Validation of a Fluid-Structure Interaction Model for the Characterization of Transcatheter Mitral Valve Repair Devices

Mitral regurgitation (MR) is the second most frequent indication for heart valve surgery and catheter interventions. According to European and US-American guidelines, transcatheter mitral valve repair in general and transcatheter edge-to-edge repair (TEER) in particular may be considered as a treatment option for selected high-risk patients. However, the biomechanical impact of TEERdevices on the mitral valve (MV) has not yet been fully understood. To address this problem, a 3D-Fluid-Structure Interaction (FSI) framework utilizing non-linear Finite Element Analysis (FEA) for the MV apparatus and Smoothed Particle Hydrodynamics (SPH) for the pulsatile fluid flow was developed and validated against in vitro data. An artificial MV-model (MVM) with a prolapse in the A2-P2 region and a custom-made TEER device implanted in the A2-P2 region were used for the in vitro investigations. In accordance with ISO 5910, projected mitral orifice areas (PMOA), flow rates as well as atrial and ventricular pressures were measured under pulsatile flow conditions before and after TEER device implantation. For the FSI-model, the MVM geometry was reconstructed by means of microcomputed tomography in a quasi-stress-free configuration. Quasi-static tensile test data was utilized for the development of linear- and hyperelastic material models of the chordae tendineae and leaflets, respectively. The fluid flow was modelled assuming an incompressible, homogenous Newtonian behaviour. Time-varying in vitro transmitral pressure loading was applied as a boundary condition. In vitro investigations show that TEER device implantation in the A2-P2 region effectively reduces the regurgitation fraction (RF) from 55 % to 13 %. Moreover, the comparison of experimental and numerical data yields a deviation of 2.09 % for the RF and a deviation of 0.40 % and 6.47 % for the maximum and minimum PMOA, respectively. The developed FSI-framework is in good agreement with in vitro data and is therefore applicable for the characterization of the biomechanical impact of different TEER devices under pulsatile flow conditions.