title: 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.
authors.affiliation: Semmelweis University, Heart Center, Budapest, Hungary. merkely.bela@kardio.sote.hu.
authors.forename: Valentina
authors.initials: V
authors.lastname: Kutyifa
authors.forename: Endre
authors.initials: E
authors.lastname: Zima
authors.forename: Levente
authors.initials: L
authors.lastname: Molnar
authors.forename: Christian
authors.initials: C
authors.lastname: Kuehne
authors.forename: Soehnke
authors.initials: S
authors.lastname: Theiss
authors.forename: Gundula
authors.initials: G
authors.lastname: Herrmann
authors.forename: Laszlo
authors.initials: L
authors.lastname: Geller
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial; D020099:Coated Materials, Biocompatible; D003907:Dexamethasone / Q000008:administration & dosage*; D017097:Electric Impedance; D004867:Equipment Design; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D011446:Prospective Studies; D058998:Remote Sensing Technology; D013256:Steroids / Q000008:administration & dosage*; D017216:Telemedicine; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible; D013256:Steroids; D003907:Dexamethasone