Evaluation of Alysis-001 cuffless blood pressure estimation algorithm against the European Society of Hypertension awake/asleep test criteria in hypertensive patients.
This represents the first evaluation of a Device Type 3 cuffless blood pressure algorithm (automated, wearable, demographic-calibrated, not at heart level) meeting ESH awake/asleep test criteria, suggesting Alysis-001's potential as a clinically viable alternative for ambulatory blood pressure monitoring in hypertensive patients.
Abstract
Accurate ambulatory blood pressure monitoring (ABPM) is essential for cardiovascular risk assessment and hypertension management, but conventional cuff-based ABPM causes discomfort and sleep disturbance, potentially affecting measurement reliability. The European Society of Hypertension (ESH) established evaluation criteria for cuffless blood pressure devices, with the awake/asleep test as the primary evaluation test for automated wearable devices. This study evaluated whether Alysis-001, a software-based cuffless blood pressure estimation algorithm using sensor data from a wrist-worn device, meets ESH awake/asleep test criteria in hypertensive patients under two data extraction strategies: (1) arm-stabilized periods only ( ≥ 10 s static); (2) including low-intensity activity (high-intensity excluded). We prospectively enrolled 92 hypertensive outpatients receiving antihypertensive treatment who simultaneously wore Alysis Wear and underwent conventional 24-h ABPM; 78 completed the study. Under both strategies, Alysis-001 demonstrated excellent agreement with reference ABPM across all measurement periods, with intraclass correlation coefficients exceeding 0.70 for systolic and diastolic blood pressure. Alysis-001 successfully met all ESH awake/asleep test criteria under both strategies: mean difference between awake-asleep blood pressure changes ≤5 mmHg, standard deviation ≤8 mmHg, and correlation coefficients ≥0.70 for both systolic and diastolic blood pressure. Alysis-001 also demonstrated high sensitivity, specificity, and accuracy in identifying non-dippers under both strategies. To our knowledge, this represents the first evaluation of a Device Type 3 cuffless blood pressure algorithm (automated, wearable, demographic-calibrated, not at heart level) meeting ESH awake/asleep test criteria, suggesting Alysis-001's potential as a clinically viable alternative for ambulatory blood pressure monitoring in hypertensive patients.
Introduction Hypertension and its pre-stages are the leading cardiovascular risk factors worldwide, why awareness and prevention are highly relevant. Novel blood pressure devices can provide a broader picture at an earlier stage and enable an assessment of elevated values. The aim of this pilot study was to provide pharmacist-led support for the use, analysis and communication of a 14-day-cuffless blood pressure monitoring in potential hypertensive adults. Methods For this pilot study ten adults were enrolled, who had elevated blood pressure values (>130 mmHg systolic and/ or >85 mmHg diastolic) in the past but no current cardiovascular diagnosis or medication. Participants were guided to use a cuffless blood pressure device (Aktiia/ Hilo bracelet) for 14 full days. The blood pressure profiles were analyzed with a previously developed blood pressure model and compared with profiles of normotensive adults. Results The blood pressure profiles demonstrated individual blood pressure patterns in all participants. Six of ten participants were above the recommended 24-hour-threshold of 135/85 mmHg, one was at the threshold and three were under the threshold during the study period. Besides the blood pressure levels, there were differences regarding variability, night-dips and number of measurements. Compared to normotensives, base blood pressure was higher in potential hypertensives. Finally, the results were communicated to the participants for further discussion with other healthcare professionals. Discussion The combination of a cuffless device, model-based analysis and pharmacist support represents a promising translational approach for individualized blood pressure monitoring. The results of the CareBP study show the extended value of 14 days of individual blood pressure monitoring and underline the relevance of this approach for cardiovascular disease prevention.
OBJECTIVE
To validate the accuracy and safety of the Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) manufactured by JOYTECH Healthcare Co., Ltd. for blood pressure (BP) measurement in adolescents and adults with arm circumference 22.0-42.0 cm, in accordance with the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) (ISO 81060-2:2018+Amd 2:2024) international standard.
METHODS
A total of 90 subjects were enrolled. Three valid datasets were collected from each subject, yielding 270 datasets for analysis. The mercury sphygmomanometer (reference device) data were used as the gold standard to evaluate whether the accuracy of the test device met the requirements.
RESULTS
Based on 270 valid datasets, the mean difference between the test device and the reference device for SBP was -0.49 mmHg (SD = 7.29 mmHg), and for DBP was 1.45 mmHg (SD = 6.14 mmHg), meeting Criterion 1 requirements. Analysis based on individual averages of the 90 subjects showed a mean difference of -0.49 mmHg (SD = 5.57 mmHg) for SBP and 1.45 mmHg (SD = 5.05 mmHg) for DBP, both meeting the requirements of Criterion 2. The device maintained stable measurement performance across different arm circumferences, ages, and BP levels.
CONCLUSION
The Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) meets the accuracy and consistency requirements of the AAMI/ESH/ISO (ISO 81060-2:2018+Amd 2:2024) standard for SBP and DBP measurement in adolescents and adults with arm circumference 22.0-42.0 cm. It can be safely and effectively used for BP monitoring in clinical settings and, by extension, is suitable for home use based on its design features and validation performance.
Background Short-term blood pressure variability (BPV) from 24-h ambulatory blood pressure monitoring (ABPM) lacks evidence for predicting subclinical target organ damage (TOD). Objective The study assessed BPV from ABPM for subclinical TOD prediction in hypertension. Methods This retrospective study screened 180 essential hypertension patients at Quanzhou First Hospital between January 2023 and December 2025, and 176 patients were enrolled after exclusion. All participants underwent standardized 24-h ABPM examination. Several short-term BPV parameters were calculated, including standard deviation (SD), coefficient of variation (CV), and average real variability (ARV) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) across 24-h, daytime, and nighttime periods. Patients were allocated into a TOD group and a non-TOD group based on the presence or absence of subclinical TOD. Multivariate logistic regression was used to assess BPV indices as independent predictors of subclinical TOD. Receiver operating characteristic (ROC) curve analysis assessed the predictive performance of these indices with the area under the curve (AUC) calculated. Results Among 176 patients, 94 were assigned to the TOD group and 82 to the non-TOD group, with balanced baseline characteristics (all P > 0.05). The TOD group showed significantly higher 24-h, daytime, and nighttime BP SD, CV, and ARV (all P < 0.001). Multivariate logistic regression identified nighttime SBP SD, 24-h SBP ARV, and nighttime SBP ARV as independent predictors of subclinical TOD (all P < 0.05). ROC analysis showed nighttime SBP SD had an AUC of 0.837 (95% CI: 0.773–0.901), cutoff 12.25 mmHg, sensitivity 89.4%, specificity 78.0%, outperforming other indices (all P < 0.05). Subgroup analyses confirmed nighttime SBP SD independently predicted cardiac, vascular, and renal TOD, while 24-h SBP ARV predicted cardiac and vascular injury (all P < 0.05). Conclusion Nighttime SBP variability (SD) from ABPM independently predicts subclinical TOD and guides organ protection in hypertension.
The salt sensitivity of blood pressure (SSBP) is rarely assessed and represents a critical barrier in precision hypertension treatment. The current approaches to assess salt sensitivity are labor and resource intensive limiting their clinical implementation. The salt sensitivity index (SSI), derived from 24-hour ambulatory blood pressure monitoring (ABPM) data, has been proposed as a clinical diagnostic approach to classify individuals at low-, intermediate-, or high-risk for the SSBP. This study utilized the Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial control diet arm dataset (N=170), in which the SSBP was assessed by the gold standard dietary approach, to address the hypothesis that identification of a high-risk SSI can predict the individual SSBP. In the high-risk SSI category 72% of DASH-Sodium Trial participants exhibited a salt-sensitive phenotype. For all participants with a high-risk SSI (male and female and normotensive and hypertensive) sensitivity (ability to correctly identify individuals with the SSBP) was 85%, specificity (ability to correctly identify individuals without the SSBP) was 41%, positive predictive value (probability that a person who tests positive has the SSBP) was 72%, negative predictive value was 60% (probability that a person who tests negative does not have the SSBP) and accuracy was 69%. For hypertensive participants only with a high-risk SSI (males and females), sensitivity was 86%, specificity was 44%, the positive predictive value increased to 83%, the negative predictive value was 50% and accuracy increased to 76%. This study validates the identification of a high-risk SSI, based on 24-hour ABPM, as a generalizable implementable approach for the clinical diagnosis of the SSBP, with a potential greater clinical diagnostic value in hypertensive versus normotensive individuals.
Xiangyu Zheng, Leonardo Máximo Cardoso, Christopher Dieffenthaller et al.· American Journal of Physiolo...· 0 citations
High blood pressure (BP) is one of the main risk factors for cardiovascular disease with a high prevalence in the adult population despite advances in its diagnosis and treatment. In accordance with the May Measurement Month (MMM) campaign, BP screening was conducted in 2023 by the Argentina Society of Arterial Hypertension (SAHA), to raise awareness of raised BP. This article reports the results of the campaign. A voluntary cross-sectional survey was conducted in public spaces and health centres from May to September 2023. Volunteer adults aged ≥18 years were recruited through convenience sampling. Two BP readings were taken in each participant, and a questionnaire completed collecting information on demographics, lifestyle factors, and comorbidities. Multiple imputation was used to estimate missing BP readings. Hypertension was defined as a systolic BP ≥140mmHg or diastolic BP ≥90mmHg, or being on BP-lowering medication. Controlled BP was defined as being on BP-lowering medication with a BP <140/90mmHg. In total, 39,391 were screened, with a mean age of 57.5 years and 63.4% of whom were female. Of all participants, 24,777 (62.9%) had hypertension, of whom 21,044 (84.9%) were aware, and 20,775 (83.8%) were on antihypertensive medication. Of those on antihypertensive medication, 11,642 (56.0%) had control, and of all participants with hypertension, 47.0% had controlled BP.
The MMM campaign in Argentina identified a substantial number of participants with untreated but more frequently inadequately treated hypertension. BP control has not significantly improved over the years. It is essential to implement more effective strategies, such as treatment adjustments, lifestyle changes, and close patient monitoring, to improve control and reduce long-term risks.
J. Zilberman, T. Beaney, G. Kerr et al.· European Heart Journal, Supp...· 0 citations
BACKGROUND
Current clinical guidelines recommend home blood pressure monitoring (HBPM) to confirm hypertension diagnosis, guide therapy, and support long-term control. However, the optimal number of HBPM measurements needed for valid assessment is not established.
METHODS
At ARIC Visit 10 (2023), participants completed an eight-day HBPM protocol with morning and evening measurements and three readings per session. We evaluated the validity between the eight-day mean (reference) and streamlined protocols (fewer days, less than three readings per session, or only morning or evening measurements). In secondary analyses, we assessed the validity of these HBPM protocols relative to ambulatory BP.
RESULTS
Among 812 participants (median age 83 years, 24% Black adults, 40% male, 84% using anti-hypertensive medications), median BP varied by less than 3 mmHg across the eight-day protocol. The greatest improvement in HBPM validity occurred when extending the averaging window from one to two days. By three days, concordance correlation coefficients exceeded 0.95, and ≥97% of participants were within 10 mmHg of the reference for both systolic and diastolic BP. Averaging ≥2 readings per session, including both morning and evening measurements, yielded greater validity than a single reading or timepoint.
CONCLUSIONS
In this community-based cohort of older adults, HBPM provided stable BP estimates within three days (can be non-consecutive within an 8-day period) using morning and evening sessions with ≥2 readings each. While further studies are required to validate generalizability beyond this engaged cohort, these findings support shorter, less burdensome HBPM protocols in clinical guidelines for hypertension management in older adults.
Frances M Wang, Hannah V Col, F. L. Kwapong et al.· American Journal of Hyperten...· 0 citations
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