Radiofrequency-induced heating of broken and abandoned implant leads during magnetic resonance examinations.

PURPOSE: The risks of RF-induced heating of active implantable medical device (AIMD) leads during MR examinations must be well understood and realistically assessed. In this study, we evaluate the potential additional risks of broken and abandoned (cut) leads. METHODS: First, we defined a generic AIMD with a metallic implantable pulse generator (IPG) and a 100-cm long lead containing 1 or 2 wires. Next, we numerically estimated the deposited in vitro lead-tip power for an intact lead, as well as with wire breaks placed at 10 cm intervals. We studied the effect of the break size (wire gap width), as well as the presence of an intact wire parallel to the broken wire, and experimentally validated the numeric results for the configurations with maximum deposited in vitro lead-tip power. Finally, we performed a Tier 3 assessment of the deposited in vivo lead-tip power for the intact and broken lead in 4 high resolution virtual population anatomic models for over 54,000 MR examination scenarios. RESULTS: The enhancement of the deposited lead-tip power for the broken leads, compared to the intact lead, reached 30-fold in isoelectric exposure, and 16-fold in realistic clinical exposures. The presence of a nearby intact wire, or even a nearby broken wire, reduced this enhancement factor to <7-fold over the intact lead. CONCLUSION: Broken and abandoned leads can pose increased risk of RF-induced lead-tip heating to patients undergoing MR examinations. The potential enhancement of deposited in vivo lead-tip power depends on location and type of the wire break, lead design, and clinical routing of the lead, and should be carefully considered when performing risk assessment for MR examinations and MR conditional labeling.

Efficient and Reliable Assessment of the Maximum Local Tissue Temperature Increase at the Electrodes of Medical Implants under MRI Exposure.

Standard risk evaluations posed by medical implants during magnetic resonance imaging (MRI) includes (i) the assessment of the total local electromagnetic (EM) power (P) absorbed in the vicinity of the electrodes and (ii) the translation of P into a local in vivo tissue temperature increase ∆T (P2∆T) in animal experiments or simulations. We investigated the implant/tissue modeling requirements and associated uncertainties by applying full-wave EM and linear bioheat solvers to different implant models, incident field conditions, electrode configurations, and tissue models. Results show that the magnitude of the power is predominately determined by the lead, while the power distribution, and the P2∆T conversion, is determined by the electrode and surrounding tissues. P2∆T is strongly dependent on the size of the electrode, tissue type in contact with the electrode, and tissue inhomogeneity (factor of >2 each) but less on the modeling of the lead (<±10%) and incident field distribution along the lead (<±20%). This was confirmed by means of full-wave simulations performed with detailed high-resolution anatomical phantoms exposed to two commonly used MRI clinical scenarios (64 and 128 MHz), resulting in differences of less than 6%. For the determination of P2∆T, only the electrode and surrounding tissues must be modeled in great detail, whereas the lead can be modeled as a computationally efficient simplified structure exposed to a uniform field. The separate assessments of lead and electrode reduce the overall computational effort by several orders of magnitude. The errors introduced by this simplification can be considered by uncertainty terms. Bioelectromagnetics. 2019;40:422-433. © 2019 Bioelectromagnetics Society.

Anatomical Model Uncertainty for RF Safety Evaluation of Metallic Implants Under MRI Exposure.

The Virtual Population (ViP) phantoms have been used in many dosimetry studies, yet, to date, anatomical phantom uncertainty in radiofrequency (RF) research has largely been neglected. The objective of this study is to gain insight, for the first time, regarding the uncertainty in RF-induced fields during magnetic resonance imaging associated with tissue assignment and segmentation quality and consistency in anatomical phantoms by evaluating the differences between two generations of ViP phantoms, ViP1.x and ViP3.0. The RF-induced 10g-average electric (E-) fields, tangential E-fields distribution along active implantable medical devices (AIMD) routings, and estimated AIMD heating were compared for five phantoms that are part of both ViP1.x and ViP3.0. The results demonstrated that differences exceeded 3 dB (-29%, +41%) for local quantities and 1 dB (±12% for field, ±25% for power) for integrated and volume-averaged quantities (e.g., estimated AIMD-heating and 10 g-average E-fields), while the variation across different ViP phantoms of the same generation can exceed 10 dB (-68% and +217% for field, -90% and +900% for power). In conclusion, the anatomical phantom uncertainty associated with tissue assignment and segmentation quality/consistency is larger than previously assumed, i.e., 0.6 dB or ±15% (k = 1) for AIMD heating. Further, multiple phantoms based on different volunteers covering the target population are required for quantitative analysis of dosimetric endpoints, e.g., AIMD heating, which depend on patient anatomy. Phantoms with the highest fidelity in tissue assignment and segmentation should be used, as these ensure the lowest uncertainty and possible underestimation of exposure. To verify that the uncertainty decreases monotonically with improved phantom quality, the evaluation of differences between phantom generations should be repeated for any improvement in segmentation. Bioelectromagnetics. 2019;40:458-471. © 2019 Bioelectromagnetics Society.

Impact of MRI RF coil design on the RF-induced heating of medical implants: fixedB1+rmsexposure versus normal operating mode.

A direct comparison of the impact of RF coil design under specific absorption rate andB1+rmslimitations are investigated and quantified using RF coils of different geometries and topologies at 64 MHz and 128 MHz. The RF-inducedin vivoelectric field and power deposition of a 50 cm long pacemaker and 55 cm long deep brain stimulator (DBS) are evaluated within two anatomical models exposed with these RF coils. The associated uncertainty is quantified and analyzed under a fixedB1+rmsincident and normal operating mode. For a fixedB1+rmsincident, thein vivoincident field shows a much higher uncertainty (>5.6 dB) to the RF coil diameter compared to other design parameters (e.g. <2.2 dB for coil length and topology), while the associated uncertainty reduced greatly (e.g. <1.5 dB) under normal operating mode exposure. Similar uncertainties are observed in the power deposition near the pacemaker and DBS electrode. Compared to the normal operating mode, applying a fixedB1+rmsfield to the untested implant will lead to a large variation in the induced incident and power deposition of the implant, as a result, a larger safe margin when different coil designs (e.g. coil diameter) are considered.

A machine learning-based approach for RF transfer function modeling of active implantable medical electrodes at 3T MRI.

Objective.The objective of this work is to propose a machine learning-based approach to rapidly and efficiently model the radiofrequency (RF) transfer function of active implantable medical (AIM) electrodes, and to overcome the limitations and drawbacks of traditional measurement methods when applied to heterogeneous tissue environments.Approach.AIM electrodes with different geometries and proximate tissue distributions were considered, and their RF transfer functions were modeled numerically. Machine learning algorithms were developed and trained with the simulated transfer function datasets for homogeneous and heterogeneous tissue distributions. The performance of the method was analyzed statistically and validated experimentally and numerically. A comprehensive uncertainty analysis was performed and uncertainty budgets were derived.Main results.The proposed method is able to predict the RF transfer function of AIM electrodes under different tissue distributions, with mean correlation coefficientsrof 0.99 and 0.98 for homogeneous and heterogeneous environments, respectively. The results were successfully validated by experimental measurements (e.g. the uncertainty of less than 0.9 dB) and numerical simulation (e.g. transfer function uncertainty <1.6 dB and power deposition uncertainty <1.9 dB). Up to 1.3 dBin vivopower deposition underestimation was observed near generic pacemakers when using a simplified homogeneous tissue model.Significance.Provide an efficient alternative of transfer function modeling, which allows a more realistic tissue distribution and the potential underestimation ofin vivoRF-induced power deposition near the AIM electrode can be reduced.

Shear wave dispersion ultrasound vibrometry based on a different mechanical model for soft tissue characterization.

Ultrasound vibrometry can measure the propagation velocity of shear waves in soft tissue noninvasively, and the shear moduli of tissue can be estimated inversely from the velocities at multiple frequencies. It is possible to choose the appropriate model for tissue characterization from mathematical methods and analysis of model behaviors. The three classic models, Voigt, Maxwell, and Zener, were applied to fit the velocity measurements and estimate shear moduli of porcine livers with different thermal damage levels and different storage times. The Zener model always provided the best estimation of the moduli with the minimum errors in our experiments. Unlike the Voigt and Maxwell models, the moduli of the Zener model cannot be used to indicate damage levels in porcine livers directly, but the creep and relaxation behaviors of the Zener model are effective.

Exposure Optimization Trial for Patients With Medical Implants During MRI Exposure: Balance Between the Completeness and Efficiency.

Elongated conductors, such as pacemaker leads, can couple to the MRI radio-frequency (RF) field during MRI scan and cause dangerous tissue heating. By selecting proper RF exposure conditions, the RF-induced power deposition can be suppressed. As the RF-induced power deposition is a complex function of multiple clinical factors, the problem remains how to perform the exposure selection in a comprehensive and efficient way. The purpose of this work is to demonstrate an exposure optimization trail that allows a comprehensive optimization in an efficient and traceable manner. The proposed workflow is demonstrated with a generic 40 cm long cardio pacemaker, major components of the clinical factors are decoupled from the redundant data set using principle component analysis, the optimized exposure condition can not only reduce the in vivo power deposition but also maintain good image quality.

Induced radiofrequency fields in patients undergoing MR examinations: insights for risk assessment.

Purpose. To characterize and quantify the induced radiofrequency (RF) electric (E)-fields andB1+rmsfields in patients undergoing magnetic resonance (MR) examinations; to provide guidance on aspects of RF heating risks for patients with and without implants; and to discuss some strengths and limitations of safety assessments in current ISO, IEC, and ASTM standards to determine the RF heating risks for patients with and without implants.Methods. InducedE-fields andB1+rmsfields during 1.5 T and 3 T MR examinations were numerically estimated for high-resolution patient models of the Virtual Population exposed to ten two-port birdcage RF coils from head to feet imaging landmarks over the full polarization space, as well as in surrogate ASTM phantoms.Results. Worst-caseB1+rmsexposure greater than 3.5µT (1.5 T) and 2µT (3 T) must be considered for all MR examinations at the Normal Operating Mode limit. Representative inducedE-field and specific absorption rate distributions under different clinical scenarios allow quick estimation of clinical factors of high and reduced exposure.B1shimming can cause +6 dB enhancements toE-fields along implant trajectories. The distribution and magnitude of inducedE-fields in the ASTM phantom differ from clinical exposures and are not always conservative for typical implant locations.Conclusions.Field distributions in patient models are condensed, visualized for quick estimation of risks, and compared to those induced in the ASTM phantom. InducedE-fields in patient models can significantly exceed those in the surrogate ASTM phantom in some cases. In the recent 19ε2revision of the ASTM F2182 standard, the major shortcomings of previous versions have been addressed by requiring that the relationship between ASTM test conditions andin vivotangentialE-fields be established, e.g. numerically. With this requirement, the principal methods defined in the ASTM standard for passive implants are reconciled with those of the ISO 10974 standard for active implantable medical devices.

Novel test field diversity method for demonstrating magnetic resonance imaging safety of active implantable medical devices.

Electromagnetic (EM) radiofrequency (RF) safety testing of elongated active implantable medical devices (AIMD) during magnetic resonance imaging (MRI) requires an RF response model of the implant to assess a wide range of exposure conditions. The model must be validated using a sufficiently large set of incident tangential electric field ([Formula: see text]) conditions that provide diversified exposure. Until now, this procedure was very time consuming and often resulted in poorly defined [Formula: see text] conditions. In this paper, we propose a test field diversity (TFD) validation method that provides more diverse exposure conditions of high fidelity, thereby decreasing the number of implant routings to be tested. The TFD method is based on the finding that the amplitude and phase of [Formula: see text] along a single lead path in a cylindrical phantom can be sufficiently varied by changing the polarization of the incident 64 and 128 MHz magnetic fields inside standard birdcage test coils. The method is validated, its benefits are demonstrated, and an uncertainty budget is developed. First, the numerically determined field conditions were experimentally verified. The RF transfer function of a 90 cm long spinal cord stimulator was successfully validated with the TFD approach and excitation conditions that cover a > 10 dB dynamic range of RF-heating enhancement factors (for identical trajectory-averaged incident field strength). The new TFD method yields an improved and reliable validation of the AIMD RF response model with low uncertainty, i.e. < 1.5 dB, for both 1.5 and 3.0 T evaluations.

Ultrasound vibrometry using orthogonal- frequency-based vibration pulses.

New vibration pulses are developed for shear wave generation in a tissue region with preferred spectral distributions for ultrasound vibrometry applications. The primary objective of this work is to increase the frequency range of detectable harmonics of the shear wave. The secondary objective is to reduce the required peak intensity of transmitted pulses that induce the vibrations and shear waves. Unlike the periodic binary vibration pulses, the new vibration pulses have multiple pulses in one fundamental period of the vibration. The pulses are generated from an orthogonal-frequency wave composed of several sinusoidal signals, the amplitudes of which increase with frequency to compensate for higher loss at higher frequency in tissues. The new method has been evaluated by studying the shear wave propagation in in vitro chicken and swine liver. The experimental results show that the new vibration pulses significantly increase tissue vibration with a reduced peak ultrasound intensity, compared with the binary vibration pulses.

Shearwave dispersion ultrasound vibrometry (SDUV) for measuring tissue elasticity and viscosity.

Characterization of tissue elasticity (stiffness) and viscosity has important medical applications because these properties are closely related to pathological changes. Quantitative measurement is more suitable than qualitative measurement (i.e., mapping with a relative scale) of tissue viscoelasticity for diagnosis of diffuse diseases where abnormality is not confined to a local region and there is no normal background tissue to provide contrast. Shearwave dispersion ultrasound vibrometry (SDUV) uses shear wave propagation speed measured in tissue at multiple frequencies (typically in the range of hundreds of Hertz) to solve quantitatively for both tissue elasticity and viscosity. A shear wave is stimulated within the tissue by an ultrasound push beam and monitored by a separate ultrasound detect beam. The phase difference of the shear wave between 2 locations along its propagation path is used to calculate shear wave speed within the tissue. In vitro SDUV measurements along and across bovine striated muscle fibers show results of tissue elasticity and viscosity close to literature values. An intermittent pulse sequence is developed to allow one array transducer for both push and detect function. Feasibility of this pulse sequence is demonstrated by in vivo SDUV measurements in swine liver using a dual transducer prototype simulating the operation of a single array transducer.

Generalized sagnac effect.

Experiments were conducted to study light propagation in a light waveguide loop consisting of linearly and circularly moving segments. We found that any segment of the loop contributes to the total phase difference between two counterpropagating light beams in the loop. The contribution is proportional to a product of the moving velocity v and the projection of the segment length Delta(l) on the moving direction, Deltaphi=4piv x Delta(l)/c(lambda). It is independent of the type of motion and the refractive index of waveguides. The finding includes the Sagnac effect of rotation as a special case and suggests a new fiber optic sensor for measuring linear motion with nanoscale sensitivity.