Carpentier-Edwards supra-annular bioprosthesis in the aortic position. Has altered design affected performance?

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.

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.

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%.

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.