OBJECTIVE: A new smartphone app called Anura can measure blood pressure (BP) any time and any place without cuffs or special equipment from video of the face. This study assessed its accuracy in close conformity with the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard for BP measurement devices.
METHODS: We validated Anura in reference to auscultation using a mercury sphygmomanometer and then assessed accuracy against the two accuracy criteria described in the guideline (n = 85 subjects; three measurement pairs per subject).
RESULTS: The mean difference between the Anura measurement and its paired auscultatory reference measurement across all 255 measurement pairs was -0.4 ± 6.7 mmHg for systolic blood pressure (SBP) and 1.2 ± 7.0 mmHg for diastolic blood pressure (DBP). Both are within the acceptable limit of 5 ± 8 mmHg and thus satisfy accuracy criterion 1. When mean differences are averaged for each subject, the mean across all 85 subjects is -0.4 ± 5.8 mmHg for SBP and 1.2 ± 6.7 mmHg for DBP. Both are within acceptable limits (based on the mean difference) and thus satisfy accuracy criterion 2.
CONCLUSIONS: Anura meets ANSI/AAMI/ISO 81060-2:2013 standard with respect to BP measurement accuracy. As the ANSI/AAMI/ISO 81060-2:2013 standard has not been developed for cuffless devices, further research assessing additional accuracy issues specific to such devices is needed.

This study aimed to validate the accuracy of the Omron HEM-9601T, an automatic wrist-type device for self-blood pressure (BP) measurement with a timer function for automatic measurement of nocturnal BP, in the sitting position according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 guidelines, and to assess its performance in the supine position by applying the same protocol as conducted in the sitting position. The mean differences between the reference BPs and HEM-9601T readings were 1.2 ± 6.9/1.1 ± 5.5 mmHg, 2.2 ± 6.5/1.8 ± 5.7 mmHg, 0.1 ± 6.6/1.5 ± 6.2 mmHg, and -0.8 ± 7.2/0.5 ± 6.4 mmHg for systolic BP/diastolic BP for criterion 1 in the sitting position, supine with sideways palm position, supine with upward palm position, and supine with downward palm position, respectively. In addition, the mean differences and their standard deviations for systolic BP and diastolic BP calculated according to criterion 2 in the ANSI/AAMI/ISO 81060-2:2013 guidelines were acceptable in all four positions. In conclusion, the Omron HEM-9601T fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines when used in the sitting position with the wrist at heart level, and its accuracy in the supine position was acceptable and roughly equivalent to that in the sitting position. The wrist-type home BP monitor could be a more suitable tool for repeated nocturnal BP measurements at home than upper-arm devices, and could improve the reliability of diagnosis and management of nocturnal hypertension.

There is growing evidence of the clinical significance of daytime masked hypertension (MHT) and blood pressure (BP) variability (BPV). Recently, watch-type wearable devices for self-BP measurement have become available. Such devices might be promising tools to identify patients with daytime MHT or large BPV in their real-life conditions. The present study aimed to validate the accuracy of the Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL, which are automatic watch-type wearable devices for self-BP measurement, according to the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 guideline. Watches were held with the wrist at heart level. The mean differences between reference BPs and HEM-6410T-ZM readings were -0.9 ± 7.6/-1.1 ± 6.1 mm Hg for systolic BP (SBP)/diastolic BP (DBP) for criterion 1, and -0.9 ± 6.8/-1.1 ± 5.5 mm Hg for SBP/DBP for criterion 2. The mean differences between reference BPs and HEM-6410T-ZL readings were 2.4 ± 7.3/0.7 ± 7.0 mm Hg for SBP/DBP for criterion 1, and 2.4 ± 6.5/0.7 ± 6.5 mm Hg for SBP/DBP for criterion 2. The Omron HEM-6410T-ZM and the Omron HEM-6410T-ZL both fulfilled both validation criteria 1 and 2 of the ANSI/AAMI/ISO 81060-2:2013 guidelines.

The purpose of the present study was to evaluate the performance of the Omron HEM-9600T, an automatic wrist-type device for self BP measurement, in the sitting position with the wrist at heart level and supine position according to the ANSI/AAMI/ISO81060-2:2013 guidelines. In the supine position, we evaluated the device under 3 different conditions: using the supine with sideways palm position, the supine with upwards palm position, and the supine with downwards palm position. After 106 subjects were screened and 21 subjects were excluded, the same 85 subjects (38 men [44.7%] and 47 women [55.3%]) were included in the analyses for each position. The average age of the subjects was 54.5 ± 12.2 years (mean ± SD). The mean wrist circumference was 17.0 ± 2.4 cm. The wrist size distribution fulfilled the requirements of the guidelines. The mean differences between reference BPs and HEM-9600T readings were 1.0 ± 6.7/1.4 ± 5.7 mm Hg, 6.6 ± 7.2/5.5 ± 6.0 mm Hg, 4.8 ± 7.2/4.9 ± 5.8 mm Hg, and 2.1 ± 7.2/2.8 ± 6.8 mm Hg for SBP/DBP in the sitting position, supine with sideways palm position, supine with upwards palm position, and supine with downwards palm position, respectively. In conclusion, the Omron HEM-9600T in the sitting position fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines. On the other hand, the accuracies of HEM-9600T in the supine position differed depending on the positioning of the palm, with only the downwards palm-position measurement fulfilling both validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines.

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.

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Self-monitoring of blood pressure by patients at home (home blood pressure monitoring (HBPM)) is being increasingly used in many countries and is well accepted by hypertensive patients. Current hypertension guidelines have endorsed the use of HBPM in clinical practice as a useful adjunct to conventional office measurements. Recently, a detailed consensus document on HBPM was published by the European Society of Hypertension Working Group on Blood Pressure Monitoring. However, in daily practice, briefer documents summarizing the essential recommendations are needed. It is also accepted that the successful implementation of clinical guidelines in routine patient care is dependent on their acceptance by involvement of practising physicians. The present document, which provides concise and updated guidelines on the use of HBPM for practising physicians, was therefore prepared by including the comments and feedback of general practitioners.

OBJECTIVE: Current guidelines for office blood pressure (BP) measurement recommend mercury devices, both arms measurement in the initial assessment and at least duplicate measurements at follow-up visits. This study presents the design and a pilot application study of an automated device that fulfils American, European, and International guidelines for office BP measurement.
UNASSIGNED: The Microlife WatchBP Office is a professional electronic mercury-free device with three function modes designed for: (a) initial assessment: triplicate automated simultaneous oscillometric both arms measurement at 60-s intervals and when there is a consistent interarm difference more than 20 mmHg systolic and/or more than 10 mmHg diastolic, the arm with the higher BP is indicated. (b) Follow-up assessment: triplicate automated oscillometric single arm measurements at 60-s intervals and their average is displayed. (c) Auscultatory measurement: by an observer using a stethoscope and a digital countdown BP display for patients with arrhythmias and other individuals in whom the oscillometric measurement is not accurate.
UNASSIGNED: The \'initial assessment\' mode was applied by three physicians in 63 patients (189 readings). Average interarm systolic BP difference was 0.04+/-5.1 mmHg and diastolic 0.4+/-3.2 mmHg. A value more than 10 mmHg interarm difference in nine systolic BP readings (5%) and three (2%) diastolic. No patient had a consistent interarm difference more than 10 mmHg in all three or two of the three readings.
CONCLUSIONS: The Microlife WatchBP Office professional device fulfils current international requirements for office BP measurement and seems to overcome several limitations of this method when applied in clinical practice.