Transcatheter mitral valve repair for functional mitral regurgitation: Evaluating the evidence

• Type of Material: Article
• Authors: Annetine C Gelijns, Icahn School of Medicine at Mount Sinai; Alan J Moskowitz, Icahn School of Medicine at Mount Sinai; Patrick T O'Gara, Brigham and Women's Hospital; Gennaro Giustino, Icahn School of Medicine at Mount Sinai; Michael J Mack, Baylor Research Institute; Donna M Mancini, Icahn School of Medicine at Mount Sinai; Emilia Bagiella, Icahn School of Medicine at Mount Sinai; Judy Hung, Massachusetts General Hospital; Gorav Ailawadi, University of Virginia; Martin B Leon, Columbia University Irving Medical Center; Michael A Acker, University of Pennsylvania Perelman School of Medicine; John H Alexander, Duke Clinical Research Institute; Neal Dickert, Emory University; Wendy C Taddei-Peters, National Heart, Lung, and Blood Institute (NHLBI); Marissa A Miller, National Heart, Lung, and Blood Institute (NHLBI)
• Language: English
• Date: 2021-11-01
• Publisher: Elsevier Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2020 Published by Elsevier Inc. on behalf of The American Association for Thoracic Surgery
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.jtcvs.2020.02.132
• Title of Journal or Parent Work: Journal of Thoracic and Cardiovascular Surgery
• Volume: 162
• Issue: 5
• Start Page: 1504
• End Page: 1511
• Grant/Funding Information: The CTSN is supported by a cooperative agreement (U01 HL088942) funded by the National Heart, Lung, and Blood Institute. The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung and Blood Institute, the National Institutes of Health, or the US Department of Health and Human Services.
• Keywords: Treatment Outcome; Registries; Risk Factors; Humans; Cardiac Catheterization; Heart Valve Prosthesis; Evidence-Based Medicine; Mitral Valve Insufficiency; randomized trial; Clinical Trials as Topic; mitral valve; Hemodynamics; Postoperative Complications; Recovery of Function; transcatheter mitral valve repair; functional mitral regurgitation; Mitral Valve; Heart Valve Prosthesis Implantation

Abstract

Objectives: Two trials (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation Trial and Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation Trial) were published in 2018 evaluating the effectiveness and safety of transcatheter repair for patients with heart failure with significant functional mitral regurgitation, which yielded different results. This article reviews the strength of the evidence, differences in trial designs, ethical and implementation implications, and delineates future research needs to help guide the appropriate dissemination of transcatheter repair for functional patients with mitral regurgitation. Methods: The National Heart, Lung, and Blood Institute convened a workshop of interdisciplinary experts to address these objectives. Results: Transcatheter repair of functional mitral regurgitation can provide significant benefits in terms of heart failure hospitalizations, survival, and quality of life when appropriate heart failure candidates with moderate to severe or severe mitral regurgitation while on optimal guideline-directed medical therapy can be identified. Key ingredients for success are preoperative evaluation and management and postoperative care by an interdisciplinary heart team. Conclusions: Given the discordance observed between trials, ongoing innovation in patient management, and potential expansion of indications for use, the evidence base must be expanded to optimize appropriate implementation of this complex therapy. This will require more complete capture of outcome data in real-world settings for all eligible candidates whether or not they receive this therapy. Inevitably, the indications for use of this therapy will expand, as will the devices and therapeutic approaches for this population, necessitating the study of comparative effectiveness through randomized trials or observational studies. Moreover, given the substantial variations in care delivery, conducting implementation research to delineate characteristics of the optimal care model would be of benefit.