To report five-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically-designed iliac branch device (IBE; W.L. Gore & Associates, Flagstaff, Ariz) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms.Sixty-three patients (98.4% male, mean age 70 years) with aortoiliac or common iliac artery aneurysms were enrolled and underwent implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n=22; 34.9%) underwent either staged occlusion or surgical revascularization of the contralateral internal iliac artery prior to study enrollment. At 5 years, 36/63 patients completed the final study follow up; 35 had clinical examination and 32 had computed tomography imaging (evaluated by an independent core laboratory and adverse events adjudicated by clinical events committee).At 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that occurred (range 132 to 1898 days) were adjudicated as unrelated to the aneurysm or the procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients experienced new onset buttock claudication on the IBE side or self-reported new onset erectile dysfunction. Common iliac artery diameter on the IBE side was either unchanged or decreased by =5 mm in 30/31 (96.8%) patients with a baseline (1 month) and a 5-year computed tomography scan (day 1641 to 2006). Of evaluable patients, 9/31 (29.0%) had an increase of =5 mm in aortic diameter, of which five patients had a concurrent Type II endoleak. There were no core laboratory-identified Type I or Type III endoleaks or device migrations. Six patients underwent a total of 8 secondary interventions which included 5 interventions for Type II endoleak. Freedom from secondary intervention was 90.5%.The 5-year results of this prospective, multicenter study confirm the safety, efficacy, and durability of the IBE device for treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture while maintaining patency of the internal iliac artery and avoiding complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that outcomes of endovascular aneurysm repair may be different in patients with or without associated common iliac artery aneurysms.
View details for DOI 10.1016/j.jvs.2022.07.006
View details for PubMedID 35842202