Intermediate clinical results after aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis

From January 1986 through December 1993, 482 patients underwent aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis at our institution. Patients ranged in age from 26 to 87 years (mean, 72.5 +/- 7.1 years), and 59.8% of them were men. Pure or predominant aortic stenosis was the indication for operation in 80.1% of the patients. Most (75.4%) of the patients were in New York Heart Association functional class III or IV preoperatively because of dyspnea. Isolated aortic valve replacement was performed in 265 patients (55.0%). The most frequent concomitant procedure was aortocoronary bypass grafting (38.4%). All patients were followed up for as many as 7 years postoperatively (average, 1.7 +/- 1.7 years). Twenty-six patients (5.4%) died within 30 days postoperatively; 53 patients died during the remainder of the follow-up period. The actuarial survival rate was 74.0% +/- 3.6% at 5 years and 59.7% +/- 7.5% at 7 years postoperatively. There were 12 valve-related deaths, and these were due to endocarditis (n = 3), thromboembolism (n = 5), anticoagulant-related hemorrhage (n = 2), reoperation necessitated by structural deterioration (n = 1), and sudden death (n = 1). After 7 years, the freedom from thromboembolic events was 86.6% +/- 3.8%, the freedom from anticoagulant-related hemorrhage was 98.0% +/- 0.9%, and the freedom from reoperation was 90.9% +/- 8.3%. There was only one structural failure, and this occurred at 6 years postoperatively.