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

Research output: Contribution to journalArticle

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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).

Original languageEnglish
Pages (from-to)2946-2953
Number of pages8
JournalCirculation Journal
Volume82
Issue number12
DOIs
Publication statusPublished - 2018 Jan 1

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Atrial Appendage
Thromboembolism
Atrial Fibrillation
Stroke
Safety
Equipment and Supplies
Warfarin
Embolism
Japan
Randomized Controlled Trials
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Percutaneous WATCHMAN left atrial appendage closure for Japanese patients with nonvalvular atrial fibrillation at increased risk of thromboembolism ― First results from the SALUTE trial ―. / Aonuma, Kazutaka; Yamasaki, Hiro; Nakamura, Masato; Ootomo, Tatsushi; Takayama, Morimasa; Ando, Kenji; Hirao, Kenzo; Morino, Yoshihiro; Hayashida, Kentaro; Kusano, Kengo; Main, Michael L.; Saito, Shigeru.

In: Circulation Journal, Vol. 82, No. 12, 01.01.2018, p. 2946-2953.

Research output: Contribution to journalArticle

Aonuma, K, Yamasaki, H, Nakamura, M, Ootomo, T, Takayama, M, Ando, K, Hirao, K, Morino, Y, Hayashida, K, Kusano, K, Main, ML & Saito, S 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 ―', Circulation Journal, vol. 82, no. 12, pp. 2946-2953. https://doi.org/10.1253/circj.CJ-18-0222
Aonuma, Kazutaka ; Yamasaki, Hiro ; Nakamura, Masato ; Ootomo, Tatsushi ; Takayama, Morimasa ; Ando, Kenji ; Hirao, Kenzo ; Morino, Yoshihiro ; Hayashida, Kentaro ; Kusano, Kengo ; Main, Michael L. ; Saito, Shigeru. / Percutaneous WATCHMAN left atrial appendage closure for Japanese patients with nonvalvular atrial fibrillation at increased risk of thromboembolism ― First results from the SALUTE trial ―. In: Circulation Journal. 2018 ; Vol. 82, No. 12. pp. 2946-2953.
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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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AU - Aonuma, Kazutaka

AU - Yamasaki, Hiro

AU - Nakamura, Masato

AU - Ootomo, Tatsushi

AU - Takayama, Morimasa

AU - Ando, Kenji

AU - Hirao, Kenzo

AU - Morino, Yoshihiro

AU - Hayashida, Kentaro

AU - Kusano, Kengo

AU - Main, Michael L.

AU - Saito, Shigeru

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N2 - 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).

AB - 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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