Search

BACKGROUND: Atrial fibrillation (AF) is often asymptomatic and undiagnosed. As AF and hypertension often coexist, opportunistic AF detection during routine automated blood pressure (BP) measurement appears to be an attractive screening method. METHODS: A systematic literature search was conducted to identify studies assessing the diagnostic test accuracy of office, home, or 24-hour ambulatory BP measuring devices with AF detection algorithms versus reference electrocardiography. Analyses were performed per participant (AF status based on several BP readings; most office/home devices) or per reading (AF status based on individual readings; all ambulatory devices). A meta-analysis stratified by device type (office/home/ambulatory) was conducted to calculate pooled measures of diagnostic accuracy. Sensitivity/meta-regression analyses were also performed. RESULTS: Among 3096 records initially retrieved, 23 diagnostic test accuracy studies were included. Data derived from 11 093 individuals (weighted age 69 years, males 56%, hypertensives 79%, diabetics 24%, and AF prevalence 17%) indicated a pooled sensitivity 0.97 (95% CI, 0.92–0.99), specificity 0.93 (95% CI, 0.90–0.95), and accuracy 0.93 (95% CI, 0.89–0.95), with generally consistent results using office, home, or ambulatory BP devices (slightly lower specificity with the latter). The positive and negative predictive values were 0.70 (95% CI, 0.60–0.80) and 0.99 (95% CI, 0.98–1.00), respectively. Sensitivity analyses indicated lower specificity in studies implementing reading versus participant analyses. Most studies presented a low risk of bias and minor applicability concerns. CONCLUSIONS: There is considerable and consistent evidence suggesting high diagnostic accuracy of AF detection algorithms implemented in automated BP monitors during routine BP measurements in and out of the office. AF diagnosis requires verification (electrocardiography) before treatment is administered. [ABSTRACT FROM AUTHOR]

Background: Hypertension management is challenged by the dynamic nature of blood pressure (BP) fluctuations. These fluctuations are influenced by factors such as physical activity, emotional changes, and sleep patterns. Traditional guidelines focus on static measurements taken in clinical settings. However, these readings may not accurately represent an individual's typical BP levels. This approach can lead to misdiagnoses, such as white coat or masked hypertension, resulting in either unnecessary treatment or missed diagnoses. Current Concepts: Recent global hypertension guidelines emphasize the importance of home BP monitoring and 24-hour ambulatory BP measurements for more accurate diagnoses and treatment plans. However, several barriers exist, such as the high cost of ambulatory BP devices and practical challenges associated with home BP monitoring, which limit their widespread utilization. Despite these challenges, integrating BP measurements into mobile devices offers a promising approach to monitoring BP outside the clinical setting. Various innovative approaches have been developed, including smartwatches utilizing photoplethysmography sensors and machine learning algorithms. However, their accuracy and the need for periodic calibration are areas of concern. Discussion and Conclusion: Mobile device BP monitoring represents a significant advancement in hypertension management, offering the potential for continuous, convenient, and less intrusive monitoring. Despite these potential benefits, challenges such as device accuracy verification, large-scale data interpretation, and calibration must be addressed. The future of hypertension management will likely rely on these technologies, along with traditional methods, to provide better insight into individual BP profiles. This integration promises to improve hypertension diagnosis, management, and ultimately patient outcomes, although further research and development are necessary to overcome the current limitations. [ABSTRACT FROM AUTHOR]

We propose an ultra-low-cost at-home blood pressure monitor that leverages a plastic clip with a spring-loaded mechanism to enable a smartphone with a flash LED and camera to measure blood pressure. Our system, called BPClip, is based on the scientific premise of measuring oscillometry at the fingertip to measure blood pressure. To enable a smartphone to measure the pressure applied to the digital artery, a moveable pinhole projection moves closer to the camera as the user presses down on the clip with increased force. As a user presses on the device with increased force, the spring-loaded mechanism compresses. The size of the pinhole thus encodes the pressure applied to the finger. In conjunction, the brightness fluctuation of the pinhole projection correlates to the arterial pulse amplitude. By capturing the size and brightness of the pinhole projection with the built-in camera, the smartphone can measure a user's blood pressure with only a low-cost, plastic clip and an app. Unlike prior approaches, this system does not require a blood pressure cuff measurement for a user-specific calibration compared to pulse transit time and pulse wave analysis based blood pressure monitoring solutions. Our solution also does not require specialized smartphone models with custom sensors. Our early feasibility finding demonstrates that in a validation study with N = 29 participants with systolic blood pressures ranging from 88 to 157 mmHg, the BPClip system can achieve a mean absolute error of 8.72 and 5.49 for systolic and diastolic blood pressure, respectively. In an estimated cost projection study, we demonstrate that in small-batch manufacturing of 1000 units, the material cost is an estimated $0.80, suggesting that at full-scale production, our proposed BPClip concept can be produced at very low cost compared to existing cuff-based monitors for at-home blood pressure management.

s u m m a r y: Purpose: This study aimed to determine factors associated with changes in adherence to hypertension management (medication adherence and blood pressure control) in respondents with hypertension before and during the COVID-19 pandemic in Bogor city, Indonesia. Methods: An observational study was conducted using two sources of data (before and during COVID-19 pandemic). Data before the pandemic were derived from the 2019 Cohort Study of non-communicable disease risk factors. Data during the pandemic were derived from an online survey conducted in September and October 2020. Information from 880 participants were analyzed. The dependent variable was the change in adherence to hypertension management before and during the COVID-19 pandemic. Multivariate analysis was performed using logistic polynomial regression. Results: Respondents who adhered to hypertension management decreased from 82.0% in 2019 to 47.8% in 2020. The likelihood of non-adherence (respondents who did not adhere to hypertension management both before and during the pandemic) increased in respondents below 55 years old, who did not own any healthcare insurance, who were not obese, and who had no other comorbidities. In the partial adherence group (respondents who did not adhere to hypertension management either before or during the pandemic), we found that most respondents adhered before the pandemic but no longer adhered during the COVID-19 pandemic. We found an increased partial adherence in young and highly educated respondents. Conclusions: Efforts to improve adherence to hypertension management after the COVID-19 pandemic should target those who were young, highly educated, who did not have any healthcare insurance, and who did not perceive themselves as not having comorbidities.

Abstract Background Based on the controversy surrounding pulmonary artery catheterization (PAC) in surgical patients, we investigated the interchangeability of cardiac index (CI) and systemic vascular resistance (SVR) measurements between ClearSight™ and PAC during living-donor liver transplantation (LDLT). Methods This prospective study included consecutively selected LDLT patients. ClearSight™-based CI and SVR measurements were compared with those from PAC at seven LDLT-stage time points. ClearSight™-based systolic (SAP), mean (MAP), and diastolic (DAP) arterial pressures were also compared with those from femoral arterial catheterization (FAC). For the comparison and analysis of ClearSight™ and the reference method, Bland-Altman analysis was used to analyze accuracy while polar and four-quadrant plots were used to analyze the trending ability. Results From 27 patients, 189 pairs of ClearSight™ and reference values were analyzed. The CI and SVR performance errors (PEs) exhibited poor accuracy between the two methods (51.52 and 51.73%, respectively) in the Bland-Altman analysis. CI and SVR also exhibited unacceptable trending abilities in both the polar and four-quadrant plot analyses. SAP, MAP, and DAP PEs between the two methods displayed favorable accuracy (24.28, 21.18, and 26.26%, respectively). SAP and MAP exhibited acceptable trending ability in the four-quadrant plot between the two methods, but not in the polar plot analyses. Conclusions During LDLT, CI and SVR demonstrated poor interchangeability, while SAP and MAP exhibited acceptable interchangeability between ClearSight™ and FAC.

Cuffless blood pressure measuring devices are emerging as alternatives for out-of-office assessment of patients with hypertension. This novel technology promises to deliver continuous or beat-to-beat blood pressure measurement and resolve some of the inconveniences associated with conventional cuff-based devices such as improper cuff fit, discomfort, low adherence to monitoring, and technical challenges. Blood pressure can be estimated based on phenomena related to cardiovascular activity: pulse wave velocity, pulse wave analysis, tonometry, and volume clamping. In this narrative review, we seek to summarize current approaches for nontraditional measurement of blood pressure and discuss some of the benefits and limitations of this technology.

Ambulatory, cuff-less blood pressure (BP) measurement devices are a promising trend to alleviate the strains of conventional, cuff-based BP determination. Cuff-less devices circumvent discomfort and nocturnal arousal reactions which can be triggered by cuff inflation from conventional, cuff-based ambulatory blood pressure measurement devices. Mitigating these discomforts is especially desirable when performing measurement in children. In this study we want to assess the clinical validity of a cuff-less BP measurement device for 24-h measurements in children and adolescents. We compared the simultaneously retrieved BP data of the cuff-less SOMNOtouch NIBP and the cuff-based Mobil-O-Graph in 24-h use in 90 children in the range from 5 to 17 years old. A total of 1218 valid measurement pairs showed a mean deviation of 0.99 mmHg (limits of agreement: 21.44/-19.46) for systolic and 3.03 mmHg (limits of agreement: 24.37/−18.31) for diastolic BP values. Patient-specific difference of means was within 15 mmHg in 97.7% (systolic BP) and 93.2% (diastolic BP) patients. 25.6% of nocturnal cuff inflations led to determinable, BP-relevant arousal reactions. The SOMNOtouch NIBP demonstrated little measurement deviation of mean BP compared to the cuff-based technique over a broad spectrum of 24-h, ambulatory BP measurements in children and adolescents. Cuff-less blood pressure measurement relieves the issue of nocturnal arousal reactions which are shown to be frequently induced by cuff-based measurements. Driven by these promising results, we encourage ongoing efforts to create enough evidence on cuff-less BP measurement to promote it into broad clinical application. What is known about the topic? Hypertension is of increasing relevance in children and adolescents Blood pressure measurement is difficult, especially in younger individuals What this study adds? The study investigated the accuracy of a cuff-less blood pressure (BP) measurement device, SOMNOtouch™ NIBP, in children and adolescents for 24-h measurements, in comparison to a traditional cuff-based device. The experiment involved 90 participants aged between 5 and 17 years old, with both devices worn simultaneously for 24 h. The results indicated that the cuff-less device showed a minor average deviation in BP measurements. The mean deviation for systolic and diastolic BP values was 0.99 mmHg and 3.03 mmHg, respectively. About 25.6% of night-time cuff inflations in traditional devices led to significant arousal reactions. The study concluded that the cuff-less device had a slight measurement deviation and could alleviate issues like nocturnal arousal reactions that are common with cuff-based devices. These findings suggest the potential for broad clinical application of cuff-less BP measurement devices, especially in children and adolescents, to reduce discomfort and improve patient adherence. However, more research is needed to solidify these findings. [ABSTRACT FROM AUTHOR]

Background: Based on the controversy surrounding pulmonary artery catheterization (PAC) in surgical patients, we investigated the interchangeability of cardiac index (CI) and systemic vascular resistance (SVR) measurements between ClearSight™ and PAC during living-donor liver transplantation (LDLT). Methods: This prospective study included consecutively selected LDLT patients. ClearSight™-based CI and SVR measurements were compared with those from PAC at seven LDLT-stage time points. ClearSight™-based systolic (SAP), mean (MAP), and diastolic (DAP) arterial pressures were also compared with those from femoral arterial catheterization (FAC). For the comparison and analysis of ClearSight™ and the reference method, Bland-Altman analysis was used to analyze accuracy while polar and four-quadrant plots were used to analyze the trending ability. Results: From 27 patients, 189 pairs of ClearSight™ and reference values were analyzed. The CI and SVR performance errors (PEs) exhibited poor accuracy between the two methods (51.52 and 51.73%, respectively) in the Bland-Altman analysis. CI and SVR also exhibited unacceptable trending abilities in both the polar and four-quadrant plot analyses. SAP, MAP, and DAP PEs between the two methods displayed favorable accuracy (24.28, 21.18, and 26.26%, respectively). SAP and MAP exhibited acceptable trending ability in the four-quadrant plot between the two methods, but not in the polar plot analyses. Conclusions: During LDLT, CI and SVR demonstrated poor interchangeability, while SAP and MAP exhibited acceptable interchangeability between ClearSight™ and FAC. [ABSTRACT FROM AUTHOR]

BACKGROUND: Home blood pressure (BP) is an important component of digital strategies for hypertension management. However, no studies have used the same device to investigate 24-hour BP control status in relation to different home BP control thresholds. METHODS: Participants in the general practitioner-based, multicenter HI-JAMP study (Home-Activity Information and Communication Technology-Based Japan Ambulatory Blood Pressure Monitoring Prospective) underwent office BP measurement, then 24hour ambulatory BP monitoring, then home BP monitoring for 5 days. A validated all-in-one BP monitoring device was used to measure office, home, and ambulatory BP. Baseline data were used to investigate ambulatory BP control status in individuals with well-controlled home BP based on the different guideline thresholds (125/75 mm Hg, 130/80 mm Hg, and 135/85 mm Hg). RESULTS: Data from 2269 patients were analyzed. For individuals with well-controlled home BP <135/85 mm Hg (59.5% of the total population), the prevalence of uncontrolled 24-hour (≥130/80 mm Hg), daytime (≥135/85 mm Hg), and nighttime ambulatory BP (≥120/70 mm Hg) was 19.9%, 18.5%, and 33.6%, respectively. Corresponding prevalence rates in the 42.7% of participants with well-controlled home BP <130/80 mm Hg were 13.4%, 12.9%, and 26.0%, and when well- controlled home BP was strictly defined as <125/75 mm Hg (23.9% of the population), prevalence of rates of uncontrolled 24-hour, daytime, and nighttime ambulatory BP were 7.0%, 9.0%, and 15.3%, respectively. CONCLUSIONS: Home BP control status defined using different thresholds could predict 24-hour ambulatory BP control status in treated hypertension. One-third of individuals still had uncontrolled nocturnal hypertension when home BP was controlled to <135/85 mm Hg, but ambulatory BP was quite well controlled when home BP was <125/75 mm Hg. [ABSTRACT FROM AUTHOR]

BACKGROUND: Home blood pressure (BP) monitoring over a 7-day period is recommended to confirm the diagnosis of hypertension. METHODS: We determined upper and lower home BP thresholds with >90% positive predictive value and >90% negative predictive value using 1 to 6 days of monitoring to identify high home BP (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg) based on 7 days of home BP monitoring. The sample included 361 adults from the Improving the Detection of Hypertension Study who were not taking antihypertensive medication. We used two 7-day periods, at least 3 days apart, the first being a sampling period and the second a reference period. For each number of days in the sampling period, we determined the percentage of participants who had a high likelihood of having (>90% positive predictive value) or not having (>90% negative predictive value) high BP and would not need to continue home BP monitoring. Only the participants in an uncertain category (ie, positive predictive value ≤90% and negative predictive value ≤90%) after each day were carried forward to the next day of home BP monitoring. RESULTS: Of the 361 participants (mean [SD] age of 41.3 [13.2] years; 60.4% women), 38.0% had high home BP during the reference period. There were 63.7%, 17.1%, 10.5%, 3.3%, 3.6%, and 1.4% participants who would not need to continue after 1, 2, 3, 4, 5, and 6 days of monitoring. CONCLUSIONS: In most people, high home BP can be identified or excluded with a high degree of confidence with 3 days or less of monitoring. [ABSTRACT FROM AUTHOR]

In persistent pulmonary hypertension of the newborn (PPHN), the ratio of pulmonary vascular resistance to systemic vascular resistance is increased. Extrapulmonary shunts (patent ductus arteriosus and patent foramen value) allow for right-to-left shunting and hypoxaemia. Systemic hypotension can occur in newborns with PPHN due to variety of reasons, such as enhanced peripheral vasodilation, impaired left ventricular function and decreased preload. Systemic hypotension can lead to end organ injury from poor perfusion and hypoxaemia in the newborn with PPHN. Thus, it must be managed swiftly. However, not all newborns with PPHN and systemic hypotension can be managed the same way. Individualised approach based on physiology and echocardiographic findings are necessary to improve perfusion to essential organs. Here we present a review of the physiology and mechanisms of systemic hypotension in PPHN, which can then guide treatment.

Purpose Ambulatory, cuff-less blood pressure (BP) measurement devices are a promising trend to alleviate the strains of conventional, cuff-based BP determination. Cuff-less devices circumvent discomfort and nocturnal arousal reactions which can be triggered by cuff inflation from conventional, cuff-based ambulatory blood pressure measurement devices. Mitigating these discomforts is especially desirable when performing measurement in children. In this study we want to assess the clinical validity of a cuff-less BP measurement device for 24-h measurements in children and adolescents. Materials and methods We compared the simultaneously retrieved BP data of the cuff-less SOMNOtouch NIBP and the cuff-based Mobil-O-Graph in 24-h use in 90 children in the range from 5 to 17 years old. Results A total of 1218 valid measurement pairs showed a mean deviation of 0.99 mmHg (limits of agreement: 21.44/-19.46) for systolic and 3.03 mmHg (limits of agreement: 24.37/−18.31) for diastolic BP values. Patient-specific difference of means was within 15 mmHg in 97.7% (systolic BP) and 93.2% (diastolic BP) patients. 25.6% of nocturnal cuff inflations led to determinable, BP-relevant arousal reactions. Conclusions The SOMNOtouch NIBP demonstrated little measurement deviation of mean BP compared to the cuff-based technique over a broad spectrum of 24-h, ambulatory BP measurements in children and adolescents. Cuff-less blood pressure measurement relieves the issue of nocturnal arousal reactions which are shown to be frequently induced by cuff-based measurements. Driven by these promising results, we encourage ongoing efforts to create enough evidence on cuff-less BP measurement to promote it into broad clinical application.

Background. Uncontrolled blood pressure is associated with significant cardiovascular mortality and morbidity, and its management is often complicated by poor medication adherence and mental health disorders. Objectives. This study aimed to evaluate the association of blood pressure control with psychological disorders and medication adherence among primary care patients with hypertension. Material and methods. A cross-sectional study that included 478 hypertensive patients from five urban primary healthcare settings in Port Said governorate, Egypt. Socio-economic and clinical characteristics were collected, and all participants were screened for depression, generalised anxiety disorder, perceived stress and medication adherence using the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder Scale-7 (GAD-7), 10-item Perceived Stress Scale (PSS-10) and General Medication Adherence Scale (GMAS). Hierarchical logistic regression analysis was used to assess predictors of blood pressure control. P-values < 0.05 were considered significant. Results. 40.17% had uncontrolled blood pressure, and 44.8% had suboptimal adherence to antihypertensive medications. The prevalence estimates of depressive and anxiety symptoms were 33.7% and 28.9%, respectively. The mean PSS-10 score was 18.50 ± 6.34. Predictors of controlled blood pressure included optimal medication adherence (OR 2.518, p < 0.001), performing physical activity (OR 2.0, p = 0.004), having a higher number of target organ damage (OR 1.514, p = 0.017), using combined antihypertensive medications, (OR 1.392, p = 0.006), having lower anxiety symptoms (OR 0.453, p = 0.013) and being younger (OR 0.970, p = 0.047). Conclusions. Symptoms of anxiety, not depression, and suboptimal medication adherence were associated with uncontrolled blood pressure. A multidisciplinary team approach should be utilised in the management of hypertensive patients to address individual patients’ biopsychosocial factors. [ABSTRACT FROM AUTHOR]

Cuffless blood pressure measuring devices are emerging as alternatives for out-of-office assessment of patients with hypertension. This novel technology promises to deliver continuous or beat-to-beat blood pressure measurement and resolve some of the inconveniences associated with conventional cuff-based devices such as improper cuff fit, discomfort, low adherence to monitoring, and technical challenges. Blood pressure can be estimated based on phenomena related to cardiovascular activity: pulse wave velocity, pulse wave analysis, tonometry, and volume clamping. In this narrative review, we seek to summarize current approaches for nontraditional measurement of blood pressure and discuss some of the benefits and limitations of this technology. [ABSTRACT FROM AUTHOR]

Background and Significance: Hypertensive disorders of pregnancy complicate about 10% of pregnancies and are a leading cause of maternal morbidity and mortality. Purpose: The purpose of this quality improvement project was to evaluate a program to provide a home blood pressure monitor to all postpartum patients who had a hypertensive diagnosis and elevated blood pressure. Methods: The program includes a blood pressure monitor, instructions for its use, education about hypertension, and a guidance grid with standardized blood pressure parameters reviewed prior to discharge from the hospital. Patients are taught about potential adverse outcomes during postpartum. Patients are instructed to follow-up with their care provider based on the parameters. A retrospective medical record review was used to evaluate clinical outcomes. Results: Medical records of 185 patients indicated that 20% (n = 36) who received the home BP monitor reported one or more mild-to-severe range blood pressure(s) during postpartum. Twenty-eight percent (n = 52) had outpatient medication adjustments, including decreasing, increasing, starting, and discontinuing medications. Nine percent (n = 17) of patients returned to the obstetric triage for evaluation. There was patient overlap between those experiencing elevated blood pressures, medication adjustments, and those who returned to hospital for evaluation. Clinical Implications: Ongoing monitoring may improve identification and management of postpartum hypertension and potentially prevent progression to hypertensive-related adverse events. In this quality improvement project, patients with a diagnosis of a hypertensive disorder of pregnancy were given a home blood pressure monitor with detailed instructions for use when they were discharged from the hospital after giving birth. Patients monitored their blood pressure at home and reported results to their providers. Timely and appropriate treatment was able to be initiated without a return in-person visit for most patients. The program was well received by patients and providers. Home blood pressure monitoring for new mothers is a feasible method of insuring timely treatment for postpartum hypertension as needed without requiring a trip to the clinic or the hosptial. [ABSTRACT FROM AUTHOR]

Background: To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs. Methods: A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website. Results: We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings. Conclusions: Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation. [ABSTRACT FROM AUTHOR]

Most guidelines have recommended lower home blood pressure (BP) threshold when clinic BP threshold of 140/90 mm Hg is used for diagnosis of hypertension. However, home BP thresholds to define hypertension have never been determined in the general population in the United States. We identified home BP thresholds for stage 1 (BP ≥130/80 mm Hg) hypertension using a regression-based approach in the DHS (Dallas Heart Study; n=5768) and the NCMH study (North Carolina Masked Hypertension; n=420). Home BP thresholds were also assessed using outcome-derived approach based on the composite of all-cause mortality or cardiovascular events in the DHS cohort. For this approach, BP thresholds were identified only for systolic BP because diastolic BP was not associated with the outcome. Among untreated participants, the regression-derived thresholds for home BP corresponding to clinic BP for stage 1 hypertension were 129/80 mm Hg in blacks, 130/80 mm Hg in whites, and 126/78 mm Hg in Hispanics, respectively. The results are similar in the North Carolina cohort. The 11-year composite cardiovascular and mortality events corresponding to clinic systolic BP >130 mm Hg were higher in blacks than in whites and Hispanics (13.3% versus 5.98% versus 5.52%, respectively). Using a race/ethnicity-specific composite outcome in the untreated DHS participants, the outcome-derived home systolic BP thresholds corresponding to stage 1 hypertension were 130 mm Hg in blacks, 129 mm Hg in whites, and 131 mm Hg in Hispanics, respectively. Our data based on both regression-derived and outcome approach support home BP threshold of 130/80 mm Hg for diagnosis of hypertension in blacks, whites, and Hispanics.

Background: Initial orthostatic hypotension (IOH) is highly prevalent in older adults and may interfere with the ability to regain function after acute hospitalization. IOH assessment requires a non-invasive, beat-to-beat continuous blood pressure device, which is not widely used in geriatric rehabilitation. Our aim was to test the feasibility of diagnosing IOH using a continuous blood pressure device in geriatric rehabilitation inpatients.Methods: Geriatric rehabilitation inpatients of the REStORing Health of Acutely Unwell AdulTs (RESORT) cohort admitted to a tertiary hospital were randomly selected to undergo continuous blood pressure monitoring (Finapres) for 5 min in the supine position and 3 min of standing or sitting when unable to stand. Interventions to warm hands and adjusting the cuff pressure sizes were attempted if no signal was obtained or an error message occurred.Results: Of 37 randomly selected inpatients, 29 {55.2% female; mean age 82.8 (standard deviation [SD]) 6.6 years} agreed to the continuous blood pressure measurement. Successful measurements were achieved in 20 out of 29 inpatients, two after hand warming. Patients with unsuccessful measurements were likely to be older (mean age 87.2 [SD] 4.4 years, p = 0.03), have cerebrovascular disease (p = 0.006), lower body mass index (p = 0.012), and a lower short physical performance battery score (p = 0.039). Eight out of 20 patients had IOH.Conclusion: The number of unsuccessful continuous blood pressure measurements was high in a population with high IOH prevalence despite multiple interventions to establish a signal. Future research should focus on improving the efficiency of continuous blood pressure devices in hospitalized patients with unsuccessful signals. [ABSTRACT FROM AUTHOR]

Purpose: Intraoperative hypotension is associated with adverse outcomes. Predicting and proactively managing hypotension can reduce its incidence. Previously, hypotension prediction algorithms using artificial intelligence were developed for invasive arterial blood pressure monitors. This study tested whether routine non-invasive monitors could also predict intraoperative hypotension using deep learning algorithms., Methods: An open-source database of non-cardiac surgery patients ( https://vitadb.net/dataset ) was used to develop the deep learning algorithm. The algorithm was validated using external data obtained from a tertiary Korean hospital. Intraoperative hypotension was defined as a systolic blood pressure less than 90 mmHg. The input data included five monitors: non-invasive blood pressure, electrocardiography, photoplethysmography, capnography, and bispectral index. The primary outcome was the performance of the deep learning model as assessed by the area under the receiver operating characteristic curve (AUROC)., Results: Data from 4754 and 421 patients were used for algorithm development and external validation, respectively. The fully connected model of Multi-head Attention architecture and the Globally Attentive Locally Recurrent model with Focal Loss function were able to predict intraoperative hypotension 5 min before its occurrence. The AUROC of the algorithm was 0.917 (95% confidence interval [CI], 0.915-0.918) for the original data and 0.833 (95% CI, 0.830-0.836) for the external validation data. Attention map, which quantified the contributions of each monitor, showed that our algorithm utilized data from each monitor with weights ranging from 8 to 22% for determining hypotension., Conclusions: A deep learning model utilizing multi-channel non-invasive monitors could predict intraoperative hypotension with high accuracy. Future prospective studies are needed to determine whether this model can assist clinicians in preventing hypotension in patients undergoing surgery with non-invasive monitoring., Competing Interests: Declarations. Ethical approval: This study was approved by the Institutional Review Boards of Samsung Medical Center, Seoul, South Korea before data analysis (SMC 2022-09-096 and SMC 2023-04-139). Consent to participate: The requirement for informed consent was waived by the Institutional Review Boards of Samsung Medical Center, Seoul, South Korea due to the retrospective nature of the study and the use of de-identified data. Competing interests: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Objective: To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020)., Methods: The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method., Results: For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg)., Conclusion: AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Some brachial cuffs for oscillometric blood pressure (BP) measurement are claimed to cover a wide range of upper-arm circumferences; however, their validation is rarely conducted. Our aim was to compare oscillometric BP measurements obtained with a universal cuff with those obtained with an appropriately sized cuff., Methods: We utilised the Microlife B6 Connect monitor, conducting oscillometric BP measurements in a random sequence with both a universal cuff (recommended for arm circumferences from 22 to 42 cm) and an appropriately sized cuff (medium for circumference 22-32 cm and large for 32-42 cm). We included 91 individuals with an arm circumference of 22-32 cm and 64 individuals with an arm circumference of 32-42 cm., Results: For arm circumferences > 32 cm, systolic and diastolic BP measured with the universal cuff was higher than that measured with the large cuff (systolic 6.4 mmHg, 95% confidence interval [CI]). 3.9-8.8, diastolic 2.4 mmHg, 95%CI, 1.2-3.7, p  < 0.001 for both). Overestimation of BP with the universal cuff was statistically significant after correcting for the sequence of measurements. No statistical difference was found between the universal cuff and medium cuff for circumferences in the 22-32 cm range. The bladder size in the universal cuff matched the dimensions of the medium-sized cuff; however, the cuff was larger., Conclusion: Overestimation of BP measured with a universal cuff in persons with large arm circumferences is clinically important. It poses the risk of unnecessary initiation or intensification of antihypertensive medication in persons using the universal cuff.

Objective: Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020., Methods: BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard., Results: This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements., Conclusion: Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Atrial fibrillation (AF) is a stroke and heart complication risk but is often overlooked due to subtle symptoms. The accessibility of sphygmomanometers that can detect AF, may play crucial roles in identifying asymptomatic patients. AViTA BPM63B is an automatic blood pressure (BP) monitor for atrial fibrillation detection. This study validated the performance of BPM63B for AF detection using two novel algorithms of time-domain analysis and frequency-domain analysis which evaluate multiple statistics., Methods: The study included 100 participants, with 47 participants being male (47%) and ages ranging from 24 to 89 years (mean ± SD: 59 ± 17 years). Each participant received three consecutive readings from the subject device and a 12-lead ECG assessment. The pulse wave data from subject device was analyzed using the two algorithms. The atrial fibrillation status thus determined was compared to the ECG results interpreted by a physician., Results: Among the 100 participants, 52 patients had chronic atrial fibrillation, along with 48 outpatients exhibiting sinus rhythm or non-atrial fibrillation arrhythmias. Using the time-domain analysis method for atrial fibrillation detection, we achieved a sensitivity of 94.8% [95% confidence interval (CI), 90.08-97.75%] and a specificity of 98.6% (95% CI, 95.07-99.83%). Similarly, utilizing the frequency-domain analysis method resulted in a sensitivity of 91.6% (95% CI, 86.08-95.46%) and specificity of 94.4% (95% CI, 89.35-97.57%)., Conclusions: These findings suggest that AViTA BPM63B, which integrates two novel algorithms for atrial fibrillation diagnosis, demonstrates high sensitivity and specificity. Utilizing the AViTA BPM63B for BP monitoring could aid in the early detection of atrial fibrillation among outpatients in cardiology clinics., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Atrial fibrillation (AF) is common with advanced aging and is often asymptomatic and undiagnosed., Aim: A blood pressure (BP) monitor with embedded algorithm for detecting AF with high diagnostic accuracy during routine automated BP measurement was used to screen individuals aged ≥ 65 years., Methods: The EMENO health survey (2013-2016) applied a multi-stage stratified random sampling method to select a random general adult population sample in Greece. Participants aged ≥ 65 years were screened for AF using an automated oscillometric device with AF detecting algorithm (Microlife BPA100 Plus AFIB) with triplicate measurements on a single occasion., Results: A total of 975 individuals with AF data on at least one BP measurement were analysed [(mean (SD) age 73.2 (6.6) years, men 45%, hypertensives 79.3%). AF was detected in all 3 BP readings in 65 individuals (6.3%, AF group), in none of 3 readings in 661 (73.6%, non-AF group), and in 1-2 readings of 3 or less readings in 249 (20.1%, uncertain AF group). AF group individuals were older (p < 0.001), had lower systolic BP (p < 0.05) and more frequent cardiovascular disease (p < 0.01) compared to the non-AF and uncertain AF group. Moreover, 44.6% were unaware of their AF and all required anticoagulant therapy (CHA 2 DS 2 -VASc ≥ 1/≥ 2, men/women)., Conclusions: About 6% of individuals aged ≥ 65 years in Greece appeared to have AF, and 44.6% of them were unaware and requiring anticoagulant treatment. AF screening during routine automated BP measurement appears to be a useful tool for early detection of asymptomatic AF in individuals aged ≥ 65 years., Competing Interests: Declarations. Funding: The EMENO survey was implemented under the Operational Program 'Education and Lifelong Learning” and was co-funded by the European Union (European Social Fund) and national resources [grant number: MIS 376659]. Additional funding was obtained from the Hellenic Diabetes Association to measure glycated hemoglobin [grant number: Κ.Ε. 12008]. Microlife AG, Widnau, Switzerland offered 20 electronic blood pressure monitors with embedded atrial fibrillation detecting algorithm. Conflicts of Interest: GT has received EU and National resources grants as well as a grant from the Hellenic Diabetes Association, all paid to her institution, to support this study and grants unrelated to this study and paid to her institution from Gilead Sciences Europe, UCL, ECDC, EU, University of Bristol, Harvard University, and National funds; GSS has received research grants and consultation fees by Microlife AG, unrelated to this work. Nothing to declare by other authors., (© 2024. The Author(s).)

Purpose: To determine the acceptability of the ClearSight™ system (Edwards Lifesciences Corp., Irvine, CA, USA) for continuous blood pressure monitoring during elective cardiac surgery compared with arterial catheterization., Methods: We enrolled 30 patients undergoing elective cardiac surgery in a prospective observational study. Blood pressure measurements were recorded every 10 sec intraoperatively. We determined agreement based on the Association for the Advancement of Medical Instrumentation (AAMI) recommendations. Statistical analysis included fixed bias (difference of measurements between methods), percentage error (accuracy between ClearSight measurement and expected measurement from arterial line), and interchangeability (ability to substitute ClearSight monitor without effecting overall outcome of analysis). We used a paired samples t test to compare the time required for placing each monitor., Results: We found fixed bias in the differences between the ClearSight monitor and invasive arterial blood pressure measurement in systolic blood pressure (SBP; mean difference, 8.7; P < 0.001) and diastolic blood pressure (DBP; mean difference, -2.2; P < 0.001), but not in mean arterial pressure (MAP; mean difference, -0.5; P < 0.001). Bland-Altman plots showed that the means of the limits of agreement were greater than 5 mm Hg for SBP, DBP, and MAP. The percentage errors for SBP, DBP, and MAP were lower than the cutoff we calculated from the invasive arterial blood pressure measurements. Average interchangeability rates were 38% for SBP, 50% for DBP, and 50% for MAP. Placement of the ClearSight finger cuff was significantly faster compared with arterial catheterization (mean [standard deviation], 1.7 [0.6] min vs 5.6 [4.1] min; P < 0.001)., Conclusions: In this prospective observational study, we did not find the ClearSight system to be an acceptable substitute for invasive arterial blood pressure measurement in elective cardiac surgery patients according to AAMI guidelines. Nevertheless, based on statistical standards, there is evidence to suggest otherwise., Study Registration: ClinicalTrials.gov ( NCT05825937 ); first submitted 11 April 2023., (© 2024. Canadian Anesthesiologists' Society.)

Background: In Cycle 7 (2022), the Canadian Health Measures Survey (CHMS) introduced the OMRON (OM) IntelliSense HEM-907XL blood pressure (BP) monitor after using the BpTRU (BT) BPM-300 BP monitor for six cycles. This study assessed differences between adult BP values measured by both devices and whether equations could be developed to compare BP measurements taken using the two devices., Data and Methods: In Cycle 6 (2018 to 2019) of the CHMS, BP was measured using BT and OM devices. Between-device estimates of systolic BP (SBP), diastolic BP (DBP), and hypertension prevalence were compared for 1,072 adults aged 18 to 79 years. Sex, age, body mass index (BMI), and the use of antihypertensive medication were examined in linear regression models to predict SBP and DBP values measured with OM based on those measured with BT., Results: Average SBP measured with OM was 6 millimetres of mercury (mmHg) higher than average SBP measured with BT, and average DBP measured with OM was 2 mmHg lower than DBP measured with BT. Hypertension prevalence based on OM readings was 35.4%, compared with 34.0% based on BT readings. Between-device BP differences varied in magnitude by sex, age group, and BMI category. Average model-predicted estimates of BP were comparable to measured estimates, but predicted values were lower at higher levels of BP., Interpretation: Switching BP monitors will substantively affect population estimates of adult SBP and DBP but may have less impact on estimates of adult hypertension prevalence. The prediction equations proposed in this study can be applied to adult BP data from cycles 1 to 6 of the CHMS for comparison with BP measurements taken in Cycle 7, with some caveats. The impact of changing to the OM monitor in Cycle 7 should be acknowledged when reporting estimates of adult BP based on the CHMS.

Blood pressure monitors (BPMs) with atrial fibrillation (AFib) detection function can be used to detect AFib early. However, conventional algorithms require multiple BP measurements. Here, the feasibility of a machine-learning-based approach for AFib detection through single BP measurement was evaluated. First, a custom AdaBoost-based software, which analyzes the pulse-to-pulse interval (PPI) pattern and classifies it based on AFib detection, was created. Then, its classification performance was validated. For the validation study, PPI and standard 12-lead electrocardiogram (ECG) datasets were collected from 79 and 92 Japanese participants with and without AFib, respectively. PPI data were obtained using two different BPMs. All ECG results were interpreted by cardiologists. The custom software output for the PPI dataset and ECG interpreted results was compared, and the sensitivity and specificity were calculated. A sensitivity and specificity for PPI from main device were 97.5% (95% confidence interval [CI] 91.2-99.3%) and 98.9 (95% CI 94.1-99.8), respectively. No significant differences in sensitivity and specificity were observed in the subgroup analysis between different devices, age groups, and arm size groups. These results reflect the high accuracy and robustness of this AFib algorithm using a single BP measurement and supports its use for widespread AFib screening., (© 2024. The Author(s).)

Background: Early detection of atrial fibrillation (AF) is key for preventing strokes. Blood pressure monitors (BPMs) with built-in AF screening features have the potential for early detection at home. Recently, 2 BPMs (HEM-7371T1-AZ and HEM-7372T1-AZAZ, Omron Healthcare Co., Ltd.) that share a novel AF screening feature have been developed. Their AF screening feature utilizes an algorithm that incorporates machine learning, with the potential to improve diagnostic accuracy., Objective: The purpose of this study was to evaluate the performance of this AF screening feature in a multicenter, prospective clinical study at 5 sites in the United States., Methods: A total of 559 subjects were enrolled for this study: 267 in AF cohort and 292 in the non-AF cohort. AF screening was performed in all subjects by the 2 Omron BPMs and by 1 Microlife BPM (BP 3MX1-3, WatchBP Home A, Microlife Corp.), and a simultaneous 12-lead electrocardiogram (ECG) was recorded for comparison. All 12-lead ECGs were interpreted by a board-certified cardiologist who was blinded to the BPM results. Sensitivity, specificity, and accuracy for the diagnosis of AF were calculated., Results: Omron HEM-7371T1-AZ BPM had sensitivity of 95.1% (95% confidence interval [CI] 91.8%-97.4%), specificity 98.6% (95% CI 96.6%-99.7%), and accuracy of 97.0% (95% CI 95.2%-98.2%). Equivalent results were obtained with the Omron HEM-7371T1-AZAZ BPM. This compared favorably to the Microlife BPM (sensitivity 78.5%, 95% CI 73.1%-83.3%; specificity 97.6%, 95% CI 95.1%-99.0%; accuracy 88.4%, 95% CI 85.5%-91.0%)., Conclusion: These data support both home and professional use of these novel Omron BPMs for the detection of AF., Competing Interests: Disclosures Omron Healthcare provided blood pressure monitors and computers used exclusively to acquire all data for this study; these were returned upon study completion. Omron Healthcare compensated all authors for the administration and oversight of the study protocol, as “Principal Investigators” at their respective institutions. Otherwise, authors have no financial relationship with the sponsor, and no additional conflicts of interest to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

The United States Food and Drug Administration restricts the use of implantable cardiac pressure monitors to patients with New York Heart Association (NYHA) class III heart failure (HF). We investigated whether single-pressure monitoring could predict survival in HF patients as part of a model constructed using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial. We validated survival models in 204 patients, using all-cause 180-day mortality. Two levels of model complexity were tested: 1) a simplified 1-pressure model based on pulmonary artery mean pressure ([PAM]1P) (information obtainable from an implanted intracardiac monitor alone), and 2) a pair of 5-variable risk score models based on right atrial pressure (RAP) + pulmonary capillary wedge pressure (PCWP) ([RAP+PCWP]5V) and on RAP + PAM ([RAP+PAM]5V). The more complex models used 5 dichotomous variables: a congestion index above a certain threshold value, baseline systolic blood pressure of <100 mmHg, baseline blood urea nitrogen level of ≥ 34 mg/dL, need for cardiopulmonary resuscitation or mechanical ventilation, and posttreatment NYHA class IV status. The congestion index was defined as posttreatment RAP+PCWP or posttreatment RAP+PAM, with congestion thresholds of 34 and 42 mmHg, respectively (median pulmonary catheter indwelling time, 1.9 d). The 5-variable models predicted survival with areas under the curve of 0.868 for the (RAP+PCWP)5V model and 0.827 for the (RAP+PAM)5V model, whereas the 1-pressure model predicted survival with an area under the curve of 0.718. We conclude that decongestion as determined by hemodynamic assessment predicts survival in HF patients and that it may be the final pathway for treatment benefit despite improvements in pharmacologic intervention since the ESCAPE trial. [ABSTRACT FROM AUTHOR]

Hypertension is associated with more end-organ damage, cardiovascular events, and disability-adjusted life years lost in the United States compared with all other modifiable risk factors. Several guidelines and scientific statements now endorse the use of out-of-office blood pressure (BP) monitoring with ambulatory BP monitoring or home BP monitoring to confirm or exclude hypertension status based on office BP measurement. Current ambulatory or home BP monitoring devices have been reliant on the placement of a BP cuff, typically on the upper arm, to measure BP. There are numerous limitations to this approach. Cuff-based BP may not be well-tolerated for repeated measurements as is utilized with ambulatory BP monitoring. Furthermore, improper technique, including incorrect cuff placement or use of the wrong cuff size, may lead to erroneous readings, affecting diagnosis and management of hypertension. Compared with devices that utilize a cuff, cuffless BP devices may overcome challenges related to technique, tolerability, and overall utility in the outpatient setting. However, cuffless devices have several potential limitations that limit its routine use for the diagnosis and management of hypertension. The review discusses the different approaches for determining BP using various cuffless devices including engineering aspects of cuffless device technologies, validation protocols to test accuracy of cuffless devices, potential barriers to widespread implementation, and future areas of research. This review is intended for the clinicians who utilize out-of-office BP monitoring for the diagnosis and management of hypertension. [ABSTRACT FROM AUTHOR]

Home health monitoring devices are consumer-grade devices that help to monitor the health of individuals at home. These devices are usually low-cost and easily procurable, and they can be operated by patients or their caretakers with minimal training. However, improper usage of these devices may provide erroneous results, which can lead to an unnecessary hospital visit or teleconsultation. In this article, we discuss the basic technology and proper usage of some of these devices, namely automatic blood pressure monitors, blood glucose monitors, body fat monitors, pulse oximeters, electrocardiographs, digital thermometers, and infrared thermometers. This brief document intends to help primary health care professionals and their patients use these devices.

Objective: Connected blood pressure (BP) monitors provide reliable data when used properly. Our objective was to analyse the engagement of real-world users with self-measurements., Methods: We included adult first-time users of a connected BP monitor from July 2019 to March 2021. They were categorized as persistent users if they continued to use the device between 311 and 400 days after inclusion. We defined a criterion to analyse the timing of self-measurements: at least 12 measurements performed within three consecutive days, at least once every 90 days. Persistent users were clustered by state sequence analysis according to the consistency of their BP monitor measurement timing with this criterion during 1 year of follow-up., Results: Among the 22 177 included users, 11 869 (54%) were persistent during the first year. Their use was consistent with the timing criterion 25% (median) of this time (first and third quartiles: 0%, 50%) and four patterns of use were identified by clustering: 5215 persistent users (44%) only performed occasional sparse measurements, 4054 (34%) complied at the start of follow-up up to eight cumulated months, 1113 (9%) complied at least once during later follow-up up to eight cumulated months, and the remaining 1487 (13%) complied nine or more cumulated months of follow-up., Conclusion: Although connected BP monitors can collect a high volume of data, the real-life timing of self-measurements is far from recommended schedules. We must promote the use of BP monitors as recommended by guidelines and/or learn to analyse more occasional and sparse measurements., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

ABSTRACT Objectives: to characterize oscillometric blood pressure measurement devices for sale in the virtual market and identify which ones have undergone a validation study. Methods: this was a cross sectional study. The search for devices for sale was conducted on websites, and the sample was composed of 137 devices obtained from 644 ads. We conducted a bibliographic survey in five databases and web pages enlisting devices submitted for validation. The Kolmogorov-Smirnov test was used to check data distribution, followed by Mann-Whitney and Kruskal-Wallis tests for comparisons, using the SAS 9.4 program. Results: only 16.7% of the devices were validated. The home devices ranged from USD 10.57 to USD 275.67. Only 102 ads informed the cuff size, with different nomenclatures. Conclusions: most ads contained non-validated devices, which were cheaper. We identified some ads falsely informing validation.

In order to be placed on the market, a medical device must comply with the EU Medical Devices current legislation. Reliable and accurate measurements and continuous monitoring of medical devices are the key to diagnosing the patient condition quickly and taking an appropriate action. Medical Device Directives and Regulations ensure that the product placed on the market is safe and it performs its intention of use. The focus of the paper is on the role of metrology in healthcare and on the new regulatory framework for medical devices. The new Medical Device Regulation (MDR) is replacing the current directives to establish a modernized legislative framework for medical devices. The technical requirements regarding the former and the new legislation are presented. [ABSTRACT FROM AUTHOR]

Objective: A novel automated auscultatory upper-arm cuff blood pressure (BP) monitor for office use (KOROT P3 Accurate, previously InBody BPBIO480KV), which displays Korotkoff sound curves for each BP reading was recently developed. This study investigated whether the review of Korotkoff sound curves by healthcare professionals further improves the accuracy of the device by identifying unreliable BP readings., Methods: Three observers assessed independently the morphology of Korotkoff sound curves of BP measurements obtained during an ISO 81060-2:2018 validation study, and classified them as of good, fair, or poor quality (low amplitude or sound intensity, aberrant morphology, background noise, signal artifact, auscultatory gap, irregular rhythm). The observers were blinded to the study BP measurements., Results: Korotkoff sound curves of 255 BP readings obtained in 85 individuals were analyzed (mean age 57.3 ± 15.0 years, 53 men). Of the SBP readings 80.4/12.2/7.4% were classified as good/fair/poor, and DBP 76.9/12.2/10.9%. Inter-observer agreement in detecting poor-quality curves was 84.7/83.1% (systolic/diastolic). Of poor-quality curves, 10.5/60.7% (systolic/diastolic) clustered in the same individuals. The validation criterion 1 [mean test-reference BP difference ≤5 ± 8 (SD) mmHg] was satisfied for readings with good (0.1 ± 4.9/0.3 ± 3.8 mmHg, systolic/diastolic) and fair-quality curves (-0.4 ± 6.4/0.2 ± 5.0), but not for poor-quality ones (2.7 ± 8.8/3.6 ± 8.1). By excluding poor-quality readings (40 of 255), criterion 1 of the validation study was improved (0.2 ± 4.9/0.2 ± 3.9 versus 0.3 ± 5.5/0.6 ± 4.7 mmHg)., Conclusion: The visual assessment of Korotkoff sounds generated during automated auscultatory BP measurement by the KOROT P3 Accurate professional monitor identifies unreliable readings and further improves the device accuracy., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: We investigated the accuracy of the OMRON HEM-7361T automated oscillometric blood pressure (BP) monitor in the differentiation between atrial fibrillation and sinus rhythm., Methods: An approximately equal number of patients with persistent atrial fibrillation and individuals with sinus rhythm were recruited from outpatients and inpatients of Ruijin Hospital, Shanghai, China. BP was measured three times consecutively with a 30-s interval with the OMRON HEM-7361T automatic electronic BP monitor for atrial fibrillation detection. A hand-held single lead electrocardiogram device was used for simultaneous electrocardiogram recordings., Results: The device accurately identified atrial fibrillation in 100 (99.0%) of the 101 patients, with only 1 patient incorrectly classified as non-atrial fibrillation. The device correctly identified 99 (95.2%) of the 104 participants with sinus rhythm as non-atrial fibrillation, with five participants incorrectly classified as atrial fibrillation. The device had a positive predictive value of 95.2%, negative predictive value of 99.0%, and overall accuracy of 97.1%. Among the six misclassified participants, one with atrial fibrillation had a heart rate of 65 beats/min, and four of the five participants with sinus rhythm had cardiac arrhythmias (atrial or ventricular premature beat in one participants, sinus tachycardia in one participant, and both arrhythmias in one participant)., Conclusion: The OMRON HEM-7361T BP monitor is accurate in the differentiation between atrial fibrillation and sinus rhythm. Whether the device is sufficiently accurate in the differentiation between atrial fibrillation and other cardiac arrhythmias remains under investigation., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Cerebral aneurysm coil embolization is often performed under general anesthesia to prevent patient movement and sudden high blood pressure. However, the optimal anesthetic agent remains uncertain. This study aimed to determine whether maintaining anesthesia with remimazolam in patients undergoing coil embolization could avoid hypotension or hypertension compared to sevoflurane. Methods: Thirty-three adult patients participated in this single-blinded, randomized controlled trial. Patients in Group R were induced and maintained with remimazolam, whereas those in Group S received propofol and sevoflurane. Results: The use of remimazolam significantly reduced the incidence of intraoperative hypotension events (33.3% vs. 80.0%; p = 0.010) but did not change the incidence of hypertension events (66.7% vs. 73.3%; p = 0.690). Patients in Group R maintained a significantly higher range of maximal (100.2 ± 16.6 vs. 88.1 ± 13.5 mmHg; p = 0.037) and minimal (69.4 ± 6.6 vs. 63.4 ± 4.8 mmHg; p = 0.008) mean arterial blood pressure than those in Group S during the intervention. Conclusions: This is the first study to demonstrate the feasibility of maintaining general anesthesia with remimazolam in patients undergoing cerebral aneurysm coil embolization. The findings suggest that remimazolam may maintains better hemodynamic stability, reducing the incidence of hypotensive events without compromising patient safety.

ABSTRACT Objective: to compare blood pressure values obtained by auscultatory and oscillometric methods in different gestational periods, considering cuff width. Method: it is a cross-sectional and quasi-experimental study approved by the Research Ethics Committee. The sample consisted of 108 low-risk pregnant women. Blood pressure measurements were performed in gestational periods of 10-14, 19-22 and 27-30 weeks. Results: The oscillometric device presented values similar to the auscultatory method in systolic blood pressure, but overestimated diastolic blood pressure. Underestimation of blood pressure occurred when using the standard width cuff rather than the correct width cuff in both measuring methods. Conclusion: Verification of brachial circumference and use of adequate cuffs in both methods are indispensable to obtain reliable blood pressure values in pregnant women. We recommend performance of additional studies to evaluate diastolic blood pressure overestimation by the Microlife 3BTO-A.

According to medical studies, cardiovascular diseases are the most common and most important risk factor for mortality and disability in Iran. Hence, the National Blood Pressure Control Program was implemented throughout the country from May 17, 2018 (coinciding with the World Blood Pressure Control Day) to July 6th. One of the important issues in blood pressure screening is the correct diagnosis of high blood pressure according to clinical standards. In this paper, the challenges of "National Blood Pressure Control Program”, has been criticized.

ObjectivesThe purpose of this study was to validate the ScottCare 320 ambulatory blood pressure monitor (ABPM) using both group-level and individual-level validation procedures. The group-level validation followed a modified protocol of the European Hypertension Society's validation protocol. The individual-level validation was conducted to ensure that the monitor is valid from both a research and clinical perspective.MethodsParticipants (n=41) had three simultaneous blood pressure (BP) measurements taken by a trained listener using a mercury column sphygmomanometer and the ScottCare ABPM, which was used to validate the monitor at the group-level and the first half of the individual-level validation (i.e. the difference between the ABPM and auscultatory means for each participant

Home health monitoring devices are consumer-grade devices that help to monitor the health of individuals at home. These devices are usually low-cost and easily procurable, and they can be operated by patients or their caretakers with minimal training. However, improper usage of these devices may provide erroneous results, which can lead to an unnecessary hospital visit or teleconsultation. In this article, we discuss the basic technology and proper usage of some of these devices, namely automatic blood pressure monitors, blood glucose monitors, body fat monitors, pulse oximeters, electrocardiographs, digital thermometers, and infrared thermometers. This brief document intends to help primary health care professionals and their patients use these devices. [ABSTRACT FROM AUTHOR]

The standard method for qualitatively evaluating the dynamic response is to see if the gain of the amplitude spectrum curve approaches 1 (input signal = output signal) over the frequency band of the blood pressure waveform. In a previous report, Watanabe reported that Gardner's natural frequency and damping coefficient, which are widely used as evaluation methods, do not reflect the dynamic response of the circuit. Therefore, new parameters for evaluating the dynamic response of pressure monitoring circuits were desired. In this study, arterial pressure catheters with length of 30, 60, 150, and 210 cm were prepared, and a blood pressure wave calibrator, two pressure monitors with analog output and a personal computer were used to analyze blood pressure monitoring circuits. All data collection and analytical processes were performed using step response analysis program. The gain at 10 Hz was close to 1 and the systolic blood pressure difference was small in the short circuits (30 cm, 60 cm), and the gain at 10 Hz was 1.3-1.5 in the 150 cm circuit and over 1.7 in the 210 cm circuit. The difference in systolic blood pressure increased in proportion to the length of the circuit. It could also be inferred that the gain at 10 Hz should be less than 1.2 to meet a clinically acceptable blood pressure difference. In conclusion, the gain at 10 Hz is sufficiently useful as an indicator to determine the correct systolic blood pressure., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Objective: To determine the accuracy of the KOROT P3 Accurate (previously InBody BPBIO480KV) monitor, an automated auscultatory blood pressure (BP) measuring device developed for professional use, in people with extra-large arms according to the ISO81060-2 2018 protocol., Methods: The KOROT P3 Accurate was tested in 37 subjects with upper-arm circumference ranging from >42 to 53 cm using a mercury sphygmomanometer coupled to a 20 × 40 cm tronco-conical cuff as the reference standard., Results: The mean BP difference between the device and the observers' reference measurements was 1.2 ± 2.0 mmHg for systolic BP and 1.0 ± 2.0 mmHg for diastolic BP. These data were in agreement with criterion 1 of the protocol standard requirements (≤5 ± 8 mmHg). Also criterion 2 was satisfied being the standard deviations ± 1.7 mmHg for systolic BP and ± 1.6 for diastolic BP, well below the maximum values required by the protocol (±6.84/6.87 mmHg). Scatterplots of device-reference systolic and diastolic BP differences showed similar accuracy across the range of participants' BP, arm circumference and upper-arm slant angle., Conclusions: These data show that the KOROT P3 Accurate monitor satisfied the ISO 81060-2:2018 standard requirements in a special population of people with extra-large arms ranging from >42 to 53 cm., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: This study aimed to determine factors associated with changes in adherence to hypertension management (medication adherence and blood pressure control) in respondents with hypertension before and during the COVID-19 pandemic in Bogor city, Indonesia., Methods: An observational study was conducted using two sources of data (before and during COVID-19 pandemic). Data before the pandemic were derived from the 2019 Cohort Study of non-communicable disease risk factors. Data during the pandemic were derived from an online survey conducted in September and October 2020. Information from 880 participants were analyzed. The dependent variable was the change in adherence to hypertension management before and during the COVID-19 pandemic. Multivariate analysis was performed using logistic polynomial regression., Results: Respondents who adhered to hypertension management decreased from 82.0% in 2019 to 47.8% in 2020. The likelihood of non-adherence (respondents who did not adhere to hypertension management both before and during the pandemic) increased in respondents below 55 years old, who did not own any healthcare insurance, who were not obese, and who had no other comorbidities. In the partial adherence group (respondents who did not adhere to hypertension management either before or during the pandemic), we found that most respondents adhered before the pandemic but no longer adhered during the COVID-19 pandemic. We found an increased partial adherence in young and highly educated respondents., Conclusions: Efforts to improve adherence to hypertension management after the COVID-19 pandemic should target those who were young, highly educated, who did not have any healthcare insurance, and who did not perceive themselves as not having comorbidities., Competing Interests: Conflict of interest The authors have no conflicts of interest associated with the material presented in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Purpose: This study aimed to compare non-invasive oscillometric blood pressure (NIBP) measurement with invasive arterial blood pressure (IBP) measurement in patients with sepsis., Methods: We conducted a retrospective study to evaluate the agreement between IBP and NIBP using the Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Paired blood pressure measurements of mean arterial pressure (MAP), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were compared using Bland-Altman analysis and paired Student's t test. We also focus on the effect of norepinephrine (NE) on the agreement between the two methods and the association between blood pressure and mortality during intensive care unit (ICU) stay., Results: A total of 96,673 paired blood pressure measurements from 6060 unique patients were analyzed in the study. In Bland-Altman analysis, the bias (± SD, 95% limits of agreement) was 6.21 mmHg (± 12.05 mmHg, - 17.41 to 29.83 mmHg) for MAP, 0.39 mmHg (± 19.25 mmHg, - 37.34 to 38.12 mmHg) for SBP, and 0.80 mmHg (± 12.92 mmHg, - 24.52 to 26.12 mmHg) for DBP between the two techniques. Similarly, large limits of agreement were shown in different groups of NE doses. NE doses significantly affected the agreement between IBP and NIBP. SBP between the two methods gave an inconsistent assessment of patients' risk of ICU mortality., Conclusion: IBP and NIBP were not interchangeable in septic patients. Clinicians should be aware that non-invasive MAP was clinically and significantly underestimated invasive MAP., (© 2024. The Author(s) under exclusive licence to Japanese Society of Anesthesiologists.)