Any nonadherence to instructions for use predicts graft-related adverse events in patients undergoing elective endovascular aneurysm repair

Abstract

A total of 43.8% of patients undergoing EVAR had a device-specific IFU violation, indicating that implanters are pushing the boundaries of device capabilities. Our study identified that any IFU violation was significantly associated with GRAEs over time. Caution should be applied to patients being considered for EVAR when IFU deviations exist.

Comparison of Outcomes in Elective Endovascular Aortic Repair vs Open Surgical Repair of Abdominal Aortic Aneurysms

“…6,39,40,41 Furthermore, a 2018 study 42 showed that these rates have increased in populations known to have more challenging anatomy, including women and elderly patients. A 2018 study by Herman et al 43 of EVARs from 2005 to 2014 demonstrated IFU violations in 43.8% of patients undergoing elective EVAR and that non-IFU EVARs were associated with higher risk of graft-related adverse events (HR, 1.8; 95% CI, 1.05-3.10). Furthermore, a 2017 international study 44 of elective AAA repair outcomes during 9 years confirmed worse EVAR perioperative mortality in octogenarians (1.8% vs 0.7%; P < .001) and women (1.9% vs 0.9%; P < .001) during the course of the study, suggesting that the long-term benefits of EVAR may be undermined by too-forceful application.…”

A unique case of bilateral lower extremity post-endovascular aneurysm repair claudication

“…7 Noncompliance to endograft recommendations is high, however, with a study reporting that nearly half of its EVAR patients had at least one IFU violation. 8 The extent to which surgical options were discussed with our patient before the initial repair is unclear, but documentation reveals that he wished to proceed with an endovascular procedure. Our patient's initial EVAR used a GORE ® EXCLUDER ® AAA Endoprosthesis with recommended IFU as follows: an infrarenal aortic neck diameter range of 19-32 mm and proximal aortic neck angulation ⩽60°.…”

Open Surgical Repair of Abdominal Aortic Aneurysms Maintains a Pivotal Role in the Endovascular Era

“…Furthermore, violation in IFUs was significantly associated with adverse outcomes including endoleak and aneurysm-related mortality. 24 We know that after treatment with EVAR, there is often proximal neck dilation that occurs overtime, even when there is early AAA sac regression. Although a proximal seal may be achieved initially, neck angulation or inadequate seal length may increase tendency for neck dilation and susceptibility to development of type Ia endoleak.…”