BS5. New Single-Sided Access EVAR Device: The HORIZON CE Pivotal Study—Short-Term Results

Abstract

26 centers in theUnited States from2013 to2014.All patients were treated using the IBE, a bifurcated stent graft designed to be used with the existing Gore Excluder device for treatment of patients with CIA. The IBE device has limbs for extension into the external iliac and hypogastric artery to allow CIA exclusion with preservation of hypogastric artery blood flow. All patients underwent placement of a single IBE device, and patients with bilateral CIA were allowed to be enrolled with coil embolization and coverage of the contralateral internal iliac artery. Follow-up is ongoing and will include clinical examination and computed tomography imaging at 1 month, 6 months, 12 months, and yearly thereafter up to 5 years. Six-month site-reported data will be reported. Results: At the time of abstract submission, data were available for 53 patients (98% male). Median age was 68 years, and 35.2% of patients had unilateral CIA and 64.8% had bilateral CIA. Mean CIA diameter was 38.4 mm. Technical success was 92.5% (successful deployment and patency of all IBE components and freedom from type 1 or 3 endoleak). Median hospital stay was 1 day, and there was no 30-day mortality. Site-reported 30-day (n 1⁄4 48) and 6-month (n 1⁄4 19) follow-up data identified two IBE internal iliac limb occlusions, both asymptomatic, and one reintervention to treat an iliac artery dissection contralateral to the IBE device. Conclusions: Preliminary results of this prospective study demonstrate that treatment of CIA with the Gore IBE device is technically feasible and safe in the vast majority of appropriately selected patients. Initial results reveal high rates of patency of the internal iliac artery limb and freedom from new-onset erectile dysfunction or buttock claudication. Ongoing follow-up will seek to verify these results and to further assess durability.