The Carpentier-Edwards pericardial aortic valve: intermediate results in 420 patients.

From July 1984 to December 1991, 420 patients underwent isolated aortic valve replacement with a Carpentier-Edwards pericardial bioprosthesis in our Institution. Of the patients 71.5% were male, the mean age was 66.9 +/- 11.9 years and 48% were in NYHA clinical stage III or IV. The operative mortality rate was 2.9% (12/420). All patients but six were followed up for an average of 3.9 years after their operation and total follow-up was 1444 patient-years. At this time of the study, over 80% of the patients are in NYHA class I or II, 6% are in atrial fibrillation and 7% receive anticoagulation treatment. There were 41 late deaths. After 8 years the actuarial survival rate is 80% +/- 6%. Nine patients died of valve-related causes (three endocarditis, three thromboembolic complication, one structural failure, and two sudden deaths). The actuarial rate of freedom from valve-related death was 97% +/- 3% at 8 years. Valve-related complications included 12 thromboembolic episodes (0.8% patient-year), 7 endocarditis (0.5% patient-year), 4 anticoagulant-related complications (0.2% patient-year), 6 reoperations (0.4% patient-year) and 2 structural valve failures (0.1% patient-year). After 8 years, freedom from thromboembolic complication was 96% +/- 3%, from endocarditis 97% +/- 2%, from reoperation 98% +/- 2% and from valve failure 99% +/- 1%. There were only two structural deteriorations (calcification and stenosis) and one explanation. No leaflet tear was observed. We conclude that these intermediate results are better than those obtained with previous pericardial bioprostheses.