{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,3,7]],"date-time":"2025-03-07T05:25:55Z","timestamp":1741325155946,"version":"3.38.0"},"reference-count":24,"publisher":"Georg Thieme Verlag KG","issue":"02","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Thorac Cardiovasc Surg"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Background\u2003This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses.<\/jats:p><jats:p>\n          Methods\u2003Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients.<\/jats:p><jats:p>\n          Results\u2003There were no differences in baseline characteristics, including sex and body surface area (1.64\u2009\u00b1\u20090.18 vs. 1.65\u2009\u00b1\u20090.15 m2) between the groups. The AVMPG on 1-year echocardiography was 14.0\u2009\u00b1\u20094.3 and 13.9\u2009\u00b1\u20095.1\u2009mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0\u2009\u00b1\u20094.3 vs. 20.0\u2009\u00b1\u20094.7\u2009mmHg, p\u2009=\u20090.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49\u2009\u00b1\u20090.40 vs. 1.53\u2009\u00b1\u20090.38\u2009cm2, p\u2009=\u20090.500) or effective orifice area index (0.91\u2009\u00b1\u20090.22 vs 0.93\u2009\u00b1\u20090.23\u2009cm2\/m2, p\u2009=\u20090.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups.<\/jats:p><jats:p>\n          Conclusion\u2003The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).<\/jats:p>","DOI":"10.1055\/a-2199-2087","type":"journal-article","created":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T23:12:22Z","timestamp":1698361942000},"page":"132-140","source":"Crossref","is-referenced-by-count":0,"title":["A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves"],"prefix":"10.1055","volume":"73","clinical-trial-number":[{"clinical-trial-number":"nct03796442","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Suk Ho","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoonjin","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji Seong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jae Woong","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4769-5340","authenticated-orcid":false,"given":"Jae Hang","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun Sung","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheong","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ho Young","family":"Hwang","sequence":"additional","affiliation":[{"name":"Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"194","published-online":{"date-parts":[[2023,12,5]]},"reference":[{"issue":"05","key":"ref1","first-page":"e72","article-title":"2020 ACC\/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology\/American Heart Association Joint Committee on Clinical Practice Guidelines","volume":"143","author":"C M Otto","year":"2021","journal-title":"Circulation"},{"issue":"36","key":"ref2","doi-asserted-by":"crossref","first-page":"2739","DOI":"10.1093\/eurheartj\/ehx391","article-title":"2017 ESC\/EACTS guidelines for the management of valvular heart disease","volume":"38","author":"H Baumgartner","year":"2017","journal-title":"Eur Heart J"},{"issue":"03","key":"ref3","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1093\/ejcts\/ezx066","article-title":"Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis","volume":"52","author":"R JM Klautz","year":"2017","journal-title":"Eur J Cardiothorac Surg"},{"issue":"03","key":"ref4","doi-asserted-by":"crossref","first-page":"ezac374","DOI":"10.1093\/ejcts\/ezac374","article-title":"Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes","volume":"62","author":"R JM Klautz","year":"2022","journal-title":"Eur J Cardiothorac Surg"},{"issue":"08","key":"ref6","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1001\/jama.1996.03540080071033","article-title":"How to report randomized controlled trials. 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