Ambulatory blood pressure monitoring (ABPM) is recommended for confirming hypertension and assessing out-of-office blood pressure (BP). However, patient burden and device tolerability may limit broader implementation. We compared participant experience with a traditional oscillometric ABPM device and a compact cuff-integrated ABPM. The PRO-BP Study was a pilot randomized crossover study of 20 adults in New York City. Participants completed two 24-h ABPM periods over 7 days using the SpaceLabs 90227 and SOMNOmedics ABPMpro devices. After each period, participants rated comfort, pain, sleep interference, embarrassment, noise, skin irritation, and interference with daytime activities. Both devices achieved guideline-based recording-quality thresholds. Compared with SpaceLabs, ABPMpro was associated with greater comfort [median: 7.0 (interquartile range – IQR: 5.0–8.5) vs. 3.5 (IQR: 2.0–6.5); P = 0.026] and less pain [1.5 (0–3.5) vs. 5.0 (0.5–7.0); P = 0.022]. Other experience ratings did not differ significantly. Participant experience should be considered alongside recording quality when evaluating validated ambulatory BP monitoring technologies.
OBJECTIVE:To validate the accuracy and safety of the Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) manufactured by JOYTECH Healthcare Co., Ltd. for blood pressure (BP) measurement in adolescents and adults with arm circumference 22.0-42.0 cm, in accordance with the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) (ISO 81060-2:2018+Amd 2:2024) international standard. METHODS:A total of 90 subjects were enrolled. Three valid datasets were collected from each subject, yielding 270 datasets for analysis. The mercury sphygmomanometer (reference device) data were used as the gold standard to evaluate whether the accuracy of the test device met the requirements. RESULTS:Based on 270 valid datasets, the mean difference between the test device and the reference device for SBP was -0.49 mmHg (SD = 7.29 mmHg), and for DBP was 1.45 mmHg (SD = 6.14 mmHg), meeting Criterion 1 requirements. Analysis based on individual averages of the 90 subjects showed a mean difference of -0.49 mmHg (SD = 5.57 mmHg) for SBP and 1.45 mmHg (SD = 5.05 mmHg) for DBP, both meeting the requirements of Criterion 2. The device maintained stable measurement performance across different arm circumferences, ages, and BP levels. CONCLUSION:The Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) meets the accuracy and consistency requirements of the AAMI/ESH/ISO (ISO 81060-2:2018+Amd 2:2024) standard for SBP and DBP measurement in adolescents and adults with arm circumference 22.0-42.0 cm. It can be safely and effectively used for BP monitoring in clinical settings and, by extension, is suitable for home use based on its design features and validation performance.
OBJECTIVE:Validation of blood pressure (BP) devices is essential for reliable BP detection in pregnant populations. This study, therefore, set out to assess the measurement performance of the iHealth Track KN-550BT oscillometric upper-arm automated BP monitor for pregnant patients with the standard International Organization for Standardization (ISO) 81060-2:2018+AMD1:2020/AMD2:2024. METHODS:This validation study enrolled a total of 45 pregnant patients. All BP measurements were performed sequentially on the left arm using the ISO unified standardized protocol. Device-reference discrepancies between the tested automated sphygmomanometer and the mercury sphygmomanometer were calculated and evaluated in strict accordance with the ISO standard specifications. RESULTS:The study cohort consisted of 15 normotensive pregnant patients, 15 patients with gestational hypertension, and 15 patients diagnosed with preeclampsia. For the ISO Validation Criterion 1, the mean differences between the test device and mercury standard were -0.90 ± 4.82 mmHg for SBP and -0.91 ± 4.14 mmHg for DBP, respectively. For Criterion 2, the standard deviations of the averaged per-participant differences between device and reference measurements were 3.95 mmHg for SBP and 3.10 mmHg for DBP, respectively. CONCLUSION:The iHealth Track KN-550BT upper-arm oscillometric automated BP monitor fully complies with the requirements of ISO 81060-2:2018+AMD1:2020/AMD2:2024, and can be recommended for clinical application and home self-BP measurement among pregnant patients.
To assess the accuracy of the Microlife WatchBP O3 upper-arm, oscillometric blood pressure (BP) device, suitable for clinic, home, and ambulatory use, in a pregnant population. This device was assessed according to the ISO 81060-2:2018 protocol in 45 pregnant women, including women with gestational hypertension and pre-eclampsia. Two cuff sizes were available for arm circumferences of 22-32 and 32-42 cm. Nine sequential same-arm measurements were obtained from each participant, alternating between the test device and auscultation. Forty-nine women were included, and four were excluded. Data from 45 women, including 14 women with gestational hypertension and 15 women with pre-eclampsia, were analyzed according to the protocol. The mean difference with SDs were 0.6 ± 7.9 mmHg for SBP and 3.4 ± 6.0 mmHg for DBP. The Microlife WatchBP O3 upper-arm, oscillometric BP device passed the criteria of the ISO 81060-2:2018 standard in normotensive pregnant women, women with gestational hypertension, and women with pre-eclampsia.
BACKGROUND:Nocturnal blood pressure patterns reflect autonomic and volume-related stress and may affect outcomes after pulmonary vein isolation (PVI). We examined their association with atrial fibrillation recurrence after PVI using ambulatory blood pressure monitoring (ABPM). METHODS AND RESULTS:We retrospectively studied 74 consecutive patients with preprocedural ABPM. Patients were classified as dipper (≥10% nocturnal systolic blood pressure decline), nondipper (0 to <10%), or riser (nighttime > daytime blood pressure). Recurrence was defined as any documented atrial tachyarrhythmia lasting greater than or equal to 30 s after the 90-day blanking period; episodes beginning during blanking and persisting beyond day 90 were assigned to day 90. Recurrence occurred in 27 patients (36.5%). Pattern distribution differed significantly by recurrence status (P = 0.002), with recurrence rates of 26.1% in dippers, 31.0% in nondippers, and 88.9% in risers. Kaplan-Meier analysis showed significantly lower freedom from recurrence in risers (log-rank P < 0.001). In univariable Cox analysis using dippers as the reference, risers were associated with recurrence (hazard ratio: 9.50, 95% confidence interval: 3.22-27.97; P < 0.001), whereas nondippers were not. In an exploratory multivariable model including nocturnal blood pressure pattern, persistent atrial fibrillation, and age, the riser pattern remained associated with recurrence (hazard ratio: 9.53, 95% confidence interval: 3.00-30.29; P < 0.001). CONCLUSION:The riser pattern on ABPM was associated with early postblanking recurrence after PVI and may provide complementary information for risk stratification.
