Comparison of the OUTBACK(®) Elite Reentry Catheter and the Bi-directional Approach after Failed Antegrade Approach for Femoro-popliteal Occlusive Disease

Aim: A successful antegrade wire crossing for femoro-popliteal chronic total occlusion (FP-CTO) is still a technical challenge. We attempted to demonstrate the safety and feasibility of the OUTBACK(®) Elite reentry catheter and the bi-directional approach for failed FP-CTO cases with the antegrade approach. Methods: Endovascular therapy for FP-CTO was performed in 219 lesions from May 2013 to December 2016 at Morinomiya Hospital. We retrospectively analyzed the data of 43 consecutive lesions which underwent endovascular therapy using the bi-directional approach with distal access and the mono-directional approach with the OUTBACK(®) Elite reentry catheter for FP-CTO lesions. The antegrade success using a combination of traditional and Intravascular Ultrasound (IVUS) -guided techniques was achieved in 170 lesions out of a total of 219 lesions. From May 2013 to June 2016 (phase 1), the bi-directional approach with distal access was applied to 22 lesions after failed antegrade approaches. From July 2016 to December 2016 (phase 2), the mono-directional approach with the OUTBACK(®) Elite reentry catheter was applied to 21 lesions. Results: Clinical and lesion characteristics in phase 1 were not significantly different from those in phase 2. The overall initial technical success rate was 100% in both phases. The total wire number and amount of contrast media were significantly less, and the total procedure time and the total fluoroscopic time were significantly shorter in phase 2 than in phase 1 (p < 0.01). Conclusions: Endovascular therapy for FP-CTO using the OUTBACK(®) Elite reentry catheter is feasible and safe after a failed antegrade approach.