Older pacemakers still safe in MR

December 28, 2017
by Thomas Dworetzky, Contributing Reporter
A new study finds that MR can be safe with older “legacy” pacemakers and defibrillators.

The findings are good news for patients and doctors needing a scan and faced with such implantable heart devices, according to the report in The New England Journal of Medicine.

The study “confirms that pretty much anybody who has a pacemaker or implanted defibrillator can, with very few restrictions, safely get an MRI scan if they need it,” as long as settings for the devices are correct for scanning and adequate precautions are taken, co-author Dr. Henry Halperin, professor of medicine, radiology and biomedical engineering at Johns Hopkins University told Reuters.

Researchers 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 issue is not just about health – the U.S. Centers for Medicare and Medicaid Services (CMS) only covers FDA-determined “MR-conditional” scans, co-author Dr. Saman Nazarian, of the University of Pennsylvania Perelman School of Medicine, told Reuters.

This study follows a similar one that revealed that legacy devices were safe, which has led Nazarian to suggest that, given these reports, the agency's position is “hard to understand,” according to the news wire.

This latest 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 issue is bound to continue to impact more patients, as the global cardiac pacemaker market is set to nearly double by 2023, according to a Stratistics MRC report last month.

In 2016 the market was worth $8.01 billion and it’s projected to grow at a 9.3 percent annualized rate and reach $14.99 billion by 2023. North America will dominate the market during the forecast period due to the higher incidences of hypertension, high cholesterol and diabetes in the region.

In addition, research published in the Journal of Clinical Electrophysiology in October confirmed that it's safe to use MR to evaluate the heart or lungs in patients with them.

In the study, researchers from the Intermountain Medical Center Heart Institute studied 212 MR studies from 178 patients with a cardiac implantable device, that took place between February 2014 and August 2016. They found that not a single study required remediation.

"That's a pretty big number of leads exposed to these very strong MRI fields. You would think if there were even a one percent chance of having a problem, it would have shown up," Dr. Jeffrey L. Anderson, senior study author and cardiologist at the institute, said in a statement. "Not even one generator or lead needed more than a minor adjustment, if any at all."