ABSTRACT
PURPOSE: To assess the feasibility of a polytetrafluoroethylene-collared (PTFE) 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 protocol, this device was implanted in 8 symptomatic patients with lower limb ischemia. The lesions, ranging from 4 to 20 cm long, were located in the superficial femoral artery (n = 5), femoropopliteal segment (n = 1), and common (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 patent (2 after reintervention for restenosis or thrombosis). The common iliac 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, the early and late complications identified several shortcomings of this design, which needs refinement.
