CHAPEL HILL, NC--In a new international clinical trial testing the safety of performing an MRI on a patient with an ICD, the first trial patient at UNC underwent the procedure in August 2014. Jennifer Schwartz, MD, assistant professor of cardiology, performed the MRI with excellent patient outcomes.
The purpose of the Evera MRITM study is to confirm the safety and effectiveness of the Evera MRI ICD (implantable cardioverter defibrillator) System in the clinical MRI environment.
Magnetic Resonance Imaging (MRI) is used to produce detailed images of organs and internal structures using strong magnetic fields and radio waves. The magnetic fields can cause ICDs, pacemakers, and other implanted medical devices containing metal to malfunction or heat up.
The current study at UNC is testing to see if patients can receive MRI scans without position restrictions, meaning MRI scans may occur anywhere on the body without causing harm to an ICD or the patient.
Dr. Schwartz has been involved in research on cardiac MRIs for many years, starting at the Scripps Clinic in La Jolla, California. She spent three years researching pacemaker and ICD safety for patients undergoing magnetic resonance imaging. Her team discovered there is a very low risk to device and patient.
“There are millions of devices out there, and as the patient population gets older, many patients will require an MRI,” explains Dr. Schwartz. “It is estimated that 50-75 percent of patients with a cardiac device will need an MRI at some point. We were able to actually show that you could do MRI safely for patients where it was important for diagnostic purposes. Using a certain protocol and certain parameters and monitoring, it can be done.”
As of May 2013, there were only two papers published on this topic, and Dr. Schwartz was the first author of one of the papers. She has presented the data many times at various medical conferences. As a researcher in the current international Evera MRI trial, she hopes to forward the research even further to provide the best patient care for those who have an ICD and need an MRI.
Medtronic Cardiac Rhythm Disease Management is sponsoring the clinical trial. The principal investigators are Michael R Gold, MD, PhD, Medical University of South Carolina; Emanuel Kanal, MD, FACR, University of Pittsburgh Medical Center; Juerg Schwitter, MD, University Hospital Lausanne (CHUV), Switzerland; and Torsten Sommer, MD, German Red Cross Hospital (DRK) Neuwied, Germany.
The Evera MRI study at UNC is currently enrolling patients. For more information on enrollment, contact tywade01 [at] email.unc.edu (Tyrone Wade), UNC Cardiology clinical trial coordinator for the Evera MRI study.