A single-center experience of the Sorin Bicarbon heart valve prosthesis: long-term clinical, hematological and hemodynamic results.

BACKGROUND AND AIM OF THE STUDY: The Sorin Bicarbon (SB) bileaflet valve, available since 1990, has a good clinical safety profile. The study aim was to assess the long-term clinical results following implantation, plus hemodynamic and hematological aspects of the valve. METHODS: A total of 195 SB prostheses (100 aortic, 67 mitral, 14 double valve replacements) was implanted in 181 patients (108 males, 73 females) since 1991. RESULTS: Mean age at implantation was 60.5 +/- 10.8 years. Actuarial analysis at 9.0 years showed an overall survival of 63.9 +/- 5.5%; 28.2% of deaths were early (n = 11), and 71.8% late (n = 28). Freedom from thrombosis was 99.4 +/- 0.6% (one early event, successfully reoperated on), and from embolic events was 86.3 +/- 4.7%. Freedom from endocarditis and hemorrhagic complications were respectively 98.1 +/- 1.1% and 98.6 +/- 0.9%. No occurrence of hemolysis was reported. Freedom from non-structural valve dysfunction was 98.7 +/- 0.9%, and from reoperation was 96.1 +/- 1.6%. Hemodynamic evaluation by echocardiography and hematological testing was performed at 7.0 +/- 1.3 years (range 5-9 years) in a subset of 31 patients (20 males, 11 females). Mean valve size was 23.9 mm for aortic mitral. Echocardiography showed that aortic valves had a mean effective orifice area (EOA) of 2.26 +/- 1.28 cm2, with peak and mean pressure gradients of 23.6 +/- 14.6 and 12.9 +/- 8.1 mmHg, respectively. The mean EOA of mitral valve prostheses was 2.67 +/- 0.66 cm2, with peak and mean pressure gradients of 12.2 +/- 4.5 and 3.8 +/- 1.6 mmHg, respectively. Overall mean hemoglobin was 13.4 +/- 1.35 g/dl, and serum lactate dehydrogenase 630 +/- 13 IU/l. Serum haptoglobin was detectable in one patient only, and the mean reticulocyte count was 1.24 +/- 0.51%. CONCLUSION: In the present authors' experience, the Sorin Bicarbon prosthesis has low complication rates and maintains an excellent hemodynamic function over time. Hemolytic potential is insignificant with this valve.