Key result
The Sorin Bicarbon prosthesis demonstrated reliable long-term durability, with 15-year actuarial survival of 61.4% for aortic, 63.4% for mitral, and 56.4% for double valve replacement.
Observational (n=1,704)
Yes
The Sorin Bicarbon mechanical prosthesis demonstrates excellent long-term durability with no structural failures and acceptable rates of valve-related complications at 15 years.
Supports observed durability of Sorin Bicarbon; extends observational data but leaves open randomized comparisons with contemporary valves.
OBJECTIVES: To present the results of a 15-year follow-up of the Sorin Bicarbon prosthesis (SBP) from a European multicentre study. METHODS: From 1990 to 1996, a total of 1900 SBPs were implanted in 1704 patients, with a mean age of 59±13 years, as aortic (AVR, 922 patients), mitral (MVR, 586) or mitro-aortic (DVR, 196) valve replacement. Most patients received an SBP for rheumatic or degenerative valve disease. Concomitant procedures were performed in 25% of cases, mainly coronary artery bypass grafting (14%) or tricuspid annuloplasty (7%). RESULTS: There were 70 (4.1%) early deaths. Actuarial survival at 15 years is 61.4% (95% confidence interval (CI): 56.4-66.0) for AVR, 63.4% (59.1-67.5) for MVR, 56.4% (47.3-64.6) for DVR. Late valve-related deaths were 260 with an actuarial freedom from valve-related deaths at 15 years of 76.4% (81.5-83.7). There were 27 cases of SBP thrombosis with an actuarial freedom from this complication at 15 years of 99.6% (98.6-99.9) after AVR, 95.8% (93.0-97.5) after MVR and 97.0% (92.8-98.7) after DVR. Thrombo-embolic episodes were 159; actuarial freedom from thrombo-embolism at 15 years is 88.8% (86.8-90.5). Haemorrhages related to anticoagulant treatment occurred in 293 cases with 39 fatal episodes; actuarial freedom at 15 years is 77.5% (74.2-80.4). There were 45 episodes of endocarditis, 21 required re-operation; actuarial freedom from endocarditis at 15 years is 96.8% (95.6-97.7). Re-operation was performed in 71 patients (non-structural valve deterioration in 28, endocarditis in 21, SBP thrombosis in 15 and non-valve-related causes in seven patients). No cases of structural failure were observed. Actuarial freedom from re-operation at 15 years is 97.6% (96.3-98.5) after AVR, 92.8% (90.1-94.8) after MVR and 90.7% (85.2-94.2) after DVR. CONCLUSIONS: The SBP continues to perform satisfactorily even in the long term with low incidence of valve-related mortality and morbidity confirming to be an extremely reliable and durable mechanical valve substitute.
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Azarnoush et al. (2010) conducted an observational in Rheumatic or degenerative valve disease (n=1,704). Sorin Bicarbon prosthesis was evaluated on Actuarial survival at 15 years (aortic valve replacement) (95% CI 56.4-66.0). The Sorin Bicarbon prosthesis demonstrated reliable long-term durability, with 15-year actuarial survival of 61.4% for aortic, 63.4% for mitral, and 56.4% for double valve replacement.
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