Description
A pneumatic compression therapy device functions as a pump to improve circulation. The device consists of an inflatable garment, usually for the arm, leg, and/or ankle, and an electric pump. The inflatable garment is intermittently inflated and deflated in a cycle of time and pressure. Pneumatic compression therapy devices are classified as non-segmented or segmented, with or without calibrated gradient pressure.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
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 (4) 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 (2) (of four (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 (e.g., amount of fluid removed) rather than health outcomes (e.g., 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 (1) 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 individual-reported outcomes and swelling, although adherence was low, with only one (1) individual 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 five (5) observational studies included in the systematic review, four (4) (80 percent) 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 individuals 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 three (3) trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, two (2) of the three (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.
