Scripps Clinic has recently announced the initiation of a registry designed to document the adverse event rate for patients with pacemakers and implantable cardioverter defibrillators (ICDs) who undergo an MRI examination.
The MagnaSafe registry is a multi-center, prospective study of patients with cardiac devices who undergo MRI for clinical purposes. An anticipated 1,500 patients from 35 participating centers will be enrolled and monitored for two years. The study is performed under an investigational device exemption (IDE) by the FDA. Scripps Clinic is coordinating the investigator-initiated study, which is funded through multiple sources, including competitive grants, institutional grants, foundation fellowship support, unrestricted educational grants from industry and philanthropy.
The first patient was enrolled in the study on April 2, 2009 at Scripps Clinic/Green Hospital in La Jolla, CA, under the direction of national principal investigator Robert J. Russo, M.D., Ph.D and Jennifer D. Cohen, M.D.
“MRI is the imaging modality of choice for the diagnosis of many diseases of the brain, spinal cord, and musculoskeletal system," said Dr. Russo. "For some disease states, no acceptable alternative diagnostic imaging method is available.”
The MagnaSafe study will create a registry of patients with pacemakers and ICDs who will undergo clinically indicated MRI and will document the adverse events associated with the imaging procedure.
“The results of this registry will provide the medical community with an accurate documentation of risk to patients and will establish a protocol of patient screening and device reprogramming for the purpose of maximizing the safe performance of MRI in patients with cardiac devices,” said Dr. Russo.
Until recently, the presence of a pacemaker or an ICD has been an absolute contraindication for the performance of MRI. Between 1990 and 2005, an estimated 2.8 million pacemakers and 690,000 ICDs were implanted in the United States. As the number of implanted cardiac devices is increasing, the clinical indications for MRI are expanding as well. It is predicted that there is a 50 to 75-percent probability that a patient with a pacemaker or ICD will have the need for an MRI over the lifetime of the device.