MagnaSafe Registry: Risks of MRI at 1.5 Tesla For Patients With Non-MRI Conditional Pacemakers and ICDs

A change in lead impedance is not associated with clinically-significant parameter changes, according to results of the MagnaSafe Registry study presented Nov. 18 at AHA 2014.

Led by Robert J. Russo, MD, PhD, FACC, of the Scripps Research Institute, the study aimed to determine the risk of clinically-indicated magnetic resonance imaging (MRI) at 1.5T for patients with permanent pacemakers and implanted cardioverter-defibrillators (ICDs).

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The primary clinical outcomes included death during the MRI scan, generator failure requiring immediate replacement, lead failure requiring immediate replacement, new onset atrial or ventricular arrhythmia during the scan, loss of pacemaker capture during the scan and electrical reset.

Results showed that of the 1,500 cases that have been successfully enrolled in the Registry, one patient experienced a device failure (ICD) requiring immediate replacement after the MRI as a result of inappropriate device programming, six episodes of atrial fibrillation/flutter were detected, and no ventricular arrhythmias occurred.

The authors ultimately conclude that a change in lead impedance is not associated with clinically-significant parameter changes, and patients with non-conditional devices are at “no significant clinical risk.”

They add that “results of the MagnaSafe Registry may change ACC/American Heart Association recommendations, Centers for Medicare and Medicaid Services’ coverage, and improve access to clinically-indicated MRI for patients with standard pacemakers and ICDs.”

Keywords: Electric Impedance, Centers for Medicare and Medicaid Services, U.S., Atrial Fibrillation, American Heart Association, Pacemaker, Artificial, Magnetic Resonance Imaging, Defibrillators, Implantable, Equipment Failure

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