Sorin Bicarbon bileaflet valve: a 9.8-year experience. Clinical performance of the prosthesis after heart valve replacement in 587 patients.

Objectives: To determine early and mid-term clinical performance of the Sorin Bicarbon bileaflet prosthesis.
Methods: Between January 1993 and October 2000, 1092 patients received at least one Sorin Bicarbon prosthesis. Six hundred and fourteen of those fulfilled the inclusion criteria and were contacted by mail and/or telephone interview. Five hundred and eighty-seven (95.6%) patients aged 16.2-85.9 years (mean 61.5 years), 368 males and 219 females, were available for clinical evaluation. Four hundred and fifteen patients underwent aortic--(AVR) (70.7%), 122 mitral--(MVR) (20.8%), 50 double valve replacement (DVR) (8.5%). 86.4% of the patients were in NYHA functional class III or IV. Cumulative duration of follow-up is 2474 patient-years (py) with a maximum of 9.8 years.
Results: Overall hospital mortality (30 days) rate was 4.2% (n=26). The early mortality rate was significantly higher in females and patients older than 70 years (P<0.05). Valve related early deaths were not documented. There were 49 late deaths (8.3%). Overall late mortality was 1.98%/patient-years. Cumulative survival rate at 9.8 years was for AVR, MVR and DVR, 80.1, 95.1 and 76.4, respectively. Multivariable logistic analysis identified high age at operation (>or=70 years) as an independent mortality risk factor (P=0.03). Valve related complications were thromboembolism: 1.33%/patient-years (n=34), anticoagulant related hemorrhage: 1.21%/patient-years (n=30), bacterial endocarditis: 0.16%/patient-years (n=4), reoperation: 0.69%/patient-years (n=17), paravalvular leak: 0.69%/patient-years (n=17). No structural dysfunction of the prosthesis has been reported. Actuarial freedom from complications at 9.8 years was: thromboembolism 86.7%, major hemorrhage 92.3%, prosthetic valve endocarditis 99.1% and reoperation 95.8%.
Conclusions: Sorin Bicarbon prosthesis provides excellent clinical results and mid-term survival with very low complication rates comparable with those of other bileaflet prostheses currently in use.