Active Fixation Atrial Leads: Randomized Comparison of Two Lead Designs

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Abstract
Active fixation leads have reduced the incidence of lead dislodgement in patients with permanent pacemakers. However, theoretic concern that the tissue trauma associated with a myocardial screw-helix may increase the chronic pacing threshold of active compared to passive fixation leads has remained. Whether active fixation leads with a stimulating electrode that is independent of the fixation mechanism are associated with a lower chronic pacing threshold than leads utilizing a screw-helix for both fixation and stimulation is unknown. The present prospective, randomized study compared the acute and chronic atrial pacing and sensing characteristics of two unipolar active fixation leads, one utilizing a screw-helix for both fixation and electrical stimulation, the other with an active porous tip electrode and an electrically inactive helix. Patients were randomized to receive either a Medtronic 6957J lead with an electrically active myocardial screw-helix or a Cordis 329-101P lead with an inactive helix and a porous tip electrode. The baseline characteristics of the groups were comparable. At implantation, the 329-101P lead had a lower mean voltage threshold than the 6957J lead (0.61 +/- 0.16 V vs 1.05 +/- 0.34 V, P = 0.0004). There were no significant differences in atrial electrogram amplitude, slew rate, or lead impedance between the groups. At 6 weeks follow-up, there were no differences in the mean threshold voltage (1.85 +/- 0.36 vs 1.93 +/- 0.69 V), impedance (528 +/- 81 vs 530 +/- 118 ohms), or atrial electrogram amplitude (2.63 +/- 0.50 vs 2.42 +/- 0.95 mV) between the two leads. At long-term follow-up (mean 16.2 +/- 2.8 months, range 13.1-20.0 months) there were no significant differences in voltage threshold (1.65 +/- 0.61 vs 1.97 +/- 0.64 V), impedance (565.5 +/- 81.6 vs 617.7 +/- 146.7 ohms), or atrial electrogram amplitude (2.79 +/- 0.75 vs 3.10 +/- 1.53 mV). Thus, these results suggest that active fixation leads in the atrium with an electrode that is independent of the fixation mechanism do not provide chronic stimulation thresholds or electrogram amplitudes that are superior to those obtained with leads utilizing a myocardial screw-helix as both the active electrode and the fixation device.

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