Leaflet Stresses During Full Device Simulation of Crimping to 6 mm in Transcatheter Aortic Valve Implantation, TAVI

Abstract

Abstract Background With continuing growth in transcatheter aortic valve implantation for the treatment of a failing aortic valve, there is increasing interest in prosthetic valve durability and the potential damage caused to leaflets by stress. Whilst most available research into the computational prediction of leaflet stresses using finite element analysis, FEA, has focussed on variations during dynamic loading, very little appears to have been reported for the impact of crimping, even though awareness of this effect is widespread. Potentially, this has been due to the difficulty of performing full model simulations of crimping to clinically meaningful diameters. Method A full model comprising a self-expanding frame, skirt and leaflets has been developed and crimped to a final diameter of 6 mm. A detailed description is provided of the FEA setup, emphasising the importance of the skirt definition needed to successfully crimp to this small diameter. Then, an analysis of leaflet folding and stresses is presented, particularly with respect to the differences produced between leaflet thicknesses of 0.20, 0.25 and 0.30 mm and for bioprosthetic and polymeric leaflet material models. Results In all cases, peak stresses occurred close to the modelled suture lines joining the leaflets and the skirt and high stresses were also present along axially aligned folds in the leaflets. Stresses were lower for the polymeric leaflets. Conclusion Successful simulation of crimping requires a finely resolved skirt mesh. Leaflet stresses during crimping are dependent on leaflet thickness, material properties and the ratio of leaflet volume to the available volume inside the crimped valve.