Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial

Yutaka Okita; Tomoyuki Fujita; Kenta ZaikokujiHiroyuki NakajimaKatsuhiro YamanakaYoshiaki FukumuraAtsushi YamaguchiHirohisa MurakamiHitoshi YakuElizabeth GearhartTatsuhiko Komiya

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Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial

机译：Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial

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Background: The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement. Methods and Results: The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cmsup2/sup/msup2/supor greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cmsup2/sup/msup2/sup, with 10 patients (91%) having an EOAI ≥0.6 cmsup2/sup/msup2/sup. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years. Conclusions: The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings.

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《circulation journal》 |2021年第7期|1035-1041|共7页
作者
Yutaka Okita; Tomoyuki Fujita; Kenta ZaikokujiHiroyuki NakajimaKatsuhiro YamanakaYoshiaki FukumuraAtsushi YamaguchiHirohisa MurakamiHitoshi YakuElizabeth GearhartTatsuhiko Komiya;
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作者单位

Takatsuki General Hospital;

National Cerebral and Cardiovascular Center;

Sakakibara Heart InstituteSaitama Medical University International Medical CenterKobe University HospitalTokushima Red Cross HospitalJichi Medical University Saitama Medical CenterHyogo Brain and Heart CenterKyoto Prefectural University of MedicineMedtronicKurashiki Central Hospital;

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正文语种英语
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Aortic regurgitation; Aortic stenosis; Bovine pericardial tissue valve; Surgical aortic valve;

Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial

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