The DETOUR procedure: no more need for conventional bypass surgery?

Background: Long segment occlusive disease in the superficial femoral artery remains a treatment challenge despite advances in open surgical and endovascular approaches. We report initial clinical results of an entirely new procedure to perform percutaneous femoro-popliteal bypass using the DETOUR System. First-in-human patients were performed in New Zealand from December 2013 to June 2014. After modifications to the technique and devices had significantly refined the procedure, the Detour I Trial commenced.
Methods: Review of initial results in the first five patients treated at a single site enrolled in IRB-approved, prospective clinical study using the DETOUR System. All patients signed informed consent with planned 2-year follow-up. The DETOUR System was used to create a stent graft bypass which originates in the SFA, travels through the femoral vein, and ends in the popliteal artery, bypassing the diseased segment.
Results: A cohort of patients were treated in Latvia from January 2015 to October 2015. The initial five patients in this cohort (age 67.2±11.4 years) with long femoral artery occlusions (29.5±14.1 cm) were treated at a single clinical site. TORUS stent grafts were successfully implanted in all 5 patients (100%) using an 8F delivery system. There were no perioperative 30-day major adverse events (death, major bleeding, deep vein thrombosis, target vessel revascularization or major amputation) observed. At 24 months' follow-up, the primary patency rate was 80% (4/5) and primary assisted patency was 100% (5/5). Significant improvement in ankle-brachial index and Rutherford class were observed in all patients. There was a single secondary procedure performed in these patients (proximal stent edge stenosis at 24 months). The venous function has not been damaged or compromised in any patient.
Conclusions: Early results suggest that properly-selected patients with long-segment occlusive disease above the knee can be safely treated using the DETOUR System for percutaneous bypass, with favorable clinical outcomes extending to 2 years. Further clinical investigation is warranted to evaluate the role of this approach in the treatment of long femoral lesions.