Impact of capped and uncapped abandoned leads on the heating of an MR-conditional pacemaker implant.

PURPOSE: To assess the risk of radiofrequency (RF)-induced heating in patients with MR-conditional pacemaker (PM) systems, in the presence of another lead abandoned from a previous implant. METHODS: Four commercial pacemaker leads were placed beside a MR-conditional PM system, inside a human trunk simulator. The phantom has been exposed to the RF generated by a 64 MHz body bird-cage coil (whole-body specific absorption rate [SAR] = 1 W/kg) and the induced heating was measured at the tip of the abandoned lead and of the MR-conditional implant. Configurations that maximize the coupling between the RF field and the leads have been tested, as well as realistic implant positions. RESULTS: Abandoned leads showed heating behaviors that strongly depend on the termination condition (abandoned-capped or saline exposed) and on the lead path (left or right positioning). Given a whole-body SAR = 1 W/kg, a maximum temperature rise of 17.6°C was observed. The presence of the abandoned lead modifies the RF-heating profile of the MR-conditional implant: either an increase or a decrease in the induced heating at its lead tip can occur, mainly depending on the relative position of the two leads. Variations ranging from -63% to +69% with respect to the MR-conditional system alone were observed. CONCLUSION: These findings provide experimental evidence that the presence of an abandoned lead poses an additional risk for the patient implanted with a MR-conditional PM system. Our results support the current PM manufacturers' policy of conditioning the MR compatibility of their systems to the absence of abandoned leads (including leads from MR-conditional implants). From a clinical point of view, in such cases, the decision whether to perform the exam shall be based upon a risk/benefit evaluation, as in the case of conventional PM systems.

An optically coupled sensor for the measurement of currents induced by MRI gradient fields into endocardial leads.

OBJECT: The gradient fields generated during magnetic resonance imaging (MRI) procedures have the potential to induce electrical current on implanted endocardial leads. Whether this current can result in undesired cardiac stimulation is unknown. MATERIALS AND METHODS: This paper provides a detailed description of how to construct an optically coupled sensor for the measurement of gradient-field-induced currents into endocardial leads. The system is based on a microcontroller that works as analog-to-digital converter and sends the current signal acquired from the lead to an optical high-speed, light-emitting diode transmitter. A plastic fiber guides the light outside the MRI chamber to a photodiode receiver and then to an acquisition board connected to a PC laptop. RESULTS: The performance of the system has been characterized in terms of power consumption (8 mA on average), sampling frequency (20.5 kHz), measurement range (-12.8 to 10.3 mA) and resolution (22.6 µA). Results inside a 3 T MRI scanner are also presented. CONCLUSIONS: The detailed description of the current sensor could permit more standardized study of MRI gradient current induction in pacemaker systems. Results show the potential of gradient currents to affect the pacemaker capability of triggering a heartbeat, by modifying the overall energy delivered by the stimulator.

Role of the lead structure in MRI-induced heating: In vitro measurements on 30 commercial pacemaker/defibrillator leads.

MRI-induced heating on endocardial leads is a serious concern for the safety of patients with implantable pacemakers or cardioverter-defibrillator. The lead heating depends on many factors and its amount is largely variable. In this study, we investigated the role of those structural properties of the lead that are reported on the accompanying documents of the device: (1) fixation modality (active vs. passive); (2) number of electrodes (unipolar vs. bipolar); (3) length; (4) tip surface; and (5) tip and ring resistance. In vitro temperature and specific absorption rate measurements on 30 leads (27 pacemakers, three implantable cardioverter-defibrillator leads) exposed to the radiofrequency field typical of a 1.5 T MRI scanner are presented. The data show that each lead has its own attitude to radiofrequency-induced heating and that the information that is available in the accompanying documents of the pacemaker is not sufficient to explain such attitude. Even if combined with that of the implant geometry, this information is still not sufficient to estimate the amount of heating due to the exposure to the radiofrequency field during MRI examination.

Daily distribution of atrial arrhythmic episodes in sick sinus syndrome patients: implications for atrial arrhythmia monitoring.

AIMS: Disorders such as paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmias (AT) are difficult to investigate because of their intermittent, and sometimes asymptomatic, nature. The aim of this study was to investigate the daily temporal distribution of AT/AF episodes--onset and occurrence--by analysing data from 250 pacemaker-implanted, brady-tachy syndrome patients who have been enrolled in the Burden II Study. METHODS AND RESULTS: Data were analysed accounting for the mode switch list which includes date, time, and duration of each mode switch episode. Chi-squared tests for goodness of fit were used to determine whether AT/AF episode were uniformly distributed. The population analysed in the present study suggests the occurrence of a circadian rhythm of paroxysmal AF episodes, similar to that described for other cardiovascular diseases, with clustering of events in the morning from 08:00 and (to a lesser degree) in the afternoon (03:00 to 18:00). The relative risk of AT/AF onset is 13% higher during daytime, 40% lower at night (P < 0.000001). CONCLUSION: The use of monitoring devices based on daily electrocardiogram (ECG) recording could be optimized with these data, thus increasing the probability to detect AT/AF episodes.

Time-domain and morphological analysis of the P wave. Part II: effects of atrial pacing on P-wave features.

BACKGROUND: The aim of this study was to compare time-domain and morphological descriptors of paced and spontaneous P wave in patients prone to atrial fibrillation (AF). METHODS: Nineteen patients (nine women, aged 72 +/- 10 years) affected by paroxysmal AF and implanted with dual-chamber pacemakers (PM) were studied. Two 5-minute recordings were performed during spontaneous and paced rhythm. Electrocardiogram (ECG) signals were acquired using a 32-lead mapping system. Patients were grouped into two classes: no previous AF and previous AF groups, according to the number of AF episodes in the 6 months before the analysis. RESULTS AND CONCLUSION: During atrial pacing P wave appeared prolonged and morphologically more complex with respect to sinus rhythm. We also found that in patients at lower risk for AF, the atrial pacing changes the atrial activation to a greater extent than in patients at higher risk for AF. Finally, all time-domain and morphological descriptors of the P wave except one succeed in discriminating "no previous AF" and "previous AF" patients in spontaneous rhythm, while no significant differences have been observed during pacing for any parameters.

Time-domain and morphological analysis of the P-wave. Part I: Technical aspects for automatic quantification of P-wave features.

INTRODUCTION: Time-domain and morphological analysis of P-wave from surface electrocardiogram has been extensively used to identify patients prone to atrial arrhythmias, especially atrial fibrillation (AF). However, since no standard procedure exists for P-wave preprocessing, standardization of cut-off values for P-wave duration and morphological features is difficult. This study is a methodological investigation of P-wave preprocessing procedures for automatic time-domain and morphological analysis. METHODS: We compared, on simulated and real data, the P-wave template obtained applying three alignment algorithms with that obtained without alignment, in terms of template error, shift error, P-wave duration, and morphological parameters. We also proposed automatic algorithms for estimation of P-wave duration. RESULTS: We found that alignment is necessary for a reliable extraction of P-wave template by the averaging procedure, in order to perform time-domain and morphological analysis. On simulated and real data, the error on P-wave duration can be as high as 30 ms on a template obtained without alignment; if alignment procedure is performed, the error on P-wave duration is negligible. Analogously, morphological features are correctly estimated only on a P-wave template obtained with P-waves alignment. We also found that the proposed algorithm for the automatic estimation of the P-wave duration gave reliable results.

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

BACKGROUND: MRI 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. METHODS: We 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. RESULTS: We 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. CONCLUSION: Our 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.

Electromagnetic immunity of infusion pumps to GSM mobile phones: a systematic review.

Electromagnetic interference with life-sustaining medical care devices has been reported by various groups. Previous studies have demonstrated that volumetric and syringe pumps are susceptible to false alarm buzzing and blocking, when exposed to various electromagnetic sources. The risk of electromagnetic interference depends on several factors such as the phone-emitted power, distance and carrier frequency, phone model and antenna type. The main recommendations and the relevant harmonized standard are also reported and discussed. >From the data available in literature emerges that, for distances lower than 1 m there is a non negligible risk of electromagnetic interferences, although significant differences exists in the reported minimum distances. Interference effects clinically relevant for the patients are rare. No permanent damage to the pumps has been ever reported, although in several cases intervention of personnel is required to resume normal operation.

Interference between mobile phones and pacemakers: a look inside.

In this study we analyzed the problem of electromagnetic interference (EMI) between mobile telephones and cardiac pacemakers (PM), by looking at the mechanisms by which the radiated radio frequency (RF) GSM signal may affect the pacemaker function. From a literature review on this topic, we noticed that older pacemakers had a higher rate of being affected by mobile phones when compared to newer ones. This is probably due to the fact that new generation of PM are more protected against electromagnetic field, being equipped with RF feedthrough filters incorporated to the internal PM circuitry. In some experiments conducted by our group, we found that modulated RF signals are somehow demodulated by the PM internal non-linear circuit elements, if no feedthrough assembly is incorporated inside the PM. Such demodulation phenomenon poses a critical problem because digital cellular phones use extremely low-frequency modulation (as low as 2 Hz), that can be mistaken for normal heartbeat. The feedthrough assembly seems instead to prevents the RF signals from accessing the PM enclosure, thus attenuating EMI signals over a broad range of frequencies.

Magnetic-resonance-induced heating of implantable leads.

In this study a methodological approach for measuring temperature and local absorption rate (SAR) on thin metallic structures, such as pacemaker (PM) leads, is provided. First preliminary experiments were performed to evaluate the error in temperature and SAR measurements made by fluoroptic temperature probes when the temperature probe is in different contact configuration with the PM lead tip. Our results show how the position of temperature probes affects the temperature and SAR value measured at the lead tip. The transversal contact between the thermal sensor and the lead tip is the configuration which leads to the highest values for temperature and SAR. In the second part of this paper we describe two physical models of a human trunk and an experimental set-up to investigate the influence of the implant geometry and of the lead path on the heating and the local SAR deposition. Experiments reveled that the implant location and configuration are crucial elements for the heat generation at the lead tip.

P-wave Variability and Atrial Fibrillation.

The analysis of P-wave template has been widely used to extract indices of Atrial Fibrillation (AF) risk stratification. The aim of this paper was to assess the potential of the analysis of the P-wave variability over time in patients suffering from atrial fibrillation. P-wave features extracted from P-wave template together with novel indices of P-wave variability have been estimated in a population of patients suffering from persistent AF and compared to those extracted from control subjects. We quantify the P-wave variability over time using three algorithms and we extracted three novel indices: one based on the cross-correlation coefficients among the P-waves (Cross-Correlation Index, CCI), one associated to variation in amplitude of the P-waves (Amplitude Dispersion Index, ADI), one sensible to the phase shift among P-waves (Warping Index, WI). The control group resulted to be characterized by shorter P-wave duration and by a less amount of fragmentation and variability, respect to AF patients. The parameter CCI shows the highest sensitivity (97.3%) and a good specificity (95%).

Regulatory frameworks for mobile medical applications.

A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.

Wrong detection of ventricular fibrillation in an implantable cardioverter defibrillator caused by the movement near the MRI scanner bore.

The static magnetic field generated by MRI systems is highly non-homogenous and rapidly decreases when moving away from the bore of the scanner. Consequently, the movement around the MRI scanner is equivalent to an exposure to a time-varying magnetic field at very low frequency (few Hz). For patients with an implanted cardiac stimulators, such as an implantable cardioverter/defibrillator (ICD), the movements inside the MRI environment may thus induce voltages on the loop formed by the leads of the device, with the potential to affect the behavior of the stimulator. In particular, the ICD's detection algorithms may be affected by the induced voltage and may cause inappropriate sensing, arrhythmia detections, and eventually inappropriate ICD therapy.We performed in-vitro measurements on a saline-filled humanshaped phantom (male, 170 cm height), equipped with an MRconditional ICD able to transmit in real-time the detected cardiac activity (electrograms). A biventricular implant was reproduced and the ICD was programmed in standard operating conditions, but with the shock delivery disabled. The electrograms recorded in the atrial, left and right ventricle channels were monitored during rotational movements along the vertical axis, in close proximity of the bore. The phantom was also equipped with an accelerometer and a magnetic field probe to measure the angular velocity and the magnetic field variation during the experiment. Pacing inhibition, inappropriate detection of tachyarrhythmias and of ventricular fibrillation were observed. Pacing inhibition began at an angular velocity of about 7 rad/s, (dB/dt of about 2 T/s). Inappropriate detection of ventricular fibrillation occurred at about 8 rad/s (dB/dt of about 3 T/s). These findings highlight the need for a specific risk assessment of workers with MR-conditional ICDs, which takes into account also effects that are generally not considered relevant for patients, such as the movement around the scanner bore.

Electromagnetic immunity of implantable pacemakers exposed to wi-fi devices.

The purpose of this study is to evaluate the potential for electromagnetic interference (EMI) and to assess the immunity level of implantable pacemakers (PM) when exposed to the radiofrequency (RF) field generated by Wi-Fi devices. Ten PM from five manufacturers, representative of what today is implanted in patients, have been tested in vitro and exposed to the signal generated by a Wi-Fi transmitter. An exposure setup that reproduces the actual IEEE 802.11b/g protocol has been designed and used during the tests. The system is able to amplify the Wi-Fi signal and transmits at power levels higher than those allowed by current international regulation. Such approach allows one to obtain, in case of no EMI, a safety margin for PM exposed to Wi-Fi signals, which otherwise cannot be derived if using commercial Wi-Fi equipment. The results of this study mitigate concerns about using Wi-Fi devices close to PM: none of the PM tested exhibit any degradation of their performance, even when exposed to RF field levels five times higher than those allowed by current international regulation (20 W EIRP). In conclusion, Wi-Fi devices do not pose risks of EMI to implantable PM. The immunity level of modern PM is much higher than the transmitting power of RF devices operating at 2.4 GHz.

Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part I: medical devices.

Radiofrequency identification (RFID) technology has acheived significant success and has penetrated into various areas of healthcare. Several RFID-based applications are used in various modalities with the ultimate aim of improving patient care. When a wireless technology is used in a healthcare environment, attention must be paid to the potential risks deriving from its use; one of the most important being electromagnetic interference with medical devices. In this paper, the regulatory framework concerning the electromagnetic compatibility between RFID and medical devices is analyzed to understand whether and how the application of the current standards allows for the effective control of the risks of electromagnetic interference.

Radiofrequency identification and medical devices: the regulatory framework on electromagnetic compatibility. Part II: active implantable medical devices.

The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.

On the resolution of ECG acquisition systems for the reliable analysis of the P-wave.

The analysis of the P-wave on surface ECG is widely used to assess the risk of atrial arrhythmias. In order to provide reliable results, the automatic analysis of the P-wave must be precise and reliable and must take into account technical aspects, one of those being the resolution of the acquisition system. The aim of this note is to investigate the effects of the amplitude resolution of ECG acquisition systems on the P-wave analysis. Starting from ECG recorded by an acquisition system with a less significant bit (LSB) of 31 nV (24 bit on an input range of 524 mVpp), we reproduced an ECG signal as acquired by systems with lower resolution (16, 15, 14, 13 and 12 bit). We found that, when the LSB is of the order of 128 µV (12 bit), a single P-wave is not recognizable on ECG. However, when averaging is applied, a P-wave template can be extracted, apparently suitable for the P-wave analysis. Results obtained in terms of P-wave duration and morphology revealed that the analysis of ECG at lowest resolutions (from 12 to 14 bit, LSB higher than 30 µV) could lead to misleading results. However, the resolution used nowadays in modern electrocardiographs (15 and 16 bit, LSB <10 µV) is sufficient for the reliable analysis of the P-wave.

RFID in healthcare environment: electromagnetic compatibility regulatory issues.

Several wireless technology applications (RFID, WiFi, GSM, GPRS) have been developed to improve patient care, reaching a significant success and diffusion in healthcare. Given the potential development of such a technology, care must be paid on the potential risks deriving from the use of wireless device in healthcare, among which one of the most important is the electromagnetic interference with medical devices. The analysis of the regulatory issues concerning the electromagnetic compatibility of medical devices is essential to evaluate if and how the application of the current standards allows an effective control of the possible risks associated to the electromagnetic interference on medical devices.

Numerical model for estimating RF-induced heating on a pacemaker implant during MRI: experimental validation.

MRI may cause tissue heating in patients implanted with pacemakers (PMs) or cardioverters/defibrillators. As a consequence, these patients are often preventatively excluded from MRI investigations. The issue has been studied for several years now, in order to identify the mechanisms involved in heat generation, and define safety conditions by which MRI may be extended to patients with active implants. In this sense, numerical studies not only widen the range of experimental measurements, but also model a realistic patient's anatomy on which it is possible to study individually the impact of the many parameters involved. In order to obtain reliable results, however, each and every numerical analysis needs to be validated by experimental evidence. Aim of this paper was to design and validate through experimental measurements, an accurate numerical model, which was able to reproduce the thermal effects induced by a birdcage coil on human tissues containing a metal implant, specifically, a PM. The model was then used to compare the right versus left pectoral implantation of a PM, in terms of power deposited at the lead tip. This numerical model may also be used as reference for validating simpler models in terms of computational effort.

P-wave characteristics after electrical external cardioversion: predictive indexes of relapse.

Atrial fibrillation (AF) is the most common arrhythmia in the western countries and accounts for hundred thousand strokes per year. Electrocardiographic characteristics of AF have been demonstrated to help identify patients at risk of developing AF. Prolonged and highly fragmented P-waves have been observed in patients prone to AF, and time-domain. Morphological characteristics of the P-wave from surface ECG recordings turned out to significantly distinguish patients at risk of AF. The aim of this study is to evaluate the morphological and time-domain characteristics of the P-wave in patients with AF relapse after cardioversion, respect to patients without. 14 patients who underwent successful electrical cardioversion for persistent AF were enrolled. Five minute ECG recordings were performed for each subject, immediately post-successful cardioversion. ECG signals were acquired by using a 16-lead mapping system for high-resolution biopotential measurements (sample frequency 2 kHz, 31 nV resolution, 0-400 Hz bandwidth). From the 16 recordings, a standard 12-lead ECG was derived and analyzed in terms of signal-averaged P-wave. Time-domain and mor-phological characteristics were estimated from the averaged P-waves of each lead. Time-domain features were quantified as: maximum P-wave duration in any of the 12 leads (Pmax), minimum P-wave duration in any of the leads (Pmin), P-wave dispersion (Pdisp=Pmax-Pmin), and Pindex (standard devia-tion of P-wave duration in any of the 12 leads). Morphological characteristics were extracted from a Gaussian function-based model of the P-wave as: average model order (Nav), maximum number of zero-crossing (PCmax), and maximum and average number of maxima and minima (FCImax and FCIav) in any of the leads. The results obtained so far indicate that the morphological and time-domain characteristics distinguish between patients with AF relapse and patients without.