title: Safety of computed tomography in patients with cardiac rhythm management devices: assessment of the U.S. Food and Drug Administration advisory in clinical practice.
abstract: OBJECTIVE
  To assess the safety of computed tomography (CT) imaging in patients with cardiac rhythm management (CRM) devices, which was subject to an advisory from the U.S. Food and Drug Administration (FDA) in 2008.
  
  
  BACKGROUND
  The FDA warned about potential interference of CT imaging with CRM devices and made recommendations for clinical practice despite only limited evidence.
  
  
  METHODS
  All 516 CT scans that involved direct radiation exposure of CRM devices (332 defibrillators, 184 pacemakers) at 2 large-volume centers between July 2000 and May 2010 were included. The primary outcome was a composite endpoint of death, bradycardia or tachycardia requiring termination of the scan or an immediate intervention, unplanned hospital admission, reprogramming of the device, inappropriate defibrillator shocks, or device replacement/revision thought to be due to CT imaging. Significant changes in device parameters were sought as a secondary outcome (control group 4:1 ratio).
  
  
  RESULTS
  The main finding was that none of the CTs were associated with the primary outcome. With serial device interrogations, there were no differences in changes in battery voltage or lead parameters between devices exposed to radiation and their controls. Potentially significant changes in device parameters were observed in a small group of devices (both the CT group and control group), but no definitive link to CT was confirmed, and there were no associated clinical consequences.
  
  
  CONCLUSIONS
  The findings suggest that the presence of CRM devices should not delay or result in cancellation of clinically indicated CT imaging procedures, and provide evidence that would be helpful when the FDA advisory is re-evaluated.
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Ayman A
authors.initials: AA
authors.lastname: Hussein
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Ameer
authors.initials: A
authors.lastname: Abutaleb
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Jean
authors.initials: J
authors.lastname: Jeudy
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Timothy
authors.initials: T
authors.lastname: Phelan
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Ronak
authors.initials: R
authors.lastname: Patel
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Melsjan
authors.initials: M
authors.lastname: Shkullaku
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Faisal
authors.initials: F
authors.lastname: Siddiqi
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Vincent
authors.initials: V
authors.lastname: See
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Anastasios
authors.initials: A
authors.lastname: Saliaris
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Shorofsky
authors.affiliation: Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland. Electronic address: tdickfel@medicine.umaryland.edu.
authors.forename: Timm
authors.initials: T
authors.lastname: Dickfeld
mesh_terms: D001145:Arrhythmias, Cardiac / Q000000981:diagnostic imaging* / Q000628:therapy; D058409:Cardiac Resynchronization Therapy Devices; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061330:Multidetector Computed Tomography / Q000592:standards*; D061214:Patient Safety / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA advisory; computed tomography; implantable cardioverter-defibrillator; pacemakers