Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 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.

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 ±â€…15.1 (SD) years, 46 men, arm circumference 32 ±â€…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 ±â€…6.5/3.6 ±â€…5.9 mmHg (systolic/diastolic; threshold ≤5 ±â€…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.

Validation of the oscillometric home blood pressure monitor Braun BUA4000 with wide-range cuff 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.

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 ±â€…16.1 (SD) years, 44 men, arm circumference 31.5 ±â€…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 ±â€…6.4/-0.3 ±â€…6.4 mmHg (systolic/diastolic; threshold ≤5 ±â€…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.

Visual assessment of Korotkoff sounds improves the accuracy of a validated professional automated auscultatory blood pressure monitor KOROT P3 Accurate.

OBJECTIVE: A novel automated auscultatory upper-arm cuff blood pressure (BP) monitor for office use (KOROT P3 Accurate, previously InBody BPBIO480KV), which displays Korotkoff sound curves for each BP reading was recently developed. This study investigated whether the review of Korotkoff sound curves by healthcare professionals further improves the accuracy of the device by identifying unreliable BP readings. METHODS: Three observers assessed independently the morphology of Korotkoff sound curves of BP measurements obtained during an ISO 81060-2:2018 validation study, and classified them as of good, fair, or poor quality (low amplitude or sound intensity, aberrant morphology, background noise, signal artifact, auscultatory gap, irregular rhythm). The observers were blinded to the study BP measurements. RESULTS: Korotkoff sound curves of 255 BP readings obtained in 85 individuals were analyzed (mean age 57.3 ±â€Š15.0 years, 53 men). Of the SBP readings 80.4/12.2/7.4% were classified as good/fair/poor, and DBP 76.9/12.2/10.9%. Inter-observer agreement in detecting poor-quality curves was 84.7/83.1% (systolic/diastolic). Of poor-quality curves, 10.5/60.7% (systolic/diastolic) clustered in the same individuals. The validation criterion 1 [mean test-reference BP difference ≤5 ±â€Š8 (SD) mmHg] was satisfied for readings with good (0.1 ±â€Š4.9/0.3 ±â€Š3.8 mmHg, systolic/diastolic) and fair-quality curves (-0.4 ±â€Š6.4/0.2 ±â€Š5.0), but not for poor-quality ones (2.7 ±â€Š8.8/3.6 ±â€Š8.1). By excluding poor-quality readings (40 of 255), criterion 1 of the validation study was improved (0.2 ±â€Š4.9/0.2 ±â€Š3.9 versus 0.3 ±â€Š5.5/0.6 ±â€Š4.7 mmHg). CONCLUSION: The visual assessment of Korotkoff sounds generated during automated auscultatory BP measurement by the KOROT P3 Accurate professional monitor identifies unreliable readings and further improves the device accuracy.

Validation of a novel professional automated auscultatory upper-arm cuff blood pressure monitor in a general population according to the AAMI/ESH/ISO Universal Standard: KOROT V2 Doctor (InBody BPBIO280KV).

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 ±â€…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 ±â€…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.

A novel professional automated auscultatory blood pressure monitor with visual display of Korotkoff sounds: InBody BPBIO480KV validation according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: A novel automated auscultatory upper arm-cuff blood pressure (BP) monitor (InBody BPBIO480KV) for office use was developed. An electronic stethoscope embedded in the device cuff records the Korotkoff sounds, which are audible to the user and graphically displayed during cuff deflation. Automated BP measurements are provided, while allowing the user to assess the Korotkoff sounds. The device accuracy was tested using 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 fulfil the age, sex, BP, arm circumference and cuff distribution criteria of the Universal Standard in general population using the same arm sequential measurement method. Three cuffs of the test device were used for arm circumference 23-28, 28-35 and 33-42 cm. RESULTS: Data from 85 individuals were analysed [mean age 57.3 ±â€Š15.0 (SD) years, 53 men, arm circumference 23-42 cm]. For validation criterion 1, the mean ±â€ŠSD of the differences between the test device and reference BP readings ( N  = 255) was 0.3 ±â€Š5.5/0.6 ±â€Š4.7 mmHg (systolic/diastolic; threshold ≤5 ±â€Š8 mmHg). For criterion 2, the SD of the averaged BP differences per individual ( N  = 85) was 3.76/3.61 mmHg (systolic/diastolic; threshold ≤6.95/6.91 mmHg). CONCLUSION: The InBody BPBIO480KV device for office use, which provides automated auscultatory measurements while reproducing and displaying the Korotkoff sounds, comfortably fulfilled the AAMI/ESH/ISO Universal Standard requirements in general population and can be recommended for clinical use. The assessment of Korotkoff sounds by healthcare professionals for evaluating the quality of automated measurements requires further evaluation.

Relationship between Short- and Mid-Term Glucose Variability and Blood Pressure Profile Parameters: A Scoping Review.

Background. Increased variability of glucose (GV) and blood pressure (BPV) is linked to a higher risk of macro- and microvascular complications and other hard endpoints. This scoping review aims to summarize the existing evidence regarding the association between the parameters of the blood pressure (BP) profile, especially BPV, with indices of short- and mid-term GV. Methods. A literature search was conducted in the MEDLINE/PubMed, Cochrane, Embase, Web of Science, and Wiley Online Library databases. Results. The main findings of this review are as follows: (i) 13 studies were included, mainly with small sample sizes; (ii) there was a considerable degree of heterogeneity in the characteristics of the study participants (age range, individuals with normoglycemia, type 1 or 2 diabetes, normal BP, or hypertension), as well as in the methodologies (mainly in terms of the duration of the data collection period) and variability indices examined (mean amplitude of glycemic excursions and coefficient of glucose variation most frequently reported); and (iii) the results were heterogeneous regarding the association between GV and the parameters of the BP profile. Conclusions. There is a significant lack of evidence on the association between GV and BPV. Future research implementing a standardized methodology should focus on the determinants, association, and clinical relevance of GV and BPV.