RESUMEN
Arterial pulse waves (PWs) such as blood pressure and photoplethysmogram (PPG) signals contain a wealth of information on the cardiovascular (CV) system that can be exploited to assess vascular age and identify individuals at elevated CV risk. We review the possibilities, limitations, complementarity, and differences of reduced-order, biophysical models of arterial PW propagation, as well as theoretical and empirical methods for analyzing PW signals and extracting clinically relevant information for vascular age assessment. We provide detailed mathematical derivations of these models and theoretical methods, showing how they are related to each other. Finally, we outline directions for future research to realize the potential of modeling and analysis of PW signals for accurate assessment of vascular age in both the clinic and in daily life.
Asunto(s)
Arterias , Fotopletismografía , Humanos , Arterias/fisiología , Fotopletismografía/métodos , Análisis de la Onda del Pulso , Modelos CardiovascularesRESUMEN
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.
Asunto(s)
Fotopletismografía , Rigidez Vascular , Presión Sanguínea/fisiología , Hemodinámica , Análisis de la Onda del Pulso , Reproducibilidad de los Resultados , Rigidez Vascular/fisiologíaRESUMEN
NEW FINDINGS: What is the central question of this study? First, we validated easy-to-use oscillometric left ventricular ejection time (LVET) against echocardiographic LVET. Second, we investigated progression of left ventricular ejection time index (LVETI), pre-ejection period index (PEPI), total electromechanical systole index (QS2I) and PEP/LVET ratio during 60 days of head-down tilt (HDT). What is the main finding and its importance? The LVETosci and LVETecho showed good agreement in effect direction. Hence, LVETosci might be useful to evaluate cardiovascular responses during space flight. Moreover, the approach might be useful for individual follow-up of patients with altered ejection times. Furthermore, significant effects of 60 days of HDT were captured by measurements of LVETI, PEPI, QS2I and PEP/LVET ratio. ABSTRACT: Systolic time intervals that are easy to detect might be used as parameters reflecting cardiovascular deconditioning. We compared left ventricular ejection time (LVET) measured via ultrasound Doppler on the left ventricular outflow tract with oscillometrically measured LVET, measured at the brachialis. Furthermore, we assessed the progression of the left ventricular ejection time index (LVETI), the pre-ejection period index (PEPI), the Weissler index (PEP/LVET) and the total electromechanical systole index (QS2I) during prolonged strict head-down tilt (HDT) bed rest, including 16 male and eight female subjects. Simultaneous oscillometric and echocardiographic LVET measurements showed significant correlation (r = 0.53 with P = 0.0084 before bed rest and r = 0.73 with P < 0.05 on the last day of bed rest). The shortening of LVET during HDT bed rest measured with both approaches was highly concordant in their effect direction, with a concordance rate of 0.96. Our results also demonstrated a significant decrease of LVETI (P < 0.0001) and QS2I (P = 0.0992) and a prolongation of PEPI (P = 0.0049) and PEP/LVET (P = 0.0003) during HDT bed rest over 60 days. Four days after bed rest, LVETI recovered completely to its baseline value. Owing to the relationship between shortening of LVETI and heart failure progression, the easy-to-use oscillometric method might not only be a useful way to evaluate the cardiovascular system during space flights, but could also be of high value in a clinical setting.
Asunto(s)
Ingravidez , Reposo en Cama , Femenino , Inclinación de Cabeza , Corazón , Humanos , Masculino , Contracción Miocárdica , Sístole/fisiologíaRESUMEN
BACKGROUND: Older age is a substantial risk factor for serious illness from COVID-19. Moreover, isolation and quarantine are more likely to cause physical, mental and social deprivation in older age. Information and Communication Tools are means to prevent such consequences. OBJECTIVE: This study aimed therefore to investigate the impact of the COVID-19 lockdown measures on the usage of an innovative technical support system deployed in Austria (AT) and Luxembourg (LU) consisting of several tools that allow independent living in older age. METHODS: Thirty-nine older adults (11 male; 28 female) with a mean age of 74.3 (SD 7.3) years were included in the study. In total, 18 older people were recruited in AT and 21 in LU. Descriptive statistics were computed, and longitudinal models were fitted for technology use and self-reported mood. RESULTS: The number of older adults using the system significantly decreased from the time before lockdown (39 [100%]) to during lockdown (26 [67%]) and thereafter (23 [59%]; p < 0.001). Multiple comparisons revealed a significant reduction in the average number of events for calendar and medication tools, but a substantial increase in communication and messaging events. Self-reported well-being declined during the lockdown and increased afterwards back to baseline levels. CONCLUSION: Communication was the main reason for using the support system. In addition, strategies and interventions are essential to support older adults when using information technology in the prolonged phases of the pandemic to sustain independent living. CLINICAL TRIAL REGISTRATION: The DAPAS protocol was published at www.researchgate.net. DOI: 10.13140/RG.2.2.24233.34401.
Asunto(s)
COVID-19 , Anciano , Control de Enfermedades Transmisibles , Femenino , Humanos , Masculino , Pandemias , Cuarentena , SARS-CoV-2RESUMEN
BACKGROUND: The Covid-19 pandemic necessitated a decrease in non-Covid-19 related diagnostic and therapeutic procedures in many countries. We explored the impact on tertiary hypertension care. METHODS: We conducted an electronic survey regarding 6 key procedures in hypertension care within the Excellence Center network of the European Society of Hypertension. RESULTS: Overall, 54 Excellence Centers from 18 European and 3 non-European countries participated. From 2019 to 2020, there were significant decreases in the median number per centre of ambulatory blood pressure monitorings (ABPM: 544/289 for 2019/2020), duplex ultrasound of renal arteries (Duplex RA: 88.5/55), computed tomographic/magnetic resonance imaging angiography of renal arteries (CT/MRI RA: 66/19.5), percutaneous angioplasties of renal arteries (PTA RA: 5/1), laboratory tests for catecholamines (116/67.5) and for renin/aldosterone (146/83.5) (p < 0.001 for all comparisons, respectively). While reductions in all assessed diagnostic and therapeutic procedures were observed in all annual 3-months periods in the comparisons between 2019 and 2020, the most pronounced reduction occurred between April and June 2020, which was the period of the first wave and the first lockdown in most affected countries. In this period, the median reductions in 2020, as compared to 2019, were 50.7% (ABPM), 47.1% (Duplex RA), 50% (CT/MRI RA), 57.1% (PTA RA), 46.9% (catecholamines) and 41.0% (renin/aldosterone), respectively. Overall differences in reduction between 3-month time intervals were statistically highly significant. CONCLUSION: Diagnostic and therapeutic procedures related to hypertension were dramatically reduced during the first year of the Covid-19 pandemic, with the largest reduction during the first lockdown. The long-term consequences regarding blood pressure control and, ultimately, cardiovascular events remain to be investigated.
Asunto(s)
COVID-19 , Hipertensión , Aldosterona , Antihipertensivos/uso terapéutico , Presión Sanguínea , Monitoreo Ambulatorio de la Presión Arterial/métodos , COVID-19/epidemiología , Catecolaminas , Control de Enfermedades Transmisibles , Humanos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Pandemias , ReninaRESUMEN
RATIONALE: Patients with end-stage renal disease (ESRD) are characterized by increased cardiovascular (CV) and all-cause mortality due to advanced remodeling of the macro- and microvascular beds. OBJECTIVE: The aim of this study was to determine whether retinal microvascular function can predict all-cause and CV mortality in patients with ESRD. METHODS AND RESULTS: In the multicenter prospective observational ISAR (Risk Stratification in End-Stage Renal Disease) study, data on dynamic retinal vessel analysis (DVA) was available in a sub-cohort of 214 dialysis patients (mean age 62.6{plus minus}15.0; 32% female). Microvascular dysfunction was quantified by measuring maximum arteriolar (aMax) and venular dilation (vMax) of retinal vessels in response to flicker light stimulation. During a mean follow-up of 44 months, 55 patients died, including 25 CV and 30 non-CV fatal events. vMax emerged as a strong independent predictor for all-cause mortality. In the Kaplan-Meier analysis, individuals within the lowest tertile of vMax showed significantly shorter three-year survival rates than those within the highest tertile (66.9{plus minus}5.8% vs 92.4{plus minus}3.3%). Uni- and multivariate hazard ratios for all-cause mortality per SD increase of vMax were 0.62 [0.47;0.82] and 0.65[0.47;0.91], respectively. aMax and vMax were able to significantly predict nonfatal and fatal CV events (HR 0.74[0.57;0.97] and 0.78[0.61;0.99], respectively). CONCLUSIONS: Our results provide the first evidence that impaired retinal venular dilation is a strong and independent predictor of all-cause mortality in hemodialyzed ESRD patients. DVA provides added value for prediction of all-cause mortality and may be a novel diagnostic tool to optimize CV risk stratification in ESRD and other high-risk CV cohorts. CLINICAL TRIAL REGISTRATION: NCT01152892.
RESUMEN
BACKGROUND: Mortality in hemodialysis patients still remains unacceptably high. Enhanced arterial stiffness is a known cardiovascular risk factor, and pulse wave velocity (PWV) has proven to be a valid parameter to quantify risk. Recent studies showed controversial results regarding the prognostic significance of PWV for mortality in hemodialysis patients, which may be due to methodological issues, such as assessment of PWV in the office setting (Office-PWV). METHOD: This study cohort contains patients from the "Risk stratification in end-stage renal disease - the ISAR study," a multicenter prospective longitudinal observatory cohort study. We examined and compared the predictive value of ambulatory 24-hour PWV (24 h-PWV) and Office-PWV on mortality in a total of 344 hemodialysis patients. The endpoints of the study were all-cause and cardiovascular mortality. Survival analysis included Kaplan-Meier estimates and Cox regression analysis. RESULTS: During a follow-up of 36 months, a total of 89 patients died, 35 patients due to cardiovascular cause. Kaplan-Meier estimates for tertiles of 24 h-PWV and Office-PWV were similarly associated with mortality. In univariate Cox regression analysis, 24 h-PWV and Office-PWV were equivalent predictors for all-cause and cardiovascular mortality. After adjustment for common risk factors, only 24 h-PWV remained solely predictive for all-cause mortality (hazard ratio 2.51 [95% CI 1.31-4.81]; p = 0.004). CONCLUSIONS: Comparing both measurements, 24 h-PWV is an independent predictor for all-cause-mortality in hemodialysis patients beyond Office-PWV.
Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/métodos , Fallo Renal Crónico/mortalidad , Análisis de la Onda del Pulso/métodos , Diálisis Renal , Anciano , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Fallo Renal Crónico/terapia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Visita a Consultorio Médico , Valor Predictivo de las Pruebas , Pronóstico , Estudios Prospectivos , Medición de Riesgo/métodos , Factores de RiesgoRESUMEN
BACKGROUND: Evidence on the utility of ambulatory BP monitoring for risk prediction has been scarce and inconclusive in patients on hemodialysis. In addition, in cardiac diseases such as heart failure and atrial fibrillation (common among patients on hemodialysis), studies have found that parameters such as systolic BP (SBP) and pulse pressure (PP) have inverse or nonlinear (U-shaped) associations with mortality. METHODS: In total, 344 patients on hemodialysis (105 with atrial fibrillation, heart failure, or both) underwent ambulatory BP monitoring for 24 hours, starting before a dialysis session. The primary end point was all-cause mortality; the prespecified secondary end point was cardiovascular mortality. We performed linear and nonlinear Cox regression analyses for risk prediction to determine the associations between BP and study end points. RESULTS: During the mean 37.6-month follow-up, 115 patients died (47 from a cardiovascular cause). SBP and PP showed a U-shaped association with all-cause and cardiovascular mortality in the cohort. In linear subgroup analysis, SBP and PP were independent risk predictors and showed a significant inverse relationship to all-cause and cardiovascular mortality in patients with atrial fibrillation or heart failure. In patients without these conditions, these associations were in the opposite direction. SBP and PP were significant independent risk predictors for cardiovascular mortality; PP was a significant independent risk predictor for all-cause mortality. CONCLUSIONS: This study provides evidence for the U-shaped association between peripheral ambulatory SBP or PP and mortality in patients on hemodialysis. Furthermore, it suggests that underlying cardiac disease can explain the opposite direction of associations.
Asunto(s)
Fibrilación Atrial/mortalidad , Monitoreo Ambulatorio de la Presión Arterial/métodos , Enfermedades Cardiovasculares/mortalidad , Insuficiencia Cardíaca/mortalidad , Fallo Renal Crónico/mortalidad , Diálisis Renal/mortalidad , Factores de Edad , Anciano , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/terapia , Causas de Muerte , Estudios de Cohortes , Femenino , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Humanos , Estimación de Kaplan-Meier , Fallo Renal Crónico/diagnóstico , Fallo Renal Crónico/terapia , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Diálisis Renal/métodos , Medición de Riesgo , Factores Sexuales , Estadísticas no Paramétricas , Análisis de SupervivenciaRESUMEN
Background: A novel in vitro test (T50 test) assesses ex vivo serum calcification propensity and predicts mortality in chronic kidney disease and haemodialysis (HD) patients. For the latter, a time-dependent decline of T50 was shown to relate to mortality. Here we assessed whether a 3-month switch to acetate-free, citrate-acidified, standard bicarbonate HD (CiaHD) sustainably improves calcification propensity. Methods: T50 values were assessed in paired midweek pre-dialysis sera collected before and 3 months after CiaHD in 78 prevalent European HD patients. In all, 44 were then switched back to acetate. Partial correlation was used to study associations of changing T50 and changing covariates. Linear mixed effect models were built to assess the association of CiaHD and covariates with changing T50. Results: A significant intra-individual increase of serum calcification resilience was found after 3 months on CiaHD (206 ± 56 to 242 ± 56 min; P < 0.001), but not after switching back to acetate (252 ± 63 to 243 ± 64 min; n = 44; P = 0.29). CiaHD, Δ serum phosphate and Δ albumin but not Δ ionized calcium and magnesium were the strongest determinants of changing T50. Beneath T50, only serum albumin but not phosphate changed significantly during 3 months of CiaHD. Conclusion: CiaHD dialysis favourably affected calcification propensity as measured by the T50 test. Whether this treatment, beyond established phosphate-directed treatments, has the potential to sustainably tip the balance towards a more anti-calcific serum milieu needs to be further investigated.
Asunto(s)
Calcinosis/sangre , Diálisis Renal/métodos , Insuficiencia Renal Crónica/sangre , Adulto , Anciano , Anciano de 80 o más Años , Bicarbonatos/uso terapéutico , Ácido Cítrico/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fosfatos/sangre , Estudios Prospectivos , Insuficiencia Renal Crónica/mortalidad , Albúmina Sérica/análisisRESUMEN
BACKGROUND: The ISAR study is a prospective, longitudinal, observational cohort study to improve the cardiovascular risk stratification in endstage renal disease (ESRD). The major goal is to characterize the cardiovascular phenotype of the study subjects, namely alterations in micro- and macrocirculation and to determine autonomic function. METHODS/DESIGN: We intend to recruit 500 prevalent dialysis patients in 17 centers in Munich and the surrounding area. Baseline examinations include: (1) biochemistry, (2) 24-h Holter Electrocardiography (ECG) recordings, (3) 24-h ambulatory blood pressure measurement (ABPM), (4) 24 h pulse wave analysis (PWA) and pulse wave velocity (PWV), (5) retinal vessel analysis (RVA) and (6) neurocognitive testing. After 24 months biochemistry and determination of single PWA, single PWV and neurocognitive testing are repeated. Patients will be followed up to 6 years for (1) hospitalizations, (2) cardiovascular and (3) non-cardiovascular events and (4) cardiovascular and (5) all-cause mortality. DISCUSSION/CONCLUSION: We aim to create a complex dataset to answer questions about the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients. Finally we hope to improve cardiovascular risk stratification in comparison to the use of classical and non-classical (dialysis-associated) risk factors and other models of risk stratification in ESRD patients by building a multivariable Cox-Regression model using a combination of the parameters measured in the study. CLINICAL TRIALS IDENTIFIER: ClinicalTrials.gov NCT01152892 (June 28, 2010).
Asunto(s)
Enfermedades Cardiovasculares/complicaciones , Fallo Renal Crónico/complicaciones , Neoplasias/mortalidad , Proyectos de Investigación , Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/fisiopatología , Causas de Muerte , Electrocardiografía , Enfermedades Gastrointestinales/mortalidad , Hospitalización/estadística & datos numéricos , Humanos , Infecciones/mortalidad , Fallo Renal Crónico/fisiopatología , Fallo Renal Crónico/terapia , Estudios Longitudinales , Enfermedades Pulmonares/mortalidad , Pruebas Neuropsicológicas , Fenotipo , Estudios Prospectivos , Análisis de la Onda del Pulso , Diálisis Renal , Vasos Retinianos/diagnóstico por imagen , Medición de Riesgo , Heridas y Lesiones/mortalidadRESUMEN
BACKGROUND: Heart rate variability is the variation of the time interval between consecutive heartbeats. Entropy is a commonly used tool to describe the regularity of data sets. Entropy functions are defined using multiple parameters, the selection of which is controversial and depends on the intended purpose. This study describes the results of tests conducted to support parameter selection, towards the goal of enabling further biomarker discovery. METHODS: This study deals with approximate, sample, fuzzy, and fuzzy measure entropies. All data were obtained from PhysioNet, a free-access, on-line archive of physiological signals, and represent various medical conditions. Five tests were defined and conducted to examine the influence of: varying the threshold value r (as multiples of the sample standard deviation σ, or the entropy-maximizing rChon), the data length N, the weighting factors n for fuzzy and fuzzy measure entropies, and the thresholds rF and rL for fuzzy measure entropy. The results were tested for normality using Lilliefors' composite goodness-of-fit test. Consequently, the p-value was calculated with either a two sample t-test or a Wilcoxon rank sum test. RESULTS: The first test shows a cross-over of entropy values with regard to a change of r. Thus, a clear statement that a higher entropy corresponds to a high irregularity is not possible, but is rather an indicator of differences in regularity. N should be at least 200 data points for r = 0.2 σ and should even exceed a length of 1000 for r = rChon. The results for the weighting parameters n for the fuzzy membership function show different behavior when coupled with different r values, therefore the weighting parameters have been chosen independently for the different threshold values. The tests concerning rF and rL showed that there is no optimal choice, but r = rF = rL is reasonable with r = rChon or r = 0.2σ. CONCLUSIONS: Some of the tests showed a dependency of the test significance on the data at hand. Nevertheless, as the medical conditions are unknown beforehand, compromises had to be made. Optimal parameter combinations are suggested for the methods considered. Yet, due to the high number of potential parameter combinations, further investigations of entropy for heart rate variability data will be necessary.
Asunto(s)
Entropía , Frecuencia Cardíaca , Informática Médica/métodos , Algoritmos , Humanos , Estadísticas no ParamétricasRESUMEN
Background.Non-invasive continuous blood pressure (BP) monitoring is of longstanding interest in various cardiovascular scenarios. In this context, pulse arrival time (PAT), i.e., a surrogate parameter for systolic BP (change), became very popular recently, especially in the context of cuffless BP measurement and dedicated lifestyle interventions. Nevertheless, there is also understandable doubt on its reliability in uncontrolled and mobile settings.Objective.The aim of this work is therefore the investigation whether PAT follows oscillometric systolic BP readings during moderate interventions by physical or mental activity using a medical grade handheld device for non-invasive PAT assessment.Approach.A study was conducted featuring an experimental group performing a physical and a mental task, and a control group. Oscillometric BP and PAT were assessed at baseline and after each intervention. Interventions were selected randomly but then performed sequentially in a counterbalanced order. Multivariate analyses of variance were used to test within-subject and between-subject effects for the dependent variables, followed by univariate analyses for post-hoc testing. Furthermore, correlation analysis was performed to assess the association of intervention effects between BP and PAT.Mainresults.The study included 51 subjects (31 females). Multivariate analysis of variances showed that effects in BP, heart rate, PAT and pulse wave parameters were consistent and significantly different between experimental and control groups. After physical activity, heart rate and systolic BP increased significantly whereas PAT decreased significantly. Mental activity leads to a decrease in systolic BP at stable heart rate. Pulse wave parameters follow accordingly by an increase of PAT and mainly unchanged pulse wave analysis features due to constant heart rate. Finally, also the control group behaviour was accurately registered by the PAT method compared to oscillometric cuff. Correlation analyses revealed significant negative associations between changes of systolic BP and changes of PAT from baseline to the physical task (-0.33 [-0.63, 0.01],p< 0.048), and from physical to mental task (-0.51 [-0.77, -0.14],p= 0.001), but not for baseline to mental task (-0.12 [-0,43,0,20],p= 0.50) in the experimental group.Significance.PAT and the used digital, handheld device proved to register changes in BP and heart rate reliably compared to oscillometric measurements during intervention. Therefore, it might add benefit to future mobile health solutions to support BP management by tracking relative, not absolute, BP changes during non-pharmacological interventions.
Asunto(s)
Determinación de la Presión Sanguínea , Presión Sanguínea , Oscilometría , Humanos , Femenino , Masculino , Presión Sanguínea/fisiología , Determinación de la Presión Sanguínea/métodos , Adulto , Sístole/fisiología , Persona de Mediana Edad , Frecuencia Cardíaca/fisiología , Ejercicio Físico , Factores de TiempoRESUMEN
Background: Risk prediction in haemodialysis (HD) patients is challenging due to the impact of the dialysis regime on the patient's volume status and the complex interplay with cardiac function, comorbidities and hypertension. Cardiac function as a key predictor of cardiovascular (CV) mortality in HD patients is challenging to assess in daily routine. Thus the aim of this study was to investigate the association of a novel, non-invasive relative index of systolic function with mortality and to assess its interplay with volume removal. Methods: A total of 558 (373 male/185 female) HD patients with a median age of 66 years were included in this analysis. They underwent 24-hour ambulatory blood pressure monitoring, including wave intensity analysis [i.e. S:D ratio (SDR)]. All-cause and CV mortality served as endpoints and multivariate proportional hazards models were used for risk prediction. Intradialytic changes were analysed in tertiles according to ultrafiltration volume. During a follow-up of 37.8 months, 193 patients died (92 due to CV reasons). Results: The SDR was significantly associated with all-cause {univariate hazard ratio [HR] 1.36 [95% confidence interval (CI) 1.20-1.54], P < .001} and CV [univariate HR 1.41 (95% CI 1.20-1.67), P < .001] mortality. The associations remained significant in multivariate analysis accounting for possible confounders. Changes in the SDR from pre-/early- to post-dialytic averages were significantly different for the three ultrafiltration volume groups. Conclusion: This study provides well-powered evidence for the independent association of a novel index of systolic function with mortality. Furthermore, it revealed a significant association between intradialytic changes of the measure and intradialytic volume removal.
RESUMEN
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.
RESUMEN
Atrial fibrillation (AF), the most common cardiac arrhythmia, is associated with adverse CV outcomes. Vascular aging (VA), which is defined as the progressive deterioration of arterial function and structure over a lifetime, is an independent predictor of both AF development and CV events. A timing identification and treatment of early VA has therefore the potential to reduce the risk of AF incidence and related CV events. A network of scientists and clinicians from the COST Action VascAgeNet identified five clinically and methodologically relevant questions regarding the relationship between AF and VA and conducted a narrative review of the literature to find potential answers. These are: (1) Are VA biomarkers associated with AF? (2) Does early VA predict AF occurrence better than chronological aging? (3) Is early VA a risk enhancer for the occurrence of CV events in AF patients? (4) Are devices measuring VA suitable to perform subclinical AF detection? (5) Does atrial-fibrillation-related rhythm irregularity have a negative impact on the measurement of vascular age? Results showed that VA is a powerful and independent predictor of AF incidence, however, its role as risk modifier for the occurrence of CV events in patients with AF is debatable. Limited and inconclusive data exist regarding the reliability of VA measurement in the presence of rhythm irregularities associated with AF. To date, no device is equipped with tools capable of detecting AF during VA measurements. This represents a missed opportunity to effectively perform CV prevention in people at high risk. Further advances are needed to fill knowledge gaps in this field.
RESUMEN
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.
Asunto(s)
Hipertensión , Rigidez Vascular , Humanos , Análisis de la Onda del Pulso/métodos , Presión Arterial , Hipertensión/diagnóstico , ArteriasRESUMEN
INTRODUCTION: Prescribing the ultrafiltration in hemodialysis patients remains challenging and might benefit from the information on absolute blood volume, estimated by intradialytic dialysate bolus administration. Here, we aimed at determining the relationship between absolute blood volume, normalized for body mass (specific blood volume, Vs), and ultrafiltration-induced decrease in relative blood volume (∆RBV) as well as clinical parameters including body mass index (BMI). METHODS: This retrospective analysis comprised 77 patients who had their dialysate bolus-based absolute blood volume extracted routinely with an automated method. Patient-specific characteristics and ∆RBV were analyzed as a function of Vs, dichotomizing the data above or below a previously proposed threshold of 65 ml/kg for Vs. Statistical methodology comprised descriptive analyses, two-group comparisons, and correlation analyses. FINDINGS: Median Vs was 68.6 ml/kg (54.9 ml/kg [Quartile 1], 83.4 ml/kg [Quartile 3]). Relative blood volume decreased by 6.3% (2.6%, 12.2%) over the entire hemodialysis session. Vs correlated inversely with BMI (rs = -0.688, p < 0.001). ∆RBV was 9.8% in the group of patients with Vs <65 ml/kg versus 6.0% in the group of patients with Vs ≥65 ml/kg (p = 0.024). The two groups did not differ significantly regarding their specific ultrafiltration volume, normalized for body mass, which amounted to 34.1 ml/kg and 36.0 ml/kg in both groups, respectively (p = 0.630). ∆RBV correlated inversely with Vs (rs = -0.299, p = 0.008). DISCUSSION: The present study suggests that patients with higher BMI and lower Vs experience larger blood volume changes, despite similar ultrafiltration requirements. These results underline the clinical plausibility and importance of dialysate bolus-based absolute blood volume determination in the assessment of target weight, especially in view of a previous study where intradialytic morbid events could be decreased when the target weight was adjusted, based on Vs.
Asunto(s)
Diálisis Renal , Ultrafiltración , Humanos , Diálisis Renal/métodos , Ultrafiltración/métodos , Soluciones para Diálisis/farmacología , Estudios Retrospectivos , Volumen SanguíneoRESUMEN
BACKGROUND: Vascular age (VA) is independent and chronological age for assessing cardiovascular disease (CVD) risk. However, tools for the implementation of VA are currently lacking. We aimed to develop a questionnaire to assess the current knowledge gaps related to VA and barriers to its implementation in routine practice. METHODS: Using a stepwise mixed-method approach, a quantitative questionnaire was constructed in four phases: (1) basic item generation and the development of a semi-qualitative questionnaire (SQQ); (2) dissemination to the VascAgeNet extended network and an analysis of the semi-qualitative questionnaire responses; (3) the development of a quantitative questionnaire (QQ); and (4) an assessment of the content and face validity and internal reliability in an additional sample. RESULTS: Based on six main topics initially identified through an expert panel, a SQQ was developed and disseminated. Finally, a 22-item QQ was developed, with questions grouped around three main themes: knowledge of VA and its risk factors; perceptions and beliefs regarding the importance and contribution of VA to risk classification; and the application of VA measurements in clinical and research practice and its potential limitations (Cronbach's alpha between 0.920 and 0.982 for all three categories). CONCLUSION: We report the development of a QQ on VA addressed to both clinicians and non-clinicians aiming to assess their knowledge, perceptions and application of VA measurements.
RESUMEN
PURPOSE: Assistive technologies have the potential for supporting people with memory complaints in their daily life. User-centered interaction design research helps developers to create systems that are suitable for users. The aim of this work is to describe the methodology and the results of the usability test for the first Memento prototype involving users. MATERIALS AND METHODS: In each country, 5 subjects with different levels of cognitive reserve and technical proficiency were enrolled in Italy, Austria and Spain, respectively (15 subjects; 6 M; 9 F, age 72.8 ± 10.8 years, MMSE score 25.6 ± 1.6). Observation methods, performance metrics and the System Usability Scale were used to collect data. RESULTS: The results are presented in terms of design, technical problems, target-group-related challenges and usability perception from the participant perspective. Suggestions for improvement were pointed out by the users. Considering the usability scores interpretation, the first prototype was classified as "OK" and "Good" by users. CONCLUSIONS: The results of the Lab Trials provide important information on usability and the users' needs in order to improve the Memento prototype and to create a final system to be evaluated during the Field Trials phase of the project.Implication for rehabilitationThe MEMENTO project mission is to improve the quality of life of people in the early and middle stages of dementia, by supporting the management of daily activities that are usually affected by the loss of memory and cognition. The Lab Trial phase is essential to have feedback on the usability of the Memento prototype to allow a better understanding of users' needs and expectations.