Surgical feasibility study of a novel polytetrafluoroethylene graft design for the treatment of peripheral arterial disease.

Disturbed flow patterns, material mismatch, and surgical injury are often cited as being significant contributors to failure at the distal end of femoropopliteal bypass grafts. The objective of this research is to propose a novel bypass graft design concept which seeks to reduce the incidence of disturbed flow in the bypass junction and to establish the surgical feasibility of the proposed device. A preliminary evaluation of the hemodynamic benefit associated with the proposed device was made using computational fluid dynamics. A prototype of the device was then constructed from commercially available materials, and it was prepared for implantation into the aorta of a pig. The computational model of the proposed device showed that significant flow correction was occurring in the in vitro model due to the geometric configuration of the design. The magnitude of the peak wall shear stress in the recirculation region was noted to decrease by 78%. Surgical feasibility of the proposed device was verified by successful implantation into the aorta of the pig. The pig was sacrificed after 7 weeks, the graft and host artery were excised, and histological examination downstream from the distal junction showed that intimal hyperplasia had developed in the host artery. The proposed device is surgically feasible and may offer a significant hemodynamic advantage over current graft designs.