Risk Assessment for Workers with Wearable Medical Devices Exposed to Electromagnetic Fields.

The exponential diffusion of wearable medical devices (WMD) in recent years has involved people of all ages, including workers. Workers who use WMDs should be considered at a particular risk from electromagnetic fields, and in accordance with EU Directive 2013/35/EU, they require an individual risk assessment. Currently, there is no international standard that provides specific guidance on how to perform such a risk assessment.

Personalized Antiarrhythmic Therapy Using a Self-Managed Daily-ECG Device.

A 50-year-old Caucasian man arrived at the emergency department presenting paucisymptomatic atrial fibrillation. Once discharged after the appropriate treatments, the patient continued to have paucisymptomatic episodes. For this reason, he was provided with the Cardionica device which made it possible to better investigate the type of arrhythmic episodes, in order to tailor his therapy and to finally restore a normal sinus rhythm in the patient.

Pacemakers, Implantable Defibrillators, and 5G Technology: What We Need to Know.

Pacemakers (PM) and implantable cardioverter defibrillators (ICD) are active implantable medical devices (AIMD) needed in case of cardiac arrhythmias. Given their potentially life-sustaining nature, the interaction between any source of electromagnetic field and these AIMDs is an ongoing concern of patients, industry, and regulators. According to the current regulatory framework, the required immunity of PM and ICD provides a reasonable unperturbed behavior in the presence of cell phones and base stations that use pre-5G technologies.

5G Service and Pacemakers/Implantable Defibrillators: What Is the Actual Risk?

Rapidly growing worldwide, 5G service is expected to deeply change the way we communicate, connect and share data. It encompasses the whole spectrum of new technology, infrastructure and mobile connectivity, and will touch not only every sector in the industry, but also many aspects of our everyday life. Although the compliance with international regulations provides reasonable protection to public health and safety, there might be specific issues not fully covered by the current technical standards.

iPhone 12 MagSafe technology and cardiac implantable devices: Assessment of the actual risk.

Background: Pacemaker (PM) and implantable cardioverter defibrillators (ICD) are equipped with a magnetic sensor activated by external application of magnets to easily manage some functions of these devices. If activated inadvertently or outside a controlled environment and without the supervision of clinical personnel, this magnetic mode introduces a potential risk. In reality, the possibility of a static magnetic field affecting a PM or ICD is remote.

Estimate and reporting of longevity for cardiac implantable electronic devices: a proposal for standardized criteria.

Background: Cardiac implantable electronic devices (CIEDs) are widely used according to consensus guidelines in various patient categories. The longevity of CIED is a major determinant of the frequency with which patients require device replacement. Given the mismatch between the useful life of the devices and patient survival, device replacement is often needed.

Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations.

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

Electrical Stun Gun and Modern Implantable Cardiac Stimulators: Update for a New Stun Gun Model.

In 2017, the Italian National Institute of Health conducted a study to evaluate the potential risks of Conducted Electrical Weapons (CEW, AKA "stun guns") for users bearing a pacemaker (PM) or an implantable cardioverter defibrillator (ICD). The study addressed two specific models of stun guns: the TASER model X2 and AXON model X26P. In 2019, the same experimental protocol and testing procedure was adopted to evaluate the risk for another model of stun gun, the MAGEN model 5 (MAGEN, Israel).

Linking Pain Sensation to the Autonomic Nervous System: The Role of the Anterior Cingulate and Periaqueductal Gray Resting-State Networks.

There are bi-directional interactions between the autonomic nervous system (ANS) and pain. This is likely underpinned by a substantial overlap between brain areas of the central autonomic network and areas involved in pain processing and modulation. To date, however, relatively little is known about the neuronal substrates of the ANS-pain association.

A new insight on postural tachycardia syndrome in 102 adults with hypermobile Ehlers-Danlos Syndrome/hypermobility spectrum disorder.

There is an association between joint hypermobility, hypermobile Ehlers-Danlos syndrome (hEDS) and different forms of orthostatic intolerance. Objective: to explore autonomic profile in a large cohort of adults with hEDS and hypermobility spectrum disorder (hEDS/HSD) with a multimodal approach. In this observational retrospective study, heart rate, blood pressure and baroreflex sensitivity were estimated in 102 hEDS/HSD subjects during deep breathing, Valsalva maneuver, standing up: 30-15 ratio, Head-Up Tilt and sustained handgrip.

[Assessment of the risk due to exposure to EMF with particular reference to the protection of sensitive subjects].

Purpose. The work illustrates useful elements for the risk assessment for workers exposed to electromagnetic fields, also in reference to sensitive subjects such as those with active implantable medical devices (AIMD). Methods.

Electrical Stun Gun and Modern Implantable Cardiac Stimulators.

The aim of the study is to investigate systematically the possible interactions between two types of stun guns and last-generation pacemakers and implantable defibrillators. Experimental measurements were performed on pacemakers and implantable defibrillators from five leading manufacturers, considering the effect of stun gun dart positioning, sensing modality, stun gun shock duration, and defibrillation energy level. More than 300 measurements were collected.

Brain-Heart Pathways to Blood Pressure-Related Hypoalgesia.

Objective: High blood pressure (BP) is associated with reduced pain sensitivity, known as BP-related hypoalgesia. The underlying neural mechanisms remain uncertain, yet arterial baroreceptor signaling, occurring at cardiac systole, is implicated. We examined normotensives using functional neuroimaging and pain stimulation during distinct phases of the cardiac cycle to test the hypothesized neural mediation of baroreceptor-induced attenuation of pain.

Fear processing is differentially affected by lateralized stimulation of carotid baroreceptors.

Information processing, particularly of salient emotional stimuli, is influenced by cardiovascular afferent signals. Carotid baroreceptors signal the state of cardiovascular arousal to the brain, controlling blood pressure and heart rate via the baroreflex. Animal studies suggest a lateralization of this effect: Experimental stimulation of the right carotid sinus has a greater impact on heart rate when compared to left-sided stimulation.

System Biology Approach: Gene Network Analysis for Muscular Dystrophy.

Phenotypic changes at different organization levels from cell to entire organism are associated to changes in the pattern of gene expression. These changes involve the entire genome expression pattern and heavily rely upon correlation patterns among genes. The classical approach used to analyze gene expression data builds upon the application of supervised statistical techniques to detect genes differentially expressed among two or more phenotypes (e.

ANMCO/AIIC/SIT Consensus Information Document: definition, precision, and suitability of electrocardiographic signals of electrocardiographs, ergometry, Holter electrocardiogram, telemetry, and bedside monitoring systems.

The electrocardiogram (ECG) signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests, and telemetry systems and bedside monitoring of vital parameters, which are useful for rhythm and ST-segment analysis and ECG screening of electrical sudden cardiac death predictors. A precise ECG diagnosis is based upon correct recording, elaboration, and presentation of the signal.

Orthostatic Intolerance and Postural Orthostatic Tachycardia Syndrome in Joint Hypermobility Syndrome/Ehlers-Danlos Syndrome, Hypermobility Type: Neurovegetative Dysregulation or Autonomic Failure?

. Joint hypermobility syndrome/Ehlers-Danlos syndrome, hypermobility type (JHS/EDS-HT), is a hereditary connective tissue disorder mainly characterized by generalized joint hypermobility, skin texture abnormalities, and visceral and vascular dysfunctions, also comprising symptoms of autonomic dysfunction. This study aims to further evaluate cardiovascular autonomic involvement in JHS/EDS-HT by a battery of functional tests.

Beat-to-beat variability of P-wave in patients suffering from atrial fibrillation.

The aim of this paper was to analyze the P-wave variability over time in patients suffering from Atrial Fibrillation (AF). Behind some time-domain and morphological features of the P-wave template, two novel indexes of P-wave variability have been estimated: one based on the cross-correlation coefficients among the P-waves (Correlation Index, CI), and one associated to variation of P-waves amplitude (Amplitude Index, AI). These indexes were estimated in two experimental models: patients suffering from persistent AF respect to control subjects and patients developing post-operative AF (POAF) after coronary artery bypass grafting respect to patients without POAF.

Seasonal trends in atrial fibrillation episodes and physical activity collected daily with a remote monitoring system for cardiac implantable electronic devices.

Background: Remote monitoring (RM) of cardiac implantable electronic devices is an ideal experimental model to evaluate long-term trends of physiological and clinical data automatically collected from large patient cohorts.

Objectives: We studied data of atrial fibrillation (AF) and physical activity (PA) transmitted daily during 3.5years from a subgroup of patients enrolled in the HomeGuide trial, a previously conducted study on patients routinely followed with a RM system transmitting clinical and diagnostic data daily.

Cardiovascular dysfunction in untreated Parkinson's disease: A multi-modality assessment.

Background: The clinical presentation of Parkinson's disease (PD) includes a wide spectrum of non-motor features, including cardiovascular autonomic failure.

Objective: To evaluate cardiovascular autonomic status and cardiac functional capacity in drug-naïve PD patients.

Methods: 18 newly-diagnosed PD patients underwent laboratory cardiovascular autonomic function tests using power spectral analysis of the R-R interval, blood pressure (BP) short-term variability and non-invasive baroreflex sensitivity (BRS).

[ANMCO/AIIC/SIT Consensus document: Definition, precision and appropriateness of the electrocardiographic signal of electrocardiographic recorders, ergometry systems, Holter systems, telemetry and bedside monitors].

The ECG signal can be derived from different sources. These include systems for surface ECG, Holter monitoring, ergometric stress tests and systems for telemetry and bedside monitoring of vital parameters, useful to rhythm and ST-segment analysis and ECG screening of cardiac electrical sudden death predictors. A precise ECG diagnosis is based upon a correct recording, elaboration and presentation of the signal.

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.

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.

High dielectric material in MRI: Numerical assessment of the reduction of the induced local power on implanted cardiac leads.

High dielectric materials (HDM) have been proposed in magnetic resonance imaging (MRI) to increase the signal-to-noise ratio (SNR) of the images acquired while reducing the radiofrequency (RF) absorption in tissue. The aim of this study is to assess the potential merit of using HDM to reduce power induced at the tip of an endocardial lead in patients undergoing MRI. Numerical simulations were performed using a commercial finite-differences time-domain (FDTD) software to model the RF field generated by a birdcage body coil at 64 MHz on a human body model.