Midterm outcomes of endovascular repair for abdominal aortic aneurysms with the on-label use compared with the off-label use of an endoprosthesis
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Endovascular repair of an abdominal aortic aneurysm (EVAR) is sometimes not performed in accordance with the instructions for use (IFU) of the endoprosthesis (“off-label use”). We investigated whether the off-label use of the endograft affected the outcomes of EVAR.
Demographic, anatomical, intraoperative and follow-up data on 100 patients in whom the endograft was used on-label in EVAR were compared retrospectively with the corresponding data of 50 patients with off-label endograft use.
The endograft IFU were most often not followed in patients with challenging aortic neck anatomy or iliac access or fixation, steep neck angulation or bilateral hypogastric artery embolization. Compared with patients in whom the device was used on-label, patients with off-label use had significantly higher rates of intraoperative type I or III endoleaks and proximal aortic cuff placement or other adjunctive procedures. However, there were no midterm differences between the two groups in the rates of type 1b or II endoleaks, sac enlargement, device–limb occlusion or patient survival.
Most midterm outcomes of EVAR in which the endografts were used off-label were similar to those associated with on-label use of the devices. Off-label use of EVAR endoprostheses is feasible, but requires the use of special techniques in patients with challenging anatomical features.
KeywordsAbdominal aortic aneurysm Endovascular aneurysm repair Endoprostheses Instructions for use
We thank Rie Nishikuma for editorial assistance, Junji Kishimoto for statistical advice, Nicholas Smith for language assistance, Renée J. Robillard for English-language editing and WL Gore and Associates for providing funding for the English-language editing.
Conflict of interest
The authors have no conflicts of interest in relation to the contents of this article.
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