Cuff-based blood pressure measurement: challenges and solutions.

OBJECTIVE: Accurate measurement of arterial blood pressure (BP) is crucial for the diagnosis, monitoring, and treatment of hypertension. This narrative review highlights the challenges associated with conventional (cuff-based) BP measurement and potential solutions. This work covers each method of cuff-based BP measurement, as well as cuffless alternatives, but is primarily focused on ambulatory BP monitoring. RESULTS: Manual BP measurement requires stringent training and standardized protocols which are often difficult to ensure in stressful and time-restricted clinical office blood pressure monitoring (OBPM) scenarios. Home Blood pressure monitoring (HBPM) can identify white-coat and masked hypertension but strongly depends on patient adherence to measurement techniques and procedure. The widespread use of nonvalidated automated HBPM devices raises further concerns about measurement accuracy. Ambulatory blood pressure measurement (ABPM) may be used in addition to OBPM. It is recommended to diagnose white-coat and masked hypertension as well as nocturnal BP and dipping, which are the BP values most predictive for major adverse cardiac events. Nonetheless, ABPM is limited by its non-continuous nature and susceptibility to measurement artefacts. This leads to poor overall reproducibility of ABPM results, especially regarding clinical parameters such as BP variability or dipping patterns. CONCLUSIONS: Cuff-based BP measurement, despite some limitations, is vital for cardiovascular health assessment in clinical practice. Given the wide range of methodological limitations, the paradigm's potential for improvement is not yet fully realized. There are impactful and easily incorporated opportunities for innovation regarding the enhancement of measurement accuracy and reliability as well as the clinical interpretation of the retrieved data. There is a clear need for continued research and technological advancement to improve BP measurement as the premier tool for cardiovascular disease detection and management.

Accurate blood pressure measurement is crucial for diagnosing, monitoring, and treating hypertension and preventing cardiovascular diseases.Manual blood pressure monitoring is common but may not always be reliable due to the stress and time constraints in clinical settings. It also fails to detect white-coat and masked hypertension.Home blood pressure monitoring helps to identify white-coat and masked hypertension but depends on how well patients follow the measurement instructions. Many devices are not validated, raising concerns about their accuracy.Ambulatory blood pressure measurement may be used in addition to office blood pressure measurement because of its better reproducibility and higher predictive value. It is recommended to diagnose white-coat and masked hypertension as well as nocturnal BP and dipping. However, it and can be prone to errors, affecting the reliability of results like BP variability or night-time dipping patterns.Patient's posture, physical activity, and conditions like atrial fibrillation can influence BP readings.Automated BP devices often have limitations in detecting measurement artefacts, underscoring the need for technological improvements.Despite its limitations, cuff-based blood pressure measurement is essential in everyday clinical practice but has unlocked potential for improvement.

Efficacy of a Web-Based Home Blood Pressure Monitoring Program in Improving Predialysis Blood Pressure Control Among Patients Undergoing Hemodialysis: Randomized Controlled Trial.

Background: Hypertension is highly prevalent among patients undergoing hemodialysis, with a significant proportion experiencing poorly controlled blood pressure (BP). Digital BP management in this population has been underused. Objective: This study aimed to explore the efficacy of a web-based home BP monitoring (HBPM) program in improving predialysis BP control and enhancing knowledge, perception, and adherence to HBPM among patients with hypertension undergoing hemodialysis. Methods: A multicenter, open-label, randomized controlled trial was conducted at 2 hemodialysis units. Patients were randomly allocated in a 1:1 ratio to either the web-based HBPM program as the intervention group or to usual care as the control group over a 6-month period. The primary outcomes were the predialysis BP control rate, defined as less than 140/90 mm Hg, and the predialysis systolic and diastolic BP, assessed from baseline to the 6-month follow-up. Secondary outcomes included patient knowledge, perception, and adherence to HBPM, evaluated using the HBPM Knowledge Questionnaire, HBPM Perception Scale, and HBPM Adherence Scale, respectively. A generalized estimating equations analysis was used to analyze the primary outcomes in the intention-to-treat analysis. Results: Of the 165 patients enrolled in the program (n=84, 50.9% in the web-based HBPM group and n=81, 49.1% in the control group), 145 (87.9%) completed the follow-up assessment. During the follow-up period, 11 instances of hypotension occurred in 9 patients in the web-based HBPM group, compared to 15 instances in 14 patients in the control group. The predialysis BP control rate increased from 30% (25/84) to 48% (40/84) in the web-based HBPM group after the 6-month intervention, whereas in the control group, it decreased from 37% (30/81) to 25% (20/81; χ22=16.82, P<.001; odds ratio 5.11, 95% CI 2.14-12.23, P<.001). The web-based HBPM group demonstrated a significant reduction after the 6-month intervention in the predialysis systolic BP (t163=2.46, P=.02; ß=-6.09, 95 % CI -10.94 to -1.24, P=.01) and the predialysis diastolic BP (t163=3.20, P=.002; ß=-4.93, 95% CI -7.93 to -1.93, P=.001). Scores on the HBPM Knowledge Questionnaire (t163=-9.18, P<.001), HBPM Perception Scale (t163=-10.65, P<.001), and HBPM Adherence Scale (t163=-8.04, P<.001) were significantly higher after 6 months of intervention. Conclusions: The implementation of a web-based HBPM program can enhance predialysis BP control and the knowledge, perception, and adherence to HBPM among patients undergoing hemodialysis. This web-based HBPM program should be promoted in appropriate clinical settings.

Impact of Remote Blood Pressure Monitoring Device Connectivity on Engagement Among Pregnant Individuals Enrolled in the Delfina Care Platform: Observational Study.

Unlabelled: User engagement with remote blood pressure monitoring during pregnancy is critical to optimize the associated benefits of blood pressure control and early detection of hypertensive disorders of pregnancy. In our study population of pregnant individuals, we found that connected blood pressure cuffs, which automatically sync measures to a monitoring platform or health record, increase engagement (2.13 [95% CI 1.36-3.35] times more measures per day) with remote blood pressure monitoring compared to unconnected cuffs that require manual entry of measures.

Antihypertensive effect of esaxerenone and correlation between brachial and wrist home monitoring devices in patients with nocturnal hypertension: A post hoc analysis of the EARLY-NH study.

Adequate management of nocturnal hypertension is crucial to reduce the risk of organ damage and cardiovascular events. The EARLY-NH study was a prospective, open-label, multicenter study conducted in Japanese patients with nocturnal hypertension who received esaxerenone treatment for 12 weeks. This post hoc analysis aimed to assess (1) the relationship between changes in morning home systolic blood pressure (SBP), bedtime home SBP, and nighttime home SBP based on changes in SBP and achievement rates of target SBP levels; and (2) the correlation between nighttime home SBP measurements using brachial and wrist home BP monitoring (HBPM) devices. This analysis evaluated 82 patients who completed the 12-week treatment period. Among those who achieved target morning home SBP (<135 mmHg) and target bedtime home SBP (<135 mmHg), the brachial HBPM device showed achievement rates of 63.6% and 56.4%, respectively, for target nighttime home SBP (<120 mmHg). The wrist device showed achievement rates of 66.7% and 63.4%, respectively, for the same targets. Significant correlations were observed between both devices for nighttime home SBP measurements at baseline (r = 0.790), Week 12 (r = 0.641), and change from baseline to Week 12 (r = 0.533) (all, p < .001). In this patient population, approximately 60% of individuals who reached target morning or bedtime home SBP levels <135 mmHg exhibited well-controlled nighttime home SBP. Although nighttime home SBP measurements obtained using both brachial and wrist HBPM devices displayed a significant correlation, the wrist device needs to be examined in more detail for clinical use.

Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.

Purpose: The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol. Methods: The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions. Results: In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled. Conclusion: The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.

Wearable cuffless blood pressure tracking: when will they be good enough?

Wearable health monitoring is a multibillion-dollar industry. But the holy grail is probably getting it right for blood pressure monitoring without a cuff, because raised blood pressure is very common and the leading cause of death in the world. Many have tried and failed, but industry is persisting: numerous cuffless wearable blood pressure devices are on the market, several technologies have been developed, hundreds of patents are registered every year, and some devices already have regulatory approval. However, to convince the die-hard blood pressure critic is a different ball game. To understand the challenges of currently accepted methods and cuffless devices, I performed a 24-h blood pressure monitoring self-test, including measurements when awake, asleep and watching an intense match of the Rugby World Cup final, with the purpose to demonstrate the challenges and opportunities we face. Blood pressure was monitored using five different devices simultaneously: validated left and right arm cuff blood pressure, and three cuffless wearable devices (wrist-band, chest patch and a ring). Whilst none of these devices proved to be perfect in capturing a physiologically challenging measure, namely blood pressure, it emphasised that our current practice of a single blood pressure measurement in clinical practice should be revisited. It further begs the question of when cuffless measurements will be good enough to incorporate in clinical decision-making.

Smart solutions in hypertension diagnosis and management: a deep dive into artificial intelligence and modern wearables for blood pressure monitoring.

Hypertension, a widespread cardiovascular issue, presents a major global health challenge. Traditional diagnosis and treatment methods involve periodic blood pressure monitoring and prescribing antihypertensive drugs. Smart technology integration in healthcare offers promising results in optimizing the diagnosis and treatment of various conditions. We investigate its role in improving hypertension diagnosis and treatment effectiveness using machine learning algorithms for early and accurate detection. Intelligent models trained on diverse datasets (encompassing physiological parameters, lifestyle factors, and genetic information) to detect subtle hypertension risk patterns. Adaptive algorithms analyze patient-specific data, optimizing treatment plans based on medication responses and lifestyle habits. This personalized approach ensures effective, minimally invasive interventions tailored to each patient. Wearables and smart sensors provide real-time health insights for proactive treatment adjustments and early complication detection.

Exploring Hypertension Patient Engagement Using mHealth. A Scoping Review.

INTRODUCTION: Widespread use of smartphone applications has opened new perspectives for home Blood Pressure monitoring based on mobile health (mHealth) technologies. Patient engagement has been dubbed 'the silver bullet of the century'. AIM: The aim was to identify the impact of engagement in patients with blood pressure using mHealth. METHODS: This scoping review was conducted in accordance with the Ark0sey and O'Malley framework. DATABASE: Pubmed, CINAHL, Scopus and PsycInfo. This review considered both qualitative and quantitative primary searches. We excluded articles belonging to grey literature, secondary literature and paediatric setting. Between September and November 2023, the review was carried out. RESULTS: A total of 569 documents were retrieved from the four databases. After the deduplication process, five articles were removed. The selection process based on titles and abstracts included 133 records. Ten studies were selected and analysed. The reviewers identified the following themes: device type and mobile applications, engagement, blood pressure control, health behaviours and hypertension knowledge. Self-management using digital technologies in the home is strongly linked to engagement, reduction and control of Blood Pressure, improved health practices and increased knowledge of hypertension. Healthcare interventions using IT platforms have had a significant impact on the health outcomes of patients diagnosed with hypertension. CONCLUSIONS: The review findings suggest the value of these technologies in improving patient engagement and, consequently, adherence to antihypertensive treatment and achieving blood pressure control rates, potentially reducing cardiovascular risk.

Recent Advances in Materials, Devices and Algorithms Toward Wearable Continuous Blood Pressure Monitoring.

Continuous blood pressure (BP) tracking provides valuable insights into the health condition and functionality of the heart, arteries, and overall circulatory system of humans. The rapid development in flexible and wearable electronics has significantly accelerated the advancement of wearable BP monitoring technologies. However, several persistent challenges, including limited sensing capabilities and stability of flexible sensors, poor interfacial stability between sensors and skin, and low accuracy in BP estimation, have hindered the progress in wearable BP monitoring. To address these challenges, comprehensive innovations in materials design, device development, system optimization, and modeling have been pursued to improve the overall performance of wearable BP monitoring systems. In this review, we highlight the latest advancements in flexible and wearable systems toward continuous noninvasive BP tracking with a primary focus on materials development, device design, system integration, and theoretical algorithms. Existing challenges, potential solutions, and further research directions are also discussed to provide theoretical and technical guidance for the development of future wearable systems in continuous ambulatory BP measurement with enhanced sensing capability, robustness, and long-term accuracy.

Virtual Expansion of the YMCA's Blood Pressure Self-Monitoring (BPSM) Program: Using Telehealth to Adapt an Evidence-Based Program to Reach Rural Communities in South Carolina.

CONTEXT: Disparities in cardiovascular disease prevalence and death exist among South Carolina's rural residents. Blood pressure self-monitoring (BPSM), where individuals measure their own blood pressure outside of the clinical environment, coupled with additional support, is an evidence-based, cost-effective strategy that is underutilized at large. PROGRAM: The YMCA's BPSM program is an evidence-based, 4-month program that includes 2 individualized office hours with a Healthy Heart Ambassador and 4 nutrition education sessions per month. Participants are provided with a blood pressure cuff and notebook to track their blood pressure at home in between sessions. IMPLEMENTATION: The SC Department of Health and Environmental Control partnered with the SC Alliance of YMCAs to expand the YMCA's BPSM program virtually. The traditional program was adapted to allow for virtual participant encounters. To target rural communities, partnerships were leveraged or established with rural health centers, federally qualified health centers, free medical clinics, and other state health department regions for participant referrals into the program. EVALUATION: A developmental evaluation design was utilized to monitor the virtual adaptation of the YMCA's BPSM program from April 2021 to May 2023. At the end of the project, 10 referral sources were identified to refer participants to the program. In total, 253 participants were referred to the program, 126 participants enrolled into the program, and 52 participants completed the program. Completers of the virtual program were successful in improving their blood pressure. DISCUSSION: Successes of the virtual program were not without challenges. Lessons learned from the virtual expansion of this program included ensuring participants' readiness to engage in a 4-month program, assessing participants' digital literacy, and considering broadband access in rural areas. Improvements in blood pressure and the program's reach demonstrate merit in continuing to scale the virtual adaptation of this program; however, contextual and structural factors should be considered.

Empowering Low-Income Patients with Home Blood Pressure Monitors to Improve Hypertension Control.

INTRODUCTION: Effective management of hypertension (HTN) is a priority in primary care. With telehealth now considered a staple care delivery method, uninsured and low-income patients without home blood pressure (BP) monitors may need additional attention and resources to achieve successful HTN control. METHODS: This prospective study at an underserved community clinic assessed the impact of distributing free BP monitors on patients' HTN control and therapy adherence. Enrollees were randomized into 2 groups, both completing 4 primary care physician (PCP) visits over a 6-month study period. Intervention participants collected home BP readings to report to their PCP and comparison participants completed an equivalent number of visits without having home BP data available for their PCP to review. Both groups completed an initial and final Therapy Adherence Scale (TAS) questionnaire. RESULTS: 263 patients were invited and 200 participants (mean age 50, 60% female, 19% Black, 67% Hispanic) completed the study. Intervention and comparison subjects featured comparable initial BP levels and TAS scores. After adjusting for age, race, ethnicity, sex, presence of diabetes and therapy adherence, intervention participants experienced higher odds of controlled HTN (OR 4.0; 95% Confidence Interval 2.1 to 7.7). A greater proportion of participants achieved BP control in the intervention arm compared with the comparison arm (82% vs 54% of participants, P < .001). TAS scores were higher in the intervention group (Mean = 44.1 vs 41.1; P < .001). DISCUSSION: The provision of free home BP monitors to low-income patients may feasibly and effectively improve BP control and therapy adherence.

Validation of the RBP-9801 oscillometric blood pressure monitor in the general population according to the association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization Universal Standard.

The aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor RBP-9801 developed for office and home BP measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. A total of 105 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.3 ± 6.4/3.1 ± 5.8 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.24/5.03 mmHg (systolic/diastolic). The conclusion is that the RBP-9801 oscillometric device for office and home BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in the general population and can be recommended for clinic and self-use at home.

Validation of the Meditech ABPM-06 24-hour blood pressure monitoring system in a pediatric population according to International Organization for Standardization Protocol 81060-2:2018.

OBJECTIVE: Ambulatory blood pressure monitoring (ABPM) devices play a crucial role in diagnosing hypertension, not only in adults but also in pediatric patients. ABPM-06, the latest oscillometric device from Meditech Ltd. (Budapest, Hungary), is the focus of this study. The objective was to validate the ABPM-06 device using the International Organization for Standardization (ISO) 81060-2 : 2018 standard. METHODS: A total of 86 healthy patients, consisting of 34 males and 52 females, aged between 3 and 17 years, were enrolled in this study. During the ambulatory phase, a total of 50 patients were enrolled, with 35 patients falling within the 3- to 12-year-old age range and 15 patients aged between 12 and 17 years. Additionally, for the dynamic test, 36 patients were selected, comprising of 10 individuals aged 3-12 years and 26 patients aged 12-17 years. These patients were recruited from the outpatient clinics of the Department of Pediatrics at Albert Szent-Györgyi University in Szeged, Hungary. The validation process involved utilizing the same-arm sequence protocol, both in resting positions and during stress testing. RESULTS: The ABPM-06 performed well in both clinical and ambulatory validations. In terms of validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -1.3 ±â€…3.5  mmHg for systolic and -0.1  ±â€…2.3 mmHg for diastolic, in children under the age of 12 years. For those over the age of 12 years, the mean ± SD of the differences was -2.8 ± 4.6 mmHg for systolic and -0.5 ± 2.7 mmHg for diastolic. Regarding the ambulatory validation, for children under 12 years old, the mean ± SD of the differences was -1.3  ±â€…3.5  mmHg for systolic and -0.1  ±â€…2.3  mmHg for diastolic. In the age group above 12 years, the mean ± SD of the differences was -2.8 ± 4.6 mmHg for systolic and -0.5 ± 2.7 mmHg for diastolic. Both tests successfully met the established criteria regarding the mean and SD values of the differences between the device readings and the observed SBP and DBP measurements. CONCLUSION: The ABPM-06 oscillometric device fully adheres to the ISO 81060-2 : 2018 standard requirements for ABPM determination in the pediatric population (ages 3-17 years). Consequently, this ABPM device proves to be suitable for effectively managing hypertension in children and adolescents.

Postpartum Remote Blood Pressure Monitoring Using a Mobile App in Women with a Hypertensive Disorder of Pregnancy.

BACKGROUND: Hypertensive disorders of pregnancy affect approximately 15% of pregnancies in the United States and are a leading cause of postpartum readmissions. Morbidity due to hypertension may be higher in the first several weeks postpartum. The ability to monitor blood pressure and intervene in the postpartum period is critical to reducing morbidity and mortality. LOCAL PROBLEM: At WellSpan Health, hypertensive disorders were increasing and a leading cause of severe maternal morbidity and readmission. INTERVENTIONS: A remote blood pressure monitoring app called BabyScripts™ myBloodPressure was implemented in September 2020. Prior to discharge postpartum, all patients with a diagnosis of a hypertensive disorder of pregnancy were given an automatic blood pressure cuff and instructions on how to monitor and track their blood pressure daily in the app. RESULTS: A total of 1,260 patients were enrolled in the BabyScripts™ myBloodPressure module between September 2020 and July 2022 across five maternity hospitals. Of those enrolled 74% ( n = 938) entered seven or more blood pressures, and of those who entered at least one blood pressure 9% ( n = 107) entered at least one critical range blood pressure ( ≥ 150 mmHg systolic and or ≥ 100 mmHg diastolic). CONCLUSION: Most women enrolled in the app were highly engaged and entered seven or more readings. Patients with critical blood pressures were identified; thus, the program has the potential to identify those at risk of severe complications. Barriers should be removed, and remote patient monitoring considered as a solution to improve postpartum assessment in patients with hypertensive disorders of pregnancy.

Development of beat-by-beat blood pressure monitoring device and nocturnal sec-surge detection algorithm.

The nocturnal blood pressure (BP) surge in seconds (sec-surge) is defined as a brief, acute transient BP elevation over several tens of seconds, triggered by obstructive sleep apnea (OSA) and sympathetic hyperactivity. Sec-surge imposes a significant strain on the cardiovascular system, potentially triggering cardiovascular events. Quantitative evaluation of sec-surge level could be valuable in assessing cardiovascular risks. To accurately measure the detailed sec-surge, including its shape as BP rises and falls, we developed a beat-by-beat (BbB) BP monitoring device using tonometry. In addition, we developed an automatic sec-surge detection algorithm to help identify sec-surge cases in the overnight BbB BP data. The device and algorithm successfully detected sec-surges in patients with OSA. Our results demonstrated that sec-surge was associated with left ventricular hypertrophy and arterial stiffness independently of nocturnal BP level or variability. Sec-surge would be worth monitoring for assessing cardiovascular risks, in addition to nocturnal BP level. Nocturnal blood pressure (BP) surge in seconds (sec-surge) places heavy load on the cardiovascular system and can trigger cardiovascular events. To identify sec-surges, we developed a beat-by-beat BP monitoring device and a sec-surge detection algorithm. Furthermore, sec-surge was more related to cardiovascular risks than conventional nocturnal BP parameters.

Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).

OBJECTIVE: The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) at rest and during dynamic exercise. METHOD: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large). RESULTS: For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ±â€…SD of the differences between the test device and reference BP readings was 0.5 ±â€…6.2/-0.2 ±â€…5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N  = 35), the mean difference was 0.4 ±â€…5.9/-1.1 ±â€…5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error. CONCLUSION: These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.

Performance of wearable watch-type home blood pressure measurement devices in a real-world clinical sample.

BACKGROUND: Independent testing of home blood pressure (BP) measurement (HBPM) devices is often lacking, particularly among older and multi-morbid patients. METHODS: We studied the Bpro G2 (using tonometry), Omron HeartGuide (using occlusive oscillometric technology), and Heartisans (using photoplethysmography) wrist watch HBPM devices against a gold standard brachial sphygmomanometer. To test device performance, we used the ISO81060-2 protocol (though this protocol cannot formally validate cuffless devices). We also used linear mixed models to compare adjusted longitudinal BP measurements between devices. Finally, as a surrogate for usability, we recorded instances of device failure where no BP measurement was returned. RESULTS: We enrolled 128 participants (median [Q1-Q3] age 53 [40-65] years, 51% male, 46% on antihypertensive drugs), of whom 100 were suitable for the primary analysis. All three devices had mean BP values within 5 mmHg of sphygmomanometry. However, due to insufficient reliability (e.g., wider than accepted standard deviations of mean BP), none of the three devices passed all criteria required by the ISO81060-2 protocol. In adjusted longitudinal analyses, the Omron device also systematically underestimated systolic and diastolic BP (- 8.46 mmHg; 95% CI 6.07, 10.86; p < 0.001; and - 2.53 mmHg; 95% CI - 4.03, - 1.03; p = 0.001; respectively). Nevertheless, compared to the Omron device, BPro and Heartisans devices had increased odds of failure (BPro: odds ratio [OR] 5.24; p < 0.0001; Heartisans: OR 5.61; p < 0.001). CONCLUSIONS: While we could not formally validate the cuffless devices, our results show that wearable technologies will require improvements to offer reliable BP assessment. This study also highlights the need for validation protocols specifically designed for cuffless BP measurement technologies.