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Characterization of Outer Insulation in Long-Term-Implanted Leads.

Mariya Tohfafarosh1, Alex Sevit1, Jasmine Patel2

  • 1School of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA.

Journal of Long-Term Effects of Medical Implants
|January 31, 2017
PubMed
Summary

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Long-term pacemaker and defibrillator lead insulation shows degradation. Polyurethane (PU) leads exhibited chemical oxidation, while polydimethylsiloxane (PDMS) leads showed surface changes but no chemical degradation in vivo.

Area of Science:

  • Biomaterials Science
  • Polymer Chemistry
  • Medical Device Engineering

Background:

  • Pacemaker and implantable cardioverter defibrillator (ICD) lead failure can be caused by polymer insulation degradation.
  • Polyurethane (PU) and polydimethylsiloxane (PDMS) are common lead insulation materials known to degrade in vivo.
  • Long-term effects of the physiological environment on lead insulation require comprehensive characterization.

Purpose of the Study:

  • To systematically characterize the chemical and surface changes in long-term implanted pacing and defibrillator leads (≥5 years).
  • To compare the in vivo degradation of PU and PDMS lead insulation materials.

Main Methods:

  • Retrieval of 104 pacing and defibrillator leads implanted for ≥5 years.
  • Systematic characterization of 37 retrieved leads using Fourier transform infrared (FTIR) spectroscopy for chemical analysis.

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  • Surface degradation evaluation using scanning electron microscopy (SEM).

    • Main Results:

    • Both PDMS and PU insulation showed surface changes after long-term implantation.
    • PDMS leads exhibited increased surface roughness but no significant changes in Si-O-Si bonds.
    • PU leads displayed uniform cracking and statistically significant changes in oxidation-indicating chemical bonds (ether, carbonyl, amino).

    Conclusions:

    • Polyurethane (PU) insulation undergoes chemical oxidation in vivo, unlike polydimethylsiloxane (PDMS).
    • While both polymers show surface alterations, only PU demonstrates chemical degradation in long-term implanted leads.
    • Findings provide critical insights for medical device manufacturers and surgeons regarding lead material performance and longevity.