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Multicenter Study
. 2023 Nov 13;16(21):2600-2610.
doi: 10.1016/j.jcin.2023.09.029. Epub 2023 Oct 24.

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

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

1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study

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

Abstract

Background: The fourth-generation mitral transcatheter edge-to-edge repair (M-TEER) device introduced an improved clip deployment sequence, independent leaflet grasping, and 2 wider clip sizes to tailor the treatment of patients with mitral regurgitation (MR) for a broad range of anatomies. The 30-day safety and effectiveness of the fourth-generation M-TEER device were previously demonstrated.

Objectives: The aim of this study was to evaluate 1-year outcomes in a contemporary, real-world cohort of subjects treated with the MitraClip G4 system.

Methods: EXPAND G4 is an ongoing prospective, multicenter, international, single-arm study that enrolled subjects with primary and secondary MR. One-year outcomes included MR severity (echocardiographic core laboratory assessed), heart failure hospitalization, all-cause mortality, functional capacity (NYHA functional class), and quality of life (Kansas City Cardiomyopathy Questionnaire).

Results: A total of 1,164 subjects underwent M-TEER from 2020 to 2022. At 1 year, there was a durable reduction in MR to mild or less in 92.6% and to none or trace in 44.2% (P < 0.0001 vs baseline). Few subjects had major adverse events through 1 year (<2% for myocardial infarction, surgical reintervention, or single-leaflet device attachment). The 1-year Kaplan-Meier estimates for all-cause mortality and heart failure hospitalization were 12.3% and 16.9%. Significant improvements in functional capacity (NYHA functional class I or II in 82%; P < 0.0001 vs baseline) and quality of life (18.5-point Kansas City Cardiomyopathy Questionnaire overall summary score improvement; P < 0.0001) were observed.

Conclusions: M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.

Trial registration: ClinicalTrials.gov NCT04177394.

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 (NCT04177394) was funded and sponsored by Abbott. Dr von Bardeleben has performed unpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and serves as an advisory board or Speakers Bureau member for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. 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 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 Maisano has received grants and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, New Valve Technology, 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) in CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr Rinaldi has been awarded honoraria and/or consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr De Marco is a consultant and has provided paid expert testimony for Abbott and Boston Scientific. Dr Chehab has received study and consulting grants from Abbott, Edwards Lifesciences, and BioTronics. Dr Price has received consulting fees from Alleviant Medical, Medtronic, Boston Scientific, Abbott, W.L. Gore, Philips Medical, and InnovHeart. Dr Williams has received funding for research from Abbott, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Leurent has received proctoring, lecture, and consulting fees from Abbott. Dr Rogers has received consulting fees from Abbott and Boston Scientific. 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 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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