Early single centre experience with 192 Sorin Bicarbon valves.

In 1990 Sorin Biomedica introduced a new pyrolytic bileaflet heart valve, the Bicarbon, developed using innovative design concepts with new materials, housing, hinge mechanism, leaflet curvature and sewing ring construction. From June 1991 to May 1995, 192 bicarbon valves were implanted in 177 patients by one team. The patient population was 102 males and 75 females with an age range from 16 to 82 years (mean 62.5 years). Ninety-six were AVR, 68 MVR, 12 double valve replacements, 2 patients received another type of bileaflet valve as did the triple valve replacement. Overall hospital mortality was 5.2%. For MVR the mortality was 12.7%; for AVR it was 4.7%. There were no deaths associated with double or triple valve replacement. Five deaths were at reoperation, 2 at emergency operation, 1 aortic dissection, 2 for endocarditis, none of the deaths were valve related. One patient had a haemorrhage due to inadequate control of Warfarin therapy. Four valves were explanted: 3 mitrals for paravalvular leaks and 1 aortic for endocarditis. No patients showed any evidence of thromboembolic complications and there were no late deaths. All the surviving patients have improved their preoperative clinical status. Maximum follow-up is nearly 4 years, mean 32 months (range 1-47). Twenty one patients underwent haemodynamic evaluation by Doppler echocardiography. The mean pressure drop across 12 mitral valves was 8.34 mmHg (mean size 29.7 mm) and for 9 aortic valves it was 15.85 mmHg (mean size 23). Based on these results we are of the opinion that the Bicarbon valve is equivalent to the best of other bileaflet valves currently available.