Clinical safety of the ProMRI pacemaker system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions

Clinical Performance of Magnetic Resonance Imaging Conditional and Nonconditional Cardiac Implantable Electronic Devices

“…We found no difference in capture threshold or lead impedances measured before and immediately after MRI scans at 1.5 T. No safety events, including device or lead failure, occurred. In the MRI conditional cohort, it was reassuring to observe excellent clinical safety, consistent with that reported in larger studies of such devices . A comparison between these groups suggests similar low risk profiles.…”

“…The novel changes can be broadly categorized as differences in lead components and architecture, pulse generator components, and programming or interface changes. Large studies have demonstrated the efficacy of these systems, including PPM and ICD, in the 1.5 T MRI environment, without specific limitations on location of scan . Thus, it appears that this clinical need has been met for patients who have yet to receive CIED.…”

“…The small sample size of patients having MRI‐conditional devices recruited during our enrollment period can lead to underestimation of events in this group. However, several large studies assessing clinical and device risk associated with MRI performance in MRI conditional pacemaker and defibrillator systems have been published, accounting for 1,144 total MRI scans . In aggregate, these studies report symptoms following 1.6% (n = 19) of scans with a lead revision rate of 0.09% (n = 1).…”

“…While uncomplicated performance of MRI scanning in patients with CIED has been reported, adverse events, including unexpected programming changes, inhibition of pacing output, and possible evidence of lead tip heating, have been demonstrated. In recent years, several manufacturers have released PPMs and ICDs with novel design for which “MRI conditional” labeling has been granted by the FDA . Patients with non‐MRI conditional CIEDs face difficulties in obtaining MR studies, though several authors have reported excellent clinical outcomes in this situation .…”

“…In recent years, several manufacturers have released PPMs and ICDs with novel design for which "MRI conditional" labeling has been granted by the FDA. [3][4][5] Patients with non-MRI conditional CIEDs face difficulties in obtaining MR studies, though several authors have reported excellent clinical outcomes in this situation. [6][7][8] In this study, we reviewed outcomes following MRI in patients with both MRI and non-MRI conditional pacing and defibrillator systems.…”