Background and aim of the study: The study aim was to evaluate 10 years' results obtained with the Pericarbon pericardial bioprosthesis.
Methods: Between September 1988 and December 1997, 277 patients (mean age 75.8 +/- 8.5 years) received a total of 287 Pericarbon pericardial valves. Of these patients, 224 (80.8%) underwent single aortic valve replacement (AVR) and 39 single mitral valve replacement (MVR); one patient had a tricuspid valve replacement (TVR), three patients had a pulmonary valve replacement (PVR) and 10 had both aortic and mitral valve replacement (DVR). Associated cardiac procedures were performed in 86 patients (31.0%), mainly coronary artery bypass graft (n = 71). Mean patient follow up was 4.9 +/- 2.6 years; total cumulative follow up was 1,221.4 patient-years.
Results: The overall hospital mortality rate was 10.1%. There were 50 late deaths (20.1%), four (1.6%) being valve-related. The patient survival rate at 10.8 years was 60.0 +/- 4.5% for AVR and 46.5 +/- 11.9% for MVR. Freedom from valve-related death at 10.8 years was 97.6 +/- 1.1% for AVR and 100% for MVR. Freedom from structural valve deterioration was 96.1 +/- 2.7% for AVR and 100% for MVR. Freedom from embolic events was 96.0 +/- 1.5% for AVR and 100% for MVR. In total, 16 patients needed reoperation, three for stenosis due to dystrophic calcification, six for endocarditis and seven for paravalvular leak. Freedom from reoperation was 89.9 +/- 4.2% for AVR and 80.6 +/- 7.3% for MVR.
Conclusion: These results show that, over a period of up to 10 years, the Pericarbon pericardial bioprosthesis constitutes an excellent and safe replacement valve.