ENDOVASCULAR FEMOROPOPLITEAL BYPASS - EARLY HUMAN CADAVER AND ANIMAL STUDIES

We report herein a feasibility study of a minimally invasive endovascular femoropopliteal bypass procedure. The steps include the following: (1) a small groin incision to expose the femoral artery, (2) guidewire passage and mechanical dilatation of the diseased superficial femoral artery, (3) semiclosed endarterectomy of the superficial femoral artery using an expandable metal endarterectomy catheter that engages atheroma, (4) placement of a 6 mm thin-walled PTFE graft, (5) balloon dilatation of the graft to press the graft flat against the arterial wall, and (6) a standard end-to-end anastomosis of the proximal graft to the femoral artery. This technique was tested in 13 limbs from eight fresh (stored 1 to 5 days at 4 degrees C) human cadavers (seven females and one male). Five limbs had stenotic superficial femoral artery lesions, 1 to 15 cm (mean 7.6 cm). Four limbs had occlusive lesions, 9 to 38 cm long (mean 26.8 cm). Four limbs had no disease. We successfully completed the procedure in 10 of 13 limbs. Completion arteriography showed a widely patent graft and a popliteal artery with a smooth distal graft/arterial interface in 9 of 10 limbs; one had a distal graft fold due to a size mismatch. Histologic studies of the superficial femoral artery revealed intima, atheromatous plaque, and media. We failed to complete our procedure in three limbs: two because of inadequate instruments and one because of perforation of the artery. We also performed the same procedure unilaterally in six dogs, except that no endarterectomy was performed. Each dog was an adult male of Greyhound or Labrador descent that weighed 32 to 86 kg (mean 49 kg). We achieved technical success in all six dogs and arteriographic success in four of six dogs. In two dogs completion arteriography revealed a longitudinal fold near the distal end of the graft that was attributed to a size mismatch. We conclude that endovascular femoropopliteal bypass is feasible and warrants further studies for possible clinical application.