Durability of bovine pericardial mitral bioprosthesis based on Heart Valve Collaboratory echocardiographic criteria.

Abstract

Objective: This study evaluated the very long-term results of the Carpentier-Edwards pericardial bioprosthesis in the mitral position, with particular attention to structural valve deterioration based on echocardiographic criteria.

Methods: From 1984 to 2016, 648 patients (mean age 68.8 years; 53.9% female) underwent mitral valve replacement using the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis. Multiple valve replacements were excluded. Clinical, operative, and follow-up data were prospectively recorded. The mean follow-up was 7.8 ± 5.4 years, for a total of 5043 valve-years. The follow-up data were 98.3% complete (11 patients lost). Structural valve deterioration was determined by strict echocardiographic assessment based on Heart Valve Collaboratory criteria.

Results: Operative mortality was 4%. A total of 322 late deaths occurred, for a linearized rate of 6.4%/valve-year. The actuarial survival rate at 15 years was 31.4 ± 2.6%. Age at implantation, male sex, and preoperative New York Heart Association class III or IV were significant risk factors affecting late survival. Actuarial freedoms from complications at 15 years were thromboembolism, 92.5 ± 1.9%; major bleeding, 93.8 ± 1.7%; endocarditis, 93.2 ± 1.3%; and explantation due to structural valve deterioration, 69.3 ± 3.5%. The median survival time for explantation due to structural valve deterioration was 21.7 years for the entire cohort (16.1 years for patients <65 years old). Based on echocardiographic data, actuarial freedom from severe and moderate/severe structural valve deterioration at 15 years were 64.0 ± 3.6% and 52.1 ± 3.6%, respectively.

Conclusions: With low 15-year rates of valve-related events and structural valve deterioration based on Heart Valve Collaboratory echocardiographic criteria, the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis remains a reliable choice for a mitral tissue valve.