SLR - April 2018 - Kevin P. Patel
Reference: Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. New England Journal of Medicine. 2017 Dec 28; 377(26): 2555–2564.Scientific Literature Review
Reviewed By: Kevin P. Patel, DPM
Residency Program: Temple University Hospital, Philadelphia, PA
Podiatric Relevance: Magnetic Resonance Imaging (MRI) is the gold standard for evaluating many foot and ankle pathologies, including, but not limited to, tendon/ligament injuries, infection, tumors, avascular necrosis, etc. However, many patients have implantable devices, such as pacemakers or defibrillators. One of the absolute contraindications to obtaining an MRI is the presence of a pacemaker or defibrillator due to safety concerns as expressed by the U.S. Food and Drug Administration. The exception to this rule are devices termed “MRI conditional” devices. Furthermore, due to lack of adequate data, access to MRI for patients with implantable devices is extremely limited. This study is a large, prospective study aimed to evaluate the safety of MRI for patients with a pacemaker or ICD systems.
Methods: This is a prospective, nonrandomized study with 1,509 patients with either a pacemaker or implantable defibrillator. Furthermore, these devices were not considered MRI-safe devices. Overall, 2,103 MRI examinations were performed that were deemed clinically necessary. Outcomes were assessed in terms of any adverse events that occurred after MRI studies and/or any changes in parameters that altered lead and generator functions.
Results: There were no long-term complications that occurred after patients underwent MRI examination in the presence of a pacemaker or implantable defibrillator. In nine MRI examinations, the patient’s device reset to backup mode. One percent of the patients demonstrated decrease in P-wave amplitude and increase in left or right ventricular capture threshold. However, these changes were deemed not clinically significant and did not require any adjustment to the devices.
Conclusion: In this study, 1,509 patients with implantable devices were evaluated in regards to use and safety of MRI. No long-term clinically significant adverse events were reported.