Safety and utility of magnetic resonance imaging in patients with cardiac implantable electronic devices. 2017

Jordan B Strom, and Jill B Whelan, and Changyu Shen, and Shuang Qi Zheng, and Koenraad J Mortele, and Daniel B Kramer
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.

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.

UI MeSH Term Description Entries
D008297 Male Males
D010138 Pacemaker, Artificial A device designed to stimulate, by electric impulses, contraction of the heart muscles. It may be temporary (external) or permanent (internal or internal-external). Cardiac Pacemaker, Artificial,Artificial Cardiac Pacemaker,Artificial Cardiac Pacemakers,Artificial Pacemaker,Artificial Pacemakers,Cardiac Pacemakers, Artificial,Pacemaker, Artificial Cardiac,Pacemakers, Artificial,Pacemakers, Artificial Cardiac
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D004869 Equipment Safety Freedom of equipment from actual or potential hazards. Device Safety,Hazards, Equipment,Medical Device Safety,Safety, Equipment,Device Safety, Medical,Safety, Medical Device,Equipment Hazard,Equipment Hazards,Hazard, Equipment,Safety, Device
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D001145 Arrhythmias, Cardiac Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction. Arrhythmia,Arrythmia,Cardiac Arrhythmia,Cardiac Arrhythmias,Cardiac Dysrhythmia,Arrhythmia, Cardiac,Dysrhythmia, Cardiac
D017147 Defibrillators, Implantable Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes. Cardioverter-Defibrillators, Implantable,Implantable Cardioverter Defibrillator,Implantable Cardioverter-Defibrillators,Implantable Defibrillators,Cardioverter Defibrillator, Implantable,Cardioverter Defibrillators, Implantable,Cardioverter-Defibrillator, Implantable,Defibrillator, Implantable,Defibrillator, Implantable Cardioverter,Defibrillators, Implantable Cardioverter,Implantable Cardioverter Defibrillators,Implantable Cardioverter-Defibrillator,Implantable Defibrillator

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