Combined Impact of Residual Mitral Regurgitation and Gradient After Mitral Valve Transcatheter Edge-to-Edge Repair.

BACKGROUND

Reducing mitral regurgitation (MR) during mitral transcatheter edge-to-edge repair (M-TEER) may come at the cost of increased mitral valve gradient (MVG). The combined impact of residual MR and MVG on clinical outcomes after M-TEER is unknown.

OBJECTIVES

This study sought to evaluate the impact of postprocedure MR and MVG on clinical outcomes after M-TEER.

METHODS

EXPANDed is a pooled, patient-level cohort of the EXPAND (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) and EXPAND G4 studies, which were designed to evaluate real-world safety and effectiveness of the third- and fourth-generation MitraClip TEER Systems. Subjects were categorized by echocardiographic core laboratory (ECL) assessments into 4 groups according to 30-day MR grade and mean MVG: 1) MR ≤1+/MVG <5 mm Hg; 2) MR ≤1+/MVG ≥5 mm Hg; 3) MR ≥2+/MVG <5 mm Hg; and 4) MR ≥2+/MVG ≥5 mm Hg.

RESULTS

A total of 1,723 subjects had evaluable echocardiograms at 30 days: 72% had MR ≤1+/MVG <5 mm Hg, 18% had MR ≤1+/MVG ≥5 mm Hg, 7% had MR ≥2+/MVG <5 mm Hg, and 3% had MR ≥2+/MVG ≥5 mm Hg. MR≤1+ was sustained through 1 year in 93% of patients who achieved 30-day MR≤1+. MVG decreased from 30 days to 1 year in subjects with MVG ≥5 mm Hg (6.7 ± 4.0 to 5.5 ± 2.5 mm Hg MR ≤1+/MVG ≥5 mm Hg and 6.5 ± 1.5 to 5.5 ± 1.7 mm Hg MR ≥2+/MVG ≥5 mm Hg). One-year rates of all-cause mortality and heart failure hospitalization were lower for subjects who achieved MR ≤1+ at 30 days, regardless of MVG.

CONCLUSIONS

Reduction of MR to mild or less after M-TEER with the latest-generation MitraClip systems was associated with clinical benefit regardless of MVG.

Informations de copyright

Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The EXPAND (NCT03502811) and EXPAND G4 (NCT04177394) studies were funded and sponsored by Abbott. Dr Singh has received consulting fees and honoraria from Abbott. Dr Price has received consulting fees and honoraria from Abbott, Boston Scientific, InnovHeart, Medtronic, Philips Medical, W.L. Gore & Associates, and Shockwave Medical. Dr Shuvy has served as a clinical proctor for Abbott. Dr Rogers has received consulting fees from Abbott, Biosense Webster, and Boston Scientific. Dr Bedogni is a consultant and proctor for Abbott, Medtronic, BSCI, and Meril. 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 Dong and Peterman are employees of Abbott. Dr Rodriguez has received grants and support for research from Abbott, Edwards Lifesciences, Boston Scientific, AtriCure, and CardioMech; and received honoraria or consulting fees from Abbott, Edwards Lifesciences, Philips, Teleflex, and CardioMech. Dr Kar is a consultant to Abbott, Boston Scientific, Medtronic, Peija Medical, and V-Wave, and has received research grants from Abbott, Boston Scientific, Medtronic, V-Wave, HighLife, Pi-Cardia, Laminar, and Cardiomech. Dr von Bardeleben has performed non-paid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and served on the advisory board or Speakers Bureau for Abbott Cardiovascular, Edwards Lifesciences, Medtronic, and NeoChord. 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. All other authors authors have reported that they have no relationships relevant to the contents of this paper to disclose.