Long-term performance of endocardial leads with steroid-eluting electrodes.

During a three-year period, 48 steroid-eluting leads (Medtronic 4003 and 4503) have been implanted in 39 patients. 23 were implanted in the atrium and 25 in the ventricle. 36 patients with 45 leads have been observed for more than 12 months. Stimulation thresholds have been followed using pulse generators with variable output (vario): 12 atrial and 11 ventricular leads, 4 atrial leads and 11 ventricular leads have been followed using pulse generators with variable pulse-width (auto-threshold), P-waves have been followed using telemetry or sensitivity programming (23 atrial leads). R-waves have been followed using telemetry in 11 ventricular leads. Mean stimulation thresholds after 2 years are 0.7 V +/- 0.2 in the atrium and 0.8 V +/- 0.3 in the ventricle. P-waves after 2 years are of magnitudes allowing a sensitivity setting of 2.5 mV in 12 cases and of 1.5 mV in 2 cases; R-waves have in all cases been high enough to permit lowest programmable sensitivity setting. During the observation time, two patients have died from nonpacing-related causes. The results obtained from this investigation document low stimulation thresholds and good sensing levels in both ventricle and atrium using the steroid-eluting electrode with no significant changes after 6 weeks postimplant.

Acute and long-term atrial and ventricular stimulation thresholds with a steroid-eluting electrode.

Thirty leads with a steroid-eluting electrode (Medtronic 4003 and 4503) have been implanted in 24 patients, 11 in the atrium and 19 in the ventricle. Six patients received the steroid lead in both atrium and ventricle. The stimulation thresholds were followed using Elema pulse generators with Vario function in 15 patients (11 atrial leads and 10 ventricular leads) during 11 +/- 3 months (mean +/- SD). At 0.5 ms pulse duration the mean atrial and ventricular thresholds were 0.55 Volt +/- 0.22 and 0.39 Volt +/- 0.22 respectively at implant, 0.94 Volt +/- 0.13 and 0.82 Volt +/- 0.16 after 12 months. During the entire follow-up period both atrial and ventricular mean thresholds never exceeded 1 V.

Mechanical wear of pacemaker lead insulation. A cause of loss of pacing.

A pacemaker-treated patient is described in whom lead insulation defect caused sudden loss of capture. The defect was caused by mechanical wear of the posterior leaflet of the tricuspid valve and resulted in shunting of the pulse generator with a current drain exceeding the capacity of the pacemaker. In three further cases a similar explanation to sudden loss of pacing was highly suspected.

Results from the use of a preshaped lead for single-pass VDD/DDD stimulation.

Main criticisms about single-pass VDD stimulation in patients with AV block and normal sinus node function concern atrial undersensing in a lead with floating atrial electrodes, and loss of AV synchrony if sinus node dysfunction develops after implantation. We evaluated the concept of a preshaped single-pass lead designed to place the atrial ring electrodes in a constant position close to, or in contact with, the atrial wall. A preshaped lead (Model 2775, Medtronic Inc.) was implanted in 14 patients and followed for up to 2 years. Mean P wave amplitudes (PWAs) were 3.1 mV at implantation, 1.2 mV at predischarge, and 1.3 mV after 12 months. In all patients, minimal PWAs were well above maximal atrial sensitivity of the pacemaker in all body positions during the complete follow-up; atrial undersensing was not observed. Effective atrial stimulation was possible in all patients at implantation (mean stimulation threshold 2.5 V at 0.50 ms), in 11 patients on the first day after implant (mean stimulation threshold 0.22 ms at 5.0 V), in 10 patients after 1 month (mean stimulation threshold 0.57 ms at 5.0 V), and in 10 patients after 1 year (mean stimulation threshold 0.65 ms at 5.0 V). Intermittent phrenic nerve stimulation could be provoked in six patients. In conclusion, the concept of a preshaped single-pass lead facilitated implantation, improved atrial sensing performance, and allowed atrial stimulation in some patients. Still, further improvements are necessary to decrease the atrial stimulation thresholds to acceptable values in all patients.