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Clinical safety of ProMRI implantable cardioverter-defibrillator systems during head and lower lumbar magnetic resonance imaging at 1.5 Tesla.


ABSTRACT: Magnetic resonance imaging (MRI) has long been contraindicated in patients with implanted pacemakers, defibrillators, and cardiac resynchronisation therapy (CRT) devices due to the risk of adverse effects through electromagnetic interference. Since many recipients of these devices will have a lifetime indication for an MRI scan, the implantable systems should be developed as 'MRI-conditional' (be safe for the MRI environment under predefined conditions). We evaluated the clinical safety of several Biotronik ProMRI ('MRI-conditional') defibrillator and CRT systems during head and lower lumbar MRI scans at 1.5 Tesla. The study enrolled 194 patients at 22 sites in Australia, Canada, and Europe. At ≥9 weeks after device implantation, predefined, non-diagnostic, specific absorption rate (SAR)-i

SUBMITTER: Bauer WR 

PROVIDER: S-EPMC6890633 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature