OBJECTIVETo evaluate immediate- and median-term outcomes from subintimal recanalization of superficial femoral arteries (SFA) chronic total occlusions (CTO) with the Outback LTD catheter.

METHODSFrom January 2010 to May 2011, 35 legs in 30 patients with CTO of the SFA and proximal popliteal artery were treated by Outback LTD catheter. There were 20 male and 10 female patients. The mean age of the patients was 68 years. Clinical presentation was severe intermittent claudication (Rutherford category 3, 10/35, 28.6%), rest pain (Rutherford category 4, 13/35, 37.1%), and minor ulceration (Rutherford category 5, 12/35, 34.3%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques. Technical success, complications, procedure times, clinical outcomes and cumulative patency rates in follow-up were evaluated.

RESULTSMedian lesion length was (210 ± 15) mm. Recanalization of the arterial occlusion was successful in 34 of 35 treated lesions (97.1%). None of the 30 patients showed any procedure-related complications during or after treatment. The mean follow-up was (7.2 ± 0.3) months. Cumulative primary patency rates after 3, 6, and 12 months were 90.9%, 84.8% and 50.6%. Three minor toe amputations and one major below-the-knee amputation were observed in patients with critical limb ischemia.

CONCLUSIONSThe Outback LTD catheter is a safe and effective device to recanalize challenging superficial femoral arteries CTO. The technique could reduce radiation exposure time and raise the technique success rate.