Introduction: As part of a reconsideration of coverage policy, the Centers for Medicare and Medicaid Services requested a systematic review of the evidence on the use of pneumatic compression devices in the home environment for treatment of chronic venous insufficiency (CVI) and venous ulcers.
Methods: Articles were found with a systematic literature search of MEDLINE, EMBASE, and AMED (Allied and Complementary Medicine) databases, hand searches of reference lists, and suggestions of experts.
Results: Eight trials that met the inclusion criteria, including several randomized control trials, were found. Most studies were small and may have been underpowered. However, several were well-designed randomized controlled trials. Three studies showed that the devices could alleviate symptoms of CVI. No studies directly measured whether the devices could prevent the occurrence of venous ulcers. Some studies on the treatment of venous ulcers did not show a benefit for pneumatic compression, but other studies showed a benefit for the devices in healing long-standing chronic ulcers that had not healed with other methods. No studies directly compared single-chamber and multiple-chamber devices or studied whether the effectiveness of the pump was dependent on types of treatment used concurrently with the pump. Few adverse events were reported in the trials. Patients generally expressed satisfaction with the pneumatic compression devices, and several studies reported higher compliance than with other compression methods.
Conclusion: The available data cannot be relied on to inform the optimal choice of compression therapy or optimal protocol for patients with CVI or venous ulcers. Methodologically rigorous research designed to answer these questions would be useful for treatment decisions. The Centers for Medicare and Medicaid Services considered the results of this study and issued a decision that pneumatic compression will only be covered for patients with refractory edema with significant ulceration of the lower extremities after a 6-month trial of standard therapies, such as compression stockings, has failed.