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.