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Bicarbon valve -- European multicenter clinical evaluation

J B Borman1, W G Brands, L Camilleri

  • 1Bikur Cholim Hospital, Jerusalem, Israel. Borman@cc.huji.ac.il

European Journal of Cardio-Thoracic Surgery : Official Journal of the European Association for Cardio-Thoracic Surgery
|August 1, 1998
PubMed
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The Bicarbon bileaflet valve shows good durability and hemodynamic function, with a low complication rate in over 1300 patients. This mechanical prosthesis offers excellent long-term outcomes for valve replacement surgery.

Area of Science:

  • Cardiovascular Surgery
  • Biomedical Engineering
  • Prosthetic Heart Valves

Background:

  • The Bicarbon bileaflet valve is a novel mechanical prosthesis for heart valve replacement.
  • Pooled data from multiple international centers are crucial for evaluating new medical devices.

Purpose of the Study:

  • To assess the safety and efficacy of the Bicarbon bileaflet valve through pooled international experience.
  • To report on early and late outcomes, including mortality, valve-related complications, and functional improvement.

Main Methods:

  • A retrospective analysis of 1351 patients undergoing valve implantation (aortic, mitral, or double valve replacement) between April 1990 and April 1996.
  • Data collected from fifteen collaborating centers across eight countries.
  • Follow-up included assessment of mortality, thromboembolism, bleeding, hemolysis, valve dysfunction, endocarditis, and reoperation rates.

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Main Results:

  • Overall mortality included 67 early and 56 late deaths. Valve-related deaths were 7 early and 40 late.
  • Major complications included valve thrombosis (9 cases), embolism (46 cases), major bleeding (29 cases), and endocarditis (24 cases).
  • Estimated 5-year freedom from valve-related death was 97.2% for AVR, 92.4% for MVR, and 4-year freedom was 90.5% for DVR. Mean NYHA improvement was 1.24.

Conclusions:

  • The Bicarbon mechanical prosthesis demonstrates favorable design, durability, and hemodynamic performance.
  • The valve exhibits an acceptably low incidence of complications, supporting its clinical utility.
  • Long-term freedom from valve-related death rates are encouraging across different valve replacement procedures.