Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

Background. Increased life expectancy and younger patients' desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV). Methods. From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Life-sciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n [310) or 2700 (n [12,259). Mean age was 71 +/- 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses. Results. Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis-patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years. Conclusions. Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered. (C) 2015 by The Society of Thoracic Surgeons