Preliminary pulsatile flow bench validation of a thermodilution right ventricular ejection fraction system

Area of Science:

• Cardiovascular Technology
• Medical Device Validation
• Hemodynamics

Background:

• Accurate measurement of Right Ventricular Ejection Fraction (RVEF) is crucial for assessing cardiac function.
• Existing methods for RVEF assessment require validation against reliable benchmarks.
• The REF-1 system is a novel computer and catheter system designed for RVEF measurement.

Purpose of the Study:

• To perform a preliminary validation of the current REF-1 system's accuracy.
• To assess the system's performance in measuring Right Ventricular Ejection Fraction (RVEF) and cardiac output.
• To establish a baseline for future system improvements and broader validation ranges.

Main Methods:

• Utilized a Pulsatile Flow Bench to simulate physiological conditions.
• Tested the REF-1 system across cardiac output ranges of 1 to 6 Lpm and ejection fractions from 15% to 60%.
• Compared measurements from the REF-1 system against established flow bench data.

Main Results:

• Achieved a high correlation coefficient (adjusted R-square) of 0.94 for ejection fraction measurements.
• Demonstrated a strong correlation coefficient (adjusted R-square) of 0.99 for cardiac output measurements.
• The current REF-1 system shows significant accuracy within the tested ranges.

Conclusions:

• The preliminary validation indicates the current REF-1 system is accurate for RVEF and cardiac output measurement.
• Results support the system's potential for clinical application, pending further development and validation.
• Future plans include expanding the validation range to higher cardiac output and ejection fraction values.