Five-year outcomes of the IceBERG study, an international, prospective, multicenter registry on the GORE EXCLUDER Iliac Branch Endoprosthesis for aortoiliac aneurysms.

Abstract

This study aimed to provide insight in the long-term outcomes of patients treated with the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) for aneurysms involving the common iliac artery. Technical, clinical, and patient-reported outcomes were evaluated. This is an investigator-initiated, international, real-world, postmarket, multicenter, prospective cohort study, enrolling patients with an indication for elective treatment of an (aorto)iliac aneurysm using the GORE EXCLUDER IBE. Technical and clinical outcomes were collected through the 5-year follow-up, together with questionnaire data. Of the initially 100 enrolled patients, 69 completed the 5-year follow-up. The 5-year freedom from all-cause and aneurysm-related mortality were 82.9% and 96.0%, respectively. The 5-year primary patency of the hypogastric artery was 84.0%. The median abdominal aortic aneurysm and common iliac artery diameters decreased significantly between baseline and 5-year follow-up (-8.0 mm [P = .001] and -6.8 mm [P < .001], respectively). One type Ib and one type Ic endoleak were detected between 2 and 5 years of follow-up and were successfully treated. Two type III endoleaks were discovered during follow-up. There were no significant differences in the occurrence nor severity of intermittent claudication between baseline and 5-year follow-up. The outcomes on the International Index of Erectile Function-5 questionnaire on erectile dysfunction showed a significant decrease between baseline (median, 12.5; interquartile range, 3.0-20.0) and 5 years follow-up (median, 4.0; interquartile range, 1.0-16.0; P = .001). The EuroQol Five Dimensions 3-Level and Walking Impairment Questionnaire showed no differences between baseline and the 5-year follow-up. The results of this study support the continued use of the GORE EXCLUDER IBE in the treatment of aortoiliac aneurysms, demonstrating favorable long-term outcomes in terms of patency, sac remodeling, clinical outcomes, and questionnaire outcomes.