Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism　― First Results From the SALUTE Trial ―

Kazutaka Aonuma; Hiro Yamasaki; Masato Nakamura; Tatsushi Ootomo; Morimasa Takayama; Kenji Ando; Kenzo Hirao; Yoshihiro Morino; Kentaro Hayashida; Kengo Kusano; Michael L. Main; Shigeru Saito

doi:10.1253/circj.CJ-18-0222

Late Breaking Clinical Trials (JCS 2018)

Percutaneous WATCHMAN Left Atrial Appendage Closure for Japanese Patients With Nonvalvular Atrial Fibrillation at Increased Risk of Thromboembolism　― First Results From the SALUTE Trial ―

Kazutaka Aonuma, Hiro Yamasaki, Masato Nakamura, Tatsushi Ootomo, Morimasa Takayama, Kenji Ando, Kenzo Hirao, Yoshihiro Morino, Kentaro Hayashida, Kengo Kusano, Michael L. Main, Shigeru Saito

Author information

Kazutaka Aonuma
Cardiovascular Division, University of Tsukuba Hospital
Hiro Yamasaki
Cardiovascular Division, University of Tsukuba Hospital
Masato Nakamura
Division of Cardiovascular Medicine, Toho University Ohashi Medical Center
Tatsushi Ootomo
Department of Cardiology, Sendai Kousei Hospital
Morimasa Takayama
Department of Cardiology, Sakakibara Heart Institute
Kenji Ando
Division of Cardiology, Kokura Memorial Hospital
Kenzo Hirao
Department of Cardiovascular Medicine, Tokyo Medical and Dental University
Yoshihiro Morino
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Kentaro Hayashida
Department of Cardiology, Keio University School of Medicine
Kengo Kusano
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Michael L. Main
Saint Luke’s Mid America Heart Institute
Shigeru Saito
Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital

Keywords: Left atrial appendage, Nonvalvular atrial fibrillation, Stroke, WATCHMAN LAA closure device

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Supplementary material

2018 Volume 82 Issue 12 Pages 2946-2953

DOI https://doi.org/10.1253/circj.CJ-18-0222

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Abstract

Background: The PROTECT AF and PREVAIL trials demonstrated that the WATCHMAN left atrial appendage (LAA) closure device is a reasonable alternative to warfarin therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the USA and Europe. We conducted the SALUTE trial to confirm the safety and efficacy of the LAA closure therapy for patients with NVAF in Japan.

Methods and Results: A total of 54 subjects (including 12 Roll-in) with NVAF who had a CHA₂DS₂-VASc score ≥2 were enrolled. All subjects were successfully implanted with the LAA closure device. No serious adverse events related to the primary procedure-safety endpoint occurred. The 2nd co-primary endpoint was a composite of all stroke, systemic embolism and cardiovascular/unexplained death. One ischemic stroke (1/42) occurred during the 6-month follow-up. The effective LAA closure rate defined as the 3rd co-primary endpoint was 100% (42/42) at both 45-day and 6-month follow-up.

Conclusions: The procedural safety and 6-month results from the SALUTE trial demonstrated that the LAA closure device was safe and effective, similar to the results of large-scale randomized clinical trials, and provides a novel perspective of LAA closure for Japanese patients with NVAF in need of an alternative to long-term oral-anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT 03033134)

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