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. (C) 2001 by The Society of Thoracic Surgeons.