Very late outcomes for mitral valve replacement with the Carpentier-Edwards pericardial bioprosthesis: 25-year follow-up of 450 implantations.

Objective The aim of the present study was to evaluate the very-long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position. Methods From 1984 to 2011, 450 Carpentier-Edwards PERIMOUNT pericardial mitral bioprostheses were implanted in 404 consecutive patients (mean age, 68 years; 53% female). Patients undergoing multiple valve replacements were excluded. The clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.2 ± 5.1 years, for a total of 3258 valve-years. The follow-up data were 97.8% complete. Results The operative mortality rate was 3.3%. A total of 188 late deaths occurred, for a linearized rate of 5.8%/valve-year. At 20 years, the overall actuarial survival rate was 16.9% ± 3.9%. Age at implantation, preoperative New York Heart Association class III or IV, and redo procedure were significant risk factors affecting late survival. The actuarial freedom from complications at 20 years was thromboembolism, 83.9% ± 7.6%; hemorrhage, 80.2% ± 10.8%; endocarditis, 94.8% ± 1.4%; structural valve deterioration, 23.7% ± 6.9%; and explantation owing to structural valve deterioration, 40.5% ± 8.0%. The competing risk analysis demonstrated an actual risk of explantation owing to structural valve deterioration at 20 years of 25.5% ± 2.9%. The expected valve durability was 16.6 years for the entire cohort (11.4, 16.6, and 19.4 years for patients aged <60, 60 to 70, and >70 years, respectively). Conclusions With a low rate of valve-related events at 20 years and, in particular, a low rate of structural valve deterioration, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve, especially in patients >60 years old. [ABSTRACT FROM AUTHOR]