Safe extraction of Riata looped extruding filler cables

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Medical Device Technology

Background:

• The Riata 1590 implantable cardioverter-defibrillator (ICD) lead model incorporates electrically active cables (AC) and filler cables (FC).
• Filler cables (FC) have not been previously characterized as lead components prone to externalization through abrasion.

Observation:

• Externalization of FC, through either external or inside-out abrasion, can occur and may not present electrical abnormalities during routine evaluations.
• Unlike AC, FC are secured only by silicone adhesive, making them susceptible to migration and extrusion through insulation breaches, forming cable loops.

Findings:

• Ten recalled Riata lead models containing electrically inactive FC require closer examination using X-ray imaging.
• Externalized FC loops significantly increase the complexity and difficulty of ICD lead extraction procedures.

Implications:

• The identification of specific Riata models with potentially externalizing FC necessitates enhanced vigilance and imaging protocols.
• A described technique effectively mitigates the challenges posed by extruded FC loops, facilitating safer lead extraction and improving patient outcomes.