Objective: The 20-year data from the ongoing long-term study of the St Jude Medical Biocor (St Jude Medical, St Paul, Minn) porcine bioprosthesis are reported. Earlier follow-ups have shown that the valve has excellent durability. After 20 years, will this continue to be true?
Methods: Data were obtained for 1712 patients who underwent valve replacement (1518 aortic valve replacements; 194 mitral valve replacements) with glutaraldehyde-preserved Biocor bioprostheses at Sahlgrenska University Hospital (Sweden) between 1983 and 2003. Follow-up after surgery was evaluated on alternate years using hospital records, interviews, and questionnaires.
Results: At 20 years, the cumulative follow-up was 8843 and 1195 patient-years for aortic valve replacement and mitral valve replacement, respectively. Survival after aortic valve replacement was 17.7% +/- 3.3%, and survival after mitral valve replacement was 16.4% +/- 4.7%. Actuarial freedom from reoperation because of structural valve deterioration was 61.1% +/- 8.5% and 79.3% +/- 6.0% after aortic valve replacement and mitral valve replacement, respectively. (The equivalent actual/cumulative values were 85.6% +/- 2.2% and 91.2% +/- 2.6%, respectively.) In aortic valve recipients aged 65 years or less and more than 65 years, actuarial freedom from reoperation because of structural valve deterioration was 44.5% +/- 9.2% and 92.1% +/- 3.9%, respectively. The equivalent values in mitral valve recipients were 75.2% +/- 7.6% and 88.0% +/- 8.1%, respectively.
Conclusion: The 20-year data confirm the excellent valve durability reported at the 17-year follow-up after both aortic valve replacement and mitral valve replacement using the Biocor porcine bioprosthesis.