Multicenter registry of the Watchman left atrial appendage closure device for patients with atrial fibrillation in Japan: The TERMINATOR registry

Abstract

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Boston Scientific Japan Background Transcatheter left atrial appendage closure (LAAC) provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation (AF). A meta-analysis of previous two randomized trials reported improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin (1). Recently, the next-generation LAAC device, the Watchman FLX system, became available, and showed a low incidence of adverse events and a high incidence of anatomic closure (2). This transcatheter stroke prevention has already been approved in Asian countries. However, there is little data of LAAC in Asian population. Purpose This study sought to assess efficacy and safety of LAAC for patients with nonvalvular AF in Asia. Methods The TERMINATOR (Transcatheter Modification of Left Atrial Appendage by Obliteration with Device) registry is a multicenter nonrandomized study in Japan. This enrolled patients who underwent LAAC in 23 Japanese institutions. The LAAC was indicated for patients with nonvalvular atrial fibrillation in whom oral anticoagulation is required, but who have a risk of bleeding (history of BARC type 3 bleeding or HAS-BLED score ≥3 points). Baseline patient and procedural characteristics and clinical outcomes were evaluated. Results A total of 729 patients were enrolled between September 2019 and November 2021. The mean age was 74.9±8.8 years and the mean CHA2DS2-VASc score was 4.7±1.5. The Watchman generation 2.5 and FLX system were used in 469 (64.3%) and 260 patients (35.7%), respectively. Procedural success was achieved in 722 patients (99.0%). In-hospital adverse events were as follows; 6 tamponades (0.8%), 3 pericardial effusion (0.4%), 2 device embolization (0.3%), no stroke (0%), and no death (0%). During follow-up, device-related thrombus and all-cause death were reported in 16 (2.2%) and 23 patients (3.2%), respectively. Conclusions LAAC with the Watchman system provides compatible efficacy and safety outcomes in Asian population.