Randomized control study of the outback LTD reentry catheter versus manual reentry for the treatment of chronic total occlusions in the superficial femoral artery.

PURPOSE: To assess the efficacy and safety of the Outback device in patients with a chronic total occlusion (CTO) of the superficial femoral artery and evaluate its impact on fluoroscopy and procedural times. MATERIALS AND METHODS: From October 2006 to March 2007, 52 patients affected by TASC II-D superficial femoral artery CTO were treated with subintimal recanalization. Clinical indications for endovascular recanalization were: claudication, tissue loss, and at rest leg pain with critical limb ischemia. In 26 patients the manual reentry technique was used and in 26 the OUTBACK® LTD Re-Entry Catheter was used. Total procedure time, fluoroscopy time and precision in targeting the expected reentry site have been compared. RESULTS: Technical success was achieved in all cases (100%). In group 2, the planned in-target re-entry was achieved in 11/26 cases (42.3%). The procedure was performed with a traditional antegrade approach in 23/26 (88.4%) cases and in three cases (11.6%) a combined antegrade/retrograde approach was necessary. In group 1, the in-target re-entry was achieved in 26/26 cases (100%). In group 2, the mean procedural time was 55.4 ± 14.2 min with a mean fluoroscopy time 39.6 ± 13.9 min compared to 36.0 ± 9.4 min and 29.8 ± 8.9 min, respectively, of group 1 (P < 0.0001). CONCLUSIONS: In our experience, the use of this device is very useful for the revascularization of chronic femoral occlusions, even calcific, in which an accurate re-entry cannot be achieved with the conventional subintimal technique. In these cases, the Outback device grants high technical success rates and a significant reduction of procedural and fluoroscopy times.