Current clinical issues for MRI scanning of pacemaker and defibrillator patients.
Dramatic increases in both magnetic resonance imaging (MRI) usage and cardiac device-based therapy have resulted in an estimated 50-75% probability of a patient being indicated for an MRI over the lifetime of their device. Some recent studies have demonstrated "safe procedures" and "no adverse events" in the limited populations, clinical situations, and specific devices and lead orientations tested. While these investigations are useful to help ascertain the hazards for patients with cardiac devices, they do not demonstrate clear freedom from risk. All components of active implantable systems must be engineered during the design stage to provide safety in current and evolving MR environments. Device manufacturers need to secure regulatory approval to confirm their products' safety under multiple clinical and technical variables.
Kalin
Ron
R
Cardiac Rhythm Management Division, Medtronic Inc., MS:T135, 7000 Central Avenue NE, Minneapolis, MN 55432, USA. ron.kalin@medtronic.com
Stanton
Marshall S
MS
D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004869:Equipment Safety; D006801:Humans; D008279:Magnetic Resonance Imaging; D010138:Pacemaker, Artificial / Q000009:adverse effects*