Abstract

Patency rates of standard femoropopliteal bypass in infra-inguinal occlusive disease have yet to be matched by minimally invasive percutaneous procedures. We report a feasibility study of a less invasive endovascular femoropopliteal bypass technique. (1) groin exposure of femoral artery, (2) guidewire passage and mechanical dilatation of superficial femoral artery (SFA), (3) expandable helical cutter endarterectomy of SFA, (4) transluminal placement of PTFE graft, (5) graft balloon dilatation to shape and set distal interface and (6) end-to-end anastomosis of proximal graft to femoral artery. Development and testing was undertaken in 48 limbs of 26 fresh human cadavers. Limbs with no demonstrable SFA disease were excluded. Seventeen limbs had mild, diffuse disease. Three limbs had a single, short, tight stenosis. Seventeen limbs had multiple, high grade stenotic lesions 12-40 cm long (mean 24 cm). Eleven limbs had occlusive lesions, 8-38 cm long (mean 24 cm). We successfully completed the procedure in 39 (81%) limbs. We failed to complete the procedure in nine limbs; four from failed guidewire passage, four from vessel avulsion, and one from graft deployment failure. Histology confirmed endarterectomy cleavage in the standard plane. Angiography and explants demonstrated a patent graft and popliteal artery, and smooth distal graft/arterial interface with no obvious defects in 24 (62%) cases. Defects included combinations of: contrast extravasation/reflux, graft malpositioned/incorrectly sized, distal graft fold, and distal intimal flap. Endovascular femoropopliteal bypass is feasible and warrants further studies for possible clinical application.

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