The Effect of Manufacturer's Instructions for Use Compliance on Cook ZBIS Iliac-Branched Endograft Long-Term Outcomes

Ann Vasc Surg. 2021 Apr:72:454-463. doi: 10.1016/j.avsg.2020.09.055. Epub 2020 Nov 5.


Background: Current guidelines indicate iliac-branched endografts (IBDs) as the ideal means to preserve pelvic perfusion during endovascular aortic repair. Because patient vascular anatomy represents the main limitation to extensive use of these devices, off-label application may be considered to expand the number of patients being treated. The aim of this study is to evaluate long-term outcomes obtained using the Cook ZBIS endograft in the treatment of aortoiliac aneurysms as per or outside manufacturer's instruction for use (IFU).

Methods: Data from all patients who underwent IBD implant in a single center were reviewed. Study population was divided into two subgroups: Group I treated as per manufacturer's IFU and group II treated outside IFU.

Results: During the study period (2008-2018), 119 patients were treated with 130 IBDs. Eighty-six patients were treated as per IFU (group I) and 44 outside IFU (group II). Overall technical success was 99.2%. Mean follow-up was of 63.5 ± 38.3 months for group I and 58.3 ± 35.9 months for group II (P = 0.45). Freedom from reintervention at ten years was 79.8% in group I and 69.6% in group II (P = 0.29). Freedom from IBD-related reintervention rate was 98.7% and 95.3% in groups I and II, respectively (P = 0.240). Iliac-branched module thrombosis occurred significantly more in patients treated outside IFU with 4 cases in group I (4.7%) and 10 cases in group II (22.7%), (P = 0.005). Cox regression analysis identified hypogastric artery aneurysm as the only independent predictor for both IBD thrombosis and hypogastric artery occlusion during follow-up.

Conclusions: When used by an experienced team, Cook IBDs are safe and effective in the treatment of aortoiliac aneurysms both inside and outside IFU. Anyway a lower target hypogastric patency rate should be expected when treating patients with hypogastric aneurysms.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Aneurysm, Abdominal / diagnostic imaging
  • Aortic Aneurysm, Abdominal / physiopathology
  • Aortic Aneurysm, Abdominal / surgery*
  • Blood Vessel Prosthesis Implantation / adverse effects
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Blood Vessel Prosthesis*
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Female
  • Humans
  • Iliac Aneurysm / diagnostic imaging
  • Iliac Aneurysm / physiopathology
  • Iliac Aneurysm / surgery*
  • Male
  • Postoperative Complications / physiopathology
  • Postoperative Complications / surgery
  • Practice Guidelines as Topic*
  • Product Labeling*
  • Prosthesis Design
  • Reoperation
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Vascular Patency