Medical Policy

Policy Num:       08.001.029
Policy Name:     Pneumatic Compression Pumps Treatment of lymphedema and Venous Ulcers
Policy ID:           [08.001.029 ]  [Ac / B / M+ / P+]   [1.01.18]

Last Review:    February, 19, 2025
Next Review:   February, 20, 2026

Related Policies:

Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers

SUMMARY

Description

Pneumatic compression pumps are proposed as a treatment for patients with lymphedema who have failed conservative measures. They are also proposed to supplement standard care for patients with venous ulcers. A variety of pumps are available; they can be single chamber (nonsegmented) or multichamber (segmented) and have varying designs and complexity.

Summary of Evidence

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb only, the evidence includes randomized controlled trials (RCTs) and systematic reviews primarily focusing on upper-limb lymphedema secondary to breast cancer. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Most of these RCTs were deemed moderate-to-high quality by the Agency for Healthcare Research and Quality, and about half reported significant improvements with the use of pumps compared to conservative care. Recent meta-analyses indicate that incorporating intermittent pneumatic compression (IPC) with complete decongestive therapy can further enhance lymphedema management within four weeks post-treatment. Similar findings are observed when IPC is combined with decongestive lymphatic therapy compared to decongestive lymphatic therapy alone in managing upper limb lymphedema after breast cancer surgery, with the former combined regimen showing improved external rotation joint mobility. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb and chest and/or trunk, the evidence includes two RCTs of the Flexitouch system (Tactile Medical), published in 2012, comparing treatment with and without truncal involvement. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. In one RCT, two (of 4) key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (eg, amount of fluid removed) rather than health outcomes (eg, functional status, quality of life). The second RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to the head and neck, the evidence includes one RCT and a systematic review to assess the use of pneumatic compression treatment for head and neck lymphedema. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The RCT, comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone, examined the feasibility, adherence, and safety of the Flexitouch advanced pneumatic compression device (APCD) by Tactile Medical. The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily as prescribed. The systematic review also suggested benefits from using the APCD, and it was considered safe and feasible according to the observational studies that reported adverse events. Most studies included participants who had completed or were concurrently undergoing complete decongestive therapy. Out of the 5 observational studies included in the systematic review, four (80%) had potential conflicts of interest related to the funding source. The only study not sponsored by the industry highlighted difficulties in obtaining the APCD, with fewer than half of the patients receiving the device as prescribed. Further research with larger sample sizes and comparisons against the criterion standard of complete decongestive therapy is necessary to establish the efficacy of this treatment approach. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have venous ulcers who receive pneumatic compression pumps, the evidence includes RCTs and one systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at high risk of bias. A 2020 RCT compared lymphedema pumps with continuous compression did not find significant between-group differences in healing rates or durability of pain relief. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

OBJECTIVE

The objective of this evidence review is to evaluate whether the use of pneumatic compression pumps improves net health outcomes in patients with lymphedema or venous ulcers.

POLICY STATEMENTS

Single-compartment or multichamber nonprogrammable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.

Single-compartment or multichamber programmable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema when:

1. The individual is otherwise eligible for nonprogrammable pumps; and

2. There is documentation that the individual has unique characteristics (eg, significant scarring) that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable lymphedema pumps.

Single-compartment or multichamber lymphedema pumps applied to the limb are considered investigational in all situations other than those specified above in the first 2 policy statements.

The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema with or without involvement of the upper and/or lower limbs is considered investigational.

The use of lymphedema pumps applied to the head and neck to treat lymphedema is considered investigational.

The use of pneumatic compression pumps to treat venous ulcers is considered investigational.

POLICY GUIDELINES

Coding

See the Codes table for details

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Compliance may be an issue with lymphedema pumps, due either to lack of effectiveness or to patient dissatisfaction with the pumping process itself. Therefore, Plans may consider requiring that a pump be rented initially for a period of 1 to 2 months before purchase to confirm compliance.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage

BACKGROUND

Lymphedema

Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. It is characterized by nonpitting swelling of an extremity or trunk, and is associated with wound healing impairment, recurrent skin infections, pain, and decreased quality of life. Lymphedema can be caused by congenital or inherited abnormalities in the lymphatic system (primary lymphedema) but is most often caused by acquired damage to the lymphatic system (secondary lymphedema). Breast cancer treatment (surgical removal of lymph nodes and radiotherapy) is one of the most common causes of secondary lymphedema. In a systematic review of 72 studies (N=29,612 women), DiSipio et al (2013) reported that nearly 20% of breast cancer survivors will develop arm lymphedema.^1, The risk factors with robust evidence for the development of lymphedema included extensive surgical procedures (such as axillary lymph node dissection, a higher number of lymph nodes removed, and mastectomy) as well as being overweight or obese.

Diagnosis and Staging

A diagnosis of secondary lymphedema is based on history (e.g., cancer treatment, trauma) and physical examination (localized, progressive edema and asymmetric limb measurements) when other causes of edema can be excluded. Imaging, such as MRI, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases.

Table 1 lists International Society of Lymphology guidance for staging lymphedema (2023) based on "softness" or "firmness" of the limb and the changes with an elevation of the limb.^2,

Table 1. Recommendations for Staging Lymphedema

Management and Treatment

Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Individuals are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by affected individuals designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all of the previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in individuals who have difficulty performing self-manual lymphatic drainage. In individuals with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.

Venous Ulcers

Venous ulcers, which occur most commonly on the medial distal leg, can develop in patients with chronic venous insufficiency when leg veins become blocked. Standard treatment for venous ulcers includes compression bandages or hosiery supplemented by conservative measures such as leg elevation.

Pneumatic Compression Pumps

Pneumatic compression pumps (PCPs) may be used in lymphedema or wound care clinics, purchased, or rented for home use; home use is addressed herein. PCPs consist of pneumatic cuffs connected to a pump. These pumps use compressed air to apply pressure to the affected limb. The intention is to force excess lymph fluid out of the limb and into central body compartments in which lymphatic drainage should be preserved. Many PCPs are available, with varying materials, designs, degrees of pressure, and complexity. There are 3 primary types of pumps. Single chamber nonprogrammable pumps are the simplest pumps, consisting of a single chamber that is inflated at 1 time to apply uniform pressure. Multichamber nonprogrammable pumps have multiple chambers ranging from 2 to 12 or more. The chambers are inflated sequentially and have a fixed pressure in each compartment. They can either have the same pressure in each compartment or a pressure gradient, but they do not include the ability to adjust the pressure manually in individual compartments. Single- or multi-chamber programmable pumps are similar to the pumps described above except that it is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered the preferred option. PCPs are also proposed to supplement standard care for patients with venous ulcers.

Regulatory Status

Several pneumatic compression pumps, indicated for the primary or adjunctive treatment of primary or secondary (eg, postmastectomy) lymphedema, have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of devices with these indications intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (MedMark Technologies); the Sequential Circulator® (Bio Compression Systems); the Lympha-Press® and Lympha-Press Optimal (Mego Afek); the Flexitouch® and Flexitouch Plus systems (Tactile Medical, formerly Tactile Systems Technology); the Powerpress Unit Sequential Circulator (Neomedic); and the EzLymph and EzLymph M (EEZCare Medical).

Several pneumatic compression devices have been cleared by the FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch, Flexitouch Plus, and Powerpress Unit (listed above) as well as NanoTherm™ (ThermoTek), CTU676 devices (Compression Technologies), and Recovery+™ (Pulsar Scientific).

FDA product code: JOW.

RATIONALE

The evidence review was created in July 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through November 25 , 2024.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population References No.1

Lymphedema–Pneumatic Compression Pumps Applied to the Limb Only

Clinical Context and Therapy Purpose

The purpose of pneumatic compression pumps (PCPs) applied to the limb only is to provide a treatment option that is an alternative to or an improvement on existing therapies for patients with lymphedema who failed to respond to conservative therapy.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is patients with lymphedema who have failed to respond to conservative therapy.

Interventions

The therapy being considered is the use of pneumatic compression pumps applied to limb only.

Comparators

The following practices are currently being used to treat lymphedema: conservative therapy (eg, exercise, compression therapy, elevation), manual lymphatic drainage, and complete decongestive therapy.

Outcomes

The general outcomes of interest are symptoms, change in disease status, functional outcomes (eg, range of motion), and quality of life (eg, ability to conduct activities of daily living). Limb volume and limb circumference are also commonly reported outcomes.

Lymphedema is a chronic condition, and follow-up of at least 6 weeks to 6 months would be desirable to assess outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

In 2010, the Agency for Healthcare Research and Quality published a technology assessment on the diagnosis and treatment of secondary lymphedema that included a discussion of intermittent pneumatic compression (IPC) pumps.^3, Oremus et al identified 12 studies focusing on the treatment of lymphedema with IPC pumpsi. Seven studies were moderate- to high-quality RCTs, 3 were low-quality RCTs, and 2 were observational studies. There was a high degree of heterogeneity between studies regarding types of lymphedema pumps used, comparison interventions (eg, compression bandages, laser, massage), and intervention protocols. Statistically, intermittent pneumatic compression was significantly better than the comparison treatment in 4 studies, worse in 1 study (vs. laser), and no different in 5 studies. Most studies assessed change in arm volume or arm circumference.

Oremus et al (2012) published an updated systematic review of conservative treatments for secondary lymphedema.^4, The authors identified 36 English-language studies on a variety of treatments, 30 of which were RCTs and 6 were observational studies. Six RCTs evaluated IPC. Study findings were not pooled. According to reviewers, 2 RCTs found that IPC was superior to decongestive therapy or self-massage, but 3 other RCTs failed to show that IPC was superior to another conservative treatment.

A systematic review by Shao et al (2014) addressed pneumatic compression pumps for the treatment of breast cancer-related lymphedema.^5, The authors identified 7 RCTs; most compared decongestive lymphatic therapy alone with decongestive lymphatic therapy plus lymphedema pump therapy. A pooled analysis of data from the 3 RCTs suitable for meta-analysis did not find a statistically significant difference in the percentage of volume reduction with and without the use of lymphedema pumps (mean difference, 4.51; 95% confidence interval [CI], -7.01 to 16.03).

Hou et al (2024) conducted a systematic review and meta-analysis of 12 studies (identified through March 2024) comparing the efficacy of IPC as an addition to complete decongestive therapy (CDT) for treatment of breast cancer-related upper limb lymphedema.^6, Results showed that additional application of IPC to CDT could further improve lymphedema within 4 weeks after the treatment period (standardized mean difference (SMD), -0.2 mL; 95% CI, -0.33 to -0.07 mL). However, this additional benefit was weakened within about 9.4±2.6 weeks' follow-up duration after ceasing physical therapy (SMD, -0.15 mL; 95% CI, -0.33 to 0.04 mL). To sustain the synergistic benefits of CDT and IPC in fostering lymphatic drainage and alleviating lymphedema, the authors recommend periodic, continuous treatment. The duration of treatment examined in the studies spanned from 4 to 12 weeks, which may introduce potential bias.

Yao et al (2024) conducted a systematic review and meta-analysis of 9 RCTs to compare the efficacy of decongestive lymphatic therapy (DLT) with IPC versus DLT alone in the management of upper limb lymphedema following breast cancer surgery.^7, The pooled SMD for percentage volume reduction was 0.63 (95% CI, -0.24 to 1.50; I² = 91%), showing no significant difference between the DLT alone and DLT combined with IPC (p=.15). Pain and heaviness scores were also comparable between the groups. There was a significant difference in external rotation joint mobility (SMD = 0.62; 95% CI, 0.08 to 1.16; I² = 23.8%), favoring DLT with IPC. Overall, the study indicates that DLT with IPC is as effective as DLT alone in managing upper limb lymphedema following breast cancer surgery. DLT with IPC has a more pronounced effect on enhancing external rotation joint mobility.

Section Summary: Lymphedema–Pneumatic Compression Pumps Applied to the Limb Only

Multiple RCTs and systematic reviews have been conducted primarily focusing on upper-limb lymphedema secondary to breast cancer. Most of these RCTs were deemed moderate-to-high quality by the Agency for Healthcare Research and Quality, and about half reported significant improvements with the use of pumps compared to conservative care. Recent meta-analyses indicate that incorporating intermittent pneumatic compression (IPC) with complete decongestive therapy can further enhance lymphedema management within four weeks post-treatment. Similar findings are observed when IPC is combined with decongestive lymphatic therapy compared to decongestive lymphatic therapy alone in managing upper limb lymphedema after breast cancer surgery, with the former combined regimen showing improved external rotation joint mobility.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb only, the evidence includes randomized controlled trials (RCTs) and systematic reviews primarily focusing on upper-limb lymphedema secondary to breast cancer. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Most of these RCTs were deemed moderate-to-high quality by the Agency for Healthcare Research and Quality, and about half reported significant improvements with the use of pumps compared to conservative care. Recent meta-analyses indicate that incorporating intermittent pneumatic compression (IPC) with complete decongestive therapy can further enhance lymphedema management within four weeks post-treatment. Similar findings are observed when IPC is combined with decongestive lymphatic therapy compared to decongestive lymphatic therapy alone in managing upper limb lymphedema after breast cancer surgery, with the former combined regimen showing improved external rotation joint mobility. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Lymphedema–Pneumatic Compression Pumps Applied to the Limb Only

Population Reference No. 2

Lymphedema–Pneumatic Compression Pumps Applied to the Limb and Chest and/or Trunk

Clinical Context and Therapy Purpose

The purpose of pneumatic compression pumps applied to the limb and chest and/or trunk in patients who have lymphedema who failed to respond to conservative therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is patients with lymphedema who failed to respond to conservative therapy.

Interventions

The therapy being considered is the use of pneumatic compression pumps on the limb and chest and/or trunk.

Comparators

The following practices are currently being used to treat lymphedema: conservative therapy (eg, exercise, compression therapy, elevation), manual lymphatic drainage, complete decongestive therapy, and pneumatic compression pump applied to the limb only.

Outcomes

The general outcomes of interest are symptoms, change in disease status, functional outcomes (eg, range of motion), and quality of life (eg, ability to conduct activities of daily living). Limb volume and limb circumference are also commonly reported outcomes.

Lymphedema is a chronic condition and follow-up of at least 6 weeks to 6 months would be desirable to assess outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Due to the Food and Drug Administration (FDA) approval of lymphedema pumps that treat the truncal area as well as the affected limb, researchers have assessed truncal clearance as part of lymphedema treatment. This literature review focuses on RCTs comparing pneumatic compression for patients who had lymphedema with and without treatment of the trunk or chest. Two RCTs were identified; both were industry-sponsored, published in 2012, and included women with breast cancer who had documented postsurgical upper-extremity lymphedema.

Randomized Controlled Trials

Fife et al (2012) compared treatment using the Flexitouch system with treatment using the Bio Compression Systems Sequential Circulator.^8, Participants had to have at least 5% edema volume in the upper extremity at trial enrollment. A total of 36 women from 3 centers were included, 18 in each group. Participants used the devices for home treatment for 1 hour daily for 12 weeks in addition to standard care (eg, wearing compression garments). The Bio Compression Systems device used an arm garment only, whereas the Flexitouch device used 3 garments and treated the full upper extremity (arm, chest, truncal quadrant). Outcome assessment was conducted by experienced lymphedema therapists; blinding was not reported. Edema outcomes were available for all participants and local tissue water analysis for 28 (78%) of 36 participants. The authors reported on 4 key outcomes at 12 weeks. There were statistically significant week by group interactions in 2 of these outcomes (edema volume reported as a percent, p=.047; tissue water, p=.049), both favoring treatment with the Flexitouch system. Groups did not differ significantly on the other 2 outcomes (affected arm volume at 12 weeks, p=.141; edema volume reported in milliliters, p=.050). Moreover, had there been statistical adjustments for multiple comparisons (ie, if p<.0125 had been used instead of p<.05 to adjust for the 4 comparisons), none of the differences would have been statistically significant. The trial was limited by its small sample size, missing data on the local tissue water outcome, and unclear blinding of outcome assessment. Also, the volume of tissue reported (a primary outcome) is of less clinical significance than outcomes such as symptoms or functional status.

Ridner et al (2012) compared treatment using the Flexitouch system for an arm only versus arm, chest, and trunk therapy in women with breast cancer who had arm lymphedema.^9, To be eligible, patients had to have a 2-cm difference in girth on the affected arm compared with the unaffected arm. Forty-seven patients were enrolled; 5 patients withdrew during the study, leaving 21 in each treatment group. Participants completed training in using the device and were observed in the laboratory to ensure they used proper technique; the remainder of the sessions were conducted at home. Patients in the experimental group (arm, chest, trunk treatment) were told to perform a 1-hour session daily for 30 days; patients in the control group (arm only) were told to perform a 36-minute session daily for 30 days. The final outcome assessment took place at the end of the 30-day treatment period. The trialists did not report whether the staff members who assessed objective outcomes were blinded to the patient treatment groups. There were no statistically significant differences between groups in efficacy outcomes. For example, change in the volume of the affected arm was -2.66 mL in the experimental group and -0.38 mL in the control group (p=.609). In addition, the mean number of symptoms reported at 30 days was 10.0 in the experimental group and 6.0 in the control group (p=.145).

Section Summary: Lymphedema–Pneumatic Compression Pumps Applied to the Limb and Chest and/or Trunk

Two industry-sponsored RCTs of the Flexitouch system (Tactile Medical), published in 2012, have compared treatment with and without truncal involvement. In one RCT, two (of 4) key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (eg, amount of fluid removed) rather than health outcomes (eg, functional status, quality of life). The second RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb and chest and/or trunk, the evidence includes two RCTs of the Flexitouch system (Tactile Medical), published in 2012, comparing treatment with and without truncal involvement. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. In one RCT, two (of 4) key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (eg, amount of fluid removed) rather than health outcomes (eg, functional status, quality of life). The second RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Lymphedema–Pneumatic Compression Pumps Applied to the Limb and Chest and/or Trunk

Poulation Reference No. 3

Lymphedema–Pneumatic Compression Pumps Applied to the Head and Neck

Clinical Context and Therapy Purpose

The purpose of pneumatic compression pumps applied to the head and neck in patients who have lymphedema who failed to respond to conservative therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is patients with lymphedema who failed to respond to conservative therapy.

Interventions

The therapy being considered is the use of pneumatic lymphatic pumps on the head and neck.

Comparators

The following practices are currently being used to treat lymphedema: conservative therapy (eg, range of motion exercises, compression therapy), manual lymphatic drainage, and complete decongestive therapy.

Outcomes

The general outcomes of interest are symptoms, change in disease status, functional outcomes (eg, range of motion), and quality of life (eg, ability to conduct activities of daily living). The Lymphedema Symptom Intensity and Distress Survey-Head and Neck is a patient-reported tool that captures symptom intensity and distress.

Lymphedema is a chronic condition and follow-up of at least 6 weeks to 6 months would be desirable to assess outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Cheng et al. (2023) performed a systematic review and meta-analysis of 23 studies published through January 2023 (N=2147 participants) to evaluate rehabilitation interventions for lymphedema of the head and neck.^10,. The studies were categorized by type of intervention, encompassing standard lymphedema therapy (standard or modified CDT, early manual lymphatic drainage, focused exercise) and adjunct therapies (advanced pneumatic compression devices (APCDs), kinesio taping, photobiomodulation, acupuncture/moxibustion, sodium selenite supplement use\). Six studies (n=399 participants), including one RCT and five observational studies, assessed the Flexitouch APCD (Tactile Medical). The RCT by Ridner et al. (2021) detailed below (n=49) revealed that most participants, who had either finished CDT or lacked access to it, used the device for a single 32-minute session per day during the 8-week industry-sponsored trial, as opposed to the recommended two sessions per day. In the observational studies, the majority of participants also adhered to one 32-minute session daily. The duration of the intervention in these studies varied from a single session to six months. Most studies featured participants who had completed CDT or were concurrently undergoing CDT, while one study specifically noted that none of its participants used CDT. Four studies (80%) were funded by or had authors affiliated with Flexitouch. The single non-industry-sponsored study reported difficulties in obtaining the APCD, with only 35 (of 84) participants (42%) receiving the device as prescribed.^11,Although the included studies showed benefits of using APCD, they had a high risk of bias and were therefore considered low-quality evidence. The Ridner RCT involved a 2-month intervention compared to a waitlist control group. This trial showed improvements in clinician-rated external lymphedema and subjective swallowing in the APCD group, although no improvement was found in endoscopic assessments of internal lymphedema. The largest observational study, conducted by Gutierrez et al (2020) with 205 participants who had used the APCD for over 5 years following a diagnosis of head and neck cancer-associated lymphedema, reported subjective improvements in symptoms and function after APCD use.^12, Overall, the current evidence does not provide sufficient information to determine the optimal timing, duration, and intensity of APCD use in the management of lymphedema associated with head and neck.

Randomized Controlled Trial

Ridner et al (2021) (included in the above systematic review) evaluated the Flexitouch system for head and neck lymphedema in an open-label, randomized, wait-list controlled study.^13, Patients were randomized to lymphedema self-management or lymphedema self-management plus the use of the Flexitouch system twice daily for 8 weeks. Patients were trained on use of the Flexitouch system and were instructed on time of use, which varied based upon size of garment and ranged from 23 to 45 minutes. Patients who were initially randomized to lymphedema self-management only could opt to continue on after the initial 8-week period to receive the Flexitouch system for a subsequent 8-week treatment period. A summary of the design and key results are included in Tables 1 and 2. Adherence to the device was low; at week 8, only 4 of the 19 patients still enrolled in the intervention group used the Flexitouch system as prescribed for at least 5 days (only 1 patient used it twice a day, every day).

Table 1. Summary of Key RCT Characteristics

Table 2. Summary of Key RCT Results

Tables 3 and 4 display notable limitations identified in the study.

Table 3. Study Relevance Limitations

Table 4. Study Design and Conduct Limitations

Section Summary: Lymphedema–Pneumatic Compression Pumps Applied to Head and Neck

One RCT and a systematic review have assessed the use of pneumatic compression treatment for head and neck lymphedema. The RCT, comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone, examined the feasibility, adherence, and safety of the Flexitouch advanced pneumatic compression device (APCD) by Tactile Medical. The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily as prescribed. The systematic review also suggested benefits from using the APCD, and it was considered safe and feasible according to the observational studies that reported adverse events. Most studies included participants who had completed or were concurrently undergoing CDT. Out of the 5 observational studies included in the systematic review, four (80%) were funded by or had authors affiliated with Flexitouch. The only study not sponsored by the industry highlighted difficulties in obtaining the APCD, with fewer than half of the patients receiving the device as prescribed. Further research with larger sample sizes and comparisons against the gold standard of CDT is necessary to establish the efficacy of this treatment approach.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to the head and neck, the evidence includes one RCT and a systematic review to assess the use of pneumatic compression treatment for head and neck lymphedema. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The RCT, comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone, examined the feasibility, adherence, and safety of the Flexitouch advanced pneumatic compression device (APCD) by Tactile Medical. The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily as prescribed. The systematic review also suggested benefits from using the APCD, and it was considered safe and feasible according to the observational studies that reported adverse events. Most studies included participants who had completed or were concurrently undergoing complete decongestive therapy. Out of the 5 observational studies included in the systematic review, four (80%) had potential conflicts of interest related to the funding source. The only study not sponsored by the industry highlighted difficulties in obtaining the APCD, with fewer than half of the patients receiving the device as prescribed. Further research with larger sample sizes and comparisons against the criterion standard of complete decongestive therapy is necessary to establish the efficacy of this treatment approach. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Lymphedema–Pneumatic Compression Pumps Applied to Head and Neck

Population Reference No. 4

Pneumatic Compression Pumps Applied to Venous Ulcers

Clinical Context and Therapy Purpose

The purpose of pneumatic compression pumps in patients who have venous ulcers is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is patients with venous ulcers.

Interventions

The therapy being considered is the use of pneumatic lymphatic pumps.

Comparators

The following practices are currently being used to treat venous ulcers: medication therapy and continuous compression (eg, stockings, bandages).

Outcomes

The general outcomes of interest are symptoms, change in disease status, morbid events, and quality of life. Complete healing is generally considered the most clinically relevant outcome; a 50% reduction in wound area over time and time to heal are also considered acceptable outcomes.

Venous ulcers are a chronic condition, and follow-up of at least 6 weeks to 6 months would be desirable to assess outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Review

A Cochrane review updated by Nelson et al (2014) addressed intermittent pneumatic compression pumps for treating venous leg ulcers.^14, Reviewers identified 9 RCTs. Five trials compared pneumatic compression pumps plus continuous compression with continuous compression alone; 2 trials compared compression pumps with continuous compression (stockings or bandages); 1 trial compared compression pumps with wound dressings only; and 1 trial compared 2 intermittent pneumatic compression regimens. In a meta-analysis of 3 of the 5 trials evaluating the incremental benefit of pneumatic compression pumps over continuous compression alone, there was a significantly higher rate of healing with combined treatment (relative risk, 1.31; 95% CI, 1.06 to 1.63). Two of these 3 trials were considered to have a high-risk of bias (eg, not blinded, unclear allocation or concealment). There was a high degree of heterogeneity among trials, and findings from other RCTs were not pooled. Neither of the 2 trials comparing intermittent pneumatic compression with continuous compression plus stockings or bandages found statistically significant between-group differences in healing rates.

Randomized Controlled Trials.

An RCT by Dolibog et al (2014) was published after the Cochrane review literature search.^15, The trial included 147 patients with venous ulcers. It compared 5 types of compression therapy: intermittent pneumatic compression using a 12-chamber Flowtron device, stockings, multilayer bandages, 2-layer bandages, and Unna boots. All patients received standard drug therapy; the compression interventions lasted 2 months. Rates of complete healing at the end of treatment were similar in 3 of the treatment groups: 16 (57%) of 28 patients in the pneumatic compression group, 17 (57%) of 30 in the stockings group, and 17 (59%) of 29 in the multilayer bandage group. On the other hand, rates of healing were much lower in the other 2 groups: 5 (17%) of 30 in the 2-layer bandage group and 6 (20%) of 30 in the Unna boot group. In 2013, a pilot study by Dolibog et al, included in the Cochrane review, had similar findings.^16,

Alvarez et al (2020) conducted an RCT in 52 patients with large (>20 cm²) chronic venous leg ulcers that compared intermittent pneumatic compression plus standard compression therapy (n=27) to standard compression therapy alone (n=25).^17, Standard compression therapy consisted of multilayer compression bandages. Intermittent pneumatic compression therapy was performed for 1 hour twice daily. At 9 months, median time to wound closure was significantly shortened in the group receiving pneumatic compression (141 days vs. 211 days; p=.03). Wound pain relief was greater in the pneumatic compression group for the first 3 weeks of therapy, but pain relief was similar between groups at subsequent time points.

Section Summary: Venous Ulcers

RCTs and a systematic review have assessed the use of pneumatic compression treatment for venous ulcers. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at high risk of bias. A more recent small RCT comparing lymphedema pumps with continuous compression did not find significant between-group differences in healing rates.

For individuals who have venous ulcers who receive pneumatic compression pumps, the evidence includes RCTs and one systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at high risk of bias. A 2020 RCT compared lymphedema pumps with continuous compression did not find significant between-group differences in healing rates or durability of pain relief. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Venous Ulcers  

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Family Physicians

In 2019, the American Academy of Family Physicians published recommendations for diagnosis and treatment of venous ulcers.^18, The following statements were issued regarding use of intermittent pneumatic compression.

• "Intermittent pneumatic compression may be considered when there is generalized, refractory edema from venous insufficiency; lymphatic obstruction; and significant ulceration of the lower extremity. Although intermittent pneumatic compression is more effective than no compression, its effectiveness compared with other forms of compression is unclear. Intermittent pneumatic compression may improve ulcer healing when added to layered compression."

American Venous Forum et al

In 2022, the American Venous Forum, American Vein and Lymphatic Society, and the Society for Vascular Medicine published an expert opinion consensus statement on lymphedema diagnosis and treatment.^19, The following statements were issued regarding use of pneumatic compression:

• "Sequential pneumatic compression should be recommended for lymphedema patients." (92% panel agreement; 32% strongly agree)

• "Sequential pneumatic compression should be used for treatment of early stages of lymphedema." (62% panel agreement - consensus not reached; 38% panel disagreement; 2% strongly disagreed)

International Union of Phlebology

A 2013 consensus statement from the International Union of Phlebology indicated that primary lymphedema could be managed effectively by a sequenced and targeted management program based on a combination of decongestive lymphatic therapy and compression therapy.^20, Treatment should include compression garments, self-massage, skin care, exercises, and, if desired, pneumatic compression therapy applied in the home.

Society for Vascular Surgery and American Venous Forum

The 2014 joint guidelines from the Society for Vascular Surgery and the American Venous Forum on the management of venous ulcers included the following statement on pneumatic compression^21,:

“We suggest use of intermittent pneumatic compression when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy. [GRADE - 2; LEVEL OF EVIDENCE - C]”

Wound Healing Society

A 2015 guideline from the Wound Healing Society states that for patients with venous ulcers, intermittent pneumatic pressure can be used with or without compression dressings and can provide another option in patients who cannot or will not use an adequate compression dressing system.^22,

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

A 2002 national coverage determination for pneumatic compression devices by the Centers for Medicare & Medicaid Services has stated the following^23,:

A. “Lymphedema

...Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.”

B. “Chronic Venous Insufficiency With Venous Stasis Ulcers

Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.”

"Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a 6 month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.”

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 5.

Table 5. Summary of Key Trials

REFERENCES

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2. International Society of Lymphology Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of the International Society of Lymphology. 2023; https://journals.librarypublishing.arizona.edu/lymph/article/id/6372/. Accessed November 25, 2024.
3. Oremus M, Walker K, Dayes I, et al. Technology Assessment: Diagnosis and Treatment of Secondary Lymphedema (Project ID: LYMT0908). Rockville, MD: Agency for Healthcare Research and Quality; 2010.
4. Oremus M, Dayes I, Walker K, et al. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer. Jan 04 2012; 12: 6. PMID 22216837
5. Shao Y, Qi K, Zhou QH, et al. Intermittent pneumatic compression pump for breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. Oncol Res Treat. 2014; 37(4): 170-4. PMID 24732640
6. Hou S, Li Y, Lu W, et al. Efficacy of intermittent pneumatic compression on breast cancer-related upper limb lymphedema: a systematic review and meta-analysis in clinical studies. Gland Surg. Aug 31 2024; 13(8): 1358-1369. PMID 39282029
7. Yao M, Peng P, Ding X, et al. Comparison of Intermittent Pneumatic Compression Pump as Adjunct to Decongestive Lymphatic Therapy against Decongestive Therapy Alone for Upper Limb Lymphedema after Breast Cancer Surgery: A Systematic Review and Meta-Analysis. Breast Care (Basel). Jun 2024; 19(3): 155-164. PMID 38894955
8. Fife CE, Davey S, Maus EA, et al. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Support Care Cancer. Dec 2012; 20(12): 3279-86. PMID 22549506
9. Ridner SH, Murphy B, Deng J, et al. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat. Jan 2012; 131(1): 147-58. PMID 21960113
10. Cheng JT, Leite VF, Tennison JM, et al. Rehabilitation Interventions for Head and Neck Cancer-Associated Lymphedema: A Systematic Review. JAMA Otolaryngol Head Neck Surg. Aug 01 2023; 149(8): 743-753. PMID 37382963
11. Shires CB, Harris P, Dewan K. Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. Laryngoscope Investig Otolaryngol. Jun 2022; 7(3): 774-778. PMID 35734055
12. Gutiérrez C, Mayrovitz HN, Naqvi SHS, et al. Longitudinal effects of a novel advanced pneumatic compression device on patient-reported outcomes in the management of cancer-related head and neck lymphedema: A preliminary report. Head Neck. Aug 2020; 42(8): 1791-1799. PMID 32187788
13. Ridner SH, Dietrich MS, Deng J, et al. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Support Care Cancer. Feb 2021; 29(2): 795-803. PMID 32488435
14. Nelson EA, Hillman A, Thomas K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. May 12 2014; 2014(5): CD001899. PMID 24820100
15. Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int J Med Sci. 2014; 11(1): 34-43. PMID 24396284
16. Dolibog P, Franek A, Taradaj J, et al. A randomized, controlled clinical pilot study comparing three types of compression therapy to treat venous leg ulcers in patients with superficial and/or segmental deep venous reflux. Ostomy Wound Manage. Aug 2013; 59(8): 22-30. PMID 23934375
17. Alvarez OM, Markowitz L, Parker R, et al. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020; 20: e6. PMID 32636985
18. Bonkemeyer Millan S, Gan R, Townsend PE. Venous Ulcers: Diagnosis and Treatment. Am Fam Physician. Sep 01 2019; 100(5): 298-305. PMID 31478635
19. Lurie F, Malgor RD, Carman T, et al. The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment. Phlebology. May 2022; 37(4): 252-266. PMID 35258350
20. Lee BB, Andrade M, Antignani PL, et al. Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP)-2013. Int Angiol. Dec 2013; 32(6): 541-74. PMID 24212289
21. O'Donnell TF, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery ® and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl): 3S-59S. PMID 24974070
22. Marston W, Tang J, Kirsner RS, et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. 2016; 24(1): 136-44. PMID 26663616
23. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Pneumatic Compression Devices (280.6). 2002; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=225. Accessed January 30, 2024.

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