Abstract
Background
Functional mitral regurgitation (FMR), resulting from left ventricular dysfunction or left atrial dilation, is associated with heart failure and increased mortality. Mitral transcatheter edge‐to‐edge repair is an established treatment for patients with severe symptomatic FMR who are at high surgical risk. However, comparative data on the 2 most commonly used mitral transcatheter edge‐to‐edge repair systems, MitraClip G4 and PASCAL, remain limited. This study compared the safety and efficacy of both devices in patients with FMR.
Methods
Consecutive patients with severe symptomatic FMR who underwent mitral transcatheter edge‐to‐edge repair using MitraClip G4 or PASCAL between 2021 and 2023 at a single center were included. Coprimary end points were 1‐year survival and freedom from heart failure hospitalization. Secondary end points included MR reduction and New York Heart Association functional class. Propensity score matching was performed to adjust for baseline differences.
Results
The study included 319 patients, of whom 150 (47.0%) were treated with MitraClip G4 and 169 (53.0%) with PASCAL. After propensity score matching, 116 matched pairs were analyzed. Procedural success, defined as MR grade ≤2, was achieved in 98.1% of the MitraClip G4 group and 97.3% of the PASCAL group (
P
=0.61). At 1 year, no significant differences were observed between groups regarding residual MR (
P
=0.83), New York Heart Association class (
P
=0.41), or freedom from heart failure hospitalization (
P
=0.41). Estimated 1‐year survival was 86.7% for MitraClip G4 and 87.8% for PASCAL (
P
=0.84).
Conclusions
In patients with FMR, MitraClip G4 and PASCAL demonstrated similarly high procedural success, durable MR reduction, and comparable clinical outcomes at 1 year.