• Rakesh M Suri, Hoda Javadikasgari, David A Heimansohn, Neil J Weissman, Gorav Ailawadi, Niv Ad, Gabriel S Aldea, Vinod H Thourani, Wilson Y Szeto, Robert E Michler, Hector I Michelena, Reza Dabir, Gregory P Fontana, William F Kessler, Michael G Moront, Louis A Brunsting, Bartley P Griffith, Alvaro Montoya, Sreekumar Subramanian, Mark A Mostovych, and Eric E Roselli.
• Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic Abu Dhabi and Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: surir@ccf.org.
• J. Thorac. Cardiovasc. Surg. 2019 May 1; 157 (5): 1773-1782.e3.

ObjectivesWe performed a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption to assess safety and efficacy of Perceval, a sutureless bovine pericardial aortic valve representing the initial US experience.MethodsFrom June 2013 to January 2015, 300 patients (mean age 76.7 ± 7.7 years, 54.3% men, 37.3% ≥80 years, median Society of Thoracic Surgeons Predicted Risk of Mortality 2.8%), underwent Perceval valve implantation at 18 centers across the United States. Twenty patients (6.7%) had a bicuspid aortic valve and 5 (1.7%) patients had previous aortic valve replacement. A minimally invasive approach was used in 80 (26.7%) and concomitant procedures were performed in 113 (37.8%) patients.ResultsTwo hundred eighty-nine patients (96.3%) were successfully implanted. Operative mortality (≤30 days) was 1.3% (n = 4) (observed to expected ratio of 0.40). One-year results included all-cause mortality in 5.2% (n = 15), stroke in 1% (n = 3), and endocarditis in 1.7% (n = 5). New permanent periprocedural pacemaker rate was 10.7% (n = 30/281); 2.5% (n = 7/281) resulted from third-degree atrioventricular block. One-year valve-related reoperation was 2.1% (n = 6). At 1-year follow-up, 98% of patients were in New York Heart Association class I/II, left ventricular mass index decreased from 103.5 ± 30.1 g/m2 at discharge to 95.8 ± 27.1 g/m2 (P = .001), and 3 (1.3%) moderate paravalvular leaks were identified. Health-related quality of life score increased from 62.7 ± 21.8 before surgery to 85.5 ± 17.8 at 1 year (P < .001).ConclusionsThese results confirm the safety and effectiveness of the Perceval sutureless aortic valve replacement in study patients with lower mortality than expected from a risk prediction model. Persistent hemodynamic benefit and improvement in quality of life at 1 year support the importance of this device in the management of aortic valve disease.Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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