Outcomes of Bioprosthetic Valves in the Pulmonary Position in Adults With Congenital Heart Disease

Background: There are limited data on the incidence of prosthetic valve dysfunction (PVD) after pulmonary valve replacement (PVR). The purpose of this study was to determine the longevity of bioprosthetic valves in the pulmonary position and the factors associated with bioprosthetic valve longevity in adults with congenital heart disease. Methods: This retrospective review of adults with bioprosthetic PVR was conducted at the Mayo Clinic in Rochester, Minnesota from 1990 to 2017. The study end point was PVD, defined as peak velocity greater than 4 m/s, severe prosthetic regurgitation, or both. For the purpose of this study we assessed bioprosthetic valve longevity by using 3 different indices: (1) cumulative incidence of PVD, (2) incidence density of PVD, and (3) time to PVD. Results: There were 807 bioprosthetic PVRs in 573 patients. PVD occurred in 267 (33%) prostheses. Time to PVD was 12.6 ± 3.9 years, the incidence of PVD was 3.2 (95% confidence interval [CI], 3.0 to 3.4) cases per 100 prosthesis-years, and the 15-year cumulative incidence was 48% (95% CI, 43%- to 53%). No difference in prosthesis longevity by type of prosthesis implanted was observed. The multivariate risk factors for PVD were a history of atrial fibrillation (hazard ratio [HR], 1.36; 95% CI, 1.08 to 2.54; P = .014), and greater than moderate right ventricular dysfunction (HR, 1.21, 95% CI, 1.01 to 1.48; P = .049). Postoperative anticoagulation with a vitamin K antagonist was associated with a lower risk of PVD (HR, 0.83; 95% CI, 0.61 to 0.92; P = .038). Conclusions: The limited longevity of bioprosthetic valves poses significant concerns about the cumulative lifetime risk of reinterventions. Prospective studies are required to determine if interventions such as treatment of atrial fibrillation and postoperative anticoagulation will delay the occurrence of PVD.