Abstract
BacgroundWe have previously reported mid-term results of a study, which ended in January 2000, on the Bicarbon valve. The study concluded that the valve showed excellent clinical results, associated with a low incidence of valve-related complications. In the present study, the same patients were prospectively followed for an additional 5 years.MethodsForty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 ± 11.3 years. The mean follow-up was 6.1 ± 1.9 years with a cumulative follow-up of 616 patient-years.ResultsThere were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 21 late deaths (3.4%/patient-year: 5 valve related deaths and 16 valve unrelated deaths). Survival at 8 years was 75.2 ± 7.0% in the AVR group, 76.6 ± 6.2% in the MVR group, and 55.4 ± 16.1% in the DVR group. The linearized incidence of thrombo-embolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 0.65 ± 1.48%, 0.81 ± 1.69%, and 0.16 ± 0.54%/patient-year respectively. No other complications were observed.ConclusionThe Bicarbon prosthetic heart valve has shown excellent long-term clinical results, associated with a low incidence of valve-related complications.
Highlights
Both mechanical and bioprosthetic heart valves have become more durable and less thrombogenic, possessing excellent clinical outcomes and hemodynamic features
One valve related death occurred in the aortic valve replacement (AVR) group, 2 in the mitral valve replacement (MVR) group and 2 in the DVR group
91.4% of the patients were in the New York Heart Association (NYHA) functional class III or IV, and 96.8% were in class I or II at follow-up
Summary
Both mechanical and bioprosthetic heart valves have become more durable and less thrombogenic, possessing excellent clinical outcomes and hemodynamic features. Lifelong anticoagulant therapy is inevitable for patients with mechanical prosthetic valves, and those with bioprosthetic valves have higher risks of structural valve dysfunction than those with mechanical ones. Bileaflet prosthetic heart valves are more preferably implanted than tilting disc valves, and surgeons choose some of them for valve replacement according to their own preference and the patients' informed consent. Many long-term clinical results showed excellent clinical performances of mechanical prostheses. The Bicarbon valve (Sorin Biomedica Cardio, Saluggia, Italy) was introduced for clinical application at our institute in 1997 [1].
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