• J. Thorac. Cardiovasc. Surg. · Jun 2016

    Multicenter Study Clinical Trial

    The sutureless aortic valve at 1 year: A large multicenter cohort study.

    • Theodor Fischlein, Bart Meuris, Kavous Hakim-Meibodi, Martin Misfeld, Thierry Carrel, Marian Zembala, Sara Gaggianesi, Francesco Madonna, François Laborde, Federico Asch, Axel Haverich, and CAVALIER Trial Investigators.
    • Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Nuremberg, Germany. Electronic address: Theodor.Fischlein@klinikum-nuernberg.de.
    • J. Thorac. Cardiovasc. Surg. 2016 Jun 1; 151 (6): 1617-1626.e4.

    ObjectiveSutureless aortic valve replacement (AVR) offers an alternative to standard AVR in aortic stenosis. This prospective, single-arm study aimed to demonstrate safety and effectiveness of a bovine pericardial sutureless aortic valve at 1 year.MethodsFrom February 2010 to September 2013, 658 patients (mean age 78.3 ± 5.6 years; 40.0% octogenarian; 64.4% female; mean Society of Thoracic Surgeons score 7.2 ± 7.4) underwent sutureless AVR in 25 European centers. Concomitant cardiac procedures were performed in 29.5% and minimally invasive cardiac surgery in 33.3%.ResultsOne-year site-reported event rates were 8.1% for all-cause mortality, 4.5% for cardiac mortality, 3.0% for stroke, 1.9% for valve-related reoperation, 1.4% for endocarditis, and 0.6% for major paravalvular leak. No valve thrombosis, migration, or structural valve deterioration occurred. New York Heart Association class improved at least 1 level in 77.5% and remained stable (70.4% New York Heart Association class I or II at 1 year). Mean effective orifice area was 1.5 ± 0.4 cm(2); pressure gradient was 9.2 ± 5.0 mm Hg. Left ventricular mass decreased from 138.5 g/m(2) before surgery to 115.3 g/m(2) at 1 year (P < .001). Echocardiographic core laboratory findings confirmed that paravalvular leak was rare and remained stable during follow-up.ConclusionsThe Perceval sutureless valve resulted in low 1-year event rates in intermediate-risk patients undergoing AVR. New York Heart Association class improved in more than three-quarters of patients and remained stable. These data support the safety and efficacy to 1 year of the Perceval sutureless valve in this intermediate-risk population.Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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