Medium-Term Outcomes of Treatment with a VIABAHN VBX Covered Stent for Aortoiliac Occlusive Lesions in Patients with Peripheral Artery Disease.

ABSTRACT

BACKGROUND: Endovascular treatment (EVT) for aortoiliac (AI) occlusive lesions is now conducted worldwide, but there are challenges in EVT for complex AI lesions. The VIABAHN VBX (W.L. Gore & Associates, Flagstaff, AZ) is a next-generation balloon-expandable covered stent designed for use with complex AI lesions. The purpose of this study is to evaluate the medium-term outcomes of VIABAHN VBX for such lesions. METHODS: Symptomatic patients who underwent EVT with VIABAHN VBX for an AI lesion from 2018 to 2020 at 7 Japanese centers were reviewed retrospectively. The primary endpoints were primary patency and freedom from target lesion revascularization (TLR). RESULTS: A total of 95 EVT procedures with VIABAHN VBX for AI occlusive lesions were performed in 71 patients. The patients had high rates of dyslipidemia (53%) and chronic kidney disease (61%), and 22% had chronic limb-threatening ischemia (CLTI). The Transatlantic Inter-Society Consensus (TASC Ⅱ) class was A in 12 patients (17%), B in 12 (17%), C in 10 (14%), and D in 37 (52%). Severe calcification (360°) of the treated lesion was present in 31 patients (33%). The median procedure time was 84 (49-158) min, with a technical success rate of 100%. The median follow-up period was 36 (32-43) months. The 3-year primary and secondary patency of VIABAHN VBX were 91% and 99%, the 3-year freedom from TLR was 92%, and the 3-year freedom from major adverse limb event (MALE) was 98%. No limbs required major amputation. Lesion severity (TASC Ⅱ C or D) and severe calcification did not affect the primary patency or freedom from TLR. CONCLUSIONS: Medium-term outcomes after EVT with VIABAHN VBX for AI lesions were acceptable regardless of lesion severity and calcification. These results suggest that VIABAHN VBX may be suitable for AI occlusive lesions with severe anatomical complexity and/or severe calcification.