Safety and Efficacy in Mitral Regurgitation Management with the MitraClip® G4 System: Insights from a Single-Center Study.

Abstract

Background: Mitral regurgitation (MR) is a common valvular disorder linked to high morbidity and mortality. For patients unsuitable for surgery, transcatheter mitral edge-to-edge repair (TEER) with the MitraClip^® G4 system offers an alternative. This study aims to evaluate procedural, echocardiographic, functional, and quality of life (QoL) outcomes in patients who underwent TEER with the MitraClip^® G4 system, along with possible predictors of New York Heart Association (NYHA) class I at 30 days and at 1 year.

Methods: Patients with moderate-to-severe (3+) or severe (4+) degenerative MR (DMR) or functional MR (FMR), classified as NYHA class III or IV, and who underwent TEER with the MitraClip^® G4 system at our center between January 2021 and December 2023 were included.

Results: A total of 83 patients [71% FMR, 66% male, median (IQR) age 70 (11) years] underwent TEER, with 100% procedural success. MR ≤ 2+ was achieved in 100% and 98% of patients at 30 days and 1 year, respectively. NYHA class I or II was achieved in 100% and 96.8% of patients at 30 days and 1 year, respectively. The Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved from 51 ± 20 at baseline to 69 ± 15 at 30 days (p < 0.001) and 70.5 ± 15 at 1 year (p < 0.001). Lower baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) predicted achieving NYHA class I at 30 days (HR: 0.63, 95% CI: 0.41-0.95, p = 0.030), while lower European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) and NT-proBNP predicted it at 1 year [(HR: 0.50, 95% CI: 0.28-0.89, p = 0.019), (HR: 0.67, 95% CI: 0.44-0.99, p = 0.049), respectively].

Conclusions: The MitraClip^® G4 system provides significant improvements in MR severity, functional class, and QoL. Lower NT-proBNP and EuroSCORE II were strong predictors of achieving optimal functional status (NYHA class I).