Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients　― Final 2-Year Follow-up Outcome Data From the SALUTE Trial ―

• Aonuma Kazutaka

  Cardiovascular Division, University of Tsukuba Hospital

• Yamasaki Hiro

  Cardiovascular Division, University of Tsukuba Hospital

• Nakamura Masato

  Division of Cardiovascular Medicine, Toho University Ohashi Medical Center

• Matsumoto Takashi

  Department of Cardiology, Sendai Kousei Hospital

• Takayama Morimasa

  Department of Cardiology, Sakakibara Heart Institute

• Ando Kenji

  Division of Cardiology, Kokura Memorial Hospital

• Hirao Kenzo

  Department of Cardiology, AOI Universal Hospital

• Goya Masahiko

  Department of Cardiovascular Medicine, Tokyo Medical and Dental University

• Morino Yoshihiro

  Division of Cardiology, Department of Internal Medicine, Iwate Medical University

• Hayashida Kentaro

  Department of Cardiology, Keio University School of Medicine

• Kusano Kengo

  Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center

• Gomi Yutaka

  Boston Scientific Japan K.K.

• Main Michael L.

  Saint Luke’s Mid America Heart Institute

• Uchida Takahiro

  Department of Cardiology, Tokyo Women’s Medical University

• Saito Shigeru

  Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital

抄録

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 NCT 03033134)

収録刊行物

• Circulation Journal

  Circulation Journal 84 (8), 1237-1243, 2020-07-22

  一般社団法人 日本循環器学会

キーワード

• Left atrial appendage closure
• Nonvalvular atrial fibrillation
• Stroke
• WATCHMAN device

詳細情報

• CRID: 1390285300177501824
• NII論文ID: 130007879330
• NII書誌ID: AA11591968
• DOI: 10.1253/circj.cj-20-0196
• ISSN: 13474820
• ISSN: 13469843
• NDL書誌ID: 030538894
• PubMed: 32595176
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I030538894
• Web Site: https://www.jstage.jst.go.jp/article/circj/84/8/84_CJ-20-0196/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2021123925
• 本文言語コード: en
• データソース種別:
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  • NDL
  • Crossref
  • PubMed
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  • KAKEN
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