Electromagnetic Interference of Digital and Analog Cellular Telephones with Implantable Cardioverter Defibrillators: In Vitro and In Vivo Studies

The present study examines the potential electromagnetic interference effects induced by cellular telephones on ICDs. We developed ad hoc protocols to conduct both in vitro and in vivo trials on most of the implantable cardioverter defibrillators available on the international market. Trials were conducted with three cellular telephones: two GSM (Global System for Mobile Communication) and one TACS (Total Access Communication System). A human trunk simulator was used to carry out in vitro observations on six ICDs from five manufacturers. In vivo tests were conducted on 13 informed patients with eight different ICD models. During the trials in air, GSM telephones induced interference effects on 4 out of the 6 cardioverter defibrillators tested. Specifically, pulse inhibition, reprogramming, false ventricular fibrillation, and ventricular tachycardia detections occurred, which would have entailed inappropriate therapy delivery had this been activated. Effects were circumscribed to the area closely surrounding the connectors. When the ICD was immersed in saline solution, no effects were observed. Three cases of just ventricular triggering with the interfering signal were observed in vivo.     

Electromagnetic Interference of External Pacemakers by Walkie-Talkies and Digital Cellular Phones: Experimental Study

A number of experimental and clinical studies have documented the risk potential of interference with implanted pacemakers by various types of cellular phones. Radiofrequency susceptibility of external medical equipment has also been reported in experimental studies. The purpose of this experimental study was to evaluate electromagnetic interference of external pacemakers by walkie-talkies and digital cellular telephones. External bipolar pacing was monitored using a digital oscilloscope to record pacemaker pulses and electromagnetic interference separately. Tests with the walkie-talkie, Private Mobile Radio (PMR) (160 MHz, 2.5 W) were conducted during the calling phase. Tests with the cellular phones, global system for mobile communications (GSM) (900 MHz, 2 W) and Digital Cellular System (DCS) (1,800 MHz, 1 W) were conducted in the test mode. Nine widely used external pacemakers from four manufacturers were tested. Various disturbances including pacing inhibition and asynchronous pacing were observed in eight pacemakers by the PMR, in four by the GSM phone, and in two by the DCS phone. The maximum distance that interference persisted ranged from 10–200 cm. This experimental study shows a potential risk of interference of external pacemakers by walkie-talkies and cellular digital phones. Appropriate warnings should be issued against the potentially serious risks of using communication devices in the vicinity of acutely ill patients treated with temporary transvenous cardiac pacemakers.     

The Safety of Digital Mobile Cellular Telephones with Minute Ventilation Rate Adaptive Pacemakers

In vitro tests suggest that rate adaptive pacemakers using changes in transthoracic impedance to vary pacing rate may be affected by digital mobile telephones. Electromagnetic fields generated by digital mobile telephones (Global System for Mobile [GSM]) represent a potential source of electromagnetic interference (EMI) for the Telectronics META rate adaptive pacemakers, which use transthoracic impedance as a sensor to determine changes in minute ventilation. Sixteen implanted Telectronics META pulse generators were exposed to 25-W simulated GSM transmissions (900-MHz carrier pulsed at 2, 8, and 217 Hz with a pulse width of 0.6 ms) and the antenna of a 2-W digital mobile telephone (900-MHz, 217-Hz pulse. 0.6-ms pulse width). The 12 dual and four single chamber devices were programmed to maximum sensitivity and assessed in unipolar and bipolar settings and rate adaptive and nonrate adaptive modes. In all cases of EMI, testing was repeated at lower, more routinely set bipolar sensitivity levels. At maximum sensitivity, 11 of 16 devices displayed no evidence of EMI. Brief ventricular triggering occurred in 2, a brief pause in 1, a combination of both in 1, and a brief episode of pacemaker-mediated tachycardia in 1. With pulse generators programmed to more routine sensitivities, only one device displayed rare single beat ventricular triggering. No changes in minute ventilation rate adaptive pacing were observed. At maximum unipolar sensitivities, the META series of rate adaptive pacemakers are resistant to clinically important EMI from digital mobile telephones. Set at routine sensitivities, these devices perform reliably in the presence of digital mobile telephones.     

Electromagnetic Interference of Pacemakers by Mobile Phones

The topic of interference of pacemakers by mobile phones has evoked a surprisingly strong interest, not only in pacemaker patients, but also in the public opinion. The latter is the more surprising, as in the past, the problem of interference has scarcely found the attention that it deserves in the interest of the patient. It was the intention of our investigation to test as many pacemaker models as possible to determine whether incompatibility with mobile phones of different modes may exist, using an in vitro measuring setup. We had access to 231 different models of 20 manufacturers. During the measurements, a pulse generator together with a suitable lead was situated in a 0.9 g/L saline solution, and the antenna of a mobile phone was positioned as close as possible. If the pulse generator was disturbed, the antenna was elevated until interference ceased. The gap in which interference occurred was defined as “maximum interference distance.” All three nets existing in Germany, the C-net (450 MHz, analogue), the D-net (900 MHz, digital pulsed), and the E-net. (1,800 MHz, digital pulsed) were tested in succession. Out of 231 pulse generator models, 103 pieces corresponding to 44.6% were influenced either by C- or D-net, if both results were totaled. However, this view is misleading as no patient will use C- and D-net phones simultaneously. Separated into Cor D-net interference, the result is 30.7% for C or 34.2% for D, respectively, of all models tested. The susceptible models represent 18.6% or 27% of today's living patients, respectively. All models were resistant to the E-net. With respect to D-net phones, all pacemakers of six manufacturers proved to be unaffected. Eleven other manufacturers possessed affected and unaffected models as well. A C-net phone only prolonged up to five pacemaker periods within 10 seconds during dialing without substantial impairment to the patient. Bipolar pacemakers are as susceptible as unipolar ones. The following advice for patients and physicians can be derived from our investigations: though 27% of all patients may have problems with D-net phones (not C- or E-net), the application should generally not be questioned. On the contrary, patients with susceptible devices should be advised that a distance of 20 cm is sufficient to guarantee integrity of the pacemaker with respect to hand held phones. Portables, on the other hand, should have a distance of about 0.5 m. Pacemaker patients really suffering from mobile phones are very rare unless the phone is just positioned in the pocket over the pulse generator. The contralateral pocket or the belt position guarantees, in 99% of all patients, undisturbed operation of the pacemaker. A risk analysis reveals that the portion of patients really suffering from mobile phones is about 1 out of 100,000. Nevertheless, it would be desirable in the future if implanting physicians would use only pacemakers with immunity against mobile phones as guaranteed by the manufacturers     

Electromagnetic interference in implantable pacemakers.

The inhibited pacemaker (VVI or AAI) has become the most popular in recent years because of its ability to combine a physiological advantage with economical current consumption in cases with spontaneous activity. One of its disadvantages is its sensitivity to external electromagnetic interference. Though today's pacemakers possess effective protection against most interference signals there may be instances in which patients are subjected to uncomfortable or even life-threatening situations. This is the case of "amplitude modulated" or "pulsed" fields with modulation frequencies in the physiological range. Fields of that sort have been found in the vicinity of a welder, an electric steel plant, and in medical practice where therapeutic currents were applied. Even touch-actuated switches may influence a demand pacemaker. However, these situations may be overcome by a device within the pacemaker for simple time analysis which can be carried out with few components. If electromagnetic fields of diathermy equipment are applied, today's pacemakers may react with intolerably high or low rates. They should, therefore, be avoided.     

Do European GSM Mobile Cellular Phones Pose a Potential Risk to Pacemaker Patients?

BARBARO, V., et al .: Do European GSM Mobile Cellular Phones Pose a Potential Risk to Pacemaker Patients? A series of in vivo trials were carried out in order to verify whether the electromagnetic field radiated by GSM (Groupe Systemes Mobiles) mobile cellular phones might affect implanted pacemakers. Two European GSM phones of 2-watt power were tested and trials conducted on 101 pacemaker implanted outpatients attending day hospital for routine check-up, who volunteered for trials. Forty-three pacemaker models from 11 manufacturers were tested in all. When the sensing threshold of the pacemakers was set at a minimum and the antenna of the phone was in direct contact with the patient's chest, interference was detected for 26 implanted pacemakers. Specifically, pulse inhibition in 10 of 101 cases, ventricular triggering in 9 of 46 DDD-VDD pacemakers, and asynchronous pacing in 4 of 52 devices. Pulse inhibition was also observed combined with asynchronous pacing in 1 of 52 cases and with ventricular triggering in 2 of 46 cases. Minimum effect duration was ca. 3 seconds but in 6 cases effects continued as long as the interfering GSM signal was on. No permanent malfunctioning or changes in the programmed parameters were detected. Whenever interference was detected, trials were repeated to determine the maximum sensing threshold at which interference persisted (with the antenna in contact with the skin over the pacemaker). Then maximum distance between antenna and pacemaker at which interference occurred was determined at pacemaker maximum and minimum sensing threshold. Under our experimental conditions electromagnetic interference effects were detected at a maximum distance of 10 cm with the pacemaker programmed at its minimum sensing threshold. When the phone antenna was in direct contact with patient's skin over the implant, electromagnetic interference effects occurred at maximum ventricular and atrial sensing thresholds of 4 mV and 2.5 mV, respectively.     

Characteristics of Telemetry Interference with Pacemakers Caused by Digital Media Players

Background: Contemporary implantable heart rhythm devices communicate multiple complex data simultaneously using radiofrequency telemetry. Interference in communication can expose them to the risk of potential corruption, leading to adverse clinical consequences. Methods & Results: We studied the characteristics of interference with uplink (real time intracardiac electrograms, marker channel, and stored histograms) and downlink (attempt to program a change in the lower rate limit, the pacing mode, and the ventricular lead configuration) data transmission between the wand and the pacemaker caused by digital media players (iPods—Photo and 3G) in 50 patients. We also measured and characterized worst‐case magnetic field emissions (MFE) from the wand (≤0.4 μT), pacemaker (≤0.004 μT), and iPod (≤0.05 μT) during telemetry to understand the modulation techniques and safety protocols employed during data transmission. Telemetry interference (TI) manifested as high‐frequency spikes (24.4%), blanking (17.7%) and interruption (22.2%), or delay (17.6%) in transmission with warning on programmer's screen. TI occurred in 25.6% of patients when the iPod was “on” and in 13% even with the iPod turned “off.” There were no inaccuracies in downlinked data when the downlink communication was successful. Wanded telemetry utilizes low‐frequency (30–300 kHz) radiowaves and simple digital modulation techniques at relatively slow rates for “sequential” data transmission protected by a continuous “handshake.” Emissions from iPods in that range interrupt the telemetry link but are too weak to cause pacemaker malfunction through corruption of vital data. Conclusion: Low‐power MFE from iPods can produce interference with establishment and maintenance of a telemetry link and can cause TI with transmission of real time data, but because of continuous check protocols, do not corrupt the stored and vital downlink data. (PACE 2010; 33:712–720)     

X‐ray Radiation Causes Electromagnetic Interference in Implantable Cardiac Pacemakers

Background: X‐rays are not thought to cause electromagnetic interference (EMI) in implantable cardiac pacemakers. However, x‐ray radiation during computed tomography (CT) scanning has been reported to cause EMI in some implantable cardiac pacemakers. The objectives of this study were to identify the location within the pacemakers where x‐ray radiation causes EMI and to investigate the association of EMI with the x‐ray radiation conditions. Methods: We verified the location where x‐ray radiation caused EMI using a CT scanner and conventional radiographic x‐ray equipment. An inhibition test and an asynchronous test were performed using five types of implantable cardiac pacemakers. Results: X‐ray radiation inhibited the pacing pulses of four types of implantable cardiac pacemakers when the body of each implantable cardiac pacemaker, containing a complementary metal‐oxide semiconductor (CMOS), was scanned using a CT scanner. We confirmed that x‐ray‐induced EMI depends on the x‐ray radiation conditions, that is, the tube voltage, tube current, x‐ray dose, and direction of x‐ray radiation, as well as the sensing thresholds of the implantable cardiac pacemakers. Conclusions: X‐ray radiation caused EMI in some implantable cardiac pacemakers, probably because the CMOS component was irradiated. The occurrence of EMI depended on the pacemaker model, sensing threshold of the pacemaker, and x‐ray radiation conditions. (PACE 2010; 33:1174–1181)     

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.     

Interference in Pacemakers

We attempt here to outline the different sources of interference and the methods of interference detection and protection with their advantages and disadvantages. A proposal is made as to how a better interference suppression could be established. A comparison of 16 pacemakers from ten manufacturers tested with different interference sources revealed a great variety, which does not allow one to generalize the problem of interference. As an example, an electric steel furnace with its magnetic field is described and how its influence on pacemakers can be estimated. Rules are given as to how pacemaker patients may be treated by electrotherapy. A test procedure for characterizing the specific interference behavior is proposed.     

Third‐Generation Mobile Phones (UMTS) Do Not Interfere with Permanent Implanted Pacemakers

Aims: Third‐generation mobile phones, UMTS (Universal Mobile Telecommunication System), were recently introduced in Europe. The safety of these devices with regard to their interference with implanted pacemakers is as yet unknown and is the point of interest in this study. Methods and Results: The study comprised 100 patients with permanent pacemaker implantation between November 2004 and June 2005. Two UMTS cellular phones (T‐Mobile, Vodafone) were tested in the standby, dialing, and operating mode with 23 single‐chamber and 77 dual‐chamber pacemakers. Continuous surface electrocardiograms (ECGs), intracardiac electrograms, and marker channels were recorded when calls were made by a stationary phone to cellular phone. All pacemakers were tested under a “worst‐case scenario,” which includes a programming of the pacemaker to unipolar sensing and pacing modes and inducing of a maximum sensitivity setting during continuous pacing of the patient. Patients had pacemaker implantation between June 1990 and April 2005. The mean age was 68.4 ± 15.1 years. Regardless of atrial and ventricular sensitivity settings, both UMTS mobile phones (Nokia 6650 and Motorola A835) did not show any interference with all tested pacemakers. In addition, both cellular phones did not interfere with the marker channels and the intracardiac ECGs of the pacemakers. Conclusion: Third‐generation mobile phones are safe for patients with permanent pacemakers. This is due to the high‐frequency band for this system (1,800–2,200 MHz) and the low power output between 0.01 W and 0.25 W. (PACE 2010; 860–864)     

Implantable Cardioverter Defibrillators and Cellular Telephones: Is There Any Interference?

The aim of our study was to consider cellular telephone interference using different cellular telephones and implantable cardioverter defibrillator (ICD) models. Thirty (26 men, 4 women) patients with ICDs were considered during follow-up. The ICD models were: Telectronics (7), CPI (7), Medtronic (7), Ventritex (5), and Ela Medical (4). All patients were monitored with surface ECG; permanent telemetric endo-ECG monitoring was activated. Then, the effect of two different European telephone systems were tested: TACS system (Sony CM-R111, 2W power) and GSM system (Motorola MG1-4A11, 2 W power). For both systems, the effect during call, reception, active conversation (dialogue), and passive conversation (listening) were observed. Cellular telephones were located first in contact with the programming head, then near the leads system, and lastly, in the hands of the patient. At the end of the evaluations, memories were interrogated again to check for false arrhythmia detections. In five of these patients during arrhythmia induction at device implant (first implant or ICD replacement), we also evaluated possible interference between cellular telephones in the reception phase and the ventricular fibrillation detection phase of the ICD. All evaluated models showed significant noise in the telemetric transmission when the cellular telephone (both TACS and GSM) was located near the ICD and the programming head; noise was particularly significant during call and reception, in most cases leading to loss of telemetry. No false arrhythmia detections have been observed during tests with cellular telephones located on the ICDs. During tests performed with cellular telephones located near the leads or in the hands of patients, no telemetric noises orfalse arrhythmia detections were observed. During induced ventricularfibrillation and cellular telephones in reception mode near the device, the arrhythmia recognition was always correct and not delayed. In conclusion, present ICD models seem to be well protected from electromagnetic interference caused by European cellular telephones (TACS and GSM), without under-/oversensing of ventricular arrhythmias. However, cellular telephones disturb telemetry when located near the programming head. ICD patients should not be advised against the use of cellular telephones, but it has to be avoided during ICD interrogation and programming.     

The Effect of Power Frequency High Intensity Electric Fields on Implanted Cardiac Pacemakers

Thirty-five patients fitted with 16 different pacemaker models (from 6 manufacturers) were exposed to 50 Hz electric fields up to a maximum of 20 kV/m. Four different response patterns were encountered: (1) normal sensing and pacing in all Medtronic and some Vitatron units; (2) reversion to the fixed (interference) rale in ail Telectronics. all Pacesetter, some Vitatron and CPI units; (3) slowand irregtilarpacing in one CPI and in all Cordis units; (4) mixed behaviorovera critical range of field strengths in which slow and irregular pacing preceded reversion to fixed-rate, in some Telectromics and Pacesetter units. The field strengths required to induce such behavior varied from unit to unit and from model to model, with Telectronics being the most sensitive. In general, the interference threshold depended on the magnitude and distribution of induced body current relative to the pacemaker as well as field strength and thus varied with patient height, build and posture. While only a small proportion of pacemaker patients are likely lo encounter electric fields strong enough to interim.¹ with pacemaker behavior, this possible hazard should be recognized.     

The Response of Implanted Dual Chamber Pacemakers to 50 Hz Extraneous Electrical Interference

Twenty-two patients with dual chamber pacemakers with interchangeable lead configuration were exposed to 50 Hz electromagnetic interference. Current, al corporeal levels from 0–600 μA, was applied between electrodes on shoulders and feet using a bedside injection unit. Pacemaker behavior was monitored with telemetered event markers and intracardiac eJectrograms. In bipolar mode, noise reversion mode was induced in all except two Medtronic units at high (> 170 μA) levels of corporeal current, In the Inlermedics, Siemens Pacesetter, and Telectronics models, onset of noise reversion mode was preceded by a window of inappropriate function, characterized by rate acceleration due to atriai maisensing, or pacemaker inhibition due to ventricular nialsensiiig. In unipolar mode, pacemaker malfunction occurred at much lower current levels. Inappropriate behavior preceded the onset of protective noise reversion mode. During current injection, all pacemakers could be interrogated and reprogrammed, and intracardiac telemetry was reliably obtained except in two Medtronic units at high current levels. No pacemaker was reset by the electrical interference, and no cross-talk was seen. Use of bipolar mode confers a high decree of protection from extraneous electrical interference, but in unipolarmode pacemakers may be inhibited by small amounts of corporeal current, potentially encountered in every day life. The current injection anit allows safe, controllable, and quantifiable investigation of the effects of the electric field induced by a current on implanted pacemakers. Telemetry of annotated intracardiac signals during electromagnetic interference clarifies observations of pacemaker acceleration and inhibition.     

The Effect of 50 Hz External Electrical Interference on Implanted Cardiac Pacemakers

The effects of injected 50 Hz alternating current on the function of cardiac pacemakers has been observed in 18 patients with implanted unipolar VVI units. Current, in the range 0-600 microA was applied via electrodes attached to the patients' upper body and feet and fed from a specially designed current injection unit at the bedside. Most implanted pacemakers reverted to interference mode in the current range 29-250 microA. At current levels just below the reversion current all units developed irregular and inappropriate pacing. This current level was pacemaker dependent and varied in the range 27-246 microA. The total reversion current depended on the location of the injecting electrodes and on the patients' posture. The sensitivity of the units to injected interference was increased by deep inspiration. Temporary pacing catheters fitted to an additional ten patients were used to monitor the interference voltage which would be sensed by an implanted unit. This voltage was similarly dependent on patient posture and on deep respiration. Current injection has proved to be a safe, controllable and reproducible method of testing the sensitivity of implanted pacemakers to 50 Hz external interference.     

Implantable Cardioverter Defibrillator: Possible Hazards of Electromagnetic Interference

We report on three patients with an automatic, implantable cardioverter defibrillator (AICD, CPI) in whom the device had been deactivated due to electromagnetic interference. In all cases, the source of the electromagnetic disturbances could be identified.     

Incidence of Electromagnetic Interference in Implantable Cardioverter Defibrillators

KOLB, C., et al. : Incidence of Electromagnetic Interference in Implantable Cardioverter Defibrillators. Electromagnetic interference (EMI) with ICDs can lead to temporary inhibition of the device or to inappropriate delivery of antitachycardia pacing and shocks. The incidence of interactions between electronic devices and the current generation of ICDs is not known. In a retrospective study of 341 patients (665 patient-years) who underwent a regular follow-up every 3 months, five episodes of EMI were detected in four different patients. The risk for receiving inappropriate shocks due to EMI is < 1% per year and patient. In conclusion, although inappropriate delivery of shocks by ICDs due to EMI rarely occurs, patient information should emphasize the avoidance of situations of possible interference. Further efforts concerning lead technology and detection algorithms are necessary to minimize the risk of EMI.     

Inappropriate Rate Change in Minute Ventilation Rate Responsive Pacemakers Due to Interference by Cardiac Monitors

Observations of inappropriate rate increase in five patients with minute ventilation rate responsive implanted pacemakers (Telectronics Meta) are reported. Pacing rate increases were observed immediately upon connection of the resting patients to two brands of widely used cardiac monitors, and one commonly used echocardiograph. In some circumstances, the rate increase remained until monitor disconnection; in others the rate increase was transient, lasting about 20 seconds. A hardware thoracic resistance variation simulator was constructed and connected to one of the pacemakers to test sensitivity to rate modifying interference from external sources. This demonstrated that the sensitivity to interference is dependent upon the frequency of the interfering signal and is highest in the range 10–60 kHz. that peak currents as low as 10 μA can cause maximum rate increase, and that the signals injected into patients by several cardiac monitors, for purposes of lead-off detection or respiratory monitoring, fall into the frequency range at which the pacemaker is most susceptible to interference.     

Induction Ovens and Electromagnetic Interference:

Electromagnetic fields may interfere with normal pacemaker function. Despite the introduction of modern pacemakers and bipolar lead systems, electromagnetic interference (EMI) still remains to be a concern during daily lives when patients are exposed to cellular phones, electronic security systems, and several household appliances. The aim of this study was to evaluate potential EMI risk of induction ovens, which are increasingly used in private households. The study included 40 consecutive patients (22 men, 18 women; age   73 ± 11  years   ) with implanted DDD, VVI, VDD, and AAI pacemaker systems. The pacemakers were programmed to unipolar sensing and pacing. Sensitivity remained unchanged, if the measured sensing threshold was more than twice the programmed value; otherwise, it was set at half of the measured sensing threshold. Patients were placed in a sitting position at the closest possible distance of about 20 cm between two cooking pots and pacemaker bending the upper part of the body slightly over the induction oven. The energy was increased stepwise to the maximum. One pot was removed and placed again at the highest oven level. Potential interference was monitored continuously. The study showed no incidence of pacemaker malfunction during the entire test while the patients with intrinsic cardiac rhythms were exposed to the induction oven at varying energy strengths. Likewise, there was no external interference when the patients were paced at heart rates of 10–15 beats/min above their heart rates. The programmed parameters remained unchanged after the study. In conclusion, this study shows no EMI risk of an induction oven in patients with bipolar or right-sided unipolar pacemakers. (PACE 2003; 26[Pt. I]:1494–1497)