Background: The first generation of pericardial valves had a high rate of premature deterioration. The aim of this study was to compare the outcome after aortic valve replacement with second generation pericardial prostheses (Pericarbon and Carpentier-Edwards).
Methods and results: Between 1987 and 1994, 162 patients underwent aortic valve replacement with either a Pericarbon (n=81, 69+/-11 years) or a Carpentier-Edwards (n=81, 70+/-11 years) pericardial prosthesis. Mean follow-up was 4.4+/-2.7 years for Pericarbon and 4.8+/-2.4 years for Carpentier-Edwards valves (P=0. 27), giving a total follow-up of 745 patient-years. Thirty-day mortality and 5-year actuarial survival were, respectively, 6.2% and 63.2+/-5.7% in the Pericarbon group and 6.2% and 63.5+/-5.6% in the Carpentier-Edwards group. At 8 years, freedom from (and linearized rates per patient-year) thromboembolism, structural failure, and all valve-related events were, respectively, 91.8+/-3.6% (1.4%), 76. 9+/-8.7% (2.5%), and 58.4+/-9.3% (5.6%) in the Pericarbon group and 94.4+/-2.7% (1%), 100% (0%, P<0.01), and 88.8+/-3.7% (2%, P<0.05) in the Carpentier-Edwards group. There were 9 (11.1%) Pericarbon structural failures related predominantly to severe calcification and stenosis. The actual reoperation rate was 7.4% (1.6% per patient-year) in the Pericarbon group for fibrocalcific degeneration (n=3), periprosthetic leak (n=1), endocarditis (n=1), and aortic dissection (n=1). There was neither structural valve failure nor valve reoperation in the Carpentier-Edwards group. Echocardiographic review of 70 patients from 85 survivors (82.3%) found 4 additional Pericarbon valves with signs of early structural failure but no Carpentier-Edwards valve with such changes.
Conclusions: Eight years after aortic valve replacement, Pericarbon pericardial prostheses compared unfavorably with Carpentier-Edwards pericardial prostheses, with a high incidence of structural valve failure and reoperation.