Design consideration of a novel polymeric transcatheter heart valve through computational modeling

Transcatheter heart valve replacement is becoming a more routine procedure, and this is further supported by positive outcomes from studies involving low-risk patients. Nevertheless, the lack of long-term transcatheter heart valve (TAV) durability is still one of the primary concerns. As a result, more research has been focused on improving durability through various methods such as valve design, computational modeling, and material selection. Recent advancements in polymeric valve fabrication showed that linear low-density polyethylene (LLDPE) could be used as leaflet material for transcatheter heart valves. In this paper, a parametric study of computational simulations showed stress distribution on the leaflets of LLDPE-TAV under diastolic load, and the results were used to improve the stent design. The in silico experiment also tested the effect of shock absorbers in terms of valve durability. The results demonstrated that altering specific stent angles can significantly lower peak stress on the leaflets (13.8 vs. 6.07 MPa). Implementing two layers of shock absorbers further reduces the stress value to 4.28 MPa. The pinwheeling index was assessed, which seems to correlate with peak stress. Overall, the parametric study and the computational method can be used to analyze and improve valve durability.