Endovascular treatment of atherosclerotic lower limb lesions using a PTFE-collared stent-graft

Purpose: To assess the feasibility of a polytetrafluoroethylene-collared (P TFE) endoluminal graft in the treatment of lower limb atherosclerosis. Methods: We designed an endograft using a 3-mm-diameter balloon-expandable PTFE graft with terminal Palmaz stents placed on the outside of the graft, folding the PTFE back over the stents to form a collar at each end. Under p rotocol, this device was implanted in 8 symptomatic patients with lower lim b ischemia. The lesions, ranging from 4 to 20 cm long, were located in the superficial femoral artery (n = 5), femoropopliteal segment (n = 1), and co mmon (n = 1) and external (n = 1) iliac arteries. The device required a 14- F introducer system. Results: Graft lengths varied from 4 to 35 cm. Implantation was successful in all cases, but procedural complications occurred in 4 patients (2 access site hematomas, 1 leading to endograft occlusion; 1 arterial injury, and 1 distal thromboembolism). At a mean 14-month follow-up, 5 endografts were p atent (2 after reintervention for restenosis or thrombosis). The common ili ac endograft and 2 superficial femoral artery devices occluded after 3, 2, and 12 months, respectively. Conclusions: Although this endoluminal graft system is technically feasible and showed encouraging intermediate-term patency in a small pilot study, t he early and late complications identified several shortcomings of this des ign, which needs refinement.