Initial Clinical Experience with the Endologix AFX Unibody Stent Graft System for Treating Patients with Abdominal Aortic Aneurysms: A Case Controlled Comparative Study

Abstract

PurposeThe newly designed unibody AFX endograft system for endovascular aortic aneurysm repair is the only graft with anatomical fixation to the aortic bifurcation in comparison to most other grafts that use the infrarenal neck as the main fixation point. The aim of this study was to assess the preliminary results of the AFX stent-graft system used with infrarenal aortic component and compare them with those obtained in patients treated with a well established endograft of the same material and pure infrarenal fixation as the Gore Excluder.Materials and MethodsA retrospective analysis of prospectively collected data from March 2014 to December 2014 identified 10 elective abdominal aortic aneurysm patients treated with the AFX endograft, in comparison to a matched group of 20 patients treated with the Excluder stent-graft. Endpoints included technical and clinical success, freedom from any secondary intervention, any type of endoleak and aneurysm related death.ResultsPrimary technical success was achieved in all patients and no 30-day device related complications or deaths were occurred. The two groups were similar in terms of radiation burden, contrast media, duration of the procedure, post implantation syndrome and in-hospital stay. During a median follow-up period of 23 months (range, 18–26 months) there were no differences in clinical success, freedom from reintervention and aneurysm related death. No type I endoleak was observed in either group. Five of the 6 type II endoleaks (1 in the AFX and 4 in the Excluder group) spontaneously resolved, while in only one patient (Excluder) the endoleak remained without however any change in aneurysm sac diameter (log rank=0.34).ConclusionThe initial experience with the AFX stent graft system is promising, with successful aneurysm exclusion and good short-term results. Further and larger studies are needed to fully evaluate the sort as well as the long-term results.

Use of the AFX Stent Graft in Patients with Extremely Narrow Aortic Bifurcation: A Multicenter Retrospective Study

“…The type II EL incidence is comparable to reports by other researchers using the same stent graft system. For example, Kouvelos et al reported a type II EL rate of 10% after a median follow-up of 23 months when using the AFX stent graft, whereas Welborn et al found a rate of 5.7% at 9-month follow-up [ 29 , 30 ].…”

Initial Experience and Potential Advantages of AFX2 Bifurcated Endograft System: Comparative Case Series

“…This graft stiffness is also a problem in cases of wide beta angulation. In our experience, the telescopic technique of the AFX2 stent can be used to overcome these limitations, although more research is needed [21].…”

Endovascular Aortic Aneurysm Repair in Patients with Aortoiliac Occlusive Disease

“…The AFX bifurcated unibody aortic endograft (Endologix, Irvine, California)-FDA-approved for EVAR-has also been successful in treating TASC D AIOD lesions with primary and assisted primary patency rates of 91 and 97% at 1 year, respectively (Figure 3) [48]. Unlike traditional modular bifurcated aortic endografts with fixation points at the infrarenal proximal aortic neck, the AFX is fixed at the aortic bifurcation [49]. Furthermore, it is delivered through a 17-Fr ipsilateral and a 9-Fr contralateral sheath facilitating advancement and deployment in heavily calcified, small-caliber iliac arteries [49].…”

“…Unlike traditional modular bifurcated aortic endografts with fixation points at the infrarenal proximal aortic neck, the AFX is fixed at the aortic bifurcation [49]. Furthermore, it is delivered through a 17-Fr ipsilateral and a 9-Fr contralateral sheath facilitating advancement and deployment in heavily calcified, small-caliber iliac arteries [49]. In a recent study, the AFX unibody stent was successfully used in the treatment of TASC C/D lesions in patients with concomitant AAA [50].…”