The CarboMedics prosthetic heart valve: experience with 1,084 implants.

Background and aim of the study: The study aim was to evaluate our clinical experience with the CarboMedics heart valve prosthesis. Methods: Between October 1991 and December 2000, 942 consecutive patients (514 males, 428 females; mean age 58+/-11 years; range: 6-78 years) underwent mechanical valve implantation with the CarboMedics prosthesis. Preoperatively, 47% of patients were in NYHA class III and 22% in class IV; in addition, 134 patients (14.2%) had undergone a previous cardiac operation. Aortic valve replacement (AVR) was performed in 469 patients (49.8%), mitral valve replacement (MVR) in 330 (35.0%), double valve replacement (DVR) in 142 (15.1%), and isolated tricuspid valve replacement (TVR) in one patient. Eighty-eight patients (9.3%) underwent associated myocardial revascularization. Mean cardiopulmonary bypass and aortic cross-clamp times for the entire group were 107+/-39 min and 74+/-24 min, respectively. Results: Overall early mortality was 2.3% (6/469 AVR, 1.2%; 12/330 MVR, 3.6%; 4/142 DVR, 2.8%). Late mortality was 3.1% (n=29; including 17 cardiac deaths (10 were valve-related). Mean follow up was 66+/-31 months (range: 1-109 months), and was 98% complete yielding a total follow up of 4959 years. Actuarial survival at five years for the entire group was 89.3+/-1.6% (AVR 91.1%, MVR 86.4%, DVR 90.5%). Thromboembolism occurred in 26 patients (2.8%, 0.52%/pt-year) and major hemorrhagic events in 20 (2.1%, 0.4%/pt-year). Nine patients (0.9%) required a reoperation, in three cases (0.3%) after Staphylococcus epidermidis-mediated endocarditis. No structural deterioration occurred. Among 891 survivors, 94% of the patients are currently in NYHA classes I or II (p<0.05). Conclusion: This study confirmed the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis showed no structural deterioration, and a low incidence of overall complications.