In silico modeling of transcatheter heart valve oversizing and ellipticity, Part II: Effects on leaflet mechanics, hemodynamics, and stent deflection contributing to thrombogenic risk and structural degeneration

Background and objectives Transcatheter aortic valve implantation (TAVI) is the leading treatment for aortic stenosis. Self-expanding transcatheter heart valves (THVs) are oversized to prevent paravalvular leakage and then deployed over the diseased native valve. However, this can result in incomplete expansion and elliptical deployment, which may influence thrombogenic risk and structural degeneration, although this is not fully understood. Methods In this study, we utilized a validated in silico framework to assess the impact of THV oversizing and ellipticity on leaflet mechanics, hemodynamic shear stress and stent deformation, which are indicators of structural degeneration and thrombogenicity. We simulated self-expansion of a deformable THV stent within an idealized aortic annulus, applied pulsatile loading conditions representative of the cardiac cycle and then evaluated post-deployment frame deformation, leaflet mechanics, hemodynamics and stent fatigue. Results We predicted stent-frame decoupling of the supra-annular THV, with increased expansion and circularity at the functional valve level compared to the inflow. THV oversizing reduced valve expansion at the supra-annular valve level (' 90% expansion), which increased leaflet coaptation and pinwheeling, but reduced peak leaflet stresses and stent deflection compared to nominal sizing. Oversizing also altered hemodynamics, causing early mainstream flow separation, which increased leaflet oscillatory shear and viscous shear stress downstream of the THV, potentially increasing thrombogenic risk and promoting tissue degeneration. THV ellipticity induced heterogenous stent deflections, leading to variable leaflet stress distributions and coaptation mismatch. Conclusion We propose that flexible THV stents may mitigate adverse effects of elliptical deployment and emphasize the importance of assessing THV expansion through fluoroscopy and considering post-TAVI balloon-dilatation to increase expansion and improve long-term functional valve performance.