Interactions between Pacemakers and Security Systems

Electromagnetic fields arising from a variety of different sources have been shown to interfere with normal pacemaker function. This study evaluated the possible interactions between two modern security systems and different pacemaker types. Fifty–three patients (27 single chamber pacemakers, 25 dual chamber pacemakers) have been tested routinely for their pacemaker function. Thirty–eight patients presented with unipolar sensing and 15 with bipolar sensing. The patients were asked to walk through an installed security system, an antitheft device, and electromagnetic access device with different field strengths while a six–channel ECG monitored the patients. The pacemaker systems were first measured in their basic programmed modes, then the intervention frequency was changed to 100/min and, thereafter, the maximum sensitivity without T wave over– sensing was added. In the security system with the highest field strength (2,700 mA/m), a pacemaker malfunction could be observed in 13% of the monitored patients. In one case, a pacemaker (VVIR) switched to ventricular safety pacing (VOO mode). In the security system with the lower field strength (1,600 mA/m) we found a pacemaker malfunction in 4% of the tested patients. In the antitheft device (50 mA/m). in the electromagnetic access device (300 mA/m), and in pacemaker systems with bipolar sensing, none of these dysfunctions were observed. Phantom programming as described previously did not occur in any of the systems. Persons who are often in the vicinity of security systems should be equipped with a bipolar pacemaker system. Our findings indicate that patients with pacemakers should avoid contact with security systems.     

植入心脏起搏器患者回归社会健康知识需求调查

目的总结永久性心脏起搏器植入术患者回归社会所需健康教育知识要点。方法通过20例永久性心脏起搏器植入术患者回归社会健康知识需求问卷调查,总结健康知识要点。根据患者健康教育前后对所需知识的掌握情况作出效果评价。结果分别有100％和90％的患者将安全需求和社会适应能力需求列为最需要掌握的知识,并且通过健康教育使永久性心脏起搏器植入术患者对回归社会所需知识掌握程度有显著提高（P〈0.01）。结论通过对患者实施有针对性的健康教育,可以解除患者出院后心理负担,使其能够更好地对自身进行护理,保障患者生命安全,提高患者生活质量。     

Electronic security systems and active implantable medical devices

IRNICH, W.: Electronic Security Systems and Active Implantable Medical Devices. How do active implantable medical devices react in the presence of strong magnetic fields in the frequency range between extremely low frequency (ELF) to radiofrequency (RF) as they are emitted by electronic security systems (ESS)? There are three different sorts of ESSs: electronic article surveillance (EAS) devices, metal detector (MDS) devices, and radiofrequency identification (RFID) systems. Common to all is the production of magnetic fields. There is an abundance of literature concerning interference by ESS gates with respect to if there is an influence possible and if such an influence can bear a risk for the AIMD wearers. However, there has been no attempt to study the physical mechanism nor to develop a model of how and under which conditions magnetic fields can influence pacemakers and defibrillators and how they could be disarmed by technological means. It is too often assumed that interference of AIMD with ESS is inevitable. Exogenous signals of similar intensity and rhythm to heart signals can be misinterpreted and, thus, confuse the implant. Important for the interference coupling mechanism is the differentiation between a “unipolar” and a “bipolar” system. With respect to magnetic fields, the left side implanted pacemaker is the most unfavorable case as the lead forms approximately a semicircular area of maximum 225 cm² into which a voltage can be induced. This assumption yields an interference coupling model that can be expressed by simple mathematics. The worst‐case conditions for induced interference voltages are a coupling area of 225 cm² that is representative for a large human, a homogeneous magnetic field perpendicular to the area formed by the lead, and a unipolar ventricular pacemaker system that is implanted on the left side of the thorax and has the highest interference sensitivity. In bipolar systems the fields must be 17 times larger when compared to a unipolar system to have the same effect. The magnetic field for interfering with ICDs must be 1.7 stronger than that of the most sensitive unipolar pacemaker. The lowest interference thresholds measured over the last 10 years in the low frequency range (16 2/3 Hz–24 kHz) together with thresholds > 24 kHz that were supplied by the CETECOM study are listed. Both sets of data together with the coupling model, allow for judging which fields of ESSs could influence AIMDs. From measurements at gate antennas, it is possible to derive a “maximum allowed field” curve over the whole frequency range, below which no interference will occur. Comparison of data from literature with these maximum allowed fields confirm the correctness of the calculations. Thus, it is possible to predict interference situations in gates if the magnetic field is known. If all future pacemakers were to have the immunity against interference of the better 50% of today's pacemakers, the magnetic field ceiling values could be at least four times higher. The same is true if the ventricular sensitivity is routinely set at 7 mV. Pacemaker manufacturers should consider filter improvement with modern technology, but gate manufacturers should not claim the privilege of being out of bounds.     

Electromagnetic Interference of an Implantable Loop Recorder by Commonly Encountered Electronic Devices

De COCK, C.C., et al. : Electromagnetic Interference of an Implantable Loop Recorder by Commonly Encountered Electronic Devices. Electromagnetic interference of pacemaker systems has been well established and can lead to an inappropriate function of these devices. Recently, an implantable loop recorder (ILR) (REVEAL, Medtronic Inc.) has been introduced to evaluate the possible arrhythmic etiology of patients with recurrent syncope. We evaluated the interference of this device in two patients with implantable ILR and in three nonimplanted ILRs with four electromagnetic sources: cellular phones (GSMs), electronic article surveillance systems (EASs), metal detector gates (MDGs), and magnetic resonance imaging (MRI). The GSM did not affect appropriate function of the ILR whereas radiofrequency (RF) EAS could interfere with normal function in implanted and nonimplanted systems. The MDG had no influence on ILR function. The magnetic field induced by the MRI resulted in an irreversible error in one nonimplanted ILR. Therefore, although interference between electromagnetic sources and ILRs appears to be rare in our study, physicians should be aware of possible malfunctioning of these devices.     

Comparison of Myopotential Interference in Unipolar-Bipolar Programmable DDD Pacemakers

Myopotential interference (MPI) can inhibit or trigger single and dual chamber unipolar pacemakers while bipolar pacemakers are resistant. Twenty units of two different models of dual chamber pacemaker, each capable of being programmed to single chamber or dual chamber and unipolar or bipolar function were tested to provoke myopotential interference. No patient had evidence of myopotential interference at any sensitivity setting in the bipolar configuration either in atrium or in ventricle. All patients (20/20) interfered with pacemaker function at the highest atrial or ventricular sensitivity settings in the unipolar configuration. T wave sensing occurred at the 0.25 mV sensitivity setting in four patients in pacemaker model 925, in both bipolar and unipolar configurations. Twenty-five percent of patients had myopotential interference at the unipolar atrial sensing threshold and did not allow a setting which would reject myopotential interference while providing satisfactory atrial sensing. Twenty percent (2/10) had myopotential caused ventricular inhibition at the least sensitive ventricular channel setting in model 240G so that myopotential interference could not be avoided in that unit no matter how large the electrogram.     

Central venous oxygen saturation for the control of automatic rate-responsive pacing

A rate-adjusting pacemaker system is described which uses central venous oxygen saturation (SO2) for the regulation of the pacing rate. This system was tested externally in ten patients with chronically implanted VVI units. There was an average increase in cardiac output of 18% with the SO2-regulated pacemaker as compared to the situation during fixed rate stimulation. Central venous oxygen saturation appears to be an ideal biological parameter for autoregulating the pacing rate. It represents the only sensor suitable for the realization of a closed feedback loop concept.     

Apparent Pacemaker Failure due to Reversion Circuitry within the Programming Device

While being evaluated for a recurrent tachyarrhythmia, a patient with a permanent pacemaker underwent reprogramming of the unit from the DVI to the VVI mode for assessment of the underlying rhythm. Subsequent reprogramming of the pacemaker to the DVI or DDD mode was impossible despite multiple attempts and the use of multiple programmers. The problem was considered to be a malfunction of the pacemaker circuitry, and plans were made for the pacemaker to be explanted and a replacement unit implanted. Before the procedure, the pacemaker company was notified of the explantation. We subsequently learned that a special programming sequence had to be carried out because of reversion circuitry present in the pacemaker but not described in the available literature. This report emphasizes the need for familiarity with each of the individual pacemakers being implanted and the need for the manufacturer to be as specific as possible given the complexity of current units.     

Influence of D-net (EUROPEAN GSM-standard) cellular telephones on implanted pacemakers in children

This study was designed to evaluate possible interactions between digital cellular telephones and implanted pacemakers in children. The study comprised 95 patients (53 males and 42 females) with a mean age of 11.5 +/- 4.6 years (range 1-22 years). The average time from pacemaker implantation was 2.5 years (range 1 month-12 years). Fourteen (15%) devices were dual chamber and the remaining were single chamber pacemakers. The following companies manufactured the pacemakers tested: Medtronic (n = 42), Telectronics (n = 9), Vitatron (n = 16), Pacesetter (n = 19), CPI (n = 8), and Biotronik (n = 1). All the patients were tested in the supine position during continuous ECG monitoring. After completion of the routine pacemaker check, the effects of the European Global system for mobile communication (GSM) was tested using two cellular telephone models (Ericsson GA 628 and Siemens S 25, 2-W power). For this purpose, atrial and ventricular sensitivity settings were programmed to the most sensitive values, and the tests were carried out in the unipolar and bipolar sensing modes. The evaluation was performed during ringing, switching on/off, and conversation phase with the cellular telephone positioned over the pulse generator and around the pacemaker pocket. A malfunction of the pacemaker was not observed in any patient. Only 1 (1%) of 95 patients showed a brief oversensing problem during calls with the cellular telephone. In this case, an AAIR pacemaker was implanted transvenously in a subcutaneous pocket and the sensing defect occurred only with the unipolar sensing mode and was not reproducible. Once the source of interference was removed, no sensing defect was detected and the patient remained asymptomatic. No symptoms were experienced in this study. The authors believe that pacemaker dependent patients with nonprotected pulse generators manufactured at the beginning of 1990s may be tested by their physicians for possible interferences before they use a digital cellular telephone.     

Hepatitis C virus RNA in blood units with antibodies detectable by a second-generation passive hemagglutination assay,antibodies to synthetic core peptides or elevated transaminase levels

Blood units from 3383 donors were tested for antibodies to hepatitis C virus (HCV) by a second-generation passive hemagglutination assay (PHA-2) with detector cells coated with three recombinant HCV proteins. They were tested also for antibodies to synthetic HCV core peptides (anti-CP9 and anti-CP10) by enzyme immunoassays and for alanine aminotransferase (ALT). PHA-2 was reactive in 32 (0.9%) units, high-titered anti-CP9 and/or anti-CP10 was detected in 101 (3.0%), and elevated ALT levels (> 45IU/L) in 99 (2.9%). At least one of these markers were detected in 209 units (6.2%), and HCV RNA was tested for in 197 of them. HCV RNA was detected in 21 units including 19 initially reactive on PHA-2 of which 17 were repeatedly reactive, 19 with anti-CP9 and/or anti-CP10 in high titers, and 5 with elevated ALT levels. Two units were reactive only on PHA-2, while the other two had anti-CP9/anti-CP10 as the sole indicator of hepatitis C viremia. These results indicated that PHA-2 and anti-CP9/anti-CP10 would be complementary in detecting blood units with HCV RNA, and effective in further decreasing the risk of post-transfusion hepatitis C.     

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.     

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) rate in all Telectronics, all Pacesetter, some Vitatron and CPI units; (3) slow and irregular pacing in one CPI and in all Cordis units; (4) mixed behavior over a critical range of field strengths in which slow and irregular pacing preceded reversion to fixed-rate, in some Telectronics 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 to encounter electric fields strong enough to interfere with pacemaker behavior, this possible hazard should be recognized.     

Testing of Work Environments for Electromagnetic Interference

A challenge for pacemaker therapists is whether a patient working in an environment with the potential for electromagnetic interference (EMI) can return to their work after a pacemaker has been implanted. Common practice has been to prohibit pacemaker patients from using electric welding machines. Twelve work environments and a new method for monitoring the pacemaker rhythm in the presence of EMI were tested. The new method uses a special memory called the event record found in several Siemens Pacesetter pacemaker models. Surface ECGs with a marking system, intracardiac electrograms, and a digital monitor were used to verify the results with event records. The results from several sources of EMI are reported. Twenty-one in vivo and in vitro tests were performed in the work environments of 12 patients. Event records were useful and accurate both in vivo and in vitro. Electric arc welding machines up to 225 A did not affect these pacemakers. Arc welding machines using 1,000 A or more inhibited the in vitro test system within 1 or 2 meters of the weld or power generator. Electric welding machines with high frequency voltage superimposed on the welding current affected the pacemaker when it was within 2 meters of the power unit and 1 meter of the weld. Very large industrial degaussing coils affected pacemakers within 2 meters. The test method using event records was found to be an effective addition to monitoring the pacemaker. These results are specific for the pacemaker models tested. Such testing allows the physician to make a knowledgeable decision regarding return to work for the pacemaker patient in a high EMI environment.     

Treadmill Assessment of an Activity-Modulated Pacemaker: The Importance of Individual Programming

Maximum benefit from a rate-modulated pacemaker requires individualized programming of rate response settings. We tested an externally strapped activity-sensing pacemaker (Activitrax-Medtronic 8400) in eight healthy volunteers, to assess the pacing responses of the different rate response and activity threshold settings. Five males and three females, aged 20 to 70 years (mean 40), performed a total of 67 treadmill exercise tests, using a specific protocol designed to assess the activity-sensing unit. The external unit was compared to implanted units in four patients, to validate its accuracy. A reproducible sinus response to the treadmill protocol was observed, against which pacing responses were compared. The activity threshold determines the degree of activity required to elicit a pacing rate response, whereas the rate response setting determines the rate attained. Rates of 140 bpm were rarely achieved, despite vigorous exercise. The sensor responds rapidly to activity, not to physiologic demand; to increase in speed, not grade. Four patients performed repeated limited treadmill tests to determine their optimum program setting, with symptomatic status and the healthy volunteer sinus response as guides. These results, and those from the external Activitrax unit, suggest that LOW 6 and MEDIUM 6-10 settings will prove optimum for most patients.     

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.     

Resetting of DDD Pacemakers Due to EMI

Multiprogrammable pacemakers have long been subject to inappropriate reprogramming and electromagnetic interference (EMI). A limited clinical experience with DDD pacing systems precludes the significance of such phenomena in these units. Since August 1981, in a series of 140 DDD systems, certain units demonstrated consistent and reproducible resetting to the back-up modes caused by electrocautery. One unit was permanently reset to the VOO mode. These observations suggest the need for renewed caution at the time of surgery; they also underscore the importance of a thorough understanding of any DDD system and careful follow-up so that such phenomena will not be misinterpreted as pacemaker failure, resulting in erroneous pacemaker removal.     

Cardiac safety of conducted electrical devices in pigs and their effect on pacemaker function

Objective

The aims of this study are to evaluate the cardiac safety of the Stinger S-200 Conducted Energy Weapon Device (CED) (Stinger Systems, Tampa, Fla) on a human-sized pig model and to test the effect of various commercially available CEDs, specifically the Stinger S-200, TASER M26 (Taser International, Scottsdale, Ariz), and TASER X26 on pacemaker function.

Methods

Two groups of pigs, divided based on weight as group 1 (n = 3, 67.3 ± 4.7 kg) and group 2 (n = 3, 89.3 ± 1.2 kg), were used. In protocol 1, the Stinger S-200 was applied in multiple different orientations to simulate possible field scenarios across the heart. In protocol 2, a single-chamber bipolar lead connected to a pacemaker was placed in the right ventricle of the pig, and different CEDs were applied to test the pacemaker function during CED application.

Results

In protocol 1, the S-200 was applied a total of 216 times in the 6 pigs, and neither episodes of ventricular fibrillation nor episodes of sustained ventricular tachycardia were noted. In protocol 2, the CED discharges (1) were recognized by the pulse generator and sensed as either high-rate atrial or ventricular activity, (2) did not affect the native rhythm, (3) did not conduct down the lead systems to cause any extra systoles, and (4) had no effect on paced rhythm.

Conclusions

In this model, the application of the S-200 in various orientations across the heart did not result in any sustained abnormal cardiac rhythms. None of the tested CEDs adversely affected the functioning of the tested pacemaker. Stinger Systems has now replaced the S-200 with the S-200T with a different output.     

Effects of capsule endoscopy on cardiac pacemakers

BACKGROUND AND STUDY AIMS: Capsule endoscopy is a new, noninvasive diagnostic technique which enables visualization of the mucosa of the small intestine in physiological conditions and without the need to subject the patient to external radiation. Wireless capsule video endoscopy is contraindicated in patients with a cardiac pacemaker. However, on the basis of the characteristics of the radiofrequency band used by the endoscopic capsule, together with a series of other factors, it is possible that the patient's use of a pacemaker should not be a contraindication to capsule endoscopy. PATIENTS AND METHODS: This work had two phases: an in vitro study, using an interference detector, and an in vivo study involving 20 patients with cardiac pacemakers who showed symptoms or signs that justified a capsule endoscopy investigation. RESULTS: No interference was observed during the first, in vitro, phase of the study. In the second phase, patients wore a Holter recorder for a mean time of 10 hours, during which the average number of recorded QRS complexes exceeded 30,000. All the pacemakers functioned normally. Interference due only to myopotentials was detected in a single patient in whom modification of the pacemaker programming was necessary. In the other 19 patients, neither sensing nor stimulation failures were observed. CONCLUSIONS: No interference between the pacemaker and the endoscopic capsule was observed. All the pacemakers functioned normally, and no increased incidence of adverse effects was observed. Neither was any pacemaker-induced interference observed on the capsule endoscopy images.     

Chronotropic Response of an Activity Detecting Pacemaker Compared with the Normal Sinus Node

We compared the rate responsiveness of an activity-detecting muitiprogrammable, single chamber pacemaker (Medtronic Acfivitrax) to rate responsiveness of the normal sinus node. This pacemaker changes its basic pacing rate in response to physical activity. The rate responsiveness is programmable by selecting one of three activity thresholds, and one of 10 rate response settings. The study included a group of six normal volunteers and 12 patients implanted with Activitrax to examine the similarity of the pacemaker rate to normal sinus rhythm during acceleration and deceleration. The pacemaker was set to Activity mode, at a basic rate of 60 bpm. In voiunteers, the device was externally secured on the chest wall and tested at two programmed settings. When programmed at a high threshold of activity and high rate response in voiunteers, there was no significant difference in maximum normal sinus rates and pacemaker rates during arm waving, jumping in place, and walking during stress testing. At a medium activity threshold, the only significant difference occurred during submaximal stess testing, when the maximum sinus rate achieved was 141 ± 19 bpm and the maximum pacing rate was 105 ± 8 bpm (p < .02). The pacemaker behaved in a similar manner in patients, successfully simulating the typical fast acceleration and slow deceleration of a normal sinus node in exercise testing. There was no difference in pacer response when implanted in abdominal or in/raclavicular locations. The implanted units have functioned normally over a follow-up period of nine to 22 months. Activitrax can be programmed to achieve physiologic pacing rates in response to normal daiiy activities with appropriate programming.     

Multiple pulse generator malfunctions with a dual chamber pacemaker

The aim of this study was to evaluate the dual chamber uni/bipolarpacemaker Minidual 50, manufactured by Sorin Biomedica. Between 1995 and 1998, 66 Minidual 50 models were implanted at the Heart Institute. During the follow-up period of 33 +/- 12.8 months (range 0-50 months), total function loss in seven (10.6%) units and false threshold measurement of sensing and pacing in three (4.5%) patients were observed. Average time from implantation to malfunction was 37 months (range 28-42). Malfunction was unrelated to battery status and could not be predicted by any measures obtained during the pacemaker follow-up period. Kaplan Meyer survival curve predicted a 70% 4-year malfunction-free survival of that pacemaker model. Given this high rate of total malfunction and the unpredictable nature of its occurrence, the authors recommend the replacement of all remaining Minidual 50 units at risk, at least in dependent patients.     

Learning retention in patients receiving midazolam during permanent pacemaker implantation.

This pilot study (N = 20) tested the effects of intravenous midazolam administration on learning retention after pacemaker implantation. Patients were randomized to receive teaching at 1 or 3 hours after the last dose of midazolam. Using a standardized teaching format, one of two study nurses performed the teaching that included incision care, activity restrictions, environmental factors potentially affecting pacemaker function, and follow-up requirements. Learning was evaluated by one of the investigators blinded to teaching time. Subjects in the 1-hour group retained significantly less information than those taught at 3 hours after drug administration. Patients taught later answered similar numbers of questions correctly, whereas there was much more variability in correct responses for the group taught earlier. This article reviews the effects of midazolam on memory and learning as well as provides suggestions for alterations in patient education protocols for patients receiving midazolam for pacemaker implantation. The effect of shortened length of stay on care practices is also discussed.