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Objectives: In general, a terminology shared and agreed by different stakeholders is important to facilitate communication and cooperation. This holds true in the field of vascular ageing for the benefit of global cardiovascular health. The need to promote a common language and understanding across this area was recognised by VascAgeNet, a collaborative network with relevant and diverse expertise in the vascular ageing field, supported by the European Cooperation in Science and Technology. To contribute to the spread of unified terms in the vascular ageing field, a glossary was created by VascAgeNet and this paper describes the systematic process used for its development. Methods: An initial list of terms and preliminary definitions were collated from the network. A dedicated team was created to design the glossary development process, to facilitate its implementation and to maximise outreach and dissemination. The key steps of the process were to determine: (1) the target audience; (2) a list of priority terms; (3) a template structure for definitions; (4) methods for collecting feedback and (5) the dissemination plan. Results: An implementation strategy was provided for each key step and shared within the network; main decisions were agreed by all members of the glossary team. Small groups of definitions were released on a regular basis within a pilot phase including 19 terms (status: 05.09.2023) that were published openly at https://vascagenet.eu/official-glossary. Conclusions: The strategy for creating the first Vascular Ageing Glossary has been successfully designed and developed within VascAgeNet. A pilot phase covering the first publicly available terms was completed. The glossary is a living document, available to the scientific community, which aims to unify the vascular ageing language. Supplementary Information: The online version contains supplementary material available at 10.1007/s44200-023-00041-5.
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Vascular ageing is the deterioration of arterial structure and function which occurs naturally with age, and which can be accelerated with disease. Measurements of vascular ageing are emerging as markers of cardiovascular risk, with potential applications in disease diagnosis and prognosis, and for guiding treatments. However, vascular ageing is not yet routinely assessed in clinical practice. A key step towards this is the development of technologies to assess vascular ageing. In this Roadmap, experts discuss several aspects of this process, including: measurement technologies; the development pipeline; clinical applications; and future research directions. The Roadmap summarises the state of the art, outlines the major challenges to overcome, and identifies potential future research directions to address these challenges.
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BACKGROUND: Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field. RESEARCH DESIGN AND METHODS: A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform. RESULTS: Results were derived from 94 participants (27% clinicians, 62% researchers, 11% companies) and evidenced mostly a fair knowledge of MDR (despite self-judged as poor by 51%). Safety (83%), validation (56%), risk management (50%) were considered relevant and associated with the regulatory process. Structured support and regulatory procedures connected with medical devices in daily practice at the institutional level are lacking (only 33% report availability of a regulatory department). CONCLUSIONS: Regulation was recognized relevant by the VascAgeNet community and specific support and training in medical device regulatory science was considered important. A direct link with the regulatory sector is not yet easily available.
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BACKGROUND: Arterial stiffness, as measured by arterial pulse wave velocity (PWV), is an established biomarker for cardiovascular risk and target-organ damage in individuals with hypertension. With the emergence of new devices for assessing PWV, it has become evident that some of these devices yield results that display significant discrepancies compared with previous devices. This discrepancy underscores the importance of comprehensive validation procedures and the need for international recommendations. METHODS: A stepwise approach utilizing the modified Delphi technique, with the involvement of key scientific societies dedicated to arterial stiffness research worldwide, was adopted to formulate, through a multidisciplinary vision, a shared approach to the validation of noninvasive arterial PWV measurement devices. RESULTS: A set of recommendations has been developed, which aim to provide guidance to clinicians, researchers, and device manufacturers regarding the validation of new PWV measurement devices. The intention behind these recommendations is to ensure that the validation process can be conducted in a rigorous and consistent manner and to promote standardization and harmonization among PWV devices, thereby facilitating their widespread adoption in clinical practice. CONCLUSIONS: It is hoped that these recommendations will encourage both users and developers of PWV measurement devices to critically evaluate and validate their technologies, ultimately leading to improved consistency and comparability of results. This, in turn, will enhance the clinical utility of PWV as a valuable tool for assessing arterial stiffness and informing cardiovascular risk stratification and management in individuals with hypertension.
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Hipertensión , Rigidez Vascular , Humanos , Análisis de la Onda del Pulso/métodos , Presión Arterial , Hipertensión/diagnóstico , ArteriasRESUMEN
Magnetic resonance imaging and computed tomography allow the characterization of arterial state and function with high confidence and thus play a key role in the understanding of arterial aging and its translation into the clinic. Decades of research into the development of innovative imaging sequences and image analysis techniques have led to the identification of a large number of potential biomarkers, some bringing improvement in basic science, others in clinical practice. Nonetheless, the complexity of some of these biomarkers and the image analysis techniques required for their computation hamper their widespread use. In this narrative review, current biomarkers related to aging of the aorta, their founding principles, the sequence, and postprocessing required, and their predictive values for cardiovascular events are summarized. For each biomarker a summary of reference values and reproducibility studies and limitations is provided. The present review, developed in the COST Action VascAgeNet, aims to guide clinicians and technical researchers in the critical understanding of the possibilities offered by these advanced imaging modalities for studying the state and function of the aorta, and their possible clinically relevant relationships with aging.
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Arterias , Imagen por Resonancia Magnética , Reproducibilidad de los Resultados , Imagen por Resonancia Magnética/métodos , BiomarcadoresRESUMEN
Non-invasive ultrasound (US) imaging enables the assessment of the properties of superficial blood vessels. Various modes can be used for vascular characteristics analysis, ranging from radiofrequency (RF) data, Doppler- and standard B/M-mode imaging, to more recent ultra-high frequency and ultrafast techniques. The aim of the present work was to provide an overview of the current state-of-the-art non-invasive US technologies and corresponding vascular ageing characteristics from a technological perspective. Following an introduction about the basic concepts of the US technique, the characteristics considered in this review are clustered into: 1) vessel wall structure; 2) dynamic elastic properties, and 3) reactive vessel properties. The overview shows that ultrasound is a versatile, non-invasive, and safe imaging technique that can be adopted for obtaining information about function, structure, and reactivity in superficial arteries. The most suitable setting for a specific application must be selected according to spatial and temporal resolution requirements. The usefulness of standardization in the validation process and performance metric adoption emerges. Computer-based techniques should always be preferred to manual measures, as long as the algorithms and learning procedures are transparent and well described, and the performance leads to better results. Identification of a minimal clinically important difference is a crucial point for drawing conclusions regarding robustness of the techniques and for the translation into practice of any biomarker.
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Arterias , Ultrasonografía Doppler , Humanos , Ultrasonografía/métodos , Arterias/diagnóstico por imagen , Algoritmos , TecnologíaRESUMEN
OBJECTIVE: Children and adolescents with adiposity excess are at increased risk of future cardiovascular (CV) disease. Fat accumulation promotes the development of elevated blood pressure (BP) and arterial stiffness, two main determinants of CV risk which are strongly inter-related. We aimed at investigating whether the association between overweight and arterial stiffness, taken at different arterial segments, is mediated by increased BP or is BP-independent. METHODS: Three hundred and twenty-two Italian healthy adolescents (mean age 16.9±1.4âyears, 12% with overweight) attending the "G. Donatelli" High School in Terni, Italy, underwent measurement of arterial stiffness by arterial tonometry (aortic stiffness) and semiautomatical detection of pressure-volume ratio of the common carotid (carotid stiffness). The mediator effect of BP was tested for each anthropometric or biochemical measure of fat excess related to arterial stiffness. RESULTS: Both carotid and aortic stiffness showed positive correlations with body mass index, waist, hip, and neck circumferences (NC). Only carotid stiffness, but not aortic stiffness, was associated with serum markers of fat accumulation and metabolic impairment such as insulin, homeostatic model of insulin resistance (HOMA-IR), serum gamma-glutamyl transferase (sGGT) and uric acid. The association with NC was stronger for carotid than for aortic stiffness (Fisher z -to- R 2.07, P â=â0.04), and independent from BP. CONCLUSIONS: In healthy adolescents, fat accumulation is associated with arterial stiffness. The degree of this association differs by arterial segments, since carotid stiffness is more strongly associated to adipose tissue excess than aortic stiffness and shows a BP-independent association with NC whereas aortic stiffness does not.
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Enfermedades Cardiovasculares , Rigidez Vascular , Adolescente , Humanos , Adiposidad , Presión Sanguínea , Arterias Carótidas , Obesidad/complicaciones , Sobrepeso/complicaciones , Factores de Riesgo , Circunferencia de la CinturaRESUMEN
Prevention of cardiovascular disease (CVD) remains one of the largest public health challenges of our time. Identifying individuals at increased cardiovascular risk at an asymptomatic, sub-clinical stage is of paramount importance for minimizing disease progression as well as the substantial health and economic burden associated with overt CVD. Vascular ageing (VA) involves the deterioration in vascular structure and function over time and ultimately leads to damage in the heart, brain, kidney, and other organs. Vascular ageing encompasses the cumulative effect of all cardiovascular risk factors on the arterial wall over the life course and thus may help identify those at elevated cardiovascular risk, early in disease development. Although the concept of VA is gaining interest clinically, it is seldom measured in routine clinical practice due to lack of consensus on how to characterize VA as physiological vs. pathological and various practical issues. In this state-of-the-art review and as a network of scientists, clinicians, engineers, and industry partners with expertise in VA, we address six questions related to VA in an attempt to increase knowledge among the broader medical community and move the routine measurement of VA a little closer from bench towards bedside.
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Enfermedades Cardiovasculares , Humanos , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/prevención & control , Arterias , EnvejecimientoRESUMEN
Medical devices are subject to strict regulatory and approval processes to enter the market and to be used by operators and patients. These are needed to guarantee the users' safety. The different activities of these processes have important implications for all involved stakeholders and for the whole lifecycle of a medical device. The aim of this work is to provide an overview of some key aspects of the new EU Medical Device Regulation and to show why researchers, innovators and clinicians should care about it. Awareness of regulatory requirements can improve the innovation process and its efficiency in terms of both social and ethical impact, but this awareness needs to be raised in the upcoming months and years. One can shortly say "yes, one needs to take care" of the new EU Medical Device Regulation. First and foremost, it is crucial for the sake of the users' safety, which is the regulation's intrinsic goal. Second, it should not just be seen as an obstacle for new innovations in the medical domain, but as a chance as it can provide new opportunities.
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After publishing an in-depth study that analyzed the ability of computerized methods to assist or replace human experts in obtaining carotid intima-media thickness (CIMT) measurements leading to correct therapeutic decisions, here the same consortium joined to present technical outlooks on computerized CIMT measurement systems and provide considerations for the community regarding the development and comparison of these methods, including considerations to encourage the standardization of computerized CIMT measurements and results presentation. A multi-center database of 500 images was collected, upon which three manual segmentations and seven computerized methods were employed to measure the CIMT, including traditional methods based on dynamic programming, deformable models, the first order absolute moment, anisotropic Gaussian derivative filters and deep learning-based image processing approaches based on U-Net convolutional neural networks. An inter- and intra-analyst variability analysis was conducted and segmentation results were analyzed by dividing the database based on carotid morphology, image signal-to-noise ratio, and research center. The computerized methods obtained CIMT absolute bias results that were comparable with studies in literature and they generally were similar and often better than the observed inter- and intra-analyst variability. Several computerized methods showed promising segmentation results, including one deep learning method (CIMT absolute bias = 106 ± 89 µm vs. 160 ± 140 µm intra-analyst variability) and three other traditional image processing methods (CIMT absolute bias = 139 ± 119 µm, 143 ± 118 µm and 139 ± 136 µm). The entire database used has been made publicly available for the community to facilitate future studies and to encourage an open comparison and technical analysis (https://doi.org/10.17632/m7ndn58sv6.1).
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Arterias Carótidas , Grosor Intima-Media Carotídeo , Arterias Carótidas/diagnóstico por imagen , Arteria Carótida Común/diagnóstico por imagen , Humanos , Ultrasonografía/métodos , Ultrasonografía DopplerRESUMEN
The photoplethysmogram (PPG) signal is widely measured by clinical and consumer devices, and it is emerging as a potential tool for assessing vascular age. The shape and timing of the PPG pulse wave are both influenced by normal vascular aging, changes in arterial stiffness and blood pressure, and atherosclerosis. This review summarizes research into assessing vascular age from the PPG. Three categories of approaches are described: 1) those which use a single PPG signal (based on pulse wave analysis), 2) those which use multiple PPG signals (such as pulse transit time measurement), and 3) those which use PPG and other signals (such as pulse arrival time measurement). Evidence is then presented on the performance, repeatability and reproducibility, and clinical utility of PPG-derived parameters of vascular age. Finally, the review outlines key directions for future research to realize the full potential of photoplethysmography for assessing vascular age.
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Fotopletismografía , Rigidez Vascular , Presión Sanguínea/fisiología , Hemodinámica , Análisis de la Onda del Pulso , Reproducibilidad de los Resultados , Rigidez Vascular/fisiologíaRESUMEN
The development and use of medical devices are subject to regulations and approval activities to enter the market. These are mandatory for manufacturers and have important implications for all involved professionals. In fact, the innovation process, starting from a clinical need, includes the identification of a solution and its implementation, and requires taking into account crucial aspects according to regulatory requirements in each phase. These include exemplary validation or risk management. The aim of this work is to provide an overview of some key aspects of regulation and their implementation in medical devices for vascular ageing assessment. In particular, regulatory scenarios in Europe, Australia and the United States of America are described and examples of marketed medical devices for vascular ageing assessment are provided. Strong and active links among industry, research, clinical experts and governments adds value for the community, requiring the ability to communicate between different skills and backgrounds: this multidisciplinary and multi-partner collaboration can speed up the innovation process and can increase the system's efficiency related to both social and ethical impact.
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Envejecimiento , Australia , Europa (Continente) , Humanos , Estados UnidosRESUMEN
OBJECTIVE: The objective of this work was to investigate technical validation and usability of an innovative, technically simple, easy-to-use, and portable integrated system to assess carotid function and structure by ultrasound. METHODS: The studied system integrated a hardware (the Interson SP-L01 embedded ultrasound probe [Interson, Pleasanton, CA, USA]) and a software measuring the instantaneous diameter of the carotid artery in real-time from B-mode ultrasound image sequences (Carotid Studio, by Quipu Srl [Pisa, Italy]). Technical validation was evaluated by intra-operator reproducibility of two measurements acquired by an expert operator, and agreement with state-of-the-art technique (Mylab25 by Esaote SpA [Genova, Italy], Carotid Studio 4.3 by Quipu Srl) was evaluated in laboratory settings in 12 healthy volunteers; usability of the portable integrated system was investigated by administering questionnaires to users and the results were reported with scores based on a five-point scale. RESULTS: Twelve (12) healthy volunteers (five men, mean age 44.5±13.6 years, free of cardiovascular disease or risk factors), were recruited. Agreement with state-of-the-art technique was satisfactory, with no significant bias. Coefficient of variation (intra-operator reproducibility) was 3.2% (2.5% SD) for intima-media thickness, 0.9% (0.7% SD) for diameter, and 2.5% (2.2% SD) for distension. Usability questionnaires showed an overall positive judgement of the integrated system with respect to the traditional one, obtaining an average score greater than 4 (on a five-point scale). CONCLUSIONS: A portable, innovative prototype to easily assess ultrasound carotid parameters of vascular ageing was successfully designed, developed, and demonstrated to be comparable with state-of-the art technique. Usability was also satisfactory.
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Envejecimiento , Grosor Intima-Media Carotídeo , Adulto , Arterias Carótidas/diagnóstico por imagen , Arteria Carótida Común , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Reproducibilidad de los Resultados , UltrasonografíaRESUMEN
Common carotid intima-media thickness (CIMT) is a commonly used marker for atherosclerosis and is often computed in carotid ultrasound images. An analysis of different computerized techniques for CIMT measurement and their clinical impacts on the same patient data set is lacking. Here we compared and assessed five computerized CIMT algorithms against three expert analysts' manual measurements on a data set of 1088 patients from two centers. Inter- and intra-observer variability was assessed, and the computerized CIMT values were compared with those manually obtained. The CIMT measurements were used to assess the correlation with clinical parameters, cardiovascular event prediction through a generalized linear model and the Kaplan-Meier hazard ratio. CIMT measurements obtained with a skilled analyst's segmentation and the computerized segmentation were comparable in statistical analyses, suggesting they can be used interchangeably for CIMT quantification and clinical outcome investigation. To facilitate future studies, the entire data set used is made publicly available for the community at http://dx.doi.org/10.17632/fpv535fss7.1.
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Algoritmos , Arterias Carótidas/diagnóstico por imagen , Grosor Intima-Media Carotídeo , Anciano , Sistemas de Computación , Femenino , Humanos , Masculino , Persona de Mediana Edad , UltrasonografíaRESUMEN
OBJECTIVES: A high prevalence of cardiovascular disease (CVD), not fully explained by the prevalence of traditional risk factors only, is reported in patients with idiopathic inflammatory myopathies (IIMs). Thus, we investigated if novel markers of CVD risk, like carotid diameter and advanced glycated end products, can better predict increased CVD risk in IIM patients. METHODS: We studied 43 consecutive patients diagnosed with IIM. All the patients underwent a clinical and laboratory evaluation of cardiovascular risk factors and characterisation of myositis disease activity. Non-invasive instrumental examinations performed included the measurement of carotid parameters (intima-media thickness, IMT and mean arterial diameter, mAD) by ultrasonic techniques, advanced glycation end-product accumulation in the skin by autofluorescence (AF) and body composition by bioelectrical impedance analysis. The parameters were compared to those measured in 29 controls, with similar mean age, BMI, blood pressure and smoking habits. RESULTS: IIM patients showed normal carotid IMT and distensibility, but higher carotid mAD (p=0.012), higher skin AF (p<0.001), lower fat free mass (p=0.036) and increased waist circumference compared to controls. A significant correlation was observed among AF and mAD (rho=0.317 p<0.05), carotid distension (rho=0.391 p=0.036) and IMT (rho=0.627 p<0.001). CONCLUSIONS: Abnormalities of the studied parameters suggest a higher risk of CV disease in IIM patients independent of disease activity. In this population, a thorough assessment of CV risk is recommended also in absence of overt CV disease during the clinical evaluation.
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Enfermedades Cardiovasculares , Arterias Carótidas/patología , Miositis , Presión Sanguínea , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Grosor Intima-Media Carotídeo , Humanos , Miositis/complicaciones , Factores de Riesgo , Circunferencia de la CinturaRESUMEN
BACKGROUND AND OBJECTIVES: Similarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the European Regulations for medical devices MDR (EU) 2017/745 and in-vitro diagnostic medical devices IVDR (EU) 2017/746 and it is on the way to become a worldwide standard. The aim of this work was to provide a possible approach for the implementation of UDI and traceability in Europe for standalone software medical devices according to lifecycle and quality system standards. METHODS: The key points of the UDI regulation were determined and analyzed in order to identify the main issues related to the manufacturing of software medical devices and, in particular, labeling, privacy aspects, UDI assignment criteria, and international standards compliance. RESULTS: An approach for the management of each key point was suggested, resulting in different levels of implementation for UDI and traceability. CONCLUSIONS: Among the various types of medical devices, software is an increasingly large reality with very specific characteristics that must be taken into consideration. All the relevant aspects for the implementation of the UDI should be taken into consideration to combine safety and feasibility in order to effectively pursue the traceability of these medical devices.
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Equipos y Suministros , Programas Informáticos , Equipos y Suministros/normas , PrivacidadRESUMEN
OBJECTIVES: The aim of this study was to evaluate the acute effects of participation in an Ironman distance triathlon competition on arterial function by ultrasound, in relation to cardiac function and body water content. METHODS: Twenty-eight male triathletes participating in an Ironman distance competition underwent carotid, femoral, and cardiac ultrasound examinations. Moreover, the presence of extravascular lung water was identified by lung echo B-lines (echogenic coherent wedge-shaped signal with a narrow origin from the hyperechoic pleural line) at rest and within 20 minutes of arrival. RESULTS: At the end of the competition, athletes showed an increased heart rate (mean ± SD, from 60.2 ± 13.1 to 82.8 ± 15.6 beats/min; P < .0001) and unchanged mean blood pressure (from 93 ± 14 to 91 ± 10 mm Hg; P > .05) in the presence of negligible dehydration (total body water from 48.0 ± 4.0 to 46.5 ± 3.9 kg; P > .05). Cardiac output increased (from 5.5 ± 1.2 to 6.7 ± 2.4 L/min; P < .05) in the presence of an unchanged stroke volume (from 64 ± 14 to 59 ± 16 mL; P > .05) and unchanged left ventricular elastance (from 1.52 ± 0.48 to 1.39 ± 0.48 mm Hg/mL/m2 ; P > .05). The mean carotid diameter increased (from 7.19 ± 0.65 to 7.61 ± 0.76 mm; P < .05), whereas the mean femoral diameter was unchanged at the end of the competition (from 10.41 ± 0.83 to 10.49 ± 0.82 mm; P > .05). Carotid intima-media thickness was significantly reduced (from 537 ± 70 to 495 ± 70 µm; P < .05), whereas B-lines increased significantly after the competition (from 1 [0-4] to 12 [5-23]; P < .0001). CONCLUSIONS: These data suggest different acute functional adaptation in central arteries with respect to peripheral leg vessels.
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Atletas/estadística & datos numéricos , Agua Corporal/diagnóstico por imagen , Arterias Carótidas/fisiología , Ejercicio Físico/fisiología , Arteria Femoral/fisiología , Corazón/fisiología , Adulto , Ciclismo , Presión Sanguínea/fisiología , Gasto Cardíaco/fisiología , Arterias Carótidas/diagnóstico por imagen , Grosor Intima-Media Carotídeo , Arteria Femoral/diagnóstico por imagen , Corazón/efectos de los fármacos , Frecuencia Cardíaca/fisiología , Humanos , Pulmón/diagnóstico por imagen , Pulmón/fisiología , Masculino , Valores de Referencia , Carrera , Volumen Sistólico/fisiología , Natación , Ultrasonografía/métodosRESUMEN
BACKGROUND: The literature shows that a healthy diet, rich in fruits and vegetables, has positive effects on overall cardiovascular risk, protecting against atherosclerosis. DESIGN: A cross sectional study in a population of apparently healthy young-adult men with the aim of investigating dietary determinants of early atherosclerosis, assessed by measuring carotid intima-media thickness (cIMT) and flow-mediated dilation (FMD) of the brachial artery. METHODS: 615 males (mean age ± SD: 40.8±9.8 years) without overt atherosclerosis were evaluated. Dietary intake was quantified by the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Intake of antioxidants was expressed in relation to total caloric intake. RESULTS: Neither absolute, recommended daily allowance or weight-related values of nutritional intake variables were associated with cIMT. Vitamin E to total calories intake (odds ratio, OR=0.08, 95%CI=0.03-0.89) was inversely associated with impaired FMD. Non-nutritional correlates of FMD <10% were: age (OR=1.02, 95%CI=1.0-1.05) and waist circumference (OR=1.03, 95%CI=1.0-1.06), and those of cIMT >0.8 mm were age (OR=1.10, 95%CI=1.05-1.15), pack-years (OR=1.02, 95%CI=1.0-1.04), C-reactive protein (OR=1.17, 95%CI=1.04-1.33) and total cholesterol (OR=1.01, 95%CI=1.0-1.02). CONCLUSION: Differences in the factors correlating with cIMT >0.8 mm and FMD <10% might have implications for cardiovascular risk reduction. A lower antioxidant to caloric intake ratio might be a risk factor for impaired FMD.