CLINICAL RESEARCH: ORTHOSTATIC HYPOTENSION
Lower Limb and Abdominal Compression Bandages Prevent Progressive Orthostatic Hypotension in Elderly Persons
A Randomized Single-Blind Controlled Study
Cristian Podoleanu, MD*,
Roberto Maggi, MD ,
Michele Brignole, MD,*,
Francesco Croci, MD,
Alexander Incze, MD*,
Alberto Solano, MD,
Enrico Puggioni, MD and
Emilian Carasca, MD*
* Cardiologie–Clinica Medicala 4, Spitalul Clinic de Urgenta, University Hospital, Targu Mures, Romania
Department of Cardiology and Arrhythmologic Center, Ospedali del Tigullio, Lavagna, Italy
Manuscript received March 27, 2006;
revised manuscript received May 8, 2006,
accepted May 29, 2006.
* Reprint requests and correspondence: Dr. Michele Brignole, Department of Cardiology, Arrhythmologic Center, Ospedali del Tigullio, Via don Bobbio 24, 16033 Lavagna, Italy (Email: mbrignole{at}ASL4.liguria.it).
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Abstract
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OBJECTIVES: This study sought to assess the efficacy of compression bandage of legs and abdomen in preventing hypotension and symptoms.
BACKGROUND: Progressive orthostatic hypotension can occur in elderly people during standing.
METHODS: Twenty-one patients (70 ± 11 years) affected by symptomatic progressive orthostatic hypotension underwent 2 tilt-test procedures, with and without elastic bandage of the legs (compression pressure 40 to 60 mm Hg) and of the abdomen (compression pressure 20 to 30 mm Hg) in a randomized crossover fashion. Leg bandage was administered for 10 min and was followed by an additional abdominal bandage for a further 10 min. Symptoms were evaluated by a 7-item Specific Symptom Score (SSS) questionnaire before and after 1 month of therapy with elastic compression stockings of the legs (prescribed in all patients irrespective of the results of the tilt study).
RESULTS: In the control arm, systolic blood pressure decreased from 125 ± 18 mm Hg immediately after tilting to 112 ± 25 mm Hg after 10 min of sham leg bandage and to 106 ± 25 mm Hg after 20 min despite the addition of sham abdominal bandage. The corresponding values with active therapy were 129 ± 19 mm Hg, 127 ± 17 mm Hg (p = 0.003 vs. control), and 127 ± 21 mm Hg (p = 0.002 vs. control). In the active arm, 90% of patients remained asymptomatic, versus 53% in the control arm (p = 0.02). During the month before evaluation, the mean SSS score was 35.2 ± 12.1 with dizziness, weakness, and palpitations accounting for 64% of the total score. The SSS score decreased to 22.5 ± 11.3 after 1 month of therapy (p = 0.01).
CONCLUSIONS: Lower limb compression bandage is effective in avoiding orthostatic systolic blood pressure decrease and in reducing symptoms in elderly patients affected by progressive orthostatic hypotension.
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Abbreviations and Acronyms
| | SSS-OI = Specific Symptom Scale Questionnaire for Orthostatic Intolerance |
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Progressive orthostatic hypotension is commonly seen in elderly persons because of age-related impairment in baroreflex-mediated vasoconstriction and chronotropic response of the heart, as well as deterioration of the diastolic filling of the heart (1,2). In patients with impaired compensatory reflexes, the increased downward pooling of the venous blood and the consequent reduction in stroke volume and cardiac output exaggerates the orthostatic decrease of the blood pressure (1).
Progressive orthostatic hypotension is characterized by a slow progressive decrease of systolic blood pressure on the assumption of a standing position. Typically these patients remain asymptomatic initially after standing and develop hypotensive symptoms that cause orthostatic intolerance after a few minutes of standing. Thus, their hemodynamic profile on standing differs from the immediate hypotension with or without a reflex compensatory tachycardia described in patients with pure autonomic failure (3) or other forms of dysautonomia (4) during a gravitational stimulus. This form of orthostatic hypotension is frequently diagnosed by tilt testing, which shows the typical patterns of decrease of systolic blood pressure over several minutes (5,6), whereas it may remain undetected using the classic criteria for the diagnosis of orthostatic hypotension recommended by the American Autonomic Society (7,8) because of the lack of a significant decrease in blood pressure within 3 min of standing. In a recent systematic study on patients referred urgently to general hospitals (9), progressive orthostatic hypotension was established by tilt testing in 9 of 46 patients affected by syncope caused by orthostatic hypotension. Clinical features of progressive orthostatic hypotension may mimic those of vasovagal syncope, suggesting that the pathophysiology of both disorders might be similar (5,6,9,10).
The cerebral hypoperfusion caused by hypotension leads to the clinical manifestation of orthostatic intolerance, which has a strong negative impact on the quality of life of patients (11,12).
We hypothesized that the use of elastic compression bandage of the legs and abdomen could be a simple and efficient means of counteracting orthostatic volume shift, thus avoiding orthostatic hypotension and its symptoms.
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Methods
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The study enrolled patients with documented symptomatic progressive orthostatic hypotension causing symptoms of orthostatic intolerance. The study consisted of an acute tilt-table efficacy study of elastic bandage and a clinical follow-up feasibility study. The study was approved by the ethical committee of the 2 participating hospitals, and the patients gave their informed consent to participate.
Enrollment.
We studied patients who had: 1) symptoms and signs of orthostatic intolerance (i.e., patients were asymptomatic after standing in the initial 3 min), but afterward they could not tolerate the standing position because they had increasing hypotensive symptoms (dizziness, presyncope, weakness, palpitations, hyperhidrosis, and so on) caused by cerebral hypoperfusion; and 2) documentation of a progressive decrease in blood pressure pattern during diagnostic tilt testing (as shown in the left panels of Figs. 1, 2, and 3), with reproduction of spontaneous symptoms or asymptomatic decline of systolic blood pressure to or below a value of 90 mm Hg. Exclusion criteria were the inability of the patient to collaborate and to perform tilt testing.
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Figure 1 Case patient. From top to bottom are shown heart rate (HR) curve and blood pressure (BP) curves (systolic and diastolic). The arrows indicate the passage from supine to standing and vice versa. (Left panel) Inactive sham treatment. There is an absence of adaptation of blood pressure to the upright position. Blood pressure declines slightly and progressively throughout the test. Systolic blood pressure declines below 80 mm Hg for 6 min, and the patient has severe presyncopal symptoms. Heart rate continuously increases until the end of the test. There is no clear vasovagal reaction. (Right panel) Active treatment. There is a slight decrease in blood pressure and a heart rate increase immediately after standing, then these parameters stabilize all along the treatment period.
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Figure 2 Case patient. From top to bottom are shown heart rate (HR) curve and blood pressure (BP) curves (systolic and diastolic). The arrows indicate the passage from supine to standing and vice versa. (Left panel) Inactive sham treatment. There is an absence of adaptation of blood pressure to the upright position. Blood pressure progressively declines throughout the test; after 8 min there is a sudden decrease in blood pressure. After an initial slight increase, heart rate also declines. The patient becomes syncopal. The decrease in heart rate in association with blood pressure decrease suggests a late activation of a vagal reflex, which is triggered by the initial dysautonomia. Thus the mechanism producing reflex syncope seems to be different from that of the typical vasovagal reaction usually observed in younger subjects. (Right panel) Active treatment. There is a slight decrease in all parameters after standing, then they stabilize all along the treatment period.
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Figure 3 Patient case. From top to bottom are shown heart rate (HR) curve and blood pressure (BP) curves (systolic and diastolic). The arrows indicate the passage from supine to standing and vice versa. (Left panel) Inactive sham treatment. There is an absence of adaptation of blood pressure to the upright position. Blood pressure declines slightly and progressively throughout the test. Systolic blood pressure declines below 80 mm Hg. Heart rate remains stable at about 50 beats/min (chronotropic incompetence pattern). (Right panel) Active treatment. Treatment increases blood pressure during the test. Heart rate remains stable at about 50 beats/min (chronotropic incompetence pattern).
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Finally, to assess the burden of the symptoms of orthostatic intolerance, we developed a specific symptom questionnaire that was administered to the patients at baseline and after 1 month of treatment with elastic leg compression stockings.
The evaluation at enrollment consisted of a detailed medical history and physical examination and execution of the diagnostic tilt test (eligible patients were referred for the acute tilt-table study to be performed on a different day; their baseline characteristics are shown in Table 1). Moreover, the patients were asked to complete the questionnaire, and the baseline value of Specific Symptom Scale Questionnaire for Orthostatic Intolerance (SSS-OI) was calculated. Concomitant medications were recorded and left unchanged during the study.
Acute tilt-table study.
The acute tilt-table study was a single-blind, placebo-controlled, randomized, crossover study that was designed to evaluate the ability of compression bandage applied over the legs and abdomen to prevent orthostatic hypotension and to reduce the symptoms of orthostatic intolerance. The patients underwent two tilt tests during the same day, at least 1 h apart to allow for complete recovery of baseline parameters. During active compression treatment, an elastic bandage was applied over the legs (with a pressure of 40 to 60 mm Hg at the ankles and 30 to 40 mm Hg at the hip) for 10 min, then an abdominal bandage was added for a further 10 min (with a pressure of 20 to 30 mm Hg). During inactive sham treatment, the same elastic bandages were applied with a pressure of 5 mm Hg overall (Fig. 4). A cuff manometer was used to calibrate the appropriate pressure of the bandage. The type of treatment was blinded to the patient. The sequential order of the treatments was randomized; the randomization sequence was computer generated and blocked per center. The treatment—and the test—were interrupted if syncope occurred or intolerable hypotensive symptoms developed.
The modified Italian tilt protocol (13,14), consisting of 60° passive tilting for 20 min followed by 0.4 mg nitroglycerine challenge for a further 20 min when the passive phase failed to induce syncope, was used for the diagnostic test and for the acute study. The electrocardiogram tracing was continuously recorded, and the blood pressure was monitored noninvasively (Finapres Ohmeda, Madison, Wisconsin; Task Force Monitor, CNSystem, Graz, Austria; and ABPM 04, Meditech, Budapest, Hungary). If the diagnostic tilt test result was positive during the passive phase, the acute study was performed only during passive tilt; conversely, if the diagnostic tilt result was positive during the drug challenge, the acute study was performed directly after administration of nitroglycerine without a passive phase.
Symptom questionnaire.
The most common posture-related symptoms (12,15) were included in a self-administered SSS-OI. The questionnaire evaluated the following symptoms grouped into 7 items: dizziness and presyncope; visual disturbances (including blurring, color changes, white-out, gray-out, enhanced brightness, darkening or blackening, and tunnel vision); syncope; hearing disturbances (including impaired hearing, crackles, and tinnitus); pain in the neck (occipital/paracervical and shoulder region), low back pain, or precordial pain; weakness, fatigue, lethargy; palpitations and hyperhidrosis. The patients were asked to asses the severity of each of the aforementioned symptoms on a visual scale from 0 to 10 (10 = maximum entity of the symptom). The sum of scores of the 7 items was the total symptom score (maximum score, 70). The questionnaire was administered to the patients at baseline before the diagnostic tilt test, and was repeated after 1 month of treatment with elastic leg compression stockings.
The results of the SSS-OI questionnaire were compared with those obtained in 21 age- and gender-matched hospitalized subjects. They had a similar mean age (70 ± 9 years), gender (11 female subjects), and mean number of comorbidities (2.6 ± 1.6) as the patients.
Follow-up.
Irrespective of the results of the acute tilt phase, all patients were trained to apply daily elastic leg compression stockings. The elastic compression stockings were chosen from among those commonly available to have a nominal degree of compression of 40 to 60 mm Hg at the level of the ankles and 30 to 40 mm Hg at the level of the hip (Fig. 5). Thereafter, the patients were seen and were asked to complete the questionnaire again after 1 month. Finally, their compliance and comfort with the therapy was evaluated after 6 months of follow-up.
Statistical methods.
Intrapatient comparison was carried out by means of 2-tailed paired Student t test for continuous variables and the McNemar test for proportions. The treatment-period interaction (carryover effect) was tested by a t test applied to the individual sum of the first- and second-period data.
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Results
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From April to September 2005, 21 patients met the inclusion criteria and were recruited (Table 1).
Acute tilt-table study results.
The results are shown in Table 2 and Figure 6. In the inactive sham treatment arm, systolic blood pressure decreased from 125 ± 18 mm Hg immediately after tilting to 112 ± 25 mm Hg after 10 min of placebo leg bandage and to 106 ± 25 mm Hg after 20 min despite the addition of placebo abdominal bandage. The corresponding values with active therapy were 129 ± 19 mm Hg, 127 ± 17 mm Hg (+15 ± 19 mm Hg vs. placebo, p = 0.003 vs. placebo) and 127 ± 21 mm Hg (+23 ± 26 mm Hg vs. placebo, p = 0.002 vs. placebo), respectively. The difference became statistically significant starting from the fourth min after standing. Hypotensive symptoms occurred in 7 patients (33%) with inactive sham treatment and in 3 patients (14%) in the active treatment arm (not significant) during the leg bandage phase and in 9 (47%) and 2 (10%), respectively, during the leg plus abdomen bandage phase (p = 0.02). Significant carryover or period effect was not observed (Fig. 7).
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Table 2. Effects of Elastic Bandage During Tilt Testing in the 20 Patients With Progressive Orthostatic Hypotension
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Figure 6 (A, B) Acute tilt-table study results. Systolic blood pressure (A) and heart rate (B) in the active treatment arm (continuous line) and control arm (dotted line). Values are expressed as mean ± 1 SE. During the test, some patients had syncope and the test was interrupted; numbers at the top refer to patients free of syncope at that time. (A) With inactive sham treatment there was a progressive decrease in systolic blood pressure all along the test; on the contrary, after a mild decrease from supine to standing, bandage maintained pressure at a stable level all along the test. The difference became significant (p < 0.05) from the fourth minute to the end of the test. The small nonsignificant higher value of blood pressure in the supine position in the active treatment arm is likely to be caused by an effect of an elastic bandage already present in the supine position. (B) Heart rate behavior was similar in the 2 study arms. There was a progressive compensatory heart rate increase all along the test of similar entity with both treatments. HR = heart rate; SBP = systolic blood pressure.
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Figure 7 (A, B) Evaluation of the effect of the two sequences of randomization and the treatment–period interaction (carryover effect) on decrease in systolic blood pressure (with standard error of the mean bars) during leg bandage (A) and leg plus abdomen bandage (B). SBP = systolic blood pressure.
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Overall, the test was prematurely interrupted because of severe symptoms in 5 patients (24%) in the control arm and in no patient in the active treatment arm (p = 0.07).
Symptom burden.
In patients, at baseline, the most frequently encountered symptoms were dizziness/presyncope, weakness/fatigue, and palpitations/hyperhidrosis, which together accounted for 64% of the total symptom score of the SSS-OI questionnaire (Fig. 8). Overall, the SSS-OI score was 35.2 ± 12.1 (Table 3). After 1 month of therapy, the SSS-OI score decreased to 22.5 ± 11.3 (p = 0.01), which means a relative reduction of 34% (95% confidence interval 28 to 38). Dizziness, weakness, visual disturbances, and palpitations were the symptoms that improved the most.
In control subjects, the total score was 10.4 ± 5.6 (p = 0.01 vs. patients); every item of the SSS-OI was also significantly lower than the corresponding value observed in patients.
After 6 months of follow-up, 15 (71%) patients continued to use elastic stockings (12 daily and 3 intermittently) and 13 (62%) declared that they were comfortable and satisfied with that therapy.
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Discussion
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The study population was affected by progressive orthostatic hypotension that caused an inability to tolerate a standing position and caused important impairment of the quality of life, mainly because of dizziness, presyncope, weakness, and palpitations. The median time to symptom onset was 20 min during tilt testing. These patients were elderly, with a mean of 3.2 associated comorbid conditions under treatment and a mean of 2.2 vasoactive medications. In this, the population was very different from that affected by the common form of "rapid" orthostatic hypotension, in which symptoms occur after a few seconds. Classically, studies dealing with orthostatic intolerance have focused on patients with orthostatic hypotension caused by autonomic failure. The definition commonly used of a systolic blood pressure decrease >20 mm Hg or to below 90 mm Hg within 3 min (7,8) comes from a consensus designed to be used in patients with autonomic failure. Progressive orthostatic hypotension is a condition different from classical "rapid" autonomic failure (3,4).
The acute placebo-controlled study showed that an elastic bandage applied over the legs and abdomen is able to improve systemic blood pressure and to reduce symptoms in patients affected by progressive orthostatic hypotension. We used a 2-step protocol in which compression of the legs was followed by compression of both legs and abdomen. Leg compression alone was effective compared with placebo and seems to be sufficient in most patients. Abdominal bandage has an additive effect.
In the uncontrolled clinical follow-up feasibility study, home treatment based on self-administered elastic leg stockings was feasible, safe, and well accepted by the majority of patients. Moreover, in the short-term period, this treatment halved the symptom burden of the patients; these results were consistent with the short-term findings. Although elastic stockings were well accepted and tolerated during the short-term follow-up duration of this study, a common experience of clinicians treating patients with autonomic failure is that elastic bandage is not well accepted in the long term. The use of stockings instead of bandages and the fact that most of our patients were old or very old could explain the good compliance we observed. However, studies with longer follow-up measuring the comfort of the patients are needed.
Elastic bandage has been previously evaluated in patients affected by the common form of rapid orthostatic hypotension. In one randomized crossover study, it was shown that the lower limb compression bandage was effective in preventing signs and symptoms of postural hypotension but did not reduce the incidence of postural hypotension (15). Another study showed that compression of the abdomen is more effective than compression of the legs in preventing the decrease in blood pressure while standing in patients with orthostatic hypotension (16). In patients with neurogenic orthostatic hypotension, abdominal compression increases standing blood pressure to a varying degree by increasing stroke volume (17).
Among alternative treatments that were shown to be effective in the common form of orthostatic hypotension, physical counter-maneuvers (leg crossing, squatting, bending forward, skeletal muscle pumping) are probably of less utility in progressive orthostatic hypotension because they cannot be applied for a longer time (18,19). Moreover, in elderly and incapacitated people, who often have comorbid conditions that limit their mobility, these measures are difficult to achieve. Volume expanders and vasoconstrictor drugs are effective (20–22), but they are often contraindicated in patients with cardiovascular diseases. Pharmacological treatment is often problematic in hypertensive patients, who usually are on combination therapy (11). A home-based resistance training program using specially designed exercises resulted in no change in the orthostatic pressure (23). Although the use of external mechanical compression devices (antigravity suit) or portable folding chairs proved to be an effective approach (24,25), these methods seem to be difficult to manage and are not very much used. For these reasons we suggest that the simple elastic bandage is appropriate to use in this patient population.
The rationale for the use of elastic compression bandage is to apply external counter pressure to the capacitance beds of the abdomen and legs to improve the venous return to the heart. In patients with impaired compensatory reflexes, the increased downward pooling of the venous blood and the consequent reduction in stroke volume and cardiac output exaggerates the orthostatic decrease in blood pressure (1). The location of the excessive blood pooling seems to be the abdominal compartment and the leg skin vasculature. Approximately 80% of the blood pooled in the lower limb is contained in the upper limb (thighs, buttocks), with less pooling in the calf and foot (1,26). The individual tolerance of postural blood pressure decrease is variable. Some patients remain asymptomatic even after a decrease in mean arterial pressure of 40 mm Hg or more, whereas others become symptomatic even with a systolic blood pressure above 120 mm Hg. The range of symptoms is very broad (11). They have a negative impact on the quality of life of the affected patient. The magnitude of these symptoms (and their burden on quality of life) largely depends on the impairment of the target organs or their vascular supply. Dizziness, presyncope, and weakness are caused mainly by cerebral and muscular hypoperfusion secondary to systemic blood pressure decrease; palpitations and hyperhidrosis are thought to be caused by a compensatory increase in sympathetic activity; pain in the neck ("coat-hanger" pain), low back pain, and precordial pain probably are caused by comorbid conditions (musculoskeletal degenerative disease, ischemic heart disease) (12).
Study limitations.
Even if the rationale for the use of elastic compression bandage is the improvement of the venous return to the heart caused by external lower limb compression, we did not perform a direct measure of venous return to confirm its mechanism. However, this effect seems to be sufficiently proven in the literature to warrant no additional investigation (1,26).
The prospective follow-up study was designed to evaluate the feasibility and compliance of elastic stockings, but not their efficacy. Furthermore, although we measured the magnitude of the applied pressure with elastic bandage in the acute study in any individual patient, the pressure of the elastic stockings was nominal as made by the manufacturer. Finally, it is a common experience that the magnitude of elastic compression may vary over time with the prolonged usage of the stockings. For all of these reasons, no definite conclusion regarding the efficacy of elastic stockings over the long term can be drawn from this study until confirmed by formal randomized long-term therapy studies. However, the physiology and clinical experience seem to be sufficient to warrant their use in clinical daily practice.
The patients were taking vasoactive medications potentially worsening orthostatic tolerance, and these could not be discontinued because of associated comorbidities. However, these medications were left unchanged all along the study period.
Conclusions.
Lower limb compression bandage is effective in avoiding orthostatic systolic blood pressure decrease and reducing symptoms in elderly patients affected by progressive orthostatic hypotension. Home treatment based on self-administered elastic leg stockings seems feasible, safe, and well accepted by most patients. If the efficacy of the therapy is confirmed in a larger controlled follow-up study, elastic compression stockings may become a widely used therapy.
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References
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Abstract
Methods
