ニイナミ　ヒロシ   NIINAMI Hiroshi   新浪　博    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	その他
言語種別	英語
査読の有無	査読なし
表題	1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study.
掲載誌名	正式名：Heart and vessels 略　 称：Heart Vessels ISSNコード：16152573/09108327
掲載区分	国外
巻・号・頁	38(7),pp.949-956
著者・共著者	Niinami Hiroshi†, Sawa Yoshiki, Shimokawa Tomoki, Domoto Satoru, Nakamura Yoshitsugu, Sakaguchi Taichi, Ito Toshiaki, Toda Koichi, Amano Atsushi, Gersak Borut
発行年月	2023/07
概要	Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm2 at discharge remaining stable up to 1 year. No moderate or severe leakages were present at discharge or at 1 year. NYHA class improved by ≥ 1 level in 55.1% of the patients at discharge and in 69.4% of the patients at 1 year. 1-year outcomes of SAVR with the Perceval sutureless valve in Japanese patients were favorable. This valve offers a promising alternative to conventional biological AVR in this Japanese population.
DOI	10.1007/s00380-023-02240-1
PMID	36773041