Long-term failure after endovascular aneurysm sealing in a real-life, single-center experience with the Nellix endograft

We performed a device-specific comparison of long-term outcomes following endovascular abdominal aortic aneurysm repair (EVAR) to determine the effect(s) of device type on early and late clinical outcomes. In addition, the impact of performing EVAR both within and outside of specific instructions for use (IFU) for each device was examined. Between January 8, 1999 and December 31, 2005, 565 patients underwent EVAR utilizing one of three commercially available stent graft devices. Study outcomes included perioperative ( .05), but a lower freedom from GRAE (74% outside IFU vs 86% within IFU; P = .021), likely related to a higher incidence of graft thrombosis (2.3% outside IFU vs 0.3% within IFU; P = .026). The differences in outcome for grafts placed within vs outside IFU were not device-specific. EVAR performed with three commercially available devices provided similar clinically relevant outcomes at 5 years, although no graft migration occurred with a suprarenal fixation device. As anticipated, application outside of anatomically specific IFU variables had an incremental negative effect on late results, indicating that adherence to such IFU guidelines is appropriate clinical practice.