Fifteen-year experience with the Bicarbon heart valve prosthesis in a single center

BACKGROUND: The purpose of this study was to evaluate retrospectively the clinical performance of the Bicarbon valve (Sorin Biomedica Cardio, Saluggia, Italy) implanted at our center in Japan. METHODS: Between January 1997 and December 2011, 415 patients in our institution were implanted with the Bicarbon valve. Nine of these recipients were excluded from the study because they had already undergone valve implantation and received a Bicarbon valve in a different position. The remaining patients were analyzed for evaluation of the postoperative clinical outcomes. Of the 406 patients (mean age 60.2 ± 11.7 years), 179 underwent aortic valve replacement (AVR), 149 mitral valve replacement (MVR), and 78 both aortic and mitral valve replacement (DVR). RESULTS: There were 10 early deaths (2.5 %: 4 in the AVR group and 6 in the MVR group). Three hundred eighty-nine patients were followed up (95.8 % completeness of follow-up) with a mean follow-up of 6.6 ± 4.2 years overall (AVR 6.8 ± 4.2, MVR, 6.7 ± 4.4, and DVR 5.7 ± 3.4 years) and a cumulative follow-up of 2661 patient-years (1214, 1001, and 446 patient-years for AVR, MVR, and DVR, respectively). Ninety-nine patients died (3.7 % per patient-year: 22 valve-related and 77 valve-unrelated deaths). Survival at 10 years was 74.1 ± 4.0 % in the AVR group, 73.7 ± 4.2 % in the MVR group, and 61.0 ± 7.9 % in the DVR group. The linearized incidence of thromboembolic complications, bleeding complications, prosthetic valve endocarditis, paravalvular leaks, and sudden death in all patients was 0.5 %, 0.5 %, 0.2 %, 0.2 %, and 0.4 % per patient-year, respectively. The incidence of valve-related complications and reoperation was 1.6 % and 0.4 %, respectively. No other valve-related complications were observed. CONCLUSIONS: The Bicarbon prosthetic heart valve has shown excellent clinical results and is associated with a low incidence of valve-related complications.