First-generation aortic endografts: analysis of explanted Stentor devices from the EUROSTAR Registry

R Guidoin1, Y Marois, Y Douville

  • 1Department of Surgery, Laval University, and Québec Biomaterials Institute, CHUQ, Québec City, Canada. robert.guidoin@crsfa.ulaval.ca

Insights

Explanted Stentor endografts showed fabric damage and incomplete healing. Nitinol wires exhibited corrosion and non-uniform elemental composition, indicating a need for improved biomaterial assembly in endovascular grafts.

Area of Science:

  • Biomaterials Science
  • Medical Device Engineering
  • Vascular Surgery

Background:

  • Endovascular grafts are crucial for treating aortic aneurysms.
  • Long-term performance of implanted devices requires thorough evaluation.
  • Stent-graft structural integrity and host tissue interaction are key concerns.

Purpose of the Study:

  • To investigate the structural integrity and healing characteristics of explanted Stentor endografts.
  • To identify failure modes and material degradation in chronically implanted devices.

Main Methods:

  • Explantation of Stentor endografts after 13-53 months of implantation.
  • Radiography, endoscopy, and MRI for structural analysis.
  • Histology, SEM, and chemical analysis for material and healing assessment.

Main Results:

  • Woven polyester fabric showed distortion, damage, and breakage, creating openings.
  • Incomplete luminal healing with a nonadherent thrombotic matrix was observed.
  • Nitinol wire corrosion and non-uniform titanium/nickel distribution were noted, alongside metallic frame compaction and dislocation.

Conclusions:

  • Despite judicious material selection, the assembly of biomaterials in Stentor endografts requires enhancement.
  • Fabric integrity, healing response, and nitinol stability are critical areas for improvement.
Abstract

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