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

Abstract

1.5 T MRI scanning in patients with MRI conditional and non-MRI conditional cardiac devices was performed with similar, low clinical risk.

Safety and effectiveness of a 6‐French MRI conditional pacemaker lead: The INGEVITYTM clinical investigation study results

“…Furthermore, magnetic resonance imaging (MRI) conditional lead design offers an additional safety benefit, as MRI scanning is now the imaging modality of choice for many neurological and musculoskeletal conditions. In the past, implanted cardiac devices, including pacemakers and implanted cardioverter‐defibrillators, have been contraindicated in MRI scanners, but recent studies and medical societies in both Europe and the United States have suggested that select patients may be safely scanned . Potential adverse effects of an MRI scanner on pacemaker function, such as tissue heating at the lead tip resulting in failure of capture and induced arrhythmias due to unintended cardiac stimulation, remain, however, an ongoing concern .…”

Off‐Label MRI in 2017 of CIEDs: A Daily “Fork‐in‐the Road” for Implanters and the Case for Common Sense

“…While Shah et al. saw no power‐on‐resets in their relatively small series presented in this issue, the six power‐on‐resets reported and one ICD replacement required after MRI in MagnaSafe (a far larger series of 1500 off‐label MRIs) may somewhat temper the enthusiasm for implanting non‐MR‐conditional devices . As noted in a recent review, “The greatest potential risk is that of power‐on reset in pacemaker dependent patients, which may change the programmed mode from asynchronous to synchronous, permitting oversensing of CMR signals and inhibition of pacing output.”…”

“…In this issue of PACE, Emory University reports their experience of both magnetic resonance (MR) imaging (MRI) of non‐MRI‐conditional devices (often called, “legacy devices” or “off‐label MRI”) and MRI‐conditional devices . Using the metric that any difference in outcomes of off‐and on‐label MRI only be considered relevant if “clinically actionable,” Shah et al.…”

“…Shah et al. note that the average time from implant to MRI was 3 years emphasizing the importance that clinicians who must choose which device to implant today have impact on their patient's future access to MRI …”

“…Despite claims to the contrary suggesting no difference in the supervisory burden of on‐label and off‐label MRI, the additional supervisory burdens of off‐label MRI continues during the run up to the off‐label scan itself with centers typically reporting “all MRI requests in patients with pacemakers or ICDs are reviewed jointly by cardiac electrophysiology and radiology physicians” and “scans are limited to 1.5 Tesla machines.” At Emory University, Shah et al. relate in their manuscript, “All patients underwent formal, face‐to‐face evaluation with a cardiac electrophysiologist.” While it is hoped the appropriateness of all MRIs are reviewed, it goes without saying that such burdensome collaborative risk‐benefit assessment efforts are not required when scanning MR‐conditional patients as the risk of mishap has been deliberately engineered out of the product.…”