The MitraClip G4 System significantly reduced mitral regurgitation at 30 days, with 98% of patients achieving MR ≤ 2+ (P<0.0001), alongside a 2.7% major adverse event rate.
Observational (n=1,141)
Yes
Does the fourth-generation MitraClip G4 System safely and effectively reduce mitral regurgitation in patients with primary and secondary MR?
The fourth-generation MitraClip G4 System demonstrated high procedural success, significant MR reduction, and low adverse event rates at 30 days in a large, real-world cohort.
p-value: p=< 0.0001
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 1,000 patients with MR in a contemporary, real-world setting.
Bardeleben et al. (Thu,) conducted a observational in Primary (degenerative) and secondary (functional) mitral regurgitation (n=1,141). MitraClip G4 System vs. Baseline was evaluated on Mitral regurgitation severity ≤ 2+ (p=< 0.0001). The MitraClip G4 System significantly reduced mitral regurgitation at 30 days, with 98% of patients achieving MR ≤ 2+ (P<0.0001), alongside a 2.7% major adverse event rate.