Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions

William M. Bailey, Lawrence Rosenthal, Lameh Fananapazir, Marye Gleva, Alexander Mazur, C. A. Rinaldi, Alexander Kypta, B. Merkely, Pamela K. Woodard

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Background Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. Methods The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (

Original languageEnglish
Pages (from-to)1183-1191
Number of pages9
JournalHeart Rhythm
Volume12
Issue number6
DOIs
Publication statusPublished - Jun 1 2015

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Head
Magnetic Resonance Imaging
Safety
Equipment and Supplies

Keywords

  • Bradycardia pacing
  • Clinical trial
  • Entovis
  • Evia
  • Magnetic resonance imaging
  • Pacemaker
  • ProMRI
  • Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Bailey, W. M., Rosenthal, L., Fananapazir, L., Gleva, M., Mazur, A., Rinaldi, C. A., ... Woodard, P. K. (2015). Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm, 12(6), 1183-1191. https://doi.org/10.1016/j.hrthm.2015.02.010

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. / Bailey, William M.; Rosenthal, Lawrence; Fananapazir, Lameh; Gleva, Marye; Mazur, Alexander; Rinaldi, C. A.; Kypta, Alexander; Merkely, B.; Woodard, Pamela K.

In: Heart Rhythm, Vol. 12, No. 6, 01.06.2015, p. 1183-1191.

Research output: Contribution to journalArticle

Bailey, William M. ; Rosenthal, Lawrence ; Fananapazir, Lameh ; Gleva, Marye ; Mazur, Alexander ; Rinaldi, C. A. ; Kypta, Alexander ; Merkely, B. ; Woodard, Pamela K. / Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions. In: Heart Rhythm. 2015 ; Vol. 12, No. 6. pp. 1183-1191.
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