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Safety of Computed Tomography Imaging in Patients with Cardiac Rhythm Management Devices: Assessment of the FDA Advisory in Real-world Practice.
J Am Coll Cardiol. 2014 Feb 14;
Authors: Hussein A, Abutaleb A, Jeudy J, Phelan T, Patel R, Shkullaku M, Siddiqi F, See V, Saliaris A, Shorofsky SR, Dickfeld T
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 United States 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 which 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 admissions, 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 was 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 controls) but no definitive link to CT was confirmed and there were no associated clinical consequences.
CONCLUSIONS: The findings suggest that the presence of cardiac devices should not delay or result in cancellation of clinically indicated CT imaging procedures, and provides evidence which would be helpful when the FDA advisory is reevaluated.
PMID: 24583299 [PubMed - as supplied by publisher]