Key result
BT-10 dedicated bipolar leads linked to ~200% greater lead failure risk versus Endotak integrated leads.
Why the study?
The long-term performance of dedicated bipolar versus integrated bipolar ICD sensing leads has not been directly compared.
Does the use of BT-10 dedicated bipolar leads compared to Endotak integrated leads affect the incidence of lead failure in patients undergoing abdominal ICD implant?
Population
247 consecutive patients undergoing abdominal ICD implant at a single center between 1991 and 1995
Comparison
BT-10 dedicated bipolar leads vs Endotak integrated bipolar leads
Design
Prospective cohort study at a single center
Follow-up
Mean 860 +/- 442 days
Authors
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Dedicated bipolar leads associated with higher failure rates than integrated; leaves open whether design influences outcomes with modern leads.
Cohort (n=247)
No
Does the use of BT-10 dedicated bipolar leads compared to Endotak integrated leads affect the incidence of lead failure in patients undergoing abdominal ICD implant?
Relative Risk: 3 (95% CI 1.2–7.6)
Absolute Event Rate: 17.8% vs 4.3%
p-value: p=0.015
BT-10 dedicated bipolar sensing leads have a significantly higher rate of late failure due to insulation defects compared to Endotak integrated leads, warranting consideration for replacement during elective pulse generator changes.
DEGERATU et al. (2000) conducted a cohort in abdominal ICD implant (n=247). BT-10 (dedicated bipolar) leads vs. Endotak (integrated bipolar) leads was evaluated on lead failure manifested by inappropriate arrhythmia detection (RR 3.0, 95% CI 1.2 to 7.6, p=0.015). BT-10 dedicated bipolar sensing leads were associated with a significantly higher rate of lead failure compared to Endotak integrated leads (17.8% vs 4.3%; RR 3.0, 95% CI 1.2-7.6, P=0.015).
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