Clinical Outcomes in Patients Treated With a Repositionable and Fully Retrievable Aortic Valve ― REPRISE Japan Study ―
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- Saito Shigeru
- Department of Cardiology, Shonan Kamakura General Hospital
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- Hayashida Kentaro
- Department of Cardiology, Keio University School of Medicine
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- Takayama Morimasa
- Department of Cardiology, Sakakibara Heart Institute
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- Goto Tsuyoshi
- Department of Cardiology, Kurashiki Central Hospital
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- Ihlberg Leo
- Boston Scientific Corporation
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- Sawa Yoshiki
- Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine
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<p>Background:The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.</p><p>Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%).</p><p>Conclusions:Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.</p>
収録刊行物
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- Circulation Journal
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Circulation Journal 85 (7), 991-1000, 2021-06-25
一般社団法人 日本循環器学会
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詳細情報 詳細情報について
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- CRID
- 1390851430024316800
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- NII論文ID
- 130008056930
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- NII書誌ID
- AA11591968
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- ISSN
- 13474820
- 13469843
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- NDL書誌ID
- 031532178
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- PubMed
- 33191317
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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