Clinical experience with the Bicarbon heart valve prosthesis

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science

Background:

• Previous mid-term results of the Bicarbon valve study (ending Jan 2000) showed excellent clinical results and low valve-related complications.
• This study prospectively followed the same patient cohort for an additional 5 years to assess long-term outcomes.

Purpose of the Study:

• To evaluate the long-term clinical performance and safety of the Bicarbon prosthetic heart valve.
• To assess survival rates and the incidence of complications in patients who received Bicarbon valves for aortic, mitral, or double valve replacement.

Main Methods:

• A prospective follow-up study of 105 patients who underwent aortic valve replacement (AVR), mitral valve replacement (MVR), or double valve replacement (DVR) with Bicarbon valves.
• Mean patient age was 61.2 years; mean follow-up was 6.1 years, totaling 616 patient-years.
• Data collected included early and late mortality, survival rates, and linearized incidences of thrombo-embolic events, hemorrhagic complications, and paravalvular leaks.

Main Results:

• Five early deaths (4.7%) occurred. Late mortality was 3.4%/patient-year, with 5 valve-related and 16 valve-unrelated deaths.
• Eight-year survival rates were 75.2% (AVR), 76.6% (MVR), and 55.4% (DVR).
• Low incidences of complications were observed: thrombo-embolic (0.65%/patient-year), hemorrhagic (0.81%/patient-year), and paravalvular leaks (0.16%/patient-year).

Conclusions:

• The Bicarbon prosthetic heart valve exhibits excellent long-term clinical results.
• The valve is associated with a low incidence of major valve-related complications, supporting its use in valve replacement procedures.