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

Valentina Kutyifa, E. Zima, Levente Molnar, Christian Kuehne, Soehnke Theiss, Gundula Herrmann, L. Gellér, B. Merkely

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)431-438
Number of pages8
JournalCardiology Journal
Volume20
Issue number4
DOIs
Publication statusPublished - 2013

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Multicenter Studies
Randomized Controlled Trials
Steroids
Berlin
Electric Impedance
Germany
Outpatients
Safety
Equipment and Supplies
Lead

Keywords

  • Atrial pacing lead
  • Remote monitoring
  • Steroid
  • Steroid-eluting pacing leads
  • Ventricular pacing lead

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Direct comparison of steroid and non-steroid eluting small surface pacing leads : Randomized, multicenter clinical trial. / Kutyifa, Valentina; Zima, E.; Molnar, Levente; Kuehne, Christian; Theiss, Soehnke; Herrmann, Gundula; Gellér, L.; Merkely, B.

In: Cardiology Journal, Vol. 20, No. 4, 2013, p. 431-438.

Research output: Contribution to journalArticle

Kutyifa, Valentina ; Zima, E. ; Molnar, Levente ; Kuehne, Christian ; Theiss, Soehnke ; Herrmann, Gundula ; Gellér, L. ; Merkely, B. / Direct comparison of steroid and non-steroid eluting small surface pacing leads : Randomized, multicenter clinical trial. In: Cardiology Journal. 2013 ; Vol. 20, No. 4. pp. 431-438.
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AU - Kutyifa, Valentina

AU - Zima, E.

AU - Molnar, Levente

AU - Kuehne, Christian

AU - Theiss, Soehnke

AU - Herrmann, Gundula

AU - Gellér, L.

AU - Merkely, B.

PY - 2013

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N2 - 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.

AB - 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.

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KW - Ventricular pacing lead

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