A novel method for conformity assessment testing of electrocardiographs for post-market surveillance purposes.

BACKGROUND: Monitoring cardiac parameters is the fundamental aspect of every diagnostic process and is facilitated by electrocardiography (ECG) devices. This way, continuous state-of-the-art performance of ECG devices can be ensured. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods. OBJECTIVE: This paper proposes a novel method for conformity assessment testing of ECG devices for post-market surveillance purposes. METHOD: The method was developed on the basis of International Organisation of Legal Metrology (OIML) guidelines and applied in healthcare institutions from 2018 to 2021. RESULTS: The developed method was validated in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of the ECG device as a method used during PMS contributes to significant improvement in devices' accuracy and reliability. CONCLUSION: A standardized approach in conformity assessment testing of ECG devices during PMS, besides increasing reliability of the devices, is the first step in the digital transformation of the management of these devices in healthcare institutions opening possibility for use of artificial intelligence.

Event-Centered Data Segmentation in Accelerometer-Based Fall Detection Algorithms.

Automatic fall detection systems ensure that elderly people get prompt assistance after experiencing a fall. Fall detection systems based on accelerometer measurements are widely used because of their portability and low cost. However, the ability of these systems to differentiate falls from Activities of Daily Living (ADL) is still not acceptable for everyday usage at a large scale. More work is still needed to raise the performance of these systems. In our research, we explored an essential but often neglected part of accelerometer-based fall detection systems-data segmentation. The aim of our work was to explore how different configurations of windows for data segmentation affect detection accuracy of a fall detection system and to find the best-performing configuration. For this purpose, we designed a testing environment for fall detection based on a Support Vector Machine (SVM) classifier and evaluated the influence of the number and duration of segmentation windows on the overall detection accuracy. Thereby, an event-centered approach for data segmentation was used, where windows are set relative to a potential fall event detected in the input data. Fall and ADL data records from three publicly available datasets were utilized for the test. We found that a configuration of three sequential windows (pre-impact, impact, and post-impact) provided the highest detection accuracy on all three datasets. The best results were obtained when either a 0.5 s or a 1 s long impact window was used, combined with pre- and post-impact windows of 3.5 s or 3.75 s.

Investigation of safety for electrochemotherapy and irreversible electroporation ablation therapies in patients with cardiac pacemakers.

BACKGROUND: The effectiveness of electrochemotherapy of tumors (ECT) and of irreversible electroporation ablation (IRE) depends on different mechanisms and delivery protocols. Both therapies exploit the phenomenon of electroporation of the cell membrane achieved by the exposure of the cells to a series of high-voltage electric pulses. Electroporation can be fine-tuned to be either reversible or irreversible, causing the cells to either survive the exposure (in ECT) or not (in IRE), respectively. For treatment of tissues located close to the heart (e.g., in the liver), the safety of electroporation-based therapies is ensured by synchronizing the electric pulses with the electrocardiogram. However, the use of ECT and IRE remains contraindicated for patients with implanted cardiac pacemakers if the treated tissues are located close to the heart or the pacemaker. In this study, two questions are addressed: can the electroporation pulses interfere with the pacemaker; and, can the metallic housing of the pacemaker modify the distribution of electric field in the tissue sufficiently to affect the effectiveness and safety of the therapy? RESULTS: The electroporation pulses induced significant changes in the pacemaker ventricular pacing pulse only for the electroporation pulses delivered during the pacing pulse itself. No residual effects were observed on the pacing pulses following the electroporation pulses for all tested experimental conditions. The results of numerical modeling indicate that the presence of metal-encased pacemaker in immediate vicinity of the treatment zone should not impair the intended effectiveness of ECT or IRE even when the casing is in direct contact with one of the active electrodes. Nevertheless, the contact between the casing and the active electrode should be avoided due to significant tissue heating at the site of the other active electrode for the IRE protocol and may cause the pulse generator to fail to deliver the pulses due to excessive current draw. CONCLUSIONS: The observed effects of electroporation pulses delivered in close vicinity of the pacemaker or its electrodes do not indicate adverse consequences for either the function of the pacemaker or the treatment outcome. These findings should contribute to making electroporation-based treatments accessible also to patients with implanted cardiac pacemakers.

Segmentation of hepatic vessels from MRI images for planning of electroporation-based treatments in the liver.

INTRODUCTION: Electroporation-based treatments rely on increasing the permeability of the cell membrane by high voltage electric pulses delivered to tissue via electrodes. To ensure that the whole tumor is covered by the sufficiently high electric field, accurate numerical models are built based on individual patient geometry. For the purpose of reconstruction of hepatic vessels from MRI images we searched for an optimal segmentation method that would meet the following initial criteria: identify major hepatic vessels, be robust and work with minimal user input. MATERIALS AND METHODS: We tested the approaches based on vessel enhancement filtering, thresholding, and their combination in local thresholding. The methods were evaluated on a phantom and clinical data. RESULTS: Results show that thresholding based on variance minimization provides less error than the one based on entropy maximization. Best results were achieved by performing local thresholding of the original de-biased image in the regions of interest which were determined through previous vessel-enhancement filtering. In evaluation on clinical cases the proposed method scored in average sensitivity of 93.68%, average symmetric surface distance of 0.89 mm and Hausdorff distance of 4.04 mm. CONCLUSIONS: The proposed method to segment hepatic vessels from MRI images based on local thresholding meets all the initial criteria set at the beginning of the study and necessary to be used in treatment planning of electroporation-based treatments: it identifies the major vessels, provides results with consistent accuracy and works completely automatically. Whether the achieved accuracy is acceptable or not for treatment planning models remains to be verified through numerical modeling of effects of the segmentation error on the distribution of the electric field.

Biomedical engineering education--status and perspectives.

Biomedical Engineering programs are present at a large number of universities all over the world with an increasing trend. New generations of biomedical engineers have to face the challenges of health care systems round the world which need a large number of professionals not only to support the present technology in the health care system but to develop new devices and services. Health care stakeholders would like to have innovative solutions directed towards solving problems of the world growing incidence of chronic disease and ageing population. These new solutions have to meet the requirements for continuous monitoring, support or care outside clinical settlements. Presence of these needs can be tracked through data from the Labor Organization in the U.S. showing that biomedical engineering jobs have the largest growth at the engineering labor market with expected 72% growth rate in the period from 2008-2018. In European Union the number of patents (i.e. innovation) is the highest in the category of biomedical technology. Biomedical engineering curricula have to adopt to the new needs and for expectations of the future. In this paper we want to give an overview of engineering professions in related to engineering in medicine and biology and the current status of BME education in some regions, as a base for further discussions.

Model for assessing aesthetic devices based on interdisciplinary work among the government, academy and industry.

In Colombia, just the same as in the whole World, globalization of the market led to a large increase in importating of diverse devices. In case of devices for aesthetic use, importing a large number of different device types without adequate control of products, increases the risk of appearance of adverse events for their users. On the other hand, there are very few studies of adverse events caused by their use, or risk assessment studies. This paper presents the role of academy in defining the conditions for safety of aesthetic devices and evaluation of medical devices "Class 1", for use in aesthetics. With support of the Colombian government, the Pan American Health Organization PAHO, and the regulating entity INVIMA, we proposed a model of control and regulation of use of devices for aesthetics in order to achieve ease of classification and ensure adequate use of devices for aesthetics, and to minimize the risk for users of the technology. As a result of this model, a tool was developed to facilitate to the regulatory entity the classification and evaluation of devices for aesthetic use "Class 1", which will be implemented by the Colombian government with the support of biomedical engineers having the required knowledge and skills.

A simplified 3D model of whole heart electrical activity and 12-lead ECG generation.

We present a computationally efficient three-dimensional bidomain model of torso-embedded whole heart electrical activity, with spontaneous initiation of activation in the sinoatrial node, incorporating a specialized conduction system with heterogeneous action potential morphologies throughout the heart. The simplified geometry incorporates the whole heart as a volume source, with heart cavities, lungs, and torso as passive volume conductors. We placed four surface electrodes at the limbs of the torso: V R , V L , V F and V GND and six electrodes on the chest to simulate the Einthoven, Goldberger-augmented and precordial leads of a standard 12-lead system. By placing additional seven electrodes at the appropriate torso positions, we were also able to calculate the vectorcardiogram of the Frank lead system. Themodel was able to simulate realistic electrocardiogram (ECG) morphologies for the 12 standard leads, orthogonal X, Y, and Z leads, as well as the vectorcardiogram under normal and pathological heart states. Thus, simplified and easy replicable 3D cardiac bidomain model offers a compromise between computational load and model complexity and can be used as an investigative tool to adjust cell, tissue, and whole heart properties, such as setting ischemic lesions or regions of myocardial infarction, to readily investigate their effects on whole ECG morphology.

New cardiomechanic pacing lead sensor based on high frequency parameters: experimental studies in sheep.

UNLABELLED: Pacing Lead as a High Frequency Cardiomechanic Sensor. INTRODUCTION: The purpose of this study was to investigate the possibility of detecting and quantifying ventricular contraction in sheep utilizing the cardiomechanic sensor based upon the high frequency (HF) parameters measurements on bipolar cardiac pacing leads. Measurement of the HF reflection coefficient yields the lead-bending signal (LBS) caused by myocardial contraction. The correlation between the lead-bending acceleration (LBA) expressed as the rate of rise of LBS and LV dP/dt should reveal that LBS may be utilized as a cardiomechanic sensor in implantable cardiac electrotherapy devices. METHODS AND RESULTS: We implanted 3 different pacing leads and tested the measurement system in 9 sheep (42 ± 6 kg) at baseline and during acute hemodynamic intervention with dobutamine infusion and tachycardia induced by VVI pacing at 200 bpm. A stable, consistent, and reproducible LBS was obtained in all sheep during the implantation procedure and 4 months after the implantation during different experimental conditions that included hemodynamic interventions. The dependence between LBAmax and LV dP/dtmax was found to be statistically significant and with high Pearson's correlation coefficient (r = 0.855, P <0.001). We could also observe the hemodynamic deterioration caused by fast ventricular pacing with the decrease of LV dp/dt and LBA compared with sinus rhythm. CONCLUSION: This study confirms the feasibility and efficacy of the hemodynamic sensor based upon HF lead parameters. Moreover, it was demonstrated that LBAmax is highly correlated to the ventricular contractility and, therefore, can be efficiently used as a hemodynamic and cardiomechanic sensor. (J Cardiovasc Electrophysiol, Vol. 24, pp. 338-346, March 2013).

Promoting harmonization of BME education in Europe: the CRH-BME Tempus project.

Biomedical Engineers should be prepared to adapt to existing or forecasted needs. There is a strong pressure on education, training and life long learning programs to continuously adapt their objectives in order to face new requirements and challenges. The main objective of the TEMPUS IV, CRH-BME project is to update existing curricula in the field of Biomedical Engineering (BME) in order to meet recent and future developments in the area, address new emerging inter-disciplinary domains that appear as a result of the R&D progress and respond to the BME job market demands. The first step is to extensively review the curricula in the BME education field. In this paper, a proposal for a generic curriculum in the BME education is presented, in order to meet recent and future developments and respond to the demands of the BME job market. Adoption of the core program structure will facilitate harmonization of studies as well as student and staff exchange across Europe, thus promoting the European Higher Education Area.

Challenges of the biomedical engineering education in Europe.

Higher education in Europe has passed through a very dynamic period of changes during the last ten years. Since the signing of the Bologna Declaration in 1999 by the Ministers of Education from the EU states, European higher education system has aimed toward establishing harmonized programs enabling students and teachers to extensively exchange knowledge, ideas and skills. Education in the field of Biomedical Engineering has experienced changes also because of the research and development in the field which was more intensive than in other fields. Besides research in new power sources, it is the most intensive and productive research field. Much of the development in BME education in Europe is influenced by the European research policy expressed through the 7th Framework Programme where health is the major theme. In order to foster and support the changes in the European Higher Education Area (EHEA) according to the needs of research sector and the labor market, the Tempus scheme of projects was established. Tempus scheme aims to support the modernization of higher education and create an area of co-operation in the countries surrounding the EU. Our Tempus project, CRH-BME "Curricula Reformation and Harmonization in the field of Biomedical Engineering" aims to create guidelines for updating existing curricula in the field of BME in Europe in order to meet recent and future developments in the area, address new emerging interdisciplinary domains that appear as the result of the R&D progress and respond to the BME job market demands. In this paper, some policy and economic factors affecting BME education in Europe are discussed and the results of a BME education survey we prepared within the Tempus CHR-BME project are presented. The number of BME programmes in Europe has in the last decade significantly increased and there are more BME specializations as the result of growing complexity of the research and production in the field.

ECG-based prediction of atrial fibrillation development following coronary artery bypass grafting.

In patients undergoing coronary artery bypass grafting (CABG) surgery, post-operative atrial fibrillation (AF) occurs with a prevalence of up to 40%. The highest incidence is seen between the second and third day after the operation. Following cardiac surgery AF may cause various complications such as hemodynamic instability, heart attack and cerebral or other thromboembolisms. AF increases morbidity, duration and expense of medical treatments. This study aims at identifying patients at high risk of post-operative AF. Early prediction of AF would provide timely prophylactic treatment and would reduce the incidence of arrhythmia. Patients at low risk of post-operative AF could be excluded on the basis of the contraindications of anti-arrhythmic drugs. The study included 50 patients in whom lead II electrocardiograms were continuously recorded for 48 h following CABG. Univariate statistical analysis was used in the search for signal features that could predict AF. The most promising ones identified were P wave duration, RR interval duration and PQ segment level. On the basis of these, a nonlinear multivariate prediction model was made by deploying a classification tree. The prediction accuracy was found to increase over time. At 48 h following CABG, the measured best smoothed sensitivity was 84.8% and the specificity 85.4%. The positive and negative predictive values were 72.7% and 92.8%, respectively, and the overall accuracy was 85.3%. With regard to the prediction accuracy, the risk assessment and prediction of post-operative AF is optimal in the period between 24 and 48 h following CABG.

EEG/MEG source imaging: methods, challenges, and open issues.

We present the four key areas of research-preprocessing, the volume conductor, the forward problem, and the inverse problem-that affect the performance of EEG and MEG source imaging. In each key area we identify prominent approaches and methodologies that have open issues warranting further investigation within the community, challenges associated with certain techniques, and algorithms necessitating clarification of their implications. More than providing definitive answers we aim to identify important open issues in the quest of source localization.

Effect of cell electroporation on the conductivity of a cell suspension.

An increased permeability of a cell membrane during the application of high-voltage pulses results in increased transmembrane transport of molecules that otherwise cannot enter the cell. Increased permeability of a cell membrane is accompanied by increased membrane conductivity; thus, by measuring electric conductivity the extent of permeabilized tissue could be monitored in real time. In this article the effect of cell electroporation caused by high-voltage pulses on the conductivity of a cell suspension was studied by current-voltage measurements during and impedance measurement before and after the pulse application. At the same time the percentage of permeabilized and survived cells was determined and the extent of osmotic swelling measured. For a train of eight pulses a transient increase in conductivity of a cell suspension was obtained above permeabilization threshold in low- and high-conductive medium with complete relaxation in <1 s. Total conductivity changes and impedance measurements showed substantial changes in conductivity due to the ion efflux in low-conductive medium and colloid-osmotic swelling in both media. Our results show that by measuring electric conductivity during the pulses we can detect limit permeabilization threshold but not directly permeabilization level, whereas impedance measurements in seconds after the pulse application are not suitable.