Mid-term results of "off-label" use of the Endurant stentgraft in patients with infrarenal abdominal aortic aneurysms.

OBJECTIVES: EVAR is the preferred treatment modality for patients with an infrarenal abdominal aortic aneurysm with suitable anatomy. Each manufacturer of aortic stentgrafts has specific anatomic requirements. In some patients, it is not possible to adhere to the instructions for use, but alternative treatment is also not possible. In these patients, EVAR can be performed outside instructions for use.

METHODS: In this study, all consecutive patients in whom an Endurant II or IIS stentgraft was used between 1 January and 31 December were reviewed. We compared the two patient groups in whom this stentgrafts was used outside and inside instructions for use. Patients with planned adjuvant therapy, for example, chimney procedure or iliac side branches, were excluded.

RESULTS: In 74 of 178 (41.6%) patients, the instructions for use were not adhered. The main reason was pathology of the aortic neck. There were more patients with type IA endoleak, this difference was borderline significant ( p = .06). There were more patients with limb occlusion in the early postoperative period, but at the end of the follow-up period, the incidence was comparable. Aneurysm-related mortality and all-cause mortality were comparable in both groups.

CONCLUSION: In this study, real-life experience with the Endurant II and IIS stentgraft is described. Non-adherence with instructions for use was associated with a higher risk of endoleak type IA ( p = .06). In the early postoperative period, there were more patients with limb occlusion; this finding was not observed anymore at the end of the follow-up period.