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

Introduction 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. Results 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