Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions

William M. Bailey, Alexander Mazur, Craig McCotter, Pamela K. Woodard, Lawrence Rosenthal, Whitney Johnson, Theofanie Mela

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Background Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). Objective The purpose of the ProMRI Phase B Study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI pacemaker system in patients undergoing thoracic spine and cardiac MRI. Methods The ProMRI Phase B study enrolled 245 patients with stable baseline pacing indices implanted with an Entovis pacemaker (DR-T or SR-T) and Setrox 53-cm and/or 60-cm lead(s). Device interrogation was performed at enrollment, pre- 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 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 (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. Results In total, 216 patients completed the MRI and 1-month post-MRI follow-up. One adverse event possibly related to the implanted system and the MRI procedure occurred, resulting in a serious adverse device effect-free rate of 99.6% (220/221; P <.0001. Freedom from atrial and ventricular pacing threshold increase was 100% (194/194, P <.001) and 100% (206/206, P <.001) respectively. Freedom from P- and R-wave amplitude attenuation was 98.2% (167/170, P <.001) and 100% (188/188, P <.001) respectively. Conclusion The results of the ProMRI Phase B study demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac MRI conditions.

Original languageEnglish
Pages (from-to)464-471
Number of pages8
JournalHeart rhythm
Volume13
Issue number2
DOIs
StatePublished - Feb 1 2016

Keywords

  • Bradycardia pacing
  • Clinical trial
  • ENTOVIS
  • Magnetic resonance imaging
  • Pacemaker
  • ProMRI
  • Safety

Fingerprint

Dive into the research topics of 'Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions'. Together they form a unique fingerprint.

Cite this