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A multicenter experience with a bipolar tined polyurethane ventricular lead.

D L Hayes1, K J Graham, M Irwin

  • 1Division of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minnesota 55905.

Pacing and Clinical Electrophysiology : PACE
|July 1, 1992
PubMed
Summary

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The Medtronic 4012 pacing lead shows an unacceptable failure rate of 20.9% at 6 years due to insulation issues. Pacemaker-dependent patients may need lead replacement, while others require close monitoring.

Area of Science:

  • Cardiovascular Medicine
  • Biomedical Engineering
  • Medical Device Technology

Background:

  • A multicenter study evaluated the failure rate of the Medtronic 4012 polyurethane bipolar tined pacing lead.
  • 1,190 leads were implanted across six centers in the US and Canada to assess lead failure probability and manifestations.

Discussion:

  • Failures were specifically linked to insulation problems, manifesting as sensing abnormalities, capture failure, and early battery depletion.
  • A significant decrease in measured impedance was also a key indicator of lead malfunction.
  • Of 95 definite failures, 16.8% presented with symptoms mirroring pre-pacemaker placement conditions.

Key Insights:

  • Kaplan-Meier analysis revealed a 20.9% probability of Medtronic 4012 lead failure by 6 years post-implantation.

Related Experiment Videos

  • The observed failure rate is deemed unacceptable by the study authors.
  • Insulation failure is the primary concern for this specific pacing lead model.

    • Outlook:

    • Strong consideration for lead replacement in pacemaker-dependent patients is recommended.
    • Close monitoring of non-dependent patients is advised due to the high failure rate.
    • Further research into lead material durability and design improvements is warranted.