Long-term evaluation of the Carpentier-Edwards pericardial valve in the aortic position

From July 1980 to December 1985, 124 patients underwent isolated aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis. The mean age of the patients was 64.9 +/- 13.1 years. All patients but one (0.7%) were followed for an average of 5.52 +/- 0.21 years after the operation and follow-up totaled to 677 patient-years. There were six early deaths (30-day mortality of 4.8%) and 25 late deaths (3.7% +/- 0.7% patient-year). After 9 years the actuarial survival rate was 64% +/- 14%. Six patients died of valve-related deaths (three anticoagulant-related hemorrhage, one endocarditis, one thromboembolic complication, and one sudden death) for an actuarial rate of 95% +/- 5% patients free of valve-related death at 9 years. Valve-related complications included five thromboembolic episodes (0.7% +/- 0.3% patient-year), eight anticoagulant-related hemorrhagic complications (1.2% +/- 0.4% patient-year), and two reoperations (0.3% +/- 0.2% patient-year). After 9 years, freedom from thromboembolic events was 96% +/- 4%, that from anticoagulant-related hemorrhage was 93% +/- 5%, and that from reoperation was 98% +/- 2%. There was no structural deterioration of the valve. We conclude that the Carpentier-Edwards pericardial prosthesis has a low incidence of valve-related complication and mortality within the 9-year time frame of this study.