Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms

Gore Bilateral IBE Study Group

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: The Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. Methods: A retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. Results: There were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. Conclusions: Preservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

Original languageEnglish (US)
Pages (from-to)100-108.e3
JournalJournal of Vascular Surgery
Volume68
Issue number1
DOIs
StatePublished - Jul 1 2018

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Iliac Aneurysm
Iliac Artery
Endoleak
Therapeutics
United States Food and Drug Administration
Drug Approval

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms. / Gore Bilateral IBE Study Group.

In: Journal of Vascular Surgery, Vol. 68, No. 1, 01.07.2018, p. 100-108.e3.

Research output: Contribution to journalArticle

Gore Bilateral IBE Study Group. / Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms. In: Journal of Vascular Surgery. 2018 ; Vol. 68, No. 1. pp. 100-108.e3.
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abstract = "Objective: The Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. Methods: A retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. Results: There were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7{\%}) were symptomatic and 12 (25.5{\%}) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9{\%}). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1{\%}; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30{\%}) and no type I or type III endoleaks were detected. Two of 80 (2.5{\%}) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. Conclusions: Preservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.",
author = "{Gore Bilateral IBE Study Group} and Maldonado, {Thomas S.} and Mosquera, {Nilo J.} and Peter Lin and Raffaello Bellosta and Michael Barfield and Albeir Moussa and Robert Rhee and Schermerhorn, {Marc L.} and Jeffrey Weinberger and Marald Wikkeling and Jan Heyligers and Veith, {Frank J.} and Ross Milner and Reijnen, {Michel P.J.} and {Van Brussel}, {Jerome P.} and Naslund, {Thomas C.} and Azarbal, {Amir Farzin} and Camacho, {Marc A.} and Hue Tai and Woo, {Edward Y.} and Gustavo Oderich and Mark Randon and Daniel Eefting and {van Sambeek}, Marc and Nicola Mangialardi and Chaer, {Rabih A.} and Campbell, {Danielle N.} and Khanjan Nagarsheth",
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T1 - Gore Iliac Branch Endoprosthesis for treatment of bilateral common iliac artery aneurysms

AU - Gore Bilateral IBE Study Group

AU - Maldonado, Thomas S.

AU - Mosquera, Nilo J.

AU - Lin, Peter

AU - Bellosta, Raffaello

AU - Barfield, Michael

AU - Moussa, Albeir

AU - Rhee, Robert

AU - Schermerhorn, Marc L.

AU - Weinberger, Jeffrey

AU - Wikkeling, Marald

AU - Heyligers, Jan

AU - Veith, Frank J.

AU - Milner, Ross

AU - Reijnen, Michel P.J.

AU - Van Brussel, Jerome P.

AU - Naslund, Thomas C.

AU - Azarbal, Amir Farzin

AU - Camacho, Marc A.

AU - Tai, Hue

AU - Woo, Edward Y.

AU - Oderich, Gustavo

AU - Randon, Mark

AU - Eefting, Daniel

AU - van Sambeek, Marc

AU - Mangialardi, Nicola

AU - Chaer, Rabih A.

AU - Campbell, Danielle N.

AU - Nagarsheth, Khanjan

PY - 2018/7/1

Y1 - 2018/7/1

N2 - Objective: The Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. Methods: A retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. Results: There were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. Conclusions: Preservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

AB - Objective: The Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) has recently been approved by the Food and Drug Administration for treatment of common iliac artery (CIA) aneurysms. Despite early excellent results in clinical trial, none of 63 patients were treated for bilateral iliac aneurysms. The goal of this study was to examine real-world experience using the Gore IBE for bilateral CIA aneurysms. Methods: A retrospective review of an international multicenter (16 U.S., 8 European) experience using the Gore IBE to treat bilateral CIA aneurysms was performed. Cases were limited to those occurring after Food and Drug Administration approval (February 2016) in the United States and after CE mark approval (November 2013) in Europe. Demographics of the patients, presentation, anatomic characteristics, and procedural details were captured. Results: There were 47 patients (45 men; mean age, 68 years; range, 41-84 years) treated with bilateral Gore IBEs (27 U.S., 20 European). Six patients (12.7%) were symptomatic and 12 (25.5%) patients were treated primarily for CIA aneurysm (aorta <5.0 cm). Mean CIA diameter was 40.3 mm. Four patients had aneurysmal internal iliac arteries (IIAs). Two of these were sealed proximally at the IIA aneurysm neck and two required coil embolization of IIA branches to achieve seal in the largest first-order branches. Technical success was achieved in 46 patients (97.9%). No type I or type III endoleaks were noted. There was no significant perioperative morbidity or mortality. IIA branch adjunctive stenting was required in four patients (one IIA distal dissection, three kinks). On follow-up imaging available for 40 patients (85.1%; mean, 6.5 months; range, 1-36 months), 12 type II endoleaks (30%) and no type I or type III endoleaks were detected. Two of 80 (2.5%) IIA branches imaged were occluded; one was intentionally sacrificed perioperatively. Conclusions: Preservation of bilateral IIAs in repair of bilateral CIA aneurysms can be performed safely with excellent technical success and short-term patency rates using the Gore IBE device. Limb and branch occlusions are rare, usually are due to kinking, and can almost always be treated successfully with stenting.

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