IV Guideline for Ambulatory Blood
Pressure Monitoring
II Guideline for Home Blood Pressure
Monitoring
IV ABPM / II HBPM
Mogi das Cruzes, São Paulo
February 17 to 19, 2005
Sponsors
Sociedade Brasileira de Cardiologia, Sociedade Brasileira de Hipertensão
e Sociedade Brasileira de Nefrologia
(Brazilian Society of Cardiology, Brazilian Society of Hypertension,
and Brazilian Society of Nephrology)
Participants
Alexandre Alessi (PR)
Andréa A. Brandão (RJ)
Ângela Pierin (SP)
Audes Magalhães Feitosa (PE)
Carlos Alberto Machado (SP)
Cláudia Lúcia de Moraes Forjaz (SP)
Cristina S. Atie (SP)
Dante Marcelo Artigas Giorgi (SP)
Décio Mion Jr. (SP)
Eduardo Cantoni Rosa (SP)
Fernando Nobre (SP)
Giovânio Vieira Silva (SP)
Hilton Chaves Jr. (PE)
Istênio José Fernandes Pascoal (DF)
Jorge Ilha Guimarães (RS)
José Luis Santello (SP)
José Márcio Ribeiro (MG)
José Nery Praxedes (SP)
Kátia Coelho Ortega (SP)
Lílian Soares da Costa (RJ)
Luis Aparecido Bortolotto (SP)
Marco Antonio Mota Gomes (AL)
Maurício Wajngarten (SP)
Miguel Gus (RS)
Osvaldo Kohlmann Jr. (SP)
Paulo César Veiga Jardim (GO)
Tufik José Magalhães Geleilete (SP)
Vera Koch (SP)
Organizing committee
Décio Mion Jr.
Carlos Alberto Machado
Marco Antonio Mota Gomes
Fernando Nobre
Osvaldo Kohlmann Jr.
José Nery Praxedes
Dante Marcelo Artigas Giorgi
Editing committee
Décio Mion Jr.
Alexandre Alessi
Kátia Coelho Ortega
Eduardo Cantoni Rosa
Giovânio Vieira Silva
Cláudia Lúcia de Moraes Forjaz
Audes Magalhães Feitosa
Tufik José Magalhães Geleilete
Fernando Nobre
Lilian Soares da Costa
Work Groups
1. Blue Group
Facilitators: Dante Marcelo Artigas Giorgi (SP), and Fernando Nobre (SP); Secretaries: Alexandre Alessi (PR), and
Kátia Coelho Ortega (SP)
Members: Andréa A. Brandão (RJ), Cristina S. Atie (SP), José Luis Santello (SP), and Jorge Ilha Guimarães (RS)
Topics: Methods for recording blood pressure; Equipment, validation and calibration, cuffs and cost; Normality criteria; Production of reports and interpretation of results; The future of the method.
2. Orange Group
Facilitators: Décio Mion Jr., and Osvaldo Kohlmann Jr. (SP); Secretaries: Eduardo Cantoni Rosa (SP) and Giovânio Vieira Silva (SP)
Members: Hilton Chaves Jr. (PE), José Márcio Ribeiro (MG), Miguel Gus (RS)
Topics: Blood pressure variability and sources of error in blood pressure measurement; Reproducibility of the method; Protocols and repetition of procedure; Clinical use in diagnosis, prognosis, and risk stratification, evaluation of therapeutic efficacy; White-coat phenomenon, effect, hypertension, and normotension.
3. Green Group:
Facilitators: Carlos Alberto Machado (SP) and José Nery Praxedes (SP); Secretary: Cláudia Lúcia de Moraes Forjaz (SP)
Members: Istênio José Fernandes Pascoal (DF), Lílian Soares da Costa (RJ), Maurício Wajngarten (SP), and Vera Koch (SP)
Topics: Establishing ABPM services; Selection and care of the device; Instructing patients on scheduling an examination, installing and removing the device. The use of ABPM in selected populations and special situations and respective normality criteria.
4. Red Group:
Moderador: Marco Antonio Mota Gomes (AL);
Facilitator: Marco Antonio Mota Gomes (AL); Secretaries: Audes Magalhães Feitosa (PE) and Tufik José Magalhães Geleilete (SP)
Members: Ângela Pierin (SP), Luis Aparecido Bortolotto (SP), and Paulo César Veiga Jardim (GO)
Topics: Establishing ABPM services; Selection and care of the device; Instructing patients on scheduling an examination, installing and removing the device; Clinical use in diagnosis, prognosis, and risk stratification, evaluation of the efficacy of therapy; White-coat phenomenon, effect, hypertension, and normotension. Equipment, validation and calibration, cost and cuffs; Normality criteria; Production of reports and interpretation of result; The future of the method.
Presentation
In light of the growing knowledge provided by Ambulatory and Home Blood Pressure Monitoring (ABPM and HBPM), a review of the Guidelines issued in 2000 is imperative. This "new look" at pressure measurement without the influence of the physician, outside the office, provided by ABPM and HBPM recordings, has greatly improved our understanding of blood pressure behavior, as well as the diagnosis and management of hypertension.
The influence of these methods is so great that we now have, in addition to classical diagnosis of normotension and hypertension, two other diagnostic possibilities: white-coat hypertension and masked hypertension. Such methods are well established in Brazil, and there are a great number of doctors interested in learning them. Thus, Brazilian Societies of Cardiology, Hypertension and Nephrology convened a 28-member expert panel of physicians from many parts of the country, with broad experience in these methods, to draw up this Guideline.
Once more an effort was made to standardize procedures, so that the methods are used judiciously, according to the best available scientific evidence. The purposes of this publication are to improve diagnosis of hypertension and to establish a prognosis for hypertensive patients and anti-hypertensive therapy, using resources offered by ABPM and HBPM.
Organizing Committee
Degrees of Recommendation and Levels of Evidence set forth in these Guidelines
Degrees of Recommendation
When applicable, the following classes should be used:
I - When there is consensus on indication.
IIa - When there is disagreement regarding indication, but is approved by the majority.
IIb - When there is disagreement regarding indication, with opinion divided.
III - When there is consensus on contraindication or when it is not applicable.
Levels of Evidence
A: Large, randomized clinical trials and meta-analyses.
B: Well-designed clinical trials and observational studies.
C: Case reports and case series.
D: Publications based on consensus and expert opinion.
Introdução
1. Physiological behavior of the blood pressure (BP) over a 24-hour period
Blood pressure varies due to the interaction of neurohumoral, behavioral and environmental factors (Table I).1 There is a continuous variation of beat-to-beat blood pressure according to the individual's activity, and this variability has a wider range in hypertensive than in normotensive patients. Values are higher during daytime than those obtained at night-time.
2. Blood pressure recording
Blood pressure may be registered by direct, or intra-arterial, and indirect methods, and the most commonly used are:
a) Auscultatory method - use of auscultation to identify the onset and disappearance of Korotkoff's sounds, corresponding to systolic and diastolic blood pressure, respectively.
b) Oscillometric method - use of oscillometry to identify the point of maximum oscillation, which corresponds to the mean blood pressure and determines the systolic and diastolic BP through algorithms.2
3. Casual blood pressure measurement taken in the physician's office
Casual blood pressure measurement taken in the physician's office, albeit considered a standard procedure for the diagnosis of hypertension and the follow-up of hypertensive patients,3 is subject to numerous sources of error, especially the influence of the observer and of the environment where pressure is taken. Also, it provides a few readings that do not show good long-term reproducibility (Degree of Recommendation I - Evidence Level A).
4. Equipment used for ABPM and HBPM
4.1. Validation
ABPM (Ambulatory Blood Pressure Monitoring) and HBPM (Home Blood Pressure Monitoring) devices are considered validated after they have been submitted to validation protocols and have been approved. There are well-defined protocols for validation of the devices,4 such as that of the Association for the Advancement of Medical Instrumentation - AAMI, that classify them as approved or non-approved, or that of the British Hypertension Society - BHS, which assigns grades from A to D and considers the device validated when it is graded A or B for systolic and diastolic pressures. Before buying any device, it is important to check whether it is validated by looking at:
www.hyp.ac.uk/bhs/bp_monitors/automatic.htm
www.dableducational.com/sphygmomanometers/devices_3_abpm.html
(Degree of Recommendation I - Evidence Level B).
4.2. Calibration
Calibration must be performed by the manufacturer or its representative at least once a year or according to manufacturer's specifications (Degree of Recommendation I - Evidence Level D). Calibration should also be performed whenever readings differ by more than 5 mmHg from those obtained with a calibrated mercury-column device, through a Y-connector, a procedure that must be done at least every 6 months. (Degree of Recommendation IIa - Evidence Level D).
4.3. Cuffs
Cuff size should be appropriate for the upper arm circumference (Table 2) and supplied by the original instrument manufacturer.3 (Degree of Recommendation I - Evidence Level B). The use of correction charts is not recommended, and neither is placement of the cuff on the forearm (Degree of Recommendation IIa - Evidence Level B).
5. White-coat phenomenon: white-coat effect, hypertension and normotension.
Blood pressure values obtained in the office setting may be higher, similar or lower than those measured during daytime by ABPM or HBPM. Based on these differences, patients can be classified into four different categories (Figure 1): normotension, hypertension, white-coat hypertension (isolated office hypertension)5 and masked hypertension (white-coat normotension).6
Normotension is characterized by normal blood pressure values measured in the office (lower than 140/90 mmHg) and by 24-hour ABPM (equal to or lower than 130/80 mmHg) or by HBPM (equal to or lower than 135/85 mmHg), while hypertension is characterized by abnormal blood pressure values measured in the office (equal to or higher than 140/90 mmHg) and by 24-hour ABPM (higher than 130/80 mmHg) or by HBPM (higher 135/85 mmHg).
White-coat effect is defined as the value obtained by the difference between the blood pressure measured in the office and by ABPM during daytime or HBPM, without any change in the diagnosis of normotension or hypertension. The white-coat effect is considered relevant when the difference is higher than 20 mmHg and 10 mmHg for systolic pressure and diastolic pressure, respectively.7
White-coat hypertension occurs when abnormal values are obtained at the physician's office (equal to or higher than 140/90 mmHg) and normal values are obtained by daytime ABPM (equal to or lower than 135/85 mmHg) or by HBPM (equal to or lower than 135/85 mmHg). It is important to note that, under such circumstances, the diagnosis changes from normotension outside the office to hypertension in the office.
Masked hypertension occurs when blood pressure values are normal in the office setting (lower than 140/90 mmHg) and abnormal with daytime ABPM (higher than 135/85 mmHg) or HBPM (higher than 135/85 mmHg). Under these circumstances, the diagnosis also changes from hypertension outside the office to normotension in the office.
5.1. Clinical significance and prognosis of white-coat hypertension
Aspects that guide diagnostic research in this case are: young or elderly, female, report of normal readings out of the office and hypertension stage I with no target organ damage. Some studies suggest that white-coat hypertension represents an intermediate cardiovascular risk between normotension and hypertension, howbeit closer to the risk of normotense patients8,9,10 (Degree of Recommendation IIb - Evidence Level B). Even though there is no evidence of benefits from interventions in this group, patients must be considered within the context of global cardiovascular risk and remain in clinical follow-up.
5.2. Clinical significance and prognosis of "masked" hypertension (white-coat normotension)
Aspects that guide diagnostic research in this case are: youngsters with normal or borderline casual blood pressure and left ventricle hypertrophy; hypertensive parents; reports of occasionally high readings outside the office and high cardiovascular risk.11 Some studies suggest that target organ damages are more prevalent among these patients than among normotense patients, but this is controversial.12
6. Establishing public or private ABPM or HBPM
Establishing public or private ABPM or HBPM medical services in offices, outpatient clinics or diagnostic centers requires trained staff and compliance with protocols recommended by Brazilian Guidelines. A physician shall be responsible for the service provided, preferably with specific knowledge on hypertension, ABPM and HBPM.
IV Guideline for Ambulatory Blood Pressure Monitoring
1. Definition
Ambulatory Blood Pressure Monitoring (ABPM) is a method of recording indirect and intermittent blood pressure readings over a 24-hour period while the patient performs his/her usual activities of daily life, including waking and sleeping hours. The term "holter pressure" should be avoided.
2. Indications, advantages and limitations of ABPM
ABPM allows a large number of blood pressure readings to be recorded, usually over 24 hours, providing BP variations profile during daytime and night-time. Today, evidence shows that the variables obtained by ABPM are better predictors of primary results, that is to say, major cardiovascular events, including myocardial infarction and stroke, when compared to casual office blood pressure measurements.13, 14, 15, 16, 17 Moreover, it offers certain potential advantages over casual office blood pressure measurement, such as, attenuation of observer effect on blood pressure; elimination of record bias; the obtaining of values closer to the patient's usual blood pressure; the possibility of evaluating the effect of blood pressure during night sleep and early morning surge; and evaluation of therapeutic response during the 24-hour period. ABPM is useful for evaluating some clinical conditions (Table 3), and both its advantages (Table 4) and limitations should be considered (Table 5).
3. Equipment
The most commonly used devices currently are those based on the oscillometric method with a cuff attached to the upper arm. Wrist devices should not be used for 24-hour measurements, since they have not been validated (Degree of Recommendation III - Evidence Level D).
4. Protocol for the examination and instructions to patients
The device should be programmed to take BP at least every 30 minutes, in such a way that, at the end of the 24-hour period, a minimum of 16 valid daytime and 8 valid nighttime readings have been taken (Degree of Recommendation I - Evidence Level B)14, 18. At the physician's discretion, in view of a possible loss of measurements or for the purpose of evaluating symptoms, a larger number of readings may be recommended. Also, depending on the goal of the test, for example, to evaluate a sub-period of the 24 hours, a number of readings below the one advocated may be accepted.
The monitor may be installed by a trained nurse or technician, who may instruct the patients. Ideally, a 24-hour phone number should be provided for clarification of doubts and resolution of any problems that may arise, including excessive discomfort, allergic reactions, and edema. Scheduling guidelines (Table 6), installation protocol (Table 7), guidelines protocol for appropriate diary completion (Table 8) and removal protocol (Table 9) are fundamental to the quality of the examination.
5. Repeated ABPM evaluation during follow-up period
There is no consensus recommendation regarding periodicity of ABPM examinations. Nevertheless, it is suggested that:
a) ABPM test be repeated on an annual basis for patients with white-coat hypertension, as these may become hypertensive (Degree of Recommendation IIb - Evidence Level D)19.
b) Blood pressure be evaluated in hypertensive patients under treatment with relevant white-coat effect, usually defined as the difference between casual blood pressure and mean awake ambulatory blood pressure equal to or higher than 20 mmHg for systolic pressure and 10 mmHg for diastolic pressure (Degree of Recommendation IIb - Evidence Level D)20.
6. Costs of the examination
The costs should not be considered a limitation for the test, because therapeutic and diagnostic approaches based on ABPM do not necessarily raise the overall cost of treatment, since ABPM may allow identification of patients with white-coat hypertension, decrease prescription of anti-hypertensive drugs and reduce the number of visits to the doctor21. (Degree of Recommendation I - Evidence Level B).
7. Reproducibility of the Method
ABPM examination demonstrates good reproducibility (Degree of Recommendation I - Evidence Level C). Values of systolic, diastolic, and mean blood pressure, as well as heart rate obtained in a 24-hour period, daytime and night-time, demonstrate similar results in consecutive tests performed within a short-time interval22-23. Blood pressure variation between daytime BP and night-time BP also shows good reproducibility, when considered as a continuous variable. Conversely, reproducibility of conditions with and without nocturnal dip has been debated in the literature, because 30% to 50% of the individuals are likely to change category in subsequent tests24. Variation phenomenon between awake and asleep BP, therefore, should be considered in its percentage and absolute value in mmHg.
8. Normal values for blood pressure obtained by ABPM
8.1. Mean blood pressures
Among all parameters derived from ABPM, mean blood pressures are the best data to be analyzed, because they have higher indices of correlation with diagnosis, target organ damage, and cardiovascular prognosis, and are the only ones associated with mortality25. Analysis of 24-hour periods, waking and sleeping hours, is critical for evaluation of mean blood pressures (Degree of Recommendation IIa - Evidence Level B).
As in the case of casual blood pressure measurement, normali-ty criteria for pressure values obtained by ABPM are arbitrary. Table 10 shows values considered abnormal for ABPM (Degree of Recommendation IIb - Evidence Level B). For the adult population, abnormal readings represent only a guide to interpretation of the test. Lower pressure levels may be clinically significant in patients with multiple risk factors and/or associated diseases (Degree of Recommendation IIb - Evidence Level D). It is important to emphasize that no longitudinal studies have been conducted with ABPM within the Brazilian population. Mean systolic and diastolic values obtained by ABPM during daytime are usually lower than those obtained by casual measurements14, 26-28.
Clinical relevance of specific periods, such us the first hours after waking and during the afternoon nap, is yet to be established. In hypertensive elderly Japanese, it was demonstrated that the rapid surge in blood pressure during the first two hours after waking is associated with a higher incidence of stroke (Degree of Recommendation IIb, Evidence Level B)29.
8.2. Blood pressure loads and areas under the curve (AUC)
Although the percentage of values above a fixed threshold was defined since 1988, this criterion has been widely criticized. One of the most consistent criticisms refers to the fact that the same value of blood pressure loads may mean different behaviors estimated by mean blood pressures.
Despite the fact that a direct relationship between load values, especially above 50%, and damage to target organs has been documented, the trend observed in the most recent guidelines for ABPM is to not consider blood pressure loads in clinical interpretation (Degree of Recommendation IIa, Evidence Level B)20,31.
Even though some suggestions have been made regarding the use of calculations of the areas under the curve for evaluating pressure behavior, there is a need for studies on their application (Degree of Recommendation IIa, Evidence Level B).
8.3. Mean blood pressure, pulse pressure and variability
Mean blood pressure is provided by the examination, its applicability being restricted to clinical research.
In spite of the great clinical relevance placed on pulse pressure, based on casual measurements and with strong evidence of pro gnostic implications, so far there are no criteria for the interpretation of this parameter by ABPM. A study conducted with a limited number of patients, however, shows that pulse pressure evaluated by ABPM may also have prognostic implications (Degree of Recommendation IIa, Evidence Level B).8
It is known that blood pressure variability (BPV) has a strong prognostic correlation with cardiovascular events and the development of target organ damage. Nevertheless, only through continuous blood pressure recording (beat-to-beat), can variability be appropriately evaluated, unlike 24-hour BP recordings. Standard deviation of mean blood pressure obtained by ABPM should not be used as indicative of blood pressure variability, because as yet there are no normality criteria for its interpretation (Degree of Recommendation III - Evidence Level D).
8.4. Heart rate
Despite recording heart rates, ABPM devices are not appropriate for measuring this parameter; thus, they should not be considered, except in the cases of devices that can register 24-hour ECG simultaneously (Degree of Recommendation III - Evidence Level D.)
8.5. Day-night differences in blood pressure
The definition of awake and asleep periods relies heavily on the accurate recording of times when the individual undergoing the test slept and woke up. This data should be clearly recorded in the activities diary. The quality of sleep reported by the patient throughout the examination should be taken into account in interpreting wake-sleep pressure variations (Degree of Recommendation I - Evidence Level C).
Usually, there is a decrease, or dip, in systolic and diastolic BP during sleep, compared to the waking period. It was noted that a decrease of less than 10% in hypertensive individuals is related to a worsening in the cardiovascular prognostic32. The clinical significance of lack of blood pressure decrease during sleep also was confirmed in normotensive patients33. Kario et al.34 showed that, in elderly hypertensive patients with nocturnal dips greater than 20%, there was an increase in cardiovascular risk, especially of stroke.
It should be remembered that either a reversal of physiological behavior in awake and asleep pressure or a lack of nocturnal dip might be related to certain circumstances, such as sleep disorder caused by the examination, inappropriate blood pressure control in treated patients and, in some cases, secondary hypertension, sleep apnea, dysautonomia, and use of some drugs such as cyclosporine.
Day-night blood pressure variation can be expressed in absolute values (mean awake BP - mean asleep BP); day/night BP ratio (mean asleep BP/mean awake BP x 100); or in percentage values (mean awake BP - mean asleep BP/mean awake BP x 100. Table 11 shows a classification of the percentage variation of systolic and diastolic awake-asleep blood pressure, according to Ohkubo et al.25 (Degree of Recommendation IIa - Evidence Level B). If there is a dip in systolic and diastolic blood pressures that belong to different classifications, they should be described separately in the report (Degree of Recommendation I - Evidence Level D).
9. ABPM in special situations and populations
9.1. Children and adolescents
In children and adolescents, ABPM is indicated for suspected white-coat hypertension35, evaluation and follow-up of primary and secondary hypertension or conditions with associated risk of arterial hypertension, such as diabetes mellitus36-37, chronic pyelonephritis38, chronic renal failure39-40, and autosomal dominant polycystic kidney disease41, because it shows better correlation with the development of target organ damages than office blood pressure measurement (Degree of Recommendation IIa - Evidence Level C).
Only a few ABPM devices have been validated for use in children. Applicability, however, is promising, and there have been reports of good precision and reproducibility42. The success percentage in obtaining measurements increases with age42-43. The primary limitation to its use in children and adolescents is the lack of normative pediatric values. Values were defined using, as a reference for awake blood pressure, the 95th percentile of the tables of casual blood pressure measurement for age, sex and height, and, during sleep, normal values 10% below these44. When the value corresponding to the 95th percentile is greater than the limits of normality established for the adult population, the values applicable to adults should be considered for the reports (Degree of Recommendation IIb - Evidence Level D). Just as in the case of adults, there is a tendency to consider the 90th percentile as limit of normality, especially in the presence of comorbidities. The relevance of and normality criteria for pressure loads and dip in blood pressure during sleep in children and adolescents have not yet been established.45
9.2. Elderly patients
ABPM can provide valuable clinical support for suspected orthostatic, postprandial, drug-related and situational arterial hypotension, as well as for evaluation of patients with dysautonomia and syncope (Degree of Recommendation IIa - Evidence Level D)26. In elderly individuals with isolated systolic hypertension, ABPM is useful to rule out white-coat effect (Degree of Recommendation IIa - Evidence Level A)46. Some limitations must be emphasized in this age group. Age-related arterial stiffening underestimates blood pressure measurement obtained by the oscillometric method and thus, ABPM is subject to errors in the presence of pseudo-hypertension47. The presence of auscultatory gap, commonly seen at an elderly age, might compromise the evaluation by the auscultatory method48. The same normality values applied to younger adults are accepted for elderly individuals (Degree of Recommendation I - Evidence Level D)26. Elderly individuals with high blood pressure variability, however, often sleep during the day, and suffer from sleep disorders. Thus, special care should be taken when registering activities in the diary, emphasizing these aspects, which must be taken into account during ABPM evaluation. The use of asleep and awake preset periods is not advisable. The drawback of nocturnal dip, increased pulse pressure, and early morning surge in blood pressure, common among the elderly, are related to increased cardiovascular risk21,46,49.
9.3. Pregnant women
Ambulatory blood pressure monitoring during pregnancy has been used to identify white-coat hypertension, whose prevalence is similar in both pregnant and nonpregnant women. Its identification is critical, however, during pregnancy to prevent unnecessary treatment that could be potentially harmful to the fetus (Degree of Recommendation IIa - Evidence Level B)51-52. Diagnosis of preeclampsia by ABPM, suggested by sleep-wake cycle alteration is still controversial, since a number of cases with confirmed diagnosis do not show this alteration53-54. Nevertheless, when found, it must be taken into account. The possibility of anticipating the development of preeclampsia by ABPM has not been confirmed55. ABPM reference parameters during pregnancy concur with the findings of a linear decrease in blood pressure during the first half of pregnancy measured by casual blood pressure, followed by a continuous increases until delivery. Table 12 shows the mean values observed in each trimester of pregnancy (Degree of Recommendation IIa - Evidence Level C)56.
9.4. Diabetes mellitus
ABPM in diagnosed diabetics may contribute to clarify symptoms related to hypotension secondary to autonomic neuropathy (syncope, dizziness, sweating among others), thus aiding differential diagnosis with hypoglycemia. In addition, it can help in the identification of patients with masked hypertension.26 Although the change in wake-sleep pattern seems to be associated with the development of microalbuminuria and increased cardiovascular risk26,57-59, these findings are still debatable (Degree of Recommendation IIa - Evidence Level C). The target value for controlling casual blood pressure in the hypertensive diabetic patient is lower than that for hypertensives in general. This value for ABPM, however, has not yet been established, and this must be taken into account in the report.
9.5. Obesity
Indications for the use of ABPM in obese patients are the same as those for the general population (Degree of Recommendation I - Evidence Level D). As the buildup of fat tissue may preclude blood pressure measurement by the auscultatory method, the oscillometric is preferred.26 Use of the appropriate cuff for arm circumference cannot be over-stressed. In obese patients with arm circumference above 20,5 inches or short arms, the examination is contraindicated, because ABPM devices do not have appropriate cuffs (Degree of Recommendation III - Evidence Level D)27.
It should also be emphasized that in obese patients, particularly those with visceral fat distribution, an increased frequency of alert reactions to casual blood pressure measurement has been reported, causing a higher prevalence of white-coat phenomenon.60-62
9.6. Renal failure
The target value for controlling casual blood pressure in hypertensive patients with renal disease is lower than that for hypertensives in general. This value for ABPM, however, has not yet been established, and this must be taken into account in the report. In hemodialysis patients, a 24-hour ABPM may identify changes in wake-sleep patterns and detect hypotension episodes, but do not provide an evaluation of blood pressure along the dialysis cycle63. Thus, the use of a 44-hour ABPM (installed after a hemodialysis session and removed just before the next session) allows a more complete evaluation. When performed during 24 hours, the analysis of the report should consider whether the test was conducted on the day of the dyalisis session or between sessions. In this population, the cuff cannot be placed on the arm of patients with arteriovenous fistula. Blood pressure pattern behavior during sleep do not change in most patients submitted to continuous ambulatory peritoneal dialysis (CAPD)63.
9.7. Heart failure
ABPM may be indicated to optimize treatment in patients with heart failure whose symptoms are related to blood pressure changes, such as paroxysmal nocturnal dyspnea or diastolic heart failure. Likewise, it can useful for orienting therapy of patients with symptoms caused by hypotension. Changes in wake-sleep pattern have been associated to the severity of systolic dysfunction (Degree of Recommendation IIb - Evidence Level C).64, 65
9.8. Heart transplant
In heart transplant patients, ABPM may be used to improve blood pressure control and, thus, minimize cardiac and renal complications related to the use of cyclosporine. These patients sustain loss of modulation of blood pressure and heart rate during sleep, with greater blood pressure variability in the waking period and wake-sleep pattern change (Degree of Recommendation IIb - Evidence Level C)66.
9.9. Sleep apnea syndrome
In patients with clinical signs suggestive of sleep apnea, a change in wake-sleep pattern at ABPM may reinforce this diagnosis67.
9.10. Secondary hypertension
In curable forms of hypertension, once cured, some ABPM variables may reveal changes early, suggesting possible recurrence68.
9.11. Physical exercise and ABPM
Physical exercise should be avoided during ABPM tests, because continuous muscle contraction produces both inaccurate readings and loss of measurements. Indeed, blood pressure obtained during exercise has been validated only for the standard auscultatory method (Degree of Recommendation IIa - Evidence Level B)69.
Aerobics (dynamic exercises involving large muscle groups that are cyclically contracted, at moderate intensity and over a prolonged time - more than 30 minutes - such as, walking, running, cycling, swimming, dancing, etc.), causes post-exercise reduction in blood pressure that lasts up to 16 hours, reducing mean 24-hour post-exercise blood pressure. Such effect is greater in individuals with higher blood pressure levels70, 71, 72. Therefore, exercise should be avoided on the day prior to the examination, especially by individuals who do not practice regularly, or prior exercise should be taken into account when producing the ABPM report (Degree of Recommendation IIa - Evidence Level B).
The recognized blood pressure reduction promoted by regular exercising on casual blood pressure73 has not yet been conclusively established at ABPM71.
Little is known about acute and chronic effects of resistive exercise (weight training) on ABPM74.
10. The role of ABPM on prognostic evaluation of hypertensive patients
Blood pressure values obtained by ABPM are more strongly correlated with target organ damages, morbidity, and mortality than casual blood pressure measurements13-17.
Mean 24-hour systolic and diastolic BP values, daytime and night-time, shows a positive correlation with target organ damages, such as left ventricle hypertrophy, ischemic brain lesions, and microalbuminuria47.
In elderly patients evaluated in the Syst-Eur Study, the variable that showed the best correlation with major cardiovascular events, such as stroke, acute myocardial infarction and death, was sleep systolic BP, followed by 24-hour systolic BP and wake systolic BP15, 25.
Regarding prognosis associated to nocturnal dip, it is known that the magnitude of blood pressure dipping during sleep shows a reverse correlation with cardiovascular outcomes. Thus, for every 5% increment in systolic or diastolic night-day BP ratio, there is a 20% increase in cardiovascular mortality, even in individuals with normal mean blood pressure values obtained by ABPM7, 75.
As for blood pressure variability, which is obtained by the standard deviation of pressure values yielded by ABMP, there is evidence of association with target organ damages76.
On the other hand, the morning surge in blood pressure, calculated by the difference between morning systolic BP (mean blood pressures during the 2 hours after awakening) and the lowest sleep systolic BP (mean lowest reading and the readings immediately before and after), has been demonstrating negative implications on cardiovascular outcomes. In elderly patients, it was found that a morning surge above 55 mmHg was associated to a greater prevalence of ischemic stroke (Figure 2)29.
Pulse pressure, obtained with ABPM and calculated by the difference between mean 24-hour systolic and diastolic blood pressures, was also found to be predictive of events. Values exceeding 53 mmHg are related to an almost five-fold increase in cardiovascular events46. Thus, it has been suggested that daytime BP, pulse BP and the presence of dip during sleep (Figure 3) be used for an additional cardiovascular stratification risk of hypertensive patients diagnosed by casual in-office measurements and left untreated8. Nevertheless, this variables are not indicated as a guide to therapy.
11. Production of reports and interpretation of results
The results are considered valid for an appropriate interpretation when the following aspects are observed: minimum duration of the test - 21 hours; number of valid readings - 16 daytime readings and 8 night-time readings (Degree of Recommendation I - Evidence Level B)14, 18. Tests with 20% or more of manual and/or automatic exclusions of readings are probably due to inadequate technique concerning the device or inappropriate patient behavior. Under some circumstances, such as loss of readings in non-relevant time periods, a number of readings lower than that advocated may be acceptable at the physician's discretion (Degree of Recommendation IIb - Evidence Level D).
It is mandatory that ABPM report includes all of the items listed in table 13 (Degree of Recommendation IIa - Evidence Level D)77.
In accordance with the information currently available, a hypertensive diagnosis using ABPM should not be made, since this is a clinical diagnosis (Degree of Recommendation Ia - Evidence Level A). Upon completion, the report should include normal or abnormal blood pressure behavior, and mention all drugs in use (anti-hypertensives or not) (Degree of Recommendation IIa - Evidence Level D).
12. The future of the method
The judicious use of ABPM based on scientifically acceptable conclusions, and its growing application, will lend the necessary support to a widespread use of the method, exploring its main advantages for the understanding of hypertension and care required for its treatment. The applications and possible uses of ABPM in the future include: a) adjustable cuffs; b) evaluation of other parameters, besides systolic and diastolic pressures, such as heart rate, pulse pressure, pulse velocity and waveform, morning surge in blood pressure; c) development of international unified protocols for validation of devices; d) reference values for 24-hour ABPM; e) prospective studies for prognostic evaluation of diagnoses of populations followed by ABPM; f) determination of the usefulness of ABPM in special populations, including pregnant women, children and diabetics; g) development of reliable, portable and low-cost monitors for non-invasive recording of beat-to-beat blood pressure78-79.
II Guideline for Home Blood Pressure Monitoring
1. Definition
Home Blood Pressure Monitoring (HBPM) refers to an indirect method of recording blood pressure, in the morning and at night, over a five-day period, performed by the patient or other trained person, during daytime, at home or at the workplace. Is should not be mistaken for self-blood pressure monitoring, which is the non-systematized recording of blood pressure conducted according to the orientation of the patient's physician.
2. Indications, advantages, and limitations
Foremost among the primary indications of HBPM (Table 14),80-92, 102 are the assessment of anti-hypertensive therapy and follow-up of patients with white-coat hypertension. HBPM is a useful alternative to overcome the inconveniences associated to blood pressure measurement taken at the physician's office82, 92-104 thanks to its numerous advantages (Table 15), the most important of which are the possibility of taking a greater number of readings outside the office setting and good acceptance of the method. The major limitation of HBPM is the difficulty to take the readings during sleep (Table 16)26, 105-106.
This is not an innovative approach, since in 1940 it was already demonstrated that home measurements yielded values from 30 to 40 mm Hg lower than office measurements107. Blood pressure values obtained by HBPM are lower than those obtained in the office (Degree of Recommendation I - Evidence Level B)108. The development of compact, digital devices that are reliable, validated and affordable allowed the procedure to be used in large scale both in daily clinical practice and research.
3. Equipment
Digital, compact, validated devices fitted with data-storing memory and/or built-in printer, or capable of transmitting data to a central unit are recommended. Most validated devices are designed for upper arm measurement (Degree of Recommendation I - Evidence Level D). Wrist measuring devices are of restricted use (Degree of Recommendation IIb - Evidence Level D), and finger measuring devices are contraindicated (Degree of Recommendation III - Evidence Level D)109-110.
Table 17 lists the factors that should be considered when acquiring a HBPM device.
4. Protocol for performing the examination and instructing the patient
The following protocol is recommended (Table 18) for HBPM examination (Degree of Recommendation IIa - Evidence Level D).
a) performed during the five working days of the week (Degree of Recommendation IIa - Evidence Level D);
b) the first day is dedicated to instructions, training, selection of the arm with the highest blood pressure values, where measurements will be taken (Degree of Recommendation IIa - Evidence Level D), and delivery of the device (Tables 19 and 20) (Degree of Recommendation IIa - Evidence Level D);26, 111-121
c) during the next four days, blood pressure should be taken at least three times in the morning and three times at night, between 6:00 and 10:00 am and 6:00 and 10:00 pm (Degree of Recommendation IIa - Evidence Level A).26, 122-123
5. Normality criteria
Based on the analysis of international studies and guidelines, it is recommended that mean blood pressure above 135/85 mm Hg (Degree of Recommendation I - Evidence Level B) be considered abnormal (Table 21).95, 102, 124-125 Just as in blood pressure measurements taken in the office, lower HBPM values should be considered in high risk patients (diabetes melittus, renal failure and heart failure). In children and pregnant women, normality criteria have not yet been established (Degree of Recommendation I - Evidence Level D).26, 126-128
6. Clinical value of HBPM
6.1. Diagnosis of white-coat hypertension
HBPM allows the diagnosis of white-coat effect and hypertension. Although HBPM is not as appropriate as ABPM in the diagnosis of white-coat hypertension, it is indicated in the follow-up of these patients because of its low cost and convenience (Degree of Recommendation I - Evidence Level B).80, 81, 82, 129
6.2. Evaluation of the efficacy of anti-hypertensive therapy
Because of its low cost,130 good acceptance,131 and ease of use, as well as the possibility to allow medium- and long-term evaluation and distance monitoring, HBPM is appropriate for evaluating the efficacy of anti-hypertensive therapies. Several studies have shown the usefulness of HBPM in the assessment of patients with refractory hypertension (Degree of Recommendation I - Evidence Level A).26, 82, 85, 87-91, 132
6.3. Prognosis of hypertensive patients
Prospective studies have showed an increasing role of HBPM in evaluation of prognosis related to office blood pressure measurement.83, 132, 133 The Ohasama study, which analyzed a large number of individuals during a long time, demonstrated that HBPM is correlated with total cardiovascular mortality rate, morbidity from stroke and non-cardiovascular mortality.132 The 10-year follow-up period showed that the rise of 10 mmHg in blood pressure obtained by HBPM increased stroke risk by 35%.
Several studies have shown that HBPM has a better correlation with the left ventricle mass index than office measurement (Degree of Recommendation I - Evidence Level C).108, 134
7. Interpretation of data obtained and production of reports (Degree of Recommendation I - Evidence Level D)
The HBPM report should include the following aspects:
a) Description of the protocol followed
b) Quality of the procedure
The record should be accepted for interpretation when it reaches at least 12 valid measures (Degree of Recommendation I - Evidence Level B), as long as there are valid measures each day during the test (Degree of Recommendation IIa - Evidence Level D)90, 133. Aberrant measurements should be excluded, such as diastolic pressure above 140 mmHg and below 40 mmHg, systolic pressure below 70 mmHg and above 250 mmHg and pulse pressure below 20 mmHg or above 100 mmHg, provided there is no clinical justification (Degree of Recommendation I - Evidence Level D).
c) Mean blood pressures
The report should include both daily mean blood pressure and total blood pressure. It is interesting to analyze mean blood pressure values obtained in the morning and at night, especially in patients under drug therapy. These mean values are obtained through effective records of at least four days, excluding values collected in the first day of monitoring. It should be emphasized that the values obtained during this day should be included in the record for evaluation of the alarm reaction. When mean blood pressures are above 135 and/or 85 mm Hg, it is recommended that the test be considered as abnormal (Degree of Recommendation I - Evidence Level A)95, 124-125.
8. Special situations
8.1. Elderly patients
Physical and cognitive limitations may restrict use of HBPM in geriatric patients, making the aid of another person necessary in order to ensure compliance with protocol. Special attention should be given to the increase of arterial stiffening, often seen in these patients, which may compromise the accuracy of dada obtained through the use of oscillometric devices. Prior evaluation through Osler maneuver may be useful for identification of these cases. Studies have shown the benefit of HBPM in therapeutic control of elderly patients (Degree of Recommendation I - Evidence Level B).83, 90
8.2. Pregnant women
This method may be useful for evaluation of white-coat hypertension in pregnant women. The few studies available suggest the value of HBPM in the gestational period, because it allows better control of blood pressure and reduces the number of visits (Degree of Recommendation I - Evidence Level C).128, 135
8.3 Children and adolescents
There are few studies using HBPM in children and adolescents, and this restricts its clinical application. Despite being a complementary source of information, it should not be used for decision making in this population (Degree of Recommendation I - Evidence Level D)126.
9. Perspectives of HBPM
Some devices currently available can store records and transmit them via telephone or internet to a central computer, providing greater adherence and better control of blood pressure with fewer number of visits to the doctor's office (Degree of Recommendation I - Evidence Level B)127, 136-138.
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Moderadores: Décio Mion Jr. e Osvaldo Kohlmann Jr. (SP);
Publication Dates
-
Publication in this collection
29 Sept 2005 -
Date of issue
July 2005
