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Related Experiment Videos

Examination of explanted polyurethane pacemaker leads using the scanning electron microscope.

F Beyersdorf, J Kreuzer, L Schmidts

    Pacing and Clinical Electrophysiology : PACE
    |July 1, 1985
    PubMed
    Summary
    This summary is machine-generated.

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    Polyurethane (PU) cardiac pacing leads show surface degradation, particularly at the ligature site, but no insulation failures occurred in 2,365 implanted leads. Further surveillance is recommended.

    Area of Science:

    • Biomaterials Science
    • Cardiovascular Engineering
    • Medical Device Analysis

    Background:

    • Transvenous implantation of polyurethane (PU) insulated cardiac pacing leads has been performed since 1978.
    • No insulation failures have been reported for 2,365 implanted PU leads at this institution.
    • Explanted leads provide insight into long-term material performance.

    Purpose of the Study:

    • To investigate the surface integrity of explanted polyurethane (PU) insulated cardiac pacing leads.
    • To identify potential degradation patterns and their correlation with implantation factors.
    • To inform best practices for lead implantation and patient monitoring.

    Main Methods:

    • Analysis of 37 explanted PU leads, with 28 examined using scanning electron microscopy (SEM).

    Related Experiment Videos

  • SEM evaluation focused on surface changes across all lead segments, including the ligature site.
  • Regression analysis was used to assess the time-dependency of surface changes.

    • Main Results:

    • 56% of examined leads exhibited homogeneous surface changes.
    • Severe surface cracking (up to 40 microns) was observed in 21% of leads, predominantly at the ligature site.
    • No statistically significant time-dependency was found for surface changes (r = 0.32, p > 0.05).

    Conclusions:

    • Polyurethane (PU) cardiac pacing leads demonstrate surface degradation, especially at the ligature site, without insulation failure in this cohort.
    • Minimizing stress during implantation is crucial to mitigate lead surface changes.
    • Ongoing surveillance of implanted leads is necessary to monitor long-term outcomes.