Mid-term results after heart valve replacement with the CarboMedics bileaflet prosthesis: experience with 785 implants.

Background: The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis.

Methods: Between October 1991 and December 1997, six hundred seventy-two consecutive patients (361 men, 54%; 311 women, 46%; mean age 57 +/- 12 year, range 6-73 years) underwent mechanical valve implantation at the Division of Cardiac Surgery of the University of Verona. Preoperatively, 69% of the patients were in NYHA FC III or IV. Eighty-one patients (12%) had undergone a previous cardiac operation and 14.5% had an ejection fraction less than 35%. We performed an aortic valve replacement in 309 patients (78 valved-conduits for replacement of the entire aortic root), a mitral valve replacement in 250, and a double valve in 113. 52 patients (8%) underwent associated myocardial revascularization.

Results: Early mortality was 2.8% (5/309 aortic, 1.6%; 11/250 mitral, 4.4%; 3/113 double, 2.6%). Late mortality was 4.4%. Actuarial survival at 5 years was 89.3% (aortic, 91.1%, mitral 86.4%, double 90.5%). Thromboembolism occurred in 26 patients (3.9%) and major hemorrhagic events in 20 (3%). Nine patients (1.3%) required a reoperation, in 3 cases (0.4%) after endocarditis (Staphylococcus epidermidis). No structural deterioration occurred in our series.

Conclusion: Our study appears to confirm the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance.