Direct comparison of steroid and non-steroid eluting small surface pacing leads: randomized, multicenter clinical trial

Abstract

Background: The aim of the study was to evaluate the efficacy and safety of small surface steroid-eluting atrial and ventricular pacing leads in comparison to non-steroid leads using remote monitoring system (Biotronik Home Monitoring®).

Methods: In this randomized multicenter prospective trial, SIELLO T steroid-eluting ventricular leads (n = 42) were compared to BPPU T non-steroid leads (n = 46) and SIELLO JT steroid-eluting atrial leads (n = 24) to BPPU JT non-steroid leads (n = 27) (Biotronik, Berlin, Germany) in pacemaker devices with remote monitoring capabilities. Lead parameters were evaluated during implantation, at 1-week and 1, 3, 6-month outpatient follow-up. Remote monitoring data were collected weekly.

Results: Atrial and ventricular steroid-eluting leads had stable sensing and impedance as compared to non-steroid leads at implantation and during follow-up. Patients with non-steroid atrial leads had significantly higher threshold compared to steroid leads at 1-week and at 1, 3, 6-month follow-up with a peak at 1-month (1-month 1.4 ± 0.6 vs. 0.7 ± 0.3 V at 0.4 ms, p < 0.001; 6-month 0.3 ± 0.5 vs. 0.2 ± 0.3 V at 0.4 ms, p = 0.002). Patients with non-steroid ventricular leads had significantly higher threshold compared to steroid leads at 1, 3, 6-month (6-month 1.0 ± 0.3 vs. 0.6 ± 0.2 V at 0.4 ms, p < 0.001). Remote monitoring confirmed consistent results. During the study, 3 patients died of non-lead-related death. Lead repositioning was necessary in 2 atrial, 2 ventricular steroid leads and in 1 ventricular non-steroid lead.

Conclusions: Atrial and ventricular pacemaker leads with steroid showed significantly lower pacing threshold compared to non-steroid leads, confirmed by remote monitoring.

Trial registration: ClinicalTrials.gov NCT01000532.