Inter-laboratory comparisons: approaching a new standard for prosthetic heart valve testing in vitro

Area of Science:

• Biomedical Engineering
• Medical Device Evaluation
• Cardiovascular Devices

Background:

• Current standards for prosthetic heart valve evaluation, focusing on pressure drops and regurgitant flow, are insufficient and ambiguous.
• Insufficient standards fail to address critical issues like thrombosis and structural damage.
• Ambiguity in standards leads to inconsistent results across different pulse duplicator systems.

Purpose of the Study:

• To explore the physical sources of disagreement in pressure and flow measurements between pulse duplicator systems.
• To suggest methods for accounting for these physical phenomena to improve inter-system similarity.
• To inform the development of new standards for testing chambers that enhance consistency in prosthetic heart valve evaluation.

Main Methods:

• Analysis of physical phenomena causing measurement discrepancies in pulse duplicators.
• Exploration of factors contributing to variability in pressure and flow measurements.
• Review of existing studies on pulse duplicator system variability.

Main Results:

• Identified key physical phenomena responsible for inconsistent pressure and flow measurements.
• Proposed strategies to mitigate ambiguity and improve similarity between pulse duplicator systems.
• Highlighted the need for updated standards to address measurement inconsistencies.

Conclusions:

• Addressing the ambiguity in current standards is crucial for reliable prosthetic heart valve testing.
• Developing standardized testing chambers can improve the comparability of results across different laboratories.
• Enhanced standards will facilitate more accurate evaluation of prosthetic heart valve performance without stifling innovation.