Dainis Krievins1, Janis Savlovskis2, Natalija Ezite2, Andrew Hill3, Kaspars Kisis4, Marcis Gedins4, Edgars Zellans5, Andrew Holden6. 1. Department of Vascular Surgery, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia - dainis.krievins@stradini.lv. 2. Department of Invasive Radiology, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. 3. Vascular Services, Auckland City Hospital, Auckland, New Zealand. 4. Department of Vascular Surgery, Pauls Stradins Clinical University Hospital, Riga, Latvia. 5. Department of Vascular Surgery, Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia. 6. Department of Radiology, Auckland City Hospital, Auckland, New Zealand.
Abstract
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.
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-humanpatients 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.