The way the researchers went about their study highlights the best approach to patients with such implants. The team set these legacy devices to a standard heart rhythm and blocked other settings that could let them react to erratic signals during the MR procedure. After the scan, the devices got reset to proper daily settings.

The research was prompted in part because of the CMS coverage issue.


That study followed a similar one that revealed that legacy devices were safe, which led co-author Dr. Saman Nazarian, of the University of Pennsylvania Perelman School of Medicine, to suggest that, given these reports, the agency's position was “hard to understand,” according to the news wire.

His study looked at approximately 200 of 1,509 pacemaker and defibrillator patients who received chest scans using a 1.5 Tesla machine.

No scanning, to chest or elsewhere, led to any “significant problems,” according to Nazarian.

Nine legacy devices were triggered by the scans but restarted to backup mode successfully.

A single device had to be replaced, which had a low battery; but “pacemakers do funny things when the battery is low,” observed Halperin.

He noted that most heart devices, pacemakers and defibrillators passed by the FDA from 2000 on are better able to handle the energy inside an MR, adding, “and we program them to avoid most any problems that might happen.”

For patients with an unrated device, Nazarian recommended that, “many centers across the U.S. are capable of performing safe imaging despite your device.”

The impact of the change could be significant, as the global market for cardiovascular devices in general is predicted to hit $59 billion by 2022 up from $42.4 billion in 2017, a compound annual growth rate (CAGR) of 6.9 percent for the period, according to a January report by BCC research.

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