Results of percutaneous subintimal angioplasty using routine stenting.

OBJECTIVE: To assess the long-term patency and clinical success of subintimal angioplasty in patients with limb-threatening ischemia.
METHODS: From 1999 through 2004, 29 patients with superficial femoral artery (SFA) or popliteal artery occlusion and rest pain or tissue loss underwent subintimal angioplasty. Patients had subintimal wire placement followed by percutaneous transluminal angioplasty and stent placement. From 1 to 10 stents were placed. Technical success required stenosis less than 30% by arteriography, a velocity ratio less than 1.5 by duplex scan, and improvement of the ankle-brachial index greater than 0.15. Follow-up duplex scanning was performed every 3 months for 2 years and then every 6 months thereafter.
RESULTS: Initial success was obtained in 26 (90%) of the 29 patients, with an improvement in the mean ankle-brachial index of 0.25. Mean follow-up was 38 months (range, 28-54 months). During follow-up, 16 arteries reoccluded. Six of the 16 patients had recurrent symptoms, four required below-knee amputation, two required above-knee amputation, and four died with an intact limb. After treatment failure, two patients had attempted tissue plasminogen activator (TPA), and four had prosthetic tibial bypass. Overall, 15 patients died, and only 2 of the 14 who lived had a patent artery. One of the two required percutaneous transluminal angioplasty of the recanalized artery. By life-table analysis, success was 85%, 64%, 18%, and 9% at 1, 2, 3, and 4 years, respectively. Periprocedural complications occurred in four patients. Of the 13 patients with wounds, six died (four healed), two were alive with healed wounds, and five had limb loss. Of 16 patients with rest pain, 14 developed recurrent symptoms after reocclusion, 1 was alive without pain, and 1 underwent amputation.
CONCLUSIONS: Subintimal angioplasty is technically successful in most patients, with few complications. Most procedures provide short-term clinical success and have allowed for successful wound healing and temporary relief of rest pain. However, late arterial patency is poor, with a high rate of symptom recurrence. Many patients will have recurrent pain, and some will require major amputation. Nevertheless, limb-salvage rates are significantly better than arterial patency. Intermediate-term patency is higher than that commonly reported for prosthetic bypass, and despite the lack of durable long-term patency, the procedure offers an additional potentially effective therapeutic option in the treatment of patients with limb-threatening ischemia and femoropopliteal occlusion.