Antegrade and retrograde crossing of chronic total occlusions using the outback re-entry device

Purpose. The Outback device (Cordis) enables true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs). This study compared outcomes of patients who underwent subintimal recanalization of lower-extremity arterial CTOs utilizing the Outback device via antegrade and retrograde approaches. Methods. A retrospective analysis identified 39 patients with Rutherford 3 (n = 13), 4 (n = 13), and 5 disease (n = 13) where the Outback device was utilized (19 antegrade crossing femoropopliteal CTOs, 20 retrograde [17/20 transpedal access crossing femoropopliteal/tibioperoneal CTOs, 3/20 femoral access crossing iliac CTOs]) after conventional techniques failed. Mean age was 70.5 years and 67% were men. Most patients had multifocal and/or long-segment occlusions, with 41% having combined above- and below-knee disease. Results. Overall technical success was 90% (95% antegrade and 85% retrograde cohort; P=.15). There were no major complications and 4 minor complications (prolonged bleeding, femoral pseudoaneurysm requiring thrombin injection, and 2 small access-site hematomas). Fifteen percent of the retrograde cohort subsequently underwent distal bypass, compared with 0% in the antegrade cohort (P=.23). A single amputation occurred, in the antegrade group. Twelve-month target-vessel unassisted primary patency was higher with antegrade use (76% in the antegrade group vs 48% in the retrograde group; P=.03), but 12-month assisted primary patency was similar (85% in the antegrade group vs 79% in the retrograde group; P=.85). Conclusion. The Outback can be used safely and effectively from both antegrade and retrograde approaches during recanalization of CTOs. Lower target-vessel unassisted primary patency using the retrograde transpedal approach indicates the need for closer surveillance to achieve high rates of limb salvage.