Treatment of limb-threatening ischemia with percutaneous intentional extraluminal recanalization: a preliminary evaluation

Abstract Objective We assessed the technical success, safety, and short-term effectiveness of percutaneous intentional extraluminal recanalization (PIER) in patients with limb-threatening ischemia and no autologous vein or with a major contraindication to surgery. Methods From 1999 through 2002, 25 patients with femoropopliteal occlusion and rest pain or tissue loss underwent PIER. Thirteen patients had undergone one or more failed bypass surgeries in the treated lower extremity, and no patient had suitable vein for bypass grafting. In four patients the ejection fraction was less than 15%; four patients had severe nonreconstructable coronary artery disease; and two patients with metastatic cancer refused amputation. All patients underwent subintimal wire placement, followed by percutaneous transluminal angioplasty and intracoil stent placement. Occlusions ranged in length from 6 to 18 cm, and 1 to 10 stents were placed. Technical success required no residual stenosis greater than 30% on arteriography, velocity ratio less than 1.5 on duplex ultrasound scanning, and improvement in ankle-brachial index of 0.15 or greater. Follow-up duplex scanning was performed every 3 months. Results Initial success was obtained in 23 of 25 patients (92%), with ankle-brachial index improvement of .31 to .54. All successful procedures resulted in symptomatic improvement. Mean follow-up was 13.3 months (range, 4-30 months). During follow-up, 10 patients died and 2 arteries demonstrated recurrent occlusion. With life table analysis, success rate was 92% at 12 months. Of the 4 patients in whom the procedure failed, 3 required major amputation and symptoms persisted in one. Complications occurred after two procedures, one myocardial infarction and one groin hematoma. Conclusions PIER is technically possible in patients with femoropopliteal occlusion, and the procedure is associated with a low complication rate. Most procedures provide at least short-term clinical success and have enabled successful wound healing and pain relief in patients without other effective options. Further studies and longer follow-up are required to determine long-term success and the role of PIER in treatment of femoropopliteal occlusion.