Safety of computed tomography in patients with cardiac rhythm management devices: Assessment of the U.S. food and drug administration advisory in clinical practice

Ayman A. Hussein, Ameer Abutaleb, Jean Jeudy, Timothy Phelan, Ronak Patel, Melsjan Shkullaku, Faisal Siddiqi, Vincent See, Anastasios Saliaris, Stephen R. Shorofsky, Timm Dickfeld

Research output: Contribution to journalArticle

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 languageEnglish (US)
Pages (from-to)1769-1775
Number of pages7
JournalJournal of the American College of Cardiology
Volume63
Issue number17
DOIs
StatePublished - May 6 2014
Externally publishedYes

Fingerprint

United States Food and Drug Administration
Tomography
Safety
Equipment and Supplies
Defibrillators
Control Groups
Bradycardia
Tachycardia
Shock
Radiation

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 journalArticle

Hussein, AA, Abutaleb, A, Jeudy, J, Phelan, T, Patel, R, Shkullaku, M, Siddiqi, F, See, V, Saliaris, A, Shorofsky, SR & Dickfeld, T 2014, 'Safety of computed tomography in patients with cardiac rhythm management devices: Assessment of the U.S. food and drug administration advisory in clinical practice', Journal of the American College of Cardiology, vol. 63, no. 17, pp. 1769-1775. https://doi.org/10.1016/j.jacc.2013.12.040
Hussein, Ayman A. ; Abutaleb, Ameer ; Jeudy, Jean ; Phelan, Timothy ; Patel, Ronak ; Shkullaku, Melsjan ; Siddiqi, Faisal ; See, Vincent ; Saliaris, Anastasios ; Shorofsky, Stephen R. ; Dickfeld, Timm. / Safety of computed tomography in patients with cardiac rhythm management devices : Assessment of the U.S. food and drug administration advisory in clinical practice. In: Journal of the American College of Cardiology. 2014 ; Vol. 63, No. 17. pp. 1769-1775.
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AU - Phelan, Timothy

AU - Patel, Ronak

AU - Shkullaku, Melsjan

AU - Siddiqi, Faisal

AU - See, Vincent

AU - Saliaris, Anastasios

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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.

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