Background: The purpose of this study was to evaluate the long-term performance of the St. Jude Medical Biocor stented porcine prosthesis in the aortic position.
Methods: From January 1985 to December 1996, 455 patients admitted for aortic valve replacement were consecutively enrolled in this study. The mean age was 72.5 +/- 9 years, 18 patients (3.5%) had had previous cardiac surgery, and coronary artery bypass grafting was performed in 171 patients (37.6%). Follow-up was complete in 99.6%; up to 21 years were covered. Actuarial event-free rates are given as mean +/- standard error and adverse events were classified according to the guidelines for reporting morbidity and mortality after cardiac valvular operations.
Results: Cumulative follow-up time was 3,321 patient-years with a mean follow-up of 8.2 years. The actuarial survival rate after 20 years was 9.4% +/- 2.8%. The actuarial rates for freedom from structural valve deterioration were 93.1% +/- 1.7% at 10 years, 88.4% +/- 3.5% at 15 years, and 70.3% +/- 10.9% at 20 years. The actuarial rates for freedom from reoperation due to structural valve deterioration were 91.9% +/- 1.6% at 10 years, 90.6% +/- 2.1% at 15 years, and 86.5% +/- 4.5% at 20 years.
Conclusions: This study presents one of the largest series of St. Jude Medical Biocor aortic valves in the world. Results indicate an age-dependent risk of structural valve degeneration beginning as soon as 7 years postoperatively for patients below the age of 65 years, but show a low overall incidence of valve-related complications and excellent durability.