Background: The Carpentier-Edwards supraannular porcine bioprosthesis experience for more than 18 years has been evaluated by actuarial and actual analysis to determine the clinical performance in aortic valve replacement.
Methods: From 1981 to 1998, 1,823 patients (mean age 68.5 years, range 20 to 90 years) underwent 1,846 procedures. Previous coronary artery bypass was performed in 3.1% (56) and previous valve repair/replacement in 6.0% (110). Concomitant coronary artery bypass grafting was performed in 41.5% (756).
Results: The overall valve-related complication rate was 4.5%/patient-year (567 patients) with a fatality rate of 0.9%/patient-year (110 patients). The patient survival, at 15 years, was 33.0%+/-3.7% for the 61 to 70 years age group and 13.5%+/-2.4% for the older than 70 years group. At 15 years, the overall actual, cumulative freedom from reoperation was 83.2%+/-1.4%, valve-related mortality was 88.0%+/-1.2%, and valve-related residual morbidity was 92.0%+/-0.8%. The actual freedom from structural valve deterioration at 15 years was 84.2%+/-2.8% for the 61 to 70 years group and 97.1%+/-0.9% for the older than 70 years group.
Conclusions: The Carpentier-Edwards porcine bioprosthesis provides excellent freedom from structural valve deterioration, and overall freedom from valve-related morbidity, mortality, and reoperation for aortic valve replacement for up to 15 years. The prosthesis is recommended for patients older than 70 years and for patients 61 to 70 years, especially when extended survival is not anticipated.