Prospective Study of the Iliac Branch Device E-liac in Patients with Common Iliac Artery Aneurysms: 12 Month Results

Abstract

WHAT THIS PAPER ADDS New dedicated iliac branch devices (IBDs) help to minimise ischaemic complications by preserving internal iliac artery (IIA) flow. There are currently three dedicated IBDs available on the market, including the E-liac Stent Graft System. The present study evaluates the safety and efficacy of this stent graft and is the first and largest prospective trial on this iliac side branch device. The favourable results demonstrate its promising performance and safe application. Objectives: At 12 months follow up of the PLIANT study, clinical success and efficacy of the E-liac Stent Graft System (JOTEC GmbH, Hechingen, Germany) were evaluated. Clinical success was defined as aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the internal iliac artery (IIA) and external iliac artery (EIA) on the E-liac implantation side. Methods: In this prospective multicentre European observational study, clinical and morphological data of 45 patients (93% male, mean age 72 y) were prospectively collected in 11 European centres between July 2014 and June 2016. Forty patients underwent an aorto-iliac (three patients bilaterally) treatment and five an isolated iliac treatment. Results: At 12 months follow up, data were available for 42 patients. Overall clinical success at 12 months was 90%, with a survival rate of 100%. Four patients (10%) did not achieve clinical success, one with an internal iliac artery (IIA) occlusion on the E-liac implantation side, one with an infrarenal type Ia endoleak, and two with type Ib endoleaks in IIA. At 12 months the primary patency rate in the internal iliac artery on the iliac side branch implantation side was 98%. Two patients (5%) received E-liac related re-interventions: one caused by an edge stenosis at the distal end of the graft limb in the external iliac artery (EIA) and one caused by thromboembolism in the external iliac artery. Thus, for the EIA, primary and secondary patency rates were 98% and 100%, respectively. Conclusions: The low device related re-intervention rate of 5%, the high survival rate of 100%, and the high primary patency rates of 98% for the IIA and EIA at 12 month follow up demonstrate the safety and efficacy of the E-liac Stent Graft System. Long term 36 month results are awaited to confirm the efficacy and durability.

Mid-Term Outcomes of a Pre-Cannulated Iliac Branched Device in the Treatment of Abdominal Aortoiliac Aneurysms: A Retrospective Analysis from a Single Center

“…In both cases, the kinking of the EIA was identified as the reason for the thrombosis, which was fixed with the relining of the iliac limb (with PTA or bare-metal stent implantation). Brunkwall et al reported one-year results of 48 E-iliac devices and also found edge stenosis and thrombosis in two EIAs, which needed re-intervention [19]. Thus, the extern iliac artery limb of the E-iliac needs to be carefully evaluated in the completion angiography for kinking and stenosis, particularly in tortuous anatomies, as it appears to be the major complication site of this system.…”

Results of Iliac Branch Devices in Octogenarians Within the pELVIS Registry

“…The PLIANT study documented the performance of the Jotec E-Iliac endograft in 45 patients; clinical success at 12 months was 90%. 13 In the pELVIS registry of over 900 IBD implants, 9 IBDs provided satisfying estimated rates of 8-year freedom from IBD and IIA occlusion (87% and 95.1%, respectively) and freedom from reintervention (85.7%) due to occlusion and/ or type I endoleak.…”

Endovascular repair of bilateral isolated common iliac artery aneurysms with unsuitable anatomy utilizing an aortic bifurcated unibody endograft and modified sandwich technique to preserve pelvic blood flow: a case series

“…In the first prospective multicenter study of 52 patients with CIAAs treated with IBDs combined with different aortic components, Haulon et al [ 23 ] reported CIA shrinkage in 81% of patients at the 1-year follow-up and iliac branch occlusion in 11% of cases within the first month. Several research investigations have demonstrated outstanding early and midterm safety and efficacy of IBDs in treating aorto-iliac aneurysms or isolated CIAAs, as well as low rates of complications and mortality [ 7 , 24 ]. These results support the use of IBDs as the primary treatment option for patients with intra-abdominal aneurysms and a suitable vascular anatomy [ 15 , 25 ].…”