The fourth-generation MitraClip G4 system achieved 96.7% procedural success and significantly reduced the median number of clips used per patient compared to the third-generation system (1 vs 2; p=0.023).
Observational (n=61)
Yes
Does the fourth-generation MitraClip system improve procedural success and reduce the number of clips needed compared to the third-generation system in patients with mitral regurgitation?
The fourth-generation MitraClip system demonstrates high procedural success and requires fewer clips per procedure compared to the previous generation.
Absolute Event Rate: 1% vs 2%
p-value: p=0.023
OBJECTIVES: We present our initial experience with the fourth-generation MitraClip™ (G4) system and propose preliminary criteria for device selection. BACKGROUND: The MitraClip™ G4 system recently underwent a "controlled release" for transcatheter edge-to-edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient-specific device selection algorithm, and the technology's impact on procedural times and success, have not been described. METHODS: We present an initial multi-center experience and short-term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection. RESULTS: Sixty-one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30-day follow-up, there were three deaths (4.9%), four neurological events (6.6%), and seven re-hospitalizations (11.5%). Fifty-nine patients achieved device and procedural success (96.7%), and there was one device-related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1-2 vs. 2 IQR 1-3, p = .023) and a trend toward shorter device times. CONCLUSION: Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement.
Garcia‐Sayan et al. (2021) conducted an observational in mitral regurgitation (n=61). fourth-generation MitraClip™ (G4) system vs. third generation MitraClip™ was evaluated on median number of clips used per patient (p=0.023). The fourth-generation MitraClip G4 system achieved 96.7% procedural success and significantly reduced the median number of clips used per patient compared to the third-generation system (1 vs 2; p=0.023).