persistent unmet medical needs, define benchmark outcomes that next generation technologies should improve upon, and identify target populations for early-stage studies of novel drug and device therapies for patients with heart failure.
- Heart Failure
- Advanced Heart Failure
- Cardiogenic Shock
- Mechanical Circulatory Support
- Critical Care Cardiology
- Heart Transplantation
- Structural Heart Disease
Member (Postdoc), Cardiovascular Institute
Honors & Awards
Charles L. Feldman, Sc.D. Research Scholar Award, Brigham and Women’s Hospital Vascular Profiling Laboratory (2018)
Resident Mentor Award, Brigham and Women’s Hospital Department of Medicine (2017)
Martin P. Solomon Primary Care Scholarship Award, Brigham and Women’s Hospital Department of Medicine (2016)
Hemphill-Gojer Award in Internal Medicine, University of Texas Southwestern Medical School (2014)
Boards, Advisory Committees, Professional Organizations
Advisor, Broadview Ventures (2017 - Present)
Advisor, Texas Health Catalyst at UT Austin Dell Medical School (2021 - Present)
Fellowship, Brigham and Women's Hospital / Harvard Medical School, Cardiovascular Medicine (2022)
Residency, Brigham and Women's Hospital / Harvard Medical School, Internal Medicine (2017)
MD, University of Texas Southwestern Medical School, Medicine (2014)
BS, Washington University in St. Louis, Biomedical Engineering (2010)
Virtual Care Team-Guided Therapeutic Optimization During Hospitalization in Patients with Heart Failure: The IMPLEMENT-HF Study.
Journal of the American College of Cardiology
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
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
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.
2022; 1 (5): 100156
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
2022; 28 (7): 1149-1157
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
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
2022; 11 (9): e024451
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
2022; 28 (4): 675-681
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
2022; 79 (11): 1092-1107
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
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
2022; 11 (1): e022010
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
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
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
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
2021; 23 (7): 1191-1201
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.
2021; 320: 98-104
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
2021; 232: 105-115
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
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.)
2020; 37 (12): 2134-2138
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.
2020; 142 (22): 2095-2106
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
2020; 39 (11): 1191-1194
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
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
2020; 76 (3): 280-288
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
2020; 35 (7): 2173-2175
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
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.
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
2020; 13 (4): 1069-1081
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
2019; 14 (5): 386-393
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
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
2019; 12 (4): 373-382
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
2018; 33 (6): 638-644
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
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
2018; 7 (1): 71-77
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
2017; 243: 95-97
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.
2016; 151 (4): 374-81
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