Single-institution, 22-year follow-up of 786 CarboMedics mechanical valves used for both primary surgery and reoperation

Objectives: The long-term (>20 years) results for CarboMedics mechanical valves (Sorin Group, Milano, Italy) used for both primary surgery and reoperation have never been reported or compared. Methods: Since 1990, a total of 787 CarboMedics valves have been implanted in 694 patients for aortic valve replacement, including 19 redo cases in 220 patients; for mitral valve replacement, including 108 redo cases in 381 patents; and for double (aortic and mitral) valve replacement, including 29 redo cases in 93 patients. The follow-up data were complete for 7201 patient-years in 99.3% of the patients. Results: The hospital mortality rate of the aortic, mitral, and double valve replacement groups was 0.9%, 3.7%, and 4.3%, respectively. The corresponding freedom from valve-related morbidity rates in each group were 66.0%, 40.6%, and 48.0% at 20 years (P =.0206). A higher incidence of paravalvular leakage was observed in the mitral and double valve replacement groups than in the aortic valve replacement group (P =.0019). Of the cases of mitral paravalvular leakage after single mitral valve replacement, 97% occurred after redo single mitral valve replacement; 73% of the cases of mitral paravalvular leakage after double valve replacement occurred after redo double valve replacement. Conclusions: CarboMedics mechanical valves used for both primary surgery and reoperation for aortic, mitral, and double valve replacement can achieve satisfactory early and long-term results, even 20 years after surgery. Care should be taken, however, to prevent paravalvular leakage in the mitral position during reoperation.