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Early single centre experience with 192 Sorin Bicarbon valves.
1London Chest Hospital, The Royal Hospitals Trust, UK.
The Journal of Cardiovascular Surgery
|December 1, 1996
Summary
The Bicarbon bileaflet heart valve demonstrated favorable outcomes in 177 patients, with no thromboembolic events and improved clinical status. This innovative valve is comparable to other leading bileaflet options.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Device Engineering
Background:
- Sorin Biomedica introduced the Bicarbon pyrolytic bileaflet heart valve in 1990.
- The valve features innovative design, materials, housing, hinge mechanism, leaflet curvature, and sewing ring construction.
Purpose of the Study:
- To evaluate the clinical performance and hemodynamic characteristics of the Bicarbon heart valve.
- To compare the Bicarbon valve's efficacy against existing bileaflet heart valves.
Main Methods:
- Implantation of 192 Bicarbon valves in 177 patients between June 1991 and May 1995.
- Patient demographics included age range 16-82 years, with 102 males and 75 females.
- Follow-up included clinical assessment and Doppler echocardiography for hemodynamic evaluation.
Main Results:
- Overall hospital mortality was 5.2% (AVR: 4.7%, MVR: 12.7%).
- No thromboembolic complications or valve-related deaths were observed.
- All surviving patients showed improved clinical status; Doppler evaluation showed mean pressure drops of 8.34 mmHg (mitral) and 15.85 mmHg (aortic).
Conclusions:
- The Bicarbon valve exhibits promising clinical and hemodynamic results.
- The valve appears equivalent to other high-performing bileaflet heart valves currently available.