No major difference in outcomes for endovascular aneurysm repair stent grafts placed outside of instructions for use

Abstract

Despite most EVAR patients being treated outside of IFU, there was no difference in outcomes with respect to all-cause mortality or aneurysm-related mortality. In addition, with the exception of perioperative blood transfusions, there was no association between IFU adherence and late-onset rupture, need for reintervention, rates of endoleak, aneurysm sac enlargement, or most other major complications.

Preoperative Neck Angulation is Associated with Aneurysm Sac Growth Due to Persistent Type Ia Endoleak after Endovascular Abdominal Aortic Aneurysm Repair

“…However, recently, it has been reported that there is no difference in the outcomes of EVAR between the patients within and outside of the IFU. [4][5][6]10,11) Beckerman et al concluded that there was no difference in the all-cause mortality or the aneurysm-related mortality despite most EVAR patients being treated outside the IFU. 6) Moreover, aneurysm sac enlargement was identified in 11.7% of overall patients, but no significant difference between patients treated within and outside the IFU (p=0.870).…”

“…Besides its clinical importance, IFU adherence remains controversial as that is said by the reported studies. [4][5][6] This study aimed to determine how IFU influences the incidence of sac growth and endoleaks post-EVAR and to recognize the computed tomography (CT) features of IFU, which may predict adverse events post-EVAR.…”

Comparable perioperative mortality outcomes in younger patients undergoing elective open and endovascular abdominal aortic aneurysm repair

“…This suggests that further study is needed to define concrete benefits related to the use of EVAR in younger patients with longer lifespans. Recent studies have suggested that patients with less anatomically favorable criteria for EVAR may be more likely to experience more long-term complications compared to those with favorable aneurysm anatomy 14,22 , although solid evidence to support this conclusion remains limited and conflicting 23 . Studying younger patients within this “off-IFU” cohort with unfavorable aneurysm anatomy for EVAR may identify a population potentially benefitting from open repair.…”

Successful off-label use of the GORE EXCLUDER Iliac Branch Endoprosthesis to preserve gluteal perfusion during staged endovascular repair of bilateral isolated hypogastric aneurysms

“… 14 However, in a recent report from our group of outcomes in 566 patients, no statistical difference was found in adverse events for patients treated with EVAR outside the IFU. 15 Nevertheless, the long-term durability of our intervention will require close monitoring with clinical evaluation and imaging.…”