Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2: 2013 standard.

OBJECTIVE: The aim of this study was to validate the TM-2441 ambulatory blood pressure monitoring (ABPM) device using the ISO 81060-2:2013 standard. PARTICIPANTS AND METHODS: Participants were healthy individuals aged more than 12 years who were recruited from among the outpatients and volunteers of Jichi Medical University (Tochigi, Japan). The same-arm sequence protocol (clinical validation) and the opposite-limb simultaneous method (ambulatory validation) from the ISO 81060-2:2013 standard were used. RESULTS: One hundred and seven participants were enrolled; 85 participated in the clinical validation and 35 participated in the ambulatory validation (13 participants were included in both validation protocols). The TM-2441 device performed well against the standard in both the clinical and ambulatory validations; the mean and SD values for the differences between device and observed systolic and diastolic blood pressure values in both tests fulfilled criterion 1 and criterion 2 of the standard. The Bland-Altman plots did not show any systematic variation in the error. CONCLUSION: The TM-2441 ABPM device was accurate and fulfilled all ISO 81060-2:2013 standard requirements for ABPM determination in adults. It is therefore suitable for use for ABPM in adults with hypertension.

Validation of the A&D BP UA-1200BLE device for home blood pressure measurement according to the ISO 81060-2: 2013 standard.

OBJECTIVE: The aim of this study was to validate the UA-1200BLE device using the ISO 81060-2:2013 standard. MATERIALS AND METHODS: Individuals aged more than 12 years were recruited from among the outpatients and volunteers of Jichi Medical University (Tochigi, Japan). Eighty-five patients were included in the final analyses. Validation was performed using the same-arm sequence protocol as per the ISO 81060-2:2013 standard. RESULTS: The device performed well against the standard; the mean and SD values for the differences between device and observed systolic and diastolic blood pressure values fulfilled both criterion 1 and criterion 2 of the standard (criterion 1: -2.62±6.89 and -0.90±6.63 mmHg, respectively; criterion 2: -2.65±5.36 and -0.91±6.12 mmHg, respectively). The Bland-Altman plots did not show any systematic variation in the error. CONCLUSION: The UA-1200BLE device had a high level of accuracy and fulfilled all ISO 81060-2:2013 standard requirements in adults with a wide range of arm circumference measurements. It is therefore suitable as a wireless blood pressure monitoring tool in patients with hypertension.

Novel Triggered Nocturnal Blood Pressure Monitoring for Sleep Apnea Syndrome: Distribution and Reproducibility of Hypoxia-Triggered Nocturnal Blood Pressure Measurements.

Obstructive sleep apnea (OSA) causes blood pressure (BP) surges during sleep, which may lead to increased sleep-onset cardiovascular events. The authors recently developed a triggered nocturnal BP monitoring system that initiates BP measurements when oxygen desaturation falls below a variable threshold. The distribution and reproducibility of hypoxia-triggered nocturnal BP parameters compared with those of fixed-interval nocturnal BP parameters for two consecutive nights in 147 OSA patients (mean age 59.4 years, 86.4% men) were evaluated. The mean and distribution (standard deviation [SD]) of the hypoxia-peak systolic BP (SBP) were significantly greater than that of the mean nocturnal SBP (mean±SD: 148.8±20.5 vs 123.4±14.2 mm Hg, P<.001). The repeatability coefficient (expressed as %MV) of hypoxia-peak SBP between night 1 and night 2 was comparable to that of mean nocturnal SBP (43% vs 32%). In conclusion, hypoxia-peak nocturnal BP was much higher than mean nocturnal BP, and it was as reproducible as mean nocturnal BP.

Research and Development of Information and Communication Technology-based Home Blood Pressure Monitoring from Morning to Nocturnal Hypertension.

Asians have specific characteristics of hypertension (HTN) and its relationship with cardiovascular disease. The morning surge in blood pressure (BP) in Asians is more extended, and the association slope between higher BP and the risk for cardiovascular events is steeper in this population than in whites. Thus, 24-hour BP control including at night and in the morning is especially important for Asian patients with HTN. There are 3 components of "perfect 24-hour BP control": the 24-hour BP level, adequate dipping of nocturnal BP (dipper type), and adequate BP variability such as the morning BP surge. The morning BP-guided approach using home BP monitoring (HBPM) is the first step toward perfect 24-hour BP control. After controlling morning HTN, nocturnal HTN is the second target. We have been developing HBPM that can measure nocturnal BP. First, we developed a semiautomatic HBPM device with the function of automatic fixed-interval BP measurement during sleep. In the J-HOP (Japan Morning Surge Home Blood Pressure) study, the largest nationwide home BP cohort, we successfully measured nocturnal home BP using this device with data memory, 3 times during sleep (2, 3, and 4 am), and found that nocturnal home BP is significantly correlated with organ damage independently of office and morning BP values. The second advance was the development of trigger nocturnal BP (TNP) monitoring with an added trigger function that initiates BP measurements when oxygen desaturation falls below a variable threshold continuously monitored by pulse oximetry. TNP can detect the specific nocturnal BP surges triggered by hypoxic episodes in patients with sleep apnea syndrome. We also added the lowest heart rate-trigger function to TNP to detect the "basal nocturnal BP," which is determined by the circulating volume and structural cardiovascular system without any increase in sympathetic tonus. This double TNP is a novel concept for evaluating the pathogenic pressor mechanism of nocturnal BP. These data are now collected using an information and communication technology (ICT)-based monitoring system. The BP variability includes different time-phase variability from the shortest beat-by-beat, positional, diurnal, day-by-day, visit-to-visit, seasonal, and the longest yearly changes. The synergistic resonance of each type of BP variability would produce great dynamic BP surges, which trigger cardiovascular events. Thus, in the future, the management of HTN based on the simultaneous assessment of the resonance of all of the BP variability phenotypes using a wearable "surge" BP monitoring device with an ICT-based data analysis system will contribute to the ultimate individualized medication for cardiovascular disease.