Parameters and methods for testing artificial heart valves

Area of Science:

• Biomedical Engineering
• Medical Device Testing
• Cardiovascular Research

Background:

• Establishing robust quality assurance for heart valves is critical.
• Standardized in vitro testing is needed to define minimum performance requirements.
• Current testing methods require enhancement for comprehensive valve assessment.

Purpose of the Study:

• To develop comprehensive in vitro test standards for heart valves.
• To define minimum requirements for heart valve performance through comparative assessment.
• To advance the quality assurance of prosthetic heart valves.

Main Methods:

• Defined preliminary test parameters including geometrical, flow, deformation, force, and conditioning.
• Developed a system of geometrical parameters using standardized aortic models.
• Utilized quasi-steady flow measurement devices for leakage and pressure loss testing.

Main Results:

• A strong correlation was found between geometrical and hemodynamic parameters in 31 tested valves.
• The relative ostium cross-section (Ae/AT) ranges from 0.3 to 0.5, increasing with valve size.
• Two novel measurement devices were proposed for efficient leakage flow and pressure loss testing.

Conclusions:

• The developed geometrical parameters and testing methods provide a basis for standardized heart valve assessment.
• The findings support the definition of minimum requirements for heart valve quality assurance.
• New measurement devices offer potential for quicker and more effective in vitro valve testing.