A 20-year experience of 1712 patients with the Biocor porcine bioprosthesis.

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.