Howard Bassen

Complexity of MRI induced heating on metallic leads: Experimental measurements of 374 configurations

BackgroundMRI induced heating on PM leads is a very complex issue. The widely varying results described in literature suggest that there are many factors that influence the degree of heating and that not always are adequately addressed by existing testing methods.MethodsWe present a wide database of experimental measurements of the heating of metallic wires and PM leads in a 1.5 T RF coil. The aim of these measurements is to systematically quantify the contribution of some potential factors involved in the MRI induced heating: the length and the geometric structure of the lead; the implant location within the body and the lead path; the shape of the phantom used to simulate the human trunk and its relative position inside the RF coil.ResultsWe found that the several factors are the primary influence on heating at the tip. Closer locations of the leads to the edge of the phantom and to the edge of the coil produce maximum heating. The lead length is the other crucial factor, whereas the implant area does not seem to have a major role in the induced temperature increase. Also the lead structure and the geometry of the phantom revealed to be elements that can significantly modify the amount of heating.ConclusionOur findings highlight the factors that have significant effects on MRI induced heating of implanted wires and leads. These factors must be taken into account by those who plan to study or model MRI heating of implants. Also our data should help those who wish to develop guidelines for defining safe medical implants for MRI patients. In addition, our database of the entire set of measurements can help those who wish to validate their numerical models of implants that may be exposed to MRI systems.

In vitro assessment of tissue heating near metallic medical implants by exposure to pulsed radio frequency diathermy

A patient with bilateral implanted neurostimulators suffered significant brain tissue damage, and subsequently died, following diathermy treatment to hasten recovery from teeth extraction. Subsequent MRI examinations showed acute deterioration of the tissue near the deep brain stimulator (DBS) leads electrodes which was attributed to excessive tissue heating induced by the diathermy treatment. Though not published in the open literature, a second incident was reported for a patient with implanted neurostimulators for the treatment of Parkinsons disease. During a diathermy treatment for severe kyphosis, the patient had a sudden change in mental status and neurological deficits. The diathermy was implicated in causing damage to the patients brain tissue. To investigate if diathermy induced excessive heating was possible with other types of implantable lead systems, or metallic implants in general, we conducted a series of in vitro laboratory tests. We obtained a diathermy unit and also assembled a controllable laboratory exposure system. Specific absorption rate (SAR) measurements were performed using fibre optic thermometry in proximity to the implants to determine the rate of temperature rise using typical diathermy treatment power levels. Comparisons were made of the SAR measurements for a spinal cord stimulator (SCS) lead, a pacemaker lead and three types of bone prosthesis (screws, rods and a plate). Findings indicate that temperature changes of 2.54 and 4.88 degrees C s(-1) with corresponding SAR values of 9129 and 17,563 W kg(-1) near the SCS and pacemaker electrodes are significantly higher than those found in the proximity of the other metallic implants which ranged from 0.04 to 0.69 degrees C s(-1) (129 to 2471 W kg(-1)). Since the DBS leads that were implanted in the reported human incidents have one-half the electrode surface area of the tested SCS lead, these results imply that tissue heating at rates at least equal to or up to twice as much as those reported here for the SCS lead could occur for the DBS leads.

Temperature and SAR measurement errors in the evaluation of metallic linear structures heating during MRI using fluoroptic probes.

The purpose of this work is to evaluate the error associated with temperature and SAR measurements using fluoroptic temperature probes on pacemaker (PM) leads during magnetic resonance imaging (MRI). We performed temperature measurements on pacemaker leads, excited with a 25, 64, and 128 MHz current. The PM lead tip heating was measured with a fluoroptic thermometer (Luxtron, Model 3100, USA). Different contact configurations between the pigmented portion of the temperature probe and the PM lead tip were investigated to find the contact position minimizing the temperature and SAR underestimation. A computer model was used to estimate the error made by fluoroptic probes in temperature and SAR measurement. The transversal contact of the pigmented portion of the temperature probe and the PM lead tip minimizes the underestimation for temperature and SAR. This contact position also has the lowest temperature and SAR error. For other contact positions, the maximum temperature error can be as high as -45%, whereas the maximum SAR error can be as high as -54%. MRI heating evaluations with temperature probes should use a contact position minimizing the maximum error, need to be accompanied by a thorough uncertainty budget and the temperature and SAR errors should be specified.

CELLULAR PHONE INTERFERENCE TESTING OF IMPLANTABLE CARDIAC DEFIBRILLATORS IN VITRO

An in vitro study was undertaken to investigate the potential for cellular telephones to interfere with representative models of presently used ICDs. Digital cellular phones (DCPs) generate strong, amplitude modulated fields with pulse repetition rates near the physiological range sensed by the 1CD as an arrhythmia. DCPs with Time Division Multiple Access (TDMA) pulsed amplitude modulation caused the most pronounced effect—high voltage firing or inhibition of pacing output of the ICDs. This electromagnetic interference (EMI) occurred only when the phones were within 2.3–5.8 cm of the ICD pulse generator that was submerged 0.5 cm in 0.18% saline. ICD performance always reverted to baseline when the cellular phones were removed from the immediate proximity of the ICD. Three models of ICDs were subjected to EMI susceptibility testing using two types of digital phones and one analog cellular phone, each operating at their respective maximum output power. EMI was observed in varying degrees from all DCPs. Inhibition of pacer output occurred in one ICD. and high voltage firing occurred in the two other ICDs. when a TDMA11 Hz DCP was placed within 2.3 cm of the ICD. For the ICD that was most sensitive to delivering unintended therapy, inhibition followed by firing occurred at distances up to 5.8 cm. When a TDMA‐50 Hz phone was placed at the minimum test distance of 2.3 cm. inhibition followed by firing was observed in one of the ICDs. EMI occurred most frequently when the lower portion of the monopole antenna of the cellular phone was placed over the ICD header.

MRI‐induced heating of selected thin wire metallic implants – laboratory and computational studies – findings and new questions raised

We performed experiments and computer modeling of heating of a cardiovascular stent and a straight, thin wire by RF fields in a 1.5 T MRI birdcage coil at 64 MHz. We used ASTM F2182‐02a standard and normalized results to 4 W/kg whole body average. We used a rectangular saline‐gel filled phantom and a coiled, double stent (Intracoil by ev3 Inc) 11 cm long. The stent had thin electrical insulation except for bare ends (simulating drug eluting coating). The stent and phantom were placed close to the wall of the RF Coil and had approximately 0.5°C initial temperature rise at the ends (local SAR = 320 W/kg). We exposed a wire (24.1 cm, 0.5 mm diameter) with 0.5 mm insulation and saw an 8.6°C temperature rise (local SAR = 5680 W/kg) at the bare ends. All heating was within 1 mm3 of the ends, so the position of our fiber optic temperature probe was critical for repeatability. Our computational study used finite difference time domain software with a thermodynamics solver. We modeled a coiled bare‐wire stent as a spiral with a rectangular cross section and found a maximum increase of 0.05°C induced at the tips for plane wave exposures. A maximum local SAR of up to 200 W/kg occurred in a volume of only 8×10−3 mm. We developed improved computational exposure sources – optimized birdcage coils and quasi‐MRI fields that may eliminate the need to model an RF coil. We learned that local (point) SAR (initial linear temperature rise) is the most reliable indicator of the maximum heating of an implant. Local SAR depends greatly on implant length, insulation and shape, and position in the MRI coil. Accurate heating must be measured with sensors or software having millimeter resolution. Many commercially available fiber optic temperature probes do meet this requirement.

In vitro investigation of pacemaker lead heating induced by magnetic resonance imaging: role of implant geometry.

To evaluate the effect of the geometry of implantable pacemakers (PMs) on lead heating induced by magnetic resonance imaging (MRI).

Calculation of induced current densities and specific absorption rates (SAR) for pregnant women exposed to hand-held metal detectors

The finite difference time domain (FDTD) method in combination with a well established frequency scaling method was used to calculate the internal fields and current densities induced in a simple model of a pregnant woman and her foetus, when exposed to hand-held metal detectors. The pregnant woman and foetus were modelled using a simple semi-heterogeneous model in 10 mm resolution, consisting of three different types of tissue. The model is based on the scanned shape of a pregnant woman in the 34th gestational week. Nine different representative models of hand-held metal detectors operating in the frequency range from 8 kHz to 2 MHz were evaluated. The metal detectors were placed directly on the abdomen of the computational model with a spacing of 1 cm. Both the induced current density and the specific absorption rate (SAR) are well below the recommended limits for exposure of the general public published in the ICNIRP Guidelines and the IEEE C95.1 Standard. The highest current density is 8.3 mA m(-2) and the highest SAR is 26.5 microW kg(-1). Compared to the limits for the induced current density recommended in the ICNIRP Guidelines, a minimum safety factor of 3 exists. Compared to the IEEE C95. 1 Standard, a safety factor of 60 000 for the specific absorption rate was found. Based on the very low specific absorption rate and an induced current density below the recommended exposure limits, significant temperature rise or nerve stimulation in the pregnant woman or in the foetus can be excluded.

MRI induced heating of pacemaker leads: effect of temperature probe positioning and pacemaker placement on lead tip heating and local SAR.

The radio frequency field used in magnetic resonance imaging (MRI) procedures leads to temperature and local absorption rate (SAR) increase for patients with implanted pacemakers (PM). In this work a methodological approach for temperature and SAR measurements using fluoroptic probes is presented. Experimental measures show how the position of temperature probes affects the temperature and SAR value measured at the lead tip. The transversal contact between the active portion of the probe and the lead tip is the configuration associated with the highest values for temperature and SAR, whereas other configurations may lead to an underestimation close to 11% and 70% for temperature and SAR, respectively. In addition measurements were performed on a human-shaped phantom inside a real MRI system, in order to investigate the effect of the PM placement and of the lead geometry on heating and local SAR

In-vitro mapping of E-fields induced near pacemaker leads by simulated MR gradient fields

BackgroundMagnetic resonance imaging (MRI) of patients with implanted cardiac pacemakers is generally contraindicated but some clinicians condone scanning certain patients. We assessed the risk of inducing unintended cardiac stimulation by measuring electric fields (E) induced near lead tips by a simulated MRI gradient system. The objectives of this study are to map magnetically induced E near distal tips of leads in a saline tank to determine the spatial distribution and magnitude of E and compare them with E induced by a pacemaker pulse generator (PG).MethodsWe mapped magnetically induced E with 0.1 mm resolution as close as 1 mm from lead tips. We used probes with two straight electrodes (e.g. wire diameter of 0.2 mm separated by 0.9 mm). We generated magnetic flux density (B) with a Helmholtz coil throughout 0.6% saline in a 24 cm diameter tank with (dB/dt) of 1 T/sec (1 kHz sinusoidal waveform). Separately, we measured E near the tip of leads when connected to a PG set to a unipolar mode. Measurements were non-invasive (not altering the leads or PG under study).ResultsWhen scaled to 30 T/s (a clinically relevant value), magnetically-induced E exceeded the E produced by a PG. The magnetically-induced E only occurred when B was coincident with or within 15 msec of implantable pacemakers pulse.ConclusionsPotentially hazardous situations are possible during an MR scan due to gradient fields. Unintended stimulation can be induced via abandoned leads and leads connected to a pulse generator with loss of hermetic seal at the connector. Also, pacemaker-dependent patients can receive drastically altered pacing pulses.

EMC and wireless healthcare

Electromagnetic compatibility (EMC) is a critical part of addressing the risks related to the effects of electromagnetic interference (EMI) on active medical devices exposed to emissions from wireless technology. In addition, for wireless technology in healthcare to be safe, effective, reliable, and secure specific wireless issues must also be addressed including quality of service, coexistence with other wireless equipment, data integrity, and wireless security. Unfortunately, these issues pose risks that are poorly addressed in present medical devices standards or other consensus documents. This paper discusses risks for wireless technology in healthcare with examples from research examining the effects of emissions from wireless technology such as RFID on implantable cardiac pacemakers and defibrillators and EMC with other emitters. The paper goes into ways that the risks, including EMI, can be addressed and makes the case for substantive engagement by stakeholders, including the IT community, wireless developers, and clinical organizations. There is clear need to develop unbiased, consensus information and tools that will set the pathways and tools needed to meet the risks and challenges for widespread incorporation of wireless technology in healthcare.