title: Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices.
abstract: Off-label magnetic resonance imaging (MRI) for patients with cardiac implantable electrical devices has been limited owing to concerns about safety and unclear diagnostic and prognostic utility.
  
  
  
  The purpose of this study was to define major and minor adverse events with off-label MRI scans.
  
  
  
  We prospectively evaluated patients with non-MRI-conditional cardiac implantable electrical devices referred for MRI scans under a strict clinical protocol. The primary safety outcome was incidence of major adverse events (loss of pacing, inappropriate shock or antitachycardia pacing, need for system revision, or death) or minor adverse events (inappropriate pacing, arrhythmias, power-on-reset events, heating at the generator site, or changes in device parameters at baseline or at 6 months).
  
  
  
  A total of 189 MRI scans were performed in 123 patients (63.1% [78] men; median age 70 ± 18.5 years; 56.9% [70] patients with implantable cardioverter-defibrillators; 33.3% [41] pacemaker-dependent patients) predominantly for brain or spinal conditions. A minority of scans (22.7% [43]) were performed for urgent or emergent indications. Major adverse events were rare: 1 patient with loss of pacing, no deaths, or system revisions (overall rate 0.5%; 95% confidence interval 0.01-2.91). Minor adverse events were similarly rare (overall rate 1.6%; 95% confidence interval 0.3-4.6). Nearly all studies (98.4% [186]) were interpretable, while 75.1% [142] were determined to change management according to the prespecified criteria. No clinically significant changes were observed in device parameters acutely after MRI or at 6 months as compared with baseline across all patient and device categories.
  
  
  
  Off-label MRI scans performed under a strict protocol demonstrated excellent short- and medium-term safety while providing interpretable imaging that frequently influenced clinical care.
authors.affiliation: Richard A. and Susan F. Smith Center for Cardiovascular Outcomes Research, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
authors.forename: Jordan B
authors.initials: JB
authors.lastname: Strom
authors.affiliation: Harvard Medical School, Boston, Massachusetts; Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jill B
authors.initials: JB
authors.lastname: Whelan
authors.affiliation: Richard A. and Susan F. Smith Center for Cardiovascular Outcomes Research, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
authors.forename: Changyu
authors.initials: C
authors.lastname: Shen
authors.affiliation: Harvard Medical School, Boston, Massachusetts.
authors.forename: Shuang Qi
authors.initials: SQ
authors.lastname: Zheng
authors.affiliation: Department of Radiology, Divisions of Abdominal Imaging and Body MRI, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Koenraad J
authors.initials: KJ
authors.lastname: Mortele
authors.affiliation: Richard A. and Susan F. Smith Center for Cardiovascular Outcomes Research, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts. Electronic address: dkramer@bidmc.harvard.edu.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
mesh_terms: D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D017147:Defibrillators, Implantable; D019544:Equipment Failure Analysis; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019028:Magnetic Resonance Imaging, Cine / Q000592:standards / Q000706:statistics & numerical data*; D008297:Male; D010138:Pacemaker, Artificial; D061214:Patient Safety; D011446:Prospective Studies
keywords: Cardiac pacemakers; Implantable cardioverter-defibrillators; magnetic resonance imaging