Sorin Bicarbon bileaflet valve: a 10-year experience

Area of Science:

• Cardiovascular Surgery
• Biomaterials Science
• Clinical Outcomes Research

Background:

• Mechanical heart valves are crucial for treating valvular heart disease.
• The Sorin Bicarbon (SB) mechanical prosthesis is a widely used option.
• Long-term, multi-center data on its performance is essential for clinical decision-making.

Purpose of the Study:

• To evaluate the 10-year clinical performance of the Sorin Bicarbon mechanical prosthesis.
• To assess survival, valve-related complications, and functional outcomes.
• To provide a comprehensive analysis from a large, collaborative European study.

Main Methods:

• A 10-year retrospective analysis of 2078 Sorin Bicarbon valves implanted between April 1990 and December 1996.
• Data collected from 1875 patients across 14 centers in eight Western European countries.
• Included aortic valve replacement (AVR), mitral valve replacement (MVR), and double valve replacement (DVR) procedures.

Main Results:

• Overall survival at 8 years was favorable across AVR (71.8%), MVR (69.4%), and DVR (81.4%).
• Low rates of valve-related death (95% freedom at 8 years) and thrombosis (98.5% freedom at 8 years).
• Significant functional improvement (78% improved NYHA status) with manageable rates of embolism (90.7% freedom at 8 years) and bleeding (90.8% freedom at 8 years).

Conclusions:

• The Sorin Bicarbon mechanical prosthesis is a durable and effective option for heart valve replacement.
• It offers low rates of morbidity and mortality, contributing to good functional outcomes.
• This large-scale study supports its continued use in clinical practice.