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.
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.