Study Supports Endologix AFX to Treat Aortoiliac Occlusive Disease

May 11, 2016—Findings from an investigation of the treatment of aortoiliac occlusive disease (AIOD) with the Endologix AFX unibody endograft (Endologix, Inc.) were published by Thomas S. Maldonado, MD, et al in the European Journal of Vascular and Endovascular Surgery (EJVES).

The investigators concluded that use of the AFX stent graft appears to be a safe and effective endovascular treatment for complex AIOD. They noted that this is the largest study to date to examine the use of the Endologix AFX device for the treatment of AIOD.

As summarized in EJVES, the current study examines the safety, efficacy, and early patency rates of the Endologix AFX unibody stent graft for treatment of AIOD.

The investigators conducted a multicenter retrospective review of 91 patients (56 males) treated exclusively for AIOD with the AFX device. Primary, assisted primary, and secondary patency rates were noted. Clinical improvement was assessed using Rutherford classification and ankle brachial index. Mean duration of follow-up was 22.2 ± 11.2 months

Sixty-seven patients (74%) presented with lifestyle-limiting intermittent claudication and the remaining 24 patients (26%) had critical limb ischemia. Technical success was 100%. 

Complications included groin infection (n = 4 [4%]), groin hematoma (n = 4 [4%]), common iliac rupture (n = 4 [4%]), iliac dissection (n = 4 [4%]), and thromboembolic event (n = 3 [3%]; one femoral, one internal iliac artery, and one internal iliac with bilateral popliteal/tibial thromboemboli). 

The investigators reported that 30-day mortality was 1% (1/91) resulting from a case of extensive pelvic thromboembolism. At 1 year, 73% of patients experienced improvement in Rutherford stage of -3 or greater compared with baseline. Nine patients (10%) required 16 secondary interventions. At all time points, primary patency rates were > 90%, assisted patency rates were > 98%, and secondary patency rates were 100% for the Endologix AFX, reported the investigators in EJVES.