Enrico Caiani

• PhD in Biomedical Engineering
• Professor (Associate) at Politecnico di Milano

The European Union (EU) Medical Device Regulation and In Vitro Medical Device Regulation have introduced more rigorous regulatory requirements for medical devices, including new rules for post-market surveillance. However, EU market vigilance is limited by the absence of harmonized reporting systems, languages and nomenclatures among Member States....

Background Recent literature has identified numerous combinations of meteorological indicators, methods and comparison thresholds to define heat in order to analyse its impact on adverse cardiovascular (CV) events. In fact, despite increasing attention to the issue due to ongoing climate change, there is no standardised definition of heat nor guide...

Introduction Association between both short [1] and long-term exposure to air pollution and cardiovascular (CV) morbidity and mortality is known. Lombardy region, Italy is a hot spot for air pollution spikes in particulate matter (PM) and NO2, with over 60% and 45%, respectively, of days/year exceeding the WHO daily permissible limits. This phenome...

The increasing prevalence of scuba diving in both physically active and sedentary individuals underscores the need for technology enabling real-time cardiovascular monitoring during underwater activities. This study aimed to assess cardiac electro-mechanical activity and its adaptation underwater in controlled dives. ECG and seismocardiograph...

Introduction The EU Medical Device Regulation 2017/745 has defined new rules for medical device (MD) certification and post-market surveillance (PMS). In particular, a centralized database (Eudamed) has been established to collect and share information about the lifecycle of MD in EU market. To become effective for PMS, the European MD Nomenclature...

Background Recent research reports both direct and indirect impact of the coronavirus disease 2019 (COVID-19) on cardiovascular (CV) health. Existing case-studies mostly focus on the immediate effects, leaving the long-term consequences of the pandemic in this field as yet unrecognised. Purpose The aim of this study was to analyse the changes in C...

The quality of our habitat strongly determines the well-being of both our society and us as individuals. The Urban Health (UH) index is an emerging tool for decision-makers to bridge the disparities in the quality of life in cities. Our study assesses the quality of the built environment as a proxy for urban health and proposes a theoretical framew...

Objectives: We aimed to analyze recent literature on heat effects on cardiovascular morbidity and mortality, focusing on the adopted heat definitions and their eventual impact on the results of the analysis. Methods: The search was performed on PubMed, ScienceDirect, and Scopus databases: 54 articles, published between January 2018 and September 2...

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. Re...

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 myoca...

Funding Acknowledgements Type of funding sources: None. Background Late gadolinium enhancement (LGE) derived from cardiac magnetic resonance (CMR) has become a method of choice for the evaluation of myocardial tissue composition and detection of myocardial fibrosis. Advances in cardiac computed tomography (CCT) imaging have led to its growing role...

Funding Acknowledgements Type of funding sources: None. Background Increased epicardial adipose tissue (EAT) volume quantified with cardiac magnetic resonance (CMR) has been associated with the development of major adverse cardiac events (MACE). We sought to investigate the additional prognostic role EAT volume in patients with known or suspected...

Air pollution is identified as the primary environmental risk to health worldwide. Although most of the anthropic emissions are due to combustion processes, intensive farming activities may also contribute significantly, especially as a source of particulate matter 2.5 and ammonia. Investigations on particulate matter and precursors dynamics, ident...

Diagnosis of myocardial fibrosis has a relevant prognostic and therapeutic role. Scar–tissue analysis is commonly performed with late gadolinium contrast–enhanced (CE) cardiac magnetic resonance (CMR). However, CMR might be contraindicated or unavailable. Coronary computed tomography (CCT), which is the technique of choice for many routine assessme...

Heat waves (HWs) are becoming more frequent due to climate change. Their impact on cardiovascular (CV) health has been widely studied, and results vary depending on the disease and the geographic area. Our aim was to study this phenomenon using emergency medical service (EMS) data relevant to CV events that occurred out-of-hospital during May–Sept...

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 med...

Tracking a person’s activities is relevant in a variety of contexts, from health and group-specific assessments, such as elderly care, to fitness tracking and human–computer interaction. In a clinical context, sensor-based activity tracking could help monitor patients’ progress or deterioration during their hospitalization time. However, during rou...

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...

Introduction The EU Medical Device Regulation 2017/745 defines new rules for the certification and post-market surveillance of medical devices (MD), including an additional review by Expert Panels of clinical evaluation data for high-risk MD if reports and alerts suggest possibly associated increased risks. Within the EU-funded CORE-MD project, our...

Diagnosis of myocardial fibrosis has a relevant prognostic and therapeutic role. Scar-tissue analysis is commonly performed with late gadolinium contrast-enhanced (CE) cardiac magnetic resonance (CMR). However, CMR might be contraindicated or unavailable. Coronary computed tomography (CCT), which is the technique of choice for many routine assessme...

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...

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 accur...

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...

Introduction The EU Medical Device Regulation 2017/745, in force since May 26th 2021, defines new rules for medical device (MD) certification and post-market surveillance (PMS). For high-risk implantable MD, in the certification process notified bodies are obliged to consult clinical Expert Panels (EP) that could decide to proceed for an extensive...

Background/Introduction Diagnosis of myocardial fibrosis has a relevant prognostic and therapeutic role. Scar-tissue analysis is commonly performed with late gadolinium contrast-enhanced (CE) cardiac magnetic resonance (CMR). However, CMR might be contraindicated or unavailable. Coronary computed tomography (CCT), which is the technique of choice f...

Hypertension is the most common and preventable risk factor for cardiovascular disease (CVD), accounting for 20% of deaths worldwide. However, 2/3 of people with hypertension are undiagnosed, untreated, or under treated. A multi-pronged approach is needed to improve hypertension management. Elevated blood pressure (BP) in childhood is a predictor o...

The pandemic of COVID-19 has posed unprecedented threats to healthcare systems worldwide. Great efforts were spent to fight the emergency, with the widespread use of cutting-edge technologies, especially big data analytics and AI. In this context, the present study proposes a novel combination of geographical filtering and machine learning (ML) for...

Background Novel smartwatch-based cuffless blood pressure (BP) measuring devices are coming to market and receive FDA and CE labels. These devices are often insufficiently validated for clinical use. This study aims to investigate a recently CE-cleared smartwatch using cuffless BP measurement in a population with normotensive and hypertensive indiv...

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 d...

The aim of this study was to assess the relationship between left ventricular (LV) regional myocardial wall motion abnormality (WMA), revealed by visual interpretation of cardiac magnetic resonance (CMR) cine images together with the computed wall motion parametric image, and the transmural scar extent, as assessed by Late Gadolinium Enhancement (L...

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 diagnosi...

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...

Remote patient monitoring involves the collection of patient-generated health data, using sensors/devices and mobile apps, to allow observation of patient’s health status, also outside healthcare environments. The challenge in this field is to facilitate patient-centric data storing, sharing, and retrieving, with high attention to personal, sensiti...

Background In this paper we propose a novel framework for the definition of Personas for healthcare workers based on an online survey, with the aim of highlighting different levels of risk of developing mental disorders induced by COVID-19 and tailor psychological support interventions. Methods Data were gathered from Italian healthcare workers be...

Featured Application The innovative systems called health pods are exploiting digital health concepts by delivering preventive medicine services in a “distributed hospital” setting. Abstract Health pods are new systems such as small spaces equipped with medical devices where users can measure several biomedical parameters related to their health s...

Background: the Lombardy region in Italy was the first area in Europe to record an outbreak of COVID-19 and one of the most affected worldwide. As this territory is strongly polluted, it was hypothesized that pollution had a role in facilitating the diffusion of the epidemic, but results are uncertain. Aim: the paper explores the effect of air p...

Introduction Digital therapeutics (DTx) are a subset of digital health tools delivering evidence-based therapeutic interventions that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are studied using randomized clinical trial methodology and reviewed, cleared or certified by regulatory b...

Background: Mitral valve regurgitation (MR) is the most common valvular heart disease and current variables associated with MR recurrence are still controversial. We aim to develop a machine learning-based prognostic model to predict causes of mitral valve (MV) repair failure and MR recurrence. Methods: 1000 patients who underwent MV repair at our...

Funding Acknowledgements Type of funding sources: None. Background Covid-19 pandemic has generated a huge amount of stress upon all healthcare workers, with an increased risk of developing burnout syndrome and Post Traumatic Stress Disorder (PTSD). Mobile health could provide tools for preventive interventions, whose efficacy could be improved by...

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 adaptiv...

Background: Whereas transcatheter aortic valve implantation (TAVI) has become the gold standard for aortic valve stenosis treatment in high-risk patients, it has recently been extended to include intermediate risk patients. However, the mortality rate at 5 years is still elevated. The aim of the present study was to develop a novel machine learnin...

Background and Objective : Segmentation of the left ventricular (LV) myocardium (Myo) and RV endocardium on cine cardiac magnetic resonance (CMR) images represents an essential step for cardiac-function evaluation and diagnosis. In order to have a common reference for comparing segmentation algorithms, several CMR image datasets were made available...

Pathology reports represent a primary source of information for cancer registries. Hospitals routinely process high volumes of free-text reports, a valuable source of information regarding cancer diagnosis for improving clinical care and supporting research. Information extraction and coding of textual unstructured data is typically a manual, labou...

Commercially available health technologies such as smartphones and smartwatches, activity trackers and eHealth applications, commonly referred to as wearables, are increasingly available and used both in the leisure and healthcare sector for pulse and fitness/activity tracking. The aim of the Position Paper is to identify specific barriers and know...

Head-down tilt (HDT) bed rest elicits changes in cardiac circadian rhythms, generating possible adverse health outcomes such as increased arrhythmic risk. Our aim was to study the impact of HDT duration on the circadian rhythms of heart beat (RR) and ventricular repolarization (QTend) duration intervals from 24-h Holter ECG recordings acquired in 6...

Virtual reality (VR) headsets, with embedded micro-electromechanical systems, have the potential to assess the mechanical heart’s functionality and respiratory activity in a non-intrusive way and without additional sensors by utilizing the ballistocardiographic principle. To test the feasibility of this approach for opportunistic physiological moni...

Aims Reduced physical activity increases the risk of heart failure; however, non‐invasive methodologies detecting subclinical changes in myocardial function are not available. We hypothesized that myocardial, left ventricular, systolic strain measurements could capture subtle abnormalities in myocardial function secondary to physical inactivity. M...

Background Review of scientific literature is a time consuming but fundamental step in any kind of scientific research. A consistent manual filtering of papers is always necessary in order to evaluate their relevance with respect to the topic of interest, as the sorting provided by most common research engines is rarely efficient in terms of matchi...

Introduction Prolonged bed rest (BR) is an unnatural state, often related to hospitalization, chronic diseases and ageing, inducing reduced functional capacity in multiple body systems, possibly leading to cardiovascular deconditioning. We hypothesized that measuring this decline over time could represent the first step for the formulation of appro...

The “ideal” management of asymptomatic severe mitral regurgitation (MR) in valve prolapse (MVP) is still debated. The aims of this study were to identify pre-operatory parameters predictive of residual MR and of early and long-term favorable remodeling after MVP repair. We included 295 patients who underwent MV repair for MVP with pre-operatory two...

Head-down bed rest (HDBR) reproduces the cardiovascular effects of microgravity. We tested the hypothesis that regular high-intensity physical exercise (JUMP) could prevent this cardiovascular deconditioning, which could be detected using seismocardiography (SCG) and ballistocardiography (BCG). 23 healthy males were exposed to 60-day HDBR: 12 in a...

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 e...

Public Access Defibrillation (PAD) is the leading strategy in reducing time to first defibrillation in cases of Out-Of-Hospital Cardiac Arrest (OHCA), but PAD programs are underperforming considering their potentiality. Our aim was to develop an analysis and optimization framework, exploiting georeferenced information processed with Geographic Info...

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 impa...

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 manu...

Objective Statistical shape modelling (SSM) has established as a powerful method for segmenting the left ventricle in cardiac magnetic resonance (CMR) images However, applying them to segment the right ventricle (RV) is not straightforward because of the complex structure of this chamber. Our aim was to develop a new inter-modality SSM-based approa...

Background Changes in large artery properties including increased arterial compliance and increased carotid artery stiffness have been described after space flight. Altered vascular structure, which heralds cardiovascular risk, and reversible changes in vascular function could contribute to the response. Compared with previous bedrest studies, whic...

The P5 approach to medicine emphasizes the importance of psychological and cognitive factors in the healthcare process, namely, the enhancement of patients’ responsibility to participate in the medical decision making, patient education, as well as the measurement and support to quality of life. In the context of eHealth development and evaluation,...

Background Changes in large artery properties including increased arterial compliance and increased carotid artery stiffness have been described after space flight. Altered vascular structure, which heralds cardiovascular risk, and reversible changes in vascular function could contribute to the response. Compared with previous studies, which did no...

Ventricular arrhythmias and sudden cardiac death during long-term space missions are a major concern for space agencies. Long-duration spaceflight and its ground-based analog head-down bed rest (HDBR) have been reported to markedly alter autonomic and cardiac functioning, particularly affecting ventricular repolarization of the electrocardiogram (E...

Objective To evaluate functional myocardial contractility after 21 days of head-down bed rest (HDBR) in sedentary control (CON) or with a resistive vibration exercise (RVE) countermeasure (CM) applied, by using 4D echocardiographic (4D echo) imaging and speckle tracking strain quantification.Methods Twelve volunteers were enrolled in a crossover HD...

Objective: To assess the effects of different durations of simulated microgravity exposure on ventricular repolarization (VR) in terms of T-wave alternans (TWA) as well as to test whether an increase in VR heterogeneity could be detected once normal gravity was restored. Approach: A total of 63 healthy volunteers were recruited in several head-d...

Aims Prolonged immobilization generates cardiac deconditioning, a risk factor for cardiovascular disease, and efficient countermeasures (CM) are needed to prevent it. Our aim was to assess by Cine-MRI the effects of long-term strict head-down (−6 degrees) bed-rest (BR) deconditioning, and the effectiveness of high-intensity jump training CM, on lef...

Body acceleration due to heartbeat-induced reaction forces can be measured as mobile phone accelerometer (m-ACC) signals. Our aim was to test the feasibility of using m-ACC to detect changes induced by stress by ultra-short heart rate variability (USV) indices (standard deviation of normal-to-normal interval—SDNN and root mean square of successive...

To address the study of the deployment of publicly accessible Automated External Defibrillators (AED), Geomatics allows computing their limited area of effectiveness (i.e. ‘catchment area’, CA), traditionally set as circular surfaces with a 100m-radius. Exploiting open geospatial data related to roads network, also ‘realistic’ CAs, based on the eff...

Body acceleration due the heartbeat-induced reaction forces can be measured as smartphone accelerometer (m-ACC) signals. Our aim was to test the feasibility of using m-ACC to detect changes induced by stress by ultra-short heart rate variability (USV) indices (SDNN and RMSSD). Sixteen healthy volunteers were recruited; m-ACC was recorded while in s...

Cardiovascular disease is one of the main causes of morbidity and mortality worldwide. Despite the availability of highly effective treatments, the contemporary burden of disease remains huge. Digital health interventions hold promise to improve further the quality and experience of cardiovascular care. This position paper provides a brief overview...

Objective The aim of this paper is to investigate the use of fully convolutional neural networks (FCNNs) to segment scar tissue in the left ventricle from cardiac magnetic resonance with late gadolinium enhancement (CMR-LGE) images. Methods A successful FCNN in the literature (the ENet) was modified and trained to provide scar-tissue segmentation....

Purpose The aim of this study was to test the viability of a novel method for automated characterization of mobile health apps. Method In this exploratory study, we developed the basic modules of an automated method, based on text analytics, able to characterize the apps' medical specialties by extracting information from the web. We analyzed apps...

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Use of intima-media thickness in the assessment of the development of preclinical atherosclerosis R.N.N. Najafov

Background Cardiac Magnetic Resonance Imaging (MRI) is the commonly used technique for the assessment of left ventricular (LV) function. Apart manually or semi-automatically contouring LV boundaries for quantification of By visual interpretation of cine images, assessment of regional wall motion is performed by visual interpretation of cine images,...

Aims: Prolonged immobilization generates cardiac deconditioning, a cardiovascular disease risk factor, and efficient countermeasures (CM) are needed to prevent it. We aimed to assess by Phase-Contrast (PC) MRI the effects of long-term strict head-down (-6 degrees) bed-rest (BR) deconditioning and the effectiveness of high-intensity jump training CM...

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 performan...

Objective: Atrial fibrillation (AF) rhythm gives rise to an irregular response in ventricular activity, preventing the use of standard ECG-derived risk markers based on ventricular repolarization heterogeneity under this particular condition. In this study we proposed new indices to quantify repolarization variations in AF patients, assessing thei...