Journal of vascular surgery, 24 4 2025, Pages S0741-5214(25)01771-9 Five-year outcomes of the ICEBERG study, an international, prospective, multicenter registry on the GORE® EXCLUDER® Iliac Branch Endoprosthesis for aorto-iliac aneurysms. van der Veen D, Holewijn S, Bellosta R, Attisani L, van Sterkenburg SMM, Heyligers JMM, Ficarelli I, Gómez Palonés FJ, Mangialardi N, Mosquera NJ, Holden A, Reijnen MMPJ, IceBERG Study collaboration
Objective
This study aims 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. Both technical, clinical, and patient reported outcomes were evaluated.
Methods
This is an investigator initiated, international, real world post-market, 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 5-year follow-up, together with questionnaire data.
Results
Of the initially 100 enrolled patients, 69 patients completed the 5-year follow-up. The 5-year freedom from all-cause and aneurysm-related mortality was, respectively, 82.9% and 96.0%. 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 (-8.0mm, p=0.001, -6.8mm, p<0.001, respectively). One type 1b and one type 1c endoleak were detected between 2-5 years follow-up which 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 IIEF-5 questionnaire on erectile dysfunction showed a significant decrease between baseline (median 12.5; IQR 3.0-20.0) and 5-years follow-up (median 4.0; IQR 1.0-16.0), p=0.001. The EQ5D and WIQ showed no differences between baseline and 5-years follow-up.
Conclusions
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.
