Proven device through solid data

The E-liac stent graft system (Artivion/Jotec), according to the clinical data and expert experience, has the potential to overcome the pressing challenge of preserving the hypogastric artery in patients with an abdominal aortic aneurysm (AAA) undergoing endovascular repair.

ONE OF THE MAJOR ANATOMICAL challenges of endovascular aortic repair in patients with AAA is concomitant iliac artery aneurysms. Iliac artery aneurysms are known to exacerbate the complexity of endovascular aneurysm repair and increase the incidence of type Ib endoleaks, iliac limb occlusions and aneurysm ruptures. Furthermore, occlusion of the internal iliac artery (IIA) can cause ischaemic manifestations such as erectile dysfunction, buttock claudication and colonic ischaemia.1–3 Therefore, the European Society for Vascular Surgery recommends to avoid bilateral interruption of the IIAs, at least in standard-risk patients.4

The E-liac stent graft system is indicated for both aortoiliac and isolated iliac aneurysms, has a pre-cannulated side branch, and is designed for a broad range of anatomies. The device offers an endovascular solution for preserving the hypogastric artery and is indicated for the treatment of patients with unilateral, bilateral aortoiliac or isolated iliac aneurysms provided the following preconditions are met:5

For isolated aneurysms:

● Non-aneurysmal common iliac artery landing area in case of iliac artery aneurysm ≥20mm

● Diameter of common iliac artery in the proximal landing area: 12–17mm

For isolated and aortoiliac aneurysms:

● Diameter of the external iliac artery (EIA) in the distal landing area: 8–13mm

Clinical evidence

The E-liac stent graft system has been tested in multiple studies where its safety and efficacy to maintain pelvic blood flow have been proven.

The device has high patency rates and low reintervention rates according to multiple studies,5–7 and there have now been over 7,500 implantations.

In one study, published in 2016, Spyridon N Mylonas (University of Cologne, Cologne, Germany) et al outlined their 12-month experience with the E-liac device for the revascularisation of hypogastric arteries. The team enrolled 70 patients and reported a 0% rate of buttock claudication, an 11% rate of E-liac-related reintervention, a 97% primary patency rate in the EIA and a 100% rate in the IIA.5

In 2018, Susanne Anton (University Hospital of Schleswig-Holstein, Lübeck, Germany) and colleagues shared their initial experience with the E-liac device for the endovascular aortic repair of aortoiliac aneurysms. They followed 21 patients up for 12 months and reported that the rate of buttock claudication was 5%, with an 8.7% rate of E-liac-related reintervention. Primary patency in both the EIA and IIA was 100%.6

The following year, Jan S Brunkwall (University Clinic of Cologne, Cologne, Germany) et al announced 12-month results of a prospective study of the E-liac device in patients with common iliac artery aneurysms. In 42 patients, the buttock claudication rate was 2.4%, the E-liac-related reintervention rate was 5%, and the primary patency rate was 98% in both the EIA and IIA.7

Read ahead for some case-based reports on the E-liac stent graft system, as well as other devices in the Artivion portfolio, with experience from University Hospital Münster (Münster, Germany), Zuyderland Medical Center (Heerlen, The Netherlands), Athens Medical Center (Athens, Greece), and the University of Siena (Siena, Italy) illuminating how these products have influenced aortic practice across Europe.

References

1. Rayt HS, Bown MJ, Lambert KV, et al. Buttock claudication and erectile dysfunction after internal iliac artery embolization in patients prior to endovascular aortic aneurysm repair. Cardiovasc Intervent Radiol. 2008;31: 728–34.

2. Lin PH, Chen AY, Vij A. Hypogastric artery preservation during endovascular aortic aneurysm repair: is it important? Semin Vasc Surg. 2009;22: 193–200.

3. Pavlidis D, Hormann M, Libicher M, et al. Buttock claudication after interventional occlusion of the hypogastric artery—a mid-term follow-up. Vasc Endovascular Surg 2012;46: 236–41.

4. Instructions for use E-liac.

5. Mylonas SN, Rümenapf G, Schelzig H, et al. A multicenter 12-month experience with a new iliac side-branched device for revascularization of hypogastric arteries. J Vasc Surg 2016 Dec;64(6): 1652–1659.e1.

6. Anton S, Wiedner M, Stahlberg E, et al. Initial experience with the E-liac iliac branch device for the endovascular aortic repair of aorto-iliac aneurysm. Cardiovasc Intervent Radiol 2018 May;41(5): 683–6919.

7. Brunkwall JS, Puerta CV, Heckenkamp J, et al. Prospective study of the iliac branch device E-liac in patients with common iliac artery aneurysms: 12 month results. 2019 Oct 12, 10.1016/j.ejvs.2019.06.020.

Disclaimer: The views expressed in this article are the speaker’s own and do not necessarily reflect those of Artivion, the speaker’s employer, organization, committee, or other group or individual. Unattributed data, device selection, and procedural guidance is a matter of physician preference. Refer to the Instructions for Use and other product insert documentation that accompanies each of these devices for indications, contraindications, warnings, precautions, possible complications, and instructions for use.

All rights reserved. Published by BIBA News, London T:+44 (0)20 7736 8788, publishing@bibamedical.com.

The opinions expressed in this supplement are solely those of Artivion and the featured physicians and may not reflect the views of Vascular News