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

Kutyifa, Valentina and Zima, Endre István and Molnár, Levente Domonkos and Kuehne, C. and Theiss, S. and Gellér, László Alajos and Merkely, Béla Péter (2013) Direct comparison of steroid and non-steroid eluting small surface pacing leads: Randomized, multicenter clinical trial. CARDIOLOGY JOURNAL, 20 (4). pp. 431-438. ISSN 1897-5593

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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(R)). 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.

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