Impact of magnetic resonance imaging on functional integrity of non-conditional cardiovascular implantable electronic devices.

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.

Where do we go from here? Beyond the MagnaSafe trial: A focus beyond a 'safety-first' notion. An MRI study in 500 consecutive patients.

BACKGROUND: In patients with conventional pacemakers or ICD's, MRI is infrequently performed due to safety concerns. Recent reports have allayed many of these concerns. However, the additive clinical value of scanning patients with cardiac implants has not been established. OBJECTIVE: Assessing the additive value of thoracic and non-thoracic MRI in patients with implantable cardiac devices. METHODS AND RESULTS: Prospective data were analyzed in 500 patients with implanted cardiac devices that underwent MRI over a 12 year period at a single institution (Allegheny General Hospital, Pittsburgh, PA). A set of three questions were answered following scan interpretation by both the MRI technologist and interpreting MRI physician(s): 1) Did the primary diagnosis change? 2) Did MRI provide additional information to the existing diagnosis? 3) Did patient management change? If 'Yes' was answered to any of the above questions, it was considered that the MRI scan was of value to patient diagnosis and/or guiding therapy. Scans encountered were neurological/neurosurgical 354 (70.8%), cardiac 98 (19.6%) and orthopedic 48 (9.6%) in nature. In 431 (86%) MRI added additional information to the primary diagnosis and in 277 (55.4%) MRI changed the primary diagnosis. In 304 (60.8%) cases management changed, 265 (53%) due to a change in diagnosis and in 39 (7.8%) due to providing additional information. No safety issues were encountered and no adverse effects of MRI scan were noted. CONCLUSIONS: MRI in patients with implanted cardiac devices was of additive value to diagnosis and management thereby informing risk-benefit considerations. CONDENSED ABSTRACT: 500 patients with implanted cardiac devices who underwent a MRI examination over a 12 year period were followed prospectively. Imaging primarily focus on three anatomical regions (neurological/neurosurgical, cardiac and orthopedic) providing added information to the primary diagnosis in 431 (86%) cases and changing the primary diagnosis in 277 (55.4%) cases. In 304 (60.8%) cases management changed with 265 (53%) being due to a change of diagnosis and in 39 (7.8%) due to providing additional information. No safety issues were encountered using a defined protocol. CONCLUSIONS: MR imaging retains its diagnostic yield in patients with implanted devices.

Feasibility of MRI in patients with non-Pacemaker/Defibrillator metallic devices and abandoned leads.

OBJECTIVE: To evaluate feasibility of MRI in patients with non-pacemaker (PM)/ Implantable cardioverter defibrillator (ICD) metallic devices and abandoned leads. BACKGROUND: Relative safety of MRI performed using specified protocol has been established in MR non-conditional PM/ICDs. With limited safety data, many non-PM/ICD metallic devices and abandoned leads continue to be a contraindication for MRI. METHODS: We retrospectively analyzed consecutive patients with extra-cardiac devices, non-programmable cardiac devices, and abandoned leads, who underwent MRI (GE 1.5 Tesla, WI) at a single tertiary care center over a span of 13 years. Scan protocol was designed to maintain specific absorption rate (SAR) < 4.0 W/kg and scan time < 60 minutes. RESULTS: The cohort comprised 127 MRI exams representing 94 patients, with 13 patients having two or more scans. The devices consisted of: 23 vagal nerve stimulators (VNS), 22 implantable loop recorders, 16 spinal stimulators, 5 peripheral nerve stimulators, 3 bladder stimulators, 2 deep brain stimulators, 1 gastric stimulator, 1 bone stimulator, 1 WATCHMAN device, 22 abandoned PM/lCD leads and 1 VNS lead. There was no immediate (peri-MRI exam) morbidity or mortality. Patients did not report any discomfort, palpitations, heating, or sensation of device migration during the exam. Local follow-up data was available in 65% (100% for thoracic imaging) with a mean of 190±475 days (median 13 days). No device malfunction reported during follow-up. CONCLUSIONS: With appropriate precautions, MRI is feasible in patients with extracardiac devices, nonprogrammable cardiac devices, and abandoned leads.