January 1, 1997Pacing and Clinical Electrophysiology
A Prospective, Randomized Evaluation of a Nonthoracotomy Implantable Cardioverter Defibrillator Lead System
Key result
A subcutaneous array electrode significantly lowered the mean defibrillation threshold to 14.9 J compared to a transvenous lead alone (17.5 J, P=0.0001) or with a patch (16.9 J, P=0.007).
Why the study?
Does a transvenous lead linked to a subcutaneous array electrode lower the defibrillation threshold compared to a transvenous lead alone or linked to a patch electrode in patients undergoing ICD implantation?
Population
267 patients undergoing ICD implantation, mean age 63 +/- 11 years, 82% male, mean LVEF 0.33 +/- 0.13.
Comparison
Transvenous lead linked to an investigational… vs Single transvenous lead alone or transvenous…
Design
RCT, Randomized to one of the three nonthoracotomy ICD lead systems
Authors
Discussion
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Implication
Supports subcutaneous array use to lower defibrillation thresholds during ICD implantation; extends RCT evidence for nonthoracotomy lead optimization.
Study Design
Type
RCT (n=267)
Randomization
randomized
Structured PICO
Does a transvenous lead linked to a subcutaneous array electrode lower the defibrillation threshold compared to a transvenous lead alone or linked to a patch electrode in patients undergoing ICD implantation?
P
Population
267 patients (mean age 63 years, 18% female) requiring ICD implantation for ventricular tachycardia or fibrillation.
I
Intervention
Transvenous lead linked to an investigational subcutaneous array electrode
C
Comparator
Single transvenous lead alone (with two defibrillating electrodes) or transvenous lead linked to a subcutaneous/submuscular patch electrode
O
Outcome
Defibrillation threshold (DFT) obtained using monophasic shock waveformssurrogate
Main Result
Absolute Event Rate: 14.9% vs 17.5%
p-value: p=0.0001
A subcutaneous array electrode linked to a transvenous lead significantly lowers the defibrillation threshold compared to a standard patch or transvenous lead alone during nonthoracotomy ICD implantation.
Cite This Study
Baker et al. (1997) conducted an RCT in Ventricular tachycardia or fibrillation requiring ICD (n=267). Subcutaneous array electrode linked to a transvenous lead vs. Transvenous lead alone or linked to a subcutaneous/submuscular patch electrode was evaluated on Defibrillation threshold (DFT) (p=0.0001). A subcutaneous array electrode significantly lowered the mean defibrillation threshold to 14.9 J compared to a transvenous lead alone (17.5 J, P=0.0001) or with a patch (16.9 J, P=0.007).