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Multicenter Study
. 2023 Jun 26;16(12):1463-1473.
doi: 10.1016/j.jcin.2023.05.013.

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4

Ralph Stephan von Bardeleben  1 , Jason H Rogers  2 , Paul Mahoney  3 , Matthew J Price  4 , Paolo Denti  5 , Francesco Maisano  6 , Michael Rinaldi  7 , William A Rollefson  8 , Federico De Marco  9 , Bassem Chehab  10 , Mathew R Williams  11 , Federico M Asch  12 , Evelio Rodriguez  13
Affiliations
Free article
Multicenter Study

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4

Ralph Stephan von Bardeleben et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: The fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence.

Objectives: The primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting.

Methods: EXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality.

Results: In EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days.

Conclusions: This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.

Keywords: MitraClip G4; TEER; mitral regurgitation; mitral valve repair; transcatheter edge-to-edge repair.

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Conflict of interest statement

Funding Support and Author Disclosures The EXPAND G4 study was funded and sponsored by Abbott. Dr von Bardeleben has served in unpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and is an advisory board or Speakers Bureau for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. Dr Rogers is a consultant and proctor for Abbott and has received honoraria. Dr Mahoney serves as 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. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has served as a consultant for InnovHeart, Artiness, and Pi-Cardia. 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 and 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 Rinaldi has received honoraria or consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr Chehab has received study grants and consulting fees from Abbott, Edwards Lifesciences, and BioTronics. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and has received research grants from Abbott and Edwards Lifesciences. Dr Price has received consulting fees from Acist Medical, Medtronic, Boston Scientific, Abbott, W.L. Gore, Philips Medical, and InnovHeart (outside of the submitted work). Dr Williams has received research funding from Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. 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 Rodriquez has received grant and research support from Abbott, Edwards Lifesciences, Boston Scientific, AtriCure, and CardioMech; and has received honoraria or consultating fees from Abbott, Edwards Lifesciences, Philips, Teleflex, and CardioMech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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