Magnetic Resonance Institute for Safety, Technology and Research

ObjectiveThis study presents an extended evaluation of a numerical approach to simulate artifacts of metallic implants in an MR environment.MethodsThe 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.ResultsThe 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.ConclusionIn 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.

ObjectiveThis 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.MethodsThe 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.ResultsThe 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).ConclusionThis 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.

BackgroundTranscranial electric stimulation during MR imaging can introduce safety issues due to coupling of the RF field with the stimulation electrodes and leads. ObjectiveTo 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. MethodThe 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. ResultsThe antenna effect was found for copper leads at ¼ 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. ConclusionCoupling 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.

In the present article, interactions associated with magnetic resonance (MR) procedures and MR test procedures for implants/devices are examined. 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. 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. 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 aliability 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.

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. 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. 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. 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.

Radiotherapy (RT) treatment planning is based on computed tomography (CT) images and traditionally uses the conventional Hounsfield unit (CHU) range. This HU range is suited for human tissue but inappropriate for metallic materials. To guarantee safety of patient carrying implants precise HU quantification is beneficial for accurate dose calculations in planning software. Some modern CT systems offer an extended HU range (EHU). This study focuses the suitability of these two HU ranges for the quantification of metallic components of active implantable medical devices (AIMD). CT acquisitions of various metallic and non-metallic materials aligned in a water phantom were investigated. From our acquisitions we calculated that materials with mass-density ρ > 3.0 g/cm3 cannot be represented in the CHU range. For these materials the EHU range could be used for accurate HU quantification. Since the EHU range does not effect the HU values for materials ρ < 3.0 g/cm3, it can be used as a standard for RT treatment planning for patient with and without implants.

Abstract We report on the suitability of two different ranges of Hounsfield units (HU) in computed tomography (CT) for the quantification of metallic components of active implantable medical devices (AIMD). The conventional Hounsfield units (CHU) range, which is traditionally used in radiology, is well suited for tissue but suspected inappropriate for metallic materials. Precise HU values are notably beneficial in radiotherapy (RT) for accurate dose calculations, thus for the safety of patient carrying implants. Some of today’s CT machines offers an extended Hounsfield units (EHU) range. This study presents CT acquisitions of a water phantom containing various metallic discs and an implantable-cardioverter defibrillator (IPG). We show that the comparison of HU values at EHU and CHU ranges clearly reveals the superiority and accuracy of EHU. Some geometrical discrepancies perpendicular to slices are observed. At EHU metal artifact reduction algorithms (MAR) underestimates HU values rendering MAR potentially inappropriate for RT.

To examine radiofrequency-induced tissue heating around intracranial aneurysm clips during a 7 Tesla (T) head MR examination. 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. 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. 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.

At 64 and 127 MHz for eight electrode leads with an insulation diameter of 1.46 mm, we evaluated the dependence of RF-induced power (p) generated by a plane wave incident field at electrodes on: distance between leads, electrical properties of surrounding media. At both frequencies and for all investigated surrounding media three cases were observed: p remained practically unaffected due to presence of the second lead, p was reduced up to 90%, p was increased by as much as 3.