Effect of bioprosthetic leaflet anisotropy on stent dynamics of Transcatheter Aortic Valve Replacement devices

The assessment of stent fatigue in Transcatheter Aortic Valve Replacement (TAVR) systems is critical for the design of next-generation devices, both in vitro and in vivo. The mechanical properties of the bioprosthetic heart valves (BHVs) have a significant impact on the fatigue life of the metallic stent and thus must be taken into consideration when evaluating new TAVR device designs. This study aims to investigate the relationship between BHV anisotropic behaviour and the asymmetric deflections of the stent frame observed during in vitro testing. An explicit dynamics finite element model of the nitinol stent with attached bioprosthetic valve leaflets was developed to evaluate the deflections of the TAVR device under haemodynamic loading. Our results demonstrate that pericardium behaviour plays a dominant role in determining stent frame deflection. The anisotropic behaviour of the leaflets, resulting from collagen fibre orientation, affects the extent of deflection encountered by each commissure of the frame. This leads to asymmetric variation in frame deflection that can influence the overall fatigue life of the nitinol stent. This study highlights the importance of considering both the flexible nature of the metallic stent as well as the leaflet anisotropic behaviour in the design and fatigue assessment of TAVR systems.