Early and midterm results of covered balloon-expandable stents (VBX-Gore) for endovascular treatment of chronic aorto-iliac occlusion.

BACKGROUND: Endovascular treatment is nowadays accepted as first-line treatment for most patients with aorto-iliac obstructive disease (AIOD), including those with Trans-Atlantic Inter-Society Consensus II (TASC-II) lesion types C and D. Aim of the study was to evaluate the role of Viabahn VBX (W. L. Gore and Associates, Flagstaff, AZ, USA), in patients with chronic occlusive aorto-iliac disease (ChO).

METHODS: A retrospective review of patients undergone elective endovascular repair with VBX (W. L. Gore and Associates) for ChO at five referral vascular institutions in Italy from 2018 to 2022 was conducted. Primary endpoints were technical success and the incidence of any early and midterm procedure-related reintervention. Secondary endpoints were clinical success, primary and secondary patency.

RESULTS: Among 89 included patients, technical success was obtained in 87 patients (97.8%). Postoperative complication requiring early surgical reintervention was necessary in 5 (6%), all but one for arterial bleeding. Clinical improvement of at least 3 classes was observed in 49 (55%). After a mean follow-up of 24.1 months ±14.1, primary patency and freedom from any procedure-related reintervention at 12, 24 and 36 months was 83.0% and 94.8%, 80.0% and 91.5%, 77.9% and 89.3%, respectively. Secondary patency was 100%. TASC-II D lesion (OR=3.67, 95% CI: 1.1289-11.9823, P=0.03) and Grade III iliac calcification (OR=3.41, 95% CI: 1.0944-10.6428, P=0.03) were identified as independent predictors for procedure-related reintervention.

CONCLUSIONS: Use of VBX (W. L. Gore and Associates) in ChO was safe and effective with low rate of stenosis/occlusion in the early and mid-term follow-up. TASC-II D and Grade III calcifications resulted as independent predictors for procedure-related reintervention.