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ORIGINAL ARTICLE
Validation of Central and Peripheral Non-Invasive Hemodynamic
Variables Using an Oscillometric Method
Darı
´o Echeverri
1
•Alejandro Pizano
1
•Jaime Cabrales
1
•Karen Moreno
2
Received: 19 August 2017 / Accepted: 21 October 2017 / Published online: 28 October 2017
ÓSpringer International Publishing AG 2017
Abstract
Introduction Peripheral and central blood pressures are
parameters of arterial stiffness and important cardiovas-
cular risk markers. Today, there are non-invasive methods
that measure these pressures.
Aim To validate the non-invasive oscillometric method,
compared with invasive pressure measurements obtained
by cardiac catheterization.
Methods An open, prospective cohort clinical study in 100
patients, 64 ±11 years old. The measurement of peripheral
and central blood pressures obtained using the Arteri-
ograph
Ò
system oscillometric method, (TensioMed,
Budapest-Hungary, Ltd.) was validated in an adult popu-
lation undergoing simultaneous, contralateral left cardiac
catheterization (gold standard) using the radial technique,
evaluating the correlation and agreement between the two
methods. This study fulfils the latest standardized protocol
for central blood pressure validation published by
ARTERY Society.
Results The pressures obtained with the Arteriograph
Ò
show a high correlation with the pressures measured using
the gold standard. Overall, the intraclass correlation coef-
ficient for brachial pressures was 0.80 (p\0.001), and 0.91
(p\0.001) for central pressures. The good agreement
between the two methods was demonstrated equally by the
Bland-Altman method and independent linear regressions
for each variable.
Conclusions The oscillometric noninvasive method
employed is easy to use and valid for estimating hemo-
dynamic variables such as central and peripheral arterial
pressure, having good agreement and conformity with the
gold standard in a different type of patients and conditions.
This technique can help optimize cardiovascular assess-
ment in primary and secondary prevention, enhance treat-
ment in selected patients and it could be an important
element for future cardiovascular prevention.
Keywords Arterial stiffness Blood pressure Cardiac
catheterization Cardiovascular prevention
1 Introduction
In the last few years, the measurement of large artery
stiffness and central blood pressure (BP) as a determining
factor in the development of cardiovascular complications
has become important. Various physiological and patho-
physiological conditions have been shown to be associated
with increased arterial stiffness [1]. Arterial stiffness is a
cumulative measurement of the harmful effects of different
conditions on the arterial wall [2,3]. Currently, many
studies in patients with uncomplicated essential hyperten-
sion [4,5], type 2 diabetes mellitus [6], end stage renal
disease [7], elderly subjects [8,9] and the general popu-
lation, have prospectively validated central blood pressure
[10]. The independent predictive value of arterial stiffness
has also been demonstrated for functional neurological
outcome following a cerebrovascular accident [11]. Arte-
rial stiffness or central BP are a robust predictive factor of
cardiovascular mortality, fatal and nonfatal coronary
&Alejandro Pizano
apizanou@gmail.com
1
Vascular Function Research Laboratory, Interventional
Cardiology Department, Fundacio
´n CardioInfantil-Instituto
de Cardiologı
´a, Calle 163 A nu
´mero 13B-60, Torre H. 3 Piso,
Bogota
´, Colombia
2
Research Department, Fundacio
´n CardioInfantil-Instituto de
Cardiologı
´a, Bogota
´, Colombia
High Blood Press Cardiovasc Prev (2018) 25:65–77
https://doi.org/10.1007/s40292-017-0238-8
events, and fatal cerebrovascular accidents [12,13]. Like-
wise, it has been shown that patients with an intermediate
cardiovascular risk could be reclassified into a category of
higher or lower cardiovascular risk, when arterial stiffness
is quantified [10,14,15].
Currently, the European Society of Cardiology (ESC)
guidelines for people at intermediate risk recognize the
added value of central BP for patient stratification [16].
Furthermore, it should be considered for hypertensive
(Class IIa/B Recommendation) [17]), and may add pre-
dictive value to the estimation of the usual diabetic risk
[18]. On the other hand, it is not recommended in the
American College of Cardiology and American Heart
Association (ACC/AHA) directives for evaluating cardio-
vascular risk in asymptomatic adults (Class III/ B recom-
mendation) [19]. Its usefulness for primary and secondary
prevention of cardiovascular disease has a IIa/A level
recommendation [2].
BP measurement with a brachial cuff may overestimate
cardiovascular risk. Central aortic BP predicts mortality,
and could be a better method for patient management.
Sharman et al. [20] determined the usefulness of central BP
measurement for guiding the treatment of arterial hyper-
tension, using fewer medications to achieve BP control,
without adverse effects on left ventricular mass, aortic
stiffness, or quality of life. The European Society of
Hypertension and ESC have published recommendations
for the assessment of total cardiovascular risk [16–18].
These directives recognize that central aortic pressure, as
the BP exerted on the heart and brain, may be different
from the pressure measured in the arm [21]. They recog-
nize that central pressure may be a predictive measurement
of outcomes in specific populations.
A wide variety of invasive and noninvasive methods for
measuring arterial stiffness have been described. The most
widely used and validated techniques involve noninvasive
assessment (Arteriograph
Ò
oscillometric method, Sphyg-
moCor
Ò
-tonometric method, and Complior
Ò
-piezoelectric
method) of the pulse waves as they travel through a sig-
nificant portion of the arterial tree. To date, four studies
have compared the Arteriograph
Ò
oscillometric method
with applanation tonometry and piezoelectric methods
[22–25].
Considering the available evidence, the objective of our
study was to validate the results of central and peripheral
AP measurements obtained using the Arteriograph
Ò
(TensioMed, Budapest, Hungary, Ltd.) oscillometric
method, and those simultaneously obtained invasively
using a catheter placed in the ascending aorta and in the
contralateral brachial artery, in patients undergoing cardiac
catheterization, using a radial technique as the entry point.
2 Methods
2.1 Study Design
An open, prospective cohort clinical study to evaluate the
validity of central and peripheral pressure measurements
obtained using the oscillometric method via the Arteri-
ograph
Ò
(TensioMed, Budapest-Hungary, Ltd.) system, in
an adult population undergoing simultaneous left heart
catheterization, satisficing the mandatory recruitments of
the latest standardized protocol for central blood pressure
validation published by ARTERY Society [26].
2.2 Inclusion Criteria
Patients over the age of 18, both male and female, under-
going clinically indicated left heart catheterization using
the transradial approach and only coronary angiography.
Table 1 Demographic data of the patients whose brachial and central
arterial pressures were measured with both methods simultaneously
(invasive vs. non-invasive)
Variable Sample (n=100)
Age (years)
b
63.5 (16)
BMI (kg/m
2
)
a
26.1 ±3.8
Cardiovascular history N=93
Cardiovascular medication use N=79
Coronary artery disease N=63
Diabetes mellitus type II N=26
Arterial hypertension N=61
Dyslipidemia N=34
Atrial fibrillation N=15
Valvular heart disease
Mild N=30
Moderate N=7
Severe N=12
BMI body mass index
a
Results expressed as mean ±standard deviation
b
Results expressed as median (interquartile range)
Table 2 Comparison of the non-invasive oscillometric method (Ar-
teriograph
Ò
) to the gold reference, invasive method (intra-aortic
catheter)
Variable ICC pvalue
Peripheral pressures 0.80 \0.001
Central pressures 0.91 \0.001
ICC intraclass correlation coefficient
66 D. Echeverri et al.
Table 3 Comparison of the
non-invasive oscillometric
method (Arteriograph
Ò
) to the
gold reference, invasive method
(intra-aortic catheter)
Variable Non-invasive Invasive DICC pvalue Min–Max
SAP-B
b
137.5 (26) 145.0 (28) 4.5 (12) 0.96 \0.001 100–215
DAP-B
a
79.5 ±12.1 74.6 ±11.1 -5.0 ±7.5 0.89 \0.001 46–109
PP-B
b
57.5 (20) 69.0 (29) 12 (17) 0.81 \0.001 36–143
MAP-B
a
100.0 ±13.9 100.6 ±13.5 0.6 ±6.4 0.94 \0.001 73–140
HR
a
71.4 ±13.3 72.4 ±13.4 0.8 ±2.2 0.99 \0.001 42–103
SAP-C
a
139.1 ±26.6 139.6 ±25.9 0.5 ±4.8 0.99 \0.001 94–217
DAP-C
a
80.0 ±12.3 78.4 ±11.4 -1.7 ±7.1 0.90 \0.001 44–116
PP-C
b
56.6 (27) 56.5 (28) 2.3 (10) 0.97 \0.001 24–131
MAP-C
a
99.7 ±15.4 102.5 ±14.2 2.7 ±6.0 0.96 \0.001 73–148
Ddifference between the two methods, ICC intraclass correlation coefficient, Min minimum value, Max
maximum value, Bbrachial or peripheral, Caortic or central, SAP systolic arterial pressure, DAP diastolic
arterial pressure, PP pulse pressure, MAP mean arterial pressure, HR heart rate
a
Mean ±standard deviation
b
Median (interquartile range)
Fig. 1 Comparison between the
central systolic pressure
measured invasively with an
intra-aortic catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the central
pressure measured invasively by
the catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 67
2.3 Exclusion Criteria
Patients with conditions that do not allow the simultaneous
measurement of central and peripheral parameters by car-
diac catheterization and the Arteriograph
Ò
: subclavian and/
or humeral artery stenosis, cardiogenic shock, aortic dis-
section, coarctation of the aorta, mastectomy, pacemaker
implantation in the previous seven days, significant inter-
arm differences, severely impaired left ventricular systolic
function, constrictive pericarditis, pericardial tamponade,
use of vasoactive drugs and use of large amount of contrast
dye ([80 ml).
2.4 Equipment Used
The routine equipment, catheters and techniques used in
the Hemodynamics Department’s clinical practice were
used during the cardiac catheterization: meticulously han-
dled fluid-filled radial diagnostic catheters,
OPTITORQUE
Ò
, Tiger (5 French/1.70 mm or 6 French/
2.00 mm, length 100–110 cm), Terumo Medical Corpora-
tion, New Jersey, United States. The study never changed
the indication or technique, or put the patient at risk.
Neither was a larger dose of contrast media or radiation
employed, and no additional consumables were used out-
side of those included in the established procedure; one tap,
two extensions (non-distensible tubing) and one three-way
stopcock valve; flushing protocol with heparinized saline
(500 cc of 0.9% sodium chloride with 7500 units of hep-
arin sodium); the manifold system, pressure transducer
(wired to the monitoring system) and flush valve were
maintained at heart level mounted on a bedside support-
pole attached to the table (transducer at the phlebostatic
axis level always), and finally before the measurements we
did the calibration and zero-balancing, flushing the system
with saline solution (taking all the air out) and confirming
the zero wave on the monitor (pressure within the system is
zero, the monitor reads zero, negating the atmospheric
pressure).
Fig. 2 Comparison of the
central diastolic pressure
measured invasively with an
intra-aortic catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
68 D. Echeverri et al.
Arteriograph
Ò
equipment (TensioMed, Budapest-Hun-
gary, Ltd.), with 3.0.0.4. software, and a Dell computer
with compatible Windows XP and Bluetooth connection.
Artis ZEE angiography unit, Axiom Sensis XP Live
polygraph, Sensis RTC (Siemens AG, Berlin and Munich,
Germany) screen and HP p4014 LaserJet printer.
2.5 Procedure
After verifying the fulfillment of the inclusion and exclu-
sion criteria, the study was verbally explained to the sub-
jects, and the following procedure was performed.
Simultaneous measurements were taken on the selected
patients (supine position-flat, undisturbed rest for at least
10 min) using the appropriate Arteriograph
Ò
cuff on the
left or right upper arm (the opposite arm from the catheter)
during left heart catheterization in the hemodynamics
operating room (isolated and without disturbing influ-
ences). The following sequence was used: once the
required diagnostic and/or therapeutic procedure was
completed, without using any vasoactive drug and low
amount of contrast dye; 28 ±8 ml (controlled coronary
infusion), the catheter was placed in the ascending aorta
(confirmed by fluoroscopy) and the various pressures were
recorded under stable conditions: aortic arterial systolic
and diastolic pressure (mmHg), aortic pulse pressure
(mmHg), central mean arterial pressure (mmHg), and heart
rate (beats/min), when the wave pressure was stable trying
to have the minimum variation (20–40 s). Then, the same
measurements were taken in the brachial artery (confirmed
by fluoroscopy): peripheral arterial systolic and diastolic
pressure (mmHg), peripheral pulse pressure (mmHg), and
peripheral mean arterial pressure (mmHg). In this way, the
measurements of both methods were recorded
simultaneously.
Fig. 3 Comparison of the
central pulse pressure measured
invasively by an intra-aortic
catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 69
2.6 Noninvasive Hemodynamic Measurement
Method
The Arteriograph
Ò
(TensioMed, Budapest-Hungary, Ltd.),
is a medical unit that records and analyzes the arterial pulse
wave in a noninvasive and exceptionally simple, reliable,
and precise manner. It uses oscillometric methods to
achieve the total assessment of central and peripheral
arterial function. The unit has a patient security mechanism
which prevents the cuff pressure from exceeding
280 mmHg. Once the unit is connected to the patient, it is
also connected to a computer (Bluetooth) with software
which allows the demographic data and some physical
exam variables to be recorded. It takes physiological vas-
cular stiffness variables in real time, and measures, records
and prints them. The length of the inflatable bladder of the
cuff was least 80% of upper arm circumference and the
width of the inflatable bladder of the cuff was at least 40%
of upper arm length. The times for BP measures: Initial
inflation pressure (adding 50 mmHg to the mean arterial
pressure), offset of systolic pressure level (supra-systolic
pressure, systolic value plus 35 mmHg) and offset of
diastolic pressure level. The default time is 8 s (deviate in
7–10) for each pressure level and the deflation is automatic
(stepwise).
The new software (3.0.0.4.) for calculating PWV cal-
culates the distance between the sternal notch and the upper
border of the pubis algorithmically, according to the
patient’s characteristics. This calculation is a change from
previous editions in which the distance was measured
manually with a tape measure. The device and the mea-
surements were managed and done by an expert on the field
(software knowledgement and measurement), who has
worked for more than two years with the Arteriography
Ò
.
Fig. 4 Comparison of the
central mean arterial pressure
measured invasively with an
intra-aortic catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
70 D. Echeverri et al.
2.7 Pressures Measured Simultaneously with Both
Methods
Brachial systolic arterial pressure (SAP-B, mmHg), bra-
chial diastolic arterial pressure (DAP-B, mmHg), brachial
mean arterial pressure (MAP-B, mmHg), brachial pulse
pressure (PP-B, mmHg), HR: heart rate (beats/min), central
systolic arterial pressure (SAP-C, mmHg), aortic diastolic
arterial pressure (DAP-C mmHg), central pulse pressure
(PP-C, mmHg) and central mean arterial pressure (MAP-C,
mmHg). The device uses three D-ring cuffs of different
sizes (1: 34 98 cm, 2: 26 98 cm, 3: 18 96 cm) based
on the arm circumference range (1: 34–43 cm, 2:
26–33 cm, 3: 18–25 cm), all of them were used following
the protocol.
2.8 Data Collection Form
A data collection form was designed which included gen-
eral demographic information, personal and family medical
history, current medications, smoking habit, physical
activity and a report of the general physical exam. The
complete data collection and data form files were stored in
a data base as they were obtained by one of the researchers,
and they were reviewed and validated jointly. Finally, they
did evaluate each study (measurements from both technics)
analyzing the waves quality of 110 patients’ studies,
excluding 10 because the wave quality or central BP lec-
ture errors (algorithm errors or large standard deviation that
showed some disturbance in the measurement).
2.9 Sample Size and Statistical Analyses
The sample size was calculated to have enough power to
detect significant differences in the values produced for
Fig. 5 Comparison of the heart
rate measured invasively with
an intra-aortic catheter versus
the Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 71
individuals of both sexes, assuming an alpha level of sig-
nificance of 0.05 and an expected intraclass correlation
coefficient size greater than 0.8 (a value determined by the
researchers), resulting in a minimum sample size of 100
consecutive patients, satisficing the recommendations of
Sharman et al. [26].
The data were stored in a data base created for that
purpose (Microsoft Excel 2010). The statistical analysis
was performed using the SPSS 23 software. First, a test of
normality was performed using the Kolmogorov–Smirnov
test. Results with a normal distribution were expressed as
mean ±standard deviation, and data with a non-normal
distribution were expressed as median (interquartile range).
Next, the intraclass correlation coefficient was calculated
to determine the conformity and validity of the Arteri-
ograph
Ò
, using cardiac catheterization as the reference test.
In addition, the regression equation y=ax ?bwas used
to create a regression line to evaluate the behavior of both
methods at different pressures and evaluate the relationship
between the pressures. Finally, the Bland-Altman method
was used to once again evaluate the conformity between
these two techniques.
3 Results
3.1 Demographic Results
One hundred subjects with a big cardiovascular diversity
were included in the study, with an average age of
63.5 years, (range was 34–89 years), of which 62 were
male; with great variability on height, in range was
144–199 cm, weight was 43–104 kg, and the range of body
mass index was 17.5–35.5 kg/m
2
(Table 1).
Validation of the Arteriograph
Ò
with left heart
catheterization. Table 2shows the intraclass correlation
coefficients for the general peripheral and central pressure
measurements, which depict substantial conformity
Fig. 6 Comparison of the
brachial systolic pressure
measured invasively with an
intra-arterial catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
72 D. Echeverri et al.
between the two methods: 0.80 and 0.91 (p\0.001),
respectively. The results in Table 3show the means of the
different variables (pressures and heart rate) measured
simultaneously by the Arteriograph
Ò
and cardiac
catheterization. All the intraclass correlation coefficients
are high and significant. The intraclass correlation coeffi-
cients of the SAP-C is 0.99 and pressures range was
94–217 mmHg, and PDA-C was 44–116 mmHg. The
results show a high conformity with the gold standard
(intraclass correlation coefficients of SAP-B =0.96, intr-
aclass correlation coefficients of heart rate =0.98 (range
of HR was 42 to 103 b.p.m.), intraclass correlation coef-
ficients of MAP-B =0.94 and intraclass correlation coef-
ficients of MAP-C =0.96) which was corroborated using
the Bland-Altman method. The charts show that more than
95% of the values are interrelated (Figs. 1,2,3,4,5,6,7,
8,9). The results of patients with atrial fibrillation and
valve disease did not differ from the general cohort (similar
differences and likelihood of measurement error)
Linear regression, evaluation of agreement and the
relationship between the Arteriograph
Ò
and left heart
catheterization. Figures 1,2,3,4,5,6,7,8and 9display
the linear regression and equation of each variable. In these
figures, the data obtained for the different values are
reported, showing substantial agreement between these two
methods.
4 Discussion
In this study, we correlated the pressures obtained using the
Arteriograph
Ò
(TensioMed, Budapest-Hungary, Ltd.) non-
invasive oscillometric method with the transradial tech-
nique invasive arterial catheterization method (‘‘gold
standard’’) simultaneously in 100 consecutive patients from
the daily practice of our hospital, with different clinical
conditions. A very high correlation was documented
between the two methods used. The intraclass correlation
Fig. 7 Comparison of the
brachial diastolic pressure
measured invasively with an
intra-arterial catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 73
coefficients of the central pressures were greater than 0.9
(p\0.001), and the correlation of brachial pressures was
0.80 (p\0.001), evidencing the high conformity and
agreement between the two methods.
Even though central pressures can easily be measured
directly using invasive techniques (entailing risks and
costs), several methods have been designed today for
analyzing central pressures. The most frequently used
methods in clinical studies are (Arteriograph
Ò
, Sphyg-
moCor
Ò
and Complior
Ò
), which use radial or carotid pul-
ses and a validated generalized transference function to
estimate central pressures through a peripheral signal.
In general, arterial pressures cannot be calculated pre-
cisely with noninvasive methods. These can show various
characteristics of the aortic or carotid pulses which are not
dependent on absolute AP values, such as amplification of
the pulse wave between the central and peripheral artery,
AIx and the time of arrival of the reflected wave. Fur-
thermore, factors also influence these characteristics such
as the patient’s heart rate, height, and age [1]. This is very
important, since central hemodynamic indices are param-
eters of BP and its derivatives (central systolic AP, pulse
pressure, augmentation pressure and wave amplification),
or indices which quantify the wave reflections (AIx).
Increased arterial wave reflection is related to the extension
of myocardial ischemia in patients with or without
obstructive coronary disease [27,28]. Furthermore, it is
directly related to left ventricular hypertrophy [29] and its
regression with treatment [30], to left atrial size [31], and is
inversely related to left ventricular diastolic function at rest
and during exercise [32].
Arteriograph
Ò
(TensioMed, Budapest-Hungary, Ltd.) is
a new available equipment for measuring non-invasive
central and peripheral BP and vascular stiffness parame-
ters. It is perhaps the most popular non-invasive, automatic
method of measuring arterial pressure and arterial stiffness.
It uses the brachial artery occlusive technique and the
oscillometric method, rapidly (2–3 min), and through the
Fig. 8 Comparison of the
brachial pulse pressure
measured invasively with an
intra-arterial catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
74 D. Echeverri et al.
analyses of pressure curves registered in the upper arm
[32]. The principle of the oscillometric method is based on
plethysmography and registers changes in the pulse pres-
sure of an artery, measuring these periodic pressure chan-
ges (oscillations) as an indirect measure of the changes in
pulse pressure in the artery. In accordance with this prin-
ciple, the Arteriograph
Ò
initially measures the BP in the
upper arm oscillometrically, and then produces cuff pres-
sure over the brachial artery which is 35 mmHg greater
than the systolic BP measured. The pressure fluctuations in
the brachial artery are then detected by the cuff. These are
sent to the computer, and are registered and analyzed as
pulse waves. The time difference between the beginning of
the first wave and the beginning of the second (reflected
wave) is related to the distance between the sternal notch
and the symphysis pubis, resulting in the PWV in m/s.
Later, validation of the oscillometric method using
Arteriograph
Ò
was reported by Horva
´th in 2010 [33],
comparing the results with invasive methods. Intra-aortic
AIx measured by a catheter placed in the aortic root, and
brachial AIx measured simultaneously with the Arteri-
ograph
Ò
in identical cardiac cycles, were compared in 16
patients. In 55 cases, the central systolic pressure was
assessed invasively with a catheter in the aortic root, and
non-invasively with the Arteriograph
Ò
based on the bra-
chial systolic pressure and the pulse pressure curve, this
study reported a strong correlation between the aortic AIx
measured invasively and the oscillometric method in each
beat (r =0.9; p\0.001; r =0.94; p\0.001). Likewise,
there was a strong correlation (r =0.95; p\0.001) for
measurements of aortic systolic pressure.
Liu et al. [34] evaluated invasive brachial BP in only
eight patients during cardiac catheterization before and
after nitroglycerine infusions, and compared it with the
Arteriograph
Ò
measurements. The preliminary results
show significant reductions in the AP estimation error.
In our study, we evaluated central and peripheral BP
using both methods (non-invasive oscillometric and inva-
sive, via an intra-arterial catheter, simultaneously), vali-
dating the Arteriograph
Ò
in the presence of central and
Fig. 9 Comparison of the mean
brachial arterial pressure
measured invasively with an
intra-arterial catheter versus the
Arteriograph
Ò
oscillometric
unit. aRelationship between the
pressure measured by the
Arteriograph
Ò
and the pressure
measured invasively by the
catheter, bBland–Altman
analysis of the mean values and
differences between the
invasive measurement and the
Arteriograph
Ò
Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 75
brachial arterial catheterization as never before fulfilling
the recommendations of Sharman et al. [26]; the number of
evaluated patients, (more than 85), wide variety of clinical
conditions (coronary artery disease, atrial fibrillation, valve
disease, diabetes, dyslipidemia, arterial hypertension and
obesity), wide range of body habitus (body mass index,
arm size, weight and height), different BP range, heart rate
range, structured statistics analysis and standardized study
design. This may help make this technique known and
validate it for daily practice in patient assessment.
Although, we did the study before the standardized proto-
col for central blood pressure validation [26], our study
design satisfices the mandatory and most of the
requirements.
Following the recommendation, we did not evaluate
hemodynamic change from resting state, like using a
standard dose of trinitrate, table tilting, hand grip or supine
cycling, also the dose of contrast dye used was a very small
amount that changes on the hemodynamics variables are
nearly zero and finally, we have seen that the Arteri-
ograph
Ò
works satisfactorily in patients with valve disease
and atrial fibrillation were the results of this group did not
differ from the general cohort, but was a small group,
future studies should collect these features like ambulatory
BP and testing device performance in specific disease.
5 Conclusions
Arteriograph
Ò
is a non-invasive oscillometric method
which is easy to use and valid for estimating arterial central
pressures (stiffness parameters). It has a high agreement
(conformity) with the gold standard for measuring brachial
and central AP. This equipment can help optimize car-
diovascular assessment, save time and healthcare system
costs, and optimize cardiovascular prevention in selected
patients. This could be an important basis on the future of
primary and secondary prevention in patients even with
cardiovascular conditions.
Acknowledgements To all the nurses of the hemodynamics service
for the work and taking care of the patients.
Compliance with Ethical Standards
Good laboratory practices This study was carried out in accordance
with the Good Clinical Practice guidelines. All data obtained during
the study were kept at the local study center, under an Excel data
base. The data were collected, analyzed, and filed appropriately. This
study was evaluated and approved by the Research Ethics Committee
of the FCI-IC, and was classified as a
¨minimal risk
¨study (Chapter 1 of
Resolution No. 008430 of 1993 by the Ministry of Health).
Conflict of interest The authors express that they have no conflict of
interest. This study was carried out with funds belonging to the
Institution, as a research line of the Vascular Function Research
Laboratory at the Fundacio
´n CardioInfantil-Instituto de Cardiologı
´a.
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Validation of Central and Peripheral Non-Invasive Hemodynamic Variables 77
