Early results of expanding the anatomical indications for using a Gore Iliac branch endoprosthesis to treat aortoiliac and iliac aneurysms

Purpose To assess the safety and anatomical suitability of using a Gore Iliac Branch Endoprosthesis (IBE) in aortoiliac and iliac aneurysm repair. Methods Between 2017 and 2020, 20 patients underwent endovascular aneurysm repair (EVAR) with a Gore IBE device (bilateral IBE, n = 1) after expanding the instructions for use (IFU) criteria. We evaluated the early clinical outcomes and suitability of the IFU criteria, retrospectively. Results Six patients (30%) met all the IFU criteria. Anatomical suitability according to the IFU criteria for the collective total of 21 IBE limbs was confirmed for 10 (47.6%) proximal common iliac arteries, 21 (100%) external iliac arteries, 18 (85.7%) internal iliac arteries, and in the length from the lowest renal artery to the iliac bifurcation in 15 (71.8%) patients. Assisted primary technical success was achieved in all patients with various bail-out techniques. One patient (5%) required a bare-stent insertion 7 days after EVAR for severe stenosis in the ipsilateral limb caused by a small terminal aorta. There was no case of occlusion of an iliac branch component device. Conclusions Gore IBEs were implanted safely and effectively with various bail-out techniques to repair aortoiliac and iliac aneurysms in our Japanese patients with a low rate of inclusion IFU criteria.