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Single leg separation prevalence among explanted Björk-Shiley prosthetic heart valves
William J Blot1, Lisa B Signorello, Sarah S Cohen
1International Epidemiology Institute, Rockville, MD 20850, USA. blotw@iei.ws
The Journal of Heart Valve Disease
|December 22, 2007
Summary
Single leg separations (SLS) may affect up to 6.8% of Björk-Shiley convexo-concave (BSCC) valves. This research estimates SLS prevalence in BSCC valves, aiding potential patient screening strategies.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Prosthetic Devices
Background:
- Björk-Shiley convexo-concave (BSCC) valves implanted in over 86,000 patients worldwide.
- Limited data exists on single leg separations (SLS) of BSCC valve outlet struts.
- SLS is a potential precursor to complete valve fracture.
Purpose of the Study:
- To determine the prevalence of single leg separations (SLS) in explanted Björk-Shiley convexo-concave (BSCC) prosthetic heart valves.
- To analyze SLS prevalence based on valve characteristics such as size, angle, and position.
- To estimate the potential number of BSCC valves with SLS in the global patient population.
Main Methods:
- Manufacturer data on explanted valves and SLS examinations were compiled.
- Valve characteristics (size, angle, position) were analyzed in relation to SLS prevalence.
- Global BSCC valve distribution data were used to extrapolate SLS prevalence.
Main Results:
- Overall SLS prevalence in examined valves was 8.2%.
- SLS prevalence was significantly higher in larger valves (29+ mm) and showed non-significant trends for mitral position and 70-degree angle.
- Estimated global prevalence of SLS in BSCC valves is 6.8% (95% CI 4.1-9.4%).
Conclusions:
- SLS may affect an estimated 820 to 1,880 BSCC valves in surviving patients worldwide.
- These estimates provide context for potential patient screening strategies.
- The development of imaging and acoustic techniques for SLS detection is crucial for patient management.
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