Does subintimal angioplasty have a role in the treatment of severe lower extremity ischemia?

Objective: Subintimal angioplasty (SIA) has been advocated to treat long segment lower extremity arterial occlusions, but many question its value. We evaluated the role of SIA in a group of patients with severe lower extremity arterial occlusive disease. Methods: During a 2.5-year period, 39 patients with arterial occlusions (median length, 8 cm; range, 2 to 31 cm) were treated on an intention-to-treat basis with SIA. Twenty-five patients had gangrene, five had rest pain, and nine had disabling (<one block) claudication. There were 24 superficial femoral, two superficial-femoral-popliteal, four popliteal, two popliteal-tibial, five tibial, and two external iliac artery lesions. With fluoroscopic guidance, via a prograde common femoral artery puncture (n = 29) or a contralateral common femoral artery puncture (n = 9), a subintimal dissection plane was created across the occlusion with a standard guidewire and catheter. The arterial lumen was reentered distal to the occlusion, and the recanalized segment balloon was dilated. All patients were followed prospectively with arterial duplex scan. Results: SIA was technically successful in 34 of 39 patients (87%). All five failures were from an inability to reenter the patent lumen distally. These five patients underwent successful bypasses that in no case were more distal than would have been required before SIA. In the 34 technically successful SIAs, pain completely resolved (14/14) and areas of gangrene (21/25) healed. The cumulative patency rate in patients who underwent successful SIA was 74% ± 10% at 12 months. The mean increase in ankle-brachial index after SIA was 0.34 (range, 0.1 to 0.69). There were two distal embolic events, successfully treated surgically (n = 1) or with catheter-directed techniques (n = 1). Three patients underwent subsequent bypass, and the remaining five patients remain asymptomatic. Conclusion: SIA is feasible and can be effective in some patients with lower extremity arterial occlusions and threatened limbs. These results, plus SIA's many advantages, support an increasing role for it in the treatment of lower extremity arterial occlusive disease.