Midterm outcomes of endovascular repair for abdominal aortic aneurysms with the on-label use compared with the off-label use of an endoprosthesis

Takuya Matsumoto, Shinichi Tanaka, Jun Okadome, Ryoichi Kyuragi, Ryota Fukunaga, Eisuke Kawakubo, Hiroyuki Itoh, Jin Okazaki, Ken Shirabe, Atsushi Fukuda, Yoshihiko Maehara

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9 Citations (Scopus)

Abstract

Purpose: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)880-885
Number of pages6
JournalSurgery today
Volume45
Issue number7
DOIs
Publication statusPublished - Jul 15 2015

All Science Journal Classification (ASJC) codes

  • Surgery

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    Matsumoto, T., Tanaka, S., Okadome, J., Kyuragi, R., Fukunaga, R., Kawakubo, E., Itoh, H., Okazaki, J., Shirabe, K., Fukuda, A., & Maehara, Y. (2015). Midterm outcomes of endovascular repair for abdominal aortic aneurysms with the on-label use compared with the off-label use of an endoprosthesis. Surgery today, 45(7), 880-885. https://doi.org/10.1007/s00595-014-0978-1