Innovations in blood pressure measurement and reporting technology: International Society of Hypertension position paper endorsed by the World Hypertension League, European Society of Hypertension, Asian Pacific Society of Hypertension, and Latin American Society of Hypertension.

Blood pressure (BP) is a key contributor to the lifetime risk of preclinical organ damage and cardiovascular disease. Traditional clinic-based BP readings are typically measured infrequently and under standardized/resting conditions and therefore do not capture BP values during normal everyday activity. Therefore, current hypertension guidelines emphasize the importance of incorporating out-of-office BP measurement into strategies for hypertension diagnosis and management.

Unified Language for Knowledge Dissemination: The Vascular Ageing Glossary, an Initiative by VascAgeNet.

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.

Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception.

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.

Magnetic Resonance Imaging and Computed Tomography for the Noninvasive Assessment of Arterial Aging: A Review by the VascAgeNet COST Action.

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.

The Ultrasound Window Into Vascular Ageing: A Technology Review by the VascAgeNet COST Action.

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.

Relationship between measures of adiposity, blood pressure and arterial stiffness in adolescents. The MACISTE study.

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.

Vascular ageing: moving from bench towards bedside.

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.

Medical Device Regulation: Should We Care About It?

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.

Carotid Ultrasound Boundary Study (CUBS): Technical considerations on an open multi-center analysis of computerized measurement systems for intima-media thickness measurement on common carotid artery longitudinal B-mode ultrasound scans.

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.

Assessing hemodynamics from the photoplethysmogram to gain insights into vascular age: a review from VascAgeNet.

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.

Technical Validation and Usability of a Portable Ultrasound-Based System for Carotid Assessment of Vascular Ageing: A Pilot Study.

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.

Regulatory Requirements For Medical Devices And Vascular Ageing: An Overview.

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.

Cardiometabolic risk and subclinical vascular damage assessment in idiopathic inflammatory myopathies: a challenge for the clinician.

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.

Unique device identification and traceability for medical software: A major challenge for manufacturers in an ever-evolving marketplace.

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.

Acute Cardiovascular Adaptation to Strenuous Exercise: An Integrative Ultrasound Study.

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.

The Influence of Dietary Components on Early Signs of Atherosclerosis in Apparently Healthy Young-adult Males: An Observational Study of 615 Subjects.

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.

Carotid and aortic stiffness in essential hypertension and their relation with target organ damage: the CATOD study.

Objective: The objective of the study is to investigate in the hypertensive population the possible differential association between increased aortic and/or carotid stiffness and organ damage in multiple districts, such as the kidney, the vessels, and the heart.

Methods: In 314 essential hypertensive patients, carotid-femoral pulse wave velocity (cfPWV, by applanation tonometry) and carotid stiffness (from ultrasound images analysis), together with left ventricular hypertrophy, carotid intima-media thickness, urinary albumin-creatinin ratio, and glomerular filtration rate were measured. Increased cfPWV and carotid stiffness were defined according to either international reference values or the 90th percentile of a local control group (110 age and sex-matched healthy individuals).

Carotid-Ventricular Coupling During Exercise: A Pilot Study.

Objectives: To evaluate carotid elasticity and left ventricular elastance during a graded bicycle semisupine exercise test in patients with known or suspected coronary artery disease and compare them with a control group of healthy young volunteers.

Methods: Thirty-six elderly patients and 18 young healthy volunteers were recruited. The right carotid diameter was estimated by an automatic system applied to B-mode sonographic sequences, central mean blood and pulse pressures by radial artery tonometry, and cardiac volumes by 2-dimensional transthoracic echocardiography; from these direct measurements, the carotid cross-sectional distensibility coefficient and left ventricular elastance index were obtained.

Noninvasive Assessment of Carotid Pulse Pressure Values: An Accelerometric-Based Approach.

Objective: Central pulse pressure (cPP) is increasingly investigated as possible independent predictor of cardiovascular risk and carotid pulse pressure (carPP) can be used as a surrogate of cPP. Despite its importance, carPP measurement remains challenging in clinical practice. The aim of this study was to introduce a new easier-to-use method for noninvasive carPP evaluation based on the use of a MEMS accelerometer.

Intima media thickness, pulse wave velocity, and flow mediated dilation.

The identification of vascular alterations at the sub-clinical, asymptomatic stages are potentially useful for screening, prevention and improvement of cardiovascular risk stratification beyond classical risk factors.Increased intima-media thickness of the common carotid artery is a well-known marker of early atherosclerosis, which significantly correlates with the development of cardiovascular diseases. More recently, other vascular parameters evaluating both structural and functional arterial proprieties of peripheral arteries have been introduced, for cardiovascular risk stratification and as surrogate endpoints in clinical trials.