August 1, 1989Pacing and Clinical Electrophysiology
Active Fixation Atrial Leads: Randomized Comparison of Two Lead Designs
Key result
Active fixation atrial leads with an electrically inactive helix did not provide superior chronic voltage thresholds compared to leads with an active screw-helix (1.65 vs 1.97 V).
Why the study?
Does an active fixation lead with an independent stimulating electrode improve chronic pacing thresholds compared to a lead utilizing a screw-helix for both fixation and stimulation in patients with permanent pacemakers?
Population
Patients undergoing permanent pacemaker implantation requiring active fixation atrial leads
Comparison
Unipolar active fixation lead with an inactive… vs Unipolar active fixation lead with an…
Design
RCT, Patients were randomized to receive either a Medtronic 6957J lead or a…
Follow-up
mean 16.2 +/- 2.8 months
Authors
Discussion
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Implication
Electrically inactive helix atrial leads offer no chronic threshold benefit; confirms active screw-helix leads remain standard for permanent pacing.
Study Design
Type
RCT
Randomization
Randomized
Structured PICO
Does an active fixation lead with an independent stimulating electrode improve chronic pacing thresholds compared to a lead utilizing a screw-helix for both fixation and stimulation in patients with permanent pacemakers?
P
Population
Patients requiring permanent pacemakers randomized to receive one of two active fixation atrial leads, followed for a mean of 16.2 months.
I
Intervention
Unipolar active fixation lead with an inactive helix and a porous tip electrode (Cordis 329-101P)
C
Comparator
Unipolar active fixation lead with an electrically active myocardial screw-helix (Medtronic 6957J)
O
Outcome
Acute and chronic atrial pacing and sensing characteristics (voltage threshold, impedance, atrial electrogram amplitude, slew rate) at implantation, 6 weeks, and long-term follow-upsurrogate
Main Result
Absolute Event Rate: 1.65% vs 1.97%
Active fixation atrial leads with an independent stimulating electrode do not provide superior chronic stimulation thresholds or electrogram amplitudes compared to leads using a screw-helix for both fixation and stimulation.
Cite This Study
Kay et al. (1989) conducted an RCT in Permanent pacemaker implantation. Cordis 329-101P lead (inactive helix and porous tip electrode) vs. Medtronic 6957J lead (electrically active myocardial screw-helix) was evaluated on Chronic voltage threshold at long-term follow-up. Active fixation atrial leads with an electrically inactive helix did not provide superior chronic voltage thresholds compared to leads with an active screw-helix (1.65 vs 1.97 V).