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Evaluation of an in-line bipolar polyurethane ventricular pacing lead
M W Sweesy1, C C Forney, D L Hayes
1Robert L. Batey Cardiology Center, Bradenton, Florida 34209.
Pacing and Clinical Electrophysiology : PACE
|November 1, 1992
Summary
The Medtronic 4012 pacing lead showed a 9.7% failure rate in a 4-year study. Pacemaker-dependent patients require careful consideration for prophylactic replacement of this lead.
Area of Science:
- Cardiology
- Biomedical Engineering
Background:
- The Medtronic 4012 polyurethane in-line bipolar pacing electrode is widely used.
- Evaluating lead performance and failure modes is crucial for patient safety and device longevity.
Purpose of the Study:
- To assess the real-world performance and failure rates of the Medtronic 4012 pacing lead.
- To identify common failure mechanisms and their clinical manifestations.
Main Methods:
- A retrospective analysis of 126 patients implanted with the Medtronic 4012 lead.
- Regular clinical follow-up including stimulation/sensing threshold testing and myopotential inhibition testing.
- Kaplan-Meier analysis to estimate lead survival probability.
Main Results:
- Twelve lead failures (9.5%) were documented out of 126 implants.
- Ten failures occurred in leads implanted at the institution, all utilizing the suture anchoring sleeve.
- Common failures included oversensing, loss of ventricular capture, and decreased lead impedance.
Conclusions:
- The estimated probability of not experiencing a lead failure within 4 years is 0.9103.
- Pacemaker-dependent patients implanted with the 4012 lead warrant special consideration for prophylactic replacement.
- Suture anchoring sleeve may be associated with lead failure.