Numerical approach to investigate MR imaging artifacts from orthopedic implants at different field strengths according to ASTM F2119.

OBJECTIVE: This study presents an extended evaluation of a numerical approach to simulate artifacts of metallic implants in an MR environment. METHODS: The numerical approach is validated by comparing the artifact shape of the simulations and measurements of two metallic orthopedic implants at three different field strengths (1.5 T, 3 T, and 7 T). Furthermore, this study presents three additional use cases of the numerical simulation. The first one shows how numerical simulations can improve the artifact size evaluation according to ASTM F2119. The second use case quantifies the influence of different imaging parameters (TE and bandwidth) on the artifact size. Finally, the third use case shows the potential of performing human model artifact simulations. RESULTS: The numerical simulation approach shows a dice similarity coefficient of 0.74 between simulated and measured artifact sizes of metallic implants. The alternative artifact size calculation method presented in this study shows that the artifact size of the ASTM-based method is up to 50% smaller for complex shaped implants compared to the numerical-based approach. CONCLUSION: In conclusion, the numerical approach could be used in the future to extend MR safety testing according to a revision of the ASTM F2119 standard and for design optimization during the development process of implants.

Development and evaluation of a numerical simulation approach to predict metal artifacts from passive implants in MRI.

OBJECTIVE: This study presents the development and evaluation of a numerical approach to simulate artifacts of metallic implants in an MR environment that can be applied to improve the testing procedure for MR image artifacts in medical implants according to ASTM F2119. METHODS: The numerical approach is validated by comparing simulations and measurements of two metallic test objects made of titanium and stainless steel at three different field strengths (1.5T, 3T and 7T). The difference in artifact size and shape between the simulated and measured artifacts were evaluated. A trend analysis of the artifact sizes in relation to the field strength was performed. RESULTS: The numerical simulation approach shows high similarity (between 75% and 84%) of simulated and measured artifact sizes of metallic implants. Simulated and measured artifact sizes in relation to the field strength resulted in a calculation guideline to determine and predict the artifact size at one field strength (e.g., 3T or 7T) based on a measurement that was obtained at another field strength only (e.g. 1.5T). CONCLUSION: This work presents a novel tool to improve the MR image artifact testing procedure of passive medical implants. With the help of this tool detailed artifact investigations can be performed, which would otherwise only be possible with substantial measurement effort on different MRI systems and field strengths.

Safety evaluation of a new setup for transcranial electric stimulation during magnetic resonance imaging.

BACKGROUND: Transcranial electric stimulation during MR imaging can introduce safety issues due to coupling of the RF field with the stimulation electrodes and leads. OBJECTIVE: To optimize the stimulation setup for MR current density imaging (MRCDI) and increase maximum stimulation current, a new low-conductivity (σ = 29.4 S/m) lead wire is designed and tested. METHOD: The antenna effect was simulated to investigate the effect of lead conductivity. Subsequently, specific absorption rate (SAR) simulations for realistic lead configurations with low-conductivity leads and two electrode types were performed at 128 MHz and 298 MHz being the Larmor frequencies of protons at 3T and 7T. Temperature measurements were performed during MRI using high power deposition sequences to ensure that the electrodes comply with MRI temperature regulations. RESULTS: The antenna effect was found for copper leads at » RF wavelength and could be reliably eliminated using low-conductivity leads. Realistic lead configurations increased the head SAR and the local head SAR at the electrodes only minimally. The highest temperatures were measured on the rings of center-surround electrodes, while circular electrodes showed little heating. No temperature increase above the safety limit of 39 °C was observed. CONCLUSION: Coupling to the RF field can be reliably prevented by low-conductivity leads, enabling cable paths optimal for MRCDI. Compared to commercial copper leads with safety resistors, the low-conductivity leads had lower total impedance, enabling the application of higher currents without changing stimulator design. Attention must be paid to electrode pads.

[Test methods to determine magnetic resonance (MR) safety and MR image compatibility of implants/devices]. / Prüfverfahren für die magnetresonanztomographische (MR)-Sicherheit und MR-Bildkompatibilität von Implantaten/Geräten.

METHODICAL INNOVATIONS: In the present article, interactions associated with magnetic resonance (MR) procedures and MR test procedures for implants/devices are examined. PERFORMANCE: Since 2012, many interactions of items with MR procedures have been physically described and translated into standardized ASTM and ISO testing procedures. Despite the standardized procedures, the determination of the test method to use is an important decision. The MR user is also responsible for the transfer and interpretation of the individual technical parameters despite the MR Conditional labelling and therefore relatively unambiguous instruction. This includes the total MR examination duration, which often has no clinical practical duration, but is derived from the 15 min of the ASTM radiofrequency (RF) heating test. ACHIEVEMENTS: There has been an increasing standardization of the test methods as well as the MR labeling requirements and the advantageous transfer of the parameters to suitable input masks on the MR systems. PRACTICAL RECOMMENDATIONS: The current use of standardized MR test methods and MR marking represents the best possible state of the art from the point of view of the approval of medical devices as well as from a liability point of view for the manufacturers of implants-and for MR users in clinical practice. However, off-label decisions (i.e., deviations from the manufacturer's official MR marking) in everyday clinical practice can be medically justified.

Radiofrequency induced heating around aneurysm clips using a generic birdcage head coil at 7 Tesla under consideration of the minimum distance to decouple multiple aneurysm clips.

PURPOSE: To evaluate radiofrequency (RF) induced tissue heating around aneurysm clips during a 7T head MR examination and to determine the decoupling distance between multiple implanted clips. METHODS: A total of 120 RF exposure scenarios of clinical relevance were studied using specific absorption rate and temperature simulations. Variations between scenarios included 2 clips (18.8 and 51.5 mm length), 2 MR-operating modes, 2 head models, and 3 thermoregulation models. Furthermore, a conservative approach was developed to allow for safe scans of patients with aneurysm clips even if detailed information on the implanted clip is unknown. A dedicated simulation-based approach was applied to determine the decoupling distance between multiple implanted clips. RESULTS: For all 60 clinical scenarios with the 18.8-mm-long clip, the absolute tissue temperature remained below regulatory limits. For 15 of 60 scenarios with the 51.5-mm-long clip, limits were slightly exceeded (less than 1°C). The conservative approach led to a maximum time-averaged input power of the RF coil of 3.3W. The corresponding B1+ is 1.32 µT. A decoupling distance of 35 mm allows the aneurysm clips to be treated as uncoupled from one other. CONCLUSION: Safe scanning conditions with respect to RF-induced heating can be applied for single or decoupled aneurysm clips in a 7T ultra-high field MRI setting. Multiple aneurysm clips separated by less than 35 mm need further investigations.

In vitro and in silico assessment of RF-induced heating around intracranial aneurysm clips at 7 Tesla.

PURPOSE: To examine radiofrequency-induced tissue heating around intracranial aneurysm clips during a 7 Tesla (T) head MR examination. METHODS: Radiofrequency (RF), temperature simulations, and RF measurements were employed to investigate the effects of polarization and clip length on the electric field (E-field) and temperature. Heating in body models was studied using both a conservative approach and realistic exposure scenarios. RESULTS: Worst-case orientation was found for clips aligned parallel to the E-field polarization. Absolute tissue temperature remained below International Electrotechnical Commission regulatory limits for 44 of 50 clinical scenarios. No significant effect on heating was determined for clip lengths below 18.8 mm, and worst-case heating was found for clip length 51.5 mm. The conservative approach led to a maximum permissible E-field of 72 V/m corresponding to B1+ of 1.2 µT, and an accepted power of 4.6 W for the considered RF head coil instead of 38.5 W without clip. CONCLUSION: Safe scanning conditions with respect to RF-induced heating can be applied depending on the information about the clip gained during screening interviews. However, force and torque measurements in the MR system shall be conducted to give a final statement on the MR safety of aneurysm clips at 7T. Magn Reson Med 79:568-581, 2018. © 2017 International Society for Magnetic Resonance in Medicine.

Variation of radio frequency induced power deposition due to second surrounding tissue.

We investigated RF-induced power deposition (p) generated by insulated leads with different lengths located in proximity to two tissues. The first tissue surrounding the leads was shaped as a cylinder with a diameter of 11 mm and located in a very large box filled with the second tissue. Lead electromagnetic models and p substantially depended on electrical properties of both tissues. If the cylinder and the box were filled with the same tissue, discrepancy to results of the two-tissue setup was up to 280%.

Radio frequency induced heating of an insulated wire during magnetic resonance imaging.

Radio frequency (RF) induced power deposition near straight insulated leads excited by different incident electrical field profiles was investigated. 3-D electromagnetic (EM) simulations were used to obtain implant models as well as RF-induced power depositions calculated as the integral of power loss density. For the investigated setups up to 400% discrepancy between the implant model predictions and EM simulation values was observed.

Experience with magnetic resonance imaging of human subjects with passive implants and tattoos at 7 T: a retrospective study.

OBJECT: Over the last decade, the number of clinical MRI studies at 7 T has increased dramatically. Since only limited information about the safety of implants/tattoos is available at 7 T, many centers either conservatively exclude all subjects with implants/tattoos or have started to perform dedicated tests for selected implants. This work presents our experience in imaging volunteers with implants/tattoos at 7 T over the last seven and a half years. MATERIALS AND METHODS: 1796 questionnaires were analyzed retrospectively to identify subjects with implants/tattoos imaged at 7 T. For a total of 230 subjects, the type of local transmit/receive RF coil used for examination, imaging sequences, acquisition time, and the type of implants/tattoos and their location with respect to the field of view were documented. These subjects had undergone examination after careful consideration by an internal safety panel consisting of three experts in MR safety and physics. RESULTS: None of the subjects reported sensations of heat or force before, during, or after the examination. None expressed any discomfort related to implants/tattoos. Artifacts were reported in 52% of subjects with dental implants; all artifacts were restricted to the mouth area and did not affect image quality in the brain parenchyma. CONCLUSION: Our initial experience at 7 T indicates that a strict rejection of subjects with tattoos and/or implants is not justified. Imaging can be conditionally performed in carefully selected subjects after collection of substantial safety information and evaluation of the detailed exposure scenario (RF coil/type and position of implant). Among the assessed subjects with tattoos, no side effects from the exposure to 7 T MRI were reported.

A phantom and animal study of temperature changes during fMRI with intracerebral depth electrodes.

BACKGROUND: MRI is routinely used in patients undergoing intracerebral electroencephalography (icEEG) in order to precisely locate the position of intracerebral electrodes. In contrast, fMRI has been considered unsafe due to suspected greater risk of radiofrequency-induced (RF) tissue heating at the vicinity of intracerebral electrodes. We determined the possible temperature change at the tip of such electrodes during fMRI sessions in phantom and animals. METHODS: A human-shaped torso phantom and MRI-compatible intracerebral electrodes approved for icEEG in humans were used to mimic a patient with four intracerebral electrodes (one parasagittal and three coronal). Six rabbits were implanted with one or two coronal electrodes. MRI-induced temperature changes at the tip of electrodes were measured using a fibre-optic thermometer. All experiments were performed on Siemens Sonata 1.5T scanner. RESULTS: For coronally implanted electrodes with wires pulled posteriorly to the magnetic bore, temperature increase recorded during EPI sequences reached a maximum of 0.6°C and 0.9°C in phantom and animals, respectively. These maximal figures were decreased to 0.2°C and 0.5°C, when electrode wires were connected to cables and amplifier. When electrode wires were pulled anteriorly to the magnetic bore, temperature increased up to 1.3°C in both phantom and animals. Greater temperature increases were recorded for the single electrode implanted parasagitally in the phantom. CONCLUSION: Variation of the temperature depends on the electrode and wire position relative to the transmit body coil and orientation of the constant magnetic field (B0). EPI sequence with intracerebral electrodes appears as safe as standard T1 and T2 sequence for implanted electrodes placed perpendicular to the z-axis of the magnetic bore, using a 1.5T MRI system, with the free-end wires moving posteriorly, in phantom and animals.

Testing methods for MR safety and compatibility of medical devices.

Magnetic resonance (MR) safety and image compatibility are important issues when using medical devices in the environment of magnetic resonance imaging (MRI). MR testing of medical devices is required for device approval by the FDA and the EU notified bodies. Testing methods have been established for basic issues and were published as first ASTM International standards (formerly ASTM, the American Society of Testing and Materials). Moreover, individual safety concerns such as the safe functioning of the device and the MR system are a necessity for medical devices within an MR environment. Standardized tests increase the safety of the patient and support both the MR user and the device manufacturers. This paper describes the state of the art of MR testing methods and requirements for medical devices.