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1.
Europace ; 25(8)2023 08 25.
Artigo em Inglês | MEDLINE | ID: mdl-37622574

RESUMO

AIMS: Over the past 25 years there has been a substantial development in the field of digital electrophysiology (EP) and in parallel a substantial increase in publications on digital cardiology.In this celebratory paper, we provide an overview of the digital field by highlighting publications from the field focusing on the EP Europace journal. RESULTS: In this journey across the past quarter of a century we follow the development of digital tools commonly used in the clinic spanning from the initiation of digital clinics through the early days of telemonitoring, to wearables, mobile applications, and the use of fully virtual clinics. We then provide a chronicle of the field of artificial intelligence, a regulatory perspective, and at the end of our journey provide a future outlook for digital EP. CONCLUSION: Over the past 25 years Europace has published a substantial number of papers on digital EP, with a marked expansion in digital publications in recent years.


Assuntos
Cardiologia , Aplicativos Móveis , Humanos , Inteligência Artificial , Eletrofisiologia Cardíaca , Cognição
2.
J Cardiovasc Magn Reson ; 24(1): 62, 2022 11 28.
Artigo em Inglês | MEDLINE | ID: mdl-36437452

RESUMO

BACKGROUND: Segmentation of cardiovascular magnetic resonance (CMR) images is an essential step for evaluating dimensional and functional ventricular parameters as ejection fraction (EF) but may be limited by artifacts, which represent the major challenge to automatically derive clinical information. The aim of this study is to investigate the accuracy of a deep learning (DL) approach for automatic segmentation of cardiac structures from CMR images characterized by magnetic susceptibility artifact in patient with cardiac implanted electronic devices (CIED). METHODS: In this retrospective study, 230 patients (100 with CIED) who underwent clinically indicated CMR were used to developed and test a DL model. A novel convolutional neural network was proposed to extract the left ventricle (LV) and right (RV) ventricle endocardium and LV epicardium. In order to perform a successful segmentation, it is important the network learns to identify salient image regions even during local magnetic field inhomogeneities. The proposed network takes advantage from a spatial attention module to selectively process the most relevant information and focus on the structures of interest. To improve segmentation, especially for images with artifacts, multiple loss functions were minimized in unison. Segmentation results were assessed against manual tracings and commercial CMR analysis software cvi42(Circle Cardiovascular Imaging, Calgary, Alberta, Canada). An external dataset of 56 patients with CIED was used to assess model generalizability. RESULTS: In the internal datasets, on image with artifacts, the median Dice coefficients for end-diastolic LV cavity, LV myocardium and RV cavity, were 0.93, 0.77 and 0.87 and 0.91, 0.82, and 0.83 in end-systole, respectively. The proposed method reached higher segmentation accuracy than commercial software, with performance comparable to expert inter-observer variability (bias ± 95%LoA): LVEF 1 ± 8% vs 3 ± 9%, RVEF - 2 ± 15% vs 3 ± 21%. In the external cohort, EF well correlated with manual tracing (intraclass correlation coefficient: LVEF 0.98, RVEF 0.93). The automatic approach was significant faster than manual segmentation in providing cardiac parameters (approximately 1.5 s vs 450 s). CONCLUSIONS: Experimental results show that the proposed method reached promising performance in cardiac segmentation from CMR images with susceptibility artifacts and alleviates time consuming expert physician contour segmentation.


Assuntos
Artefatos , Inteligência Artificial , Humanos , Estudos Retrospectivos , Valor Preditivo dos Testes , Imageamento por Ressonância Magnética/métodos , Atenção
3.
Curr Heart Fail Rep ; 19(2): 38-51, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35142985

RESUMO

PURPOSE OF REVIEW: Application of deep learning (DL) is growing in the last years, especially in the healthcare domain. This review presents the current state of DL techniques applied to electronic health record structured data, physiological signals, and imaging modalities for the management of heart failure (HF), focusing in particular on diagnosis, prognosis, and re-hospitalization risk, to explore the level of maturity of DL in this field. RECENT FINDINGS: DL allows a better integration of different data sources to distillate more accurate outcomes in HF patients, thus resulting in better performance when compared to conventional evaluation methods. While applications in image and signal processing for HF diagnosis have reached very high performance, the application of DL to electronic health records and its multisource data for prediction could still be improved, despite the already promising results. Embracing the current big data era, DL can improve performance compared to conventional techniques and machine learning approaches. DL algorithms have potential to provide more efficient care and improve outcomes of HF patients, although further investigations are needed to overcome current limitations, including results generalizability and transparency and explicability of the evidences supporting the process.


Assuntos
Aprendizado Profundo , Insuficiência Cardíaca , Algoritmos , Big Data , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Aprendizado de Máquina
4.
Eur Heart J ; 41(27): 2589-2596, 2020 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-32484542

RESUMO

The new European Union (EU) law governing the regulatory approval of medical devices that entered into force in May 2017 will now take effect from 26 May 2021. Here, we consider how it will change daily practice for cardiologists, cardiac surgeons, and healthcare professionals. Clinical evidence for any high-risk device must be reported by the manufacturer in a Summary of Safety and Clinical Performance (SSCP) that will be publicly available in the European Union Database on Medical Devices (Eudamed) maintained by the European Commission; this will facilitate evidence-based choices of which devices to recommend. Hospitals must record all device implantations, and each high-risk device will be trackable by Unique Device Identification (UDI). Important new roles are envisaged for clinicians, scientists, and engineers in EU Expert Panels-in particular to scrutinize clinical data submitted by manufacturers for certain high-risk devices and the evaluations of that data made by notified bodies. They will advise manufacturers on the design of their clinical studies and recommend to regulators when new technical specifications or guidance are needed. Physicians should support post-market surveillance by reporting adverse events and by contributing to comprehensive medical device registries. A second law on In Vitro Diagnostic Medical Devices will take effect from 2022. We encourage all healthcare professionals to contribute proactively to these new systems, in order to enhance the efficacy and safety of high-risk devices and to promote equitable access to effective innovations. The European Society of Cardiology will continue to advise EU regulators on appropriate clinical evaluation of high-risk devices.


Assuntos
Cardiologia , União Europeia , Prática Clínica Baseada em Evidências , Humanos
5.
Entropy (Basel) ; 23(8)2021 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-34441079

RESUMO

Transfer entropy (TE) has been used to identify and quantify interactions between physiological systems. Different methods exist to estimate TE, but there is no consensus about which one performs best in specific applications. In this study, five methods (linear, k-nearest neighbors, fixed-binning with ranking, kernel density estimation and adaptive partitioning) were compared. The comparison was made on three simulation models (linear, nonlinear and linear + nonlinear dynamics). From the simulations, it was found that the best method to quantify the different interactions was adaptive partitioning. This method was then applied on data from a polysomnography study, specifically on the ECG and the respiratory signals (nasal airflow and respiratory effort around the thorax). The hypothesis that the linear and nonlinear components of cardio-respiratory interactions during light and deep sleep change with the sleep stage, was tested. Significant differences, after performing surrogate analysis, indicate an increased TE during deep sleep. However, these differences were found to be dependent on the type of respiratory signal and sampling frequency. These results highlight the importance of selecting the appropriate signals, estimation method and surrogate analysis for the study of linear and nonlinear cardio-respiratory interactions.

6.
Europace ; 2020 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-32853369

RESUMO

AIMS: A plethora of mobile health applications (m-health apps) to support healthcare are available for both patients and healthcare professionals (HCPs) but content and quality vary considerably and few have undergone formal assessment. The aim is to systematically review the literature on m-health apps for managing atrial fibrillation (AF) that examine the impact on knowledge of AF, patient and HCP behaviour, patients' quality-of-life, and user engagement. METHODS AND RESULTS: MEDLINE, EMBASE, CINAHL, and PsychInfo were searched from 1 January 2005 to 5 September 2019, with hand-searching of clinical trial registers and grey literature. Studies were eligible for inclusion if they reported changes in any of the following: (i) knowledge of AF; (ii) provider behaviour (e.g. guideline adherence); (iii) patient behaviour (e.g. medication adherence); (iv) patient quality-of-life; and (v) user engagement. Two reviewers independently assessed articles for eligibility. A narrative review was undertaken as included studies varied widely in their design, interventions, comparators, and outcomes. Seven studies were included; six m-health apps aimed at patients and one at HCPs. Mobile health apps ranged widely in design, features, and method of delivery. Four studies reported patient knowledge of AF; three demonstrated significant knowledge improvement post-intervention or compared to usual care. One study reported greater HCP adherence to oral anticoagulation guidelines after m-health app implementation. Two studies reported on patient medication adherence and quality-of-life; both showed improved quality-of-life post-intervention but only one observed increased adherence. Regarding user engagement, five studies reported patient perspectives on usability, three on acceptability, and one on feasibility; overall all m-health apps were rated positively. CONCLUSION: Mobile health apps demonstrate improvements in patient knowledge, behaviour, and quality of life. Studies formally evaluating the impact of m-health on HCP behaviour are scarce and larger-scale studies with representative patient cohorts, appropriate comparators, and longer-term assessment of the impact of m-health apps are warranted.

7.
Eur J Appl Physiol ; 120(7): 1699-1710, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32494859

RESUMO

PURPOSE: Prolonged weightlessness exposure generates cardiovascular deconditioning, with potential implications on ECG circadian rhythms. Head-down (- 6°) tilt (HDT) bed rest is a ground-based analogue model for simulating the effects of reduced motor activity and fluids redistribution occurring during spaceflight. Our aim was to evaluate the impact of 60-day HDT on the circadianity of RR and ventricular repolarization (QTend) intervals extracted from 24-h Holter ECG recordings, scheduled 9 days before HDT (BDC-9), the 5th (HDT5), 21st (HDT21) and 58th (HDT58) day of HDT, the 1st (R + 0) and 8th (R + 7) day after HDT. Also, the effectiveness of a nutritional countermeasure (CM) in mitigating the HDT-related changes was tested. METHODS: RR and QTend circadian rhythms were evaluated by Cosinor analysis, resulting in maximum and minimum values, MESOR (a rhythm-adjusted mean), oscillation amplitude (OA, half variation within a night-day cycle), and acrophase (φ, the time at which the fitting sinusoid's amplitude is maximal) values. RESULTS: RR and QTend MESOR increased at HDT5, and the OA was reduced along the HDT period, mainly due to the increase of the minima. At R + 0, QTend OA increased, particularly in the control group. The φ slightly anticipated during HDT and was delayed at R + 0. CONCLUSION: 60-Day HDT affects the characteristics of cardiac circadian rhythm by altering the physiological daily cycle of RR and QTend intervals. Scheduled day-night cycle and feeding time were maintained during the experiment, thus inferring the role of changes in the gravitational stimulus to determine these variations. The applied nutritional countermeasure did not show effectiveness in preventing such changes.


Assuntos
Repouso em Cama , Pressão Sanguínea/fisiologia , Ritmo Circadiano/fisiologia , Frequência Cardíaca/fisiologia , Adulto , Repouso em Cama/métodos , Feminino , Decúbito Inclinado com Rebaixamento da Cabeça/fisiologia , Coração/fisiologia , Humanos , Pressão Negativa da Região Corporal Inferior/métodos , Masculino , Pessoa de Meia-Idade , Ausência de Peso , Contramedidas de Ausência de Peso
8.
Lancet ; 392(10146): 521-530, 2018 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-30017550

RESUMO

To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device. Defining its content, however, has been delegated to implementing legislation, which is now being considered. From a clinical perspective, it is imperative that all evidence reviewed by notified bodies and regulatory authorities is disclosed-with the exception, if justified, only of technical specifications that are considered confidential or manufacturing details that are protected as intellectual property-and public access to this evidence must be guaranteed by EU law. From ethical and other perspectives, there are no grounds for less clinical evidence being available to health-care professionals about the medical devices that they use than is already available for new pharmaceutical products. Full transparency is needed; without it, informed decisions relating to the use of new medical devices will remain impossible.


Assuntos
Equipamentos e Provisões , Medicina Baseada em Evidências , Acesso à Informação , Aprovação de Equipamentos , Equipamentos e Provisões/efeitos adversos , Equipamentos e Provisões/normas , Europa (Continente) , União Europeia , Medicina Baseada em Evidências/normas , Humanos
9.
J Electrocardiol ; 49(3): 383-91, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27046100

RESUMO

We evaluate in this paper different strategies for the construction of a statistical shape model (SSM) of the left ventricle (LV) to be used for segmentation in cardiac magnetic resonance (CMR) images. From a large database of LV surfaces obtained throughout the cardiac cycle from 3D echocardiographic (3DE) LV images, different LV shape models were built by varying the considered phase in the cardiac cycle and the registration procedure employed for surface alignment. Principal component analysis was computed to describe the statistical variability of the SSMs, which were then deformed by applying an active shape model (ASM) approach to segment the LV endocardium in CMR images of 45 patients. Segmentation performance was evaluated by comparing LV volumes derived by ASM segmentation with different SSMs and those obtained by manual tracing, considered as a reference. A high correlation (r(2)>0.92) was found in all cases, with better results when using the SSM models comprising more than one frame of the cardiac cycle.


Assuntos
Ecocardiografia Tridimensional/métodos , Ecocardiografia/métodos , Endocárdio/diagnóstico por imagem , Imagem Cinética por Ressonância Magnética/métodos , Modelos Cardiovasculares , Disfunção Ventricular Esquerda/diagnóstico por imagem , Simulação por Computador , Endocárdio/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Anatômicos , Modelos Estatísticos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Técnica de Subtração , Disfunção Ventricular Esquerda/patologia
10.
J Electrocardiol ; 48(4): 617-25, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26025201

RESUMO

AIM: The aim of this study was to investigate the influence of geometrical factors on the ECG morphology and vectorcardiogram (VCG) parameters. METHODS: Patient-tailored models based on five heart-failure patients with intraventricular conduction defects (IVCDs) were created. The heart was shifted up to 6 cm to the left, right, up, and down and rotated ±30° around the anteroposterior axis. Precordial electrodes were shifted 3 cm down. RESULTS: Geometry modifications strongly altered ECG notching/slurring and intrinsicoid deflection time. Maximum VCG parameter changes were small for QRS duration (-6% to +10%) and QRS-T angle (-6% to +3%), but considerable for QRS amplitude (-36% to +59%), QRS area (-37% to +42%), T-wave amplitude (-41% to +36%), and T-wave area (-42% to +33%). CONCLUSION: The position of the heart with respect to the electrodes is an important factor determining notching/slurring and voltage-dependent parameters and therefore must be considered for accurate diagnosis of IVCDs.


Assuntos
Arritmias Cardíacas/fisiopatologia , Sistema de Condução Cardíaco/fisiopatologia , Insuficiência Cardíaca/fisiopatologia , Modelos Cardiovasculares , Posicionamento do Paciente/métodos , Vetorcardiografia/métodos , Idoso , Arritmias Cardíacas/complicações , Arritmias Cardíacas/diagnóstico , Simulação por Computador , Diagnóstico por Computador/métodos , Eletrocardiografia/métodos , Feminino , Insuficiência Cardíaca/complicações , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Modelagem Computacional Específica para o Paciente , Postura , Reprodutibilidade dos Testes , Sensibilidade e Especificidade
11.
Europace ; 16 Suppl 4: iv96-iv101, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25362176

RESUMO

AIMS: To propose a nearly automated left ventricular (LV) three-dimensional (3D) surface segmentation procedure, based on active shape modelling (ASM) and built on a database of 3D echocardiographic (3DE) LV surfaces, for cardiac magnetic resonance (CMR) images, and to test its accuracy for LV volumes computation compared with 'gold standard' manual tracings and discs-summation method. METHODS AND RESULTS: The ASM was created based on segmented LV surfaces (4D LV analysis, Tomtec) from 3DE datasets of 205 patients. Then, it was applied to the cardiac magnetic resonance imaging short-axis (SAX) images stack of 12 consecutive patients. After proper realignment using two- and four-chambers CMR long-axis views both as reference and for initializing LV apex and base (six points in total), the ASM was iteratively and automatically updated to match the information of all the SAX planes contemporaneously, resulting in an endocardial LV 3D mesh from which volume was directly derived. The same CMR images were analysed by an experienced cardiologist to derive end-diastolic and end-systolic volumes. Linear correlation and Bland-Altman analyses were applied vs. the manual 'gold standard'. Active shape modelling results showed high correlations with manual values both for LV volumes (r(2) > 0.98) and ejection fraction (EF) (r(2) > 0.90), non-significant biases and narrow limits of agreement. CONCLUSION: The proposed method resulted in accurate detection of 3D LV endocardial surfaces, which lead to fast and reliable measurements of LV volumes and EF when compared with manual tracing of CMR SAX images. The segmented 3D mesh, including a realistic LV apex and base, could constitute a novel starting point for more realistic patient-specific finite element modelling.


Assuntos
Simulação por Computador , Cardiopatias/patologia , Ventrículos do Coração/patologia , Imageamento Tridimensional , Imageamento por Ressonância Magnética , Modelos Cardiovasculares , Algoritmos , Automação , Gráficos por Computador , Estudos de Viabilidade , Cardiopatias/fisiopatologia , Ventrículos do Coração/fisiopatologia , Humanos , Interpretação de Imagem Assistida por Computador , Projetos Piloto , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Função Ventricular Esquerda
12.
Atherosclerosis ; : 117549, 2024 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-38679562

RESUMO

BACKGROUND AND AIMS: This study investigated the additional prognostic value of epicardial adipose tissue (EAT) volume for major adverse cardiovascular events (MACE) in patients undergoing stress cardiac magnetic resonance (CMR) imaging. METHODS: 730 consecutive patients [mean age: 63 ± 10 years; 616 men] who underwent stress CMR for known or suspected coronary artery disease were randomly divided into derivation (n = 365) and validation (n = 365) cohorts. MACE was defined as non-fatal myocardial infarction and cardiac deaths. A deep learning algorithm was developed and trained to quantify EAT volume from CMR. EAT volume was adjusted for height (EAT volume index). A composite CMR-based risk score by Cox analysis of the risk of MACE was created. RESULTS: In the derivation cohort, 32 patients (8.7 %) developed MACE during a follow-up of 2103 days. Left ventricular ejection fraction (LVEF) < 35 % (HR 4.407 [95 % CI 1.903-10.202]; p<0.001), stress perfusion defect (HR 3.550 [95 % CI 1.765-7.138]; p<0.001), late gadolinium enhancement (LGE) (HR 4.428 [95%CI 1.822-10.759]; p = 0.001) and EAT volume index (HR 1.082 [95 % CI 1.045-1.120]; p<0.001) were independent predictors of MACE. In a multivariate Cox regression analysis, adding EAT volume index to a composite risk score including LVEF, stress perfusion defect and LGE provided additional value in MACE prediction, with a net reclassification improvement of 0.683 (95%CI, 0.336-1.03; p<0.001). The combined evaluation of risk score and EAT volume index showed a higher Harrel C statistic as compared to risk score (0.85 vs. 0.76; p<0.001) and EAT volume index alone (0.85 vs.0.74; p<0.001). These findings were confirmed in the validation cohort. CONCLUSIONS: In patients with clinically indicated stress CMR, fully automated EAT volume measured by deep learning can provide additional prognostic information on top of standard clinical and imaging parameters.

13.
Comput Biol Med ; 153: 106484, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36584604

RESUMO

BACKGROUND AND OBJECTIVE: In patients with suspected Coronary Artery Disease (CAD), the severity of stenosis needs to be assessed for precise clinical management. An automatic deep learning-based algorithm to classify coronary stenosis lesions according to the Coronary Artery Disease Reporting and Data System (CAD-RADS) in multiplanar reconstruction images acquired with Coronary Computed Tomography Angiography (CCTA) is proposed. METHODS: In this retrospective study, 288 patients with suspected CAD who underwent CCTA scans were included. To model long-range semantic information, which is needed to identify and classify stenosis with challenging appearance, we adopted a token-mixer architecture (ConvMixer), which can learn structural relationship over the whole coronary artery. ConvMixer consists of a patch embedding layer followed by repeated convolutional blocks to enable the algorithm to learn long-range dependences between pixels. To visually assess ConvMixer performance, Gradient-Weighted Class Activation Mapping (Grad-CAM) analysis was used. RESULTS: Experimental results using 5-fold cross-validation showed that our ConvMixer can classify significant coronary artery stenosis (i.e., stenosis with luminal narrowing ≥50%) with accuracy and sensitivity of 87% and 90%, respectively. For CAD-RADS 0 vs. 1-2 vs. 3-4 vs. 5 classification, ConvMixer achieved accuracy and sensitivity of 72% and 75%, respectively. Additional experiments showed that ConvMixer achieved a better trade-off between performance and complexity compared to pyramid-shaped convolutional neural networks. CONCLUSIONS: Our algorithm might provide clinicians with decision support, potentially reducing the interobserver variability for coronary artery stenosis evaluation.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Humanos , Estudos Retrospectivos , Constrição Patológica , Angiografia Coronária/métodos , Estenose Coronária/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Valor Preditivo dos Testes
14.
Front Cardiovasc Med ; 10: 1151705, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37424918

RESUMO

Aims: Diagnosis of myocardial fibrosis is commonly performed with late gadolinium contrast-enhanced (CE) cardiac magnetic resonance (CMR), which might be contraindicated or unavailable. Coronary computed tomography (CCT) is emerging as an alternative to CMR. We sought to evaluate whether a deep learning (DL) model could allow identification of myocardial fibrosis from routine early CE-CCT images. Methods and results: Fifty consecutive patients with known left ventricular (LV) dysfunction (LVD) underwent both CE-CMR and (early and late) CE-CCT. According to the CE-CMR patterns, patients were classified as ischemic (n = 15, 30%) or non-ischemic (n = 35, 70%) LVD. Delayed enhancement regions were manually traced on late CE-CCT using CE-CMR as reference. On early CE-CCT images, the myocardial sectors were extracted according to AHA 16-segment model and labeled as with scar or not, based on the late CE-CCT manual tracing. A DL model was developed to classify each segment. A total of 44,187 LV segments were analyzed, resulting in accuracy of 71% and area under the ROC curve of 76% (95% CI: 72%-81%), while, with the bull's eye segmental comparison of CE-CMR and respective early CE-CCT findings, an 89% agreement was achieved. Conclusions: DL on early CE-CCT acquisition may allow detection of LV sectors affected with myocardial fibrosis, thus without additional contrast-agent administration or radiational dose. Such tool might reduce the user interaction and visual inspection with benefit in both efforts and time.

15.
Expert Rev Med Devices ; 20(6): 467-491, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37157833

RESUMO

INTRODUCTION: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. AREAS COVERED: AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device. The draft EU Regulation on AI proposes rules that will apply across industry sectors, while for devices the Medical Device Regulation also applies. In the CORE-MD project (Coordinating Research and Evidence for Medical Devices), we have surveyed definitions and summarize initiatives made by professional consensus groups, regulators, and standardization bodies. EXPERT OPINION: The level of clinical evidence required should be determined according to each application and to legal and methodological factors that contribute to risk, including accountability, transparency, and interpretability. EU guidance for MDSW based on international recommendations does not yet describe the clinical evidence needed for medical AI software. Regulators, notified bodies, manufacturers, clinicians and patients would all benefit from common standards for the clinical evaluation of high-risk AI applications and transparency of their evidence and performance.


Assuntos
Inteligência Artificial , Software , Humanos , Algoritmos , União Europeia , Inquéritos e Questionários
16.
J Hypertens ; 41(4): 527-544, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-36723481

RESUMO

Blood pressure is not a static parameter, but rather undergoes continuous fluctuations over time, as a result of the interaction between environmental and behavioural factors on one side and intrinsic cardiovascular regulatory mechanisms on the other side. Increased blood pressure variability (BPV) may indicate an impaired cardiovascular regulation and may represent a cardiovascular risk factor itself, having been associated with increased all-cause and cardiovascular mortality, stroke, coronary artery disease, heart failure, end-stage renal disease, and dementia incidence. Nonetheless, BPV was considered only a research issue in previous hypertension management guidelines, because the available evidence on its clinical relevance presents several gaps and is based on heterogeneous studies with limited standardization of methods for BPV assessment. The aim of this position paper, with contributions from members of the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability and from a number of international experts, is to summarize the available evidence in the field of BPV assessment methodology and clinical applications and to provide practical indications on how to measure and interpret BPV in research and clinical settings based on currently available data. Pending issues and clinical and methodological recommendations supported by available evidence are also reported. The information provided by this paper should contribute to a better standardization of future studies on BPV, but should also provide clinicians with some indications on how BPV can be managed based on currently available data.


Assuntos
Doença da Artéria Coronariana , Hipertensão , Humanos , Pressão Sanguínea , Relevância Clínica , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/complicações , Determinação da Pressão Arterial , Doença da Artéria Coronariana/complicações , Monitorização Ambulatorial da Pressão Arterial
17.
J Magn Reson Imaging ; 35(5): 1145-51, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22128094

RESUMO

PURPOSE: To evaluate the mid-term effects of implant of dynamic neutralization system (Dynesys) on disc tissue in patients with lumbar discopathy, through the quantification of glycosaminoglycans (GAG) concentration, both in treated and adjacent levels, by analysis of delayed gadolinium-enhanced MRI contrast (dGEMRIC) images. MATERIALS AND METHODS: Ten patients with low back pain underwent the dGEMRIC diagnostic protocol before, 6-months and after 2 years from surgery. Each patient was also evaluated with visual analog (VAS), Oswestry, and Prolo scales both at presurgery and during follow-up. From dGEMRIC images, a ΔT1 parametric map was obtained for each disc, as quantitative indicator of its GAG concentration, and divided in 13 sectors, which were classified at presurgery as normal or abnormal, based on a 70-ms threshold. Evolution of ΔT1 was studied during the follow-up. RESULTS: Nine of ten patients completed the follow-up. VAS, Oswestry, and Prolo grades showed an improvement. This was accompanied by a reduction of ΔT1 in abnormal segments while normal segments showed a pattern of initial worsening at 6 months, followed by an improvement after 2 years. CONCLUSION: Our study confirmed the improvement in clinical evaluation, and for the first time related this to the changes in discs GAG concentration.


Assuntos
Degeneração do Disco Intervertebral/cirurgia , Deslocamento do Disco Intervertebral/cirurgia , Dor Lombar/diagnóstico , Dor Lombar/cirurgia , Vértebras Lombares/cirurgia , Imageamento por Ressonância Magnética/métodos , Próteses e Implantes , Adulto , Meios de Contraste , Avaliação da Deficiência , Feminino , Gadolínio DTPA , Glicosaminoglicanos/metabolismo , Humanos , Degeneração do Disco Intervertebral/metabolismo , Degeneração do Disco Intervertebral/patologia , Deslocamento do Disco Intervertebral/metabolismo , Deslocamento do Disco Intervertebral/patologia , Vértebras Lombares/patologia , Masculino , Pessoa de Meia-Idade , Medição da Dor , Complicações Pós-Operatórias , Estatísticas não Paramétricas , Estresse Mecânico , Fatores de Tempo , Resultado do Tratamento
18.
Comput Methods Programs Biomed ; 219: 106753, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35338885

RESUMO

BACKGROUND: Thanks to the increased interest towards health and lifestyle, a larger adoption in wearable devices for activity tracking is present among the general population. Wearable devices such as smart wristbands integrate inertial units, including accelerometers and gyroscopes, which can be utilised to perform automatic classification of hand gestures. This technology could also find an important application in automatic medication adherence monitoring. Accordingly, this study aims at comparing the performance of several Machine-Learning (ML) and Deep-Learning (DL) approaches for the automatic identification of hand gestures, with a specific focus on the drinking gesture, commonly associated to the action of oral intake of a pill-packed medication. METHODS: A method to automatically recognize hand gestures in daily living is proposed in this work. The method relies on a commercially available wristband sensor (MetaMotionR, MbientLab Inc.) integrating tri-axial accelerometer and gyroscope. Both ML and DL algorithms were evaluated for both multi-gesture (drinking, eating, pouring water, opening a bottle, typing, answering a phone, combing hair, and cutting) and binary gesture (drinking versus other gestures) classification from wristband sensor signals. Twenty-two participants were involved in the experimental analysis, performing a 10 min acquisition in a laboratory setting. Leave-one-subject-out cross validation was performed for robust performance assessment. RESULTS: The highest performance was achieved using a convolutional neural network with long- short term memory (CNN-LSTM), with a median f1-score of 90.5 [first quartile: 84.5; third quartile: 92.5]% and 92.5 [81.5;98.0]% for multi-gesture and binary classification, respectively. CONCLUSIONS: Experimental results showed that hand gesture classification with ML/DL from wrist accelerometers and gyroscopes signals can be performed with reasonable accuracy in laboratory settings, paving the way for a new generation of medical devices for monitoring medical adherence.


Assuntos
Gestos , Dispositivos Eletrônicos Vestíveis , Algoritmos , Mãos , Humanos , Aprendizado de Máquina , Redes Neurais de Computação
19.
Front Physiol ; 13: 944587, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36277205

RESUMO

Microgravity has deleterious effects on the cardiovascular system. We evaluated some parameters of blood flow and vascular stiffness during 60 days of simulated microgravity in head-down tilt (HDT) bed rest. We also tested the hypothesis that daily exposure to 30 min of artificial gravity (1 g) would mitigate these adaptations. 24 healthy subjects (8 women) were evenly distributed in three groups: continuous artificial gravity, intermittent artificial gravity, or control. 4D flow cardiac MRI was acquired in horizontal position before (-9 days), during (5, 21, and 56 days), and after (+4 days) the HDT period. The false discovery rate was set at 0.05. The results are presented as median (first quartile; third quartile). No group or group × time differences were observed so the groups were combined. At the end of the HDT phase, we reported a decrease in the stroke volume allocated to the lower body (-30% [-35%; -22%]) and the upper body (-20% [-30%; +11%]), but in different proportions, reflected by an increased share of blood flow towards the upper body. The aortic pulse wave velocity increased (+16% [+9%; +25%]), and so did other markers of arterial stiffness ( C A V I ; C A V I 0 ). In males, the time-averaged wall shear stress decreased (-13% [-17%; -5%]) and the relative residence time increased (+14% [+5%; +21%]), while these changes were not observed among females. Most of these parameters tended to or returned to baseline after 4 days of recovery. The effects of the artificial gravity countermeasure were not visible. We recommend increasing the load factor, the time of exposure, or combining it with physical exercise. The changes in blood flow confirmed the different adaptations occurring in the upper and lower body, with a larger share of blood volume dedicated to the upper body during (simulated) microgravity. The aorta appeared stiffer during the HDT phase, however all the changes remained subclinical and probably the sole consequence of reversible functional changes caused by reduced blood flow. Interestingly, some wall shear stress markers were more stable in females than in males. No permanent cardiovascular adaptations following 60 days of HDT bed rest were observed.

20.
Eur Heart J Digit Health ; 3(3): 341-358, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36712155

RESUMO

The role of subclinical atrial fibrillation as a cause of cryptogenic stroke is unambiguously established. Long-term electrocardiogram (ECG) monitoring remains the sole method for determining its presence following a negative initial workup. This position paper of the European Society of Cardiology Working Group on e-Cardiology first presents the definition, epidemiology, and clinical impact of cryptogenic ischaemic stroke, as well as its aetiopathogenic association with occult atrial fibrillation. Then, classification methods for ischaemic stroke will be discussed, along with their value in providing meaningful guidance for further diagnostic efforts, given disappointing findings of studies based on the embolic stroke of unknown significance construct. Patient selection criteria for long-term ECG monitoring, crucial for determining pre-test probability of subclinical atrial fibrillation, will also be discussed. Subsequently, the two major classes of long-term ECG monitoring tools (non-invasive and invasive) will be presented, with a discussion of each method's pitfalls and related algorithms to improve diagnostic yield and accuracy. Although novel mobile health (mHealth) devices, including smartphones and smartwatches, have dramatically increased atrial fibrillation detection post ischaemic stroke, the latest evidence appears to favour implantable cardiac monitors as the modality of choice; however, the answer to whether they should constitute the initial diagnostic choice for all cryptogenic stroke patients remains elusive. Finally, institutional and organizational issues, such as reimbursement, responsibility for patient management, data ownership, and handling will be briefly touched upon, despite the fact that guidance remains scarce and widespread clinical application and experience are the most likely sources for definite answers.

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