Off-label use of endovascular devices is common and allows novel treatment options for challenging technical problems. In this article, Squizzato et al. present an experience with 13 cases using the Excluder 3 Iliac Branch Endoprosthesis (IBE, Gore & Associates, Flagstaff, USA) as a main body aortic endograft in patients unsuitable for standard EVAR. They thoughtfully select a patient population for this approach with a short segment between the lowest renal artery and aortic bifurcation, aneurysms in the distal aorta with a narrow neck and those with bilateral iliac branch endoprosthesis or proximal branched/fenestrated thoracoabdominal endografts1)Dr Francesco Squizzato et al. Technical feasibility and device stability of the Gore Excluder Iliac Branch Endoprosthesis as abdominal aortic bifurcated device. J Vasc Surg Cases Innov Tech. 20XX, 1(1), XX-XX. doi: XXXXGoogle Scholar. This off-label use takes advantage of the graft's short contralateral gate length (5.5 cm) and small proximal diameter (23 mm). The authors use the standard 20-25% oversizing for the proximal aortic neck diameter and selected patients with an aortic size ranging from 16 to 20 mm. The paper reports a 100% technical success rate and no adverse events with a 100% graft stability, defined as the absence in any variation of the aneurysmal sac dimensions after the procedure, absence of endoleak and device migration at the 3-month mark1)Dr Francesco Squizzato et al. Technical feasibility and device stability of the Gore Excluder Iliac Branch Endoprosthesis as abdominal aortic bifurcated device. J Vasc Surg Cases Innov Tech. 20XX, 1(1), XX-XX. doi: XXXXGoogle Scholar. While impressive, the reported results are early. The IBE lacks active fixation proximally which presents concern for long-term durability and migration in aneurysmal disease, similar to past experience with the AneuRx graft. Sampaio et al. reported results of 109 patients treated with the AneuRx graft. Migration, defined as >5 mm increase in distance from lowest renal to device, occurred in 15.6% of patients. This migration was associated with increased risk of Ia endloeak and 33% percent of patients with device migration did develop 1a endoleaks. Notably, the follow up for this study was 30 months2)Sampaio Sergio et al.AneuRx device migration: incidence, risk factors, and consequences.Ann Vac Surg. 2005; (PMID: 15782271)Abstract Full Text Full Text PDF Scopus (48) Google Scholar. It is possible that migration and development of endoleaks has not been captured in Squizzato et al. 3 month follow up. The conformability of the IBE may offer some protective effect from migration. DeRoo et al. noted the device's ability to conform to iliac tortuosity on pre and post intervention axial imaging looking at change in iliac tortuosity after deployment3)DeRoo Elise et al.Conformability of the GORE EXCLUDER iliac branch endoprosthesis is associated with freedom from adverse iliac events.J Vacs Surg. 2021; (PMID)34082005Google Scholar. Further, others have reported success using the IBE graft in off label use. Oussoren at al. presented 51 patients who underwent solitary use of the IBE for iliac artery aneurysms as compared to the on-label use with a standard EVAR. Technical success, defined by no type I or III endoleaks or graft limb obstruction, occurred in 94.1% of patients with 82% of patients being free of complications and 90% being free of secondary intervention at 24 months. No migration was noted in follow up4)Oussoren Fieke K. et al.Solitary iliac branch endoprosthesis placement for iliac artery aneurysms.J Vasc Surg. 2022; (PMID: 34655682)Abstract Full Text Full Text PDF Scopus (2) Google Scholar. Rodriguez at al. published a large retrospective study comparing IFU and non-IFU use of the IBE endograft with no difference in primary effectiveness between on and off label use at the 1-year mark5)Limael E Rodriguez et al.Comparison study of Iliac Branch Endoprosthesis when used on and off label.Ann Vasc Surg. 2023; (PMID: 35339599)Google Scholar. The conformability, proximal graft diameter and short contralateral length make the use of the IBE graft as an aortic main body intriguing. Longer follow-up looking at migration and need for reintervention within this group will be important before widely deploying into clinical practice.
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