Clinical safety of the ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 3 T: results of the ProMRI 3T ENHANCED Master study

Rainer Zbinden, Christian Wollmann, Johannes Brachmann, Jochen Michaelsen, Clemens Steinwender, Pramesh Kovoor, Sebastian Kelle, Andrew D McGavigan, Chi Keong Ching, Gemma A Figtree, Jan Schmidt, Tobias Timmel, Joachim Lotz

Research output: Journal article (peer-reviewed)Journal article

1 Citation (Scopus)

Abstract

AIMS: There have been no published studies on the safety of magnetic resonance imaging (MRI) at 3 Tesla (3 T) in patients with MRI-conditional implantable cardioverter-defibrillators (ICDs). The aim of this study was to assess clinical safety of the Biotronik ProMRI ICD system during non-diagnostic head and lower lumbar scans under 3 T MRI conditions.

METHODS AND RESULTS: The study enrolled 129 patients at 12 sites in Australia, Singapore, and Europe. Predefined head and lower lumbar MR scans (total duration ≈30 min) were performed in 112 patients. Three primary endpoints were evaluated from the pre-MRI to the 1-month post-MRI visit: (i) freedom from serious adverse device effects (SADEs) related to MRI (hypothesized to be >90%); (ii) pacing threshold invariance for all leads (geometric mean of the patient-wise ratios for 1 month vs. pre-MRI was hypothesized to be <1.07); and (iii) sensing amplitude invariance (geometric mean of the ratios was hypothesized to be >0.993). No MRI-related SADE occurred (SADE-free rate 100%, 95% confidence interval 95.98-100%). Pacing threshold and sensing amplitudes fulfilled the invariance hypotheses with high statistical significance (P < 0.0013). No threshold increase >0.5 V or sensing amplitude decrease by >50% was observed (secondary endpoints). Lead impedances, battery capacity, and detection and treatment of arrhythmias by ICDs were not affected by MRI scans.

CONCLUSION: The head and lower lumbar scans under specific 3 T MRI conditions were safe in the investigated MR-conditional ICD systems. There was no evidence of harm to the patients or any negative influence of the MRI scan on the implanted systems.

Original languageEnglish
Pages (from-to)1678-1685
Number of pages8
JournalEuropace
Volume21
Issue number11
DOIs
Publication statusPublished - 1 Nov 2019

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Arrhythmias, Cardiac/physiopathology
  • Defibrillators, Implantable
  • Equipment Design
  • Equipment Safety
  • Female
  • Follow-Up Studies
  • Head/diagnostic imaging
  • Heart Rate/physiology
  • Humans
  • Lumbar Vertebrae/diagnostic imaging
  • Magnetic Resonance Imaging/methods
  • Male
  • Middle Aged
  • Prospective Studies

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