Complex Endovascular Treatment for Critical Limb Ischemia in Poor Surgical Candidates: A Pilot Study

PURPOSE: To evaluate the effectiveness of complex endovascular treatment for limb salvage in patients with critical limb ischemia. METHODS: In a prospective study, 23 patients (13 men; mean age 70 +/- 11 years, range 44-87) with ischemic ulceration or gangrene of 25 lower limbs were enrolled at 4 sites to evaluate treatment with excimer laser recanalization followed by balloon angioplasty with optional stenting in the superficial femoral, popliteal, and/or tibial arteries. RESULTS: Multiple lesions (mean 3.1, range 1-8) were treated in most cases. Reduction of stenosis/occlusion to <50% was achieved in 22 (88%) limbs. Individual cases of vessel perforation, inability to cross the lesion, and excessive residual stenosis accounted for the 3 failures. Over a 6-month period, 4 patients died of cardiac comorbidity and 1 was lost to follow-up. Adverse events included 4 minor and 2 below-knee amputations, 4 secondary angioplasties, and 4 femorodistal bypasses. The mean wound area reduction was 70% at 3 months, increasing to 89% at 6 months. According to life table analysis, the limb salvage rate was 90% with bypass and 69% without in the successfully treated patients (corresponding intention-to-treat rates were 79% and 61%). CONCLUSIONS: Complex endovascular treatment combining laser debulking and angioplasty/stenting offers an alternative for patients with critical limb ischemia who lack good surgical options.