Outcomes following endovascular abdominal aortic aneurysm repair both within and outside of the instructions for use

Ann Thorac Cardiovasc Surg. 2014;20(1):61-6. doi: 10.5761/atcs.oa.12.02059. Epub 2013 Feb 15.

Abstract

Purpose: To determine the influence of the abdominal aortic aneurysm (AAA) anatomy on the clinical outcomes after endovascular AAA repair (EVAR).

Methods: Between January 2008 and December 2010, 53 patients underwent EVAR. The parameters outside of the device instructions for use (IFU) were: short neck length (<15 mm), proximal neck angulation (>60 degrees), small diameter of external iliac artery (<7 mm) and bilateral internal iliac embolization.

Results: A total of 37% of these grafts were placed outside of at least one IFU parameter. The intraoperative problems encountered included one (3%) acute graft limb thrombosis, and one (3%) access vessel rupture within the IFU (w-IFU) group. One perioperative mortal case was observed in the w-IFU group due to thoracic aortic dissection. After one year follow-up, type II endoleak (EL) was recognized in 8 of 28 (29%) patients in the w-IFU group, and in 2 of 12 (17%) patients outside of the IFU (o-IFU) group. There was also no significant difference of early and mid-term outcomes between favorable neck anatomy and hostile neck anatomy (HNA).

Conclusion: In our series, EVAR provided acceptable results even in the o-IFU group and HNA. This suggests that the IFU can be extended to other selected patients.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Aneurysm, Abdominal / diagnosis
  • Aortic Aneurysm, Abdominal / mortality
  • Aortic Aneurysm, Abdominal / surgery*
  • Blood Vessel Prosthesis
  • Blood Vessel Prosthesis Implantation* / adverse effects
  • Blood Vessel Prosthesis Implantation* / instrumentation
  • Blood Vessel Prosthesis Implantation* / mortality
  • Endovascular Procedures* / adverse effects
  • Endovascular Procedures* / instrumentation
  • Endovascular Procedures* / mortality
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Selection
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Prosthesis Design
  • Retrospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome