Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study
| العنوان: | Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study |
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| المؤلفون: | Rogers, Jason, Asch, Federico, Sorajja, Paul, Mahoney, Paul, Price, Matthew, Maisano, Francesco, Denti, Paolo, Morse, Michael, Rinaldi, Michael, Bedogni, Francesco, de Marco, Federico, Rollefson, William, Chehab, Bassem, Williams, Mathew, Leurent, Guillaume, Morikawa, Takao, Asgar, Anita, Rodriguez, Evelio, von Bardeleben, Ralph Stephan, Kar, Saibal |
| المساهمون: | University of California [Davis] (UC Davis), University of California (UC), Scripps Clinic [San Diego, CA, USA], CHU Pontchaillou [Rennes], Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), University Medical Center [Mainz], Los Robles Regional Medical Center [California], The EXPAND G4 study was funded and sponsored by Abbott. Dr Rogers has received institutional research funding from Abbott and Boston Scientific, and has received consulting fees from Abbott, Baylis, and Boston Scientific. Dr Asch’s work as director of an academic core laboratory is 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 Sorajja has received consulting fees from Abbott, Medtronic, Boston Scientific, vDyne, TriFlo, W.L. Gore & Associates, Anteris, Evolution Medical, Half Moon Medical, Neovasc, TeleFlex, and Shifamed, and has received grant support from Abbott, VDyne, Medtronic, and Highlife. Dr Mahoney serves as a consultant and proctor for Medtronic, Edwards Lifesciences, and Boston Scientific, is a consultant for Abbott, and has received research support from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Prof Maisano has received grant and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo, has received consulting fees, honoraria (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 share options) in CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Denti has received consulting and speaker fees from Abbott. Dr Morse is a consultant for Edwards Lifesciences. Dr Rinaldi has served on the advisory board for Boston Scientific, has taught courses for Abbott and Edwards Lifesciences, has served as a consultant for Abbott, Boston Scientific, and Edwards Lifesciences, has received research and grant support from Boston Scientific, and has served as a proctor for Abbott and Edwards Lifesciences. Dr Bedogni has received consulting and speaker fees from Abbott. Dr De Marco is a consultant and has provided paid expert testimony for Abbott and Boston Scientific. Dr Chehab has received study grants and consulting fees from Abbott, Edwards Lifesciences, and BioTronics. Dr Price has received consulting fees from ACIST, Medtronic, Biotronik, Boston Scientific, Abbott, Philips, InnovHeart, Shockwave, and W.L. Gore & Associates (outside the submitted work). Dr Williams has received research funding from Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Leurent has received proctoring, lecture, and consulting fees from Abbott. Dr Morikawa has received speaking, consulting, and proctoring fees from Abbott. Dr Asgar is a consultant for and has received research support from Abbott. Dr Rodriguez has received consulting fees from Abbott, AtriCure, Boston Scientific, Edwards Lifesciences, NeoChord, and Philips. Prof von Bardeleben has served in unpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Gottingen (IIT), and is an advisory board or Speakers Bureau member for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. Dr Kar has received consulting fees from Abbott, Boston Scientific, Medtronic, and W.L. Gore & Associates, and has received grant support from Edwards Lifesciences and V-Wave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. |
| المصدر: | JACC: Cardiovascular Interventions JACC: Cardiovascular Interventions, 2023, 16 (12), pp.1474-1485. ⟨10.1016/j.jcin.2023.05.014⟩ |
| بيانات النشر: | HAL CCSD, 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | MESH: Mitral Valve Insufficiency, MESH: Humans, transcatheter edge-to-edge repair, MESH: Quality of Life, MESH: Reactive Oxygen Species, MitraClip system, MESH: Prospective Studies, mitral valve repair, MESH: Constriction, Pathologic, MESH: Cardiomyopathies, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, mitral regurgitation, TEER, MESH: Treatment Outcome |
| الوصف: | Background: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach.Objectives: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study.Methods: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days.Results: Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events ( |
| اللغة: | English |
| تدمد: | 1936-8798 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=od______2755::07bb0ba5b4c22e0370e4972398369d81 https://univ-rennes.hal.science/hal-04167993 |
| رقم الأكسشن: | edsair.od......2755..07bb0ba5b4c22e0370e4972398369d81 |
| قاعدة البيانات: | OpenAIRE |
Full Text via ClinicalKey | تدمد: | 19368798 |
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