Although modern ICDs have proven to be highly effective in detecting and terminating malignant tachyarrhythmias, the opportunity for improving their detection specificity remains.
Previous experience with steroid-eluting small electrode designs have described their increased pacing efficiency, yet some reports have questioned their electrical stability. We report our experience with a new pacing lead design incorporating small surface (i.e. 1.2 mm2), high impedance pacing electrodes. Medtronic Model 5034 ventricular pacing leads were implanted by a single physician in 167 patients. Of those, 96 patients had an additional Model 5534 atrial lead implanted. All patients were followed for at least 9 months. Microdislodgment, as defined by a sudden increase in pacing threshold accompanied by radiographic stability, was observed in 6 of 263 (2.3%) leads implanted. Of the 4/167 (2.4%) ventricular leads that exhibited electrical instability, only 2 were sustained. Importantly, neither was significant enough to result in loss of capture. The other two cases of ventricular electrode instability manifested as a transient threshold rise with eventual return to near the original values. By comparison, the atrial lead model exhibited a sudden and sustained pacing threshold rise 5 which was evident in two patients (2.1%) with neither requiring invasive intervention. For all remaining chronic leads, clinically acceptable electrical performance profiles were demonstrated. We conclude that low microdislodgment rates and stable electrical performance profiles can be achieved with the small electrode steroid-eluting pacing electrodes as long as careful lead positioning and securing techniques are followed during implantation. We further suggest that successful high impedance lead design is critically dependent on its stiffness and mass characteristics.
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.
DFTs have shown a decline over 18 years through electrode and waveform improvements. The practice of making devices with ever increasing energy ratings may eventually merit reexamination. The animal model is a useful predictor for clinical DFTs.
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