Evaluating Mitral TEER in the Management of Moderate Secondary Mitral Regurgitation Among Heart Failure Patients.

Autor:	Asgar AW; Montreal Heart Institute, Montreal, Quebec, Canada. Electronic address: Anita.asgar@umontreal.ca., Tang GHL; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York, USA., Rogers JH; University of California-Davis, Sacramento, California, USA., Rottbauer W; Ulm University Heart Center, Department of Cardiology, Ulm, Germany., Morse MA; Ascension Saint Thomas, Nashville, Tennessee, USA., Denti P; San Raffaele University Hospital, Milan, Italy., Mahoney P; University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania, USA., Rinaldi MJ; Sanger Heart and Vascular Institute of Cardiothoracic Surgery, Charlotte, North Carolina, USA., Asch FM; Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC, USA., Zamorano JL; Department of Cardiology, Ramón y Cajal University Hospital, Madrid, Spain., Dong M; Abbott Structural Heart, Santa Clara, California, USA., Huang R; Abbott Structural Heart, Santa Clara, California, USA., Lindenfeld J; Vanderbilt University Medical Center, Nashville, Tennessee, USA., Maisano F; Division of Cardiac Surgery and Valve Center, IRCCS Ospedale San Raffaele, Milan, Italy., von Bardeleben RS; Department of Cardiology, University Medical Center of Mainz, Mainz, Germany., Kar S; Los Robles Regional, Thousand Oaks, California, USA., Rodriguez E; Ascension Saint Thomas, Nashville, Tennessee, USA.
Jazyk:	angličtina
Zdroj:	JACC. Heart failure [JACC Heart Fail] 2024 Aug 29. Date of Electronic Publication: 2024 Aug 29.
DOI:	10.1016/j.jchf.2024.08.001
Abstrakt:	Background: Moderate secondary mitral regurgitation (SMR) represents a subgroup of heart failure (HF) patients with treatment restricted to medical therapy. Outcomes in patients with moderate SMR treated with mitral transcatheter edge-to-edge repair (M-TEER) are less well known. Objectives: The aim of this study was to assess the safety and effectiveness of M-TEER in subjects with moderate SMR using the EXPANDed studies. Methods: One-year outcomes in subjects from the EXPANDed studies (EXPAND [A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices] and EXPAND G4 [A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System] MitraClip studies) with baseline moderate SMR (2+), per echocardiographic core laboratory (ECL) assessment, were compared with subjects with baseline severe SMR (≥3+). Results: There were 335 subjects with moderate SMR and 525 with severe SMR at baseline per ECL review. Baseline characteristics were similar between the 2 subgroups. After treatment with M-TEER, significant MR reduction was achieved in both groups. Significant left ventricular (LV) reverse remodeling was observed through 1 year, with a >20 mL decrease in LV end-diastolic and end-systolic volumes on average in the moderate SMR group. Significant 1-year improvements in NYHA functional class (>78% NYHA functional class I or II) and quality of life (>20 points on the Kansas City Cardiomyopathy Questionnaire-Overall Summary) were observed in subjects with moderate SMR. Similarly, low rates of major adverse events, all-cause mortality, and HF hospitalizations were observed between the 2 subgroups through 1 year. Conclusions: In the EXPANDed studies, subjects with moderate SMR treated with M-TEER had improvements similar to subjects with severe SMR in quality of life and positive LV remodeling at 1 year. Future studies are needed to evaluate if M-TEER would be beneficial for HF patients with moderate SMR. Competing Interests: Funding Support and Author Disclosures The EXPAND (NCT03502811) and EXPAND G4 (NCT04177394) studies were funded and sponsored by Abbott. Dr Asgar is a consultant to Abbott Structural Heart, Medtronic, Edwards Lifesciences, W.L. Gore, and Anteris Technologies. Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; has served as a consultant and physician screening committee member for Shockwave Medical; has served as a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Rogers is a consultant to Abbott Structural Heart, Biosense Webster, and Boston Scientific. Dr Rottbauer has received consulting fees/speaker honoraria from Abbott, Bayer Healthcare, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, and Medtronic; and is a member of the steering committee of the EXPAND G4 study for Abbott and Encourage AF study for Daiichi Sankyo. Dr Morse is a consultant for Edwards Lifesciences. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant to InnovHeart, Artiness, and Pi-Cardia. Dr Mahoney is a consultant and proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; is a consultant for Abbott; and has been awarded research grants from Edwards Lifesciences, Medtronic Abbott, and Boston Scientific. Dr Rinaldi has been awarded honoraria and/or consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Asch’s work as an academic core laboratory director is performed through institutional research grants (MedStar Health) with Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Neovasc, Ancora Heart, LivaNova, MVRx, InnovHeart, Polares Medical, and Aria CV. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and research grants from Abbott and Edwards Lifesciences. Dr Dong and Ms Huang are employees of Abbott Structural Heart. Dr Lindenfeld has been a consultant for Abbott, Alleviant, AstraZeneca, Biotronik, Boston Scientific, CVRx, Edwards Lifesciences, Merck, Medtronic, V-Wave, Vascular Dynamics, WhiteSwell, and Vectorious; and receives research funding from AstraZeneca. Dr Maisano has received grants and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received honoraria and consulting fees (personal and institutional) from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and Cardiovalve; has received royalty income and intellectual property rights from Edwards Lifesciences; and is a shareholder (including stock options) of CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr von Bardeleben has performed nonpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and serves as an advisory board or speaker bureau member for Abbott Cardiovascular Edwards Lifesciences, Medtronic, and NeoChord. Dr Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards Lifesciences; has received consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore, and Medtronic; served as a steering committee member of the TRILUMINATE study (Abbott) and as national principal investigator of the EXPAND study and the REPAIR MR study for Abbott. Dr Rodriguez has been awarded grants and support for research from Abbott, Edwards Lifesciences, Boston Scientific, AtriCure, and CardioMech; and has received honoraria or consulting fees from Abbott, Edwards Lifesciences, Philips, Teleflex, and CardioMech. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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