Pericarbon pericardial bioprosthesis: an experience based on the lessons of the past.

Background: The Pericarbon pericardial bioprosthesis, at the time of its creation, showed a breakthrough in terms of low calcification deposit rate, absence of valvular tears, and durability. The purpose of this study was to evaluate results after 10 years.

Methods: From September 1988 to December 1997, 277 patients received a total of 287 Pericarbon pericardial valves. There were 224 (80.8%) isolated aortic valve replacements (AVR), 39 isolated mitral valve replacements (MVR), 1 tricuspid valve replacement, 3 pulmonary valve replacements, and 10 aortic and mitral valve replacements. The total cumulative follow-up was 1,221.42 patient-years (mean 4.9+/-2.6 years).

Results: Overall hospital mortality was 10.1%. The overall patient survival at 10.8 years was 55.8%+/-4.2%, for AVR it was 60.0%+/-4.5%, and for MVR it was 46.5%+/-11.9%. The freedom from valve-related death for the overall population at 10.8 years was 98.0%+/-1.0%, for AVR 97.6%+/-1.1%, and for MVR 100%. The overall freedom from structural valve deterioration was 96.6%+/-2.4%, for AVR 96.1%+/-2.7%, and for MVR 100%. The overall freedom from embolic events was 96.0%+/-1.5%, for AVR 96.0%+/-1.6%, and for MVR 100%. The overall freedom from reoperation was 88.1%+/-3.8%, for AVR 89.9%+/-4.2%, and for MVR 80.6%+/-7.3%.

Conclusions: These results show that over a period of up to 10 years, the Pericarbon pericardial bioprosthesis is an excellent and safe valve substitute. Developing a detoxification process aimed at improving the biological behavior of the glutaraldehyde-tanned valve may increase those advantages.