Expanding the EVAR Pool with Non-IFU Patients: How Important is Subjective Physician Assessment?

Objectives: In order to reduce the abdominal aortic aneurysm (AAA)-related complication rate in endovascular aneurysm repair (EVAR) procedures, manufacturers recommend following the instructions for use (IFU). However, IFU is considered too conservative in many centers. In this context, we present our experience and patient follow-up data with 248 consecutive patients with or without IFU eligibility. Methods: A total of 248 patients who underwent elective EVAR for AAA between 2014 and 2019 were included. In total, 190 patients were in the IFU group and 58 in the non-IFU group. Patients were evaluated for baseline demographic and anatomic data; unexpected periprocedural intervention; and postoperative data such as development of endoleaks during follow-up, need for re-intervention, development of complications, EVAR patency, and mean 5-year survival rate. Results: The patients did not differ in terms of basic demographic data. The basic anatomical data were suitable for the IFU standard. Intraoperative endoleak development was significantly higher in the non-IFU group. In addition, the development of endoleaks at any time, the need for re-intervention, and the development of complications were higher in the non-IFU group at postoperative follow-up. Survival analysis showed no difference in the mean 5-year follow-up. The EVAR patency rate was higher in the IFU group. Conclusions: We believe that the decision for a non-IFU EVAR should be patient-specific and that the results of the subjective medical assessment should definitely be taken into account. However, we should not forget that EVAR patients, especially non-IFU patients, are susceptible to future changes in the aorta and prone to the development of endoleaks and re-interventions.