Long-term efficacy and safety of left atrial appendage closure with WATCHMAN in Japanese nonvalvular atrial fibrillation patients
M Nakano, Y Kondo, M Nakano, T Kajiyama, T Chiba, S Ryuzaki, Y Komai, Y Takanashi, Y Nishikawa, M Matsuno, S Tatebayashi, Y KobayashiAbstract
Background
Patients with nonvalvular atrial fibrillation (NVAF) have an increased risk of stroke, and oral anticoagulation (OAC) has been the cornerstone of prevention. However, long-term OAC use is often limited by bleeding complications, frailty, and renal dysfunction, particularly in elderly Asian populations. Left atrial appendage closure (LAAC) using the WATCHMAN has emerged as an alternative strategy to reduce stroke risk while potentially minimizing bleeding events. Nevertheless, real-world long-term data on the safety, efficacy, and feasibility of discontinuing OAC after LAAC remain limited in Japan. This study aimed to evaluate the long-term clinical outcomes, including procedural success, discontinuation of anticoagulation therapy, and major adverse events, after LAAC with the WATCHMAN in Japanese NVAF patients.
Methods
We retrospectively analyzed consecutive NVAF patients who implanted WATCHMAN2.5 or WATCHMAN FLX between January 2020 and August 2023. After device implantation, cardiac computed tomography (CT) was performed at 45 days, 6 months, 12 months, 2 years and 3 years to assess device position, sealing, and device leak. The five co-primary endpoints were: i) successful discontinuation of OAC, ii) incidence of stroke (ischemic and hemorrhagic), iii) all-cause death, iv) systemic embolism, and v) major bleeding.
Results
A total of consecutive 120 Japanese patients were included in this study (male, 72%; age, 75±8.1 years; body mass index, 23±4 kg/m2). The mean follow-up period was 44±13 months. The mean CHA2DS2-VASc and HAS-BLED scores were 4.3±1.2 and 3.2±0.7, respectively. The procedural success rate was 99.2%. During the follow-up period, 112 (93.3%) patients could safely discontinue anticoagulation therapy. Kaplan–Meier curves for each primary endpoint are shown in the Figure.
Conclusions
Long-term follow-up confirmed that the WATCHMAN LAAC device is an effective and safe therapy for reducing the risk of stroke and bleeding in Japanese NVAF patients. The high procedural success rate and the ability to discontinue anticoagulation therapy in most patients highlight the feasibility and safety of this therapy in real-world clinical practice. These findings support LAAC as an effective alternative to long-term anticoagulation therapy for Japanese NVAF patients.Primary Endpoint Kaplan–Meier Curves