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Background: Regulation is part of the technology innovation process and has a key role within the lifecycle of a medical device aiming at ensuring effectiveness and safety for users (1). Ever-increasing regulatory requirements (e.g., the Regulation MDR (EU) 2017/745) impact on the development of novel and already approved systems (2, 3). Debating and raising awareness is important since it can improve the transfer of knowledge and expertise among the relevant stakeholders. Thus, the implementation of a survey to explore knowledge and perception of the regulatory framework of medical devices for the assessment of vascular age can be helpful for the involved community. Methods: A multidisciplinary team including clinicians, researchers and developers from VascAgeNet was established to design and implement a digital questionnaire. A secure, open-source, two-factor authentication system for generation, distribution, and data collection of the survey supported by the European Commission (EUSurvey, https://ec. europa. eu/eusur vey) was adopted. Results: The questionnaire has received ethical clearance by National Council of Research, Italy (Notification 0063984/2021) and University College London (17999/002) Research Ethics Committees and is being distributed digitally (e.g., within VascAgeNet, Artery Society etc.). The anonymous questionnaire is available at https://ec. europa. eu/eusur vey/runner/REGUL ATORY Surve y2022 or by scanning the QR code below, it takes approximately 10 min to complete. Conclusions: A survey related to regulation and medical devices for vascular ageing assessment has been developed and is available for the community. The results could inspire concrete actions reducing gap between research and clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: Vascular Age (VA) can assess cardiovascular disease risk, independently of chronological age, however it is not yet widely applied in routine clinical practice. A quantitative questionnaire was developed to assess current knowledge gaps related to VA and barriers to implementation in routine practice in both research and clinical settings. Methods: Using a stepwise mixed-methods approach, a quantitative questionnaire was constructed. The 22-item anonymous survey was based on a previous qualitative analysis including 80 participants with multiple scientific backgrounds, and included questions on perceptions/beliefs, knowledge, and implementation of VA. The survey was disseminated to clinicians and researchers world-wide, via social media and targeted emails from well-known societies (including Artery, ESH, ISH, ESC). Results: 276 (50% female) completed the questionnaire, 46% were clinicians, 33% researchers, 10% students. Clinical specialties included cardiology (36%), internal medicine (22%) and General Practice (10%). While 84% of clinicians and researchers rate VA importance as high or very high (Table), only 11% of clinicians measure VA in clinical settings. Limiting factors include cost, lack of guidelines and lack of knowledge. Discussion: These results show that implementation of VA is very low in clinical settings and awareness of VA needs to be improved via planned targeted awareness strategies and educational material. [ABSTRACT FROM AUTHOR]

In December 2019, an outbreak of pneumonia caused by a novel Coronavirus (COVID-19) spread rapidly worldwide. Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, the cardiovascular system is extensively affected at multiple levels. Due to the unprecedented consequences of the COVID-19 pandemic, the ARTERY society decided to launch the Covid-19 effects on ARTErial StIffness and vascular AgeiNg (CARTESIAN) study - the first international multicentre study into the effects of COVID-19 on non-invasive biomarkers of vascular ageing. The main study objective is to evaluate the presence of Early Vascular Ageing (EVA) 6 and 12 months after COVID-19 infection. Secondary objectives are to study the effect of COVID-19 disease severity on EVA, to investigate the role of psychosocial factors in COVID-19 induced EVA, and to investigate the potential modifying effect of comorbidities and chronic treatments. In the CARTESIAN study, a broad array of cardiovascular measurements, including carotid-femoral pulse wave velocity, central blood pressure, carotid ultrasound, brachial flow-mediated dilatation, will be performed. To date, 43 centres from 21 countries have agreed to participate, with an expected study population of >2500 individuals. To our knowledge, CARTESIAN will be the first study to provide insight into the relationship between COVID-19, its severity, and early vascular ageing in a large cohort, potentially enabling future care and diagnostics to be more focused on the most vulnerable., Competing Interests: Conflicts of Interest The authors declare they have no conflicts of interest.