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Patients with cardiac rhythm management devices showed no clinically significant major or minor events related to computed tomography (CT) imaging over a 10-year period at two large-volume care centers, researchers reported.

The retrospective, observational study is the first large analysis of possible adverse outcomes associated with CT imaging in heart patients with pacemakers and implantable cardioverter defibrillators.

The findings should help policymakers better assess the risk and benefits of CT imaging in these patients, cardiology researcher of the University of Maryland, in Baltimore, and colleagues wrote in the

FDA Advisory Surprised Many

In 2008, the FDA issued an advisory noting that exposure to x-ray radiation during CT scanning may interfere with the proper functioning of cardiac rhythm management (CRM) devices.

The warned of possible unintended "shocks" and "transient changes in pacemaker output pulse rates," among other things, but the move was quickly criticized by many in the medical community as an over-reaction to the available evidence.

"When the FDA advisory came out everyone was very surprised because there weren't many studies out there," Dickfeld told 口袋女优. "Several organizations, including the American Association of Physicists in Medicine, expressed concern that the advisory might lead to withholding lifesaving CT scans from patients with these devices."

In an effort to better understand the prevalence of CT-related CRM device interactions, Dickfeld and colleagues reviewed all CT scans performed on patients with implanted defibrillators or pacemakers between July of 2000 and May of 2010 at the University of Maryland Medical Center and the Baltimore Veterans Affairs Medical Center.

The review included 516 CT scans (332 defibrillators, 184 pacemakers) and the primary outcome measured was a composite endpoint -- including death, bradycardia or tachycardia -- requiring termination of the scan or immediate intervention, unplanned hospital admission, reprogramming of the device, inappropriate defibrillator shock, or device replacement or revision thought to be due to CT imaging.

Secondary endpoints included unexpected decreases in battery power, lead failure to pace or sense, or other measures of interference with device function.

For every CT scan performed, device lead and function parameters were obtained from two consecutive device interrogations conducted prior to and after the CT. When multiple CT scans were performed in between consecutive interrogations, the CTs were counted as a single entry into the serial assessment of device parameters.

Because small changes in device parameters could occur over time under normal circumstances, a control group was also studied to better assess the secondary endpoint. For every four devices exposed to direct radiation beams from CT scans one control device with no exposure to CT imaging was included for comparison.

No Clinically Meaningful Signals Were Seen

The retrospective analysis showed that none of the CTs were associated with the primary outcome, and there were no differences in changes in battery voltage or lead parameters between devices exposed to radiation and their controls, or clinically meaningful changes in device parameters.

The researchers cite the retrospective nature of the study and its relatively small size as potential study limitations, noting that the analysis could have missed clinically significant events that occur at incidence rates below less than 1 in 500.

But Dickfeld said the new data should help inform the decision-making of clinicians and policymakers.

"What we can say is we did not find even a signal that CT should be withheld in these patients," Dickfeld said. "Of course, this was a retrospective study with just over 500 patients, but compared to nothing this is a huge step forward in providing useful data to CT users and the regulatory bodies."

'FDA Was Reckless'

In an editorial published with the study, cardiologists , and , of the University of Barcelona wrote that the 2008 FDA advisory was not justified because it was based on just two very small peer-reviewed studies -- one and the other in -- that they said did not reflect real-world CT-CRM interactions.

"It is our belief that in this particular case the FDA may have been somehow reckless," they wrote. "Three decades after the first CT scan, no clinically major adverse event on a real patient has been notified to the authorities or published in the literature. To answer our question, Yes, we believe that the FDA was over-reacting when issuing the 2008 alert."

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