Vol 20, No 4 (2013)
Original articles
Published online: 2013-07-26

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

Valentina Kutyifa, Endre Zima, Levente Molnar, Christian Kuehne, Soehnke Theiss, Gundula Herrmann, Laszlo Geller, Bela Merkely
DOI: 10.5603/CJ.2013.0103
Cardiol J 2013;20(4):431-438.

Abstract

Background: The aim of the study was to evaluate the effi cacy 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 signifi cantly 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 signifi cantly 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 confi rmed 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 signifi cantly lower
pacing threshold compared to non-steroid leads, confi rmed by remote monitoring.