MULTICENTER STUDY
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Treatment of Aortoiliac Occlusive Disease with the Endologix AFX Unibody Endograft.

OBJECTIVE/BACKGROUND: Aorto-bifemoral bypass remains the gold standard for treatment of aortoiliac occlusive disease (AIOD) in patients with advanced (TASC D) lesions, but has significant associated morbidity and mortality. Treatment with a unibody stent-graft positioned at the aortic bifurcation is a potential endovascular option for the treatment of AIOD. The current study examines the safety, efficacy, and early patency rates of the Endologix AFX unibody stent-graft for treatment of AIOD.

METHODS: A multicenter retrospective review was conducted of patients 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. Ninety-one patients (56 males [62%]) were studied.

RESULTS: Sixty-seven patients (74%) presented with lifestyle-limiting intermittent claudication and the remaining 24 (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). Thirty-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%.

CONCLUSION: This is the largest study to examine the use of the Endologix AFX unibody stent-graft for the treatment of AIOD. Use of the AFX stent-graft appears to be a safe and effective endovascular treatment for complex AIOD.

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