AJH 2005; 18:65–71
Determination of Arterial Compliance Using
Blood Pressure Waveform Analysis
with the CR-2000 System
Reliability, Repeatability, and Establishment of Normal Values
for Healthy European Population—The Seven European Sites
Study (SESS)
Reuven Zimlichman, Marina Shargorodsky, Mona Boaz, Daniel Duprez,
Karl-Heintz Rahn, Damiano Rizzoni, Antonio Coca Payeras, Christian Hamm,
and Gary McVeigh
Background: We determined the reliability and re-
peatability of measurements of arterial compliance (AC)
and gender- and age-specific normal ranges for a healthy
European population.
Methods: Three hundred eight healthy volunteers from
seven sites were evaluated. Two measurements were taken
during the first visit, repeated on a second visit 1 to 4
weeks later. We used the HDI/PulseWave CR-2000 for
measurements of AC.
Results: Intravisit measurements, taken 5 min apart,
differed by less than 3% (range, 0.36% to 2.97%). All
intervisit measures differed by less than 4% (range, 0.24%
to 3.67%); none of these differences was statistically sig-
nificant. All correlation coefficients for pairs of AC pa-
rameters measured 5 min apart at the same visit were
significant at P ⬍ .0001. Paired AC parameters at visit 1
and 2 were highly correlated (P ⬍ .0001). Repeated mea-
sures GLM (general linear model) failed to detect a sig-
E
xtensive clinical evidence has shown that the pres-
ence of risk factors for cardiovascular disease
(CVD) is strongly associated with impairment in
arterial compliance (AC).1,2 The AC is impaired when
CVD is present.3,4 Decreased AC develops gradually, re-
flects vascular damage, and predicts the appearance of
Received February 19, 2004. First decision August 7, 2004. Accepted
August 13, 2004.
From the The Brunner Institute for Cardiovascular Research,
Department of Medicine (RZ, MS, MB) and Epidemiology Unit (MB),
Wolfson Medical Center and Tel Aviv University, Tel Aviv, Israel;
UZ-Gent, The University Hospital, Department of Cardiovascular Dis-
eases (DD), Gent, Belgium; University of Muenster Medical School
(K-HR), Muenster, Germany; University of Breccia, Department of
© 2005 by the American Journal of Hypertension, Ltd.
Published by Elsevier Inc.
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nificant association between either of the AC parameters
and visit (first or second), time (first or second measure at
the same visit), and visit-by-time (the interaction of the
two preceding factors), suggesting that order of measure
had no effect on the final value. Analysis of reliability was
used to develop a strictly parallel model estimate of unbi-
ased reliability. Both intravisit and intervisit estimates of
reliability indicate good repeatability of measure and were
significant (P ⬍ .0001). The AC values were found to
differ significantly by age group, with an inverse associa-
tion between each of the AC parameters and age group.
Conclusions: Measurement of the arterial waveform
with the CR-2000 system is highly reproducible in healthy
subjects. Am J Hypertens 2005;18:65–71 © 2005 Amer-
ican Journal of Hypertension, Ltd.
Key Words: Arterial compliance, arterial pulsewave
contour, repeatability, reliability, normal range.
overt CVD. Therefore, it has been proposed as an indicator
of cardiovascular status and a means of estimating success
or failure of treatment.2
One of the main problems with the use of noninvasive
methods developed for estimation of AC has been repeat-
ability and accuracy of the measured parameters. The
Medical and Surgical Sciences (DR), Breccia, Italy; Servizio de Medi-
cina Interna General, Hospital General (ACP), Barcelona, Spain; Kerck-
hoff Clinic (CH), Bad Nauheim, Germany; and The Queen’s University
of Belfast, Department of Therapeutics and Pharmacology (GM), Belfast,
Northern Ireland, UK.
Address correspondence and reprint requests to Prof. Reuven
Zimlichman, Chief of Medicine and Hypertension, Wolfson Medical
Center, P.O. Box 5, Holon 58100, Israel; e-mail: zimlich@post.tau.ac.il
0895-7061/05/$30.00
doi:10.1016/j.amjhyper.2004.08.013
66 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS AJH–January 2005–VOL. 18, NO. 1

Table 1. Baseline characteristics of study participants

Characteristics Data
Age (y) 33.8 ⫾ 10.9
Gender (% females) 68.2
Race (% white) 98.7
Self-reported family history of cardiovascular disease/risk factors
Myocardial infarction, angina pectoris (%) 64 (20.8)
Cerebrovascular accident (stroke) (%) 76 (24.7)
Diabetes mellitus (%) 64 (20.8)
Hypertension (%) 125 (40.6)
Alcohol consumption
Any alcohol consumption (%) 97 (31.5)
Type of alcohol consumed
None (%) 211 (68.5)
Beer (%) 61 (19.8)

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Wine (%) 32 (10.4)
Distilled liquor (%) 4 (1.3)
Frequency of alcohol consumption (drinks per week, users only) 5.6 ⫾ 4.8
Tobacco use
Any tobacco use (%) 57 (18.5)
Type of tobacco used
None (%) 251 (81.5)
Cigarettes (%) 52 (16.9)
Other (pipes, cigars) (%) 5 (1.6)
Frequency of tobacco use (per day, users only) 13.2 ⫾ 8.8
Anthropometric measures Men Women
Height (cm) 177.1 ⫾ 7.6 164.4 ⫾ 7.4
Weight (kg) 77.8 ⫾ 11.1 61 ⫾ 10.6
Body mass index (kg/m2) 24.7 ⫾ 2.7 22.5 ⫾ 3.9
Hemodynamic parameters Men Women
Systolic blood pressure (mm Hg) 126.9 ⫾ 13.2 116.1 ⫾ 11.9
Diastolic blood pressure (mm Hg) 72.7 ⫾ 8.7 66.4 ⫾ 7.9
Mean arterial pressure (mm Hg) 91.3 ⫾ 10.8 84.1 ⫾ 8.8
Pulse pressure (mm Hg) 54.2 ⫾ 8.4 49.7 ⫾ 8.2

purpose of the present study was to estimate the AC
parameters using the HDI CR-2000 Cardiovascular Pro-
filing System (Hypertension Diagnostics, Inc., Eagen,
MN) in healthy subjects. We also aimed to determine the
extent to which these measures are repeatable when taken
5 min apart at a given visit, and also when taken at two
different visits 1 to 4 weeks apart. In addition, gender- and
age-specific population normal ranges for a healthy Euro-
pean population were developed based on these measure-
ments.
Methods
Study Design
The reproducibility of arterial compliance parameters us-
ing the HDI/PulseWave CR-2000 was measured twice,
5 min apart during the same visit, and at a second visit.
Comparisons of measures were made between the first and
second measures taken on the same visit at each of the two
visits. In addition, each measure taken on the first visit was
compared to each of the measures taken on the second visit.
A sample size of 295 individuals was calculated to be ade-
quate to provide 80% power to detect a difference of 4%,
adjusting the significance level to account for repeated mea-
sures. This calculation was based on assumptions drawn from
prior experience with AC parameters measured using the
HDI/PulseWave CR-2000. Study centers recruited a total of
308 participants who were present for both visits and had two
measurements performed in each visit.
Subjects
All participants were healthy volunteers recruited in the
following sites: Belfast, Northern Ireland (75 subjects;
12.4%), Gent, Belgium (22 subjects; 3.6%), Holon, Israel
(131 subjects; 21.7%), Muenster, Germany (119 subjects;
19.7%), Brescia, Italy (61 subjects; 10.1%), Barcelona,
Spain (102 subjects; 16.9%), Bad Nauheim, Germany (95
subjects; 15.7%).
All 308 healthy subjects were between the ages of 15
and 80 years with a body mass index (BMI) of less than 30
kg/m2. Most subjects were recruited mainly at their work
sites as a result of local advertisement. Subjects were
required to complete an Assessment Profile Questionnaire
that queried health history, especially history of cerebro-
vascular, cardiovascular and peripheral vascular disease,
hypertension, diabetes mellitus, and medications. Individ-
uals self-reporting any of the above-mentioned diseases or
medications, especially those that might affect hemody-
AJH–January 2005–VOL. 18, NO. 1 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS 67

Table 2. Mean absolute and relative differences in placed on the contralateral arm. The obtained waveforms
measurements of arterial compliance parameters (mean of 30-sec recording) were calibrated to the systolic
taken 5 min apart at the same visit and diastolic cuff pressures. A computer-based third order
four-element Windkessel model of the circulation was
Variable Mean Absolute Mean Relative
Pair Difference Difference used to match a diastolic pressure decay of the waveforms
and quantify changes in terms of SVR, C1, C2, and L.7
Visit 1
The SVR was calculated as MAP divided by cardiac
LAE 0.388 2.46%
SAE 0.212 2.97% output. The MAP was derived from waveform analysis,
Visit 2 integrating the area under the curve and calculating the
LAE 0.070 0.44% mean area of recordings during 30 sec. Cardiac output was
SAE 0.026 0.36% calculated from a multivariate algorithm using cardiac
None of the comparisons was statistically different. ejection time derived from the radial artery waveform. The
method and its results have been validated and described
in depth previously.5–7

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namic parameters, were excluded from participation. Sub-
jects with a BMI exceeding 30 kg/m2 were excluded from
participation. Also excluded were individuals determined
to have systolic or diastolic hypertension (systolic blood
pressure [BP] ⬎140 mm Hg or diastolic BP ⬎90 mm Hg)
and subjects with cardiovascular conditions that might
produce altered BP waveforms or an inadequate estima-
tion of stroke volume, such as arrhythmia, heart failure, or
cardiac valve abnormalities. A patent right radial artery
and ability to tolerate a BP cuff on the left upper arm
concurrently, with a sensor holding device on the right
wrist, were necessary for inclusion. Finally, participation
was predicated on availability to return for a scheduled
follow-up visit 1 to 4 weeks from the baseline measure-
ment. All subjects signed an informed consent form and
the study was approved by local Institutional Review
Board in each site.
Measurement of AC Parameters
Radial artery waveforms were obtained using a calibrated
proprietary tonometer (HDI, model CR-2000, Hyperten-
sion Diagnostics, Inc., Eagen, MN) as previously de-
scribed.5,6 Briefly, the tonometer was applied to the
patient’s radial artery at the wrist overlying the radial bony
prominence. The subject’s arm was supported by a wrist
stabilizer for optimal positioning and minimal movements
during the measurements. The BP measurement cuff was
Data Analysis
Data from all centers were compiled into one spreadsheet.
Distributions of continuous variables were compared to
normal using the Kolmogorov-Smirnov test. Continuous
variables are reported as mean ⫾ SD. Nominal data are
reported as frequency counts and proportions. Means of
AC parameters at the same visit were compared using the
paired t test. Means of AC parameters for each visit were
calculated and compared between visits using the same
method. In addition, repeated measures ANOVA was used
to simultaneously compare all four measures of AC (two
measures taken at each of two visits). Repeated measures
general linear model (GLM) was used to examine the
association between each of the AC parameters and visit
(first or second), time (first or second measure at the same
visit), and visit-by-time (the interaction of the two preced-
ing factors). Reliability analysis with a strict parallel
model was used to develop an unbiased estimate of overall
reliability. By-gender comparisons of AC parameters were
carried out using the t test for independent samples. Uni-
variate GLM was used to model AC parameters by age
group and gender. Means for each AC parameter were the
mean of all four values in each gender by age group.
Normal values were considered those above the fifth per-
centile for each gender in a given age group. All tests were

Table 3. Intervisit comparisons of arterial compliance parameters

Arterial Compliance Mean Absolute Mean Relative

Parameter Visits Compared Difference Difference
Visit/Reading Visit/Reading
LAEI 1/1 2/1 0.11 0.70%
1/1 2/2 0.18 1.14%
1/2 2/1 0.50 3.24%
1/2 2/2 0.57 3.67%
SAEI 1/1 2/1 0.02 0.24%
1/1 2/2 0.04 0.61%
1/2 2/1 0.20 2.64%
1/2 2/2 0.17 2.28%

None of the comparisons was statistically different.

68 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS AJH–January 2005–VOL. 18, NO. 1

Table 4. Correlation coefficients for measures of 0.81 for LAEI and 0.86 for SAEI (P ⬍ .001). Both
arterial compliance parameters: measurements intravisit and intervisit agreement of measure were signif-
taken 5 min apart of the same visit icant (P ⬍ .0001).
The AC values were found to differ significantly by age
Correlation
Visit Variable Pair Coeficient
group as displayed in Fig. 1. An inverse association is
identified between each of the AC parameters and age
1 LAE1 0.69 group. Values differ significantly by gender. Age and
SAE1 0.72
2 LAE1 0.67 gender normal values are displayed in Table 6. “Normal”
SAE1 0.75 was defined as those above the fifth percentile for a given
gender and age group.
All correlations significant at P ⬍ .0001, two tailed.
Bland-Altman plots were used to describe agreement
between measures of LAE and SAE. When the two meth-
ods are identical, the expectation is that ⬃68% of differ-
considered significant at P ⬍ .05. All analyses were per- ences will be distributed symmetrically around 0 within

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formed using SPSS 9.0 (SPSS Inc., Chicago, IL). 0 ⫾ 1␴(␦), and 95% will be within 0 ⫾ 1.96 SD (␦). In
Using Analyze-It Clinical Laboratory 1.71 analytic addition, one would expect that differences from the mean
software (Analyze-It Software, Ltd., Leeds, England, UK), would assume a normal distribution. As shown in Fig. 2,
Bland-Altman plots were developed to describe agreement intervisit measures of LAE, more than 68% of the values
between measures taken at each of the two visits. fell within 0 ⫾ 1␴(␦). The differences from the mean
assumed a normal distribution. Similarly, in intervisit
measures of SAE, more than 68% of the values fell within
Results 0 ⫾ 1␴(␦). The differences from the mean assumed a
Three hundred eight individuals, who met eligibility cri- normal distribution. These findings are confirmed using
teria, were present at both visits and had two measure- formal hypothesis testing when intervisit means are com-
ments taken at each visit. Characteristics of the study pared using the t test for paired samples.
population are described in Table 1.
Both absolute and relative differences in mean AC
Discussion
parameters, measured using the HDI/PulseWave CR-2000
are reported in Table 2. Compared are the measurements It has been suggested that AC is a reliable measure to
taken 5 min apart during the same visit. Both variables estimate the probability of event development and can
differed by less than 3% at the same visit (range, 0.36% to serve as a surrogate end point for prediction of CVD.8 –11
2.97%). None of these differences was statistically signif- Thus, precise determination of AC is important for risk
icant. stratification and for evaluation of success of therapeutic
Table 3 displays the comparison of AC measurements interventions. We aimed to evaluate the repeatability and
taken at visit 1 to each measurement taken at visit 2. All reliability of repeated determinations of AC both at the
intervisit measures differed by less than 4% (range, 0.24% same visit and at separate visits. Our results show good
to 3.67%). None of these differences was statistically repeatability in and among visits.
significant. Pearson’s correlation coefficients for pairs of Age-related changes have been found to be consistent
AC parameters measured 5 min apart at the same visit are with a gradual decrease in AC with increase in age across
displayed in Table 4. All correlations were significant at P age groups.12,13 This is easily understood, because in
⬍ .0001. In Table 5, Pearson’s correlation coefficients for
each of the AC parameter measurements at visit 1 paired
with each of the AC parameter measurements at visit 2 are Table 5. Correlation coefficients for measures of
shown. All correlations were significant at P ⬍ .0001. arterial compliance parameters: measurements
Repeated measures GLM failed to detect a significant taken at different visits
association between either of the AC parameters and visit
(first or second), time (first or second measure at the same Arterial
Compliance Visit/ Visit/ Correlation
visit), and visit*time (the interaction of the two preceding Parameter Reading Reading Coefficient
factors), suggesting that order of measure had no effect on
the final value. LAEI 1/1 2/1 0.40
1/1 2/2 0.45
Analysis of reliability was used to develop a strictly 1/2 2/1 0.40
parallel model estimate of unbiased reliability. Both intra- 1/2 2/2 0.46
visit and intervisit estimates of reliability indicate good SAEI 1/1 2/1 0.54
repeatability of measure. The reliability analysis for in- 1/1 2/2 0.51
tervisit unbiased reliability estimate was 0.68 for large 1/2 2/1 0/53
1/2 2/2 0.57
artery elasticity index (LAEI), 0.76 for small artery elas-
ticity index (SAEI) and for intravisit measurements was All correlations significant at P ⬍ .0001, two tailed.
AJH–January 2005–VOL. 18, NO. 1 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS
FIG. 1 (A) Large artery arterial elasticity index by age group. (B) Small artery arterial elasticity index by age group.
aging, there is a gradual deposition of collagen and extra-
cellular matrix.14,15
A critical question that has to be answered using vari-
ous devices to record noninvasively pulse wave contour is:
To what extent are the results repeatable? Inconsistent
modes of application of the sensor may be a potential
problem that may jeopardize potential use of a specific
method. Several publications reviewed the reproducibility
data in the literature for various devices.14 –17 In a study
that used the HDI equipment, the augmentation index,
which was determined noninvasively, compared favorably
with the Windkessel model.18
It should be mentioned that neither C1 nor C2 have
been shown yet to be predictive of events or outcome;
however, they have been found to correlate with risk
factors and with extent of disease. This implies that mea-
surement of AC, using the Windkessel model, may corre-
late with the degree of disease of the blood vessel.
69
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The Windkessel model was used to compare upper and
lower body sites, arm and leg, and showed that compliance
values were higher for the leg than for the arm.19 These
results may question the validity and utility of Windkes-
sel-derived variables by the absence of between-site cor-
relations when measured in the same subject. We believe
that leg arteries reflect different pattern of disease. Patients
with severe CVD may have minimal arterial disease in
their legs and vice versa. A study that we completed
recently confirms that there is a very weak correlation
between arterial disease in the legs when compared to
other sites and that peripheral vascular disease, measured
as ankle brachial index, does not correlate with the clinical
manifestations of disease nor with AC measured at the
radial artery. It seems that factors that affect arterial dis-
ease in the legs are not clear enough.
Another problem has been interference with measure-
ment accuracy due to movements of the hand or its mus-
70 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS AJH–January 2005–VOL. 18, NO. 1

Table 6. Normal values for large and small arterial ent occasions in the same individual was found. Unfortu-
compliance indices by age group and gender nately, there are very few studies that compare the validity
and repeatability of different methods and devices for
Women Men
evaluation of AC.14 –16
Age Age Sources of potential bias must be thoroughly examined
Range LAEI SAEI Range LAEI SAEI in the evaluation of study results in all research. The
15–19 ⬎16.1 ⬎7.7 15–19 ⬎16.1 ⬎7.7 present study, like any study in which the participants are
20–29 ⬎15.5 ⬎7.1 20–29 ⬎15.5 ⬎7.1 recruited through local ads, is vulnerable to volunteer bias.
30–39 ⬎14.9 ⬎6.6 30–39 ⬎14.9 ⬎6.6
40–49 ⬎14.3 ⬎6.0 40–49 ⬎14.3 ⬎6.0 However, for volunteer bias to influence results, we must
50–59 ⬎13.7 ⬎5.5 50–59 ⬎13.6 ⬎5.4 assume that association exists between AC and willing-
60–69 ⬎13.0 ⬎4.8 60–69 ⬎13.1 ⬎4.9 ness to volunteer for participation in the study. Although it
⬎70 ⬎12.3 ⬎4.1 ⬎70 ⬎12.5 ⬎4.3 is true that volunteers tend to be healthier than nonvolun-
teers, this is of low influence in a study designed to recruit

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cles. With the use of HDI equipment, a special wrist
stabilizer is used to overcome these problems.
In the present study we have shown that evaluation of
BP waveform analysis, using the CR-2000, gives a good
repeatability on repeated measurements. Furthermore, an
excellent correlation on repeated measurements on differ-
healthy participants. The study was not designed to de-
scribe total population values, but rather to describe those
values in healthy individuals.
Another potential source of bias in the present study
can be information bias. Personal and family medical
history was obtained from a questionnaire filled-in by the
participant. Although the potential for inaccuracy in self-

FIG. 2 (A) Bland Altman plot of between-visit measures of large artery elasticity. (B) Distribution of differences, large artery elasticity. (C)
Bland Altman plot of between visit measures of small artery elasticity. (D) Distribution of differences, small artery elasticity.
AJH–January 2005–VOL. 18, NO. 1 RELIABILITY AND REPEATABILITY OF ARTERIAL COMPLIANCE MEASUREMENTS
reported data is well documented, there is no reason to
assume that this potential inaccuracy in reporting was in
some way associated with AC measurements. Therefore,
there is no reason to believe that people with poor AC
would be more likely to inaccurately report medical his-
tory than individuals with good AC. The impact of infor-
mation bias on the results of the present study can be
considered inconsequential.
We evaluated the change in AC that occurs with age.
Our data confirm the evidence that AC decreases with
age.12,13,15,16 It can be seen that the decrease in AC with
increasing age is steeper in small (C2) than in large AC
(C1). However, it is well known that in the elderly sys-
tolic, and not diastolic, BP is the major problem. This
probably results from the fact that the stiff large arteries
hardly dilate with vasodilatory treatment because of age-
associated structural changes in the arterial wall, predom-
inantly fibrosis and calcification. Small arteries respond
easier to medical treatment because of their different struc-
ture. This probably explains why it is easier to solve the
problem of diastolic than systolic hypertension. It should
be mentioned that physiologically in the elderly the pulse
wave velocity is high and the reflected wave merges with
the systolic part of the incident wave causing high systolic
pressure and low diastolic pressure.17
Both the Bland-Altman plots and the direct comparison
of intervisit values using the t test for paired samples
confirm good agreement of measured LAE and SAE (Fig.
2). Thus, good repeatability can be claimed.
In the present study we also established a table of
normal values of AC for various age groups in healthy
European men and women. The normal range was calcu-
lated as values above the fifth percentile for each gender in
a given age group. It may be argued that the term mean
values for European population describes an heteroge-
neous population, as population differences in AC has
been shown, the present study does not stratify among
different European nations. We believe that data published
as means for a US population describe at least similar
population differences. To determine international Euro-
pean differences a bigger study should be performed and
still questions regarding different ethnic or economic
groups will be raised.
In summary, our study determined that repeated mea-
surements, performed at the same visit and at different
visits 1 to 4 weeks apart, are valid and repeatable,
despite that on repeated visit the hemodynamic status
and BP of the volunteers was not identical.
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