Evaluating the Performance of Cardiac Pulse Duplicators Through the Concept of Fidelity.

Abstract

The advanced design techniques used in modern prosthetic heart valve (PHV) development require accurate replication of the entire cardiac cycle. While cardiac pulse duplicator (CPD) design has a direct impact on the PHV test data generated, no clear guidelines exist to evaluate the CPD's performance. In response to this, we present a method to quantitatively assess CPD performance. A method to establish the fidelity of CPDs was formulated based on the pressure/time relationship and the error related to this relationship's target. This method was applied to assess the performance of a custom-made CPD. The performance evaluation included the assessment of the motion control system and overall repeatability of pressure measurements using a St Jude Epic 21mm aortic valve. The CPD's motion control system had an average root mean square error (RMSE) beat-to-beat tracking accuracy of 0.046 ± 0.008mm. Assessment of the pressure measurements yielded a repeatability of < 2.4 ± 0.9mmHg RMSE beat-to-beat differential pressure. The combination of pressure and its location within a heartbeat (fidelity) was within 5.0% of the individual targets for at least 95% of heartbeats. Fidelity can be used to objectively quantify the performance of various aspects of CPDs and to identify the cause of unexpected PHV or CPD behaviour. It also enables comparisons to be made among various CPDs in terms of overall performance. This approach may enable standardization of the assessment of CPD performance in the future.