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Clinical evaluation of a thin bipolar pacing lead
K Breivik1, D Danilovic, O J Ohm
1Medical Department A, University School of Medicine, Bergen, Norway.
Pacing and Clinical Electrophysiology : PACE
|March 1, 1997
Summary
A novel bipolar pacing lead offers unipolar-like flexibility and diameter. Clinical evaluation showed satisfactory handling and electrical parameters, with one lead failure due to manufacturing error.
Area of Science:
- Cardiovascular medicine
- Biomedical engineering
- Medical device technology
Background:
- Traditional bipolar pacing leads are thicker and stiffer than unipolar leads.
- New lead technology utilizes a "drawn filled tube" and "coated wire" construction.
- This design aims to achieve flexibility and diameter comparable to unipolar leads.
Purpose of the Study:
- To evaluate the clinical performance of a new bipolar pacing lead.
- To assess the mechanical and electrical characteristics of the novel lead design.
Main Methods:
- The study involved implanting 47 bipolar leads (23 atrial, 24 ventricular) in 25 patients across four clinics.
- Lead handling, electrical parameters (thresholds, impedance, electrogram amplitude), and long-term follow-up (up to 2 years) were assessed.
- Data were collected at implant and at multiple postoperative time points.
Main Results:
- Lead handling characteristics were reported as very satisfactory.
- Mean chronic pulse width thresholds were 0.14 ms (atrium) and 0.10 ms (ventricle).
- Mean pacing impedances were 443 Ω (atrium) and 520 Ω (ventricle), with median electrogram amplitudes ≥3.5 mV (atrium) and ≥7 mV (ventricle).
- One lead (1/47) failed due to a manufacturing short circuit.
Conclusions:
- The new bipolar pacing lead demonstrates promising mechanical and electrical characteristics.
- The lead's design provides flexibility and diameter similar to unipolar leads.
- Further monitoring is warranted, but initial results suggest suitability for pacemaker implantation.