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Original Article

Accuracy of fully automated oscillometric central


aortic blood pressure measurement techniques
Michael Gotzmann a, Maximilian Hogeweg b, Felix S. Seibert c, Benjamin Johannes Rohn c,
Martin Bergbauer b, Nina Babel c, Frederic Bauer c, Andreas Mügge a, and Timm H. Westhoff c

traditionally measured at peripheral arteries. However,


Background: Central aortic blood pressure (cBP) is a because of pulse pressure amplification, peripheral blood
valuable predictor of cardiovascular risk. The lack of fully pressure does not represent central blood pressure. In
automated measurement devices impeded an recent years, there is increasing evidence that central aortic
implementation in daily clinical practice so far. The present blood pressure (cBP) might be superior to peripheral BP in
study compares two novel automated oscillometric devices the prediction of cardiovascular events [2,3]. The close
with invasively measured cBP. association of cBP with target organ damage and cardio-
Methods: From March 2017 to March 2018, we enrolled vascular risk has anatomical reasons: both coronary and
consecutive patients undergoing elective coronary carotid arteries arise from the proximal aorta. The ASCOT
angiography to this cross-sectional study. Noninvasive and its substudy CAFE demonstrated that the differential
assessment of cBP was performed by the SphygmoCor effect of antihypertensive drugs on cBP and peripheral BP
XCEL device and the Mobil-O-Graph NG device may to some extent explain differences in their effects on
simultaneously to invasive measurement. cardiovascular events [4,5].
Results: Our study included 502 patients (228 women, In the 1990s, first noninvasive tonometric techniques
274 men) with a mean age of 67.9  11.6 years. The emerged that detected the peripheral arterial pressure
noninvasive measurement of cBP was successful in 498 waveform and calculated cBP after additional measurement
patients (99%) with SphygmoCor XCEL device and in 441 of peripheral BP. Comparative analyses showed a satisfying
patients (88%) with Mobil-O-Graph NG device (P ¼ 0.451). agreement with invasively measured cBP [6,7] For two
Measurements of both devices revealed a high correlation reasons, however, these systems never proceeded to daily
to invasively measured systolic (SphygmoCor R2 0.864, clinical practice. First, because of their high price and
P < 0.001; Mobil-O-Graph R2 0.763, P < 0.001) and second, because the procedure is time consuming and
diastolic (SphygmoCor R2 0.772, P < 0.001; Mobil-O-Graph requires well trained medical staff. Therefore, efforts have
R2 0.618, P < 0.001) cBP. Both devices slightly been made to perform pulse contour analysis in an oscil-
underestimated systolic and overestimated diastolic central lometric instead of a tonometric manner and thereby to
blood pressure: biases were 5.0  7.7/0.5  6.2 mmHg integrate it into automated cuff-based peripheral BP mea-
with SphygmoCor XCEL and 6.0  10.4/3.6  8.3 mmHg surement. Some first systems are now commercially avail-
with Mobil-O-Graph NG device. Correlations (R2) were able [8], but data on the accuracy of the systems compared
higher and biases were lower with the SphygmoCor device with the invasive measured cBP are scarce. Therefore, the
(P < 0.001 each). present study compares cBP measured noninvasively by
the SphygmoCor XCEL device (AtCor Medical, Sydney,
Conclusion: The present study is the largest validation
Australia) and Mobil-O-Graph NG device (I.E.M., Stolberg,
study of noninvasive cBP measurement techniques so far
Germany) device to invasively measured aortic BP patients
and shows that two current automated oscillometric
undergoing coronary angiography.
monitors are able to assess cBP with acceptable accuracy.
Automated oscillometric devices may facilitate the
implementation of cBP in daily clinical practice.
Keywords: central aortic blood pressure, hypertension,
measurement, oscillometric Journal of Hypertension 2019, 37:000–000
a
University Hospital St Josef Hospital Bochum, Cardiology, Ruhr University Bochum,
Abbreviations: ASCOT, Anglo-Scandinavian Cardiac b
Department of Internal Medicine, Marien Hospital Witten, Witten and cUniversity
Outcomes Trial; CAFÉ, Conduit Artery Functional Endpoint; Hospital Marien Hospital Herne, Medical Department 1, Ruhr University Bochum,
cBP, central aortic blood pressure Herne, Germany
Correspondence to Timm H. Westhoff, MD, University Hospital Marien Hospital
Herne, Ruhr-University Bochum, Medical Department I, Hölkeskampring 40, 44625
Herne, Germany. Tel: +49 2323 499 1671; fax: +49 2323 499 3302; e-mail:
INTRODUCTION timm.westhoff@elisabethgruppe.de
Received 3 January 2019 Revised 28 June 2019 Accepted 8 August 2019

H
ypertension is a cardiovascular risk factor of out- J Hypertens 37:000–000 Copyright ß 2019 Wolters Kluwer Health, Inc. All rights
standing importance and accounts for up to 50% of reserved.
vascular risk [1]. Blood pressure (BP) has been DOI:10.1097/HJH.0000000000002237

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METHODS detected from the central pressure waveform and an aver-


age central pressure is calculated. The maximum and
Study population minimum of the average central pulse represent the average
From March 2017 to March 2018, we enrolled consecutive central SBP and DBP, respectively. In addition, all of the
patients undergoing elective coronary angiography to this central pulse wave analysis parameters are calculated from
cross-sectional study. Inclusion criteria were indication for the average central pressure pulse.
an elective coronary angiography, informed consent and
age at least 18 years. Instable angina, instable hemodynam- Process of familiarization with the equipment
ics, myocardial infarction, and a stenosis of the radial or Before the start of the study, an introduction was given to
brachial artery were defined as exclusion criteria. Invasive the devices by experienced investigators. The practical
and noninvasive blood pressure measurements were per- application was tested on 20 healthy individuals and the
formed according to the recommendations of the ARTERY measurements were repeated three times. Also, five meas-
Society Consensus statement on protocol standardization urements were taken in the cardiac catheter laboratory
[9]. Written informed consent was obtained from all partic- prior to the start of the study to ensure correct simultaneous
ipants before inclusion in the study. The study was measurement of invasive and noninvasive blood pressures.
approved by the local ethics committee of the Ruhr Univer- The invasive measurement was performed by experienced
sity Bochum (reg. number 16–5759). examiners who had performed more than 1000 cardiac
catheterizations.
Devices for noninvasive blood pressure
measurement Premeasurement examinations
For this study, the following devices were used for nonin- The medical history and blood pressure medication were
vasive blood pressure measurement: SphygmoCor XCEL registered the day before the cardiac catheter examination.
device (software version 1.2, AtCor Medical) and Mobil-O- Blood was taken from all patients for routine laboratory
Graph NG device (software version HMS CS 5.1; I.E.M.). examination and ECG and echocardiography were per-
The Mobil-O-Graph (software version HMS CS 5.1; formed. For analysis in this study, atrial fibrillation was
I.E.M.) is a noninvasive blood pressure recording device. diagnosed when this atrial fibrillation occurred during
Oscillometric signals from the brachial artery are captured invasive and noninvasive measurement of central blood
using an inflatable cuff that is connected to a pressure pressure, regardless of previous episodes of paroxysmal or
sensor. The device records pulse wave oscillations in order persistent atrial fibrillation.
to provide systolic, diastolic and mean blood pressure
values after a stepwise deflation process of the cuff. Cali- Study setting
bration is performed using systolic and diastolic pressure. The hemodynamic study was performed in the cardiac
This system calculates central blood pressure, aortic pulse catheterization laboratory. Care was taken to minimize
wave velocity and additional central hemodynamic indices, disturbing influences during the examination. The meas-
all based on the oscillometric recording of pulse waves at urements were performed on supine patients. The circum-
the brachial artery site. In a first step, the recorded pulse ference of the patient’s middle upper arm was measured
waves are checked for their plausibility and qualified with the enclosed device tape measures. The cuff sizes were
according to predefined quality criteria. Once the input selected according to the upper arm circumference (Mobil-
signal has qualified as acceptable, the concepts of wave O-Graph NG device: XS 14–20 cm, S 20–24 cm, M 24–
harmonics and Fourier analysis are applied for the calcula- 32 cm, L 32–38, XL 38–55 cm; SphygmoCor XCEL device:
tion of an aortic pressure curve. In parallel, an aortic flow adults 23–33 cm, adults large 31–40 cm, adults extra large
curve is derived, by means of a modified Windkessel 38–50 cm).
model. Consecutively, the pressure and flow curves are
superimposed in a virtual model. The mathematical model Invasive assessment of central aortic blood pressure
applied by the Mobil-O-Graph system is based on the Before the measurements, the patients lay on the examina-
equations as set forth by Moens-Korteweg and subse- tion table in a quiet position for at least 10 min. A 5-French
quently further developed by Bramwell-Hill, dealing with sized sheath was inserted via femoral artery or radial artery.
the interrelation of velocity and wall elasticity in a In some patients (n ¼ 15), it was necessary to administer
closed system. 0.04 mg nitroglycerin immediately after positioning the
The SphygmoCor XCEL (software version 1.2, AtCor radial sheath. In this case, at least 5 min passed between
Medical) measures brachial blood pressure using the stan- administration of the vasoactive substance and data acqui-
dard cuff oscillometeric method (NIBP) to determine bra- sition. Patients were asked not to speak during the measure-
chial SBP and DBP, which are used for calibration. After the ments. Measurements were taken before contrast agent was
cuff deflates to zero pressure, the cuff inflates again to a set applied. No vasoactive substances or contrast agents were
pressure below brachial DBP. The device measures the cuff administered during the measurement. The guiding cathe-
oscillations that represent the brachial volume displace- ter used was 5-French Cordis infiniti trulumen (Cordis
ment waveform. The recorded brachial cuff waveform is Corporation, Miami Lakes, Florida, USA; length 100 cm,
calibrated to brachial SBP and DBP. Then the calibrated inner diameter 0.97 mm). Under fluoroscopic control, the
brachial waveform is converted to a calibrated central catheter was positioned in the aorta ascendens, about 1 cm
pressure waveform using a transfer function that represents above the aortic valve. The catheter was connected using
the harmonics ratio between the two pulses. Pulses are three taps and connectors to the measuring system

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Accuracy of central aortic blood pressure measurement techniques

(Schwarz GmbH & Co. KG, Kamen, Germany). The pres- TABLE 1. Clinical characteristics of study patients
sure transducer was attached to the patient’s heart by a fixed All patients (n ¼ 502)
suspension and remained there throughout the examina-
Age (years) 67.9  11.6
tion. Blood was then aspirated to remove any air bubbles
Female sex (n, %) 228 (45)
from the catheter. The catheter was then flushed with 10 ml BMI (kg/m2) 29  5.9
physiological saline solution and the measuring system was SBP (mmHg) 145  22
zeroed and calibrated. The natural frequency was con- DBP (mmHg) 80.2  14.6
firmed to be greater than 20 Hz, and the damping coeffi- Left ventricular ejection fraction (%) 54.3  12.4
cient was not less than 0.3. The procedure was repeated Hypertension (n, %) 454 (91)
Hypercholesterolemia (n, %) 356 (71)
when there was evidence of a damped curve. The mea-
Active smoker (n, %) 145 (29)
surement of systolic and diastolic central blood pressure Previous smoker (n, %) 103 (21)
values was digitally recorded. The data of at least 10 heart- Diabetes mellitus (n, %) 133 (26)
beats were averaged. Coronary artery disease (n, %) 287 (57)
Atrial fibrillation (n, %) 135 (27)
Noninvasive assessment of central aortic blood
pressure
The noninvasive blood pressure measurements were per- two-tailed t tests (for normally distributed variables) or a
formed under hemodynamically stable conditions by the Mann–Whitney U test (for nonnormally distributed varia-
SphygmoCor XCEL device and the Mobil-O-Graph NG bles), whenever appropriate. Dichotomic parameters were
device simultaneously and with the invasive central blood compared by chi-square test (Fisher’s exact test for inde-
pressure measurements. The sequence of the noninvasive pendent samples). P < 0.05 was regarded significant.
devices alternated randomly. In the noninvasive and inva-
sive examinations runs of bigeminy, trigeminy, or isolated
premature beats and the following compensatory beats
RESULTS
have been removed from analysis. In some cases, the Table 1 presents the epidemiological and medical charac-
devices reported error messages so that a sufficiently accu- teristics of the study population. Mean age was 67.9  11.6
rate central blood pressure measurement was not possible. ranging from 34 to 92 years. Three hundred and sixty-five
In these cases, the measurement was repeated a second patients (71%) had sinus rhythm, 135 (27%) suffered from
time with the device and, if necessary, a third time. If the atrial fibrillation at the time of the measurement procedure.
third measurement was also unsuccessful, no further Concomitant diseases constituted coronary artery disease
attempts were made. These measurements were defined (n ¼ 287, 57%), peripheral occlusive disease (n ¼ 45, 16%),
as ‘unsuccessful measurement’. and hypertension (n ¼ 454, 91%). The median number of
The recommendations of the ARTERY Society regarding antihypertensive drugs was ranging from 0 to 6, and con-
the sample characteristics and the statistical requirements tained diuretics, calcium-channel blockers, b-blockers, ACE
were fulfilled in this study [9]. inhibitors, AT1 blockers, alpha blockers, mineralocorticoid-
antagonists, and hydrazinophthalazine (Supplement Table
Statistics 1, http://links.lww.com/HJH/B145).
Results are presented as mean  standard deviation (SD) in The invasive measurement of aortic blood pressure was
case of normal distribution. Continuous variables without performed in all patients as part of the cardiac catheter
normal distribution are presented as median (first quartile, examination. The simultaneous measurement of the non-
third quartile). Pearson correlation analyses were per- invasive central blood pressure using the SphygmoCor
formed for noninvasive vs. invasive values. Fisher’s z XCEL device was successful in 498 of 502 patients (99%).
was calculated to compare the correlation coefficients. Measurements using Mobil-O-Graph NG device were suc-
Moreover, comparison of systolic and diastolic central cessful in 441 of 502 patients (88%; P ¼ 0.451). In the
blood pressure values of the two test devices and the remaining patients, no values could be determined even
simultaneous invasively assessed reference cBP was per- after the third measurement.
formed by Tukey mean-difference plots (Bland–Altman Measurement failure (unsuccessful measurement or
plots). In accordance with Krouwer [10], the x-axis presents extreme outliers in the Bland–Altman plot) occurred in
the results of the invasive measurement as the gold standard 10 patients examined with the SphygmoCor XCEL device
method. Bias and the limits of agreement (bias and in 94 patients examined with Mobil-O-Graph NG
2  standard deviation) are reported. For the calculation device. Patients with measurement failure and successful
of the extreme outliers on Bland–Altman plot, the upper examination were compared in clinical characteristics. The
and lower quartiles (Q1 and Q3) of the systolic and diastolic results are presented in Supplement Tables 2 (http://link-
bias were calculated. A point beyond an outer fence (lower s.lww.com/HJH/B145) and 3 (http://links.lww.com/HJH/
outer fence: Q1  3  interquartile range, upper outer B145). In SphygmoCor XCEL device the invasive diastolic
fence: Q3 þ 3  interquartile range) was considered an central blood pressure was significantly lower in the group
extreme outlier. Extreme outliers in the Bland–Altman plot with measurement failure than in the group of patients with
(systolic or diastolic bias) and unsuccessful measurement successful measurement. In Mobil-O-Graph NG device, the
were considered as measurement failure. SBP was significantly higher and atrial fibrillation occurred
Comparison of each method’s findings in patients with more frequently in the group with measurement failure
and without atrial fibrillation was performed by unpaired compared with the patients with successful measurement.

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TABLE 2. Results of simultaneous measurement of invasive and noninvasive central blood pressure with the SphygmoCor XCEL and
Mobil-O-Graph NG device
SphygmoCor measurements (n ¼ 498) Mobil-O-Graph measurements (n ¼ 441)
Invasive systolic cBP (mmHg) 131  21 Invasive systolic cBP (mmHg) 132  21
Invasive diastolic cBP (mmHg) 76.4  11.9 Invasive diastolic cBP (mmHg) 77.8  11.8
Noninvasive systolic cBP (mmHg) 127  20 Noninvasive systolic cBP (mmHg) 126  20
Noninvasive diastolic cBP (mmHg) 77  13 Noninvasive diastolic cBP (mmHg) 81.4  13.8

only the data from successful measurements of noninvasive devices are presented. cBP, central blood pressure.

Table 2 provides mean invasively and noninvasively the correlation coefficients in systolic and diastolic cBP
assessed cBP values. The performance of the different were significantly higher for the SphygmoCor XCEL device
noninvasively cBP measurement techniques was analyzed compared with the Mobil-O-Graph NG device (P < 0.001
using two different approaches: correlations between inva- each).
sively and noninvasively measured values, assessment of In the overall study population, the mean systolic bias of
bias and limits of agreement in a Bland–Altman analysis. SphygmoCor XCEL device to invasively assessed cBP was
Figure 1 illustrates the correlations between invasively 5.0  7.7 mmHg. The systolic bias of the Mobil-O-Graph
and noninvasively measured values. Correlations were NG device was slightly but significantly larger
highly significant for both SBP and DBP with both devices (6.0  10.4 mmHg, P ¼ 0.011). The diastolic bias of Sphyg-
(P < 0.001 each). With each device, correlation coefficients moCor XCEL device was significantly lower than the Mobil-
were higher for systolic than for diastolic cBP. Furthermore, O-Graph NG device bias (0.5  6.2 vs. 3.6  8.3 mmHg;

FIGURE 1 Relationship between systolic and diastolic central blood pressure comparing measurements of SphygmoCor device and Mobil-O-Graph device and invasively
measured central blood pressure in the overall study population (patients with and without atrial fibrillation).

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Accuracy of central aortic blood pressure measurement techniques

FIGURE 2 Tukey mean-difference plots (Bland–Altmann plots) of systolic and diastolic central blood pressure comparing SphygmoCor device and Mobil-O-Graph device to
the goldstandard of invasively measured central blood pressure in the overall study population (patients with and without atrial fibrillation). Dotted lines provide mean bias
and 95% limits of agreement (2 standard deviation).

P < 0.001). Figure 2 provides the corresponding Tukey did not signficantly change the systolic bias of the Mobil-O-
mean-difference plots including bias and limits of agree- Graph NG device (6.2  12.3 mmHg, P ¼ 0.862) or the
ment (95% confidence interval, 2 standard deviation). diastolic bias (4.7  9.6 mmHg; P ¼ 0.095). Figure 4 pro-
In a second approach, we investigated the impact of vides the corresponding Tukey mean-difference plots.
atrial fibrillation on the accuracy of noninvasive cBP mea-
surement. The corresponding correlation analyses are DISCUSSION
shown in Fig. 3. Systolic and diastolic R2 values did not
significantly differ from those of the overall study popula- Until recently, noninvasive cBP measurement was not
tion with the SphygmoCor device (P ¼ 0.220 and P ¼ 0.750, possible in an automated manner and necessitated an
respectively), and with the Mobil-O-Graph device observer trained in applanation tonometry. The present
(P ¼ 0.062 and 0.224, respectively). In analogy to the overall study shows that the cBP values obtained by automated
study population, systolic and diastolic correlation coeffi- oscillometric cuff-based pulse contour analysis highly cor-
cients were higher in SphygmoCor device compared with relate to invasive measurements. The noninvasive devices
Mobil-O-Graph device in patients with atrial fibrillation thereby slightly underestimate systolic and slightly overes-
(P ¼ 0.003 and 0.002, respectively). The mean systolic bias timate diastolic cBP. This inaccuracy (systematic underesti-
of SphygmoCor XCEL device (5.7  8.9 mmHg) was mation of SBP but overestimation of DBP) has been
almost identical to that of the overall study population described before and may be the consequence of the
(P ¼ 0.191), whereas it increased by 1 mmHg diastolic calibration method [11]. In the present study, both devices
(1.5  6.9 mmHg, P ¼ 0.042). In analogy, atrial fibrillation made use of a traditional calibration based on SBP and DBP.

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FIGURE 3 Relationship between systolic and diastolic central blood pressure comparing measurements of SphygmoCor device and Mobil-O-Graph device and invasively
measured central blood pressure in patients with atrial fibrillation.

This method, however, may underestimate true systolic With a number of 502 participants, the current study is
brachial and thereby true systolic cBP. In the meantime, the largest validation study of noninvasive cBP measure-
an alternative calibration using mean instead of SBP has ment techniques so far [6]. There are some validation
become available for the Mobil-O-Graph. There are some studies on the prior SphygmoCor system using applanation
hints that this calibration may indeed lead to a further tonometry [14–16]. To the best of our knowledge, there are
increase of the device’s accuracy [12]. only one small invasive validation study on the current
The mean differences of 5–6 mmHg in systolic and 1– oscillometric SphygmoCor device (36 patients) [17] and one
4 mmHg in diastolic cBP in our study appear acceptable small study on the Mobil-O-Graph (30 individuals) [18]. In
from a clinical point of view. Nevertheless, our findings the latter study, the device underestimated invasively mea-
should encourage manufacturers to adapt their general sured central BP by 3 mmHg. Noteworthy, the manufacturer
transfer functions. Mean biases in systolic and diastolic modified the transfer function since the publication of this
cBP were slightly but significantly lower for SphygmoCor report. The present study thereby constitutes the first vali-
XCEL compared with Mobil-O-Graph NG (P ¼ 0.011 and dation study of the device in its current form. Noteworthy,
P < 0.001, respectively). The separate analysis of those our study reveals still an underestimation of systolic cBP.
patients in the upper and lower quartiles (outliers) identi- The SphygmoCor device showed a slightly but significantly
fied a low diastolic (SphygmoCor XCEL) and a high systolic higher accuracy in the estimation of systolic and diastolic
cBP (Mobil-O-Graph) as risk factors for an inaccurate cBP compared with the Mobil-O-graph device regarding
measurement. A high SBP and a low DBP are indicators both correlation and biases.
of increased aortic stiffness and isolated systolic hyperten- A recent review on the accuracy of noninvasive mea-
sion. We have previously demonstrated that the accuracy of surement techniques identified 22 eligible studies, which
BP measurement is reduced in this population [13]. validated 11 different commercial devices in 808 study

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Accuracy of central aortic blood pressure measurement techniques

FIGURE 4 Tukey mean-difference plots (Bland–Altmann plots) of systolic and diastolic central blood pressure comparing SphygmoCor device and Mobil-O-Graph device to
the goldstandard of invasively measured central blood pressure in patients with atrial fibrillation. Dotted lines provide mean bias and 95% limits of agreement (2 standard
deviation).

participants. [6]. The number of 502 in the present study cardiovascular endpoints made use of brachial and not cBP
constitutes the largest study population investigated so far. so far. The present oscillometric technology could be easily
The vast majority of validation studies in this review used implemented in cardiovascular large-scale studies. These
applanation tonometry for pulse wave analysis. The mean studies could investigate, whether cBP is indeed superior to
error in the estimation of systolic cBP was 4.5 mmHg. brachial BP in the prediction of cardiovascular endpoints.
Thus, the diagnostic accuracy of the present two oscillo- The most crucial limitation of the present study is a
metric devices was almost exactly as accurate than the potential selection bias. Comparison of noninvasively vs.
traditional tonometric devices. A measurement procedure invasively measured aortic BP was performed in patients
takes about 1–2 min including both peripheral BP mea- undergoing cardiac catheterization and not in healthy indi-
surement and pulse wave analysis. This time is only slightly viduals. The same is true for prior validation studies and the
longer than a standard BP measurement, and may therefore majority of the manufacturers’ approaches in the develop-
facilitate an integration in daily clinical practice. The auto- ment of the devices. This limitation is inevitable to avoid
mated procedure does not necessitate an intense training of aortic catheterization of healthy probands. Noteworthy, 159
staff anymore and the results are far less observer-depen- patients (32%) of the present study population with pre-
dent than previous tonometric approaches, which required served left ventricular ejection fraction and no severe heart
placement of the tip of a hand-held high-fidelity tonometer valve disease turned out to have an unremarkable coronary
on the patient’s artery. status. The mean systolic/diastolic biases in this subgroup
Despite the increasing data on the prognostic value of were 4.1  6 mmHg/0.1  6.2 mmHg for the SphygmoCor
cBP, its measurement is not recommended by current device and -4.7  7.6 mmHg/2.4  6.7 mmHg for the Mobil-
hypertension guidelines [19,20]. This decision is mainly O-Graph device. Thus, the present selection bias may be of
based on the fact that randomized controlled trials with subordinate clinical relevance.

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The present study shows that two current automated 7. Cheng HM, Lang D, Tufanaru C, Pearson A. Measurement accuracy of
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