TY - JOUR
T1 - Five-year outcomes of the IceBERG study, an international, prospective, multicenter registry on the GORE EXCLUDER Iliac Branch Endoprosthesis for aortoiliac aneurysms
AU - van der Veen, Daphne
AU - Holewijn, Suzanne
AU - Bellosta, Raffaello
AU - Attisani, Luca
AU - van Sterkenburg, Steven M.M.
AU - Heyligers, Jan M.M.
AU - Ficarelli, Ilaria
AU - Gómez Palonés, Francisco J.
AU - Mangialardi, Nicola
AU - Mosquera, Nilo J.
AU - Holden, Andrew
AU - Reijnen, Michel M.P.J.
AU - IceBERG Study Collaboration
N1 - Presented during the Leipzig Interventional Course (LINC) Congress, Leipzig, Germany, May 28-31, 2024; and the Veith Symposium, New York, New York, November 19-23, 2024.
Publisher Copyright:
© 2025 Society for Vascular Surgery
PY - 2026/2
Y1 - 2026/2
N2 - Objective: 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.Methods: 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.Results: 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.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.
AB - Objective: 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.Methods: 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.Results: 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.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.
KW - UT-Hybrid-D
KW - EVAR
KW - Iliac aneurysm
KW - Iliac branched device
KW - Quality of life (QoL)
KW - Abdominal aortic aneurysm
KW - Erectile function
UR - https://www.scopus.com/pages/publications/105020437987
U2 - 10.1016/j.jvs.2025.09.037
DO - 10.1016/j.jvs.2025.09.037
M3 - Conference article
C2 - 41005513
AN - SCOPUS:105020437987
SN - 0741-5214
VL - 83
SP - 404-412.e2
JO - Journal of vascular surgery
JF - Journal of vascular surgery
IS - 2
T2 - Leipzig Interventional Course, LINC 2024
Y2 - 28 May 2024 through 31 May 2024
ER -