Transcatheter edge-to-edge repair using the MitraClip G4 system achieved an acute procedural success rate of 94.6%, comparable to the 94.7% success rate of the G2 system (P=0.961).
Observational (n=2,150)
Yes
Does transcatheter edge-to-edge repair with the newer G4 system compared to the G2 system maintain acute procedural success and improve procedural times in patients with mitral regurgitation?
TEER with the MitraClip system demonstrates excellent acute procedural success in a real-world Japanese registry, with the newer G4 system offering shorter procedural times compared to the G2 system.
Absolute Event Rate: 94.6% vs 94.7%
p-value: p=0.961
Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. The OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. In total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 28.7%) were significantly shorter than those with the second generation (G2) system (1,532/2,150 71.3%). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). The OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653)
Saji et al. (Tue,) conducted a observational in Mitral regurgitation (MR) (n=2,150). Transcatheter edge-to-edge repair (TEER) with MitraClip G4 system vs. TEER with MitraClip G2 system was evaluated on Acute procedural success (p=0.961). Transcatheter edge-to-edge repair using the MitraClip G4 system achieved an acute procedural success rate of 94.6%, comparable to the 94.7% success rate of the G2 system (P=0.961).