Evaluation of a compact 3 T MRI scanner for patients with implanted devices.

Access to high-quality MR exams is severely limited for patients with some implanted devices due to labeled MR safety conditions, but small-bore systems can overcome this limitation. For example, a compact 3 T MR scanner (C3T) with high-performance gradients can acquire exams of the head, extremities, and infants. Because of its reduced bore size and the patient being advanced only partially into the bore, the associated electromagnetic (EM) fields drop off rapidly caudal to the head, compared to whole-body systems. Therefore, some patients with MR conditional implanted devices can safely receive 3 T brain exams on the C3T using its strong gradients and a multiple-channel receive coil, while a corresponding exam on whole-body MR is precluded. The purpose of this study is to evaluate the performance of a small-bore scanner for subjects with MR conditional spinal or sacral nerve stimulators, or abandoned cardiac implantable electronic device (CIED) leads. The spatial dependence of specific absorption rate (SAR) on the C3T was compared to whole-body scanners. A device assessment tool was developed and applied to evaluate MR safety individually on the C3T for 12 subjects with implanted devices or abandoned CIED leads. Once MR safety was established, the subjects received a C3T brain exam along with their clinical, 1.5 T exam. The resulting images were graded by three board-certified neuroradiologists. The C3T exams were well-tolerated with no adverse events, and significantly outperformed the whole-body 1.5 T exams in terms of overall image quality.

Magnetic Resonance Imaging in Patients with Cochlear Implants without Magnet Removal: A Radiology-Administered Protocol to Enhance Operational Efficiency and Improve Workflow.

OBJECTIVE: To describe the development, implementation, and validation of a radiology-administered protocol to obtain magnetic resonance imaging (MRI) in patients with cochlear implants and auditory brainstem implants without magnet removal. STUDY DESIGN: Retrospective review and description of novel care pathway. METHODS: A radiology-administered protocol was designed based on careful input from the radiology safety committee and neurotology. Radiology technologist training modules, consent instructions, patient educational material, clinical audits, and other safeguards were implemented, with samples provided in this report. The primary outcomes measured included instances of magnet displacement during MRI and premature termination of MRI studies secondary to pain. RESULTS: Between June 19, 2018, and October 12, 2021, 301 implanted ears underwent MRI without magnet removal, including 153 devices housing diametric MRI-conditional magnets, and 148 implants with conventional axial (i.e., nondiametric) magnets. Among cases with diametric MRI-conditional magnets, all studies were completed without magnet dislodgement or need to terminate imaging early due to pain. Among cases with conventional axial (nondiametric) magnets, 29 (19.6%) MRI studies were stopped prematurely secondary to pain or discomfort; the overall rate of this event was 9.6% (29 of 301) among the entire study cohort. In addition, 6.1% (9 of 148) experienced confirmed magnet displacement despite headwrap placement; the overall rate among all cases was 3.0% (9 of 301). Eight of these patients received successful external magnet reseating through manual pressure on the external scalp without surgery, and one required surgical replacement of the magnet in the operating room. There were no documented instances of hematoma, infection, device or magnet extrusion, internal device movement (i.e., gross receiver-stimulator migration), or device malfunction in this cohort related to MRI. CONCLUSIONS: We present the successful implementation of a radiology-administered protocol designed to streamline care for cochlear implant and auditory brainstem implant recipients who require MRI and ease clinical demands for otolaryngology providers. Examples of resources developed, including a process map, radiology training modules, consent instructions, patient educational materials, clinical audit, and other procedural safety measures are provided so interested groups may consider adapting and implementing related measures according to need.

Safety of magnetic resonance imaging in patients with surgically implanted permanent epicardial leads.

BACKGROUND: Magnetic resonance imaging (MRI) safety in patients with an epicardial cardiac implantable electronic device (CIED) is uncertain. OBJECTIVE: The purpose of this study was to assess the safety and adverse effects of MRI in patients who had surgically implanted epicardial CIED. METHODS: Patients with surgically implanted CIEDs who underwent MRI with an appropriate cardiology-radiology collaborative protocol between January 2008 and January 2021 were prospectively studied in 2 clinical centers. All patients underwent close cardiac monitoring through MRI procedures. Outcomes were compared between the epicardial CIED group and the matched non-MRI-conditional transvenous CIED group. RESULTS: Twenty-nine consecutive patients with epicardial CIED (41.4% male; mean age 43 years) underwent 52 MRIs in 57 anatomic regions. Sixteen patients had a pacemaker, 9 had a cardiac defibrillator or cardiac resynchronization therapy-defibrillator, and 4 had no device generator. No significant adverse events occurred in the epicardial or transvenous CIED groups. Battery life, pacing, sensing thresholds, lead impedance, and cardiac biomarkers were not significantly changed, except 1 patient had a transient decrease in atrial lead sensing function. CONCLUSION: MRI of CIEDs with epicardially implanted leads does not represent a greater risk than transvenous CIEDs when performed with a multidisciplinary collaborative protocol centered on patient safety.

Safety Considerations in MRI and CT.

OBJECTIVE: MRI and CT are indispensable imaging modalities for the evaluation of patients with neurologic disease, and each is particularly well suited to address specific clinical questions. Although both of these imaging modalities have excellent safety profiles in clinical use as a result of concerted and dedicated efforts, each has potential physical and procedural risks that the practitioner should be aware of, which are described in this article. LATEST DEVELOPMENTS: Recent advancements have been made in understanding and reducing safety risks with MR and CT. The magnetic fields in MRI create risks for dangerous projectile accidents, radiofrequency burns, and deleterious interactions with implanted devices, and serious patient injuries and deaths have occurred. Ionizing radiation in CT may be associated with shorter-term deterministic effects on biological tissues at extremely high doses and longer-term stochastic effects related to mutagenesis and carcinogenesis at low doses. The cancer risk of radiation exposure in diagnostic CT is considered extremely low, and the benefit of an appropriately indicated CT examination far outweighs the potential risk. Continuing major efforts are centered on improving image quality and the diagnostic power of CT while concurrently keeping radiation doses as low as reasonably achievable. ESSENTIAL POINTS: An understanding of these MRI and CT safety issues that are central to contemporary radiology practice is essential for the safe and effective treatment of patients with neurologic disease.

Safety and Management of Implanted Epilepsy Devices for Imaging and Surgery.

Permanently implanted devices that deliver electrical stimulation are increasingly used to treat patients with drug-resistant epilepsy. Primary care physicians, neurologists, and epilepsy clinicians may encounter patients with a variety of implanted neuromodulation devices in the course of clinical care. Due to the rapidly changing landscape of available epilepsy-related neurostimulators, there may be uncertainty related to how these devices should be handled during imaging procedures and perioperative care. We review the safety and management of epilepsy-related implanted neurostimulators that may be encountered during imaging and surgery. We provide a summary of approved device labeling and recommendations for the practical management of these devices to help guide clinicians as they care for patients treated with bioelectronic medicine.

Scout it out! Wake-Up Stroke Protocol to Expedite MRI in Stroke Patients.

In wake-up stroke patients, magnetic resonance imaging (MRI) is useful to identify patients that would benefit from thrombolytic therapy. Our multidisciplinary stroke team developed and implemented a workflow to rapidly identify patients that are able to safely undergo an MRI exam, thus decreasing time to treatment. We employ a full-body CT scout image in our CT head protocol for acute stroke in order to identify implantable devices and foreign bodies. This protocol highlights the importance of radiology playing an active role on the multidisciplinary stroke team in order to effectively and promptly treat patients.

Cochlear Implants and Magnetic Resonance Imaging: Experience With Over 100 Studies Performed With Magnets in Place.

OBJECTIVE: To evaluate adverse events and feasibility of performing 1.5-T MRI in patients with cochlear implants (CI) and auditory brainstem implants (ABI). SETTING: Single tertiary academic referral center. PATIENTS: CI and ABI recipients undergoing 1.5-T MRI without internal magnet removal. INTERVENTION(S): MRI after tight headwrap application. MAIN OUTCOME MEASURES: Adverse events, patient tolerance. RESULTS: A total of 131 MR studies in 79 patients were performed, with a total of 157 study ears. Sixty-one patients (77%) had unilateral devices. Four patients (5%) underwent MRI with ABI magnets in place. Sixteen patients (20%) had MRI-compatible devices that did not require a head wrap. There were no instances of device stimulation, device malfunction, or excessive heating of the receiver-stimulator package. Magnet tilt requiring manual repositioning occurred during seven studies (4.5%) and magnet displacement requiring operative intervention occurred during seven studies (4.5%). Significant pain where imaging had to be discontinued occurred during three episodes (2%). No adverse events were noted among patients who underwent MRI with an MRI-compatible magnet. CONCLUSIONS: MRI with CI or ABI magnets in place is associated with a low prevalence of adverse events when performed in a controlled setting. Many partial magnet displacements can be corrected with firm manual pressure. Devices with magnets that align with the field within their housing were not associated with any adverse events and do not require immobilization of the magnet during the scan. These may be valuable in patients with known or anticipated need for MRI.

MR Safety: Active Implanted Electronic Devices.

New implanted medical devices continue to be made available for treatment of medical conditions. Many recipients can benefit from the diagnostic power of MR imaging. Provisions must be made to determine if these patients can be safely scanned. Metal-containing devices can be considered either MR unsafe or conditional. It is essential that all components of an implanted system are completely and accurately identified, with the most restrictive MR safety condition dictating the scanning approach. MR safety considerations for major classes of implanted devices are discussed, recognizing that there have been reports of serious device-related MR safety incidents.

Magnetic Resonance Safety in the 7T Environment.

The arrival of 7T MR imaging into the clinic represents a significant step-change in MR technology. This article describes safety concerns associated with imaging at 7T, including the increased magnetic forces on magnetic objects at 7T and the interaction of the 300 MHz (Larmor) radiofrequency energy with tissue in the body. A dedicated multidisciplinary 7T Safety team should develop safety policies and procedures to address these safety challenges and keep abreast of best practice in the field. The off-label imaging of implanted devices is discussed, and also the need for staff training to deal with complexities of patient handling and image interpretation.

MR Imaging Safety Events: Analysis and Improvement.

Multiple factors, including tight patient scheduling, complex electronic medical records, and increasing numbers of implanted devices, increase chances of MR imaging safety event occurrence. Several MR imaging safety incidents are described in this article, including the safety conditions and other factors that contributed to the events. MR imaging safety policy and procedural improvements that address these are also described. Specific new revision points in the American College of Radiology Manual on MR Safety are viewed in the context of these events, with emphasis on how their implementation could reduce probability of similar event recurrence.

Magnetic Resonance Imaging-Guided Focused Ultrasound Ablation of Lumbar Facet Joints of a Patient With a Magnetic Resonance Image Non-Conditional Pacemaker at 1.5T.

OBJECTIVE: To provide an initial report that patients with magnetic resonance imaging (MRI) non-conditional cardiac implanted electronic device (CIED) can undergo state-of-the-art magnetic resonance imaging-guided focused (MRgFUS) ablation procedures with careful planning and integration of the procedure into an established CIED MRI practice. PATIENT AND METHODS: We describe an MRgFUS ablation treatment of lumbar facet joints in a patient with an MRI non-conditional CIED (pacemaker), completed in accordance with our institutional CIED/MRI practice guidelines. RESULTS: A risk-benefit analysis by a coordinated multidisciplinary team before this treatment was performed to account for the risks associated with the MRI non-conditional pacemaker in the context of the MRgFUS procedure. CONCLUSION: The patient had no adverse cardiac event during or following this procedure.

Prospective evaluation of the utility of magnetic resonance imaging in patients with non-MRI-conditional pacemakers and defibrillators.

BACKGROUND: Magnetic resonance imaging (MRI) in patients with legacy cardiovascular implantable electronic devices (CIEDs) in situ is likely underutilized. We hypothesized the clinical benefit of MRI would outweigh the risks in legacy CIED patients. METHODS: This is a single-center retrospective study that evaluated and classified the utility of MRI using a prospectively maintained database. The outcomes were classified as aiding in diagnosis, treatment, or both for the patients attributable to the MRI. We then assessed the incidence of adverse effects (AE) when the MRI was performed. RESULTS: In 668, MRIs performed on 479 patients, only 13 (1.9%) MRIs did not aid in the diagnosis or treatment of the patient. Power-on reset events without clinical sequelae in three scans (0.45%) were the only AE. The probability of an adverse event happening without any benefit from the MRI scan was 1.1 × 10-4 . A maximum benefit in diagnosis using MRI was obtained in ruling out space-occupying lesions (121/185 scans, 65.4%). Scans performed in patients for elucidating answers to queries in treatment were most frequently done for disease staging at long term follow-up (167/470 scans, 35.5%). Conservative treatment (184/470 scans, 39%) followed by medication changes (153/470 scans, 28.7%) were the most common treatment decisions made. CONCLUSIONS: The utility of MRI in patients with non-MRI-conditional CIEDs far outweighs the risk of adverse events when imaging is done in the context of a multidisciplinary program that oversees patient safety.

ACR guidance document on MR safe practices: Updates and critical information 2019.

The need for a guidance document on MR safe practices arose from a growing awareness of the MR environment's potential risks and adverse event reports involving patients, equipment, and personnel. Initially published in 2002, the American College of Radiology White Paper on MR Safety established de facto industry standards for safe and responsible practices in clinical and research MR environments. The most recent version addresses new sources of risk of adverse events, increases awareness of dynamic MR environments, and recommends that those responsible for MR medical director safety undergo annual MR safety training. With regular updates to these guidelines, the latest MR safety concerns can be accounted for to ensure a safer MR environment where dangers are minimized. Level of Evidence: 1 Technical Efficacy Stage: 5 J. Magn. Reson. Imaging 2020;51:331-338.

Image Artifact Management for Clinical Magnetic Resonance Imaging on a 7 T Scanner Using Single-Channel Radiofrequency Transmit Mode.

OBJECTIVES: The aim of this work was to devise mitigation strategies for addressing a range of image artifacts on a clinical 7 T magnetic resonance imaging scanner using the regulatory-approved single-channel radiofrequency transmit mode and vendor-supplied radiofrequency coils to facilitate clinical scanning within reasonable scan times. MATERIALS AND METHODS: Optimized imaging sequence protocols were developed for routine musculoskeletal knee and neurological imaging. Sources of severe image nonuniformities were identified, and mitigation strategies were devised. A range of custom-made high permittivity dielectric pads were used to compensate for B1 and B1 inhomogeneities, and also for magnetic susceptibility-induced signal dropouts particularly in the basal regions of the temporal lobes and in the cerebellum. RESULTS: Significant improvements in image uniformity were obtained using dielectric pads in the knee and brain. A combination of small voxels, reduced field of view B0 shimming, and high in-plane parallel imaging factors helped to minimize signal loss in areas of high susceptibility-induced field distortions. The high inherent signal-to-noise ratio at 7 T allowed for high receiver bandwidths and thin slices to minimize chemical shift artifacts. Intermittent artifacts due to radiofrequency inversion pulse limitations (power, bandwidth) were minimized with dielectric pads. A patient with 2 implanted metallic cranial fixation devices located within the radiofrequency transmit field was successfully imaged, with minimal image geometric distortions. CONCLUSIONS: Challenges relating to severe image artifacts at 7 T using single-channel radiofrequency transmit functionality in the knee and brain were overcome using the approaches described in this article. The resultant high diagnostic image quality paves the way for incorporation of this technology into the routine clinical workflow. Further developmental efforts are required to expand the range of applications to other anatomical areas, and to expand the evidence- and knowledge-base relating to the safety of scanning patients with implanted metallic devices.

Segmentation errors and intertest reliability in automated and manually traced hippocampal volumes.

OBJECTIVE: To rigorously compare automated atlas-based and manual tracing hippocampal segmentation for accuracy, repeatability, and clinical acceptability given a relevant range of imaging abnormalities in clinical epilepsy. METHODS: Forty-nine patients with hippocampal asymmetry were identified from our institutional radiology database, including two patients with significant anatomic deformations. Manual hippocampal tracing was performed by experienced technologists on 3T MPRAGE images, measuring hippocampal volume up to the tectal plate, excluding the hippocampal tail. The same images were processed using NeuroQuant and FreeSurfer software. Ten subjects underwent repeated manual hippocampal tracings by two additional technologists blinded to previous results to evaluate consistency. Ten patients with two clinical MRI studies had volume measurements repeated using NeuroQuant and FreeSurfer. RESULTS: FreeSurfer raw volumes were significantly lower than NeuroQuant (P < 0.001, right and left), and hippocampal asymmetry estimates were lower for both automatic methods than manual tracing (P < 0.0001). Differences remained significant after scaling volumes to age, gender, and scanner matched normative percentiles. Volume reproducibility was fair (0.4-0.59) for manual tracing, and excellent (>0.75) for both automated methods. Asymmetry index reproducibility was excellent (>0.75) for manual tracing and FreeSurfer segmentation and fair (0.4-0.59) for NeuroQuant segmentation. Both automatic segmentation methods failed on the two cases with anatomic deformations. Segmentation errors were visually identified in 25 NeuroQuant and 27 FreeSurfer segmentations, and nine (18%) NeuroQuant and six (12%) FreeSurfer errors were judged clinically significant. INTERPRETATION: Automated hippocampal volumes are more reproducible than hand-traced hippocampal volumes. However, these methods fail in some cases, and significant segmentation errors can occur.

Safety Considerations of 7-T MRI in Clinical Practice.

Although 7-T MRI has recently received approval for use in clinical patient care, there are distinct safety issues associated with this relatively high magnetic field. Forces on metallic implants and radiofrequency power deposition and heating are safety considerations at 7 T. Patient bioeffects such as vertigo, dizziness, false feelings of motion, nausea, nystagmus, magnetophosphenes, and electrogustatory effects are more common and potentially more pronounced at 7 T than at lower field strengths. Herein the authors review safety issues associated with 7-T MRI. The rationale for safety concerns at this field strength are discussed as well as potential approaches to mitigate risk to patients and health care professionals.

Safety of thoracic magnetic resonance imaging for patients with pacemakers and defibrillators.

BACKGROUND: During magnetic resonance imaging (MRI), cardiac implantable electronic device (CIED) leads can be antennae to focus energy onto myocardium, leading to heating and arrhythmias. Clinical data on thoracic MRI safety for patients with legacy devices are limited. OBJECTIVE: The purpose of this study was to identify patients undergoing thoracic MRI with legacy devices, compare the incidence of adverse events of those patients with control patients undergoing brain MRI with legacy devices, and compare paired cardiac troponin T (cTnT) values. METHODS: In this single-center study, we reviewed a prospectively collected database of patients with CIED undergoing MRI from January 25, 2008, through February 28, 2017. RESULTS: Of 952 patients (1290 scans), 120 patients (12.6%) underwent 134 thoracic MRI scans with legacy CIEDs (median [range] age 61.98 [21.24-86.96] years; male 71.1%). Median (range; interquartile range [IQR]) age of leads across devices was 3.5 (1.6-7.1; 5.5) years; implantable cardioverter-defibrillators (ICDs) were oldest (median [range; IQR], 3.7 [1.1-8.0; 6.9] years). No difference was observed in incidence of adverse events between groups. Paired cTnT values were compared for 19 patients (19 scans) with no difference between pre- and postimaging values. No significant difference was present in device setting values before and after MRI (mean follow-up 72.5 days). Incidence of adverse events was no different after adjustment for ICD coil number. CONCLUSION: Thoracic MRI is relatively safe in an institutional multidisciplinary program. It does not represent greater risk than brain MRI for patients with legacy CIEDs.

Patient-oriented education and visual-aid intervention are inadequate to identify patients with potential capsule retention: a prospective randomized study.

Background/aims: The key procedure-related risk with video capsule endoscopy (VCE) is capsule retention, which should be suspected in patients who have not reported capsule passage. The study aims were to determine the frequency of capsule passage visualization and the difference in self-reporting of capsule passage between patients who receive patient-oriented education (POE) and patients who receive POE and a visual aid intervention in the form of a wrist band (WB). Methods: This was a prospective randomized study that enrolled patients undergoing VCE. Patients were randomly assigned to a POE group versus a POE and WB group. POE consisted of verbal education and an information booklet. Both groups received instructions to notify the study team regarding capsule passage. Results: Sixty patients (mean age 57 ± 18 years; 61% female) were included. A total of 57 patients were included in the analysis (3 lost to follow-up; 28 in POE group; 29 in WB group). Capsule passage status was reported by 68% without significant difference between POE and WB groups (72% vs. 64%; p = .51). Capsule passage status was obtained from all 57 patients with the addition of a proactive follow-up. Only 56% (n = 32) reported visualizing capsule passage. Of the remaining patients who did not visualize capsule passage, 60% (n = 15) reported on this without significant difference between the POE and WB groups (p = .23). Conclusions: Lack of visualization of capsule passage is a poor indicator of retention. Self-reporting of VCE passage status is suboptimal and the addition of a visual aid did not improve this parameter.