V. Barbaro

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 patients 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 patients skin over the implant, electromagnetic interference effects occurred at maximum ventricular and atrial sensing thresholds of 4 mV and 2.5 mV, respectively.

Electromagnetic Interference of Analog Cellular Telephones with Pacemakers

The aim of this study was to verify whether there is a public health risk from the interference of analog cellular telephones with pacemakers. We used a human trunk simulator to reproduce an actual implant, and two cellular telephones working with the TACS (Total Access Communication System) standard. Results showed that the electromagnetic field radiated from the analog cellular telephones interfered with a large number of the pacemakers tested (10/25). When the telephone antenna was in close proximity to the pacemaker head, pacemaker desensitizing and sensitizing and pulse inhibition was detected at the moment of an incoming call and throughout ringing. In the worst case of pulse inhibition, the pacemaker skipped three nonconsecutive beats and then resumed its normal pacing, while the desensitizing and sensitizing phenomena persisted as long as the interfering signal was on. Pulse inhibition was also observed when the connection did not succeed. Maximum sensing threshold variation was about 186% (increase) and 62% (decrease) for desensitizing and sensitizing phenomena, respectively. It was also demonstrated that the signal emitted by analog cellular telephones during the crossing of contiguous cells could induce pacemaker pulse inhibition, but under our experimental conditions this event did not seem to pose a risk for the pacemaker patient.

Computational model of the fluid dynamics of a cannula inserted in a vessel: incidence of the presence of side holes in blood flow

Vascular access methods, performed by the insertion of cannulae into vessels, may disturb the physiological flow of blood, giving rise to non-physiological pressure variations and shear stresses. To date, the hydrodynamic behaviour of the cannulae has been evaluated comparing their pressure loss-flow rate relationships, as obtained from in vitro experiments using a monodimensional approach; this methodology neither furnish information about the local fluid dynamics nor the established flow field in specific clinical work conditions. Since the shear stress is a critical factor in the design of artificial circulatory devices, more knowledge should be necessary about the local values assumed by the haemodynamic parameters during cannulation. An alternative way to investigate the fluid dynamic as accurately as possible is given by numeric studies. A 3D model of cannula concentrically placed in a rigid wall vessel is presented, with the finite element methodology used to numerically simulate the steady-state flow field in two different venous cannulation case studies, with two cannulae having a central hole and two or four side holes, respectively, with the same boundary conditions. Lower velocity and shear stress peak values have been computed for the model with four side holes upstream of the central hole, in the region of the cannula where the inlet flows meet and towards cannulas outlet, due to the increased flow symmetry and inlet area with respect to the model with two side holes. Starting from the investigation of different cannula designs, numerically assessing the local fluid dynamics, indications can be drawn to support both the design phase and the device optimal clinical use, in order to limit risks of biomechanical origin. Thus the presence of four side holes implied, as a consequence of the greater inlet area and of the increased symmetry, a less disturbed blood flow, together with reduced shear stress values. Furthermore, results show that the numerical simulations furnished useful informations on the interaction between vessel and cannula, e.g. on the fluid dynamics establishing in the free luminal space left, in the vessel, by the inserted cannula.

Automated classification of human atrial fibrillation from intraatrial electrograms.

The assessment of the degree of organization and the classification of atrial fibrillation (AF) according to the types defined by Wells usually resorts to the visual inspection of bipolar intraatrial electro‐grams. The focus of this study was to test, seven parameters aimed to quantify the degree of organization of the electrograms, and then to design a final classification scheme based on a multidimensional, minimum‐distance analysis. The following parameters were tested: mean atrial period (AP) and its coefficient of variation (CV); number of points lying at the baseline (NO) and the Shannon entropy (EN) of the amplitude probability density function (APDF); depolarization width (F‐WIDTH); and correlation waveform analysis (CWA) and electrogram bandwidth (BW). The signal database consisted in a set of 160 AF strips of Type I, II, and HI AF, scored by an expert cardiologist (60 Type I, 40 Type II, 60 Type III) and further divided in a training set (60) and a test set (100). Strips were 6 seconds long and were recorded with 5‐mm interspace bipolar catheters from electrically induced (n = 13) and chronic (n = 10) patients. A classification algorithm based on a minimum‐distance (Mahalanobis distance) discriminant analysis was tested. Using a single parameter, the best discriminations were provided by NO, F‐WIDTH, and CV. F‐WIDTH was found strongly inversely correlated to NO (r =−0.90). Of all the two‐parameter combinations, CV‐NO provided the best classification: 92 of WO segments were correctly classified with sensitivity > 90% and specificity > 92%. A further improvement was obtained by including BW as a third parameter (93/100 correctly classified). The use of more than three parameters not only failed to improve, but even degraded the classification.

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.

On the mechanisms of interference between mobile phones and pacemakers: parasitic demodulation of GSM signal by the sensing amplifier

The aim of this study was to investigate the mechanisms by which the radiated radiofrequency (RF) GSM (global system for mobile communication) signal may affect pacemaker (PM) function. We measured the signal at the output of the sensing amplifier of PMs with various configurations of low-pass filters. We used three versions of the same PM model: one with a block capacitor which short circuits high-frequency signals; one with a ceramic feedthrough capacitor, a hermetically sealed mechanism connecting the internal electronics to the external connection block, and one with both. The PMs had been modified to have an electrical shielded connection to the output of the sensing amplifier. For each PM, the output of the sensing amplifier was monitored under exposure to modulated and non-modulated RF signals, and to GSM signals (900 and 1800 MHz). Non-modulated RF signals did not alter the response of the PM sensing amplifier. Modulated RF signals showed that the block capacitor did not succeed in short circuiting the RF signal, which is somehow demodulated by the PM internal non-linear circuit elements. Such a demodulation phenomenon poses a critical problem because digital cellular phones use extremely low-frequency modulation (as low as 2 Hz). which can be mistaken for normal heartbeat.

Measure of synchronisation of right atrial depolarisation wavefronts during atrial fibrillation.

A new index of synchronisation (IS) between the electrical activity of pairs of close atrial sites during atrial fibrillation (AF) is introduced. The index assesses the probability of finding synchronous activations in intra-atrial bipolar electrograms and is based on the assumption that two activations closely spaced in time are likely to belong to the same depolarisation wavefront. A dedicated statistical treatment to test this hypothesis is also illustrated. Experimental data were obtained using a multipolar basket catheter in the right atrium in 20 patients during normal sinus rhythm (NSR), atrial flutter (AFL, one patient), high-frequency pacing (HFP, two patients) and chronic AF (17 patients), and 30 segments were obtained from each. From the 24 pairs of bipoles, a single averaged IS and its standard deviation were extracted. The IS was 1 in NSR and HFP and 0.95±0.02 during AFL. During AF, the IS provided a quantitative measure of the degree of coupling of various atrial sites. The IS varied significantly among the recording sites (range 0.38–0.96), showing a patient-dependent pattern, and decreased as the arrhythmia complexity increases. No temporal trends were observed for the IS values in any chronic AF patient. On average, in each site, the dispersion of the IS over time was lower than 32% of the mean, for all patients. Additional relevant features of the proposed index are its high temporal resolution (2s) and robustness to activation time estimation error, to missing or false detections and to the ever-changing pattern of propagation. The index of synchronisation is a descriptor of the electrophysiological properties of atrial tissues.

Evaluation of the surface-averaged load exerted on a blood element by the Reynolds shear stress field provided by artificial cardiovascular devices

Implantable prosthetic devices can often affect the recipients hemostasis, with possible hemolysis and thrombus formation. Since such devices can produce turbulent flow, it is important to characterize it as accurately as possible, by means of the Reynolds stress tensor. Some parameters related to the latter have been often used to provide a quantity related to the possible damage to blood constituents: the TSS(max), for instance, has been associated with hemolysis. It can be expressed as TSS(max)=(sigma(1)-sigma(3))/2, sigma(1) and sigma(3) being the highest and lowest principal normal stresses (PNSs) in each point of the flow. In the present work, the average value of the shear stress over a spherical surface, representative of a blood component, is derived. All three PNSs (sigma(1), sigma(2) and sigma(3)) are found to have an equal role in the determination of this parameter, since the relative formula shows a marked symmetry with respect to the PNSs. The average shear stress level, for a given (sigma(1), sigma(3)) pair (hence, for a given TSS(max)), has a minimum and maximum value, depending on the particular sigma(2) value yielded by the local structure of the turbulent flow field. A numerical investigation on more complex geometries shows similar results. The role of the intermediate PNS is thus shown for the first time to have a physical relevance. The presented results can be useful whenever a spatial averaging of the shear field is important to be assessed, such as in the case of platelet activation. A new parameter is thus proposed, which can be correlated with prosthetic devices complications.

Effect of autonomic stressors on rate control in pacemakers using ventricular impedance signal.

The aim of this study is to evaluate the heart rate adaptation obtained by a pacemaker, based on a measure of ventricular impedance in patients undergoing autonomic challenges. The evaluation procedure was based on the analysis of the mean value (MV) and heart rate variability (HRV) of RR and systolic pressure intervals, according to a set of neurovegetative stressors (controlled respiration in supine position and during active standing; mental stress; handgrip, and noninvasive sinusoidal stimulation of carotid baroreceptors). Each test lasted 5 minutes. Fifteen chronotropic incompetent patients first implanted, were studied three months after implantation. ECG, respiration activity, and noninvasive blood pressure were monitored. HRV was evaluated by spectral analysis. Variability in the low frequency (LF) and high frequency (HF) bands was compared by computing percentage and absolute powers. We found that baseline HR was 72.2 ± 5.5 beats/min, in mental stress was 76.8 ± 7.8 beats/min, in handgrip was 79.2 ± 6.3 beats/min, and in active standing was 80.9 ± 8.6 beats/min (P < 0.01, Friedmans test). During active standing, LF component was significantly higher with respect to baseline (25.7% of total power in standing; 9.4% in baseline, P < 0.01) and it was synchronous to the LF component of the arterial pressure variability. Carotid activation/deactivation by neck suction induced synchronous changes in the paced rates. In conclusion, closed loop strategy based on ventricular contractility continuously controls heart rate by tracking the sympathetic modulation to the heart. (PACE 2004; 27: 24–32)

On the monodimensional approach to the estimation of the highest reynolds shear stress in a turbulent flow.

The measurement of the Reynolds stress tensor, or at least of some of its components, is a necessary step to assess if the turbulence associated with the flow near prosthetic devices can damage blood constituents. Because of the intrinsic three dimensionality of turbulence, in general, a three-component anemometer should be used to measure directly the components of the Reynolds stress tensor. However, this can be practically unfeasible, especially in vivo; therefore, it is interesting to investigate the possibility of characterizing the turbulent flows that may occur in the circulatory system with the monodimensional data that a less complete equipment (e.g., a pulsed ultrasound Doppler) can yield. From the general expression of the Reynolds stress tensor, the highest shear stress can be deduced, as well as the Reynolds normal stress in the main flow direction. The relation between these two quantities, which is an issue already addressed in previous works, can thus be rigorously formulated in terms of some characteristic parameters of the Reynolds stress tensor, the principal normal stresses and the angles that the directions that define them form with the main flow direction. An experimental verification of the ratio of the two above-mentioned quantitites for the flow across bileaflet valves, investigated by means of two-dimensional laser Doppler anemometry, will illustrate the limitations of the monodimensional approach estimating the maximum load on blood constituents.