Degradation Phenomena on "Homemade" Explanted Aortic Textile Endografts

Area of Science:

• Biomaterials Science
• Vascular Surgery
• Medical Device Engineering

Background:

• Homemade endografts (EGs) were developed in the 1990s for endovascular abdominal aortic repair (EVAR) using commercially available materials.
• The long-term durability and aging characteristics of these devices were not well understood.

Purpose of the Study:

• To analyze the aging phenomena of homemade endografts (EGs) through explant analysis.
• To identify the mechanisms of degradation in textile EGs used for EVAR.

Main Methods:

• Analysis of five explanted homemade EGs (implanted for 56-202 months).
• Assessment included visual, microscopic, and endoscopic examinations following ISO 9001/13485 standards.
• Evaluation focused on fabric cover, stitch filament, and stent integrity.

Main Results:

• Explantation reasons included endoleak (3 cases) and aneurysm sac growth (2 cases).
• Sixty-three percent of fabric lesions resulted from abrasion between fabric and stents.
• Observed defects included broken stitches (up to 33%), suture rupture, and stent corrosion.

Conclusions:

• Homemade textile EGs exhibit various aging phenomena, including fabric tears and holes due to abrasion.
• Stitch ruptures and stent detachment contribute to device deformation and degradation.
• Findings underscore the risks associated with non-standardized materials in endovascular aortic repair.