September 1, 2005Pacing and Clinical Electrophysiology
Clinical Performance of a Ventricular Automatic Capture Verification Algorithm
Key result
The ventricular automatic capture feature accurately determined stimulation thresholds compared to manual testing (mean difference 0.001 V; P<0.0001) across 31 different lead types.
Why the study?
Does the ventricular automatic capture feature accurately determine the ventricular stimulation threshold and safely deliver backup pulses in patients with pacemakers?
Population
105 patients from 17 European centers utilizing 31 different types of ventricular leads
Comparison
Ventricular automatic capture feature as… vs Manual threshold test
Design
Cohort
Follow-up
3 months
Authors
Discussion
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Member takes
Implication
May enable automated threshold testing across leads; extends validation but leaves open need for randomized confirmation before practice change.
Study Design
Type
Observational (n=105)
Multicenter
Yes
Structured PICO
Does the ventricular automatic capture feature accurately determine the ventricular stimulation threshold and safely deliver backup pulses in patients with pacemakers?
P
Population
105 patients utilizing 31 different types of ventricular leads, followed for 3 months.
E
Exposure
Ventricular automatic capture feature as implemented in the Insignia I Ultra pacemaker system
C
Comparator
Manual threshold test
O
Outcome
Difference between commanded autothreshold test and manual threshold test, and incidence of loss of capture without backup pulse at 3-month follow-upsurrogate
Main Result
Mean Difference: 0.001
Absolute Event Rate: 0.652% vs 0.651%
p-value: p=< 0.0001
The ventricular automatic capture feature accurately determines stimulation thresholds and safely delivers backup pulses across a variety of ventricular leads.
Cite This Study
Sperzel et al. (2005) conducted an observational in Pacemaker indication (n=105). Ventricular automatic capture feature (Insignia I Ultra pacemaker) vs. Manual threshold test was evaluated on Difference between commanded autothreshold test and manual threshold test (MD 0.001, p=< 0.0001). The ventricular automatic capture feature accurately determined stimulation thresholds compared to manual testing (mean difference 0.001 V; P<0.0001) across 31 different lead types.