The Carpentier-Edwards supraannular porcine bioprosthesis: A new generation tissue valve with excellent intermediate clinical performance

Abstract

The Carpentier-Edwards supraannular porcine bioprosthesis, an investigational valve, was implanted in 1167 patients (1174 operations, 1274 valves) between November 1981 and December 1985 (age range 13 to 85 years, mean 61 years). The early mortality rate was 7.2% (with concomitant procedures 10.9%, without 4.8%; with previous operation 10.5%, without 6.6%). The late mortality rate was 4.5% per patient-year (aortic valve replacement, 4.0%; mitral valve replacement, 4.8%; multiple valve replacement, 5.6%). Total cumulative follow-up was 2272.3 years. The prevalence of thromboembolism was 2.6% per patient-year (fatal 0.4% per patient-year, major 1.4%, minor 1.2%); hemorrhage related to antithromboembolic therapy, 0.7% (fatal 0.1%); prosthetic valve endocarditis, 0.4% (fatal 0.2%); periprosthetic leak, 0.4% (fatal 0%); structural valve deterioration (primary tissue failure/structural failure), 0.1% per patient-year; and clinical valve dysfunction, 0.4%. The reoperation rate was 0.8% per patient-year (thromboembolism, 0.1%; clinical valve dysfunction, 0.1%; prosthetic valve endocarditis, 0.1%; periprosthetic leak, 0.4%; structural valve deterioration, 0.1%). Thromboembolism occurred throughout the observation period but with decreasing frequency, hemorrhage throughout the period in no predictable fashion, prosthetic valve endocarditis within 2 years, periprosthetic leak within 2 years, and structural valve deterioration occurred during the fourth year of assessment. The overall survival rate was 79.8% +/- 1.7% (4 years). Freedom (at 4 years) from thromboembolism was 92.2% +/- 1.2%; from structural valve deterioration, 98.8% +/- 0.8%; and from reoperation, 95.8% +/- 1.3%. Freedom from all complications (4 years) was 85.9% +/- 1.7%; from complication mortality, 98.4% +/- 0.4%; and from valve failure (mortality and reoperation), 94.3% +/- 1.3%. This investigational Carpentier-Edwards supraannular porcine bioprosthetic valve has provided excellent clinical performance and remains our overall prosthesis of choice.