Background and aim of the study: The Carpentier-Edwards supra-annular valve was introduced in 1982 and was designed to incorporate the perceived benefits of low pressure fixation and supra-annular configuration. We report an eleven year experience with the valve, concentrating on its use for single valve replacement in the aortic position.
Methods: The prosthesis was implanted in 395 patients at 399 operations between January 1984 and October 1993. Myocardial revascularization was additionally performed in 122 (31%) patients. The mean age of the patient population was 65.4 years (range 22-84 years). Sex distribution was predominantly male (62%). Three hundred and seventy-two patients left hospital (30 days operative mortality 5.8%). The mean follow up extended to 3.4 years per patient, and the cumulative follow up for the series was 1264.3 patient years.
Results: Overall actuarial survival at six years was 75.8% +/- 4.1%. The incidence of valve-related complications expressed in terms of actuarial freedom from complication at six years resulted in a freedom from reoperation of 95.1% +/- 1.8%, from prosthetic endocarditis of 97.2% +/- 1.0%, from thromboembolism and anticoagulant-related hemorrhage of 95.9% +/- 1.3% and 95.8% +/- 1.6%, respectively. Freedom from periprosthetic leak was 99.1% +/- 0.7%, whilst freedom from structural valve deterioration was 97.6% +/- 1.5%.
Conclusions: We conclude that the Carpentier-Edwards supra-annular valve compares favorably with other similar bioprostheses and that changes in its design have not impaired its structural integrity.