Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.

Background: 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.
Objectives: This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan.
Methods: 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.
Results: 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).
Conclusions: 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).
Competing Interests: The OCEAN-Mitral registry, which is part of the OCEAN-SHD registry, is supported by Edwards Lifesciences, Medtronic Japan, Boston Scientific, Abbott Medical Japan, and Daiichi Sankyo. Drs Saji, Kubo, Izumo, Watanabe, and Amaki are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical, and have received consultant fees from Abbott Medical. Drs Asami and Kodama have received speaker fees from Abbott Medical. Drs Yamamoto and Nakajima are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical, and have received lecture fees from Abbott Medical. Dr Yamaguchi is clinical proctor of transcatheter edge-to-edge repair for Abbott Medical, and has received a lecture fee and a scholarship donation from Abbott Medical. Dr Ohno has received consultant, advisor, and speaker fees from Abbott Medical. Drs Enta, Shirai, Mizuno, Naganuma, and Bota are clinical proctors of transcatheter edge-to-edge repair for Abbott Medical. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.
(© 2023 The Authors.)