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Comparison of prosthetic valve hydrodynamic function: objective testing using statistical multilevel modeling
Gillian M Bernacca1, John H McColl, David J Wheatley
1Departments of Cardiac Surgery and Statistics, University of Glasgow, Glasgow, UK.
The Journal of Heart Valve Disease
|June 30, 2004
Summary
This study introduces a new statistical method for objectively comparing prosthetic heart valve designs using in-vitro hydrodynamic tests. The multilevel modeling approach effectively identified significant performance differences between various tri-leaflet valve designs.
Area of Science:
- Biomedical Engineering
- Materials Science
- Statistics
Background:
- Novel prosthetic heart valves require rigorous in-vitro hydrodynamic assessment.
- Objective discrimination between valve designs is crucial for development.
- Five different polyurethane tri-leaflet valve designs were evaluated.
Purpose of the Study:
- To assess the hydrodynamic performance of novel prosthetic heart valves.
- To develop and illustrate a methodology for objective discrimination between valve designs.
- To identify significant differences in performance among five polyurethane tri-leaflet valve designs.
Main Methods:
- Utilized a standard hydrodynamic test rig with six valves per design tested at five flow rates.
- Employed multilevel statistical modeling to analyze valve performance data.
- Modeled hydrodynamic function (e.g., pressure gradient, leakage) against logarithmic RMS flow.
Main Results:
- The multilevel model quantitatively discriminated between designs GE and LE, with GE showing superior hydrodynamic function.
- Designs L4 and L5 exhibited relatively poor hydrodynamic performance compared to other designs.
- The methodology provided a straightforward statistical comparison of valve designs, not easily achievable by other means.
Conclusions:
- The proposed methodology offers a valuable tool for objective assessment of prosthetic heart valve function.
- Variance estimates from the analysis support quality control in valve production and testing.