Fluid\u2013Structure Interaction Models of Bioprosthetic Heart Valve Dynamics in an Experimental Pulse Duplicator

Jae H Lee,Alex D Rygg,Nandini Duraiswamy,Boyce E Griffith,Lawrence N Scotten,Ebrahim M Kolahdouz,Simone Rossi,Brent A Craven,Stephen M Retta

doi:10.1007/s10439-020-02466-4

Abstract

Computer modeling and simulation is a powerful tool for assessing the performance of medical devices such as bioprosthetic heart valves (BHVs) that promises to accelerate device design and regulation. This study describes work to develop dynamic computer models of BHVs in the aortic test section of an experimental pulse-duplicator platform that is used in academia, industry, and regulatory agencies to assess BHV performance. These computational models are based on a hyperelastic finite element extension of the immersed boundary method for fluid–structure interaction (FSI). We focus on porcine tissue and bovine pericardial BHVs, which are commonly used in surgical valve replacement. We compare our numerical simulations to experimental data from two similar pulse duplicators, including a commercial ViVitro system and a custom platform related to the ViVitro pulse duplicator. Excellent agreement is demonstrated between the computational and experimental results for bulk flow rates, pressures, valve open areas, and the timing of valve opening and closure in conditions commonly used to assess BHV performance. In addition, reasonable agreement is demonstrated for quantitative measures of leaflet kinematics under these same conditions. This work represents a step towards the experimental validation of this FSI modeling platform for evaluating BHVs.

Highlights

Worldwide, nearly 300,000 aortic valve replacements are performed annually, and the rate of heart valve replacement is projected to exceed 850,000/year by 2050.16 Bioprosthetic heart valves (BHVs) are commonly constructed from fixed porcine heart valves or bovine or porcine pericardial tissues
This study develops a computational fluid–structure interaction (FSI) model based on the immersed boundary (IB) method of an experimental pulse-duplicator platform for simulating BHV dynamics
This study has developed FSI models of BHVs in an experimental pulse-duplicator platform

Summary

Introduction

Nearly 300,000 aortic valve replacements are performed annually, and the rate of heart valve replacement is projected to exceed 850,000/year by 2050.16 Bioprosthetic heart valves (BHVs) are commonly constructed from fixed porcine heart valves or bovine or porcine pericardial tissues. BHVs generate flow patterns that mimic those of the normal human aortic valve and typically allow patients to be managed without chronic anticoagulation.[58]. Computer modeling and simulation (CM&S) can be used throughout the life cycle of prosthetic valve design and regulatory approval. Credible simulation data may be leveraged in regulatory applications to support claims of device safety and effectiveness. Using modeling and simulation to support regulatory decisionmaking is a strategic priority area for the U.S FDA Center for Devices and Radiological Health.[54].

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Conclusion