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

Mike Saji; Masanori Yamamoto; Shunsuke Kubo; Masahiko Asami; Yusuke Enta; Shinichi Shirai; Masaki Izumo; Shingo Mizuno; Yusuke Watanabe; Makoto Amaki; Kazuhisa Kodama; Junichi Yamaguchi; Yoshifumi Nakajima; Toru Naganuma; Hiroki Bota; Yohei Ohno; Masahiro Yamawaki; Hiroshi Ueno; Kazuki Mizutani; Yuya Adachi; Toshiaki Otsuka; Kentaro Hayashida; OCEAN-Mitral Investigators

doi:10.1016/j.jacasi.2023.06.008

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

JACC Asia. 2023 Aug 29;3(5):766-773. doi: 10.1016/j.jacasi.2023.06.008. eCollection 2023 Oct.

Authors

Mike Saji^{1

2}, Masanori Yamamoto^{3

4

5}, Shunsuke Kubo⁶, Masahiko Asami⁷, Yusuke Enta⁸, Shinichi Shirai⁹, Masaki Izumo¹⁰, Shingo Mizuno¹¹, Yusuke Watanabe¹², Makoto Amaki¹³, Kazuhisa Kodama¹⁴, Junichi Yamaguchi¹⁵, Yoshifumi Nakajima¹⁶, Toru Naganuma¹⁷, Hiroki Bota¹⁸, Yohei Ohno¹⁹, Masahiro Yamawaki²⁰, Hiroshi Ueno²¹, Kazuki Mizutani²², Yuya Adachi^{3

4}, Toshiaki Otsuka²³, Kentaro Hayashida²⁴; OCEAN-Mitral Investigators

Affiliations

¹ Department of Cardiology, Sakakibara Heart Institute, Fuchu, Japan.
² Division of Cardiovascular Medicine, Department of Internal Medicine, Toho University Faculty of Medicine, Tokyo, Japan.
³ Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan.
⁴ Department of Cardiology, Nagoya Heart Center, Nagoya, Japan.
⁵ Department of Cardiology, Gifu Heart Center, Gifu, Japan.
⁶ Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
⁷ Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
⁸ Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan.
⁹ Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
¹⁰ Division of Cardiology, St. Marianna University School of Medicine Hospital, Kawasaki, Japan.
¹¹ Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
¹² Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
¹³ Department of Cardiology, National Cerebral and Cardiovascular Center, Suita, Japan.
¹⁴ Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
¹⁵ Department of Cardiology Tokyo Woman's Medical University, Tokyo, Japan.
¹⁶ Division of Cardiology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan.
¹⁷ Department of Cardiology, New Tokyo Hospital, Chiba, Japan.
¹⁸ Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
¹⁹ Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
²⁰ Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Kanagawa, Japan.
²¹ Second Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.
²² Division of Cardiology, Department of Medicine, Kinki University Faculty of Medicine, Osaka, Japan.
²³ Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan.
²⁴ Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

Abstract

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).

Keywords: G4; OCEAN; mitral regurgitation; transcatheter mitral valve repair.