Validation of two watch‐type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐6410T‐ZM and HEM‐6410T‐ZL

Kuwabara, Mitsuo; Harada, Kanako; Hishiki, Yukiko; Kario, Kazuomi

doi:10.1111/jch.13499

Cited by 100 publications

(80 citation statements)

References 28 publications

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“…Thus, we propose the new definition of the “expected difference” between the two devices in the comparison study is calculated as (SD 2 of device 1 + SD 2 of device 2) 0.5 , where SD is the same SD for the difference between a device and observer BP measurements. In the first validation study of the HeartGuide, performed according to the international ANSI/AAMI/ISO 81060‐2:2013 guideline, the difference in the systolic BP (SBP) between WBPM and the standard auscultation method was −0.9 ± 7.6 mm Hg for the medium‐sized cuff (Criterion 1) . In the validation study of the TM‐2441 (A&D) used in this comparison study, the accuracy was also acceptable (the difference in the SBP between TM‐2441 and the standard auscultation method was −0.8 ± 6.46 mm Hg) (Criterion 1) .…”

Section: Methodsmentioning

confidence: 83%

“…In the first validation study of the HeartGuide, performed according to the international ANSI/AAMI/ISO 81060-2:2013 guideline, the difference in the systolic BP (SBP) between WBPM and the standard auscultation method was −0.9 ± 7.6 mm Hg for the medium-sized cuff (Criterion 1). 10 In the validation study of the TM-2441 (A&D) used in this comparison study, the accuracy was also acceptable (the difference in the SBP between TM-2441 and the standard auscultation method was −0.8 ± 6.46 mm Hg) (Criterion 1). 11 If auscultatory reading is the gold standard, and the SD of differences scores of the two devices is 7.6 and 6.46 mm Hg, then the expected SD of the difference between WBPM and ABPM would be (7.6 2 + 6.46 2 ) 0.5 = 9.97.…”

Section: Definition Of "Expected Difference" In the Comparison Studymentioning

confidence: 80%

“…We used the HeartGuide device cuff size that is appropriate for those with wrist circumferences in the range of 16.0‐19.0 cm (HEM‐6410T), or a larger cuff (HEM‐6410T‐ZL) suitable for those with a wrist circumference of 18.0‐21.5 cm is also available. The “HeartGuide” device was previously validated in the laboratory setting . ABPM was measured by using the TM‐2441 (A&D Company), an automatic oscillometric device with a BP cuff worn on the upper arm.…”

Section: Methodsmentioning

confidence: 99%

“…This device has a position sensor which assesses and ensures that the wrist is appropriately positioned within a range around the heart level during BP measurement (Figure ). The HeartGuide device was recently validated in the laboratory environment according to the protocol from the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060‐2:2013 guideline . However, no study has previously compared the HeartGuide device, or any other wrist‐worn watch‐type oscillometric BP monitoring (WBPM) device, with ABPM, the reference standard, for both office and out‐of‐office settings.…”

Section: Introductionmentioning

confidence: 99%

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The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings

Kario

Shimbo

Tomitani

et al. 2020

J of Clinical Hypertension

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Wearable blood pressure (BP) monitoring devices which measure BP levels accurately both in and out of the office are valuable for hypertension management using digital technology. The authors have conducted the first comparison study of BPs measured by a recently developed wrist‐worn watch‐type oscillometric BP monitoring (WBPM) device, the “HeartGuide,” versus BPs measured by an ambulatory BP monitoring (ABPM) device, A&D TM‐2441, in the office (total of 4 readings alternately measured in the sitting position) and outside the office (30‐minutes interval measurements during daytime) in 50 consecutive patients (mean age 66.1 ± 10.8 years). The 2 BP monitoring devices were simultaneously worn on the same non‐dominant arm throughout the monitoring period. The mean difference (±SD) in systolic BPs (average of 2 readings) between WBPM and ABPM was 0.8 ± 12.8 mm Hg (P = .564) in the office and 3.2 ± 17.0 mm Hg (P < .001) outside the office. The proportion of differences that were within ±10 mm Hg was 58.7% in the office and 47.2% outside the office. In a mixed‐effects model analysis, the temporal trend in the difference between the out‐of‐office BPs measured by the two devices was not statistically significant. In conclusion, the difference between the WBPM and ABPM device was acceptable both in and out of the office.

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Section: Methodsmentioning

confidence: 83%

Section: Definition Of "Expected Difference" In the Comparison Studymentioning

confidence: 80%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings

Kario

Shimbo

Tomitani

et al. 2020

J of Clinical Hypertension

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“…In addition, masked uncontrolled hypertension is a high‐risk condition, and thus the detection of masked hypertension is very important in clinical practice settings. The future of hypertension management in Japan is likely to be based on information and communication technology‐based monitoring devices and wearable technologies …”

Section: Specific Concerns and Perspectives For Hypertension Managemementioning

confidence: 99%

Asian management of hypertension: Current status, home blood pressure, and specific concerns in Japan

Kabutoya

Hoshide

2019

J of Clinical Hypertension

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Hypertension is highly prevalent in Japan, affecting up to 60% of males and 45% of females. Stroke is the main adverse cardiovascular event, occurring at a higher rate than acute myocardial infarction. Reducing blood pressure (BP) therefore has an important role to play in decreasing morbidity and mortality. The high use of home BP monitoring (HBPM) in Japan is a positive, and home BP is a better predictor of cardiovascular event occurrence than office BP. New 2019 Japanese Society of Hypertension Guidelines strongly recommend the use of HBPM to facilitate control of hypertension to new lower target BP levels (office BP < 130/80 mm Hg and home BP < 125/75 mm Hg). Lifestyle modifications, especially reducing salt intake, are also an important part of hypertension management strategies in Japan. The most commonly used antihypertensive agents are calcium channel blockers followed by angiotensin receptor blockers, and the combination of agents from these two classes is the most popular combination therapy. These agents are appropriate choices in South East Asian countries given that they have been shown to reduce stroke more effectively than other antihypertensives. Morning hypertension, nocturnal hypertension, and BP variability are important targets for antihypertensive therapy based on their association with target organ damage and cardiovascular events. Use of home and ambulatory BP monitoring techniques is needed to monitor these important hypertension phenotypes. Information and communication technology-based monitoring platforms and wearable devices are expected to facilitate better management of hypertension in Japan in the future. | 487KABUTOYA eT Al.

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2022

Essential Manual of 24‐Hour Blood Pressure Management

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Validation of two watch‐type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐6410T‐ZM and HEM‐6410T‐ZL

Cited by 100 publications

References 28 publications

The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings

The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings

Asian management of hypertension: Current status, home blood pressure, and specific concerns in Japan

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