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.

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.

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.

Effects of carotid pressure waveforms on the results of wave separation, wave intensity and reservoir pressure analysis.

Objective: Recently great attention has been paid to innovative cardiovascular biomarkers obtained from wave separation (WS), wave intensity (WI) and reservoir-wave (RW) theories. All these approaches share a requirement for pressure information. The aim of this study was to evaluate differences in WS-, WI- and RW-derived parameters obtained achieving pressure waveforms in different ways.

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.