Regional disparity on patient characteristics and perceptions after implantable cardioverter-defibrillator implantation: results from an EHRA patient survey.

AIMS: The aim of this study was to identify potential regional disparities in characteristics of implantable cardioverter-defibrillator (ICD) recipients, patient perceptions and perspectives after implantation and level of information provided to patients. METHODS AND RESULTS: The prospective, multicentre, and multinational European Heart Rhythm Association patient Survey 'Living with an ICD' included patients already implanted with an ICD (median ICD dwell time - 5 years, interquartile range 2-10). An online questionnaire was filled-in by patients invited from 10 European countries. A total of 1809 patients (the majority in their 40s to 70s, 65.5% men) were enrolled, with 877 (48.5%) from Western Europe (group 1), followed by 563 from Central/Eastern Europe (group 2, 31.1%), and 369 from Southern Europe (group 3, 20.4%). A total of 52.9% of Central/Eastern Europe patients reported increased satisfaction after ICD placement compared with 46.6% from Western and 33.1% from Southern Europe (1 vs. 2 P = 0.047, 1 vs. 3 P < 0.001, 2 vs. 3 P < 0.001). About 79.2% of Central/Eastern and 76.0% of Southern Europe patients felt optimally informed at the time of device implantation compared with just 64.6% from Western Europe (1 vs. 2 P < 0.001, 1 vs. 3 P < 0.001, 2 vs. 3 P = ns). CONCLUSIONS: While physicians in Southern Europe should address the patients' concerns about the impact of the ICD on quality of life, physicians from Western Europe should focus on improving the quality of information provided to their prospective ICD patients. Novel strategies to address regional differences in patients' quality of life and provision of information are warranted.

Electromagnetic Wave Absorption in the Human Head: A Virtual Sensor Based on a Deep-Learning Model.

Determining the amount of electromagnetic wave energy absorbed by the human body is an important issue in the analysis of wireless systems. Typically, numerical methods based on Maxwell's equations and numerical models of the body are used for this purpose. This approach is time-consuming, especially in the case of high frequencies, for which a fine discretization of the model should be used. In this paper, the surrogate model of electromagnetic wave absorption in human body, utilizing Deep-Learning, is proposed. In particular, a family of data from finite-difference time-domain analyses makes it possible to train a Convolutional Neural Network (CNN), in view of recovering the average and maximum power density in the cross-section region of the human head at the frequency of 3.5 GHz. The developed method allows for quick determination of the average and maximum power density for the area of the entire head and eyeball areas. The results obtained in this way are similar to those obtained by the method based on Maxwell's equations.

Implantable Cardioverter-Defibrillators in Poland Compared with other European Countries from the Patient's Perspective: Insights from the EHRA Patient Survey.

BACKGROUND: The aim of this study was to compare differences between Polish ICD recipients and ICD recipients from other European countries in terms of quality of life, information provision before ICD implantation, and end-of-life issues. METHODS: This is a sub-analysis of the "Living with an ICD" patient survey (25-item questionnaire) organized by the European Heart Rhythm Association between 12 April 2021 and 5 July 2021 in ten European countries. RESULTS: There were 410 (22.7%) patients from Poland and 1399 (77.3%) from other European countries. A total of 51.0% of Polish patients reported improvement in their quality of life compared with 44.3% in other countries (p = 0.041). Remote monitoring was three times more often utilized in other countries than in Poland (66.8% vs. 21.0%, p < 0.001). While 78.1% of Poles felt well informed before ICD implantation compared with 69.6% of subjects from other countries (p = 0.001), they were less familiar with the ICD deactivation process than others (38.9% vs. 52.5%, p < 0.001). CONCLUSIONS: Despite the less frequent use of remote monitoring and gaps in end-of-life issues, Polish ICD recipients reported more favorable quality of life and a higher level of information received before device placement than patients in other European countries.

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation.

AIMS: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation. METHODS AND RESULTS: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001). CONCLUSIONS: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women.

Wireless Capsule Endoscope Localization with Phase Detection Algorithm and Adaptive Body Model.

Wireless capsule endoscopes take and send photos of the human digestive tract, which are used for medical diagnosis. The capsule's location enables exact identification of the regions with lesions. This can be carried out by analyzing the parameters of the electromagnetic wave received from the capsule. Because the human body is a complex heterogeneous environment that impacts the propagation of wireless signals, determining the distance between the transmitter and the receiver based on the received power level is challenging. An enhanced approach of identifying the location of endoscope capsules using a wireless signal phase detection algorithm is presented in this paper. For each capsule position, this technique uses adaptive estimation of human body model permittivity. This approach was tested using computer simulations in Remcom XFdtd software using a numerical, heterogeneous human body model, as well as measurements with physical phantom. The type of transmitting antenna employed in the capsule also has a significant impact on the suggested localization method's accuracy. As a result, the helical antenna, which is smaller than the dipole, was chosen as the signal's source. For both the numerical and physical phantom studies, the proposed technique with adaptive body model enhances localization accuracy by roughly 30%.

Patients with Cardiovascular Implantable Electronic Devices in the Era of COVID-19 and Their Response to Telemedical Solutions.

Background and objectives: The COVID-19 pandemic has transformed the healthcare system, leading to the rapid implementation of telemedical solutions, especially in cardiology. The aim of this survey was to evaluate the patients (pts) with cardiac implantable electronic devices (CIED) perspectives on the telemedicine elements such as teleconsultation, telemonitoring, and e-prescription. Materials and methods: An anonymous questionnaire was created and delivered to CIED pts who came to the ambulatory outpatient clinic. In this survey, we evaluated teleconsultation, home monitoring systems, and e-prescription in the 17 single-choice and multiple-choice questions and a rating on a scale of 0 to 10. Results: During the four-month period, 226 pts (58% male) completed the questionnaire. Regular visits were most frequent in pts living in the urban area where the clinic was located, and least frequent in those living in rural areas (p = 0.0158). Moreover, 89 pts (39%) had teleconsultation before CIED interrogation, and satisfaction was 99%; 24 pts (11%) had home-monitoring control and 135 pts (60%) would have liked to have this opportunity; 88 pts (34.5%) would be able to pay additional costs for home-monitoring, with a mean amount of 65 PLN (±68.24). The e-prescription system was used by 203 pts (90%), and it was evaluated with 8.6 points (±2) on a scale from 0 to 10 points. Conclusions: The COVID-19 pandemic disrupted the previous functioning of the health system, and telemedicine became an alternative to traditional ambulatory visits and proved to be essential in the continuity of patient care. There is a substantial need for further development of telemedicine solutions in the healthcare system.

Long-term quality of life and acceptance of implantable cardioverter-defibrillator therapy: results of the European Heart Rhythm Association survey.

Implantable cardioverter-defibrillator (ICD) may impact patients' life significantly. The aim of this survey was to analyse the impact of the ICD on quality of life (QoL) metrics from the patient's perspective. 'Living with an ICD' was a prospective, multicentre study with an online questionnaire submitted to the European Heart Rhythm Association (EHRA) Research Network centres as well as patient associations from 10 European countries; it was filled-in directly and personally by the patients that were invited to participate, with a minimal interaction or influence from the healthcare professionals. Overall, the questionnaire was completed by 1809 patients (624 women, 34.5%). Patients in their 60s and 70s and from Western Europe were the most represented. The median time from first ICD implantation was 5 years (IQR 2-10). Device-related complications were reported by 505 patients (22.4%), including one or more inappropriate shocks (n = 209, 11.6%). Almost half the respondents reported improved QoL, with a more favourable impact for those receiving cardiac resynchronization therapy-defibrillator (CRT-D), and only a 10th experienced a significant decrease in QoL. The occurrence of complications remained a major predictor of deteriorated QoL (odds ratio 2.1, 95% confidence interval 1.4-3.0, P < 0.001). In conclusion, most patients have a globally positive view and acceptance of ICD therapy, reporting preserved to improved QoL after device implantation. Complications, namely inappropriate shocks, affect the expectation of living a normal life post-implant and are associated with a significant decrease in QoL. Our findings also highlight the importance of a detailed informed consent process and the involvement of the patient in the decision-making process.

Optimal Design of Switchable Wearable Antenna Array for Wireless Sensor Networks.

In the paper, we present a novel approach to the optimum design of wearable antenna arrays intended for off-body links of wireless body area networks. Specifically, we investigate a four-element array that has a switchable radiation pattern able to direct its higher gain towards a signal source and a lower gain towards an interference. The aim is to increase the signal to interference ratio. We apply a genetic algorithm to optimize both the spatial placement and the feed phasing of the elementary on-body antennas. We propose a simplified, computationally efficient model for the simulation of the array radiation pattern. The model is based on full-wave simulations obtained with a simplified cylindrical model of the human body. We also propose, implement, and evaluate four objective functions based on signal to interference ratio, i.e., min-max, nadir point distance maximization, utopia point distance minimization, and full Pareto-like. Our optimized design obtained with this approach exhibits a significant performance improvement in comparison to the initial heuristic design.

Implantation of the Micra transcatheter pacing system: Single Polish center experience with the real costs of hospitalization analysis.

BACKGROUND: The Micra transcatheter pacing system (TPS) is a miniaturized, single-chamber pacemaker system. Study reported herein is an initial experience with implantation of the Micra TPS. METHODS: The leadless pacemaker was implanted in 10 patients with standard indications for a permanent pacemaker implantation. All hospitalization costs were calculated for all patients. RESULTS: The mean age of the patients was 75 ± 7.1 years, 6 were men and 4 were women. Four patients had permanent atrial fibrillation as the basal rhythm and 6 patients had sinus rhythm. All patients had at least one relative contraindication that precluded the use of a traditional pacing system. Mean intraoperative ventricular sensing amplitude was 10.6 ± 5.4 mV, impedance 843 ± 185 ohms, and pacing threshold at 0.24 ms was 0.56 ± 0.23 V. At discharge, those values were 13.9 ± 5.6 mV, 667 ± 119 ohms and 0.47 ± 0.17, respectively. The mean duration of implantation procedure was 82 min, while mean fluoroscopy time was 3.5 min. Two patients developed hematoma at the groin puncture site post-implantation. In 1 case there was a need for erythrocyte mass transfusion and surgical intervention. Mean total time of hospitalization was 26 days and time from procedure to discharge 12 days. Average cost of hospitalization per 1 patient was 11,260.15 EUR minimal cost was 9,052.68 EUR, while maximal cost was 16,533.18 EUR. CONCLUSIONS: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Hospitalization costs vary for individual patients in wide range.

Initial experience with the subcutaneous implantable cardioverter-defibrillator with the real costs of hospitalization analysis in a single Polish center.

BACKGROUND: The recent introduction of an entirely subcutaneous implantable cardioverter-defibril-lator (S-ICD) represents an important progress in the defibrillation technology towards a less invasive approach. This is a single-center observational study of S-ICD implantations in Poland. METHODS: The S-ICD was implanted in 11 patients with standard indications for an ICD. Patients in whom the device was implanted were evaluated for adverse events and device function at hospital discharge. All hospitalization costs were calculated and summed up for all patients. Costs were divided into following categories: medical materials, pharmaceuticals, operating theatre staff, cardiology depart-ment staff, laboratory tests, non-laboratory tests and additional non-medical costs. RESULTS: The mean age of patients was 51.6 ± 16.4 years, 9 were men and 2 were women. Four pa-tients had atrial fibrillation as the basal rhythm, 1 patient had atrial flutter and 6 patients had sinus rhythm. All patients had at least one condition that precluded the use of a traditional ICD system or the S-ICD was preferred due to other conditions, i.e. a history complicated transvenous ICD therapy (18%), anticipated higher risk of infection (27%), lack or difficult vascular access (18%), young age and anticipated high cumulated risk of lifetime device therapy (36%). The mean duration of the im-plantation procedure was 2 h. One patient developed a postoperative pocket hematoma. Mean total time of hospitalization was 28 (6-92) days. Average cost of hospitalization per patient was 21,014.29 EUR (minimal = 19,332.71 EUR and maximal = 24,824.14 EUR). CONCLUSIONS: S-ICD implantation appears to provide a viable alternative to transvenous ICD, espe-cially for patients without pacing requirements.

Endovascular extraction of entrapped long-term central feeding catheter: Case series.

Long-term tunneled central venous catheters are widely used in several clinical indications, that is, hemodialysis, chemotherapy, and total parenteral nutrition. However, central venous catheters are associated with a number of complications, including catheter occlusion and sepsis, which may necessitate earlier catheter removal. In most cases manual traction is sufficient to remove the catheter. Nevertheless, in some cases severe adhesions, formed between the catheter and the vessel wall, complicate simple catheter removal. We present four cases of entrapped long-term central venous catheters and describe methods (e.g. endoluminal balloon dilatation and wire snare) performed by experienced cardiologists at high-volume center to remove them. We claim that permanent central venous catheters removal procedures may be unpredictable and hazardous. Therefore, entrapped central venous catheters should be extracted by experienced operators in specialized high-volume centers.

Do we differ in terms of indications and demographics in cardiac resynchronisation recipients in Poland? Insights from the European CRT Survey II Registry.

BACKGROUND: Multiple randomised clinical trials have proven that cardiac resynchronisation therapy (CRT) reduces morbidity and mortality in appropriately selected patients with congestive heart failure and is recommended for such patients as per the European Society of Cardiology guidelines. AIM: In this paper we compare the indications and demographics in cardiac resynchronisation recipients in Poland and other European countries. METHODS: In 2015 and 2016, physicians from 42 European countries participated in the second edition of the European Cardiac Resynchronisation Therapy Survey. For 14 months, 288 implanting centres gathered data regarding demography, indications, implanting methods, and guidance compatibility from 11,088 patients receiving CRT. RESULTS: The survey revealed that a vast group of patients were eligible for CRT implantation (although some of them with rela-tively weak guidance recommendations) and showed essential variety in clinical practice when national data were benchmarked. CONCLUSIONS: The population of CRT recipients in Poland and other European countries did not differ in terms of demographic and clinical characteristics. In most cases, indications for CRT were in accordance with the guidelines; however some devices were implanted in patients beyond the guideline recommendations. For these procedures, the decision regarding CRT im-plantation relies mainly on the physicians' experience.

Multi-Objective Optimization of a Wireless Body Area Network for Varying Body Positions.

The purpose of this research was to improve the performance of a wireless body area sensor network, operating on a person in the seated and standing positions. Optimization-focused on both the on-body transmission channel and off-body link performance. The system consists of three nodes. One node (on the user's head) is fixed, while the positions of the other two (one on the user's trunk and the other on one leg) with respect to the body (local coordinates) are design variables. The objective function used in the design process is characterized by two components: the first controls the wireless channel for on-body data transmission between the three sensor nodes, while the second controls the off-body transmission between the nodes and a remote transceiver. The optimal design procedure exploits a low-cost Estra, which is an evolutionary strategy optimization algorithm linked with Remcom XFdtd, a full-wave Finite-Difference Time-Domain (FDTD) electromagnetic field analysis package. The Pareto-like approach applied in this study searches for a non-dominated solution that gives the best compromise between on-body and off-body performance.

Analysis of Human Body Shadowing Effect on Wireless Sensor Networks Operating in the 2.4 GHz Band.

Miniaturized wireless sensors are designed to run on limited power resources, requiring minimization of transmit power and lowering of the fade margin in the link budget. One factor that has an important impact on wireless sensor network design is path loss between the transmitter and the receiver. This paper presents an analysis of the influence of human bodies on path loss in the 2.4 GHz band, which is commonly used for wireless sensor networks. The effect of body shadowing was first analyzed in full wave computer simulations using the finite-difference time-domain method. Due to the high numerical burden, the simulations were limited to only a small region around the human body. To analyze the performance of networks in larger indoor environments, a human body model is proposed that can be used for simulations with a ray-based computer program. The proposed model of human body is the main contribution of this paper. It was used to analyze the body shadowing effect in a typical indoor environment. The results were found to be in good agreement with measurements.

Many-Objective Automated Optimization of a Four-Band Antenna for Multiband Wireless Sensor Networks.

This paper describes a new design and an optimization framework for a four-band antenna to be used in wireless sensor networks. The antenna is designed to operate effectively in two open frequency bands (ISM-Industrial, Scientific, Medical), 2.4 GHz and 5.8 GHz, as well as in two bands allocated for the fifth-generation (5G) cellular networks, 0.7 GHz and 3.5 GHz. Our initial design was developed using the trial and error approach, modifying a circular disc monopole antenna widely used in ultra wideband (UWB) systems. This initial design covered the three upper bands, but impedance matching within the 700 MHz band was unsatisfactory. The antenna performance was then improved significantly using an optimization algorithm that applies a bi-objective fully-Paretian approach to its nine-parameter geometry. The optimization criteria were impedance matching and radiation efficiency. The final design exhibits good impedance matching in all four desired bands with the Voltage Standing Wave Ratio (VSWR) value below 2 and radiation efficiency of 88%. The simulated antenna performance was verified experimentally.

A new simplified electrocardiographic score predicts clinical outcome in patients treated with CRT.

Aims: Cardiac Resynchronization Therapy (CRT) reduces morbidity and mortality for patients with heart failure and wide QRS complex, but up to 1/3 of patients are "non-responders" to the therapy. This study examines the ability of a simple standard electrocardiogram (ECG)-based scoring system to predict clinical outcome. Methods and results: Four hundred and ninety-one consecutive patients with CRT-implants (79% males, mean age 71 years, LVEF 24%, 59% with ischemic cardiomyopathy, 83% in NYHA class III) were included from a single large volume centre. All patients met standard indications for CRT, and were followed for 3 years after CRT implantation. Three ECG parameters were measured on the post-implant ECG, and compared to pre-implantation measurements: QRS duration, time to intrinsicoid deflection onset (ID) in V1 lead, amplitude change in V1 lead. Each positive ECG variable was given a numerical value of 1 to create the score (ranging 0-3). Clinical outcome was assessed as a composite of all-cause death, left ventricular assist device implantation, cardiac transplantation and HF hospitalization. Event-free survival was predicted by shortening of QRS duration ≥20 ms (HR 0.66 [95% CI 0.48-0.90] P = 0.009), ≥50% decreased summed R + S amplitude in V1 lead (HR 0.67 [0.49-0.90] P = 0.009) and ≤40 msec ID time in lead V1 during pacing (HR 0.63 [0.46-0.86] P = 0.004). The total score was an independent predictor for both event-free survival (HR 0.65 [0.54-0.77] P < 0.001) and for ≥10% left ventricular ejection fraction improvement (OR 1.7 [1.3-2.3] P < 0.001). Conclusions: Composite data from 12-lead ECG during CRT-treatment can be used in a simple score to predict long-term clinical outcome.

Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study.

BACKGROUND: Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system. METHODS: An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device. DISCUSSION: The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52-59).