Evaluation of the oscillometric method for noninvasive blood pressure measurement during cuff deflation and cuff inflation with reference to intra-arterial blood pressure.

There is little quantitative clinical data available to support blood pressure measurement accuracy during cuff inflation. In this study of 35 male and 5 female lightly anaesthetized subjects aged 64.1 ±â€Š9.6 years, we evaluate and compare the performance of both the oscillometric ratio and gradient methods during cuff deflation and cuff inflation with reference to intra-arterial measurements. We show that the oscillometric waveform envelopes (OWE), which are key to both methods, exhibit significant variability in both shape and smoothness leading to at least 15% error in the determination of mean pressure (MP). We confirm the observation from our previous studies that K1 Korotkoff sounds underestimate systolic blood pressure (SBP) and note that this underestimation is increased during cuff inflation. The estimation of diastolic blood pressure (DBP) is generally accurate for both the ratio and the gradient method, with the latter showing a significant increase during inflation. Since the gradient method estimates SBP and DBP from points of maximum gradient on each OWE recorded, it may offer significant benefits over the ratio method. However, we have shown that the ratio method can be optimized for any data set to achieve either a minimum mean error (ME) of close to 0 mmHg or minimum root mean square error (RMSE) with standard deviation (SD) of <5.0 mmHg. We conclude that whilst cuff inflation may offer some advantages, these are neither significant nor substantial, leaving as the only benefit, the potential for more rapid measurement and less patient discomfort.

Validation of oscillometric ratio and maximum gradient methods for non-invasive blood pressure measurement with intra-arterial blood pressure measurements as reference.

Most non-invasive blood pressure (BP) measurements are carried out using instruments which implement either the Ratio or the Maximum Gradient oscillometric method, mostly during cuff deflation, but more rarely during cuff inflation. Yet, there is little published literature on the relative advantages and accuracy of these two methods. In this study of 40 lightly sedated individuals aged 64.1 ± 9.6 years, we evaluate and compare the performance of the oscillometric ratio (K) and gradient (Grad) methods for the non-invasive estimation of mean pressure, SBP and DBP with reference to invasive intra-arterial values. There was no significant difference between intra-arterial estimates of mean pressure made via Korotkoff sounds (MP-OWE) or the gradient method (MP-Grad). However, 17.7% of MP-OWE and 15% of MP-Grad were in error by more than 10 mmHg. SBP-K and SBP-Grad underestimated SBP by 14 and 18 mmHg, whilst accurately estimating DBP with mean errors of 0.4 ±â€Š5.0 and 1.7 ±â€Š6.1 mmHg, respectively. Relative to the reference standard SBP-K, SBP-Grad and DBP-Grad were estimated with a mean error of -4.5 ±â€Š6.6 and 1.4 ±â€Š5.6 mmHg, respectively, noting that using the full range of recommended ratios introduces errors of 12 and 7 mmHg in SBP and DBP, respectively. We also show that it is possible to find ratios which minimize the root mean square error (RMSE) and the mean error for any particular individual cohort. We developed linear models for estimating SBP and SBP-K from a range of demographic and non-invasive OWE variables with resulting mean errors of 0.15 ±â€Š5.6 and 0.3 ±â€Š5.7 mmHg, acceptable according to the Universal standard.

Association of 24-h central hemodynamics and stiffness with cardiovascular events and all-cause mortality. The VASOTENS Registry.

OBJECTIVES: In hemodialysis patients, central hemodynamics, stiffness, and wave reflections assessed through ambulatory blood pressure monitoring (ABPM) showed superior prognostic value for cardiovascular (CV) events than peripheral blood pressures (BPs). No such evidence is available for lower-risk hypertensive patients. METHODS: In 591 hypertensive patients (mean age 58 ±â€Š14 years, 49% males), ambulatory brachial and central BP, pulse wave velocity (PWV), and augmentation index (AIx) were obtained with a validated upper arm cuff-based pulse wave analysis technology. Information on treatment for hypertension (73% of patients), dyslipidemia (27%), diabetes (8%), CV disease history (25%), was collected. Patients were censored for CV events or all-cause death over 4.2 years. RESULTS: One hundred and four events (24 fatal) were recorded. Advanced age [hazard ratio and 95% confidence interval: 1.03 (1.01, 1.05), P = 0.0001], female sex [1.57 (1.05, 2.33), P = 0.027], CV disease [2.22 (1.50, 3.29), P = 0.0001], increased 24-h central pulse pressure (PP) [1.56 (1.05, 2.31), P = 0.027], PWV [1.59 (1.07, 2.36), P = 0.022], or AIx [1.59 (1.08, 2.36), P = 0.020] were significantly associated with a worse prognosis (univariate Cox regression analysis). The prognostic power of peripheral and central BPs was lower. However, PWV [1.02 (0.64, 1.63), P = 0.924], AIx [1.06 (0.66, 1.69), P = 0.823], and central PP [1.18 (0.76, 1.82), P = 0.471], were not significant predictors in multivariate analyses. CONCLUSIONS: In hypertensive patients, ambulatory central PP, PWV, and AIx are associated with an increased risk of CV morbidity and all-cause mortality. However, this association is not independent of other patient characteristics.

Simulating impaired left ventricular-arterial coupling in aging and disease: a systematic review.

Aortic stenosis, hypertension, and left ventricular hypertrophy often coexist in the elderly, causing a detrimental mismatch in coupling between the heart and vasculature known as ventricular-vascular (VA) coupling. Impaired left VA coupling, a critical aspect of cardiovascular dysfunction in aging and disease, poses significant challenges for optimal cardiovascular performance. This systematic review aims to assess the impact of simulating and studying this coupling through computational models. By conducting a comprehensive analysis of 34 relevant articles obtained from esteemed databases such as Web of Science, Scopus, and PubMed until July 14, 2022, we explore various modeling techniques and simulation approaches employed to unravel the complex mechanisms underlying this impairment. Our review highlights the essential role of computational models in providing detailed insights beyond clinical observations, enabling a deeper understanding of the cardiovascular system. By elucidating the existing models of the heart (3D, 2D, and 0D), cardiac valves, and blood vessels (3D, 1D, and 0D), as well as discussing mechanical boundary conditions, model parameterization and validation, coupling approaches, computer resources and diverse applications, we establish a comprehensive overview of the field. The descriptions as well as the pros and cons on the choices of different dimensionality in heart, valve, and circulation are provided. Crucially, we emphasize the significance of evaluating heart-vessel interaction in pathological conditions and propose future research directions, such as the development of fully coupled personalized multidimensional models, integration of deep learning techniques, and comprehensive assessment of confounding effects on biomarkers.

Accurate detection of Korotkoff sounds reveals large discrepancy between intra-arterial systolic pressure and simultaneous noninvasive measurement of blood pressure with brachial cuff sphygmomanometry.

Cardiovascular disease is the number 1 cause of death globally, with elevated blood pressure (BP) being the single largest risk factor. Hence, BP is an important physiological parameter used as an indicator of cardiovascular health. Noninvasive cuff-based automated monitoring is now the dominant method for BP measurement and irrespective of whether the oscillometric or the auscultatory method is used, all are calibrated according to the Universal Standard (ISO 81060-2:2019), which requires two trained operators to listen to Korotkoff K1 sounds for SBP and K4/K5 sounds for DBP. Hence, Korotkoff sounds are fundamental to the calibration of all NIBP devices. In this study of 40 lightly sedated patients, aged 64.1 ±â€Š9.6 years, we compare SBP and DBP recorded directly by intra-arterial fluid filled catheters to values recorded from the onset (SBP-K) and cessation (DBP-K) of Korotkoff sounds. We demonstrate that whilst DBP-K measurements are in good agreement, with a mean difference of -0.3 ±â€Š5.2 mmHg, SBP-K underestimates true intra-arterial SBP (IA-SBP) by an average of 14 ±â€Š9.6 mmHg. The underestimation arises from delays in the re-opening of the brachial artery following deflation of the brachial cuff to below SBP. The reasons for this delay are not known but appear related to the difference between SBP and the pressure under the cuff as blood first begins to flow, as the cuff deflates. Linear models are presented that can correct the underestimation in SBP resulting in estimates with a mean difference of 0.2 ±â€Š7.1 mmHg with respect to intra-arterial SBP.

Myocardial oxygen supply and demand imbalance predicts mortality in older nursing home residents: The PARTAGE study.

BACKGROUND: A mismatch between myocardial oxygen supply and demand is the most common cause of ischemic myocardial injury in older persons. The subendocardial viability ratio (SEVR) can usefully estimate the degree of myocardial perfusion relative to left-ventricular workload. The aim of the present study was to evaluate the ability of SEVR to predict long-term mortality in the older population. Additionally, we aimed to identify the SEVR cutoff value best predicting total mortality. METHODS: This is a multicenter, longitudinal study involving a large population of individuals older than 80 years living in nursing homes. Patients with cancer, severe dementia, and very low level of autonomy were excluded from the study. Participants were monitored for 10 years. Adverse outcomes were recorded every 3 months from inclusion to the end of the study. SEVR reflects the balance between subendocardial oxygen supply and demand, and was estimated non-invasively by analyzing the carotid pressure waveform recorded by applanation arterial tonometry. RESULTS: A total of 828 people were enrolled (mean age: 87.7 ± 4.7 years, 78% female). 735 patients died within 10 years and 24 were lost to follow-up. SEVR was inversely associated with mortality at univariate Cox-regression model (risk ratio, 0.683 per unit increase in SEVR; 95% confidence interval (CI) [0.502-0.930], p = 0.015) and in a model including age, sex, body mass index, Activity of Daily Living index and Mini-Mental State Examination score (risk ratio, 0.647; 95% CI [0.472-0.930]). The lowest tertile of SEVR was associated with higher 10-years total mortality than the middle (p < 0.001) and the highest (p < 0.004) tertile. A SEVR cutoff value of 83% was identified as the best predictor of total mortality. CONCLUSIONS: SEVR may be considered as a marker of "cardiovascular frailty." An accurate non-invasive estimation of SEVR could be a useful and independent parameter to assess survival probability in very old adults. TRIAL REGISTRATION: NCT00901355, registered on ClinicalTrials.gov website.

Comparison of cuff inflation and cuff deflation brachial sphygmomanometry with intra-arterial blood pressure as reference.

Conventional sphygmomanometry with cuff deflation is used to calibrate all noninvasive BP (NIBP) instruments and the International Standard makes no mention of calibrating methods specifically for NIBP instruments, which estimate systolic and diastolic pressure during cuff inflation rather than cuff deflation. There is however increasing interest in inflation-based NIBP (iNIBP) instruments on the basis of shorter measurement time, reduction in maximal inflation pressure and improvement in patient comfort and outcomes. However, we have previously demonstrated that SBP estimates based on the occurrence of the first K1 Korotkoff sounds during cuff deflation can underestimate intra-arterial SBP (IA-SBP) by an average of 14 ±â€Š10 mmHg. In this study, we compare the dynamics of intra-arterial blood pressure (IABP) measurements with sequential measurement of Korotkoff sounds during both cuff inflation and cuff deflation in the same individual. In 40 individuals aged 64.1 ±â€Š9.6 years (range 36-86 years), the overall dynamic responses below the cuff were similar, but the underestimation error was significantly larger during inflation than deflation, increasing from 14 ±â€Š10 to 19 ±â€Š12 mmHg ( P  < 0.0001). No statistical models were found which could compensate for this error as were found for cuff deflation. The statistically significant BP differences between inflation and deflation protocols reported in this study suggest different behaviour of the arterial and venous vasculature between arterial opening and closing which warrant further investigation, particularly for iNIBP devices reporting estimates during cuff inflation. In addition, measuring Korotkoff sounds during cuff inflation represents significant technical difficulties because of increasing pump motor noise.

2024 Recommendations for Validation of Noninvasive Arterial Pulse Wave Velocity Measurement Devices.

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.

New Perspectives on Non-invasive Blood Pressure Measurement.

Noninvasive blood pressure (NIBP) devices are calibrated against validated auscultation sphygmomanometers using Korotkoff sounds. This study aimed to investigate the timing of Korotkoff sounds in relation to pulse appearance in the brachial artery and values of intra-arterial blood pressure. Experiments were carried out on 15 participants, (14 males, 64.3 ± 10.4 years; one female, 86 yo), undergoing coronary angiography. A conventional occluding cuff, with a microphone for Korotkoff sounds, was placed on the upper arm (on the brachial artery). Intra-arterial blood pressure (IABP) was measured below the cuff with a fluid-filled catheter inserted via the radial artery and an external transducer. Finger photoplethysmography was used to measure brachial pulse wave velocity (PWV). Korotkoff sounds were processed electronically and custom algorithms identified the cuff pressure (CP) at which the first and last Korotkoff sounds were heard. PWV and max slope of the IABP pressure pulse were recorded to estimate arterial stiffness. The brachial artery closed at a CP of 132.0 ± 17.1 mmHg. Systolic and diastolic blood pressure (SBP and DBP) were 147.6 ± 14.3 and 72.7 ± 10.1 mmHg; mean pressure (MP, 100.1 ± 10.4 mmHg) was similar to MP derived from the peak of the oscillogram (98.5 ± 13.6 mmHg). Difference between IABP and CP recorded at first and last occurrence of Korotkoff sounds were, SBP: 19.0 ± 8.3 (range 2-29) mmHg, DBP: 4.0 ± 4.3 (range 2-12) mmHg. SBP derived from the onset of Korotkoff sounds can underestimate IABP by up to 19 mmHg. Since Korotkoff sounds are the recommended method mandated by the universal standard for the validation of blood pressure measuring devices, these errors are propagated through to all NIBP measurement devices irrespective of whether they use auscultatory or oscillometric methods.

Interaction of large artery stiffness and baroreceptor function explored through multiple measurement techniques - a pilot study.

Baroreceptors, sensors that play a role in controlling arterial blood pressure (BP), are mechanical stretch receptors located in the aortic arch and carotid sinuses. Factors affecting the degree of stretch in the vessel wall with BP, such as increased arterial stiffness, may compromise baroreceptor sensitivity (BRS) to BP changes. Yet, evidence of this is scattered, as both baroreceptor sensitivity (BRS) and arterial stiffness are calculated variables with multiple methodological approaches. This pilot study (n=10) investigates the correlation of arterial stiffness and BRS using multiple BRS calculation techniques (spectral and sequence methodologies at aortic and finger sites) and arterial stiffness measurement [carotid-femoral pulse wave velocity (cfPWV), carotid compliance and distensibility]. BRS was assessed under resting BP conditions and during BP altered by maneuvers (0.1 Hz controlled breathing and leg ischemia). Magnitude of arterial stiffness - BRS correlation was positive for carotid distensibility and compliance, and negative for cfPWV, supporting the theory. A sample size of 100 participants (not rounded - exact figure by power calculation) would be required to confirm or reject all permutations of correlation between BRS by multiple calculation methods and large artery stiffness by PWV and compliance/distensibility measures.

From peripheral finger-derived pulse waveforms to aortic pressure waveform features: an application of a generalized transfer function.

OBJECTIVE: Aortic (central) pressure features are associated with cardiovascular complications and can be algorithmically derived from non-invasive peripheral arterial waveforms. This has conventionally been performed with a pressure waveform (i.e., tonometry or oscillometry) rather than with the optical-based sensor (photoplethysmography (PPG)) that is predominantly used in wearable health devices. Extraction of aortic features from a peripheral PPG waveform has yet to be investigated. This study aims to compare aortic features extracted from peripheral arterial waveforms acquired with different sensor modalities using the same transfer function. DESIGN AND METHOD: Radial tonometry (reference), finger volume-clamped PPG (Penáz) and fingertip PPG waveforms were measured in participants (n=29, 36±16 years, 15 female) under baseline conditions. Waveforms were converted into an aortic pressure waveform using the transfer function. Waveform features were extracted from the converted waveform. Extracted features were compared with correlation plots and a Bland-Altman analysis. RESULTS: Aortic pressure features extracted from a finger using the Penáz technique were comparable to radial tonometry derived features. Aortic features extracted from a fingertip waveform were more variable in comparison to radial tonometry-derived features. CONCLUSIONS: Aortic (central) pressure waveform features contain valuable haemodynamic information and have the capacity to be easily and conveniently implemented in wearable health devices. Future use of these features in wearable health devices incorporating PPG requires the development, and/or, optimization of a unique transfer function to more accurately represent the aortic pressure waveform for cardiovascular assessment.Clinical Relevance- Aortic pressure features might be used in wearable health devices following the development of a unique transfer function for optical-transduced peripheral vascular signals.

Comparison of effects of peripheral vasculature on tonometric radial pulse and cuff-based brachial pulse waveform as used in estimation of central aortic pressures.

OBJECTIVE: Aortic pressure estimation requires reliable peripheral pulse waveform acquisition. The peripheral waveform can change with local vascular effects that can be independent of aortic pressure. This study quantifies the effects of peripheral vasculature changes on radial and brachial waveforms. DESIGN AND METHOD: In 20 subjects (37± 15 years, 7 female), brachial volumetric displacement (cuff-based) and radial tonometry waveforms were simultaneously measured whilst a cuff around the hand on the same arm was inflated to induce transmural pressures of -60, -30, -15, 0, 15 and 30 mmHg, altering local peripheral resistance and compliance by graded arterial wall unloading. Aortic blood pressure (BP), augmentation index (AIx) and ejection duration were calculated from the measurements using a generalized transfer function. The parameters under unloaded conditions were compared to baseline measurements. RESULTS: Brachial systolic and diastolic BP did not change throughout the experiment. Altering peripheral resistance and compliance did not significantly change calculated aortic BP values, although changes were nominally greater for radial (maximum +8±1 mmHg) compared to brachial (maximum +2±1 mmHg) waveforms. AIx at 0 mmHg transmural pressure (maximum arterial wall unloading) was higher when derived from radial waveforms (+24±3%, p<0.001) but not when derived from brachial waveforms. CONCLUSIONS: Localized changes in peripheral resistance and compliance affect tonometer acquired radial waveforms but not volumetric displacement acquired brachial pressure waveforms, as judged by computed central aortic augmentation pressure parameters. This suggests aortic pressure estimation from the brachial cuff waveform is less sensitive to peripheral vasculature disturbances that alter the peripheral arterial pulse morphology.

Bilateral cuff-induced lower limb post-ischemia hyperemia as a method for acute reduction in blood pressure for cuffless blood pressure device testing.

OBJECTIVE: Development and testing of cuffless blood pressure (BP) devices requires methods to increase and decrease BP. This is also required by cuffless BP validation standards. Pharmacological interventions, whilst successful, are not always feasible for all subpopulations or research settings. Non-pharmacological approaches for increasing BP are available, however, methods for decreasing BP are not well described. This study investigates the hyperemic response following bilateral leg-cuff ischemia as a method for acute BP lowering. DESIGN AND METHOD: Participants (n=8, 24±8 years, 6 female) had their BP measured by continuous (finger, Penáz technique) and intermittent (brachial cuff, oscillometric) methods before, during and following 3-minute leg-ischemia with the participant in an upright position. Total peripheral resistance (TPR) and cardiac output (CO) were calculated from finger BP waveforms. Maxima and minima responses in the variables were extracted and compared to resting conditions by repeated measures analysis of covariance. RESULTS: During the hyperemic period, systolic BP decreased by -22±3 mmHg (finger) and -6±1 mmHg (brachial). Diastolic BP decreased by -14±5 mmHg (finger) and -4 ±1 mmHg (brachial). Calculated TPR and CO varied, with both decreasing by half and almost doubling during the hyperemic response period. CONCLUSIONS: Leg-cuff ischemia provides a controlled, non-pharmacological intervention for decreasing systemic arterial BP. This removes some of the limitations in testing, development and validation of cuffless BP techniques and devices.

Arteriosclerosis and Atherosclerosis Assessment in Clinical Practice: Methods and Significance.

Alongside cancer, cardiovascular disease (CVD) exhibits the highest rates of morbidity and mortality globally, in western society as well as in Asian countries. Aging is a serious problem for the Asian population as progression toward a super-aged society is moving at a remarkably high rate. This increased rate of aging leads to increased CVD risk and, consequently, high CVD incidence. However, aging is not the only deleterious factor of vascular problems; hypertension, hypercholesterolemia, diabetes mellitus, and kidney disease may induce atherosclerosis and arteriosclerosis (i.e., arterial stiffening), and the progression of these diseases ultimately leads to cardiovascular, cerebrovascular, chronic kidney, or peripheral artery disease. Despite the existence of several guidelines on the treatment of risk factors such as hypertension and CVD, there is still an ongoing debate regarding the clinical need for assessment of arteriosclerosis and atherosclerosis, which act as a bridge between cardiovascular risk factors and CVD. In other words, although arteriosclerosis and atherosclerosis are essential to our understanding of vascular diseases, the need for additional tests beyond the conventional diagnosis method remains disputed. This is presumably due to insufficient discussion on how to apply such tests in clinical practice. This study aimed to fill this gap.

Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol.

BACKGROUND: Despite high blood pressure being the leading preventable risk factor for death, only 1 in 3 patients achieve target blood pressure control. Key contributors to this problem are clinical inertia and uncertainties in relying on clinic blood pressure measurements to make treatment decisions. METHODS: The NEXTGEN-BP open-label, multicenter, randomized controlled trial will investigate the efficacy, safety, acceptability and cost-effectiveness of a wearable blood pressure monitor-based care strategy for the treatment of hypertension, compared to usual care, in lowering clinic blood pressure over 12 months. NEXTGEN-BP will enroll 600 adults with high blood pressure, treated with 0 to 2 antihypertensive medications. Participants attending primary care practices in Australia will be randomized 1:1 to the intervention of a wearable-based remote care strategy or to usual care. Participants in the intervention arm will undergo continuous blood pressure monitoring using a wrist-wearable cuffless device (Aktiia, Switzerland) and participate in 2 telehealth consultations with their primary care practitioner (general practitioner [GP]) at months 1 and 2. Antihypertensive medication will be up-titrated by the primary care practitioner at the time of telehealth consults should the percentage of daytime blood pressure at target over the past week be <90%, if clinically tolerated. Participants in the usual care arm will have primary care consultations according to usual practice. The primary outcome is the difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. Secondary outcomes will be assessed at month 3 and month 12, and include acceptability to patients and practitioners, cost-effectiveness, safety, medication adherence and patient engagement. CONCLUSIONS: NEXTGEN-BP will provide evidence for the effectiveness and safety of a new paradigm of wearable cuffless monitoring in the management of high blood pressure in primary care. TRIAL REGISTRATION: ACTRN12622001583730.

European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.

BACKGROUND: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use. OBJECTIVE: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common. VALIDATION PROCEDURES: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position. CONCLUSION: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.

Central Aortic Blood Pressure Waveform Estimation with a Temporal Convolutional Network.

A novel temporal convolutional network (TCN) model is utilized to reconstruct the central aortic blood pressure (aBP) waveform from the radial blood pressure waveform. The method does not need manual feature extraction as traditional transfer function approaches. The data acquired by the SphygmoCor CVMS device in 1,032 participants as a measured database and a public database of 4,374 virtual healthy subjects were used to compare the accuracy and computational cost of the TCN model with the published convolutional neural network and bi-directional long short-term memory (CNN-BiLSTM) model. The TCN model was compared with CNN-BiLSTM in the root mean square error (RMSE). The TCN model generally outperformed the existing CNN-BiLSTM model in terms of accuracy and computational cost. For the measured and public databases, the RMSE of the waveform using the TCN model was 0.55 ± 0.40 mmHg and 0.84 ± 0.29 mmHg, respectively. The training time of the TCN model was 9.63 min and 25.51 min for the entire training set; the average test time was around 1.79 ms and 8.58 ms per test pulse signal from the measured and public databases, respectively. The TCN model is accurate and fast for processing long input signals, and provides a novel method for measuring the aBP waveform. This method may contribute to the early monitoring and prevention of cardiovascular disease.

Wave reflection quantification analysis and personalized flow wave estimation based on the central aortic pressure waveform.

Pulse wave reflections reflect cardiac afterload and perfusion, which yield valid indicators for monitoring cardiovascular status. Accurate quantification of pressure wave reflections requires the measurement of aortic flow wave. However, direct flow measurement involves extra equipment and well-trained operator. In this study, the personalized aortic flow waveform was estimated from the individual central aortic pressure waveform (CAPW) based on pressure-flow relations. The separated forward and backward pressure waves were used to calculate wave reflection indices such as reflection index (RI) and reflection magnitude (RM), as well as the central aortic pulse transit time (PTT). The effectiveness and feasibility of the method were validated by a set of clinical data (13 participants) and the Nektar1D Pulse Wave Database (4,374 subjects). The performance of the proposed personalized flow waveform method was compared with the traditional triangular flow waveform method and the recently proposed lognormal flow waveform method by statistical analyses. Results show that the root mean square error calculated by the personalized flow waveform approach is smaller than that of the typical triangular and lognormal flow methods, and the correlation coefficient with the measured flow waveform is higher. The estimated personalized flow waveform based on the characteristics of the CAPW can estimate wave reflection indices more accurately than the other two methods. The proposed personalized flow waveform method can be potentially used as a convenient alternative for the measurement of aortic flow waveform.