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

Daphne van der Veen; Suzanne Holewijn; Raffaello Bellosta; Luca Attisani; Steven M.M. van Sterkenburg; Jan M.M. Heyligers; Ilaria Ficarelli; Francisco J. Gómez Palonés; Nicola Mangialardi; Nilo J. Mosquera; Andrew Holden; Michel M.P.J. Reijnen; IceBERG Study Collaboration

doi:10.1016/j.jvs.2025.09.037

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

Daphne van der Veen
, Suzanne Holewijn
, Raffaello Bellosta
, Luca Attisani
, Steven M.M. van Sterkenburg
, Jan M.M. Heyligers
, Ilaria Ficarelli
, Francisco J. Gómez Palonés
, Nicola Mangialardi
, Nilo J. Mosquera
, Andrew Holden
, Michel M.P.J. Reijnen^*
, IceBERG Study Collaboration

^*Corresponding author for this work

Research output: Contribution to journal › Conference article › Academic › peer-review

1 Citation (Scopus)

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Abstract

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.

Original language	English
Pages (from-to)	404-412.e2
Journal	Journal of vascular surgery
Volume	83
Issue number	2
Early online date	24 Sept 2025
DOIs	https://doi.org/10.1016/j.jvs.2025.09.037
Publication status	Published - Feb 2026
Event	Leipzig Interventional Course, LINC 2024 - Messe Leipzig, Leipzig, Germany Duration: 28 May 2024 → 31 May 2024

Keywords

UT-Hybrid-D
EVAR
Iliac aneurysm
Iliac branched device
Quality of life (QoL)
Abdominal aortic aneurysm
Erectile function

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van der Veen, D., Holewijn, S., Bellosta, R., Attisani, L., van Sterkenburg, S. M. M., Heyligers, J. M. M., Ficarelli, I., Gómez Palonés, F. J., Mangialardi, N., Mosquera, N. J., Holden, A., Reijnen, M. M. P. J., & IceBERG Study Collaboration (2026). Five-year outcomes of the IceBERG study, an international, prospective, multicenter registry on the GORE EXCLUDER Iliac Branch Endoprosthesis for aortoiliac aneurysms. Journal of vascular surgery, 83(2), 404-412.e2. https://doi.org/10.1016/j.jvs.2025.09.037

@article{57b6a29f6b09461b866ef3d8be248336,

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

abstract = "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.",

keywords = "UT-Hybrid-D, EVAR, Iliac aneurysm, Iliac branched device, Quality of life (QoL), Abdominal aortic aneurysm, Erectile function",

author = "\{van der Veen\}, Daphne and Suzanne Holewijn and Raffaello Bellosta and Luca Attisani and \{van Sterkenburg\}, \{Steven M.M.\} and Heyligers, \{Jan M.M.\} and Ilaria Ficarelli and \{G{\'o}mez Palon{\'e}s\}, \{Francisco J.\} and Nicola Mangialardi and Mosquera, \{Nilo J.\} and Andrew Holden and Reijnen, \{Michel M.P.J.\} and \{IceBERG Study Collaboration\}",

note = "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: {\textcopyright} 2025 Society for Vascular Surgery; Leipzig Interventional Course, LINC 2024, LINC 2024 ; Conference date: 28-05-2024 Through 31-05-2024",

year = "2026",

month = feb,

doi = "10.1016/j.jvs.2025.09.037",

language = "English",

volume = "83",

pages = "404--412.e2",

journal = "Journal of vascular surgery",

issn = "0741-5214",

publisher = "Elsevier",

number = "2",

}

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 2026, 'Five-year outcomes of the IceBERG study, an international, prospective, multicenter registry on the GORE EXCLUDER Iliac Branch Endoprosthesis for aortoiliac aneurysms', Journal of vascular surgery, vol. 83, no. 2, pp. 404-412.e2. https://doi.org/10.1016/j.jvs.2025.09.037

Five-year outcomes of the IceBERG study, an international, prospective, multicenter registry on the GORE EXCLUDER Iliac Branch Endoprosthesis for aortoiliac aneurysms. / van der Veen, Daphne; Holewijn, Suzanne; Bellosta, Raffaello et al.
In: Journal of vascular surgery, Vol. 83, No. 2, 02.2026, p. 404-412.e2.

Research output: Contribution to journal › Conference article › Academic › peer-review

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 -

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

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Keywords

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