Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes

Rakesh M. Suri, Cleveland Clinic Abu Dhabi
Hoda Javadikasgari, Cleveland Clinic Abu Dhabi
David A. Heimansohn, St. Vincent Heart Center of Indiana
Neil J. Weissman, MedStar Health Research Institute
Gorav Ailawadi, University of Virginia
Niv Ad, West Virginia University School of Medicine Morgantown
Gabriel S. Aldea, University of Washington Medical Center
Vinod H. Thourani, Emory Healthcare
Wilson Y. Szeto, Hospital of the University of Pennsylvania
Robert E. Michler, Montefiore-Einstein Heart Center
Hector I. Michelena, Mayo Clinic
Reza Dabir, Beaumont Hospital
Gregory P. Fontana, HCA
William F. Kessler, Heart Hospital of Austin
Michael G. Moront, The Toledo Hospital
Louis A. Brunsting, East Alabama Medical Center
Bartley P. Griffith, University of Maryland, Baltimore
Alvaro Montoya, Cardiothoracic Surgery
Sreekumar Subramanian, Centennial Medical Center
Mark A. Mostovych, St. Vincent's Medical Center, Jacksonville
Eric E. Roselli, Cleveland Clinic Abu Dhabi


© 2018 The American Association for Thoracic Surgery Objectives: We 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. Methods: From 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. Results: Two 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). Conclusions: These 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.