The Effect of Manufacturer's Instructions for Use Compliance on Cook ZBIS Iliac-Branched Endograft Long-Term Outcomes

Abstract

Current guidelines indicate iliac-branched endografts (IBDs) as the ideal means to preserve pelvic perfusion during endovascular aortic repair. Because patient vascular anatomy represents the main limitation to extensive use of these devices, off-label application may be considered to expand the number of patients being treated. The aim of this study is to evaluate long-term outcomes obtained using the Cook ZBIS endograft in the treatment of aortoiliac aneurysms as per or outside manufacturer's instruction for use (IFU). Data from all patients who underwent IBD implant in a single center were reviewed. Study population was divided into two subgroups: Group I treated as per manufacturer's IFU and group II treated outside IFU. During the study period (2008-2018), 119 patients were treated with 130 IBDs. Eighty-six patients were treated as per IFU (group I) and 44 outside IFU (group II). Overall technical success was 99.2%. Mean follow-up was of 63.5±38.3months for group I and 58.3±35.9months for group II (P=0.45). Freedom from reintervention at ten years was 79.8% in group I and 69.6% in group II (P=0.29). Freedom from IBD-related reintervention rate was 98.7% and 95.3% in groups I and II, respectively (P=0.240). Iliac-branched module thrombosis occurred significantly more in patients treated outside IFU with 4 cases in group I (4.7%) and 10 cases in group II (22.7%), (P=0.005). Cox regression analysis identified hypogastric artery aneurysm as the only independent predictor for both IBD thrombosis and hypogastric artery occlusion during follow-up. When used by an experienced team, Cook IBDs are safe and effective in the treatment of aortoiliac aneurysms both inside and outside IFU. Anyway a lower target hypogastric patency rate should be expected when treating patients with hypogastric aneurysms.