Long awaited results of the MagnaSafe study regarding the safety of MRIs in patients with implantable devices were published in February. The MagnaSafe study established a multi-center prospective registry for patients undergoing MRI scans despite their having an implanted device not deemed safe for MRI scanning by the FDA.
During the study, MRI scans were performed on a variety of patients who underwent the scans despite the perceived risk. MagnaSafe ultimately found that these MRI scans were relatively safe, and the risk to patients was low. However, one shortcoming of the Magna-Safe study was that none of the scans involved in the study involved areas of the body near the implantable device: instead they involved more remote body parts such as the head, legs or arms.
Now, a new study by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City has built upon the findings of the Magna-Safe study and further established the safety of MRIs in patients with non-MRI conditional devices while following the special protocols established by the Magna-Safe study. The study specifically included patients undergoing scans of the heart, lungs and chest area, all of which had previously been excluded from the MagnaSafe data.
The study looked at 212 MRI exams in 178 patients with an MRI or pacemaker between February 2014 and August 2016. During the 2+ year period of observation, the researchers encountered no problems related to either the implantable devices themselves, or to the 418 leads associated with the devices. Due the absence of problems, the researchers concluded that these studies are safe for patients.
Now, lead author, Dr. Jeffrey L. Anderson, MD, along with several of the researchers involved in the MagnaSafe trial, have signed and submitted a letter to the U.S. Centers for Medicare & Medicaid Services, asking that it cover medically-necessary MRIs in patients with non-MRI conditional implantable devices and performed under the protocol used in the MagnaSafe study.
[Editor’s note – This is good news for implantable device patients who may need high quality imaging for treatment of various medical problems. You can find a blog entry here describing my own experiences seeking a brain MRI while implanted with an older, non-MRI conditional defibrillator here.]