Textile Aging Characterization on New Generations of Explanted Commercial Endoprostheses: A Preliminary Study.

Area of Science:

• Biomaterials science
• Medical device engineering
• Materials science

Background:

• Second-generation textile endoprostheses (EPs) are widely used in vascular surgery.
• Understanding the aging process and material degradation of EPs is crucial for long-term patient safety.
• Explant analysis provides valuable insights into the in vivo performance of medical devices.

Purpose of the Study:

• To investigate aging phenomena in explanted textile endoprostheses (EPs).
• To classify observed defects and material damages in second-generation EPs.
• To establish a preliminary classification of aging-related issues in vascular EPs.

Main Methods:

• Analysis of 41 explanted polyethylene terephthalate textile EPs (2011-2014).
• Standardized evaluation protocol including visual inspection and optical microscopy.
• Classification system based on fabric, stitches, and stent features, measuring hole surface area.

Main Results:

• Sixty-four percent of EPs showed compression damage (holes, tears) from insertion.
• Ninety-five percent exhibited abrasion on stitches, increasing with implantation duration.
• Stitch degradation and ruptures correlated with longer implantation times; stent degradation was infrequent.

Conclusions:

• Commercial textile EPs exhibit various aging-related defects.
• Compression and abrasion are primary damaging mechanisms.
• These mechanisms lead to fabric tears, holes, and stitch ruptures, impacting EP integrity over time.