Pericarbon pericardial bioprosthesis: An experience based on the lessons of the past

Background. The Pericarbon pericardial bioprosthesis, at the time of its cr eation, showed a breakthrough in terms of low calcification deposit rate, a bsence 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 tota l of 287 Pericarbon pericardial valves. There were 224 (80.8%) isolated aor tic valve replacements (AVR), 39 isolated mitral valve replacements (MVR), 1 tricuspid valve replacement, 3 pulmonary valve replacements, and 10 aorti c and mitral valve replacements. The total cumulative follow-up was 1,221.4 2 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 M VR it was 46.5% +/- 11.9%. The freedom from valve-related death for the ove rall population at 10.8 years was 98.0% +/- 1.0%, for AVR 97.6% +/- 1.1%, a nd for MVR 100%. The overall freedom from structural valve deterioration wa s 96.6% +/- 2.4%, for AVR 96.1% +/- 2.7%, and for MVR 100%. The overall fre edom from embolic events was 96.0% +/- 1.5%, for AVR 96.0% +/- 1.6%, and fo r MVR 100%. The overall freedom from reoperation was 88.1% +/- 3.8%, for AV R 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 P ericarbon pericardial bioprosthesis is an excellent and safe valve substitu te. Developing a detoxification process aimed at improving the biological b ehavior of the glutaraldehyde-tanned valve may increase those advantages. ( C) 2001 by The Society of Thoracic Surgeons.