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Cardiovascular (CV) diseases are burdened by high mortality and morbidity, being responsible for half of the deaths in Europe. Although hypertension is recognized as the most important CV risk factor, hypertension awareness, and blood pressure (BP) control are still unsatisfactory. In 2017 and 2018, respectively >10 000 and >5000 individuals took part in the May Measurement Month (MMM) campaign in Italy, of whom 30.6% and 26.3% were found to have high BP, respectively. To raise public awareness on the importance of hypertension and to collect BP data on a nation-wide scale in Italy. In the frame of the MMM campaign, an opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May 2019. BP measurement, the definition of hypertension, and statistical analysis followed the standard MMM protocol. Screening was conducted in multiple sites by health personnel. Among the 10 182 people screened (females: 52.3%, mean age 58 ± 16years) mean BP was 127/78 mmHg, and 3171 (31.1%) participants had arterial hypertension, of whom 62.1% were aware of being hypertensive. Diabetes, body mass index >25 kg/m2 were associated with higher BP and previous myocardial infarction with lower BP. For the third consecutive year we collected a nation-wide snapshot of BP control in a large sample of individuals. The high participation, with some yearly fluctuations likely due to the limitations of the sampling technique, confirms the power of this kind of health campaign in reaching a significant number of people to raise awareness on health topics.

Background Left ventricular end-diastolic pressure (LVEDP) is the gold-standard for the assessment of LV filling pressure. For practical reasons, pulmonary artery wedge pressure (PAWP) is used as a surrogate for LVEDP. However, the interposition of the left atrium (LA) may account discrepancies between LVEDP and PAWP. The imprecision of both end-diastolic (or mid-A) and mean PAWP estimates for LVEDP has been widely described for cardiac catheterization at rest. PAWP measurement during exercise has been advocated to discriminate heart failure with preserved ejection fraction (HFpEF) from non-cardiac dyspnea, with an end-expiratory pathologic threshold ≥25 mmHg. However, a formal comparison of PAWP (either mid-A or mean PAWP) vs LVEDP during exercise has never been performed. Aim To compare LVEDP and PAWP during exercise. Methods We retrospectively analyzed consecutive patients with unexplained dyspnea and a normal LV ejection fraction, who had a clinical indication of right and left heart catheterization at rest and during exercise to assess unexplained dyspnea. Patients with mitral regurgitation ≥ moderate were excluded. Hemodynamic measurements were always taken at end-expiration. Results Forty-six consecutive patients were included in the analysis (80% with a peak mean PAWP ≥25 mmHg). We found a good correlation between both mid-A and mean PAWP on one side, and LVEDP on the other side (R2>0.55). At peak exercise, mid-A PAWP had no bias as compared with LVEDP, while mean PAWP slightly overestimated LVEDP by 1–2 mmHg. However, confidence intervals were quite large (Figure 1), suggesting imprecision of PAWP estimates for LVEDP in the individual patient. A disagreement between mean PAWP and LVEDP, using a threshold of ≥25 mmHg for both variables at peak exercise, was found in 11% of patients. In 4% of them, mean PAWP was ≥25 but LVEDP 2 mmHg/L/min, as an alternative parameter suggesting HFpEF. Conclusions In patients with unexplained exertional breathlessness, both mid-A and mean PAWP showed good correlation with LVEDP during exercise with minimal average bias, but their ability to estimate LVEDP was burdened by a relevant imprecision. Therefore, when in these patients peak PAWP is Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship.

Background Right heart failure (RHF) represents the final step of distinct diseases, such as pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) due to heart failure with preserved ejection fraction (HFpEF). RHF may be defined by the inability of the heart to maintain a normal cardiac output (CO) or to do so at the expense of high right atrial pressure (RAP), at rest or during exercise. However, exercise hemodynamic features suggestive of RHF, as well as their determinants, have still not been defined. Aim We sought to i. define the limits of normal of RAP increase during exercise; ii. describe the behavior of RAP during exercise in PAH and in PH-HFpEF, and its relation to right heart afterload and preload. Methods We retrospectively analyzed data from consecutive patients referred for suspicion of PH, who underwent both a resting and exercise right heart catheterization at two centers with identical methodology. We included patients with PH-HFpEF or PAH. Right heart adaptation to exercise was described either using absolute or CO-normalized RAP increase during exercise (RAP/CO slope), this latter representing the inverse of the Frank-Starling reserve. A control cohort of subjects with normal hemodynamics at rest and during exercise served to define abnormal increase in RAP, i.e. values of RAP and RAP/CO slope > mean ± 2 standard deviation of controls. Estimated stressed blood volume (eSBV), as a measure of effective preload, was computed using a commercially-available software. Results 80 patients were included in the analysis, of which 29 were PH-HFpEF, 30 PAH and 21 controls. HFpEF patients were older than PAH patients and with a higher burden of cardiovascular comorbidities (p Mean pulmonary artery pressure (PAP), pulmonary vascular resistance (PVR) and total vascular resistance (TPR) were higher in PAH than in PH-HFpEF both at rest and during exercise (p On average, PH-HFpEF had higher resting and peak RAP than PAH, as well as higher RAP/CO slope (Figure 1). The upper limit of normal of exercise RAP and of RAP/CO slope, as determined in control subject, was 12 mmHg and 1.55 mmHg/L/min. A higher rate of HFpEF patients, compared with PAH, had a RAP/CO slope and a peak RAP above normal limits (78% and 91% of PH-HFpEF vs 47% and 44% of PAH, respectively, p RAP/CO slope in the whole cohort was associated with eSBV but not with right ventricular afterload measures (PAP, TPR, PVR). Conclusions PH-HFpEF display more frequently a steeper increase of RAP during exercise than PAH patients in spite of similar CO, suggesting a more exhausted Frank-Starling reserve. The steep RAP increase during exercise seems to reflect a dysfunctional preload rather than an afterload-mismatch. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship.

BackgroundNovel 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 individuals scheduled for 24-h BP measurement. MethodsPatients that were scheduled for 24-h ambulatory blood pressure monitoring (ABPM) were recruited and received an additional Samsung Galaxy Watch Active 2 smartwatch for simultaneous BP measurement on their opposite arm. After calibration, patients were asked to measure as much as possible in a 24-h period. Manual activation of the smartwatch is necessary to measure the BP. Accuracy was calculated using sensitivity, specificity, positive and negative predictive values and ROC curves. Bland-Altman method and Taffe methods were used for bias and precision assessment. BP variability was calculated using average real variability, standard deviation and coefficient of variation. ResultsForty patients were included. Bland-Altman and Taffe methods demonstrated a proportional bias, in which low systolic BPs are overestimated, and high BPs are underestimated. Diastolic BPs were all overestimated, with increasing bias toward lower BPs. Sensitivity and specificity for detecting systolic and/or diastolic hypertension were 83 and 41%, respectively. ROC curves demonstrate an area under the curve (AUC) of 0.78 for systolic hypertension and of 0.93 for diastolic hypertension. BP variability was systematically higher in the ABPM measurements compared to the smartwatch measurements. ConclusionThis study demonstrates that the BP measurements by the Samsung Galaxy Watch Active 2 show a systematic bias toward a calibration point, overestimating low BPs and underestimating high BPs, when investigated in both normotensive and hypertensive patients. Standards for traditional non-invasive sphygmomanometers are not met, but these standards are not fully applicable to cuffless devices, emphasizing the urgent need for new standards for cuffless devices. The smartwatch-based BP measurement is not yet ready for clinical usage. Future studies are needed to further validate wearable devices, and also to demonstrate new possibilities of non-invasive, high-frequency BP monitoring. PD received funding through the Horizons 2020 CoroPrevention project, project number 848056. MF received funding through the Flanders Research Foundation FWO, file number 1SE1222N. PC and AF received funding from the Italian Ministry of HealthRicerca Corrente.

Il contributo intende esaminare l’evoluzione della tutela relativa alla proprietà intellettuale alla luce del mutato contesto di riferimento derivato dall’impatto della dimensione digitale e, parallelamente, dai cambiamenti intervenuti nel quadro giuridico, costellato di recente dalla direttiva europea 2019/790 e dal suo recepimento nell’ordinamento nazionale con il d.lgs. 177/2021. L’analisi intende evidenziare gli aspetti critici dell’interazione tra diritto d’autore e tecnologie informatiche, in particolare il difficile equilibrio nel contesto digitale tra interessi diversi in cui prendono forma le contrapposte istanze di chiusura e controllo, da una parte, e apertura e condivisione, dall’altra, di cui sono latori gli attori protagonisti (autori, utenti e provider), che caratterizzano la società contemporanea. Nelle conclusioni il lavoro valuta il mutato framework giuridico di riferimento e ipotizza direzioni utili ai fini della regolazione giuridica futura in materia. The paper aims to examine the evolution of the intellectual property protection in the light of the changed context of reference derived from the impact of the digital dimension and, in parallel, the changes in the legal framework, recently innovated by the European Directive 2019/790 and its transposition into national law with Legislative Decree 177/2021. The analysis aims to highlight the critical aspects of the interaction between copyright and information technologies, in particular the difficult balance in the digital context between different interests in which take shape the opposing instances of closure and control, on the one hand, and openness and sharing, on the other hand, of which the protagonists (authors, users and providers) that characterize contemporary society are bearers. In the conclusions, the paper assesses the legal framework of reference and suggests useful directions for future legal regulation in this area.

Il contributo intende analizzare la disciplina normativa europea e nazionale in materia di documenti informatici e firme elettroniche. In particolare, il saggio esamina il diverso valore giuridico e probatorio dei documenti informatici in relazione alle differenti tipologie di firma elettronica che caratterizzano l’ordinamento, anche alla luce dei principi che governano la materia, quali neutralità tecnologica e non discriminazione. L’analisi è tesa ad affrontare gli aspetti critici che scaturiscono dall’applicazione concreta delle disposizioni a strumenti specifici e tecnologie determinate, sviluppando alcune riflessioni al riguardo. The contribution aims to analyze the European and national legal framework concerning electronic documents and electronic signatures. In particular, the paper examines the different legal and evidentiary value of electronic documents in relation to the different types of electronic signatures that characterize the legal system, also in the light of the principles that govern the matter, such as technological neutrality and non-discrimination. The analysis deals with the critical aspects that arise from the concrete application of the provisions to specific tools and technologies, developing some reflections in this regard.

Psychopathology (and depression in particular) is a cardiovascular risk factor independent from any co-occurring pathology. This link is traced back to the mind-heart-body connection, whose underlying mechanisms are still not completely known. To study psychopathology in relation to the heart, it is necessary to observe the autonomic nervous system, which mediates among the parts of that connection. Its gold standard of evaluation is the study of heart rate variability (HRV). To investigate whether any association exists between the HRV parameters and sub-threshold depressive symptoms in a sample of healthy subjects.In this cross-sectional study, two short-term HRV recordings (5 min - supine and sitting) have been analyzed in 77 healthy subjects. Here we adopted a three-fold approach to evaluate HRV: a set of scores belonging to the time domain; to the frequency domain (high, low, and very low frequencies) and a set of 'nonlinear' parameters. The PHQ-9 (Patient Health Questionnaire-9) scale was used to detect depressive symptoms.Depressive symptoms were associated only with a parameter from the non-linear approach and specifically the long-term fluctuations of fractal dimensions (DFA-α2). This association remained significant even after controlling for age, gender, BMI (Body-Mass-Index), arterial hypertension, anti-hypertensive drugs, dyslipidemia, and smoking habits. Moreover, the DFA-α2 was not affected by the baroreflex (postural change), unlike other autonomic markers.Fractal analysis of HRV (DFA-α2) allows then to predict depressive symptoms below the diagnostic threshold in healthy subjects regardless of their health status. DFA-α2 may be considered as an imprint of subclinical depression on the heart rhythm.

Tanzania is in the final stages to roll out pre-exposure prophylaxis (PrEP) to Female Sex Workers (FSWs) so as to reduce new infections. PrEP demonstration projects support programming through gaining first experiences.We analyzed data from a cohort of 700 HIV negative FSWs in Dar-es-Salaam to determine proportions of FSWs who were aware, willing and used PrEP. We compared proportions at cohort enrolment and after 12 months. Logistic regression was used to determine factors associated with PrEP use. PrEP awareness increased from 67% to 97% after 12 months. Willingness was high at both time points (98% versus 96%). Only 8% (57/700) had used PrEP. Being married/cohabiting or separated/divorced/widowed and having sex with a HIV infected partner were independently associated with PrEP use. The PrEP program should focus on scaling up access as willingness to use PrEP is high.

Mobile-health solutions based on heart rate variability often require electrocardiogram (ECG) recordings by inexperienced operators or real-time automatic analyses of long-term recordings by wearable devices in free-moving individuals. In this context, it is useful to associate a quality index with the ECG, scoring the adequacy of the recording for heart rate variability to identify noise or arrhythmias. Therefore, this work aims to propose and validate a computational method for assessing the adequacy of single-lead ECGs for heart rate variability analysis that may run in real time on wearable systems with low computational power. The method quantifies the ECG pseudo-periodic structure employing cepstral analysis. The cepstrum (spectrum of log-spectrum) is estimated on a running ECG window of 10 s before and after “liftering” (filtering in the cepstral domain) to remove slower noise components. The ECG periodicity generates a dominant peak in the liftered cepstrum at the “quefrency” of the mean cardiac interval. The Cepstral Quality Index (CQI) is the ratio between the cepstral-peak power and the total power of the unliftered cepstrum. Noises and arrhythmias reduce the relative power of the cepstral peak decreasing CQI. We analyzed a public dataset of 6072 single-lead ECGs manually classified in normal rhythm or inadequate for heart rate variability analysis because of noise or atrial fibrillation, and the CQI = 47% cut-off identified the inadequate recordings with 79% sensitivity and 85% specificity. We showed that the performance is independent of the lead considering a public dataset of 1,000 12-lead recordings with quality classified as “acceptable” or “unacceptable” by visual inspection. Thus, the cepstrum describes the ECG periodic structure effectively and concisely and CQI appears to be a robust score of the adequacy of ECG recording for heart rate variability analysis, evaluable in real-time on wearable devices.

Background Right heart failure (RHF) represents the final step of distinct diseases, differently involving the pulmonary circulation, such as pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) due to heart failure with preserved ejection fraction (HFpEF). Exercise may unmask right heart maladaptation as a sign of RHF, but cut–offs for right atrial pressure (RAP) rise during exercise remain to be defined. We hypothesized that PH–HFpEF may present with worse right heart adaptation to exercise than PAH due to increased chamber stiffness and dysfunctional preload. Aim We sought to describe the behavior of RAP during exercise in PAH and in PH–HFpEF, and the mechanisms underlying right heart maladaptation. Methods We performed a retrospective analysis of data (2007–2021) obtained from patients with either PAH or PH–HFpEF who underwent a right heart catheterization at rest and during exercise. Right heart adaptation to exercise was described using either absolute or cardiac output (CO)–normalized RAP increase during exercise (RAP/CO slope). Patients with non–cardiac dyspnea (NCD) served to define RAP limits of normality. Estimated stressed blood volume (eSBV), as a measure of effective preload, was computed based on hemodynamics using a commercially–available software. Results Ninety–four patients were included (32 PH–HFpEF, 32 PAH and 30 NCD). The upper limit of normal for absolute peak RAP and RAP/CO slope were 12 mmHg and 1.55 mmHg/L/min. Compared with PH–HFpEF, PAH patients showed higher systolic, diastolic and mean pulmonary artery pressure (PAP) as well as higher indices of right ventricular afterload both at rest and during exercise, but lower filling pressures and similar CO (Figure 1).In particular, PH–HFpEF had higher peak RAP and higher RAP/CO slope than PAH (Figure 1,2). Additionally, 78% and 91% of PH–HFpEF, as compared with 47% and 44% of PAH had a RAP/CO slope and a peak RAP above normal, respectively (p Conclusions PH–HFpEF display worse right heart maladaptation to exercise than PAH, likely due to a combination of increased right heart stiffness and a more exhausted Frank–Starling reserve.

Background Left ventricular end–diastolic pressure (LVEDP) approximates LV stiffness. Pulmonary artery wedge pressure (PAWP) reflects the hemodynamic load imposed by the left heart on the pulmonary circulation, with the interposition of the left atrium (LA). PAWP is frequently seen as a surrogate measure for LVEDP, but the two measures may not coincide. The imprecision of PAWP estimates for LVEDP and the disagreement between the two measures have been widely described for cardiac catheterization at rest. PAWP measurement during exercise has been advocated to discriminate heart failure with preserved ejection fraction (HFpEF) from non–cardiac dyspnea (NCD), with an end–expiratory pathologic threshold ≥25 mmHg. However, a formal comparison of PAWP vs LVEDP during exercise has never been performed. Aim. We sought to compare LVEDP and PAWP during exercise. Methods We retrospectively analyzed consecutive patients with unexplained dyspnea and a normal LV ejection fraction, who performed right and left heart catheterization at rest and during exercise. Results Forty–six consecutive patients were included in the analysis (80% with a peak PAWP ≥25 mmHg). We found a good correlation between both end–diastolic and mean PAWP on one side, and LVEDP on the other side (R2>0.55). End–expiratory, end–diastolic (mid–A) peak PAWP had no bias as compared with LVEDP, while mean PAWP slightly overestimated LVEDP by 1–2 mmHg. However, confidence intervals were quite large (Figure 1), suggesting imprecision of PAWP estimates for LVEDP. A disagreement between PAWP and LVEDP, using a threshold of ≥ 25 mmHg for both variables at peak exercise, was found in 11% of patients. In 4%, PAWP was ≥25 but LVEDP 2 mmHg/L/min, as an alternative parameter confirming HFpEF. Conclusions PAWP estimates for LVEDP during exercise bear a good correlation and a minimal bias, albeit being burdened by a relevant imprecision. In patients with unexplained exertional dyspnea and peak PAWP