Initial Japanese Multicenter Experience and Age-Related Outcomes Following Left Atrial Appendage Closure: The OCEAN-LAAC Registry

Masahiko Asami; Toru Naganuma; Yohei Ohno; Tomoyuki Tani; Hideharu Okamatsu; Kazuki Mizutani; Yusuke Watanabe; Masaki Izumo; Mike Saji; Shingo Mizuno; Hiroshi Ueno; Shunsuke Kubo; Shinichi Shirai; Masaki Nakashima; Masanori Yamamoto; Kentaro Hayashida; OCEAN-LAAC Investigators

doi:10.1016/j.jacasi.2022.11.003

Initial Japanese Multicenter Experience and Age-Related Outcomes Following Left Atrial Appendage Closure: The OCEAN-LAAC Registry

JACC Asia. 2023 Feb 14;3(2):272-284. doi: 10.1016/j.jacasi.2022.11.003. eCollection 2023 Apr.

Authors

Masahiko Asami¹, Toru Naganuma², Yohei Ohno³, Tomoyuki Tani⁴, Hideharu Okamatsu⁵, Kazuki Mizutani⁶, Yusuke Watanabe⁷, Masaki Izumo⁸, Mike Saji^{9

10}, Shingo Mizuno¹¹, Hiroshi Ueno¹², Shunsuke Kubo¹³, Shinichi Shirai¹⁴, Masaki Nakashima¹⁵, Masanori Yamamoto^{16

17

18}, Kentaro Hayashida¹⁹; OCEAN-LAAC Investigators

Affiliations

¹ Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
² Department of Cardiology, New Tokyo Hospital, Chiba, Japan.
³ Department of Cardiology, Tokai University School of Medicine, Kanagawa, Japan.
⁴ Department of Cardiology, Sapporo East Tokushukai Hospital, Hokkaido, Japan.
⁵ Department of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, Japan.
⁶ Department of Cardiology, Kinki University School of Medicine, Osaka, Japan.
⁷ Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
⁸ Department of Cardiology, St Marianna University School of Medicine, Kanagawa, Japan.
⁹ Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
¹⁰ Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, Japan.
¹¹ Department of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
¹² Department of Cardiology, Toyama University Hospital, Toyama, Japan.
¹³ Department of Cardiology, Kurashiki Central Hospital, Okayama, Japan.
¹⁴ Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan.
¹⁵ Department of Cardiology, Sendai Kousei Hospital, Miyagi, Japan.
¹⁶ Department of Cardiology, Toyohashi Heart Center, Aichi, Japan.
¹⁷ Department of Cardiology, Nagoya Heart Center, Aichi, Japan.
¹⁸ Department of Cardiology, Gifu Heart Center, Gifu, Japan.
¹⁹ Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.

Abstract

Background: Limited data are available describing left atrial appendage closure (LAAC) and age-related outcomes in Asians.

Objectives: This study summarizes the initial experience with LAAC in Japan and determines age-related clinical outcomes in patients with nonvalvular atrial fibrillation undergoing percutaneous LAAC.

Methods: In an ongoing, prospective, investigator-initiated, multicenter, observational registry of patients undergoing LAAC in Japan, we analyzed short-term clinical outcomes in patients with nonvalvular atrial fibrillation who underwent LAAC. Patients were classified into younger, middle-aged, and elderly groups (≤70, 70 to 80, and >80 years of age, respectively) to determine age-related outcomes.

Results: Patients (n = 548; mean age, 76.4 ± 8.1 years; male, 70.3%) who underwent LAAC at 19 Japanese centers between September 2019 and June 2021 were enrolled in the study, including 104, 271, and 173 patients in the younger, middle-aged, and elderly groups, respectively. Participants had a high-risk of bleeding and thromboembolism with a mean CHADS₂ score of 3.1 ± 1.3, a mean CHA₂DS₂-VASc score of 4.7 ± 1.5, and a mean HAS-BLED score of 3.2 ± 1.0. Device success rates were 96.5% and anticoagulants discontinuation at the 45-day follow-up was achieved in 89.9%. In-hospital outcomes were not significantly different, but major bleeding events during the 45-day follow-up were significantly higher in the elderly group compared to the other groups (younger vs middle-aged vs elderly, 1.0% vs 3.7% vs 6.9%, respectively; P = 0.047) despite the same postoperative drug regimens.

Conclusions: The initial Japanese experience with LAAC demonstrated safety and efficacy; however, perioperative bleeding events were more common in the elderly and postoperative drug regimens must be tailored (OCEAN-LAAC [Optimized Catheter Valvular Intervention-Left Atrial Appendage Closure] registry; UMIN000038498).

Keywords: age-related outcomes; left atrial appendage occlusion; left atrial appendage closure; multicenter registry; nonvalvular atrial fibrillation.