Abstract
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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1769-1775 |
| Number of pages | 7 |
| Journal | Journal of the American College of Cardiology |
| Volume | 63 |
| Issue number | 17 |
| DOIs | |
| State | Published - May 6 2014 |
| Externally published | Yes |
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Keywords
- computed tomography
- FDA advisory
- implantable cardioverter-defibrillator
- pacemakers
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Safety of computed tomography in patients with cardiac rhythm management devices : Assessment of the U.S. food and drug administration advisory in clinical practice. / Hussein, Ayman A.; Abutaleb, Ameer; Jeudy, Jean; Phelan, Timothy; Patel, Ronak; Shkullaku, Melsjan; Siddiqi, Faisal; See, Vincent; Saliaris, Anastasios; Shorofsky, Stephen R.; Dickfeld, Timm.
In: Journal of the American College of Cardiology, Vol. 63, No. 17, 06.05.2014, p. 1769-1775.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety of computed tomography in patients with cardiac rhythm management devices
T2 - Assessment of the U.S. food and drug administration advisory in clinical practice
AU - Hussein, Ayman A.
AU - Abutaleb, Ameer
AU - Jeudy, Jean
AU - Phelan, Timothy
AU - Patel, Ronak
AU - Shkullaku, Melsjan
AU - Siddiqi, Faisal
AU - See, Vincent
AU - Saliaris, Anastasios
AU - Shorofsky, Stephen R.
AU - Dickfeld, Timm
PY - 2014/5/6
Y1 - 2014/5/6
N2 - 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.
AB - 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.
KW - computed tomography
KW - FDA advisory
KW - implantable cardioverter-defibrillator
KW - pacemakers
UR - http://www.scopus.com/inward/record.url?scp=84899648169&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84899648169&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2013.12.040
DO - 10.1016/j.jacc.2013.12.040
M3 - Article
C2 - 24583299
AN - SCOPUS:84899648169
VL - 63
SP - 1769
EP - 1775
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 17
ER -