Rakesh M Suri1, Hoda Javadikasgari2, David A Heimansohn3, Neil J Weissman4, Gorav Ailawadi5, Niv Ad6, Gabriel S Aldea7, Vinod H Thourani8, Wilson Y Szeto9, Robert E Michler10, Hector I Michelena11, Reza Dabir12, Gregory P Fontana13, William F Kessler14, Michael G Moront15, Louis A Brunsting16, Bartley P Griffith17, Alvaro Montoya18, Sreekumar Subramanian19, Mark A Mostovych20, Eric E Roselli2. 1. 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. 2. Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic Abu Dhabi and Cleveland Clinic Foundation, Cleveland, Ohio. 3. Department of Cardiothoracic Surgery, St Vincent Heart Center of Indiana, Indianapolis, Ind. 4. Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC. 5. Section of Adult Cardiac Surgery, Advanced Cardiac Valve Center, University of Virginia, Charlottesville, Va. 6. Cardiac Surgery, The Inova Heart and Vascular Institute, West Virginia University Medical Center, Morgantown, WVa. 7. Division of Cardiothoracic Surgery, University of Washington Medical Center, Seattle, Wash. 8. Cardiothoracic Surgery, Emory Midtown Hospital, Atlanta, Ga. 9. Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania Medical Center, Philadelphia, Pa. 10. Cardiothoracic Surgery and Surgery, Montefiore-Einstein Heart Center, New York, NY. 11. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minn. 12. Cardiovascular and Thoracic Surgery, Beaumont Hospital, Dearborn, Mich. 13. Cardiothoracic Surgery, Cardiovascular Institute, Los Robles Hospital and Medical Center, Thousand Oaks CA Hospital Corporation of America, Nashville, Tenn. 14. Cardiothoracic and Vascular Surgeons, Heart Hospital, Austin, Tex. 15. Cardiothoracic Surgery, The Toledo Hospital, Toledo, Ohio. 16. Heart and Lung Surgeons of East Alabama, East Alabama Medical Center (EAMC), Opelika, Ala. 17. Division of Cardiac Surgery, University of Maryland, Baltimore, Md. 18. Cardiothoracic Surgery, Baptist Health, South Florida, Fla. 19. Department of Cardiac Surgery, TriStar Centennial Medical Center, Nashville, Tenn. 20. Cardiac and Vascular Surgery, St Vincent's Medical Center, Jacksonville, Fla.
Abstract
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.
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.
Authors: Daniel Hernandez-Vaquero; Carlota Vigil-Escalera; Yvan Persia; Carlos Morales; Isaac Pascual; Alberto Domínguez-Rodríguez; Emiliano Rodríguez-Caulo; Manuel Carnero; Rocío Díaz; Pablo Avanzas; Cesar Moris; Jacobo Silva Journal: J Clin Med Date: 2020-09-14 Impact factor: 4.241