Background: Pericardial valves have excellent hemodynamic function; however, long-term durability is questionable. To determine the function of the Carpentier-Edwards pericardial valve in the aortic position, the results of 310 aortic valve replacements performed between 1982 and 1985 were analyzed. Mean age was 64.2+/-10.8 years (range, 22 to 95 years); 190 (61.3%) were men. Isolated valve replacement was performed in 135 patients (43.5%). There were 18 hospital deaths (5.8%), none of them valve related.
Methods: Follow-up of 292 survivors was 100% complete at a mean of 8.8 years; 2,556 patient-years of follow-up were analyzed. There were 150 late deaths (51.4%). Survival at 5, 10, and 12 years were 83%+/-2%, 47%+/-3%, and 34%+/-3%, respectively. The 12-year actuarial and actual freedom from thromboembolism was 87%+/-2% and 89%+/-2%, respectively. Freedom from hemorrhage was 91%+/-2% and 92%+/-2%; freedom from endocarditis was 93%+/-2% and 95% +/- 1%; and freedom from structural deterioration was 82%+/-4% and 91%+/-2%, respectively.
Results: Actuarial freedom from structural deterioration at 12 years was considerably higher for 153 hospital survivors 65 years or older, 93% (5 explants) compared to 76% (19 explants) for patients younger than 65 years, p = 0.03. Of 24 explanted valves for structural deterioration, leaflet calcification resulting in stenosis occurred in 20 (83%) and 4 were wear-related leaflet tears.
Conclusions: We conclude that the Carpentier-Edwards pericardial valve has a low incidence of valve-related complications, that structural deterioration is infrequent and results from leaflet calcification, and that the low incidence of structural deterioration in patients 65 years or older makes this an increasingly appropriate option in this age group.