Key result
High impedance model 6944 leads yield ~129% higher pacing impedance versus conventional leads.
Why the study?
Does a high impedance defibrillation lead with a small electrode surface improve pacing impedance without compromising system performance compared to a conventional lead in patients with ICD indications?
RCT (n=34)
one to one
Does a high impedance defibrillation lead with a small electrode surface improve pacing impedance without compromising system performance compared to a conventional lead in patients with ICD indications?
Absolute Event Rate: 988.6% vs 431.7%
p-value: p=<0.0001
A defibrillation lead with a small electrode surface safely achieves high pacing impedance without compromising other performance metrics over 1 year.
Supports high-impedance leads to extend ICD battery longevity; confirms safe performance of small-electrode design in this RCT.
A small electrode surface reduces pacing current drain and can extend generator longevity. The study evaluated the performance of a tined, quadripolar defibrillation lead (model 6944) that has a small-surfaced, steroid-eluting electrode tip for high impedance pacing. In a prospective, controlled study, 34 patients with conventional ICD indications were randomized one to one to receive the high impedance model 6944 or a tined defibrillation lead with a conventional sized, steroid-eluting electrode tip model 6942. Lead performance was evaluated at implant, prior to hospital discharge, and 1, 3, 6, and 12 months thereafter. Baseline characteristics did not differ significantly between patients implanted with lead model 6942 (n = 16) or model 6944 (n = 17). One patient randomized to receive the model 6942 was excluded from the study and was implanted with an active-fixation lead after stable lead positioning was neither possible with the 6942 nor with the 6944 electrode. No other lead related adverse events were observed. At implant, there were no significant differences between pacing thresholds, sensing performance, defibrillation impedances, and defibrillation thresholds in both groups, but pacing impedance of the model 6944 (988.6 +/- 217.7 omega) was approximately twice as high as high as in the model 6942 (431.7 +/- 83.7 omega; P < 0.0001). This difference remained highly significant throughout the observation period of 12 months, while R wave amplitudes and pacing thresholds remained equal in both lead models. The use of a tined defibrillation lead with a small, steroid-eluting electrode tip appears safe and results in a high pacing impedance without compromising system performance.
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Vollmann et al. (2002) conducted an RCT in conventional ICD indications (n=34). High impedance model 6944 defibrillation lead vs. Conventional sized model 6942 defibrillation lead was evaluated on Pacing impedance at implant (p=<0.0001). The high impedance model 6944 defibrillation lead resulted in significantly higher pacing impedance compared to the conventional model 6942 (988.6 vs 431.7 ohms; P<0.0001) over 12 months.
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