One‐Year Outcomes and Their Relationship to Residual Mitral Regurgitation After Transcatheter Edge‐to‐Edge Repair With MitraClip Device: Insights From the OCEAN‐Mitral Registry
Shunsuke Kubo, Masanori Yamamoto, Mike Saji, Masahiko Asami, Yusuke Enta, Masaki Nakashima, 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, Kentaro Hayashida, Yuya Adachi, Masanori Yamamoto, Masanori Yamamoto, Shinichi Shirai, Yusuke Watanabe, Toru Naganuma, Masahiro Yamawaki, Yusuke Enta, Masaki Nakashima, Shingo Mizuno, Hiroshi Ueno, Yohei Ohno, Yoshifumi Nakajima, Masaki Izumo, Hiroki Bota, Kazuhisa Kodama, Junichi Yamaguchi, Shunsuke Kubo, Makoto Amaki, Masahiko Asami, Mike Saji, Kazuki Mizutani
Abstract
Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge‐to‐edge repair in the large Asian‐Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN‐Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge‐to‐edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02). Conclusions The OCEAN‐Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge‐to‐edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge‐to‐edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information https://upload.umin.ac.jp . Identifier: UMIN000023653.