A Prospective Randomized Study of Three Expanded Polytetrafluoroethylene (PTFE) Grafts as Small Arterial Substitutes

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Abstract
A prospective, double-blind, randomized study was performed to determine the relative patency rate of polytetrafluoroethylene (PTFE) grafts, Gore-Tex, Impra and a Surgikos prototype PTFE graft. The 48 grafts (40 .times. 4 mm) replaced excised segments of femoral arteries in adult dogs, whose mean wt was 20.6 .+-. 0.9 kg; the grafts were removed after 12 wk. Sterile technique and antibiotic therapy were included in the study. Anticoagulation was not employed. Anastomoses were performed with 6 = 0 polypropylene. Angiographic assessment of each anastomosis was made at surgery and prior to sacrifice. Patency was assessed daily by palpation and Doppler flow signals and angiographically prior to sacrifice. The overall patency rate was 62.5%. No statistically significant differences in patency rates occurred among the 3 groups (Gore-Tex, 56%; Impra, 75%; Surgikos, 56%). Histologic evaluation revealed incomplete neointima formation and significant pannus formation in all 3 types of grafts without any significant discernible difference among them. Further experimental evaluation of PTFE as a small vessel substitute is indicated prior to its clinical use in preference to autogenous vein.