Compression Garments for the Legs

Number: 0482

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses compression garments for the legs.

1. Medical Necessity

   1. Aetna considers inflatable compression garmentsFootnote*, non-elastic bindersFootnote**, or individually fitted prescription graded compression stockingsFootnote*** as medically necessary for members who have any of the following medical conditions:

      1. Treatment of any of the following complications of chronic venous insufficiency:
         
         
         1. Lipodermatosclerosis
         2. Stasis dermatitis (venous eczema)
         3. Varicose veins (except spider veins)
         4. Venous edema
         5. Venous ulcers (stasis ulcers);
      2. Edema accompanying paraplegia, quadriplegia, etc.;
      3. Edema following surgery, fracture, burns, or other trauma;
      4. Persons with lymphedema (see CPB 0069 - Lymphedema);
      5. Post sclerotherapyFootnote****;
      6. Post-thrombotic syndrome (post-phlebitic syndrome);
      7. Postural hypotension;
      8. Prevention of thrombosis in immobilized persons (e.g., immobilization due to surgery, trauma, general debilitation, etc.);
      9. Severe edema in pregnancy;
   2. Silver impregnated compression stockings are considered not medically necessary because there is insufficient evidence that silver impregnated compression stockings are superior to standard compression stockings;
      
      
   3. Replacements
      
      
      1. Replacements are considered medically necessary when the compression garment can not be repaired or when required due to a change in the member's physical condition. For pressure gradient support stockings, no more than 4 replacements per year are considered medically necessary for wear.
      2. Two pairs of compression stockings are considered medically necessary in the initial purchase (the 2nd pair is for use while the 1st pair is in the laundry).

2. Experimental and Investigational

   1. Compression garments for the legs are considered experimental and investigational for the following indications (not an all-inclusive list) because the effectiveness for these indications has not been established:

      1. Improvement of functional performance in individuals with Parkinson disease;
      2. Improvement of knee proprioception in rehabilitation setting;
      3. Management of delayed-onset muscle soreness;
      4. Management of pain during post-natal care;
      5. Management of spasticity following stroke;
   2. Stockings purchased over the counter without a prescription which have a pressure of less than 20 mm Hg (e.g., elastic stockings, support hose, surgical leggings, anti-embolism stockings (Ted hose) or pressure leotards) are considered experimental and investigational because these supplies have not been proven effective in preventing thromboembolism. Note: These OTC stockings are also not covered because they are not primarily medical in nature;
      
      
   3. Compression garments are considered experimental and investigational for members with severe peripheral arterial disease or septic phlebitis because they are contraindicated in these conditions.

3. Policy Limitations and Exclusions 

   Note: Aetna's standard benefit plans do not cover graded compression stockings or non-elastic binders because they are considered an outpatient consumable or disposable supply. Please check benefit plan descriptions for details. If the benefit plans covers graded compression stockings or non-elastic binders, please see list of medical conditions in Section I to meet medical necessity criteria.
   

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
HCPCS codes covered if selection criteria are met:
A4465	Non-elastic binder for extremity
A6507	Compression burn garment, foot to knee length, custom fabricated
A6508	Compression burn garment, foot to thigh length, custom fabricated
A6530 - A6549	Gradient compression stocking
E0650	Pneumatic compressor, non-segmental home model
E0651	Pneumatic compressor, segmental home model without calibrated gradient pressure
E0652	Pneumatic compressor, segmental home model with calibrated gradient pressure
E0660	Non-segmental pneumatic appliance for use with pneumatic compressor, full leg
E0666	Non-segmental pneumatic appliance for use with pneumatic compressor, half leg
E0667	Segmental pneumatic appliance for use with pneumatic compressor, full leg
E0669	Segmental pneumatic appliance for use with pneumatic compressor, half leg
E0671	Segmental gradient pressure pneumatic appliance, full leg
E0673	Segmental gradient pressure pneumatic appliance, half leg
HCPCS codes not covered for indications listed in the CPB:
E0675	Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system)
ICD-10 codes covered if selection criteria are met:
G81.00 - G81.94	Hemiplegia and hemiparesis
G82.20 - G83.9	Paraplegia (paraparesis), quadriplegia (quadriparesis) and other paralytic syndromes
I80.00 - I80.209 I80.221 - I80.3	Phlebitis and thrombophlebitis of superficial or deep vessels of lower extremities
I83.001 - I83.899	Varicose veins of lower extremities, with ulcer, with inflammation, with ulcer and inflammation, or with other complications
I87.00 - I87.099	Postthrombotic syndrome
I87.2	Venous insufficiency (chronic)(peripheral)
I89.0 - I89.9	Other noninfective disorders of lymphatic vessels and lymph nodes
I95.1	Orthostatic hypotension
O12.00 - O12.05	Gestational edema
O22.00 - O22.03, O87.4	Varicose veins of lower extremity in pregnancy
O90.89	Other complications of the puerperium, not elsewhere classified [postpartum edema] [not covered for pain during post-natal care]
Q82.0	Hereditary lymphedema
R60.0 - R60.9	Edema, not elsewhere classified
Z74.01	Bed confinement status
ICD-10 codes not covered for indications listed in the CPB:
G20	Parkinson's disease
I70.201 - I70.299	Atherosclerosis of native arteries of the extremities
I70.301 - I70.799	Atherosclerosis of bypass graft of the extremities
I73.00 - I73.9 I77.70 - I77.79	Other peripheral vascular disease
I74.2 - I74.4	Embolism and thrombosis of arteries of the extremities
I77.1	Stricture of artery
I77.89	Other specified disorders of arteries and arterioles
M79.18	Myalgia, other site [delayed-onset muscle soreness]

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Background

Compression garments are usually made of elastic material, and are used to promote venous or lymphatic circulation.  Compression garments worn on the legs can help prevent deep vein thrombosis and reduce edema, and are useful in a variety of peripheral vascular conditions.  Compression garments can come in varying degrees of compression.  The higher degrees require a physician's prescription. 

Fabric support garments are stockings or sleeves, usually made of elastic that may be utilized for, but not limited to, cases of severe edema, prevention of deep vein thrombosis (DVT), venous insufficiency or for certain burn injuries to lessen swelling and/or to reduce scarring. Alternatives to fabric support garments include dietary changes, exercise, limb elevation and weight control.

In an outcome-blinded, randomized controlled trial, Dennis et al (2009) evaluated the effectiveness of thigh-length graduated compression stockings (GCS) to reduce deep vein thrombosis (DVT) following stroke.  A total of 2,518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centers in the United Kingdom, Italy, and Australia.  Patients were allocated via a central randomization system to routine care plus thigh-length GCS (n = 1,256) or to routine care plus avoidance of GCS (n = 1,262).  A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7 to 10 days and, when practical, again at 25 to 30 days after enrolment.  The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins.  Analyses were by intention-to-treat.  All patients were included in the analyses.  The primary outcome occurred in 126 (10.0 %) patients allocated to thigh-length GCS and in 133 (10.5 %) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0.5 % (95 % confidence interval [CI]: -1.9 % to 2.9 %).  Blisters, ulcers, skin breaks, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5 %] versus 16 [1 %]; odds ratio 4.18, 95 % CI: 2.40 to 7.27).  The authors concluded that these findings do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke.  National guidelines for stroke might need to be revised on the basis of these results.

The National Comprehensive Cancer Network's clinical practice guideline on venous thromboembolic disease (2010) states that GCS can be used in conjunction with a venous compression device as a method of mechanical prophylaxis.

Ibuki and colleagues (2010) examined the effect of 3 tone-reducing devices (dynamic foot orthosis, muscle stretch, and orthokinetic compression garment) on soleus muscle reflex excitability while standing in patients with spasticity following stroke.  A repeated measures intervention study was conducted on 13 patients with stroke selected from a sample of convenience.  A custom-made dynamic foot orthosis, a range of motion walker to stretch the soleus muscle and class 1 and class 2 orthokinetic compression garments were assessed using the ratio of maximum Hoffmann reflex amplitude to maximum M-response amplitude (Hmax:Mmax) to determine their effect on soleus muscle reflex excitability.  Only 10 subjects were able to complete the testing.  There were no significant treatment effects for the interventions (F = 1.208, df = 3.232, p = 0.328); however, when analyzed subject-by-subject, 2 subjects responded to the dynamic foot orthosis and 1 of those 2 subjects also responded to the class 1 orthokinetic compression garment.  Overall, the results demonstrated that the tone-reducing devices had no significant effect on soleus reflex excitability suggesting that these tone-reducing orthotic devices have no significant neurophysiologic effect on spasticity.

Jaccard and colleagues (2007) noted that silver fiber-containing compression stockings for the use in patients with chronic venous insufficiency (CVI) were introduced to the market.  In order to gain some first insight into the effects of these fabrics on the cutaneous microcirculation, a double-blind, randomized cross-over trial was performed in 10 healthy volunteers.  A 3 days run-in phase preceded the (2 x 10 days) treatment phases and was used to assess the reproducibility of the primary endpoint, which was the transcutaneous partial oxygen pressure (tcpO(2)) measured at a probe temperature of 44 degrees C in the peri-malleolar region of the reference leg in supine and dependent leg positions.  Coefficients of variation for double measured tcpO(2) values were 4.2 % (3.1 SD) and 5.8 % (6.0 SD) for the leg in supine and dependent position.  The intra-individual comparison of the effects from both treatment phases (value end of treatment - start of treatment) resulted in a negative tcpO(2) net balance for the regular hosiery (-0.93 (2.7 SD) mm Hg, supine; -1.1 (3.5 SD) mm Hg, dependent) but a positive net balance for the silver fibers containing stockings (0.25 (4.0 SD) mm Hg, supine; 1.7 (3.9 SD) mm Hg, dependent).  The inter-treatment differences were statistically significant for the leg in a dependent position.  The trial provides first evidence that interweaving silver threads into regular compression stockings may result in a positive effect regarding the nutritive skin perfusion.  This was a small study done with healthy subjects; it is unclear whether these findings can be extrapolated to patients who require compression stockings.

In a Cochrane review, O'Meara et al (2012) noted that the main treatment for venous (or varicose or stasis) ulcers is the application of a firm compression garment (bandage or stocking) in order to aid venous return.  There is a large number of compression garments available and it was unclear whether they are effective in treating venous ulcers and, if so, which method of compression is the most effective.  These researchers performed a systematic review of all randomized controlled trials (RCTs) evaluating the effects on venous ulcer healing of compression bandages and stockings.  Specific questions addressed by the review are: does the application of compression bandages or stockings aid venous ulcer healing? and which compression bandage or stocking system is the most effective?  For this second update these investigators searched: the Cochrane Wounds Group Specialised Register (May 31, 2012); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 5, 2012); Ovid MEDLINE (1950 to May Week 4 2012); Ovid MEDLINE (In-Process & Other Non-Indexed Citations May 30, 2012); Ovid EMBASE (1980 to 2012 Week 21); and EBSCO CINAHL (1982 to May 30, 2012).  No date or language restrictions were applied.  Randomized controlled trials recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression stockings were eligible for inclusion.  Eligible comparators included no compression (e.g., primary dressing alone, non-compressive bandage) or an alternative type of compression.  Randomized controlled trials had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). Secondary outcomes of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals.  There was no restriction on date, language or publication status of RCTs.  Details of eligible studies were extracted and summarized using a data extraction table.  Data extraction was performed by 1 review author and verified independently by a 2nd review author.  A total of 48 RCTs reporting 59 comparisons were included (4,321 participants in total).  Most RCTs were small, and most were at unclear or high-risk of bias.  Duration of follow-up varied across RCTs.  Risk ratio (RR) and other estimates were shown below where RCTs were pooled; otherwise findings refer to a single RCT.  There was evidence from 8 RCTs (unpooled) that healing outcomes (including time to healing) are better when patients receive compression compared with no compression.  Single-component compression bandage systems are less effective than multi-component compression for complete healing at 6 months (1 large RCT).  A 2-component system containing an elastic bandage healed more ulcers at 1 year than one without an elastic component (1 small RCT).  Three-component systems containing an elastic component healed more ulcers than those without elastic at 3 to 4 months (2 RCTs pooled), RR 1.83 (95 % CI: 1.26 to 2.67), but another RCT showed no difference between groups at 6 months.  An individual patient data meta-analysis of 5 RCTs suggested significantly faster healing with the 4-layer bandage (4LB) than the short stretch bandage (SSB): median days to healing estimated at 90 and 99 respectively; hazard ratio 1.31 (95 % CI: 1.09 to 1.58).  High-compression stockings were associated with better healing outcomes than SSB at 2 to 4 months: RR 1.62 (95 % CI: 1.26 to 2.10), estimate from 4 pooled RCTs.  One RCT suggested better healing outcomes at 16 months with the addition of a tubular device plus single elastic bandage to a base system of gauze and crepe bandages when compared with 2 added elastic bandages.  Another RCT had 3 arms; when 1 or 2 elastic bandages were added to a base 3-component system that included an outer tubular layer, healing outcomes were better at 6 months for the 2 groups receiving elastic bandages.  There is currently no evidence of a statistically significant difference for the following comparisons: alternative single-component compression bandages (2 RCTs, unpooled); 2-component bandages compared with the 4LB at 3 months (3 RCTs pooled); alternative versions of the 4LB for complete healing at times up to and including 6 months (3 RCTs, unpooled); 4LB compared with paste bandage for complete healing at 3 months (2 RCTs, pooled), 6 months or 1 year (1 RCT for each time point); adjustable compression boots compared with paste bandages for the outcome of change in ulcer area at 3 months (1 small RCT); adjustable compression boots compared with the 4LB with respect to complete healing at 3 months (1 small RCT); single-layer compression stocking compared with paste bandages for outcome of complete healing at 4 months (1 small RCT) and 18 months (another small RCT); low compression stocking compared with SSB for complete healing at 3 and 6 months (1 small RCT);⋅compression stockings compared with a 2-component bandage system and the 4LB for the outcome of complete healing at 3 months (1 small, 3-armed RCT); and tubular compression compared with SSB (1 small RCT) for complete healing at 3 months.  Secondary outcomes: 4LB was more cost-effective than SSB.  It was not possible to draw firm conclusions regarding other secondary outcomes including recurrence, adverse events and health-related quality of life.  The authors concluded that compression increases ulcer healing rates compared with no compression.  Multi-component systems are more effective than single-component systems.  Multi-component systems containing an elastic bandage appear to be more effective than those composed mainly of inelastic constituents.  Two-component bandage systems appear to perform as well as the 4LB.  Patients receiving the 4LB heal faster than those allocated the SSB.  More patients heal on high-compression stocking systems than with the SSB.  They stated that further data are required before the difference between high-compression stockings and the 4LB can be established.

Improvement of Functional Performance in Individuals with Parkinson Disease

Improvement of Knee Proprioception in Rehabilitation Setting

In a counter-balanced, single-blinded, cross-over study, Ghai and associates (2018) examined the influence of below-knee CG on proprioception accuracy under differential information processing constraints designed to cause high or low conscious attention to the task.  A total of 44 healthy participants (26 males/18 females) with a mean age of 22.7 ± 6.9 years performed an active joint re-positioning task using their non-dominant and their dominant leg, with and without below-knee CG and with and without conducting a secondary task.  Analysis of variance revealed no main effect of leg dominance and no interactions (p's > 0.05).  However, a main effect was evident for both compression (F1, 43 = 84.23, p < 0.001, ηp2 = 0.665) and secondary task (F1, 43 = 4.391, p = 0.04, ηp2 = 0.093).  The authors concluded that this study was the first to evaluate the effects of a below knee CG on knee proprioception under differential information processing constraints.  They stated that proprioception accuracy of the knee joint is significantly enhanced post application of below-knee CG and when a secondary task is conducted concurrently with active joint re-positioning.  They noted that these findings suggested that below-knee CG may improve proprioception of the knee, regardless of leg dominance, and that secondary tasks that direct attention away from proprioceptive judgments may also improve proprioception, regardless of the presence of compression.  The authors discussed clinical implications with respect to proprioception in modern sports and rehabilitation settings.

Management of Delayed-Onset Muscle Soreness

Heiss and colleagues (2018a) noted that delayed-onset muscle soreness (DOMS), an ultra-structural muscle injury, is one of the most common reasons for impaired muscle performance.  These investigators examined the influence of sport compression garments on the development of exercise-induced intra-muscular (IM) edema in the context of DOMS.  DOMS was induced in 15 healthy subjects who performed a standardized eccentric exercise of the calf muscles.  Magnetic resonance imaging (MRI) was performed at baseline and 60 hours after exercise (T2-weighted signal intensity and T2 relaxation time was evaluated in each compartment and the IM edema in the medial head of the gastrocnemius muscle was segmented).  After the exercise, a conventional compression garment (18 to 21 mmHg) was placed on 1 randomized calf for 60 hours.  The level of muscle soreness was evaluated using a visual analogue scale (VAS) for painn.  T2-weighted signal intensity, T2 relaxation time and IM edema showed a significant interaction for time with increased signal intensities/IM edema in the medial head of the gastrocnemius muscle at follow-up compared to baseline.  No significant main effect for compression or interaction between time and limb occurred.  Furthermore, no significant differences in the soleus muscle and the lateral head of the gastrocnemius muscle were observed between limbs or over time.  After exercise, there was significantly increased muscle soreness in both lower legs in resting condition and when going downstairs and a decreased range of motion (ROM) in the ankle joint.  No significant difference was observed between the compressed and the non-compressed calf.  The authors concluded that the findings of this study showed that wearing conventional compression garments after DOMS has been induced had no significant effect on the development of muscle edema, muscle soreness, ROM and calf circumference.

Heiss and colleagues (2018b) examined the influence of compression garments on the development of DOMS, focusing on changes in muscle perfusion and muscle stiffness.  In this controlled laboratory study with repeated measures, muscle perfusion and stiffness, calf circumference, muscle soreness, passive ankle dorsiflexion, and creatine kinase levels were assessed in subjects before (baseline) a DOMS-inducing eccentric calf exercise intervention and 60 hours later (follow-up).  After DOMS induction, a sports compression garment (18 to 21 mmHg) was worn on 1 randomly selected calf until follow-up, while the contralateral calf served as an internal control.  Muscle perfusion was assessed using contrast-enhanced ultrasound (US; peak enhancement and wash-in area under the curve), while muscle stiffness was assessed using acoustic radiation force impulse (shear-wave velocities).  A MRI scan of both lower legs was also performed during the follow-up testing session to characterize the extent of exercise-induced muscle damage.  Comparisons were made between limbs and over time.  Shear-wave velocity values of the medial gastrocnemius showed a significant interaction between time and treatment (p = 0.006), with the non-compressed muscle demonstrating lower muscle stiffness values at follow-up compared to baseline or to the compressed muscle.  No significant differences in soleus muscle stiffness were noted between limbs or over time, as was the case for muscle perfusion metrics (peak enhancement and wash-in area under the curve) for the medial gastrocnemius and soleus muscles.  Further, compression had no significant effect on passive ankle dorsiflexion, muscle soreness, calf circumference, or injury severity, per MRI scans.  The authors concluded that continuous wearing of compression garments during the inflammation phase of DOMS may play an important role in regulating muscle stiffness; however, compression garments had no significant effects on IM perfusion or other common clinical assessments.

In a prospective cohort study, Riexinger and colleagues (2021) examined the effect of compression garments under resting conditions and after the induction of delayed-onset muscle soreness (DOMS) by MR perfusion imaging using intra-voxel incoherent motion (IVIM).  These researchers carried out MRI of both lower legs of 16 volunteers before and after standardized eccentric exercises that induced DOMS.  A compression garment (21 to 22 mmHg) was worn during and for 6 hours after exercise on 1 randomly selected leg.  IVIM-MRI, represented as total muscle perfusion D*f, perfusion fraction f and tissue diffusivity D, were compared between baseline and directly, 30 mins, 6 hours and 48 hours after exhausting exercise with and without compression.  Creatine kinase levels and T2-weighted images were recorded at baseline and after 48 hours.  DOMS was induced in the medial head of the gastrocnemius muscle (MGM) in all volunteers.  Compression garments did not show any significant effect on IVIM perfusion parameters at any time-point in the MGM or the tibialis anterior muscle (p > 0.05).  Microvascular perfusion in the MGM increased significantly in both the compressed and non-compressed leg between baseline measurements and those taken directly after and 30 mins after the exercise: the relative median f increased by 31.5 % and 24.7 % in the compressed and non-compressed leg, respectively, directly after the exercise compared with the baseline value.  No significant change in tissue perfusion occurred 48 hours after the induction of DOMS compared with baseline.  The authors concluded that these findings indicated that wearing compression garments (21 to 22 mmHg) did not alter microvascular muscle perfusion at rest, nor did it have any significant effect during regeneration of DOMS.  This study provided new insights into muscle perfusion during exercise and regeneration in the context of exercise‐induced muscle damage, showing normalization of blood supply independently of compression after 6 hours, which may have implications for diagnostic and therapeutic strategies and for the understanding of pathophysiological pathways in DOMS.

The authors stated that this study had several drawbacks.  First, the number of subjects included was small (n = 16), considering that there can be inter-individual differences in DOMS expression and there may be non-responders; however, their sample size of 16 was larger than the median sample size of current methodological MR studies.  Notably, these investigators carried out a high‐resolution MRI at follow‐up, which confirmed the presence of DOMS as intra-muscular edema in every subject.  Second, these researchers used only IVIM perfusion imaging for the evaluation of muscle perfusion and did not conduct a comparison with other MRI modalities or with other techniques such as spectral Doppler or contrast‐enhanced ultrasound.  However, IVIM is a well‐established non-invasive imaging modality for the quantification of microvascular soft tissue perfusion and, unlike most other measurement approaches, allows the study participants to wear the compression garments during the measurement.  A 3rd drawback was the use of each subject as their own control.  One calf may influence the outcome of the other calf due to a systemic inflammatory healing response.  Nonetheless, these investigators chose an intra-individual control group because inter-individual differences in DOMS expression and CK expression were observed in their preliminary tests and had been described in several studies.  A 4th drawback was that these researchers did not use a fat‐suppression technique such as short tau inversion recovery (STIR) that also suppresses olefinic fat signals.  Insufficient fat suppression may lead to artifacts in the diffusion and IVIM maps of the muscle; however, the authors feared that the inversion pulse might change the observed perfusion fractions.  Moreover, they wanted to avoid the extended acquisition times such a technique would entail.  Another drawback was that the study participants were all younger than 30 years old; therefore, conclusions regarding older subjects were difficult to infer from this trial.  In addition, an evaluation of the dependence of IVIM parameters on the compression pressure was not carried out.  This should be a subject of investigation in future studies.  Likewise, a further investigation of the sensitivity of IVIM examinations in revealing perfusion differences caused by different compression pressures would be interesting.  Finally, a limitation of the T2‐corrected evaluation was that a T2 value of blood must be set in the respective equations.  These researchers employed the value of 275 ms; however, the strong dependence on hematocrit and oxygenation made this choice difficult; thus, this evaluation must be regarded with caution.

Management of Pain During Post-Natal Care

Szkwara and colleagues (2019) stated that conservative interventions for addressing pre-natal and post-natal ailments have been described in the literature.  Research findings indicated that maternity support belts assist with reducing pain and other symptoms in these phases; however, compliance in wearing maternity support belts is poor.  To combat poor compliance, commercial manufacturers designed dynamic elastomeric fabric orthoses (DEFO) / lycra-based compression garments that target pre-natal and post-natal ailments.  In a systematic review, these investigators evaluated and synthesized key findings on the feasibility, effectiveness, and the acceptability of using DEFO to manage ailments during pre-natal and post-natal phases of care.  They searched electronic data-bases to identify relevant studies, resulting in 17 studies that met the eligibility criteria.  There were variations in DEFO descriptors, including hosiery, support belts, abdominal binders and more, making it difficult to compare findings from the research articles regarding value of DEFO during pre-natal and/or post-natal phases.  A meta-synthesis of empirical research findings suggested wearing DEFOs during pregnancy has a significant desirable effect for managing pain and improving functional capacity.  Moreover, the authors concluded that further research is needed to examine the use of DEFOs / compression garments for managing pain in the post-natal period and improving quality of life (QOL) during pre-natal and post-natal care.

These researchers stated that although 17 studies were included in this review, which examined a DEFO as an intervention during pre-natal and post-natal phases, to-date, there is still little high-quality evidence to support the use of DEFO in pre-natal and post-natal populations.  Small study samples, inconsistent use of reliable and valid outcome measures, and varied definitions of a DEFO and/or maternity support belts have all contributed to the lack of high-quality empirical studies on this topic.  The meta-synthesis conducted in the present review suggested that, during pregnancy, wearing a DEFO can have a desirable positive effect for managing pain and improving functional capacity.  However, there is limited evidence available to suggest that wearing a DEFO during pregnancy can affect QOL.  They stated that more research is needed to determine the clinical relevance of wearing a DEFO for women in the post-natal period.  These investigators noted that future research in this field should include standardized outcome measures, standardized criteria for DEFO, accurate product descriptions, and high-quality study designs so that valid conclusions can be drawn and, where applicable, research evidence can be implemented in clinical practice.

Management of Orthostatic Intolerance

Hockin and Claydon (2020) noted that orthostatic fluid shifts reduce the effective circulating volume; therefore, contributing to syncope susceptibility.  Recurrent syncope has a devastating impact on QOL and is challenging to manage effectively.  To blunt orthostatic fluid shifts, static calf compression garments are often prescribed to patients with syncope; but have questionable efficacy.  Intermittent calf compression, which mimics the skeletal muscle pump to minimize pooling and filtration, holds promise for the management of syncope.  In a randomized, single-blinded, cross-over study, these researchers examined the effectiveness of intermittent calf compression for increasing orthostatic tolerance (OT; time to pre-syncope).  Subjects (n = 21) underwent 3 graded 60° head-up-tilt tests to pre-syncope with combined lower body negative pressure on separate days.  Low frequency intermittent calf compression (ICLF; 4 s “on” and 11 s “off”) at 0 to 30 and 0 to 60 mmHg was applied during 2 tests and compared to a placebo condition where the garment was fitted, but no compression applied.  These investigators measured continuous leg circumference changes (strain gauge plethysmography), cardiovascular responses (finger plethysmography; Finometer Pro), end tidal gases (nasal cannula), and cerebral blood flow velocity (CBFv, transcranial Doppler).  The 0 to 60 mmHg ICLF increased OT (33 ± 2.2 mins) compared to both placebo (26 ± 2.4 mins; p < 0.001) and 0 to 30 mmHg ICLF (25 ± 2.7 mins; p < 0.001).  Throughout testing 0 to 60 mmHg ICLF reduced orthostatic fluid shifts compared to both placebo and 0 to 30 mmHg ICLF (p < 0.001), with an associated improvement in stroke volume (p < 0.001), allowing blood pressure (BP) to be maintained at a reduced heart rate (p < 0.001).  Furthermore, CBFv was higher with 0 to 60 mmHg ICLF than 0 to 30 mmHg ICLF and placebo (p < 0.001).  The authors concluded that intermittent calf compression is a promising novel intervention for the management of orthostatic intolerance, which may provide affected individuals renewed independence and improved QOL.  These researchers stated that this research will be instrumental in the design and production of a “smart” device that would activate during motionless standing; and inactivate during ambulation or recumbence to maximize both physiological gain and patient comfort.

Compression Stockings in patients with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

van Campen and colleagues (2021) noted that orthostatic intolerance (OI) is a clinical condition in which symptoms worsen upon assuming and maintaining upright posture and are ameliorated by recumbency.  OI has a high prevalence in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).  Limited data are available to guide the treatment of OI in ME/CFS patients.  These researchers and others have previously described patient-reported subjective improvement in symptoms using compression stockings.  They hypothesized that these subjective reports would be accompanied by objective hemodynamic improvements.  These researchers carried out a randomized cross-over trial in 16 ME/CFS patients.  Each underwent 2 15-min head-up tilt (HUT) table tests, 1 with and 1 without wearing knee-high compression stockings that provided 20 to 25 mm Hg compression.  The order of the tests was randomized.  These researchers measured heart rate (HR) and BP as well as cardiac output (CO) and cerebral blood flow (CBF) using extra-cranial Doppler of the internal carotid and vertebral arteries.  There were no differences in supine measurements between the 2 baseline measurements.  There were no differences in HR and BP at either end-tilt testing period.  Compared to the test with the stockings off, the mean percentage reduction in CO during the test with compression stockings on was lower, 15 (4) % versus 27 (6) % (p < 0.0001), as was the mean percentage CBF reduction, 14 (4) % versus 25 (5) % (p < 0.0001).  The authors concluded that in ME/CFS patients with orthostatic intolerance symptoms, CO and CBF were significantly reduced during a tilt test.  These abnormalities were present without demonstrable HR and BP changes and were ameliorated by the use of compression stockings.  Moreover, these investigators stated that compression stockings may also be beneficial in non-ME/CFS populations with orthostatic intolerance.

These researchers stated that several observations in this study warrant further emphasis.  First, while these investigators studied a limited number of patients (n = 16), which could have introduced an inclusion bias, their age, gender, disease duration, and CBF reductions were consistent with their data from a large group of patients.  Furthermore, in a previous study, these researchers reported changes in cardiac index (CI) during tilt testing in ME/CFS patients with a normal HR and BP response.  For comparison with that study, these investigators not only calculated CO but also the CI in the present study.  Comparison of the CI of the previous study and the present study showed no significant differences; therefore, the authors were confident that the patient data of this trial were representative for the whole ME/CFS patient population.  Second, although an improvement of CO and CBF was observed while wearing the compression stockings, the reductions in CO and CBF during the standing period of the tilt test remained significant compared to the supine position.  Nevertheless, when comparing the percent CO reduction with stockings on in the present study with the percent CI reduction in healthy controls of a previous study, a difference in CO/CI reduction during the tilt was observed, being 15 % with stockings on versus 8 % in healthy controls (HC; without stockings) in the previous study.  Similarly, the percent CBF reduction with stockings on in the present study was 14 %, while in HC of a previous study, the percent CBF reduction was 5 %, suggesting that although the CO and CBF improved with stockings on, compared to stockings off, the CO and CBF reductions did not normalize.  These researchers stated that further studies with more extensive compression garments (lower and upper leg compression/compression panties) or with a higher degree of compression are needed to examine if this approach will further improve CO and CBF changes in ME/CFS patients.

Third, using a questionnaire in their previous study on compression stockings, the positive and negative responses of wearing compression stockings to a variety of physical activities was variable and dependent on the degree of physical activity in question.  In contrast, in the present study these investigators found a uniform hemodynamic improvement when patients wore the stockings.  These researchers stated that future work is needed to examine if specific symptoms such as exercise intolerance, pain, cognitive symptoms, lightheadedness or co-morbid disease are more likely to improve with compression stockings.  Fourth, most prior studies had focused on the use of compression garments in patients with orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS) or vasovagal syncope (VVS).   These investigators had previously reported that an abnormal CBF reduction may also be present in ME/CFS patients with a normal HR and BP response.  Thus, it was plausible that in non-ME/CFS populations with OI symptoms, CBF abnormalities can be present despite HR or BP responses to upright posture.  These researchers stated that further study could examine if these patients would also benefit from compression therapy.  Fifth, several methodological considerations need to be addressed: Reproducibility, tilt duration, the use of extra-cranial Doppler, and calculation of differences between supine and standing.  Reproducibility was good for both CO and CBF measurements, as percent errors were below 10 %.  This strengthened the use of these Doppler measurements in clinical practice.  In this study, tilt duration was 15 mins.  In a previous tilt study of CBF, measurements were performed at 12 mins and at 22 mins.  CBF reduction in the patients with a normal HR and BP response at 12 mins was 19 % and at 22 mins was 24 %.  Although the reduction at 22 mins was significantly larger than at 12 mins, the major change in CBF occurred in the first half of the study.  A previous transcranial Doppler study (TCD) in patients with orthostatic cerebral hypoperfusion syndrome showed that CBF velocity measurements were already abnormal compared to HC in the first minute of the tilt.  Similarly, a significant CO reduction was present in HC within 30 s of head-up tilt.  Therefore, the major hemodynamic changes occurred very early after onset of tilting.  Given the observation that CBF further decreased during a longer tilt test, it remained to be determined whether compression stockings are as effective during a prolonged period of standing compared to a short period of standing.  These researchers expressed the change in CO during the tilt as a percentage reduction instead of an absolute reduction.  For the CO calculation of the CO, the aortic valve area was multiplied with the mean VTI.  A large number of studies have shown that the left ventricular outflow tract used for this calculation may have an ellipsoid form, leading to under-estimation of the aortic valve area.  To limit the influence of this under-estimation, the percent CO change was used, being independent of the fixed valve area.

Sixth, many studies with a variety of patients and HC had related CBF to CO using interventions like vasoactive drugs, lowering of BP, exercise, postural changes, and blood volume changes.  Thus far, these studies have not included ME/CFS patients, and have not measured subjects during a tilt test.  In this study, a significant positive correlation was found between the percent change in CO during the tilt and the percent change in CBF.  This was present with or without stockings, with a shift to improved hemodynamics with stockings on.  Although the percent reductions in both CO and CBF were lower while wearing stockings, the slope of the relation was not significantly different between stockings on and off, nor did the ratio percent CBF reduction/percent CO reduction change during the 2 test periods.  This indicated that CBF closely followed the CO changes in the setting of a tilt test in these patients.  However, these investigators did not measure end-tidal CO2, right atrial pressure and catecholamine/sympathetic tone changes, nor were they able to measure regional differences in brain perfusion.  Thus, further and more extensive studies are needed to examine the nature of these variables.  Nevertheless, the majority of studies examining the relationship between CO and CBF had used TCD to estimate CBF.  The major limitation of TCD was that TCD measures flow velocity.  For the calculation of CBF, a measure of the area of the vessel is needed.  Because the vessel area of the large intra-cranial arteries is dependent on PCO2, a change in PCO2 may result in a vessel area change and therefore also a change in flow velocity, whether or not the arterial flow changes.  The second limitation was that the TCD studies usually reported results from 1 vessel and do not take possible heterogeneity of vessel responses into account.  The use of extra-cranial Doppler with measurements of both internal carotid and vertebral arteries overcame this potential confounding factor.  Seventh, 93 % of the subjects in this study were female, slightly higher than the 87 % enrolled in their larger CBF study of 429 individuals, and likely related to the smaller sample size in this study.  In their clinical experience, males have a slightly lower incidence of reporting OI and less often choose treatment with compression stockings.  These researchers stated that further studies with a larger number of males are needed to examine if there are differences in response between males and females.  Finally, these investigators did not analyze the heterogeneity of responses of the 2 internal carotid and 2 vertebral arteries on the use of the compression stockings.  For this purpose, a larger group of patients is mandatory, and this research question needs to be studied in the future.

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