Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes.
The Journal of thoracic and cardiovascular 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/m
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.
Suri RM, Javadikasgari H, Heimansohn DA, Weissman NJ, Ailawadi G, Ad N, Aldea GS, Thourani VH, Szeto WY, Michler RE, Michelena HI, Dabir R, Fontana GP, Kessler WF, Moront MG, Brunsting LA 3rd, Griffith BP, Montoya A, Subramanian S, Mostovych MA, Roselli EE. Prospective US investigational device exemption trial of a sutureless aortic bioprosthesis: One-year outcomes. J Thorac Cardiovasc Surg. 2019 May;157(5):1773-1782.e3. doi: 10.1016/j.jtcvs.2018.08.121. Epub 2018 Oct 23. PMID: 30553598.