The impact of implantation depth of the Lotus™ valve on mechanical stress in close proximity to the bundle of His.

It has been proposed that inappropriate positioning of transcatheter aortic valves (TAVs) is associated with procedural complications and decreased device durability. Second-generation TAVs allow for repositioning giving greater control over the final deployment position. However, the impact of positioning on the tissue surrounding these devices needs to be better understood, in particular for the interleaflet triangle in which the conductance system (bundle of His) resides. In this study, we investigate the impact of implantation depth on the frame-tissue interaction for a next-generation repositionable Lotus™ valve. For this purpose, a computational model simulating deployment of the Lotus valve frame into a calcified patient-specific aortic root geometry was generated to predict aortic root stress and frame eccentricity at three different deployment depths. The results of this study predicted that positioning of the Lotus valve had an influence on the stresses in the aortic sinus and frame eccentricity. An analysis of levels of stress arising in the vicinity of the bundle of His, as a function of implantation depth, was conducted, and it was found that, for the specific patient anatomy studied, although the sub-annular position showed reduced peak stress in the aortic sinus, this implantation position showed the highest stress in the area of greatest risks of conductance interference. In contrast, while a supra-annular position increased the peak arterial stress, this implantation position resulted in lower stress in the interleaflet triangle and thus might reduce the risk of conductance interference. These results provide pre-operative information that can inform clinical decision-making regarding TAVI positioning.