The Bicarbon heart valve prosthesis: short-term results.

BACKGROUND AND AIMS OF THE STUDY: To determine the short-term results of the Bicarbon (Sorin Biomedica, Saluggia, Italy) heart valve prosthesis at our institution.

METHODS: Between November 1991 and December 1995, 256 patients (mean age 59.9 +/- 9.8 years) underwent valve replacement with a Bicarbon valve prosthesis. The mean ejection fraction was 60 +/- 14.8% and the mean left ventricular end-diastolic pressure 15.9 +/- 8.7 mmHg. Redo (n = 61) and combined procedures (n = 72) were included in this study; mixed types of prostheses were excluded. The procedures were divided into groups: aortic valve replacement (n = 163), mitral valve replacement (n = 60) and aortic-mitral (double) valve replacement (n = 33). Kaplan-Meier survival analysis was performed and predictors for survival were tested univariately and multivariately.

RESULTS: The mean follow up was 30 +/- 25.1 months with a total of 7,696 patient-months (641.3 patient-years) and was 100% complete. The Kaplan-Meier survival rate at 48 months was 87 +/- 2%. The valve-related morbidity expressed as linearized incidence rate (% per patient-year) was: anticoagulation bleeding 2.3 +/- 0.6; thromboembolic event 1.0 +/- 0.4; periprosthetic leak 0.6 +/- 0.3; and endocarditis 0.3 +/- 0.2. Univariate significant factors for worse survival were: higher preoperative New York Heart Association (NYHA) functional class, valve implantation site, presence of associated operation, increasing age, decreasing ejection fraction, longer aortic cross-clamp time, and longer cardiopulmonary bypass time. In multivariate analysis longer aortic cross-clamp time and higher preoperative NYHA classification were significant independent predictors.

CONCLUSIONS: These good short-term results after Bicarbon valve replacement are encouraging and comparable with those obtained with other bileaflet mechanical heart valves. However, further follow up is mandatory.