Kazutaka Aonuma1, Hiro Yamasaki1, Masato Nakamura2, Takashi Matsumoto3, Morimasa Takayama4, Kenji Ando5, Kenzo Hirao6, Masahiko Goya7, Yoshihiro Morino8, Kentaro Hayashida9, Kengo Kusano10, Yutaka Gomi11, Michael L Main12, Takahiro Uchida13, Shigeru Saito14. 1. Cardiovascular Division, University of Tsukuba Hospital. 2. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center. 3. Department of Cardiology, Sendai Kousei Hospital. 4. Department of Cardiology, Sakakibara Heart Institute. 5. Division of Cardiology, Kokura Memorial Hospital. 6. Department of Cardiology, AOI Universal Hospital. 7. Department of Cardiovascular Medicine, Tokyo Medical and Dental University. 8. Division of Cardiology, Department of Internal Medicine, Iwate Medical University. 9. Department of Cardiology, Keio University School of Medicine. 10. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center. 11. Boston Scientific Japan K.K. 12. Saint Luke's Mid America Heart Institute. 13. Department of Cardiology, Tokyo Women's Medical University. 14. Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital.
Abstract
BACKGROUND: The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results: A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score. CONCLUSIONS: Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT03033134).
BACKGROUND: The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results: A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score. CONCLUSIONS: Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT03033134).