Elena Lucano1,2, Micaela Liberti2, Gonzalo G Mendoza1, Tom Lloyd3, Francesca Apollonio2, Steve Wedan3, Wolfgang Kainz1, and Leonardo M Angelone1
1Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, United States, 2Department of Information Engineering, Electronics and Telecommunications, Univerisity of Rome "Sapienza", Rome, Italy, 3Imricor Medical Systems, Burnsville, MN, United States
Synopsis
We aim to generate a
quantitative method for RF-safety of patients with partially implanted
leads at 64 MHz. Within this aim, the position of the RF
feeding sources and the orientation of the polarization is often
unknown, as it is the quantitative effect of such variables on the
induced currents on the leads. The Electric field profile was studied by
means of simulations and measurements with a coil loaded
with a phantom, and simulations with an anatomical human model. Changes
of up to 40% of E-field magnitude were observed. Future work is needed
to develop a systematic exposure procedure.Purpose
Commercial
1.5T MRI scanners used in clinical applications are typically driven with a
dual port excitation for which the position of the feeding sources and the orientation of the polarization (i.e., clockwise CW vs. counterclockwise CCW) with respect to the patient is
often unknown. For partially implanted leads (e.g., interventional
cardiac ablation catheters), the radiofrequency (RF) induced heating of tissue
near the lead tip depends on the magnitude and phase of the tangential electric field component
($$$ \overrightarrow{E}_{tan}$$$) along the lead. This
study aims to answer the question on how position of feeding sources
and field polarization affect $$$ \overrightarrow{E}_{tan}$$$.
The study was based on electromagnetic (EM) measurements and simulations inside
an ellipsoidal phantom and on simulations with an anatomical human body model.
Methods
The MITS1.5 for 1.5 Tesla RF Safety Evaluation
(ZurichMedTech) was used for the measurements. The system consists of a high-pass
64 MHz birdcage body coil [1]. The coil was driven at two ports (I and Q in Figure1a) physically shifted at 90
o. The EM fields
were measured with the DASY52NEO robotic measurement system (SPEAG) [2]. The computational
model was geometrically equivalent to the physical coil (Figure 1b) and it
was implemented with Sim4Life software (ZurichMedTech). Both coil and shield were
modeled as perfect electric conductors. Four different positions of the feed points
were studied (Figure 1d): starting from the one implemented in the physical
coil (“left” position) the pair of sources were turned 90
o. Feeding
phase was imposed such to have opposite quadrature setup (i.e., 0
o-90
o
CW and 90
o-0
o CCW polarization). Both the physical and
the numerical coil was loaded with a superellipse-shaped phantom (Figure 1b).
Three different planes
inside the phantom were measured for comparison. The measured and numerical
dataset were normalized to the same magnetic field magnitude for a location inside
the phantom. Additionally, the coil model and source configuration were used with
an anatomical human female model (“Ella” Figure1c [3]). The $$$ \overrightarrow{E}_{tan}$$$ profile was studied along the
extraction lines shown in Figures 3a and 4a. The
extraction line in the phantom was along a device mount track for evaluation of a partially inserted catheter, whereas in the “Ella”
model was based on a typical path of MR-interventional ablation catheters. Data with “Ella”
were normalized to a whole body average SAR of 2 W/kg.
Results
Figure 2 shows the electric field magnitude
for the physical vs the numerical model in one plane of the phantom. The
results with the sources in “left” and same polarization (CW) of the physical
coil were closer to measurements with a 15.3 % Symmetric Mean Absolute Percent Error (SMAPE)[4] . When using a CCW polarization
the field distribution was mirrored with respect to the central line compared
to CW. When comparing
CW vs. CCW in the phantom (Figure 3b) the
highest difference of $$$\parallel \overrightarrow{E}_{tan}\parallel$$$ was found around the exit point (x=1579 in Figure 3a), with up
to 14 % higher $$$\parallel \overrightarrow{E}_{tan}\parallel$$$ in the left and top position. Spikes
in the profile were due to the pins of the device mount track made of plexiglass. With respect to the $$$\angle \overrightarrow{E}_{tan}$$$ inside the
phantom, the top and right positions showed variations less than 0.5 rad,
and the left and bottom positions changed by a mean of 4.5 rad
and 3 rad, respectively; conversely, outside the phantom the profile of
the phase was the opposite with a change of up to 3.5 rad for top/right and
less than 1.3 rad for left/bottom. In the “Ella” model (Figure 4b) differences
of up to 40% were observed (e.g., $$$\parallel \overrightarrow{E}_{tan}\parallel$$$ 40 % less with CCW vs. CW near the exit point, x=786 in Figure 4b).
Additionally, when changing sources positions the phase had qualitatively
comparable trends, but differences in values up to 4.8 rad (CW).
Discussion and Conclusions
Accurate modeling of both the magnetic and electric fields is important when
evaluating RF-induced heating medical devices that are partially implanted or
have external components in contact with the body. Information
about field polarization and source position with respect to the patient
undergoing an MRI scan can be essential in the determination of RF safety.
Future work is needed to develop a systematic exposure procedure for RF heating
evaluations of partially implanted leads in phantoms. These procedures must be able
to mimic worst-case exposure in the patient.
The mention of commercial products,
their sources, or their use in connection with material reported herein is not
to be construed as either an actual or implied endorsement of such products by
the Department of Health and Human Services.
Acknowledgements
This
project was supported in part by a Cooperative Research and Development
Agreement between Imricor Medical Systems and the Center for Devices
and Radiological Health (CDRH), FDA, and in part by the Office of Women’s Health, U.S. FDA.References
[1] Lucano et al., ISMRM (2014), 4903
[2] SPEAG, Zurich, Switzerland
[3] Christ , et al., The Virtual Family—development of surface-based anatomical models of two adults and two children for dosimetric simulations. Physics in Medicine and Biology, 2010. 55(2): p. N23
[4] J. S. Armstrong, Long-Range Forecasting: From
Crystal Ball to Computer: Wiley 1985.