Clinical UM Guideline

This document addresses the use of devices that create compression for the treatment of lymphedema. This therapy involves the use of garments and devices designed for various body parts and includes mechanisms intended to compress specific body parts targeted for treatment. Compression devices may be used in clinics or can be purchased or rented for home use.

Note: This document addresses the home and community use of compression devices used to treat lymphedema. Use of such devices in the inpatient and facility setting is not within the scope of this document.

Note: This document addresses devices for the treatment of lymphedema only. Compression devices used in the treatment or prevention of venous thrombosis, venous insufficiency with refractory edema or ulceration, and therapy for musculoskeletal injury are NOT addressed in this document. For information regarding the use of compression devices for other indications please see:

• CG-DME-46 Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Extremities in the Home Setting

Note: This document does not address compression devices with combined cooling or heating functions intended to treat conditions other than lymphedema. For more information regarding such devices, please see:

• DME.00037 Cooling Devices and Combined Cooling/Heating Devices

Note: This document does not address gradient compression sleeves used to treat upper extremity lymphedema following breast surgery. Such sleeves are considered DME and may be subject to The Women’s Health and Cancer Rights Act of 1998 (WHCRA) coverage mandate.

Note: WHCRA is federal legislation that provides that any individual with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA. This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedemas. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well. The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to men, as well as women. WHCRA does not address lumpectomies. Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy.

Medically Necessary:

Single or multi-chamber or segment non-programmable compression devices are considered medically necessary when the criteria below have been met:

1. Treatment of upper or lower limb lymphedema; and
2. The individual’s lymphedema is not improving; and
3. The individual has been compliant with conservative therapy*.

*Conservative therapy may include any combination of the following: elevation of the affected limb, exercise, massage, use of an appropriate compression bandage system or compression garment.

Single or multi-chamber or segment programmable (for example, calibrated gradient pressure) compression devices are considered medically necessary when the criteria below have been met:

1. The criteria above for a non-programmable compression device have been met; and
2. Criteria 1 or 2 below have been met:
   1. All of the below:
      1. A single or multi-chamber or segment non-programmable compression device has been tried for a minimum of 3 months; and
      2. There is documentation of compliance with treatment with the non-programmable pneumatic compression device; and
      3. The records provide objective documentation that lymphedema has progressed;
         or
   2. There is clear documentation of a condition that prevents the satisfactory treatment of lymphedema with a non-programmable device. Such conditions may include, but are not limited to the following:
      1. Contracture; or
      2. Sensitive skin; or
      3. Significant scarring.

Not Medically Necessary:

Single or multi-chamber or segment programmable or non-programmable compression devices for the treatment of upper or lower limb lymphedema are considered not medically necessary when the criteria above have not been met.

Two-stage* multi-chamber or segment programmable compression devices are considered not medically necessary for the treatment of upper or lower limb lymphedema.

*Note: Two-stage devices involve an initial programmed compression of the chest and/or trunk, the “preparatory stage,” followed by a second programmed compression of the affected limb(s), the “drainage” stage.

Compression devices to treat lymphedema in any body part other than the upper or lower extremities is considered not medically necessary.

Non-pneumatic, non-sequential, peristaltic wave compression devices are considered not medically necessary for the treatment of upper or lower limb lymphedema.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

When services are also Not Medically Necessary:
For the following procedure codes; or when the code describes a procedure designated in the Clinical Indications section as not medically necessary.

Summary

Lymphedema is a term for swelling of specific body parts caused by blocked lymph vessels. Such blockage may be due to damaged or absent lymph vessels because of congenital issues (primary lymphedema) or due to surgery, cancer, radiation, or injury (secondary lymphedema). Treatment for lymphedema focuses on prevention of fluid buildup and methods to move fluid out of the affected body parts. Treatment may include compression garments, massage, exercise, and mechanical devices such as compression pumps. Evidence shows that standard pneumatic devices can reduce swelling, improve symptoms, and support quality of life for limb lymphedema, with benefits similar to manual therapy. Lymphedema pumps have traditionally been pneumatic, but some newer devices use alternative mechanical methods to induce compression. The simplest types of pumps use an ankle to hip compression sleeve which is inflated to squeeze the affected limb. More technologically advanced devices may be appropriate when simple pump therapy fails. Such pumps involve sleeves that are compartmentalized to allow sequential compression from the ankle to hip, as well as programs that vary the pressure, time, sequence and other parameters to improve treatment efficacy. Two-stage devices treat the trunk as well as the limb. Other types of devices are available to treat head and neck lymphedema, but there is a lack strong evidence to demonstrate the clinical utility of such devices and they are not generally accepted in clinical practice. There are also newer non-pneumatic peristaltic devices that treat only specific parts of the leg. Such devices similarly lack supporting evidence and are not widely accepted as a treatment for lymphedema.

Discussion

Lymphedema is characterized by swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. This results from impairment of the normal clearing function of the lymphatic system, from an excessive production of lymph, or from both. Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition due to congenital absence of lymph vessels and nodes, such as can occur in Milroy’s Disease. Secondary lymphedema is much more common and results from the destruction or damage of formerly functioning lymphatic channels. Examples include radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy), post-radiation fibrosis, and spread of malignant tumors to regional lymph nodes with lymphatic obstruction. Treatment for lymphedema may include mechanical measures (for example, compression garments, bandaging, manual massage, compression devices), drugs, and in rare cases, surgery.

Multiple compression devices have been approved through the U.S. Food and Drug Administration's (FDA's) 510(k) process. Such devices are classified as Class II devices: cardiovascular therapeutic devices, and compressible limb sleeves. Such devices, also known as lymphedema pumps, are used to simulate muscle action in the extremities to stimulate lymph and blood circulation with the goal of decreasing edema. These devices involve the use of sleeve or wrap-like garments that have mechanisms to apply compression. The traditional type of compression device involves the use of one or several inflatable air chambers. Another type of device uses metal bands that contract under electrical stimulation to create calibrated compression (Dayspring system, Koya, Inc., San Francisco, CA). During treatment, these devices apply compression in a distal to proximal fashion, squeezing in such a way as to encourage lymphatic fluid to flow back to the heart. Some devices have programmable control units that allow variation in the duration and frequency of the inflation cycles, as well as the degree of compression in individual air chambers or metal band segments in the garment. The ability to vary different parameters of treatment has been proposed as a method of optimizing the treatment process, but there is insufficient evidence to demonstrate the superiority of programmable devices compared to non-programmable devices.

WHCRA mandated that treatment of physical complications of all stages of the mastectomy, including lymphedemas, may be covered by their benefits for individuals who have undergone surgical breast procedures. This includes the use of compression devices that involve externally applied pressure to move fluid from the distal portions of the body toward the heart.

Treatment of the Extremities

The scientific literature addressing the use of compression devices for the treatment of lymphedema has predominantly focused on the treatment of affected limbs using pneumatically driven devices.

Evidence published prior to 2013 on conservative treatments for secondary lymphedema, particularly upper limb lymphedema after breast cancer, was generally low quality, with significant heterogeneity preventing firm conclusions about the superiority of any therapy (Johansson, 1998; Dini, 1998; Szuba, 2002; Oremus, 2012; Gurdal, 2013; Uzkeser, 2013). Small randomized controlled trials (RCTs) provided mixed results for pneumatic compression devices. Some of these studies showed short-term limb volume reduction compared to standard care, but with benefits often not persisting, while others found no significant differences compared to no care or standard care. Trials comparing different combinations of manual lymphatic drainage, compression bandaging, self-lymphatic drainage, complex decongestive therapy, and intermittent pneumatic compression consistently reported improvements in limb volume and some quality-of-life measures, but no clear advantage of one regimen over another. A small RCT (Fife, 2012) suggested that programmable pneumatic compression devices may offer greater edema reduction than standard non-programmable devices. This study’s limitations, including small sample size, lack of blinding, and absence of patient-centered outcomes restrict its applicability. Overall, larger, well-designed trials were identified as necessary to clarify optimal treatment approaches.

Desai (2019) reported the results of a case series study involving 128 participants with lower extremity lymphedema treated with pneumatic compression therapy. The authors report significant benefits after the completion of 1 year of treatment. Benefits included a 28% decrease in absolute limb volume (p<0.001), decrease in body-mass index (BMI) (p<0.001), improvement in SF-36 quality of life score in 7 of 8 domains (p<0.001), and improvement in a lymphedema complexity score (LLCS) (p<0.001).

Tastaban (2020) reported the results of a non-blind RCT involving 76 participants with cancer-related lymphedema assigned to receive either standard care (n=38) or standard care plus pneumatic compression therapy (n=38). The authors reported that both groups showed significant improvements in limb volume reduction, limb heaviness, and limb tightness. There were no significant differences between groups.

Rockson (2022a) and colleagues reported the results of a prospective, non-randomized pilot study involving 40 participants with unilateral upper extremity lymphedema. The lymphedematous arm was treated with the Koya Dayspring system and the contralateral arm was used as a control group. Treatment was applied for a minimum of 45 minutes a day, every day, for 28 days. The authors reported that overall LYMQOL results improved 18% (7.05 points at baseline to 8.27 points at 28 days, p<0.001). Similar improvements were reported in a subset of 15 participants who had previously received treatment with pneumatic compression device therapy (17%, 7.07 points to 8.27 points at 28 days, p<0.001). Limb volume reduction in the treated arm was reported on average of 2% by the end of the study period at 28 days (p~0.042), compared to no significant change in the control arms. Previously treated participants also had significant improvements in limb volume (2-12%, p<0.05). Adherence to protocol was 95%, as measured by mobile application linked to the Dayspring device. The lack of a parallel control group leaves open a high risk of placebo effect, Hawthorne effect, and confounding. The small study size, its extremely short duration, and focus exclusively on individuals recovering from breast cancer severely limit the applicability of these results to broader populations.

Rockson (2022b) also published the results of an unblinded non-inferiority RCT involving 50 participants with breast-cancer-related upper limb lymphedema. Participants were treated with either the Dayspring device or an advanced pneumatic compression device (control group) for 28 days. They then underwent a 4-week washout period with no compression device use, followed by a second 28-day treatment period with the alternative device. The Dayspring device was used first for 23 participants and the control device was used in the remaining 27 participants. The mean reduction in edema volume was reported to be 64.6% in the Dayspring device group and 27.7% in the control group which the authors concluded met the primary endpoint of non-inferiority. LYMQOL scores in the Dayspring group indicated a 2.44 point increase compared to no change in the control group. The difference in improvement for the Dayspring group was statistically significant (p<0.05). However, these results should be viewed in light of a significant difference in use compliance between groups, with 95.6% of Dayspring participants complying with the 60-minute per day therapy and only 49.8% of the control group participants complying. No serious adverse events were reported for either device, with no new hand or chest swelling observed in either group.

This group published a subanalysis of their RCT of all participants 65 years of age and older (Rockson, 2023). A total of 14 participants were included in the analysis. The reported mean percentage change in edema during treatment with the Dayspring device decreased 100.3% (95% confidence interval [CI], 30.8-169.7 decrease, p=0.0082). During the control treatment with an advanced pneumatic compression device the mean change decreased 2.9% (95% CI, -47.1 to 41.3, p=0.8899). Compared to advanced pneumatic compression devices, the percentage reduction in edema experienced with the Dayspring device was significantly greater (mean difference=97.4%, p=0.0034). Significant improvements in mean LYMQOL subscale scores (Function, Appearance, Symptoms, and Mood) and Overall QOL were reported in the Dayspring group (all p<0.01), but not in the control group. The authors also reported that mean adherence for the Dayspring group was 96.6% compared to 58.3% in the control group (p<0.0001). While these results are interesting, the limited sample size does not allow generalizable conclusions regarding the use of the Dayspring device compared to advanced pneumatic compression devices in older populations. The authors acknowledge that, stating, “The original study was not powered for a subanalysis, and the results should be viewed with caution, given that the sample size is 14.”

Dunn (2022) reported on an RCT involving 40 participants with lower limb lymphedema treated with pneumatic compression using the LymphAssist (Huntleigh Healthcare Ltd., Cardiff, U.K.) intermittent pneumatic compression regimen or a sequential compression therapy regimen. Treatments used 40 mmHg of pressure for 35 minutes twice daily for 5 weeks. A total of 33 participants had bilateral lower limb disease and 7 had unilateral disease. All participants were blinded to group assignment. The authors reported that the LymphAssist group had significantly reduced distal leg volume when compared to the control sequential compression group (reduction of 230-135 mL vs. 140-84 mL, respectively, p=0.01). No differences in proximal leg volume were reported (reduction of 124-118 mL vs. 150-158 mL, respectively, p=0.7).

Barfield (2025) reported the results of an unblinded RCT involving 71 participants with lower extremity lymphedema treated with compression therapy with either a nonpneumatic compression device (NPCD, the Dayspring device) or an advanced pneumatic compression device (APCD). All participants were randomly assigned to treatment with either type of device for an initial phase of 90 days, followed by a 4-week washout period before beginning another 90-day treatment phase with the other device type. In the control phase, participants received treatment with an Airos device (n=2), a LymphaPress device (n=1), or a Flexitouch^® plus (n=68). The primary efficacy outcomes were change in limb volume at the end of each treatment phase, change in LYMQOL, and treatment adherence. The mean limb volume decrease from baseline to 90 days was 369.9 mL in the NPCD phase (p<0.05). In the APCD phase the mean limb volume decrease in the same time period was 83.1 mL (p<0.05). The between group comparison was statistically significant in favor of the NPCD group (p<0.005). In the NPCD group the overall LYMQOL score improved 1.01 points (p<0.05) compared to 0.17 (p>0.05) in the control group. The between group was statistically significant in favor of the NPCD group (p<0.05). Treatment adherence in the NPCD group was 81.0% compared to 56.0% in the control group and the between group analysis revealed a statistically significant difference in favor of the NPCD group (p<0.001). No device-related adverse events were reported in either treatment group. The authors concluded that the NPCD device was more effective than advanced pneumatic compression devices. It should be noted, however, that the study was designed to show non-inferiority, so superiority cannot be established by its results. The study initially included 99 participants but 24 participants withdrew consent and an additional 4 were lost to follow-up. Of those withdrawing consent, 15 of 24 did so during their NPCD phase. The authors’ analysis appears to be per‑protocol, not clearly intention‑to‑treat, risking attrition bias and overestimation of benefit. Arm measurements were assessed by unblinded therapists, risking detection bias. Adherence was based on participant diaries (self‑report) which is prone to recall and social‑desirability biases. Higher reported adherence to NPCD may have contributed to the observed outcomes.

Overall, the available evidence indicates significant benefits to upper and lower extremity compression therapy with standard or “advanced” devices. Pneumatic and nonpneumatic devices appear to provide comparable results. While these benefits do not appear to be better than manual decompressive treatment, the evidence to date appears to point to equivalence. On the basis of this data the use of compression therapy has become widely recognized in the practicing community as a reasonable option and part of the standard of care for the treatment of upper and lower limb lymphedema.

Two-Stage Devices

Multi-chamber or segment programmable pneumatic compression devices may also function with two-phases. The first phase, referred to as the “preparatory phase,” compresses the trunk (chest/abdomen). The preparatory phase is designed to prepare the limb and adjacent trunk or torso to receive lymph fluid for a secondary (drainage) compression phase. The combination of these two phases (preparation plus drainage) has been proposed as a method to further enhance lymph drainage.

A device available and marketed by Tactile Medical^® (Minneapolis, MN), the Flexitouch Plus^® system, has been referred to as an “advanced pneumatic compression device” or “APCD”. This system provides lymphatic decompression therapy using compression garments for treatment of the head and neck, upper body (chest), lower torso (trunk), upper extremities, and lower extremities. When the lower extremity garment is used alone the system may be considered a single-stage device. When garments for the neck, upper body, or lower torso are used in conjunction with limb garments, the device is considered a two-stage device. Of note, Flexitouch also markets another device, the Flexitouch Entre^® Plus, a single-stage device that can only be used to treat the extremities.

The available evidence addressing the clinical use of two-stage multi-chamber or segment programmable pneumatic compression devices is limited. In addition to several case reports published in journals not recognized in the National Library of Medicine’s PubMed database (Cannon, 2009; Hammond, 2009a, 2009b), there are a few case series and a limited number of RCTs available.

From 2006 to 2013, several small studies evaluated two-stage compression therapy for lymphedema, using varying designs and outcome measures. In a randomized controlled cross-over trial (Wilburn, 2006) of 10 participants with unilateral breast cancer-associated upper extremity lymphedema, two-stage compression therapy was compared to self-administered massage over 4 weeks. The study found significant improvements in limb volume and participant weight but no quality-of-life differences, with no comparison to single-stage pumps. Ridner (2008) conducted a case series of 286 participants using two-stage compression for 2 months, assessing self-reported quality of life and satisfaction; methodological limitations included lack of a control group, no blinding, high loss to follow-up (36%), reliance on self-report, and no reporting of objective health outcomes. Ridner et al. (2012) randomized 42 participants to upper-extremity-only compression versus upper extremity plus chest/trunk compression, finding functional and anatomical improvements in both groups but no significant differences between them; most treatments were performed unsupervised at home. In the largest study, Muluk et al. (2013) prospectively followed 196 participants with lower extremity lymphedema, 88% of whom achieved significant limb volume reductions (mean 1,150 mL or 8%, p<0.0001) and most showing improved skin fibrosis (86%) and function (77%), although the assessment tools were not clearly described. Across studies, strengths included prospective data collection and some use of randomization; limitations included small sample sizes, short follow-up, lack of control groups or blinding in most studies, variable outcome measures, incomplete reporting of methods, and, in some cases, heavy reliance on self-reported outcomes without objective clinical measures.

In 2017, Karaca-Mandic and colleagues published the results of a retrospective analysis of administrative claims from 1731 participants with cancer (n=621) and non-cancer-related (n=1110) lymphedema who were treated with either a segmented non-programmable pneumatic compression device (n=1013) or the Flexitouch^™ device (n=718). Further stratification for the participants with cancer-related lymphedema resulted in 247 participants treated with the non-programmable pump and 374 treated with the Flexitouch device. For the non-cancer participants, there were 766 participants treated with the non-programmable pump and 344 in the Flexitouch group. Data were presented for the first 12 months of therapy. At baseline, the non-programmable group had a higher proportion of obesity, diabetes, hypertension, and renal disease (p<0.001 for all). The Flexitouch group had a significantly higher proportion of breast cancer (76% vs. 43%, p=<0.001). In the cancer group, the Flexitouch group had a higher rate of improvement in cellulitis than the non-programmable group (79% reduction vs. 53%, p=0.02). The rate of outpatient services was significantly lower in the Flexitouch group (reduction of 1.84 vs. 0.31, p=0.001). The  hospitalization rate was not significantly different between groups, and use of manual therapy declined a similar amount for each group, with no significant differences. In the non-cancer group, the Flexitouch group had a higher rate of improvement in cellulitis vs the non-programmable group (76% reduction vs. 54%, p=0.003). The use of manual therapy declined at a greater rate in the Flexitouch group compared to the non-programmable group (p=0.04). The rate of outpatient services was significantly better in the Flexitouch group compared to the non-programmable group (reduction of -22.8% vs. -7.8%, p<0.001). The rate of hospitalizations did not change in non-programmable group, whereas it did improve significantly in the Flexitouch group (6/6% to 2/9%, p=0.03). Overall the authors noted that outpatient service use was reduced in both device groups, with greater reductions observed in Flexitouch group. Also, both device groups experienced reductions in manual therapy use. Inpatient hospitalizations were largely stable with reductions observed only in the non-cancer cohort of the Flexitouch group. They concluded that use of the Flexitouch device “was associated with superior lymphedema-related health outcomes and reductions in cellulitis.” The retrospective , unblinded, unrandomized nature of this study hinders the generalizability of these findings to a wider population.

Maldonado (2021) reported the interim results of a prospective case series study involving 178 participants with obesity and lower limb lymphedema being treated with the Flexitouch Advanced pneumatic compression device (APCD). The report includes data from the first 74 participants to reach the 52-week study endpoint. LYMQOL results demonstrated significant improvement from baseline at 52 weeks (6.3 points vs. 7.4 points, p<0.0001). Additionally, limb circumference decreased significantly during the same timeframe (28.5 cm vs. 227.7 cm, p<0.0005). This finding was durable throughout the study period. Finally, the authors reported a reduction in the number of episodes per participant of the following: cellulitis (24.3% vs. 8.1%, p=0.005), lymphedema-related clinic visits (2.2 vs. 0.7, p=0.02), urgent care visits (1.2 vs. 0.3, p=0.004), and hospital admissions (0.5 vs. 0.1, p=0.047). These results are supportive of compression therapy, but results of the full cohort will provide better data.

In 2024, Padberg published the final results of the study described above by Maldonado. The final report includes 179 participants who completed 52 weeks of treatment with the original two-stage Flexitouch APCD device or the Flexitouch Plus device. In the full cohort, measures in all four LYMQOL-leg domains (function, appearance, symptoms, and emotion) and the overall summary score were significantly improved by 12 weeks. This improvement persisted through 52 weeks (p<0.0001). In SF-36v2 results, six domains demonstrated significant improvements compared to baseline. These results showed the following statistical significance at 12, 24, and 52 weeks: role-physical (p<0.02-0.0006), bodily pain (p<0.0077-0.0001), and physical component (p<0.0014-0.0001). At 52 weeks, physical function (p<0.0001), social functioning (p<0.0181), and mental health (p<0.0333) had also improved. No differences were identified in the four domains of general health, vitality, role-emotional, or mental component (no p-values provided). Mean limb girth at 52 weeks was reported to have decreased by 1.2 cm (p<0.0001) in the 121 participants with full datasets available. The incidence of cellulitis was reported to have reduced from 21.4% to 6.1% in cellulitis events (p<0.0011), with 21 participants reported a history of medical encounters for cellulitis in the year preceding enrollment compared to seven events in six participants during the 52-week trial. The number of participants with recorded skin assessments decreased substantially over time, resulting in wide 95% confidence intervals and making accurate statistical evaluation impossible. Two device-related events were reported (i.e., self-limited “ankle pain”). Finally, the authors noted that health care utilization for lymphedema and venous-related events during the study (n=279) were less than the 395 events experienced during the year prior to the study, the difference was not statistically significant. The results of this study indicate some benefit to the use of the Flexitouch APCD devices. Importantly, the trial did not include a direct comparison between advanced two-stage APCDs and standard single-stage pneumatic compression devices, leaving unanswered the question of the incremental benefit of the Flexitouch technology over the current standard of care.

In summary, the available evidence in the peer-reviewed medical literature does not demonstrate that the use of two-stage devices improves the net health outcome or is as beneficial as established alternatives, such as single-stage (non-programmable or programmable) treatment of lymphedema.

Treatment of the Head and Neck.

There are few studies available describing the use of compression devices for the treatment of head and neck lymphedema. A small case series study involving 44 participants and reported on the usability and treatment-related lymphedema changes following a single treatment (Mayrovitz, 2018). The authors reported a small but statistically significant reduction in composite metrics of the face (82.5 ± 4.3 cm vs 80.9 ± 4.1 cm; p<0.001) and neck (120.4 ± 12.2 cm vs 119.2 ± 12.1 cm; p<0.001), with no adverse events. The results of this study are limited due to the lack of a comparison group and low statistical power.

Gutiérrez (2020) reported the results of a case series involving 499 participants with head and neck lymphedema treated with the Flexitouch device. A total of 205 participants had complete data and were included in the report. The authors reported that the results of self-reported questionnaires demonstrated a significant increase compared to baseline in the ability to control lymphedema symptoms through at-home treatment (1.89 ± 0.96 vs. 3.61 ± 0.96; p<0.00001), a decrease in the frequency of lymphedema-related limitations to perform daily activities (3.22 ± 1.38 vs. 4.01 ± 1.17; p<0.00001), improvement in head and neck pain or discomfort (3.13 ± 1.16 vs. 3.61 ± 1.03; p<0.00001), decreased difficulty with swallowing (2.90 ± 1.28 vs. 3.57 ± 1.21; p<0.00001), and improved ability to breathe (3.94 ± 1.13 vs. 4.44 ± 0.88; p<0.00001). The results of this study are promising, but generalizability is limited by the lack of a comparison group, use of self-reported subjective outcomes data, and large loss to follow-up.

Ridner (2020) reported results for a non-blinded RCT involving 49 participants with head and neck lymphedema treated with standard care (n=25) or the Flexitouch device (n=24). Six participants withdrew from the study before completion: 1 in the control group and 5 in the Flexitouch group. This left 24 control participants and 19 Flexitouch participants. Most Flexitouch participants (< 50%) did not follow the prescribed treatment schedule of 2 treatments per day and only used it once per day. Flexitouch group participants reported an increase in perceived ability to control lymphedema (26% good or excellent at baseline vs. 84% good or excellent at 8 weeks, p=0.003). Statistically significant reductions in the reported severity of soft tissue (p=0.008) and neurological (p=0.047) symptom clusters were reported in the Flexitouch group vs. controls, based on the Lymphedema Symptom Intensity and Distress Survey-Head and Neck (LSIDS-HN) tool. A statistically significant improvement in swallowing solids (p=0.016) and mucous-related symptoms (p=0.050) was reported for the Flexitouch group vs. controls as measured on the Vanderbilt Head and Neck Symptom Survey plus General Symptom Survey version 2.0 (VHNSS-GSS). Furthermore, control participants reported an increase in general pain vs. Flexitouch group participants who reported the same level as at baseline (p=0.008). Based on photographic analysis, the degree of visible external swelling was significantly better in the Flexitouch group (front view p<0.001, right view p=0.004, left view p=0.005). Differences in internal swelling via endoscopic evaluation were not statistically significant between groups. These results indicate some significant benefits, but are hampered by the study’s short duration, low treatment adherence, loss to follow-up, low power, and lack of blinding. Larger, independent, multicenter RCTs with diverse populations, longer follow-up, and pragmatic dosing regimens are needed to better understand the role of treatment.

Gregor (2025) reported the results of a retrospective case series, proof of concept study involving 30 participants treated for head and neck cancer-related internal lymphedema with the Flexitouch Plus device. All subjects were at least 3 months post-radiation therapy and underwent a single 32-minute treatment. All subjects underwent post-treatment assessment of structural width measured by fluoroscopic scouts and TIMS Review software. The authors reported that all participants had demonstrated significant reductions for both external and internal neck structures following their treatment. No statistics were provided to support this reported outcome. This report is insufficient to provide generalizable data supporting the clinical utility of compression therapy for lymphedema of the head and neck.

While these results are promising, the use of pneumatic compression devices for treatment of lymphedema involving the head and neck is not a widely accepted treatment method in the practicing community.

Lymphedema Related to Massive Obesity

There is low-level evidence that massive obesity may rarely be a cause of massive localized lymphedema (MLL), a condition affecting the pelvic region and lower extremities (Chopra, 2015; Mehrara, 2014). Several case reports and small case series studies have been published characterizing MLL (Fife, 2008, 2014; Greene, 2013, 2015a).

In the only report of its kind, Greene (2015b) published the results of a case series study involving 51 participants with Body Mass Index (BMI) greater than 30 kg/m² and lymphedema with no other potential causes of the condition. All participants underwent lymphoscintigraphy to assess lower extremity lymphatic function. The authors reported that participants with abnormal lymphoscintigraphy results had higher BMI compared to participants with normal results (mean 64.9 kg/m² vs. 38.8 kg/m²; p<0.0001). Participants were stratified into two groups. Group 1 participants were at their maximum BMI (n=33), while group 2 participants had experienced some weight loss at the time of lymphoscintigraphy (n=18). All participants in group 1 with a BMI less than 50 kg/m² (n=20) had normal lymphoscintigraphy results. In the same group, all participants with a BMI greater than 60 kg/m² (n=9) had abnormal results. In group 2, participants with abnormal lymphoscintigraphy results had higher maximum BMI history (p=0.03) as well as higher BMI at the time of the scan (p=0.005) compared to participants in group 1 with normal results. These results appear to indicate that MLL is directly correlated with higher BMI, specifically BMI over 50 kg/m².

The treatment of MLL can be a significant challenge due to the large size and location of the lymphedema. The preferred method of treatment is currently surgical excision, especially when ulcers or infections are present. However, there is some anecdotal evidence that such lesions may return, and with greater severity than the initial lesion (Fife, 2014). Additionally, there is some evidence that massive weight loss does not reverse the presence of MLL (Greene, 2015a, 2015b). Given the difficulty in treating MLL, conservative therapy of the lower extremities with pneumatic compression therapy may be reasonable. The use of pneumatic compression therapy for MLL related truncal lymphedema has not been demonstrated to provide any significant benefit.

Non-Pneumatic, Non-Sequential, Peristaltic Wave Compression Devices

The Venowave VW5 (Venowave LLC, Ontario, Canada) is a non-pneumatic, non-sequential, peristaltic wave compression devices cleared by the FDA in 2008 for the treatment of a wide variety of lower extremity conditions such as lymphedema, vascular insufficiency, varicose veins, intermittent claudication, and deep vein thrombosis. This device applies mechanical peristaltic pressure waves in a proximal direction to move lymph fluid and blood toward the trunk. Unlike standard lymphedema pumps, the Venowave is worn and applies pressure to a small portion of the leg, specifically the calf muscle, and not an entire section of the lower limb. With standard lymphedema pumps, compression is applied to a large portion of the limb, such as from the ankle to the knee, or from the foot to hip. At this time, it is unclear what role non-pneumatic, non-sequential, peristaltic wave compression devices play in the treatment of lymphedema, given the lack of national physician specialty society recommendations supporting the use of these devices. Additionally, use of devices that apply compression to limited anatomical areas does not appear to be widely recognized by the practicing community. In summary, use of non-pneumatic, non-sequential, peristaltic wave compression devices is not considered in accordance with generally accepted standards of medical practice.

Peer Reviewed Publications:

1. Barfield M, Winokur R, Berland T, et al. Results from a comparative study to evaluate the treatment effectiveness of a nonpneumatic compression device vs an advanced pneumatic compression device for lower extremity lymphedema swelling (TEAYS study). J Vasc Surg Venous Lymphat Disord. 2025; 13(1):101965.
2. Cannon S. Pneumatic compression devices for in-home management of lymphedema: two case reports. Cases J. 2009; 2:6625.
3. Chopra K, Tadisina KK, Brewer M, et al. Massive localized lymphedema revisited: a quickly rising complication of the obesity epidemic. Ann Plast Surg. 2015; 74(1):126-132.
4. Desai SS, Shao M; Vascular Outcomes Collaborative. Superior clinical, quality of life, functional, and health economic outcomes with pneumatic compression therapy for lymphedema. Ann Vasc Surg. 2020; 63:298-306.
5. Dini D, Del Mastro L, Gozza A, et al. The role of pneumatic compression in the treatment of postmastectomy lymphedema. A randomized phase III study. Ann Oncol. 1998; 9(2):187-190.
6. Fife C. Massive localized lymphedema, a disease unique to the morbidly obese: a case study. Ostomy Wound Manage. 2014; 60(1):30-35.
7. Fife CE, Benavides S, Carter MJ. A patient-centered approach to treatment of morbid obesity and lower extremity complications: an overview and case studies. Ostomy Wound Manage. 2008; 54(1):20-2, 24-32.
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. 2012; 20(12):3279-3286.
9. Greene AK, Grant FD, Maclellan RA. Obesity-induced lymphedema nonreversible following massive weight loss. Plast Reconstr Surg Glob Open. 2015a; 3(6):e426.
10. Greene AK, Grant FD, Slavin SA, Maclellan RA. Obesity-induced lymphedema: clinical and lymphoscintigraphic features. Plast Reconstr Surg. 2015b; 135(6):1715-1719.
11. Greene AK, Maclellan RA. Obesity-induced upper extremity lymphedema. Plast Reconstr Surg Glob Open. 2013; 1(7):e59.
12. Gregor JW, Chang B, Keole N, et al. Initial proof-of-concept study on immediate effects of external advanced pneumatic compression on pharyngeal and laryngeal internal lymphedema using a fluoroscopic measurement tool. Head Neck. 2025; 47(3):962-973.
13. Gurdal SO, Kostanoglu A, Cavdar I, et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol. 2012; 10(3):129-135.
14. Gutiérrez C, Mayrovitz HN, Naqvi SHS, Karni RJ. 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. 2020; 42(8):1791-1799.
15. Hammond T. Reduction of complications and costs associated with Flexitouch therapy for lymphedema. Open Rehabil J. 2009; 2:54-57.
16. Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998; 31(2):56-64.
17. Karaca-Mandic P, Hirsch AT, Rockson SG, Ridner SH. A comparison of programmable and non-programmable compression devices for treatment of lymphedema using an administrative health outcomes dataset. Br J Dermatol. 2017; 177(6):1699-1707.
18. Macdonald JM, Sims N, Mayrovitz HN. Lymphedema, lipedema and the open wound: the role of compression therapy. Surg Clin North Am. 2003; 83(3):639-658.
19. Maldonado TS, Rokosh RS, Padberg F, et al. Assessment of quality of life changes in patients with lower extremity lymphedema using an advanced pneumatic compression device at home. J Vasc Surg Venous Lymphat Disord. 2021; 9(3):745-752.
20. Mayrovitz HN, Ryan S, Hartman JM. Usability of advanced pneumatic compression to treat cancer-related head and neck lymphedema: a feasibility study. Head Neck. 2018; 40(1):137-143.
21. Mehrara BJ, Greene AK. Lymphedema and obesity: is there a link? Plast Reconstr Surg. 2014; 134(1):154e-160e.
22. Muluk SC, Hirsch AT, Taffe EC. Pneumatic compression device treatment of lower extremity lymphedema elicits improved limb volume and patient-reported outcomes. Eur J Vasc Endovasc Surg. 2013; 46(4):480-487.
23. Oremus M, Dayes I, Walker K, Raina P. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer. 2012; 12:6.
24. Padberg FT Jr, Ucuzian A, Dosluoglu H, et al. Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2024; 12(4):101892.
25. Pappas CJ, O'Donnell TF Jr. Long-term results of compression treatment for lymphedema. J Vasc Surg. 1992; 16(4):555-562.
26. 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. 2021; 29(2):795-803.
27. Ridner SH, McMahon E, Dietrich MS, Hoy S. Home-based lymphedema treatment in patients with cancer-related lymphedema or noncancer-related lymphedema. Oncol Nurs Forum. 2008; 35(4):671-680.
28. 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. 2012; 131(1):147-158.
29. Rockson SG, Karaca-Mandic P, Skoracki R, et al. Clinical evaluation of a novel wearable compression technology in the treatment of lymphedema, an open-label controlled study. Lymphat Res Biol. 2022a; 20(2):125-132..
30. Rockson SG, Skoracki R. Effectiveness of a nonpneumatic active compression device in older adults with breast cancer-related lymphedema: a subanalysis of a randomized crossover trial. Lymphat Res Biol. 2023; 21(6):581-584.
31. Rockson SG, Whitworth PW, Cooper A, et al. Safety and effectiveness of a novel non-pneumatic active compression device for treating breast cancer-related lymphedema, a multi-center randomized, crossover trial (NILE). J Vasc Surg Venous Lymphat Disord. 2022b; 10(6):1359-1366.
32. Szuba A, Achalu R, Rockson SG. Decongestive lymphatic therapy for patients with breast carcinoma-associated lymphedema. A randomized, prospective study of a role for adjunctive intermittent pneumatic compression. Cancer. 2002; 95(11):2260-2267.
33. Tastaban E, Soyder A, Aydin E, et al. Role of intermittent pneumatic compression in the treatment of breast cancer-related lymphoedema: a randomized controlled trial. Clin Rehabil. 2020; 34(2):220-228.
34. Uzkeser H, Karatay S, Erdemci B, et al. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. 2015; 22(3):300-307.
35. Wilburn O, Wilburn P, Rockson SG. A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema. BMC Cancer. 2006; 6:84.
36. Zanolla R, Monzeglio C, Balzarini A, Martino G. Evaluation of the results of three different methods of postmastectomy lymphedema treatment. J Surg Oncol. 1984; 26(3):210-213.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services. National Coverage Determination: Pneumatic Compression Devices. NCD #280.6. Effective January 14, 2002. Available at: https://www.cms.gov/medicare-coverage-database/search.aspx?redirect=Y&from=Overview&list_type=ncd. Accessed on October 29, 2025.
2. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2009 Consensus Document of the International Society of Lymphology. Lymphology. 2009; 42(2):51-60.
3. 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. 2022; 37(4):252-266.
4. O'Donnell TF Jr, Passman MA, Marston WA, et al.; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery^® and the American Venous Forum. J Vasc Surg. 2014; 60(2 Suppl):3S-59S.

ACTitouch Adaptive Compression Therapy
AIROS 8 sequential compression therapy
Dayspring^™
Flexitouch Entre™ Plus system
Flexitouch Plus
Koya Dayspring^™
LymphAssist
LymphFlow Advance
LymphaPress Optimal^™
NormaTec PCD
Venowave

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

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