Feasibility of Endovascular Abdominal Aortic Aneurysm Repair Outside of the Instructions for Use and Morphological Changes at 3 Years after the Procedure

Abstract

Introduction:We retrospectively analyzed outcomes of patients who had undergone endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) more than 3 years previously in a single institution. We compared outcomes between patients who underwent EVAR within and outside of the devices' instructions for use (IFU) and examined mid-term morphological changes in AAA. Methods: A total of 275 patients who underwent EVAR for AAA were selected. IFU parameters included aneurysmal neck length, angulation and presence of massive atheroma. Patients were divided into 2 groups: the Within IFU group (W-IFU: n = 193) and the Outside of IFU group (O-IFU: n = 82). Results: Patients in the O-IFU group were older and had a larger AAA diameter. Other comorbid factors were similar between the 2 groups. There was no difference in overall survival rates and reintervention rates between the 2 groups. The most common cause for reintervention was AAA enlargement 3 years after EVAR. Irrespective of the IFU, mid-term morphological changes, including neck angulation, neck diameter, sac re-expansion, and Palmaz stent displacement, were found. Conclusion: Outcomes of EVAR were considered acceptable in the O-IFU group. Careful follow-up is necessary considering the morphological changes in AAAs after EVAR.

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

“…Hoshina et al [4] used a Palmaz stent to prevent type 1a endoleaks in some patients, with excellent midterm results. However, in their study comparing the on-and off-label use of eVar endografts, the displacement of the Palmaz stent occurred in most patients treated with the device, presumably because of the gradual neck dilatation caused by unfolding of the graft [5]. We agree with their conclusion that an aortic cuff, instead of a Palmaz stent, should be used to treat intraoperative type 1a endoleaks.…”

“…Hoshina et al [5] also compared the outcomes in patients who underwent eVar in which the endograft was used on-label (n = 193) with those in patients in whom it was used off-label (n = 82). like us, they usually inserted a Zenith device in patients with a short aortic neck and an excluder endograft in patients with tortuous vessels.…”

“…Our intraoperative management of type 1a endoleaks used a procedure that was previously described by Hoshina et al [4,5]; this involved a "touch up" with a semi-compliant occlusion balloon, and if the endoleak did not stop, the use of a noncompliant balloon, aortic cuff or Palmaz stent. In some patients in whom the iliac artery diameter was larger than 20 or 25 mm, we used an aortic cuff to prevent bilateral occlusion of the internal iliac arteries.…”

Effectiveness of proximal intra-operative salvage Palmaz stent placement for endoleak during endovascular aneurysm repair

“…It has been shown in large clinical cohorts that up to 42% of EVARs are performed outside the instructions for use for commercially available stent grafts. 3,[17][18][19] Multiple measures have been developed to include more of these difficult necks for endovascular treatment.…”

“…[1][2][3] Data from the EUROSTAR Registry more than a decade ago looking at aneurysm morphology and procedural details of 2272 patients showed that perioperative New knowledge added by this study • Palmaz stenting is effective and safe as a salvage treatment of proximal endoleak during endovascular aortic repair (EVAR).…”