Joint British Society consensus recommendations for magnetic resonance imaging for patients with cardiac implantable electronic devices

Magnetic Resonance Imaging (MRI) is increasingly a fundamental component of the diagnostic pathway across a range of conditions. Historically, the presence of a cardiac implantable electronic device (CIED) has been a contraindication for MRI, however, development of MR Conditional devices that can be scanned under strict protocols has facilitated the provision of MRI for patients. Additionally, there is growing safety data to support MR scanning in patients with CIEDs that do not have MR safety labelling or with MR Conditional CIEDs where certain conditions are not met, where the clinical justification is robust. This means that almost all patients with cardiac devices should now have the same access to MRI scanning in the National Health Service as the general population. Provision of MRI to patients with CIED, however, remains limited in the UK, with only half of units accepting scan requests even for patients with MR Conditional CIEDs. Service delivery requires specialist equipment and robust protocols to ensure patient safety and facilitate workflows, meanwhile demanding collaboration between healthcare professionals across many disciplines. This document provides consensus recommendations from across the relevant stakeholder professional bodies and patient groups to encourage provision of safe MRI for patients with CIEDs

COMPUTER MODELING AND SIMULATION OF IMPLANTABLE MEDICAL DEVICE HEATING DUE TO MRI GRADIENT COIL FIELDS

For patients with implantable medical devices, the ability to safely undergo MRI scanning is critical to ensuring the highest standard of care. The gradient coils of an MRI generate kilohertz frequency, time varying magnetic fields. These magnetic fields induce a voltage on the external case of metallic, implantable medical devices through electromagnetic induction. Since the magnetic field generated by a gradient coil is time varying, the induced voltage results in the flow of eddy currents which can cause heating effects. These heating effects have been successfully modeled using ANSYS Maxwell and ANSYS Mechanical software packages. The multi-physics simulation and solution used ANSYS Maxwell for electromagnetic field simulation and ANSYS Mechanical for the transient thermal simulation while utilizing ANSYS Workbench to integrate the models. To validate the model, simulations and physical testing were completed on a number of samples that varied in size and material. The model was then used to simulate the impact of implant size (both radius and thickness) on MRI gradient induced heating. These results can be used to support MRI safety assessments and design choices for a range of implantable medical devices. The current regulatory landscape requires extensive safety testing that is often expensive and time consuming. While the complicated question of medical device heating due MRI gradient coil fields remains open, computer simulation is now a proven tool that can provide easier and more thorough analysis for future evaluations

Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator Primary Results of a Randomized Study

AbstractBackgroundMagnetic resonance imaging (MRI) of patients with conventional implantable cardioverter-defibrillators (ICD) is contraindicated.ObjectivesThis multicenter, randomized trial evaluated safety and efficacy of a novel ICD system specially designed for full-body MRI without restrictions on heart rate or pacing dependency. The primary safety objective was >90% freedom from MRI-related events composite endpoint within 30 days post-MRI. The primary efficacy endpoints were ventricular pacing capture threshold and ventricular sensing amplitude.MethodsSubjects received either a single- or dual-chamber ICD. In a 2:1 randomization, subjects either underwent MRI at 1.5-T of the chest, cervical, and head regions to maximize radiofrequency exposure up to 2 W/kg specific absorption rate and gradient field exposure to 200 T/m/s per axis (MRI group, n = 175), or they underwent a 1-h waiting period without MRI (control group, n = 88). A subset of MRI patients underwent ventricular fibrillation induction testing post-MRI to characterize defibrillation function.ResultsIn 42 centers, 275 patients were enrolled (76% male, age 60.4 ± 13.8 years). The safety endpoint was met with 100% freedom from the composite endpoint (p < 0.0001). Both efficacy endpoints were met with minimal differences in the proportion of MRI and control patients who demonstrated a ≤0.5 V increase in ventricular pacing capture threshold (100% MRI vs. 98.8% control, noninferiority p < 0.0001) or a ≤50% decrease in R-wave amplitude (99.3% MRI vs. 98.8% control, noninferiority p = 0.0001). A total of 34 ventricular tachyarrhythmia/ventricular fibrillation episodes (20 induced; 14 spontaneous) occurred in 24 subjects post-MRI, with no observed effect on sensing, detection, or treatment.ConclusionsThis is the first randomized clinical study of an ICD system designed for full-body MRI at 1.5-T. These data support that the system is safe and the MRI scan does not adversely affect electrical performance or efficacy. (Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access; NCT02117414

Analysis of Metallic Shielding for Reduction of RF Induced Heating of Electrode During MRI for Active Implants

The options available to patients with implantable devices are limited. It is because there are multiple interactions between the MRI environment and the implantable medical devices. The three main components of MRI systems- static magnet, RF coil, and a gradient coil- interact with the implantable medical devices. These interactions can cause force, torque, device vibrations and RF-induced heating. Among all these potential hazards is the heating caused by the RF electromagnetic field. The lead wires of the implants can act as antennas and pick up the electric field generated by the RF coil. This results in the induced current traveling along the length of the device that will dissipate as heat where it is coupled to tissue. The combination of critically sensitive tissues and high heat makes this interaction the most significant risk for patient safety. Hence, there arises a need to design effective techniques that can minimize RF heating induced during an MRI. The technique of shielding has been proven to reduce RF-induced heating. The focus of current research is to provide analysis of shielding technique for reduction of RF-induced heating of electrodes during MRI. Shielded leads have been developed as a method to reduce RF-heating responsible for temperature rise at the electrodes. The purpose of this work is to provide a quantitative understanding of how a conducting metallic shield over a lead will reduce RF heating at the electrode during MRI scans. A physical model and equations for reduction of RF heating by a shielded lead are presented. Temperature rises are calculated for different lengths of shielded and unshielded leads. Confirming measurements are made for a quarter-wavelength coaxial cable model of the lead. Measured temperature rise and transfer function depended on terminations conditions, with the shorted lead exhibiting the temperature rise sixteen times less than an open-ended lead. The information provided by this work is expected to facilitate the development of lead wires with reduced RF-induced heating. The availability of lead wires with reduced heating will allow expanded access to MRI by patients with implantable devices

Investigating the mechanism of action of Deep Brain Stimulation using functional magnetic resonance imaging

Depleted of dopamine, the dynamics of the Parkinsonian brain impact on both “action” and “resting” motor behaviour. Subthalamic nucleus deep brain stimulation (STN DBS) has become an established means of managing these symptoms, although its mechanisms of action remain unclear. Functional magnetic resonance imaging (fMRI) using the blood oxygen level dependent (BOLD) contrast provides the opportunity to study the human brain in vivo, collecting indirect measures of neural activity across the whole brain. To date, technical difficulties and safety concerns have precluded the use of fMRI in DBS patients. Previous work from this department has demonstrated that scanning patients with certain DBS systems and MRI equipment is both safe and feasible. This thesis explores the neuromodulatory actions of STN DBS on both action and resting motor behaviours in patients with Parkinson’s disease (PD) using fMRI. In brief, I present two fMRI studies conducted on STN DBS patients, one task-based, and one resting, collected under a previously approved protocol. I then present experiments exploring the safety of scanning DBS patients using an improved protocol, and then detail two further experiments collected under this new protocol, again one task-based, and one resting. Specifically, I employ statistical parametric mapping to determine DBS-induced changes in motor evoked responses. Using dynamic causal modelling (DCM) and Bayesian model selection, I compare generative models of cortico-subcortical interactions to explain the observed data, inferring which connections DBS may be affecting, and which modulations predict efficacy. I proceed to use stochastic DCM to model the modulatory effects of DBS on endogenous (resting-state) dynamics. Abstract | 4 4 This work casts DBS in terms of modulating effective connectivity within the cortico-basal ganglia motor loops. I discuss how this may explain its current usage in PD, as well as exploratory uses to treat other pathological brain states

MRI compatible lead designs for implantable medical devices

Ankara : The Department of Electrical and Electronics Engineering and the Institute of Engineering and Science of Bilkent University, 2007.Thesis (Master's) -- Bilkent University, 2007.Includes bibliographical references leaves 70-71.It is currently estimated that 600,000 cardiac pacemakers are implanted per year worldwide. It is expected that the usage of other stimulators such as deep brain stimulators (DBS) will reach this number in a short period. On the other hand, 2,000,000 MRI examinations are carried out each year worldwide and usage of MRI is expected to increase. Unfortunately, people with metallic implants have significant risks in the MRI scanners. It is known that radio frequency and gradient fields of the MRI scanners may induce harmful currents on the implant leads. Radio frequency pulses may cause excessive heating and burns. In addition to this, time-varying gradient magnetic field induced currents on the leads can cause nerve stimulation. In case of cardiac pacemakers, this nerve stimulation may cause cardiac arrest. In this thesis, novel MRI compatible lead designs were proposed. Lead designs are presented to ensure safe magnetic resonance scanning of patients with active metallic implants such as pacemakers, neurostimulators, and implantable cardio defibrillators. Semiconductor components such as transistors and diodes are used to prevent these undesired induced currents on the implant leads. Circuits on the implants are designed such that while the induction of currents is prevented, the desired signal transmission in between the implanted pulse generator and the body part is maintained. The designs were tested by using experiments and computer stimulation. It was seen that the new techniques are effective in making MRI safe implantable devices. Benefits and problems of each design will be discussed in this text. It is believed that using this or similar techniques, patients with the implants will be able to be examined safely in MRI scanners.Ermeydan, AhmetM.S

Safety of Simultaneous Scalp and Intracranial Electroencephalography Functional Magnetic Resonance Imaging

Understanding the brain and its activity is one of the great challenges of modern science. Normal brain activity (cognitive processes, etc.) has been extensively studied using electroencephalography (EEG) since the 1930’s, in the form of spontaneous fluctuations in rhythms, and patterns, and in a more experimentally-driven approach in the form of event-related potentials allowing us to relate scalp voltage waveforms to brain states and behaviour. The use of EEG recorded during functional magnetic resonance imaging (EEG-fMRI) is a more recent development that has become an important tool in clinical neuroscience, for example, for the study of epileptic activity. The primary aim of this thesis is to devise a protocol in order to minimise the health risks that are associated with simultaneous scalp and intracranial EEG during fMRI (S- icEEG-fMRI). The advances in this technique will be helpful in presenting a new imaging method that will allow the measurement of brain activity with unprecedented sensitivity and coverage. However, this cannot be achieved without assessing the safety implications of such a technique. Therefore, five experiments were performed to fulfil the primary aim. First, the safety of icEEG- fMRI using body transmit RF coil was investigated to improve the results of previous attempts using a head transmit coil at 1.5T. The results of heating increases during a high-SAR sequence were in the range of 0.2-2.4 °C at the contacts with leads positioned along the central axis inside the MRI bore. These findings suggest the need for careful lead placement. Second, also for the body transmit coil we compared the heating in the vicinity of icEEG electrodes placed inside a realistically-shaped head phantom following the addition of scalp EEG electrodes. The peak temperature change was +2.7 °C at the most superior icEEG electrode contact without scalp electrodes, and +2.1 °C at the same contact and the peak increase in the vicinity of a scalp electrode contact was +0.6 °C (location FP2). These findings show that the S-icEEG-fMRI technique is feasible if our protocol is followed carefully. Third, the heating of a realistic 3D model of icEEG electrode during MRI using EM computational simulation was investigated. The resulting peak 10 g averaged SAR was 20% higher than without icEEG. Moreover, the superior icEEG placed perpendicular to B0 showed significant local SAR increase. These results were in line with previous studies. Fourth, the possibility of simplifying a complete 8-contact with 8 wires depth icEEG electrode model into an electrode with 1-contact and 1 wire using EM simulations was addressed. The results showed similar patterns of averaged SAR values around the electrode tip during phantom and electrode position along Z for the Complete and Simplified models, except an average maximum at Z = ~2.5 W/kg for the former. The SAR values during insertion depth for the Simplified model were double those for the Complete model. The effect of extension cable length is in agreement with previous experiments. Fifth, further simulations were implemented using two more simplified models: 8-contact with 1 wire shared with all contact and 8-contact 1 wire connected to each contact at a time as well as the previously modelled simplified 1-contact 1 wire. Two sets of simulations were performed: with a single electrode and with multiple electrodes. For the single electrode, three scenarios were tested: the first simplified model used only, the second simplified models used only and the third model positioned in different 13 locations. The results of these simulations showed about 11.4-20.5-fold lower SAR for the first model than the second and 0.29-5.82-fold lower SAR for the first model than the complete model. The results also showed increased SAR for the electrode close to the head coil than the ones away from it. For the multiple electrodes, three scenarios were tested: two 1-contact and wire electrodes in different separations, multiple electrodes with their wires separated and multiple electrodes with their wires shorted. The results showed interaction between the two tested electrodes. The results of the multiple electrodes presented 2 to ~10 times higher SAR for the separated setup than the shorted. The comparison between the 1-contact with 1 wire model and the complete model is still unknown and more tests are required to show it. From the findings of this PhD research, we conclude that a body RF coil can be utilized for icEEG-fMRI at 1.5 T; however, the safety protocol has to be implemented. In addition, scalp EEG can be used in conjunction with icEEG electrodes inside the body RF coil at 1.5 T and the safety protocol has to be followed. Finally, it is feasible to perform EM computational simulations using realistic icEEG electrodes on a human model. However, simplifying the realistic icEEG electrode model might result in overestimations of the heating, although it is possible that the simplification of the model can help to simulate more complex implantations such as the implantation of multiple electrodes with their leads open circuited or short circuited, which can provide more information about the safety of implanted patients inside the MRI

Safety of Simultaneous Scalp or Intracranial EEG during MRI: A Review

Understanding the brain and its activity is one of the great challenges of modern science. Normal brain activity (cognitive processes, etc.) has been extensively studied using electroencephalography (EEG) since the 1930's, in the form of spontaneous fluctuations in rhythms, and patterns, and in a more experimentally-driven approach in the form of event-related potentials (ERPs) allowing us to relate scalp voltage waveforms to brain states and behavior. The use of EEG recorded during functional magnetic resonance imaging (EEG-fMRI) is a more recent development that has become an important tool in clinical neuroscience, for example for the study of epileptic activity. The purpose of this review is to explore the magnetic resonance imaging safety aspects specifically associated with the use of scalp EEG and other brain-implanted electrodes such as intracranial EEG electrodes when they are subjected to the MRI environment. We provide a theoretical overview of the mechanisms at play specifically associated with the presence of EEG equipment connected to the subject in the MR environment, and of the resulting health hazards. This is followed by a survey of the literature on the safety of scalp or invasive EEG-fMRI data acquisitions across field strengths, with emphasis on the practical implications for the safe application of the techniques; in particular, we attempt to summarize the findings in terms of acquisition protocols when possible

Comprehensive analysis of Lenz effect on the artificial heart valves during magnetic resonance imaging

This work presents results of a comprehensive analysis of the Lenz effect due to motion of artificial heart valves during magnetic resonance imaging. The interaction of rotating metallic heart valves with magnetic fields is studied by performing a time-domain analysis of the corresponding electromagnetic problem. We applied the finite element method (FEM) to solve the T - Omega formulation of Maxwell equations in two cases: first, for metallic disks located in the high intensity homogenous field of the magnet iso-center, and second, disks located in the non-uniform fringe field of the bore entrance. We showed that for valves with full solid disks (such as Starr-Edwards 6500) located in the magnet iso-center, the magnitude of adverse forces can be comparable to the forces applied by the beating heart. However, for rings which consist of multiply connected conductive regions, skin effect and proximity effect counteract, which leads to a diminished magnetic force. Results of this study show that mechanical heart valves with strengthening rings may be considered safe even under ultra-high imaging conditions with field intensities as high as 10 T. However, heart valves with full conducting disks should be considered as a contraindication to MR imaging