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.