Upper-arm Blood Pressure Monitor Research Articles

IMPACT OF OCCUPATIONAL NOISE ON THE CIRCULATORY SYSTEM OF WORKERS IN A TYPICAL FLOATING PRODUCTION VESSEL

This study investigates the possible impacts of occupational noise exposure on the circulatory system of workers in a typical floating, production, storage and offloading (FPSO) unit in the Niger Delta Offshore work environment in Nigeria. The VLIKE iiVL6708 digital sound level meter was used to measure noise levels at 2-hour interval overianii8-houriiworkday. OMRON-10iiSeries iiBP7450 Upper Arm Blood Pressure monitor was used to measure arterial blood pressure i(systolic and diastolic) and pulse rate of work before and after exposure for 8-hour workday.

Validation of the ANDON KD-595 automated upper-arm blood pressure monitor according to the universal standard.

To validate the ANDON KD-595 automated upper-arm blood pressure monitor for clinical use and self-measurement blood pressure measurement according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Same left-arm blood pressure was sequentially measured in 90 qualified adult participants and compared with a standard mercury sphygmomanometer. A total of 270 comparison pairs were obtained and analyzed according to the universal standard. For the validation Criterion 1 of the universal standard, the mean ± SD of the differences between the test device and reference blood pressure readings was 0.96 ± 5.35 and 0.82 ± 5.08 mmHg for SBP and DBP, respectively. For Criterion 2, the SDs of the averaged blood pressure differences between the test device and reference blood pressure per subject were 4.84 and 4.64 mmHg (with maximum allowed SDs of 6.87 and 6.89 mmHg) for SBP and DBP, respectively. The ANDON KD-595 automated upper-arm blood pressure monitor passed all the validation requirements according to the AAMI/ESH/ISO Universal Standard and can be recommended for clinical use and self-measurement blood pressure measurement in the general population.

Validation of the iHealth Track upper-arm blood pressure monitor KN-550BT in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020).

To validate the iHealth Track KN-550BT oscillometric upper-arm blood pressure monitor in general population according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020). Participants were recruited and the same left-arm sequential method was used for blood pressure measurement according to the ISO 81060-2:2018+AMD1:2020. The validation results were assessed following the protocol and the Bland-Altman scatterplot was used to show the difference between the test device and reference results. A total of 89 qualified participants were included in the final analysis. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference readings was -1.22 ± 5.76 mmHg and -0.08 ± 4.40 mmHg for systolic and diastolic blood pressure, respectively. For Criterion 2, the mean ± SD of the differences between the test device and reference readings per participant was -1.22 ± 5.06 mmHg and -0.08 ± 3.84 mmHg for systolic and diastolic blood pressure, respectively. The iHealth Track KN-550BT upper-arm blood pressure monitor passed all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018+AMD1:2020) and can be recommended for clinical use and self-measurement in general population.

Validation of the JOYTECH DBP-6279B blood pressure monitor in adults and adolescents according to the AAMI/ESH/ISO universal standard(ISO 81060-2:2018 + Amd.1:2020).

This study aimed to validate the accuracy of DBP-6279B, an automated inflationary oscillometric upper-arm blood pressure (BP) monitor, in the sitting position according to the AAMI/ESH/ISO (81060-2 : 2018 + Amd.1 : 2020) universal standard protocol. SBPs and DBPs were measured simultaneously on the same arm in 88 adults (female : male = 47 : 41) with a mean age of 56.85 years using a mercury sphygmomanometer (two observers) and a DBP-6279B device (one supervisor). The AAMI/ESH/ISO 81060-2 : 2018 and Amd.1 : 2020 universal standards for the validation of BP-measuring devices in adults and adolescents were followed. A total of 259 valid pairs of data were used in the analysis. According to Criterion 1, the mean difference of SBP between the test device (DBP-6279B) and the reference device (the mercury sphygmomanometer) was 0.75 mmHg, with a SD of 7.66 mmHg. The mean difference in DBP was 1.13 mmHg, with a SD of 6.14 mmHg. The mean difference of both SBP and DBP was less than 5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, the mean difference of SBP between the test device and the reference device was 0.85 mmHg, and the SD was 6.56 mmHg, which was less than 6.88 mmHg and met the requirements. The mean difference in DBP was 1.27 mmHg, and the SD was 5.42 mmHg, which was less than 6.82 mmHg and met the requirements. DBP-6279B fulfilled the requirements of the AAMI/ESH/ISO universal standard (ISO 81060-2 : 2018 + Amd.1 : 2020); hence, it can be recommended for both clinical and self/home BP measurement in adults and adolescents.

Validation of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) and the International Organization for Standardization Amendment 1. 2020.

To evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure (BP) monitor in general population (for clinic and home BP measurements in adults) 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. Subjects were recruited to fulfill the age, sex, 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 circumferences 22-32 cm (standard) and 22-45 cm (wide range). Ninety-two subjects were recruited and 85 subjects were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.3 ± 7.2/2.2 ± 5.5 mmHg (systolic/diastolic). For validation criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 6.1/4.8 mmHg (systolic/diastolic). The YuWell YE660D oscillometric upper-arm electronic BP monitor has passed the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its Amendment 1. 2020 in adults and hence can be recommended for home and clinical use.

Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013.

To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013). BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22-42 cm. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1 ± 5.49/2.9 ± 5.17 mmHg (systolic/diastolic) for adults; and -2.2 ± 5.93/1.5 ± 4.92 mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20 mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96. The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.

Effect of the inferior alveolar nerve block injection versus maxillary infiltration with two local anesthetic agents on cardiovascular parameters: A randomized comparative double-blind clinical trial

Abstract This study aimed to assess the effect of inferior alveolar nerve (IAN) block of the mandible and infiltration anesthesia of the maxilla using lidocaine plus epinephrine or prilocaine with felypressin anesthetic agents on systolic and diastolic blood pressures, heart rate (HR) and peripheral oxygen saturation rate of patients. This randomized double-blind clinical trial evaluated 112 patients in four groups (n=28) based on the jaw (maxilla or mandible) and type of anesthetic agent (lidocaine with epinephrine or prilocaine with felypressin). Groups 1 and 2 received IAN block of the mandible or infiltration anesthesia of the maxilla, respectively, with 2% lidocaine plus 1:80.000 epinephrine. Groups 3 and 4 received IAN block of the mandible or infiltration anesthesia of the maxilla, respectively, using prilocaine with felypressin. Systolic and diastolic blood pressures and HR were measured by an automatic upper arm blood pressure monitor and the percentage of peripheral oxygen saturation rate was measured by a finger pulse oximeter 10 minutes before the injection, immediately after injection, 10 minutes after injection and 20 minutes after injection. The mean diastolic blood pressure showed a greater reduction following the administration of lidocaine with epinephrine, as compared with prilocaine with felypressin (p<0.001). The mean HR showed a significantly greater increase following the administration of lidocaine with epinephrine, as compared with prilocaine with felypressin (p<0.001). The effect of type of anesthetic agent on diastolic blood pressure depended on the type of injection (p=0.033). Administration of 2% lidocaine with 1:80.000 epinephrine, in comparison to prilocaine with felypressin, can cause changes in cardiovascular parameters such as heart rate and diastolic blood pressure in patients undergoing restoration of a maxillary or mandibular molar tooth. Type of injection has no significant effect on cardiovascular parameters.

Assessing Variability in Vascular Response to Cocoa With Personal Devices: A Series of Double-Blind Randomized Crossover n-of-1 Trials.

Controlled clinical intervention studies have demonstrated that cocoa flavanols (CF) can decrease blood pressure and arterial stiffness in healthy humans, although a large variability in the effect size across trials has been reported. In this study, we evaluated the intra- and inter-individual variability of responses to CF in everyday life using a series of n-of-1 trials in healthy free-living individuals with normal blood pressure carrying personal devices. In total, eleven healthy young humans participated in a repeated crossover randomized controlled double-blind n-of-1 trial. On 8 consecutive days, each volunteer consumed on alternating days 6 CF capsules (862 mg CF) on 4 days and 6 matched placebo capsules (P, 0 mg CF/day) on another 4 days in one of the two randomized sequences (CF-P-CF-P-CF-P-CF-P or P-CF-P-CF-P-CF-P-CF). On each day, the capsules were taken at the same time in the morning with breakfast after baseline measurements. Each subject was provided with an upper arm blood pressure monitor and a finger clip that measures pulse wave velocity (PWV). Measurements of blood pressure, heart rate, and PWV were taken at least hourly over 12 h during the day by the participants. On the first 2 days, measurements were performed under supervision to provide training. The overall mixed model analysis showed that CF significantly decreased 12-h systolic blood pressure and PWV by −1.4 ± 0.3 mmHg and −0.11 ± 0.03 m/s, respectively. Peak effects were observed within the first 3 h (1.5 h SBP: −4.9 ± 2.2 mmHg, PWV: −0.32 ± 0.17 m/s) and again after 8 h post-ingestion. Large inter-individual variation in responses was found [intra-cluster correlation coefficients (ICC): 0.41, 0.41]. When analyzing single individuals’ datasets, there was also considerable between-day variation in individual responses that varied greatly between subjects (ICC: 0–0.30, 0–0.22, 0–0.45). Effect sizes inversely correlated with baseline blood pressure values both between- and within-subjects. The data confirm that cocoa can decrease blood pressure and arterial stiffness in everyday life when elevated within the normal range. The large inter- and intra-individual variation in responses calls for more personalized nutritional intervention strategies.

Validation of the G.LAB MD41A0 upper arm blood pressure monitor in patients with diabetes mellitus according to the AAMI/ESH/ISO 81060-2:2018 Universal Standard.

The objective of this study is to determine the accuracy of the G.LAB MD41A0 upper-arm oscillometric blood pressure (BP) monitor for self/home BP measurement in patients with diabetes 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). Patients with diabetes were recruited according to AAMI/ESH/ISO Universal Standard using the same arm sequential BP measurement method. The standard cuff of the test device was used for arm circumference 22-44 cm. A total of 92 patients with diabetes were recruited and 85 were analyzed with an average age of 55.1 ± 17.7 years, 48 men, and arm circumference of 32.0 ± 6.0 cm. For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.89 ± 6.04/-0.84 ± 5.11 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.23/4.19 mmHg (systolic/diastolic). The G.LAB MD41A0 upper arm BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in patients with diabetes and can be recommended for self/home use.

Prevalence and control of hypertension among people living with HIV receiving care at a Nigerian hospital

Introductionwith the introduction of newer and safer antiretroviral drugs, HIV positive persons are now living longer. Consequently, cardiovascular diseases associated with ageing and chronic low grade inflammation due to the presence of the virus are increasingly found in this population. This study aimed to assess the prevalence and control of hypertension among people living with HIV (PLHIV) receiving care at a Nigerian hospital.Methodsthis cross-sectional study was conducted as part of the Patient´s HIV Knowledge Questionnaire (PHKQ) validation study among HIV positive outpatients at the University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria. Hypertension was self-reported and confirmed by a documented physician diagnosis in the patient´s case notes and/or self-reported use of antihypertensive medication. For each participant, the average of two close blood pressure (BP) measurements obtained using an automatic upper arm BP monitor was taken as the BP. Hypertension control was defined as SBP <140 mmHg and DBP <90 mmHg. Data were analysed using the Statistical Product and Service Solutions (SPSS) v.21.0. Results were considered significant at p < 0.05.Resultsprevalence of hypertension among PLHIV was 24.9%. Age (OR = 1.112, CI = 1.074 – 1.151, p < 0.001), body mass index (OR = 1.087, CI = 1.024 – 1.154, p = 0.004) and duration on antiretroviral therapy (OR = 1.169, CI = 1.090 – 1.254, p < 0.001) significantly predicted hypertension. Only 19 (24.4%) participants had controlled hypertension.Conclusionhypertension is common among PLHIV seeking care at a Nigerian hospital. However, its control remains suboptimal. Regular screening for hypertension, its appropriate treatment and optimal control are essential in PLHIV.

Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol.

Aim of this study was to validate the Microlife BP B3 AFIB/enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060-2:2019 in adolescents and adults from a general population. BP measurements on the upper arm were performed in 85 subjects (age range 12-88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer. A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and -0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and -0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg). The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 protocol and can be recommended for home BP measurements in adolescents and adults.

Validation of the PHILIPS DL8760 upper arm blood pressure monitor, in oscillometry mode, for self-measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to determine the accuracy of the PHILIPS DL8760, an oscillometric blood pressure (BP) measuring device designed for self-measurement in the general population according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The PHILIPS DL8760 measures BP at the brachial level. The validation was performed in 33 subjects. The mean age of the participants was 55.8 ± 14 years. SBP 146.1 ± 26 mmHg (range: 103-193), DBP was 86.8 ± 17.0 mmHg (range: 47-123), and arm circumference was 28.3 ± 4.0 cm (range: 22-39). The PHILIPS DL8760 fulfilled the criteria of the ESH-IP by passing phases one and two for both SBP measurements and DBP measurements. The device overestimated SBP by 1.5 ± 5.0 mmHg and underestimated DBP by 0.7 ± 3.9 mmHg. The PHILIPS DL8760 BP device, with its specially designed cuff covering a broad range of arm circumferences, fulfilled the requirements of the International Protocol Revision 2010.

Validation of Omron HEM-7600T, a wearable device for monitoring blood pressure, according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 protocol in the general population without arrhythmias.

The present study aimed to evaluate the accuracy of the Omron HEM-7600T automated oscillometric upper-arm blood pressure (BP) monitor according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol. We recruited individuals until we obtained 86 eligible participants whose BP levels and ranges of arm circumference met the BP distribution requirements specified by the ANSI/AAMI/ISO. In each individual, we sequentially measured systolic and diastolic blood pressures (DBPs) using a mercury sphygmomanometer (two observers) and the HEM-7600T device (one supervisor) in the left upper arm. Data analysis was performed according to the ANSI/AAMI/ISO guidelines. A total of 101 individuals were recruited, and 86 were finally included in the analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP was -0.6 ± 6.6/1.0 ± 6.5 mmHg (systolic/diastolic). The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 86 participants was -0.6 ± 5.65 mmHg for systolic blood pressure and 1.0 ± 5.96 mmHg for DBP, fulfilling criterion 2 with an SD of ≤6.91 mmHg for systolic blood pressure and ≤6.87 mmHg for DBP. The Omron HEM-7600T BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation protocol in adults and can be recommended for home BP measurements.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010: Erratum.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010: Erratum.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol: Erratum

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol: Erratum

Validation of the Globalcare GCE603 automated blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

To evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor Globalcare GCE603 for home BP monitoring according to the International Protocol of the European Society of Hypertension (ESH) revision 2010. BP was sequentially measured in 33 adult participants and compared with a standard mercury sphygmomanometer. A total of 99 comparison pairs were obtained and analyzed according to the ESH international protocol. For the 33 eligible participants, the device achieved 80/99, 98/99 and 99/99 measurements of absolute differences between device and observers within 5, 10 and 15 mmHg for systolic BP (SBP) and 87/99, 98/99 and 99/99 for diastolic BP (DBP), respectively. The average device-observer difference was 1.01 ± 4.11 mmHg for SBP and -0.69 ± 3.56 mmHg for DBP, respectively. The number of participants with two or three of the device-observer difference within 5 mmHg was 28 for SBP and 30 for DBP, and there was no subject with none of the device-observer difference within 5 mmHg. According to the validation results on the basis of the ESH international protocol revision 2010, the Globalcare GCE603 automated upper-arm BP monitor can be recommended for home measurement in general population.

Validation of the Rossmax AC1000f upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol.

To evaluate the accuracy of the Rossmax AC1000f oscillometric upper-arm blood pressure monitor in adults according to the British Hypertension Society Protocol. Eighty-five subjects (male 42 and female 43) with a mean age of 48.1 years were recruited to fulfill the blood pressure distribution criteria of the British Hypertension Society Protocol in general population using the same arm sequential blood pressure measurement method. For each subject, we sequentially measured blood pressure using a mercury sphygmomanometer (two observers) and the AC1000f device (one supervisor). Data analysis was carried out according to the British Hypertension Society Protocol. A total of 255 comparison pairs were obtained for analysis. The device achieved grade A. The percentage of blood pressure differences within 5, 10 and 15 mmHg was 66.7, 92.2 and 98.0%, respectively, for SBP, and 64.7, 90.2 and 98.4%, respectively, for DBP. The average (±SD) of the device-observer differences was -0.5 ± 6.0 mmHg for SBP and -1.4 ± 5.9 mmHg for DBP, respectively. The automated upper-arm blood pressure monitor Rossmax AC1000f has passed the requirements of the British Hypertension Society Protocol, and hence can be recommended for blood pressure measurement in adults.

Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor HL868ED for clinical use and self-measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressure were measured sequentially in 43 adult Chinese (21 women, mean age 51.7 years) using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). A total of 99 pairs of comparisons were obtained from 43 participants for judgements in two parts with three grading phases. The HL868ED device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10 and 15 mmHg was 68/99, 91/99 and 97/99, respectively, for systolic blood pressure and 85/99, 95/99 and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-four and 30 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). Three participants for systolic and one participant for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The Health & Life blood pressure monitor HL868ED has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurements in adults.

QardioArm Upper Arm Blood Pressure Monitor Against Omron M3 Upper Arm Blood Pressure Monitor in Patients With Chronic Kidney Disease: A Validation Study According to the European Society of Hypertension International Protocol Revision 2010.

BackgroundHypertension is considered as a main risk factor for chronic kidney disease development and progression. Thus, the control and evaluation of this disease with new software and devices are especially important in patients who suffer from chronic kidney disease.ObjectiveThis study aimed to validate the QardioArm mobile device, which is used for blood pressure (BP) self-measurement in patients who suffer from chronic kidney disease, by following the European Society of Hypertension International Protocol 2 (ESH-IP2) guidelines.MethodsA validation study was carried out by following the ESH-IP2 guidelines. A sample of 33 patients with chronic kidney disease self-measured their BP by using the QardioArm and Omron M3 Intellisense devices. Heart rate (HR), diastolic BP, and systolic BP were measured.ResultsThe QardioArm fulfilled the ESH-IP2 validation criteria in patients who suffered from chronic kidney disease.ConclusionsThus, this study is considered as the first validation using a wireless upper arm oscillometric device connected to an app to measure BP and HR meeting the ESH-IP2 requirements in patients who suffer from chronic kidney disease. New validation studies following the ESH-IP2 guidelines should be carried out using different BP devices in patients with specific diseases.

P60 Invasive Validation of Antares, a New Algorithm to Calculate Central Blood Pressure from Oscillometric Upper Arm Pulse Waves

BackgroundAntares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure monitors in order to estimate central (aortic) blood pressure (cBP). Antares aims to enable brachial cuff-based blood pressure (BP) monitors to be type II-devices, determining absolute cBP values independently of potential peripheral BP inaccuracies. The present study is an invasive validation of the Antares algorithm.MethodsWe followed entirely the 2017 ARTERY protocol for validation of non-invasive cBP devices, the 2013 ANSI/AAMI/ ISO 81060-2 and 2018 AAMI/ESH/ISO validation standard protocols. In total, 191 patients undergoing cardiac catheterization were included, of which 145 patients entered analysis. Invasive cBP recordings were prospectively compared to simultaneous non-invasive cBP estimations using Antares, integrated into an oscillometric BP monitor. Antares analyses pulse waves during deflation of the cuff (patent of Redwave Medical GmbH). Generally speaking, pulse waves of a normal oscillometric BP measurement are taken for PWA with no need for altering standard BP pump operation.ResultsMean difference between invasive and non-invasively estimated systolic cBP was 0.71 mmHg with standard deviation of 5.95 mmHg, fulfilling the highest validation criteria. Bland-Altman plot reveals good limits of agreement.ConclusionAntares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols including criteria for high accuracy devices. The Antares algorithm turns the oscillometric upper arm blood pressure monitor into a type II-device for estimation of true cBP. Integration of Antares into BP monitors could enable the measurement of PWA parameters in virtually every practice in future.Bland altman of estimated vs. invasive central SBP