Midterm Results Presented for Iliac Artery Repair With Gore's IBE Device
June 14, 2017—A study by Darren Schneider, MD, et al concluded that endovascular aneurysm repair (EVAR) of iliac artery aneurysms with hypogastric artery preservation using Gore & Associates' iliac branch endoprosthesis (IBE) device was effective and showed good midterm outcomes in both multicenter trial and real-world settings. The investigators reported that through 3 years of follow-up in both settings, the incidence of ischemic complications, device occlusion, and need for reintervention remained low and support the treatment of iliac aneurysms with iliac branch devices. The findings were presented at the Society of Vascular Surgery's (SVS) Vascular Annual Meeting, held June 1–3 in San Diego, California.
As summarized in the study abstract from SVS, the investigation included all patients who underwent treatment of iliac artery aneurysms with the IBE device as participants in the pivotal IBE 12-04 prospective United States multicenter study and the Global Registry for Endovascular Aortic Treatment (GREAT) prospective multicenter international registry study between 2013 and 2015.
The investigators analyzed pooled, as well as side-by-side comparison, outcomes through 3 years of follow-up. Data was analyzed for procedural success, overall survival, iliac patency, reinterventions, and incidence of new-onset buttock claudication or sexual dysfunction.
A total of 190 patients underwent treatment with 207 IBE devices, including 98 patients in IBE 12-04 (pivotal study cohort n = 63 and continued access cohort n = 35) and 92 patients in GREAT. Seventeen patients (8.9%) underwent bilateral IBE device placement.
The GREAT cohort included more women (7.6% vs 1.0%; P = .03), more nonwhites (25.9% vs 11.1%; P < .001), and were older (mean age, 72.7 ± 7.7 years vs 69 ± 9.3 years; P < .011) than the IBE 12-04 cohort. However, mean common iliac aneurysm diameters were similar in the IBE 12-04 and GREAT cohorts (39.3 ± 10.9&;mm vs 36.6 ± 11.0 mm).
The investigators noted that 62% of patients in GREAT were treated outside of the indications for use guidelines and would not have met inclusion/exclusion criteria for the IBE 12-04 study. Procedural survival was 100% in both cohorts. Mean follow-up was 537 days for IBE 12-04 and 225 days for GREAT.
All-cause mortality was 6.1% in IBE 12-04 and 5.4% in GREAT. Device-related reinterventions occurred in 8.2% of patients in IBE 12-04 and 4.3% in GREAT.
The incidence of hypogastric or external iliac artery occlusion was 8.2% in IBE 12-04 and 1.1% in GREAT, with no reports of new-onset buttock claudication or sexual dysfunction in either study cohort, reported the investigators at the SVS Vascular Annual Meeting.