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Pacemaker shown safe, effective during MRI
Wilkoff B. Heart Rhythm. 2011;8:65-73.
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Patients with a pacemaker system designed for use in MRI scans had no MRI-related complications during or after imaging, according to new results published in Heart Rhythm.
The researchers tested 464 patients with the Revo MRI SureScan pacing system (Medtronic) that included EnRhythm MRI SureScan implantable pulse generator and CapSureFix MRI leads. The pacing system was tested in 1.5 Tesla MRI systems from three manufacturers (General Electric, Siemens and Philips). After successful implantation, patients in the prospective, international study were randomly assigned to undergo an MRI between 9 and 12 weeks (MRI group; n=258) or not to undergo MRI (control; n=206).
During a mean follow-up of 11.2 months, 11 patients died, with nine deaths reported in the MRI group, although none were related to MRI procedure, implantation or the pacemaker system. Researchers reported that all MRI scans were completed safely with continuous pacemaker stimulation. For both groups, changes regarding pacing capture threshold and sensed electrogram amplitude were minimal.
“All pacemaker system-related complications were within an expected and clinically acceptable range,” the researchers wrote. “[The study’s] results indicate that this pacemaker system can be used safely in an MRI environment when used in accordance with its labeling.”
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