Carpentier-Edwards porcine bioprostheses: assessment of clinical performance

Carpentier-Edwards porcine bioprostheses have been implanted since 1975, commencing with the previous generation standard prosthesis in that year and the new generation supra-annular prosthesis in 1981. The first 700 operations with each prosthesis were evaluated: Carpentier-Edwards standard porcine bioprosthesis (CE-S), 692 patients (772 valves) and Carpentier-Edwards supra-annular porcine bioprosthesis (CE-SA), 698 patients (756 valves). The incidence of thromboembolism was CE-S 1.4% per patient-year and CE-SA 2.1% per patient-year (hazard interval rates not considered). The rate of structural valve deterioration was CE-S 1.8% per patient-year (79 prostheses) and CE-SA 0.2% (four prostheses). The reoperation rate was 2.5% per patient-year (110 prostheses) for CE-S and for CE-SA it was 0.9% (six prostheses). The late mortality rate was 3.7% per patient-year and 4.2%, respectively. The 10-year freedom rates for CE-S were thromboembolism, 82.7 +/- 2.8%; prosthetic valve endocarditis, 93.5 +/- 1.6%; structural valve deterioration, 77.1 +/- 2.9%; reoperation, 69.9 +/- 3.1%; valve related mortality, 85.9 +/- 2.4%; valve failure, 62.8 +/- 3.2%; treatment failure, 82.0 +/- 2.7%; mortality, reoperation and residual morbidity, 59.5 +/- 3.2%; and all complications, 53.4 +/- 3.1%. The four-year freedom rates for CE-SA were thromboembolism, 93.0 +/- 1.3%; prosthetic valve endocarditis, 98.7 +/- 0.5%; structural valve deterioration, 98.3 +/- 1.0%; reoperation, 95.6 +/- 1.3%; mortality, 97.9 +/- 0.6%; valve failure, 93.6 +/- 1.4%; treatment failure, 94.6 +/- 1.1%; mortality, reoperation and residual morbidity, 90.9 +/- 1.6%; and all complications, 85.6 +/- 1.9%.(ABSTRACT TRUNCATED AT 250 WORDS)