Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration

Certain low-frequency magnetic fields cause interference in implantable medical devices. Electromagnetic compatibility (EMC) standards prescribe injecting voltages into a device under evaluation to simplify testing while approximating or simulating real-world exposure situations to low-frequency magnetic fields. The EMC standard ISO 14117:2012, which covers implantable pacemakers and implantable cardioverter defibrillators (ICDs), specifies test levels for the bipolar configuration of sensing leads as being one-tenth of the levels for the unipolar configuration. The committee authoring this standard questioned this testing level difference and its clinical relevance. To evaluate this issue of EMC test levels, we performed both analytical calculations and computational modeling to determine a basis for this difference. Analytical calculations based upon Faraday's law determined the magnetically induced voltage in a 37.6-cm lead. Induced voltages were studied in a bipolar lead configuration with various spacing between a distal tip electrode and a ring electrode. Voltages induced in this bipolar lead configuration were compared with voltages induced in a unipolar lead configuration. Computational modeling of various lead configurations was performed using electromagnetic field simulation software. The two leads that were insulated, except for the distal and proximal tips, were immersed in a saline-conducting media. The leads were parallel and closely spaced to each other along their length. Both analytical calculations and computational modeling support continued use of a one-tenth amplitude reduction for testing pacemakers and ICDs in bipolar mode. The most recent edition of ISO 14117 includes rationale from this study.

The effect of device configuration and patient’s body composition on image artifact and RF heating of deep brain stimulation devices during MRI at 1.5T and 3T

BACKGROUNDPatients with deep brain stimulation (DBS) implants have limited access to MRI due to safety concerns associated with RF-induced heating. Currently, MRI in these patients is allowed only in 1.5T horizontal scanners and with pulse sequences with reduced power. Nevertheless, off-label use of MRI at 3T is increasingly reported based on limited safety assessments. Here we present results of systematic RF heating measurements for two commercially available DBS systems during MRI at 1.5T and 3T.PURPOSETo assess the effect of imaging landmark, DBS lead configuration, and patient body composition on RF heating of DBS leads during MRI at 1.5 T and 3T.STUDY TYPEPhantom study.POPULATION/SUBJECTS/PHANTOM/SPECIMEN/ANIMAL MODELGel phantoms and cadaver brain.FIELD STRENGTH/SEQUENCE1.5T and 3T, T1-weighted turbo spin echo.ASSESSMENTRF heating was measured at tips of DBS leads implanted in brain-mimicking gel.STATISTICAL TESTSNone.RESULTSWe observed substantial fluctuation in RF heating mainly affected by phantom composition and DBS lead configuration, ranging from 0.14°C to 23.73°C at 1.5 T, and from 0.10°C to 7.39°C at 3T. The presence of subcutaneous fat substantially altered RF heating at electrode tips (−3.06°C < ΔT < 19.05°C). Introducing concentric loops in the extracranial portion of the lead at the surgical burr hole reduced RF heating by up to 89% at 1.5T and up to 98% at 3T compared to worst case heating scenarios.DATA CONCLUSIONDevice configuration and patient body composition significantly altered the RF heating of DBS leads during MRI at 1.5T and 3T. Interestingly, certain lead trajectories consistently reduced RF heating and image artifact over different imaging landmarks, RF frequencies, and phantom compositions. Such trajectories could be implemented in patients with minimal disruption to the surgical workflow.

Pulse generator replacement

This chapter covers pulse generator replacement, from general principles to pocket revision. Indications for pulse generator replacement are briefly covered, including pre-operative checks such as lead configuration and underlying rhythms being confirmed prior to the operation. Patient preparation is described, and the operative technique for removing the old pulse generator and new implantation are described, including common pitfalls. Different techniques, including moving from dual to single chamber or the addition of new leads are outlined, rationales are provided, and methods for carrying out each technique are discussed. The opportunity for pocket revision is described.

Body Surface Mapping of T-wave Alternans Depends on the Distribution of Myocardial Scarring

T-Wave alternans (TWA) testing using 12-lead electrocardiogram/Frank leads is emerging as an important non-invasive biomarker to identify patients at high risk of Sudden Cardiac Death (SCD). Cardiac scarring is very common among cardiomyopathy patients; however, its influence on the body surface distribution of TWA has not yet been defined. Our objective was to perform a simulation study in order to determine whether cardiac scarring affects the distribution of TWA on thorax such that the standard leads fail to detect TWA in some of cardiomyopathy patients; thereby producing a false-negative test. Developing such a novel lead configuration could improve TWA quantification and potentially optimize electrocardiogram (ECG) lead configuration and risk stratification of SCD in cardiomyopathy patients. The simulation was performed in a 1500-node heart model using ECGSIM. TWA was mimicked by simulating action potential duration alternans in the ventricles. Cardiac scarring with different sizes were simulated by manipulating the apparent velocity, transmembrane potential and transition zone at varied locations along the left ventricular posterior wall. Our simulation study showed that the location of maximum TWA depends on the location and size of the myocardium scarring in patients with cardiomyopathy, which can give rise to false-negative TWA signal detection using standard clinical leads. The TWA amplitude generally increased with the increment of scar size (P<0.00001). We found one specific location (a non-standard lead) that consistently appeared as the top five maximum TWA leads and could be considered as an additional lead to improve the outcome of the TWA testing in cardiomyopathy patients.