(Hypertension. 2000;36:484.)
© 2000 American Heart Association, Inc.
Scientific Contributions |
From the Department of Epidemiology and Biostatistics, Erasmus Medical Center Rotterdam (N.M. van P., D.A.M. van der K., A.H., D.E.G., J.C.M.W.); Department of Internal Medicine (W.J.W.B) and TNO-Biomedical Instrumentation (N.A.M. de B.), Academic Medical Center, Amsterdam; and Julius Center for Patient Oriented Research, University Medical Center Utrecht (D.E.G.) (Netherlands).
Correspondence to J.C.M. Witteman, Department of Epidemiology and Biostatistics, Erasmus Medical Center Rotterdam, Dr Molewaterplein 50, PO Box 1738, 3000 DR Rotterdam, Netherlands. E-mail witteman{at}epib.fgg.eur.nl
| Abstract |
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Key Words: blood pressure monitoring oscillometry sphygmomanometry arterial stiffness
| Introduction |
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An oscillometric blood pressure device determines blood pressure by detecting a sequence of oscillations in cuff pressure while the pressure is reduced.8 Since diabetic patients have stiffer arteries than nondiabetic subjects,9 arterial stiffness could be the underlying mechanism of the more pronounced differences between oscillometric devices and sphygmomanometers in this group. We evaluated determinants of differences between an oscillometric blood pressure device and a sphygmomanometer in a large population-based cohort of elderly subjects.
| Methods |
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Measurement of Blood Pressure
Blood pressure was measured in a fixed order, first with a
Dinamap xl vital signs monitor (Critikon Inc) and approximately
15 minutes later with a Hawksley MKII random-zero sphygmomanometer
(Hawksley and Sons Ltd). A physician took all Dinamap readings with the
subject in the supine position. An experienced research nurse, who was
not aware of Dinamap recordings, took all random-zero readings
while the subject was sitting. Blood pressure was measured twice at the
right arm after 5 minutes of rest; cuff size as recommended by the
manufacturer was used on all occasions. For random-zero
recordings, Korotkoff sounds phase 1 and 5 were taken for SBP
and DBP, respectively. Readings were recorded to the nearest 2
mm Hg.
Measurement of Arterial Stiffness
Arterial stiffness was assessed by carotid-femoral
pulse wave velocity (PWV). The time delay between the rapid upstroke of
the feet of simultaneously recorded pulse waves in the
carotid artery and the femoral artery was measured with an automatic
device (Complior, Colson).11 The distance traveled by the
pulse wave between carotid and femoral artery was measured over the
surface of the body with a tape measure. PWV was calculated as the
ratio of the distance traveled by the pulse wave and the foot-to-foot
time delay and expressed in meters per second. To cover a complete
respiratory cycle, the average of at least 10 successive measurements
was used in the analyses.
Control Study
The population-based study was performed on a large number of
subjects, thereby optimizing the opportunity to study determinants of
differences between blood pressuremeasuring devices. However, several
aspects in the design of the population-based study may create
differences between measurements obtained by different blood pressure
devices. We conducted a second study to examine whether observed
differences between the 2 monitors in the population-based study were
due to these nonoptimal design aspects. To optimize conditions, this
control study was performed according to the British Hypertension
Society protocol part II validation procedures in elderly
subjects.12 Both devices were compared in 2 groups
of 28 subjects, selected from the 1808 subjects of the population-based
study. Selection was based on their SBP and DBP differences, age, and
arterial stiffness status, as defined by PWV, observed in
the population-based study. One group comprised subjects with SBP and
DBP differences between devices, age, and PWV all below the mean of the
respective distributions in the population-based study (nonstiff
group), and the other group comprised subjects with these
characteristics all above the mean of the respective distributions in
the population-based study (stiff group). This selection resulted in
assigning subjects with lower or slightly higher Dinamap readings than
random-zero readings to the group referred to as the nonstiff group and
assigning subjects with considerably higher Dinamap readings than
random-zero readings to the group referred to as the stiff group. Thus,
selection was made on the basis of both arterial stiffness
status and blood pressure differences between devices. Under the
assumption that there are no unknown alternative explanations for the
association between arterial stiffness and differences
between the devices, observing the same difference between the devices
in a new study, in which nonoptimal design aspects are removed,
indicates that the difference can be truly ascribed to
arterial stiffness. A sequential comparison was performed
on the right arm with a single cuff. The length of the cuff was chosen
to be sufficient to encircle 80% of the subjects arm circumference.
A conventional sphygmomanometer was included in the comparison. The 3
different devices were used alternately. A total of 3 blood pressure
measurements, 2 minutes apart, were performed with each device while
the subject was sitting, without prior rest. The order of the device
was determined by randomization with a die. One experienced research
assistant, who was unaware of the research question, performed all
measurements. For readings with a sphygmomanometer, Korotkoff sounds
phase 1 and 5 were taken for SBP and DBP, respectively. Readings were
recorded to the nearest 2 mm Hg. The same equipment was used
throughout the study period.
Statistical Analysis
In the population-based study, blood pressure values are based
on the mean of 2 successive readings. Differences are presented
as Dinamap minus random-zero values. A paired t test was
used to evaluate whether differences between random-zero and Dinamap
methods were significantly different from zero. Determinants of the SBP
and DBP difference were evaluated by multiple linear regression
analyses with SBP or DBP difference as dependent variable,
adjusted for average mean blood pressure level of both devices
(Dinamap+random-zero/2). This analysis was done for the total
cohort and in strata of gender. Subsequently, mean SBP and DBP
differences were calculated per quartile of PWV, adjusted for age,
gender, and average mean blood pressure level of both devices, with
ANCOVA. A test for trend was performed with multiple linear regression
analyses, with quartiles of PWV as ordinal variable.
In the control study, blood pressure values were based on the mean of 3 readings with each device. Differences are presented as Dinamap minus random-zero values, Dinamap minus conventional sphygmomanometer values, and random-zero minus conventional sphygmomanometer values. A paired t test was used to evaluate whether observed differences were significantly different from zero. A 2-sample t test was used to evaluate blood pressure differences between the nonstiff group and the stiff group within and between devices.
A difference was considered to be statistically significant when the 2-sided P value was <0.05. All analyses were performed with the statistical package SPSS 8.0 for Windows 95 (SPSS Inc).
| Results |
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Control Study
The characteristics of the study population of the control study
are shown in Table 2. Observed
differences in all comparisons, for both the stiff and nonstiff group,
were significantly different from zero, except the DBP difference
between Dinamap and the random-zero device in the stiff group and the
SBP difference between Dinamap and a conventional sphygmomanometer in
the stiff group (Table 3). The direction
of SBP and DBP differences varied, and agreement between monitors was
sometimes better in the stiff group than in the nonstiff group.
However, in agreement with the population-based study, there was a
general trend toward more positive SBP and DBP readings in the stiff
group than in the nonstiff group by the Dinamap compared with both
sphygmomanometers. In the comparison of Dinamap with the random-zero
device, the SBP and DBP differences were significantly more positive in
the stiff group than in the nonstiff group. In the comparison of
Dinamap with a conventional sphygmomanometer, the SBP difference was
borderline significantly more positive and the DBP difference was
significantly more positive in the stiff group compared with the
nonstiff group. In the comparison of random-zero with a conventional
sphygmomanometer, the SBP and DBP differences were not significantly
different between the nonstiff and stiff groups.
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| Discussion |
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Some aspects of the study need to be discussed. First, we adjusted all analyses for mean blood pressure level (average of both devices) because PWV is highly dependent on blood pressure, and the difference between the devices increased with increasing blood pressure level (data not shown). Second, PWV was calculated using the distance between carotid and femoral artery as distance associated with the time delay between the pulse waves. This distance is longer than the "true" distance, resulting in overestimation of the pulse wave velocity. Because variations in anatomy are limited, this overestimation can be considered similar for all subjects and therefore will not have seriously affected our results. Third, we related carotid-femoral PWV to blood pressure difference between devices measured at the brachial artery. We thereby assumed that vessel wall stiffness of the carotid-femoral vessel bed is representative of brachial arterial stiffness. It is known, however, that there is a reasonable heterogeneity among vessel wall properties of different arterial regions.13 14 To the best of our knowledge, there are no studies comparing vessel wall properties of brachial artery with those of the carotid-femoral vessel bed, which makes it difficult to accurately assess the validity of our assumption. However, we assume that misclassification in brachial arterial stiffness status is nondifferential and thus, if present, will have resulted in an underestimation of the association.
Design aspects of the population-based study may have created the observed differences between devices. Examples of such design aspects are the fixed order in which the device were used, the subjects body position during measurement (sitting versus supine), and the observer (nurse versus doctor). The expected effect of these aspects on differences between the devices, however, does not always correspond with observed differences. For example, it is known that blood pressure measured in the sitting position is generally higher than blood pressure measured in the supine position.15 16 The difference in body position in the population-based study cannot explain our results since Dinamap blood pressures were higher than random-zero blood pressures and subjects were in the supine position during Dinamap recordings and were sitting during random-zero recordings. The design aspects of the population-based study also cannot explain that the blood pressure differences between devices are dependent on arterial stiffness status, which is confirmed in the control study.
An alternative interpretation of our findings is that increased arterial stiffness leads to underestimation of SBP and DBP by the random-zero sphygmomanometer compared with the Dinamap. Previous studies indicate that the random-zero device underestimates SBP and DBP compared with a conventional sphygmomanometer.17 In agreement with this, we found an underestimation of SBP and DBP measured by the random-zero device in comparison with the conventional sphygmomanometer in both the stiff and nonstiff groups of the control study. However, between the stiff and nonstiff group, no significant difference in blood pressure differences between devices was observed, indicating that the underestimation by the random-zero device was not related to arterial stiffness. The underlying mechanism by which blood pressure is measured by a sphygmomanometer is also not compatible with this alternative interpretation. Current thinking on the origin of Korotkoff sounds during sphygmomanometry is that they might be generated by movement of the vessel wall.18 Increased arterial stiffness could diminish vessel wall movements, resulting in decreased loudness of Korotkoff sounds.18 This would lead to lower SBP but higher DBP readings with a sphygmomanometer in subjects with stiff arteries. Since we found both lower SBP and DBP by the random-zero method compared with the Dinamap, this alternative explanation is only compatible with the observed difference in SBP and therefore unlikely.
Previous studies showed that oscillometric devices tend to overestimate SBP and underestimate DBP compared with conventional sphygmomanometers.1 2 3 4 In the population-based study, Dinamap overestimated both SBP and DBP compared with the random-zero device. The relatively old age of this study population could be the reason for finding an overestimation of DBP, since increasing age was a determinant of overestimation of SBP and DBP by Dinamap. In agreement with the previous studies, we found an overestimation of SBP and an underestimation of DBP by Dinamap compared with the random-zero device in younger subjects with distensible arteries (nonstiff group) in the control study. In comparison with a conventional sphygmomanometer, Dinamap underestimated both SBP and DBP in the nonstiff group. This underestimation became less in the stiff group. Although not in agreement with previous studies, it supports our hypothesis that a Dinamap uniformly gives more positive blood pressure readings in subjects with stiff arteries.
Our results with respect to stiffness are in accord with a previous study that found more overestimation of SBP and less underestimation of DBP in diabetic subjects compared with healthy controls by a SpaceLabs device compared with a conventional sphygmomanometer.7 It is well known that diabetic subjects have stiffer arteries than nondiabetic subjects.9 Increased arterial stiffness in diabetic subjects might be the underlying mechanism of the observed difference between the devices. Another study evaluated differences between a Dinamap 8100 and a random-zero sphygmomanometer in diabetic subjects and found an overestimation of SBP at low SBP values, an underestimation of SBP at higher SBP levels, and an underestimation of DBP at all DBP values by Dinamap compared with the random-zero device.5 This is discordant with our results. We observed an increasing difference between the Dinamap and the random-zero sphygmomanometer with increasing blood pressure level. If arterial stiffness is indeed a determinant of SBP difference, this is what one would expect to find since SBP rises when arteries become stiffer.
The mechanism by which arterial stiffness leads to higher SBP and DBP readings by Dinamap is not clear. It might be explained by changes in oscillograms of subjects with stiff arteries. The algorithm by which Dinamap determines SBP and DBP from an oscillogram is not known publicly. Therefore, it is not feasible to speculate about the effect of changes, observed in oscillograms of subjects with stiff arteries, on blood pressure determination by Dinamap.
Accurate blood pressure determination and diagnosis of hypertension is essential in subjects with a compromised cardiovascular system. Therefore, more studies are needed to elucidate the effects of arterial characteristics on blood pressure measurement by oscillometric devices. Most subjects participating in validation studies are healthy volunteers. Elderly volunteers might have relatively young arterial systems. We suggest including special subgroups such as subjects with arterial stiffness, advanced atherosclerosis, hypertension, cardiovascular disease, or diabetes in validation studies of blood pressuremeasuring devices.
In conclusion, the results of our study suggest that arterial stiffness is a determinant of higher SBP and DBP readings by a Dinamap oscillometric blood pressure device compared with sphygmomanometers.
| Acknowledgments |
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Received January 26, 2000; first decision February 14, 2000; accepted April 24, 2000.
| References |
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