Author + information
- Received October 14, 2013
- Revision received December 4, 2013
- Accepted December 23, 2013
- Published online May 6, 2014.
- Ayman A. Hussein, MD,
- Ameer Abutaleb, MS,
- Jean Jeudy, MD,
- Timothy Phelan, MD,
- Ronak Patel, MD,
- Melsjan Shkullaku, MD,
- Faisal Siddiqi, MD,
- Vincent See, MD,
- Anastasios Saliaris, MD,
- Stephen R. Shorofsky, MD, PhD and
- Timm Dickfeld, MD, PhD∗ ()
- Maryland Arrhythmia and Cardiology Imaging Group (MACIG), Division of Cardiology, University of Maryland, Baltimore, Maryland
- ↵∗Reprint requests and correspondence:
Dr. Timm Dickfeld, Division of Cardiology, University of Maryland, 22 South Greene Street, Baltimore, Maryland 21201.
Objectives 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.
Dr. Dickfeld has received consulting fees and honoraria grants from Biosense Webster Inc.; and honoraria grants from General Electric. All other authors report that they have no relationships relevant to the contents of this paper to disclose.
- Received October 14, 2013.
- Revision received December 4, 2013.
- Accepted December 23, 2013.
- American College of Cardiology Foundation