Undergoing MRI with a pacemaker has long been considered a tricky proposition. Individuals with the devices, and those with cardioverter defibrillators, were often kept from undergoing such imaging because of safety concerns.
CMS only allows beneficiaries with “MRI-conditional” devices—those deemed safe by the U.S. Food and Drug Administration (FDA)—to undergo MRI. But new research in the New England Journal of Medicine argues such safety concerns are incorrected and outdated.
“Patients who have permanent pacemakers or implantable cardioverter-defibrillators are often denied the opportunity to undergo MRI because of safety concerns,” Nazarian said. “These concerns exist because of previous case reports in which appropriate protocols were not followed. While some resistance to MRI in the setting of pacemakers or ICDs exists in the cardiology and radiology communities, a main hurdle is (CMS).”
Nazarian and a team of Penn researchers performed a prospective, nonrandomized study of 1,509 patients to assess the safety of MRI at a magnetic field strength of 1.5 Tesla, according to the research. Of those participants, 58 percent had a pacemaker and 42 percent were fitted with an implantable cardioverter-defibrillator; no devices were considered “MRI-conditional.”
In total, no long-term, clinically relevant adverse events were reported during the study, the team said, but in nine MRI exams a patient’s device reset to a backup mode—a finding that was transient in eight of the nine instances.
Read more, including comments from Nazarian, at Cardiovascular Business.