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The lack of outcome-driven operational thresholds limits the clinical application of home blood pressure (BP) measurement. Our objective was to determine an outcome-driven reference frame for home BP measurement. We measured home and clinic BP in 6470 participants (mean age, 59.3 years; 56.9% women; 22.4% on antihypertensive treatment) recruited in Ohasama, Japan (n=2520); Montevideo, Uruguay (n=399); Tsurugaya, Japan (n=811); Didima, Greece (n=665); and nationwide in Finland (n=2075). In multivariable-adjusted analyses of individual subject data, we determined home BP thresholds, which yielded 10-year cardiovascular risks similar to those associated with stages 1 (120/80 mm Hg) and 2 (130/85 mm Hg) prehypertension, and stages 1 (140/90 mm Hg) and 2 (160/100 mm Hg) hypertension on clinic measurement. During 8.3 years of follow-up (median), 716 cardiovascular end points, 294 cardiovascular deaths, 393 strokes, and 336 cardiac events occurred in the whole cohort; in untreated participants these numbers were 414, 158, 225, and 194, respectively. In the whole cohort, outcome-driven systolic/diastolic thresholds for the home BP corresponding with stages 1 and 2 prehypertension and stages 1 and 2 hypertension were 121.4/77.7, 127.4/79.9, 133.4/82.2, and 145.4/86.8 mm Hg; in 5018 untreated participants, these thresholds were 118.5/76.9, 125.2/79.7, 131.9/82.4, and 145.3/87.9 mm Hg, respectively. Rounded thresholds for stages 1 and 2 prehypertension and stages 1 and 2 hypertension amounted to 120/75, 125/80, 130/85, and 145/90 mm Hg, respectively. Population-based outcome-driven thresholds for home BP are slightly lower than those currently proposed in hypertension guidelines. Our current findings could inform guidelines and help clinicians in diagnosing and managing patients. [ABSTRACT FROM AUTHOR]

Objective: A novel automated auscultatory upper arm cuff blood pressure (BP) monitor KOROT V2 Doctor (InBody BPBIO280KV) was developed for professional use. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are graphically displayed during deflation allowing visual evaluation by the healthcare professional. The device provides automated measurements of BP and this study evaluated its accuracy., Methods: The requirements of the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 were applied. Participants were recruited to fulfill the age, sex, BP, arm circumference, and cuff distribution criteria of the Universal Standard and its Amendment in a general population using the same arm sequential measurement method. Three cuffs of the test device were tested for arm circumference 23-28, 28-35, and 33-42 cm., Results: Data from 85 individuals were analyzed [mean age: 56.4 ± 16.0 (SD) years, 50 men, arm circumference 23-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was -1.3 ± 6.0/1.5 ± 5.0 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences per individual (N = 85) was 4.61/3.48 mmHg (systolic/diastolic; threshold ≤6.82/6.78 mmHg)., Conclusion: The KOROT V2 Doctor (InBody BPBIO280KV) device for professional use, which provides automated auscultatory measurements with visual display of the Korotkoff sounds, comfortably fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the blood pressure (BP) measurement accuracy of the Braun BUA4000 automated oscillometric upper-arm cuff device for self-home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01., Methods: Participants were recruited to fulfill the age, sex, BP and limb circumference distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. A single wide-range cuff of the test device was used for arm circumference range 22-42 cm., Results: A total of 98 individuals were recruited and 85 were analyzed [mean age 60.3 ± 16.1 (SD) years, 44 men, arm circumference 31.5 ± 5.1 cm, range 22-41.5 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N  = 255) was 0.9 ± 6.4/-0.3 ± 6.4 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N  = 85) was 5.15/5.81 mmHg (systolic/diastolic; threshold ≤6.88/6.95 mmHg)., Conclusion: The Braun BUA4000 automated oscillometric BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in a general population and can be recommended for self-monitoring of BP by patients at home., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: This study evaluated the accuracy of the automated oscillometric upper-arm cuff device AVITA BPM82 intended for home use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01., Methods: Participants were recruited to fulfill the age, sex, blood pressure (BP), and limb distribution criteria of the AAMI/ESH/ISO Universal Standard and its Amendment 1.2020-01 in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-33 (medium) and 33-42 cm (large)., Results: One-hundred-one individuals were recruited and 85 were analyzed [mean age 57.3 ± 15.1 (SD) years, 46 men, arm circumference 32 ± 5.1 cm, range 22.3-42 cm]. For validation Criterion 1, the mean difference ±SD between the test device and reference BP readings (N = 255) was 1.3 ± 6.5/3.6 ± 5.9 mmHg (systolic/diastolic; threshold ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual (N = 85) was 5.70/5.25 mmHg (systolic/diastolic; threshold ≤6.82/5.89 mmHg)., Conclusions: The automated oscillometric home BP monitor AVITA BPM82 comfortably fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and its Amendment 1.2020-01 in a general population and can be recommended for clinical use., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018)., Methods: Subjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large)., Results: A total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic)., Conclusions: The InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor InBody BPBIO750 developed for self-measurement by adults in public spaces (kiosk) according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018)., Methods: Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method., Results: A total of 102 subjects were recruited and 85 were analyzed [mean age 56.7 ± 15.4 (SD) years, 40 men, arm circumference 32.3 ± 5.3 cm, range 22-42 cm]. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.2 ± 6.1/-2.2 ± 5.2 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.00/4.63 mmHg (systolic/diastolic)., Conclusion: The InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use in adults., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The aim of this study was to evaluate the accuracy of the InBody BPBIO250 oscillometric upper-arm professional office blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018)., Methods: Subjects were recruited to fulfil the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large)., Results: Ninety-seven subjects were recruited and 88 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.9 ± 5.9/0.9 ± 4.9 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.78/4.31 mmHg (systolic/diastolic)., Conclusion: The InBody BPBIO250 professional oscillometric device for office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

Objective: To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018)., Methods: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large)., Results: One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic)., Conclusion: The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

Objective: The aim of this study was to assess the accuracy of the single-cuff oscillometric blood pressure (BP) monitor InBody BPBIO320 developed for self-measurement by adults in public spaces according to the 2010 European Society of Hypertension International Protocol (ESH-IP)., Participants and Methods: Adults were recruited to fulfill the ESH-IP requirements. The same-arm sequential BP measurement method was used., Results: A total of 38 participants were recruited and 33 were included in the analysis. The average difference between test and reference BP measurements was-0.4±5.3 (SD)/-0.5±4.6 mmHg (systolic/diastolic). The number of test-reference BP differences within 5, 10, and 15 mmHg was 73, 91, and 98 for systolic BP and 79, 93, and 99 for diastolic. The number of participants with at least two of their three BP differences within 5 mmHg was 28 for both systolic and diastolic BPs. The number of participants with none of their three BP differences within 5 mmHg was 1 for both systolic and diastolic BPs., Conclusion: The InBody BPBIO320 device fulfilled the requirements of the ESH-IP validation protocol and can be recommended for clinical use in adults.

Objective: To assess the accuracy of the professional oscillometric blood pressure (BP) monitor Microlife WatchBP Office in adults and children according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard., Methods: Adults and children (aged 3-12 years) were recruited to fulfil the age, sex, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same-arm sequential BP measurement method. Three cuffs of the test device were used for arm circumferences of 14-22, 22-32 and 32-42 cm., Results: A total of 115 participants were recruited and 88 were included in the analysis (51 adults and 37 children). For criterion 1, the mean±SD of the differences between the test device and reference BP was -1.0±7.0/-4.7±5.4 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference per participant was 5.15/4.77 mmHg (systolic/diastolic)., Conclusion: The professional Microlife WatchBP Office BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard for adults and children and can be recommended for clinical use.

Objective: To assess the accuracy of the iHealth oscillometric ambulatory blood pressure (BP) monitor in adults according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard., Methods: Adults were recruited to fulfil the age, sex, BP and cuff distribution criteria of the ANSI/AAMI/ISO standard using the same-arm sequential BP measurement method. Two cuffs of the test device were used for arm circumferences 22-34 and 30-42 cm., Results: A total of 100 individuals were recruited and 85 were included in the analysis. For validation criterion 1, the mean±SD of the differences between the test device and reference BP was -0.7±6.0/0.7±4.8 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference per participant was 4.72/3.97 mmHg (systolic/diastolic)., Conclusion: The iHealth ambulatory BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard in adults and can be recommended for clinical use.

Objectives: This study describes the development of a new digital sphygmocorder (DS-II), which allows the digital recording and playback of the Korotkoff sounds, together with cuff pressure waveform, and its performance in a pilot validation study., Materials and Methods: A condenser microphone and stethoscope head detect Korotkoff sounds and an electronic chip, dedicated to audio-signal processing, is used to record high-quality sounds. Systolic and diastolic blood pressure (SBP/DBP) are determined from the recorded signals with an automatic beat detection algorithm that displays the cuff pressure at each beat on the monitor. Recordings of Korotkoff sounds, with the cuff pressure waveforms, and the simultaneous on-site assessments of SBP/DBP were performed during 100 measurements in 10 individuals. The observers reassessed the recorded signals to verify their accuracy and differences were calculated., Results: The features of the high-fidelity DS-II, the technical specifications and the assessment procedures utilizing the playback software are described. Interobserver absolute differences (mean±SD) in measurements were 0.7±1.1/1.3±1.3 mmHg (SBP/DBP) with a mercury sphygmomanometer and 0.3±0.9/0.8±1.2 mmHg with the DS-II. The absolute DS-II mercury sphygmomanometer differences were 1.3±1.9/1.5±1.3 mmHg (SBP/DBP)., Conclusion: The high-fidelity DS-II device presents satisfactory agreement with simultaneous measurements of blood pressure with a mercury sphygmomanometer. The device will be a valuable methodology for validating new blood pressure measurement technologies and devices.

Background: Obstructive sleep apnea (OSA) is known to be related to nocturnal blood pressure (BP) and nondipping hypertension. This pilot study evaluated night-time BP assessed using a home monitor in patients with OSA., Participants and Methods: Patients referred to a sleep clinic were subjected to polysomnography, clinic BP measurements, and home BP monitoring using a device that allows daytime (3 days, two duplicate readings per day) and automated night-time BP measurement (3 nights, three readings per night)., Results: Thirty-nine patients were included [72% men, mean age 48.7±10.8 years, clinic BP 131.2±19.6/84.1±11.9 mmHg, apnea-hypopnea index (AHI): 35.2±25.7]. All BP measurements were significantly correlated with the polysomnography indices. There was a consistent trend toward stronger correlations of the night-time diastolic home BP with the AHI (r=0.56), the duration of desaturation (0.53), and the maximum (-0.57) and minimum (-0.48) arterial oxygen saturation (all P<0.001). In stepwise multivariate analysis (independent variables age, sex, body weight, smoking status, and BP parameters), the AHI was associated independently with weight and night-time diastolic home BP (R=0.53)., Conclusion: In patients with OSA, the assessment of night-time BP using a home monitor appears to be feasible and related to the severity of OSA. Given the wide availability of home BP monitoring in clinical practice, this method appears to be useful in the evaluation of BP in patients with OSA.

Background: We evaluated the agreement between office blood pressure (OBP) measured by a mercury sphygmomanometer (Sphyg) and an automatic (Auto) device without any observers, and compared Auto and Sphyg OBP with ambulatory blood pressure (ABP) and home blood pressure (HBP)., Methods: OBP was measured in 75 hypertensive patients at two sites using an automatic monitor without a doctor or a nurse present and by Sphyg during three clinic visits. Between visits, monitoring of ABP and HBP was also performed., Results: The mean Auto OBP was similar to that of Sphyg OBP and the values were closely correlated (intraclass correlation coefficient=0.84 for systolic OBP and 0.91 for diastolic OBP); however, the difference between Auto and Sphyg systolic OBP (1.6 ± 8.2 mmHg) varied by the first office visit, sex, and the site. Auto systolic OBP was lower than both systolic awake ABP (137.1 ± 14.7 mmHg) and HBP (139.2 ± 15.6 mmHg). Auto systolic OBP and Sphyg OBP were similarly correlated with systolic awake ABP (both r=0.59, P<0.001). The mean Auto diastolic OBP was similar to that of Sphyg OBP (81.1 ± 11.3 vs. 80.3 ± 13.3 mmHg, P=0.20, intraclass correlation coefficient=0.91), and diastolic awake ABP and HBP. Auto diastolic OBP and Sphyg OBP were related to diastolic awake ABP (both r>0.68, P<0.001). In multivariable analyses, neither OBP measure was a significantly stronger predictor of out-of-office blood pressure than the other., Conclusion: Auto systolic OBP measured without a doctor or a nurse present was lower than systolic awake ABP and HBP. Auto and rigorously assessed Sphyg OBP had similar means and were similarly related to awake ABP. Auto OBP might be an advantageous alternative to Sphyg measurements in the usual clinic setting.

Objective: Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria., Methods: A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria., Results: Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria., Conclusion: This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

Objective: To perform a systematic review of validation studies of blood pressure measuring devices done using the European Society of Hypertension International Protocol (ESH-IP) since its publication in 2002., Methods: Major aspects of ESH-IP studies are described. A review of the ESH-IP performance, problems and violations in its application, and the effect of applying several more stringent validation criteria in an ESH-IP revision is carried out., Results: From January 2002 to June 2009, 104 validation studies had been conducted using the ESH-IP, 36 using the British Hypertension Society protocol and 28 using the US Association for the Advancement of Medical Instrumentation protocol. Among 78 studies reported up to June 2008, in 66 (85%) the tested device has passed the ESH-IP. In 19 validations a modification of the ESH-IP was performed to adapt for specific study needs (population or device). Protocol violations of the ESH-IP were identified in 23 studies (eight major violations). A test of several arbitrarily chosen changes in the ESH-IP validation criteria applied in the published studies showed the phase 2.1 criterion (BP differences < or =15 mmHg) and the phase 2.2 criteria to be the more stringent., Conclusion: The ESH-IP has succeeded in expanding the validation procedure worldwide by three to four-fold compared with the period before its publication. There is a need for protocol revision aiming to address issues that appeared in published studies, prevent protocol violations, and ensure complete data reporting. Standardization of the ESH-IP validation studies' report and application of more stringent criteria should be considered.

It is common practice to coadminister proton pump inhibitors with aspirin to diminish the risk of upper gastrointestinal bleeding. This is the first study that investigated the potential impact of a proton pump inhibitor on aspirin effects on platelet aggregation. Twenty-four hypertensive subjects eligible for treatment with low-dose enteric-coated aspirin (LDECA) for primary prevention of cardiovascular disease were randomized to receive 100 mg LDECA or 100 mg LDECA plus 30 mg lansoprazole for 4 weeks. Then, participants were crossed over to the alternative regimen for another 4 weeks. Salicylic, gastrin, and pepsinogen I blood level counting were used to ensure adherence to treatment. Platelet aggregation was evaluated by light transmittance aggregometry and PFA100. The LDECA administration reduced arachidonic acid (P < 0.001), collagen (P < 0.01), and epinephrine (P < 0.001) tests. These changes paralleled an increase in collagen/epinephrine duration (P < 0.001) but not in collagen/adenosine diphosphate duration and platelet count. No significant difference was found in any of these platelets' function tests with LDECA alone versus LDECA plus lansoprazole. A significant increase in salicylic levels was observed in patients on LDECA as well as in those on LDECA plus lansoprazole, whereas gastrin and pepsinogen I levels were increased only when lansoprazole was added. These data suggest that the concomitant use of the lansoprazole at 30-mg daily does not influence the long-term effect of LDECA on platelet aggregation. Furthermore, they might imply that an interaction of LDECA with other proton pump inhibitors on platelet aggregation is unlikely.

Objective: To assess the accuracy of oscillometric and auscultatory blood pressure (BP) measurement taken using the professional electronic device Microlife Watch BP Office according to the European Society of Hypertension International Protocol., Methods: Thirty-three participants were included for the assessment of each measurement mode (oscillometric and auscultatory). Simultaneous BP measurements were taken by two observers (mercury sphygmomanometers) four times, sequentially with three measurements taken using the tested device. Absolute observer device BP differences were calculated. For each participant the number of measurements with a difference within 5 mmHg was calculated., Results: In phase 1 the device produced 32, 40 and 40 oscillometric systolic BP (SBP) measurements within 5, 10 and 15 mmHg, respectively and diastolic BP (DBP) 30, 40 and 43 (for auscultatory SBP 29, 42, 45 and DBP 33, 43, 45). In phase 2.1 the device produced 71, 90 and 96 SBP measurements within 5, 10 and 15 mmHg, respectively and DBP 71, 88 and 97 (for auscultatory SBP 72, 96, 99 and DBP 83, 96, 99). Twenty-four participants had at least two of their SBP differences within 5 mmHg and one participant had no difference within 5 mmHg, and DBP 23 and three participants, respectively (for auscultatory SBP 29 and 0 and DBP 29 and 1). Mean SBP difference was -1.4+/-6.3 mmHg and DBP -0.8+/-6.0 mmHg (auscultatory SBP -1.8+/-4.5 and DBP -0.4+/-4.0)., Conclusion: The Microlife Watch BP Office device used in the oscillometric or the auscultatory mode fulfills the validation criteria of the International protocol and therefore can be recommended for clinical use.

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., Design and Functions: 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., Pilot Application Study: 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., Conclusion: 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.

Objective: Assessment of the accuracy of the A&D UM-101 mercury-free professional device for auscultatory blood pressure (BP) measurement according to the European Society of Hypertension International Protocol. Further to auscultation, the device has a button to mark readings during deflation., Methods: Fifteen adults were included in phase 1 and another 18 in phase 2. Simultaneous BP measurements were taken by two observers (connected mercury sphygmomanometers) four times, sequentially with three measurements using the tested device (two connected tested devices, one used with and the other without the mark button)., Results: In phase 1, the device produced 44/45/45 measurements within 5/10/15 mmHg, respectively, for systolic BP (SBP) and 39/43/45 for diastolic (DBP). In phase 2.1, 87/97/99 measurements within 5/10/15 mmHg, respectively, for SBP, and 91/97/99 for DBP (using the mark button 65/93/98 for SBP and 76/96/99 for DBP). In phase 2.2, 29 participants had at least two of their SBP differences within 5 mmHg and none had any differences within 5 mmHg, whereas 32 and none, respectively, for DBP (with mark 24/4 participants for SBP; 29/1 for DBP). Mean SBP differences were -1.5+/-3.5 mmHg and DBP -1.3+/-3.0 (with mark -3.6+/-4.2 and -2.8+/-3.7). The difference in SBP measured by the tested device with versus without using the mark button was 3.0+/-3.3 mmHg (P<0.001) and DBP 1.9+/-2.5 mmHg (P<0.001)., Conclusion: The device comfortably passed the validation protocol requirements. Using the mark button, the device, however, failed to meet the validation criteria. Therefore, it is recommended for clinical use without using the mark button.

Although self-monitoring of blood pressure by patients at home is being widely used in clinical practice, the evidence on its prognostic value is still limited. Five long-term studies with nearly 60,000 patients/year have provided prognostic information for home blood pressure measurements. Differences exist among these studies regarding the population characteristics, the sample size and follow-up, the methodology and protocol for office and home blood pressure measurement and the adjustment procedure for other risk factors. All these studies, nevertheless, showed systolic home blood pressure to be a significant predictor of cardiovascular risk, and three of them also showed prognostic value of diastolic home blood pressure. Moreover, the prognostic value of home blood pressure appeared to be consistently superior to that of conventional office measurements. The prognostic significance of the white coat and the masked hypertension phenomena detected by home measurements were investigated in two studies, one in treated hypertensive patients and another in a general population sample. These studies showed that patients with white-coat phenomenon have similar cardiovascular risk as those with low office and home blood pressure, whereas the masked hypertension phenomenon is associated with high risk as in patients with uncontrolled hypertension. In conclusion, the available evidence suggests that home blood pressure has strong prognostic value, which appears to be superior to that of the conventional office measurements. More outcome studies on the prognostic value of home blood pressure, however, are needed.

Objective: Current guidelines recommend that self monitoring of blood pressure at home should only be performed using validated devices. This study assessed the accuracy of the Microlife WatchBP Home device for self home blood pressure measurement according to the European Society of Hypertension International Protocol., Methods: Thirty-three participants were included (15 in phase 1 and an additional 18 in phase 2). Simultaneous blood pressure measurements were taken by two observers (Y-tube-connected mercury sphygmomanometers) four times sequentially, with three measurements taken using the tested device. Absolute differences between observer and device measurements were classified into three zones (within 5, 10 and 15 mmHg). The number of measurements with a difference within 5 mmHg was calculated for each individual., Results: In phase 1, the device produced 38, 43 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 35, 45 and 45 for diastolic blood pressure. In phase 2.1, the device produced 75, 91 and 97 measurements within 5, 10 and 15 mmHg for systolic, and 74, 93 and 99 for diastolic blood pressure. In phase 2.2, 30 participants had at least two of their differences within 5 mmHg and two participants had no differences within 5 mmHg for systolic blood pressure, whereas for diastolic blood pressure the number of participants were 27 and three, respectively. Mean difference for systolic blood pressure was -0.3+/-5.6 mmHg and for diastolic -2.4+/-4.8 mmHg., Conclusions: The Microlife WatchBP Home device for self home blood pressure measurement fulfills all the validation criteria of the International Protocol and can, therefore, be recommended for clinical use in the adult population.