(Hypertension. 1995;26:912-918.)
© 1995 American Heart Association, Inc.
Articles |
From The Fourth International Consensus Conference on 24-Hour Ambulatory Blood Pressure Monitoring. A complete list of the participants appears at the end of this article.
Correspondence to Jan A. Staessen, MD, PhD, Klinisch Laboratorium Hypertensie, Inwendige Geneeskunde-Cardiologie, U.Z. Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium.
| Abstract |
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Key Words: blood pressure monitoring, ambulatory blood pressure determination blood pressure monitors
| Introduction |
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| Cuff Size |
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In 14% of a random population sample aged 20 to 88 years, arm circumference exceeded 32 cm.4 These findings highlight the necessity of using large cuffs in a substantial number of subjects. Manufacturers should therefore provide ambulatory monitors that include large cuffs as a standard part of the equipment. The energy supply and pumps of the portable monitors should be adequate to inflate these bigger cuffs at the shortest interval possible. Whenever ambulatory monitoring is carried out in conjunction with conventional readings, both should be performed with cuffs and bladders of the same size so that comparisons between the results of both types of measurement can be possible.
| Position of the Arm |
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| Short-term Blood Pressure Variability |
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| Disturbance of Sleep |
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Manual inflation of a cuff in the case of self-measurement may lead to a small and transient rise in blood pressure.15 By contrast, researchers who used simultaneous continuous recordings as a reference have demonstrated that the automated or semiautomated inflation of a cuff does not necessarily lead to a pressor effect.16 In addition, there is large interindividual variability in the nightly awakenings caused by noninvasive monitoring.10 11 12 Thus, in general, ambulatory monitoring does not change the average nighttime pressure, so group means can be reliably reproduced.13
Interference with sleep also seems to vary among devices.12 Predictably, it increases with the noise generated by the recorder but also by the rate of cuff inflation and deflation9 and by the height of the pressure to which the cuff needs to be inflated to occlude the brachial artery,17 that is, by factors determining the duration and intensity with which the upper arm is compressed.
| Performance During Ambulatory Conditions |
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Validation of noninvasive monitors under truly ambulatory conditions has been proposed.18 However, sphygmomanometric measurements, which are the standard for validation of portable monitors in resting subjects in the laboratory, cannot be used as a reliable reference during exercise and ambulation because of their relative imprecision.21 The guidelines of the British Hypertension Society do not recommend the routine comparison of indirect and intra-arterial blood pressure measurements for obvious ethical reasons.24 25 Moreover, the systolic and diastolic pressure values obtained by the direct technique are different from those obtained by the indirect method, which so far have been used to establish the epidemiological and clinical criteria for the management of hypertensive patients. However, the latter criteria are applicable only to subjects examined at rest. More important, under ambulatory conditions intra-arterial recordings are the only practical way to gain insight into the accuracy of noninvasive devices.18
| Reproducibility |
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Group means of the blood pressure level13 27 28 and of the parameters of the diurnal blood pressure profile13 can be accurately reproduced when intermittent noninvasive recordings are repeated in the same subjects. In addition, as far as the blood pressure level is concerned, ambulatory measurements are characterized by a greater within-subject reproducibility than conventional blood pressure readings.27 28 This can be explained by the absence of digit preference, observer bias, and the white coat effect16 29 but foremost by the greater number of readings averaged for calculation of the ambulatory blood pressure means.27 28
The better within-subject reproducibility makes it possible to enroll fewer patients in crossover trials with ambulatory monitoring than with conventional sphygmomanometry, provided that the averages of at least 20 ambulatory readings are compared.27 28 However, in contrast to what is often perceived, the advantage of the better within-subject reproducibility of ambulatory measurements is lost when the blood pressure over a short time (for example, hourly averages) constitutes the focus of attention30 31 and/or when in trials with a parallel group design the between-subject rather than the within-subject variability is driving the statistical tests.31 For these reasons, trials involving the comparison of diurnal blood pressure profiles, for example, to determine the duration of action of antihypertensive agents, should recruit considerably more patients than the usual clinical trial.31
In contrast to the blood pressure level, the parameters of the diurnal blood pressure profile as determined by noninvasive ambulatory monitoring are poorly reproducible within subjects.13 This may be due to measurement error accumulated over the day but also to true biological variability and diurnal, seasonal, and random changes in the pattern of activity, which constitute an important, if not the overriding, determinant of the ambulatory pressure. Thus, studies based on a single ambulatory recording are insufficient for characterizing individuals with respect to their diurnal blood pressure profile, regardless of whether the profile has been analyzed by Fourier analysis32 or by other statistical techniques.33 Increasing the number of recordings per subject or standardizing activity patterns during the recordings may increase the potential of 24-hour ambulatory monitoring to reproduce the diurnal blood pressure profile of individual subjects.
| Auscultatory Versus Oscillometric Techniques |
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Auscultation of the Korotkoff sounds remains the established standard technique for determination of blood pressure in clinical medicine. Dependable physiological principles underlie the determination of mean arterial pressure by oscillometry,39 but a firm conceptual basis is still lacking for the determination of systolic and diastolic pressures by the latter approach. Some oscillometric devices record systolic pressure when the oscillations in the cuff suddenly increase in amplitude, mean pressure at maximal oscillation, and diastolic pressure when the amplitude of the oscillations abruptly falls off.
Most if not all manufacturers of monitoring devices refuse to disclose the proprietary algorithms for pressure measurement. Moreover, manufacturers tend to modify the devices and algorithms without prior notice.40 41 42 Especially for oscillometric devices, which put empirically derived algorithms into practice for the estimation of systolic and diastolic pressures, this practice is no longer acceptable. The original guidelines of the British Hypertension Society stated that when manufacturers incorporate modifications into externally identical or indistinguishable versions of a model this should be clearly indicated and that full details on how the new device differs from earlier versions should be provided.24 The revision of the British guidelines stressed that it is incumbent upon manufacturers to clearly indicate all modifications made to the hardware and software components of automated devices, for instance, by changing the device number.25 Furthermore, modified devices must be subject to a new validation.25
| Validation Studies in Special Populations |
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The Elderly
Blood pressure rises with advancing age, which explains why
hypertension is more prevalent among older people.49 Blood
pressure variability increases with advancing age and higher
pressure.50 51 It is therefore unfortunate that ambulatory
monitors seem to be less accurate in older subjects52 53 54
and hypertensive patients.52 54 55 56 Ambulatory monitoring
is often used in older subjects, but unfortunately, few reports
specifically addressing the validation of ambulatory monitors in the
elderly52 are available in the literature.
Several investigators reported in population-based studies that the age-related increase in systolic pressure was less when the latter was measured by ambulatory monitoring instead of conventional sphygmomanometry.4 57 58 59 It is unlikely that these observations are due to only measurement artifact, because in these surveys4 57 58 59 various types of monitors have been used. Across studies, the relationship with age was also consistently weaker for ambulatory blood pressure, regardless of whether the reference pressure had been measured by classic sphygmomanometry,4 57 58 by a stationary automated device,59 at home,4 58 or in special clinics.57 59
Pregnant Women
In conditions characterized by a high cardiac output, such as
anemia, thyrotoxicosis, or pregnancy, systolic pressure may be
elevated and the Korotkoff sounds may be heard until the pressure in
the cuff falls to zero.60 Under these circumstances both
phase IV and phase V should be recorded. Phase IV has been
recommended for use in pregnant women,60 although
comparisons with intra-arterial pressure have not yet
produced the evidence to substantiate the claim that the phase IV
diastolic pressure is more accurate.61
The accuracy of the auscultatory A&D TM-2420 (A&D Engineering Co) was evaluated in pregnant women by comparing its measurements with those taken simultaneously by two trained observers using a random-zero sphygmomanometer. The mean differences (±SD) between the two observers were -0.2±2.5 mm Hg for systolic pressure, +1.2±2.5 mm Hg for phase IV diastolic pressure (P=.01), and +0.04±2.6 mm Hg for phase V diastolic pressure. The mean differences between the mercury standard (average of the readings by the two observers) and the monitor were -0.5±2.7 mm Hg for systolic pressure, -5.4±5.3 mm Hg for phase IV diastolic pressure (P<.001), and +0.9±3.7 mm Hg for phase V diastolic pressure. These findings demonstrated that compared with a mercury standard it is possible to obtain reliable measurements of systolic pressure and phase V diastolic pressure in pregnant women.45
The SpaceLabs 90207 has also been validated in pregnant normotensive women. According to the protocol of the British Hypertension Society, it achieved an A mark for systolic pressure but only a C grading for diastolic pressure.46 The mark attained for systolic pressure was one grade higher than in nonpregnant subjects,62 and the result for diastolic pressure was one grade lower. Phase IV diastolic pressure was used for determination of the mercury standard. As in the previous study45 the agreement on phase IV diastolic pressure among the observers was low, suggesting that the lower accuracy with respect to diastolic pressure may be due to this phenomenon rather than to an inherent inaccuracy of the devices in a pregnant population.46
| The Peñáz or Volume-Clamp Method |
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Several studies using intra-arterial tracings as a reference reported on the accuracy of the volume-clamp method for measurement of pressure in digital arteries under stationary66 67 68 69 70 71 or ambulatory66 conditions, during physiological66 67 72 73 or pharmacological67 interventions in the laboratory, or during the induction of anesthesia.74 The differences between the intra-arterial and noninvasive measurements, however, were obviously influenced by the change in the pressure wave, as the blood is propagated through the arterial vascular tree from the heart to the peripheral vessels. As a consequence of the age-related hemodynamic changes, systolic pressure is lower in the brachial than in the digital arteries in younger subjects, whereas in older people the opposite is observed.75 Furthermore, the pressure gradient from the brachial to the digital arteries explains why mean and diastolic pressures are lower at the latter, more distal, site.76
In general, the devices for measurement of arterial pressure in the digital arteries by the volume-clamp method are reasonably accurate and perform well in evaluating blood pressure changes over shorter time intervals. Nevertheless, they tend to slightly underestimate systolic, mean, and diastolic pressures at the level of the brachial artery66 67 68 69 70 71 72 73 74 (Fig 2). Two studies showed an unexpected overestimation of diastolic pressure by the Finapres.67 74 In one,74 the Ohmeda Finapres TM was used and shown to measure significantly higher pressure than the Dutch-made models68 ; also, the cuffs were applied to the thumb, for which they were originally not designed.65 An overestimation of systolic pressure was reported for the Finapres in one study67 and for the Ohmeda Finapres TM in another.68
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In conclusion, the finger arterial volume-clamp method makes continuous beat-to-beat recordings of blood pressure possible in a noninvasive manner and under a variety of conditions. It also provides the means for evaluation of blood pressure and heart rate variability.77 78 On balance, the available literature66 67 68 69 70 71 72 73 74 suggests that finger plethysmography enables one to record blood pressure level with an accuracy that is imperfect but under ideal conditions comparable to that of the noninvasive intermittent technique.
| Blood Pressure Monitoring as a Tool for Evaluation of Arteries |
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Reference values for the QKD interval have recently been proposed.85 Moreover, Gosse et al84 found that as expected under the above hypothesis84 85 the QKD interval was reduced with advancing age and in the presence of hypertension. Although the possibility of noninvasively monitoring arterial distensibility in ambulatory conditions undoubtedly constitutes an attractive prospect, the QKD technique is still being debated and awaits further validation by other groups.
| Conclusions |
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Whether an auscultatory or oscillometric technique is preferred remains debatable, because both techniques have specific advantages and disadvantages and both can provide accurate results under a variety of operating conditions. Their combination in a single device, however, may be useful for attaining a higher percentage of successfully completed readings and enabling the informative comparison between simultaneous pressure readings by two different methods. The opinion strongly prevails that manufacturers should disclose the algorithms of their devices, especially if these programs are not directly based on physiological principles but are empirically determined. This would give researchers involved in validation, as well as scientific and clinical users, a better insight on what can be expected with respect to performance in particular patient populations and under specific operating conditions. Moreover, manufacturers should specify all changes made to the hardware and software of a previously validated monitor.
| Acknowledgments |
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| Footnotes |
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Received November 16, 1994; first decision January 13, 1995; accepted August 25, 1995.
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