Evaluating the Performance of Cardiac Pulse Duplicators Through the Concept of Fidelity
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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.
Materials and Methods
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 21 mm aortic valve.
The CPD’s motion control system had an average root mean square error (RMSE) beat-to-beat tracking accuracy of 0.046 ± 0.008 mm. Assessment of the pressure measurements yielded a repeatability of < 2.4 ± 0.9 mmHg 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.
KeywordsHeart valve testing Cardiac pulse duplicator Fidelity In vitro hemodynamics Prosthetic heart valves Performance assessment
The authors wish to thank Dr. Helmuth Weich and Prof Anton Doubell (Division of Cardiology, Tygerberg Hospital and Stellenbosch University, South Africa) for supplying the prosthetic heart valve used in this study.
Conflict of interest
RA Rodriguez and JH Muller declare that they have no conflict of interest. KH Dellimore is an employee of Philips Research, in Eindhoven, The Netherlands.
No human studies were carried out by the authors for this article.
No animal studies were carried out by the authors for this article.
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