1-year outcomes with fourth-generation Mitral Valve Transcatheter edge-to-edge repair from the EXPAND G4 study

Files

1year_outcomes_with_fourthgen-20250725075642466491.pdf (2.35 MB)

Date issued

2023

Authors

Editors

Journal Title

Journal ISSN

Volume Title

Publisher

License

CC-BY-4.0
 https://creativecommons.org/licenses/by/4.0/
CC-BY-4.0
ItemZeitschriftenaufsatzOpen Access

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 fourthgeneration 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 #1þ in more than 90% of patients and concomitant improvements in functional status and quality of life

DOI

https://doi.org/10.25358/openscience-12824

Description

Keywords

Citation

URI

https://openscience.ub.uni-mainz.de/handle/20.500.12030/12845

Published in

JACC Cardiovascular interventions : a journal of the American College of Cardiology, 16, 21, Elsevier, New York, NY, 2023, https://doi.org/10.1016/j.jcin.2023.09.029

Relationships

Collections

DFG-491381577-H