Background
Cardiovascular implantable electronic devices (CIEDs) have historically restricted the use of magnetic resonance imaging (MRI) due to the potential clinical and configurational risks associated with electromagnetic interference. In this study, the authors investigated the impact of MRI on the functional integrity of non‐conditional CIEDs and their clinical correlates.
Methods
In this prospective, observational single‐center study, we enrolled patients undergoing MRI over a 5‐year period. Prior to assessing the impact of MRI on CIEDs, we performed interrogations in sequential duplication to assess the intrinsic variability of devices. Subsequently, we performed interrogations immediately after MRI, and monitored changes in device parameters and clinical events.
Results
We completed 492 MRI studies, 58% in patients with permanent pacemakers (PPMs) and 42% with implantable cardioverter defibrillators (ICDs). Subsequent MRI exposures occurred in 15% encounters. Accounting for intrinsic variability in CIED leads, there were no significant changes in RA, RV, or LV parameters after MRI, regardless of the region imaged (thoracic vs. non‐thoracic), type of CIED (PPMs vs. ICDs) and among those with serial MRIs. When ranked for % change pre‐ to post‐MRI, the majority of RA, RV, and LV metrics for thresholds, sensing, and impedance conformed to ≤20% change from baseline. No significant clinical adverse cardiac events or effect on device microcircuitry occurred during the study.
Conclusion
Incorporating a novel reproducibility tactic, there were neither clinically meaningful device parameter changes nor adverse clinical events during or following MRIs, suggesting the effects of MRI on non‐conditional CIED integrity are far less than previously perceived.
Introduction:
Magnetic Resonance Imaging (MRI) non-conditional cardiovascular implantable electronic devices (CIEDs) have historically restricted the use of MRI. We investigated the impact of MRI on the functional integrity of CIEDs.
Methods:
In this prospective, observational single-center study, we enrolled patients undergoing MRI over a 5-year period. Prior to assessing the impact of MRI on CIED integrity, we performed interrogations in sequential duplication to assess the intrinsic variability of the device. Subsequently, we performed interrogations immediately after MRI and monitored changes in device parameters and clinical events.
Results:
We completed 492 MRI studies, 283 (58%) in patients with permanent pacemakers (PPMs), and 209 (42%) with implantable cardioverter defibrillators (ICDs). Subsequent MRI exposures occurred in 73 of 492 (15%) encounters. Accounting for intrinsic variability in CIED lead parameters, there were no significant changes in RA, RV, or LV lead parameters after MRI, regardless of the region of scan (thoracic vs non-thoracic), type of CIED (PPMs vs ICDs) and among those with serial MRIs. When ranked for % change pre- to post-MRI, the majority of RA, RV, and LV metrics for thresholds, sensing, and impedance conformed to ≤20% change. No significant clinical adverse cardiac events or effect on device microcircuitry occurred during the study.
Conclusion:
Incorporating a novel reproducibility tactic, there were no clinically meaningful device parameter changes nor were there adverse clinical events during or following MRIs, suggesting the effects of MRI on non-conditional CIED integrity are far less than previously perceived.
Introduction:
The evolution of pacemaker/ICD safety in the magnetic field has triggered considerable interest in more clinical routine use. However, many limitations to widespread adoption of this seemingly implausible idea just a few years ago remain: unresolved impact of the high magnetic field, RF amplitude and oscillatory forces on electronics with possible high field damage to capacitor, solenoid and microcircuitry. However, given recent vender refinements over the last 10 years, we hypothesized that the impact on such circuitry may be far less than expected.
Method:
Consecutive interrogation of 940 pts who underwent clinically indicated MRI were evaluated over 5 years. This cohort was comprised of neuro/neurosurgical (72%), orthopedic (11%) and cardiac (17%) cases. Routine interrogation was performed within 10 min of entry into the bore of a dedicated Cardiac MRI (GE, 1.5T, WI). As well, reinterrogation was performed within 10 min of departure MRI (average 21±12min). At the time of interrogation pre and post MRI, a separate, repeat interrogation was performed within 5 min of each other such that 2 sets of PM/ICD parameters were obtained pre and post MRI.
Result:
No complications to either pt or device occurred during the MRI comprising 564 PMs and 376 ICDs. A cardiologist was present guiding the interrogation, configuration, and reconfiguration of the PM/ICD as well was present for entire MRI. There were no significant differences in common clinical parameters. More importantly, there was no difference in any parameter when compared in any order pre to post MRI scan. See Table.
Conclusion:
Intrinsic variability and inherent changes triggered by MRI environments are clinically insignificant and statistically negligible thereby removing yet another of the last remaining fears and apprehensions for primary PM/ICD failure and destruction as we move towards a more uniform acceptance of this technology for clinically meaningful use, dissemination and acceptance.
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