Twenty-Seven-Year Experience With the St. Jude Medical Biocor Bioprosthesis in the Aortic Position.

BACKGROUND: The aim of this study was to evaluate the long-term performance of the St. Jude Medical Biocor porcine stented bioprosthesis in the aortic position.

METHODS: From January 1985 to December 1996, 455 patients underwent aortic valve replacement with the St. Jude Medical Biocor prosthesis at the German Heart Center Munich. Mean age at time of operation was 72.5 ± 9 years. In all, 172 patients (37.8%) underwent concomitant coronary artery bypass grafting and 20 patients (4.4%) had had previous cardiac surgery. Event-free rates are given as mean ± SD. Adverse events were recorded according to the guidelines for reporting morbidity and mortality after cardiac valvular operations.

RESULTS: Follow-up was complete in 93.4%. Mean follow-up time was 8.4 ± 5.6 years, with a total of 3,834 patient-years and a maximum of 27.4 years. Thirty patients were lost to follow-up after a mean of 9.2 ± 4.1 years. Overall survival rate at 10 and 15 years was 43.3% ± 2.4% and 19.2% ± 2.0%, respectively. Freedom from structural valve deterioration at 10 and 15 years was 92.1% ± 1.7% and 84.8% ± 3.0%, respectively. Freedom from valve-related reoperation at 10 and 15 years was 90.6 ± 1.7% and 86.3 ± 2.5%, respectively. Twenty-four patients needed reoperation for structural valve deterioration, 9 patients for endocarditis, 3 patients for paravalvular leakage, and 2 patients for aortic root aneurysm. At 15 years, freedom from major bleeding was 91.0% ± 2.0% and freedom from thromboembolism was 72.2% ± 2.8%.

CONCLUSIONS: This study represents the longest follow-up for the St. Jude Medical Biocor prosthesis and shows an excellent durability with a low incidence of valve-related complications.