Cardiology

Généreux, P., Piazza, N., Alu, M.C., Nazif, T., Hahn, R.T., Pibarot, P., Bax, J.J., Leipsic, J.A., Blanke, P., Blackstone, E.H., Finn, M.T., Kapadia, S., Linke, A., Mack, M.J., Makkar, R., Mehran, R., Popma, J.J., Reardon, M., Rodes-Cabau, J., Van Mieghem, N.M., Webb, J.G., Cohen, D.J. and Leon, M.B. (2021). “Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research.” J Am Coll Cardiol.

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AIMS: The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research. METHODS AND RESULTS: Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs. CONCLUSIONS: Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.

Chikwe, J., O’Gara, P., Fremes, S., Sundt, T., Habib, R.H., Gammie, J., Gaudino, M., Badhwar, V., Gillinov, M., Acker, M., Rowe, G., Gill, G., Goldstone, A.B., Schwann, T., Gelijns, A., Trento, A., Mack, M. and Adams, D.H. (2021). “Mitral Surgery after Transcatheter Edge-to-Edge Repair: Society of Thoracic Surgeons Database Analysis.” J Am Coll Cardiol.

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BACKGROUND: Transcatheter edge-to-edge (TEER) mitral repair may be complicated by residual or recurrent mitral regurgitation. Increasing need for surgical reintervention has been reported but operative outcomes are ill-defined. OBJECTIVES: This study evaluated national outcomes of mitral surgery after TEER. METHODS: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was used to identify 524 adults who underwent mitral surgery after TEER between July 2014 and June 2020. Emergencies (5.0%, n=26), previous mitral surgery (5.3%, n=28) or open implantation of transcatheter prostheses (1.5%, n=8) were excluded. The primary outcome was 30-day or in-hospital mortality. RESULTS: In the study cohort of 463 patients median age was 76 years (interquartile range (IQR) 67-81 years), median left ventricular ejection fraction 57% (IQR 48-62%), and 177 (38.2%) patients had degenerative disease. Major concomitant cardiac surgery was performed in 137 (29.4%) patients: in patients undergoing isolated mitral surgery median STS predicted mortality was 6.5% (IQR 3.9-10.5%), observed mortality was 10.2% (n=23/225) and the ratio of observed to expected mortality was 1.2 (95% CI 0.8-1.9). Predictors of mortality included urgent surgery (odds ratio (OR) 2.4, 95% confidence interval (CI) 1.3-4.6), non-degenerative / unknown etiology (OR 2.2, 95% CI 1.1-4.5), creatinine >2.0mg/dl (OR 3.8, 95% CI 1.9-7.9) and age >80 (OR 2.1, 95% CI 1.1-4.4). In a volume outcomes analysis in an expanded cohort of 591 patients at 227 hospitals, operative mortality was 2.6% (n=2/76) in 4 centers that performed >10 cases versus 12.4% (n= 64/515) in centers performing fewer (p=0.01). The surgical repair rate after failed TEER was 4.8% (n=22), and 6.8% (n=12) in degenerative disease. CONCLUSION: This study indicates mitral repair is infrequently achieved after failed TEER, which may have implications for treatment choice in lower-risk and younger patients with degenerative disease. These findings should inform patient consent for TEER, clinical trial design and clinical performance measures.

Hoffman, M.E., Hamandi, M., Lanfear, A.T. and Shutze, W. (2021). “Rare Etiology of Ischemic Steal Syndrome in the Left Peroneal Artery.” Ann Vasc Surg.

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Ischemic steal syndrome (ISS) secondary to an arteriovenous fistula (AVF) in the lower extremity (LE) is a rare occurrence. Herein, we report a case of symptomatic ISS in an adult male due to an iatrogenic AVF in the left LE, which was surgically repaired by placing an arterial stent across the acquired AVF of the peroneal artery to the peroneal vein.

Hamandi, M., Lanfear, A.T., Squiers, J.J., George, T., Harrington, K., Szerlip, M.A., DiMaio, J.M. and Smith, R.L. (2021). “Double-Valve Replacement in Patients With Mitral Annular Calcification and Aortic Stenosis.” Ann Thorac Surg 111(5): e311-e313.

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Mitral annular calcification (MAC) is a degenerative process of the fibrous structure of the mitral valve. Surgical mitral valve replacement in the presence of MAC is technically challenging because of a high calcium burden and is associated with prohibitive operative mortality. There is no standard management strategy for patients with severe aortic stenosis and severe mitral valve disease with MAC. We report a case series of 3 patients who underwent concomitant surgical, transatrial implantation of a transcatheter heart valve in the mitral position and transcatheter aortic valve replacement.

Mehra, M.R., Cleveland, J.C., Jr., Uriel, N., Cowger, J.A., Hall, S., Horstmanshof, D., Naka, Y., Salerno, C.T., Chuang, J., Williams, C. and Goldstein, D.J. (2021). “Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants.” Eur J Heart Fail.

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AIM: The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal-flow pump, over the HeartMate II axial-flow pump. We now evaluate HM3 LVAD outcomes in a single-arm prospective continuous access protocol (CAP) post-pivotal trial study. METHODS AND RESULTS: We enrolled 2200 HM3 implanted patients (515 pivotal trial and 1685 CAP patients) and compared outcomes including survival free of disabling stroke or reoperation to replace or remove a malfunctioning device (primary composite endpoint), overall survival and major adverse events at 2 years. The 2-year primary endpoint [76.7% vs. 74.8%; adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.71-1.08, P = 0.21] and overall survival (81.2% vs. 79.0%) were similar among CAP and pivotal cohorts despite sicker patients (more intra-aortic balloon pump use and INTERMACS profile 1) in CAP who were more often intended for destination therapy. Survival was similar between the CAP and pivotal trial in transplant ineligible patients (79.1% vs. 76.7%; adjusted HR 0.89, 95% CI 0.68-1.16, P = 0.38). In a pooled analysis, the 2-year primary endpoint was similar between INTERMACS profiles 1-2 (‘unstable’ advanced heart failure), profile 3 (‘stable’ on inotropic therapy), and profiles 4-7 (‘stable’ ambulatory advanced heart failure) (75.7% vs. 77.6% vs. 72.9%, respectively). The net burden of adverse events was lower in CAP (adjusted rate ratio 0.93, 95% CI 0.88-0.98, P = 0.006), with consequent decrease in hospitalization. CONCLUSIONS: The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.