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

Ralph Stephan von Bardeleben; Jason H Rogers; Paul Mahoney; Matthew J Price; Paolo Denti; Francesco Maisano; Michael Rinaldi; William A Rollefson; Federico De Marco; Bassem Chehab; Mathew R Williams; Federico M Asch; Evelio Rodriguez

doi:10.1016/j.jcin.2023.05.013

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

JACC Cardiovasc Interv. 2023 Jun 26;16(12):1463-1473. doi: 10.1016/j.jcin.2023.05.013.

Authors

Affiliations

¹ Department of Cardiology, University Medical Center of Mainz, Mainz, Germany. Electronic address: stephan.von_bardeleben@unimedizin-mainz.de.
² University of California Davis Medical Center, Sacramento, California, USA.
³ Sentera Heart and Valve and Structural Disease Center, Norfolk, Virginia, USA.
⁴ Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.
⁵ Cardiac Surgery Department, San Raffaele University Hospital, Milan, Italy.
⁶ San Raffaele University Hospital, Milan, Italy.
⁷ Sanger Heart and Vascular Institute of Cardiothoracic Surgery, Charlotte, North Carolina, USA.
⁸ Arkansas Heart Hospital, Little Rock, Arkansas, USA.
⁹ Centro Cardiologico Monzino IRCCS, Milan, Italy.
¹⁰ Ascension Via Christi, Wichita, Kansas, USA.
¹¹ Heart Valve Center, New York University Langone Health, New York, New York, USA.
¹² Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, District of Columbia, USA.
¹³ Ascension Saint Thomas, Nashville, Tennessee, USA.

PMID: 37380228
DOI: 10.1016/j.jcin.2023.05.013

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.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Cardiomyopathies*
Echocardiography
Humans
Mitral Valve Insufficiency* / diagnostic imaging
Mitral Valve Insufficiency* / surgery
Prospective Studies
Quality of Life
Treatment Outcome