Clinical UM Guideline

This document addresses the use of pneumatic compression devices, also known as intermittent pneumatic compression (IPC), for the prevention of deep vein thrombosis (DVT) of the extremities or venous thromboembolism (VTE) in the home setting, such as the Venowave VW5^™ (ThermaBright; Toronto, ON, Canada). This therapy involves the use of an inflatable garment and an electrical pneumatic pump. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices. Pneumatic compression devices can be purchased or rented for home use for prevention and treatment of a number of conditions.

Note: This document addresses devices for the prevention of DVT only. Pneumatic devices used in the treatment or prevention of lymphedema or venous insufficiency, or in therapy for musculoskeletal injuries, are NOT addressed in this document. This document also does not address pneumatic compression devices with combined cooling or heating functions. For more information regarding such devices, please see the following related documents:

• CG-DME-06 Compression Devices for Lymphedema
• DME.00037 Cooling Devices and Combined Cooling/Heating Devices

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Not Medically Necessary:

The use of pneumatic compression devices in the home setting for prevention of venous thromboembolism of the extremities is considered not medically necessary for all indications.

This document describes clinical studies and expert recommendations related to the home use of inflatable leg wraps to prevent blood clots. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Mechanically inflated leg wraps have been proposed for use at home to prevent blood clots in the legs. Such devices are technically called pneumatic compression devices and are sometimes called "leg pumps" or "compression sleeves." They use air pressure to gently squeeze and release the legs to help pump blood through the veins to prevent blood clots. Blood clots that form in the deep veins of the legs are part of a condition called deep vein thrombosis, or DVT. DVT can be serious if a clot breaks free and travels to the lungs, brain, or other vital organ. Such a clot in the lungs is called a pulmonary embolism. A blood clot that blocks blood flow to the brain can cause a stroke.

These devices are often used in hospitals during and after surgery. Their use in the home has been proposed and is under investigation.

What the Studies Show

Blood clots after outpatient surgery are not common. In studies of people who had knee surgery without being admitted to a hospital, fewer than 1 in 200 developed a blood clot. Even after hip surgery, which carries a higher risk, blood clots occurred in fewer than 5 out of 100 people. In some studies, no one who had outpatient surgery developed a blood clot by 28 days after their surgery.

Most research on compression devices has only been done in hospitals. Better studies are needed to know if using these devices at home prevents blood clots and improves health. No completed study has tested whether these devices prevent blood clots when used at home.

One concern is that people often do not use these devices as directed outside of a hospital. In 1 study, only about 1 in 3 people used the device on the first day home. By day 14, only about 1 in 7 were still using it. People reported that the devices were hard to use and caused discomfort.

Major medical groups recommend using these devices only in the hospital. The American Society of Hematology (ASH) recommends against extending any type of blood clot prevention beyond the hospital stay. These medical groups note that there is not enough information about how well compression devices work outside a hospital. One group called home use of compression devices a "research gap," meaning more study is needed before it can be recommended.

A study of more than 30,000 people in the hospital found that those who used compression devices had the same rate of blood clots as those who did not. Even in the hospital, where the devices are closely monitored, the benefit was not clear for people who were sick but did not have surgery.

Is This Clinically Appropriate?

Because they have not been shown to prevent blood clots or otherwise improve health, the use of pneumatic compression devices at home to prevent blood clots in the legs is not clinically appropriate. This applies to all reasons for blood clot prevention in the home setting.

This does not apply to using these devices for other health problems. For example, using them to treat swelling from lymphedema (long-term swelling caused by fluid buildup) or chronic vein problems is reviewed in separate documents.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline 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 are Not Medically Necessary:
For the following procedure codes when devices are used in the home for prophylaxis for DVT of the extremities

Summary

The published evidence on intermittent pneumatic compression (IPC) for deep vein thrombosis (DVT) or venous thromboembolism (VTE) prevention is derived almost exclusively from hospitalized surgical, trauma, and critically ill populations, with no completed clinical trial demonstrating efficacy of these devices in the home setting. The incidence of symptomatic DVT or VTE following outpatient surgical procedures is consistently low across large observational cohorts, even in the absence of prophylactic intervention. Major clinical practice guidelines from multiple professional societies recommend IPC only during hospitalization and recommend against extending any form of thromboprophylaxis beyond the inpatient stay. Studies examining home use of mechanical compression devices consistently report poor adherence, with rates declining rapidly in the days following hospital discharge.

Discussion

Venous Thromboembolism Incidence in Ambulatory and Outpatient Populations

While there is an established body of published evidence on the use of IPC devices to prevent deep vein thrombosis (DVT) in the hospital setting, their efficacy in the home setting has not been well studied. Findings from a large observational study suggest that this may, in part, be due to the low risk of DVT in the outpatient setting. In a cohort of 10,032 individuals who underwent outpatient orthopedic surgical procedures between June 1993 and June 2012, none developed symptomatic DVT by 28 days post-procedure (Martín-Ferrero, 2014). Preoperative risk was evaluated according to American Society of Anesthesiologists (ASA) physical status criteria, and individuals were considered eligible for enrollment if their ASA status was I, II, or a well-controlled III or IV. The major complication rate was minimal. This study was not designed to detect DVT through routine screening; therefore, asymptomatic events would have remained undetected, and the occurrence of DVT after the study period cannot be ruled out. Nonetheless, in this very large cohort following outpatient orthopedic surgery, symptomatic DVT was absent.

Arthroscopic knee surgery, one of the most common outpatient orthopedic procedures, has been studied extensively for post-procedural VTE risk. In a retrospective study of 20,770 eligible individuals who had no documented history of VTE and underwent elective knee arthroscopy without prophylaxis, the incidence of symptomatic VTE was 0.25% for DVT and 0.17% for pulmonary embolism (PE) at 90 days (Maletis, 2012). A population-based retrospective cohort study of 4,833 individuals similarly found that within 6 weeks of knee arthroscopy, only 18 (0.4%) developed VTE, and no VTE was reported between 6 weeks and 3 months post-procedure (Mauck, 2013). Of the 18 VTE events, 2 occurred in individuals taking oral contraceptives, 1 in a pregnant individual, 2 in individuals with known or suspected joint infections, and 3 in individuals who had recently experienced trauma. The investigators concluded that their findings support the American College of Chest Physicians (ACCP) recommendations for no routine pharmacologic or mechanical VTE prophylaxis in this population.

Arthroscopic hip surgery is generally considered a higher-risk procedure than knee arthroscopy. A prospective study of 120 low-risk individuals who underwent outpatient arthroscopic hip surgery without prophylactic intervention found a DVT incidence of 4.3% (5 events, most of which were distal DVTs) at 10 to 22 days post-procedure (Mohtadi, 2016). The investigators concluded that routine prophylaxis and screening may not be necessary in low-risk individuals undergoing elective hip arthroscopy. A similar study of 139 individuals undergoing arthroscopic hip surgery without prophylaxis reported an overall VTE incidence of 1.4% (1 symptomatic DVT and 1 PE) at 2 weeks, with no cases of asymptomatic VTE detected by bilateral venous duplex ultrasound (Alaia, 2014).

Evidence from additional surgical populations confirms that VTE incidence remains low even in higher-acuity settings. In a large retrospective analysis of Medicare claims, 2,509,530 lower extremity and 130,258 upper extremity arthroplasty procedures performed in the hospital setting were analyzed for VTE occurrence. VTE complications occurred in 1.2% of lower extremity arthroplasties and 0.53% of upper extremity arthroplasties; individuals with a primary diagnosis of fracture, a history of VTE, and comorbidities were significantly more likely to experience VTE (Day, 2015). To date, there is no published evidence demonstrating the efficacy of IPC devices in reducing the incidence of VTE of the upper extremities. In a study of 16,120 individuals undergoing colorectal surgery, use of perioperative and in-hospital VTE prophylaxis increased significantly over the time period from 2006 to 2012 (from 31.6% to 86.4% preoperatively and from 59.6% to 91.4% during hospitalization). Despite this increase, the incidence of VTE remained largely unchanged. These findings led investigators to question the incremental benefit of extending prophylaxis into the discharge setting (Colorectal Writing Group for SCOAP-CERTAIN, 2015). There is also evidence from a systematic review and from clinical trials evaluating pharmacologic prophylaxis for DVT after outpatient orthopedic procedures showing that even in control populations receiving no intervention, the incidence of DVT was so low that pharmacologic prophylaxis was deemed unwarranted (Huang, 2018; Kaye, 2015; Matthews, 2018).

Clinical Practice Guideline Recommendations on Mechanical Thromboprophylaxis

Multiple major clinical practice guidelines address the role of IPC in VTE prevention, and all confine their recommendations to the hospital setting. The American Society of Hematology (ASH) published guidelines in 2018 addressing VTE prophylaxis for hospitalized and nonhospitalized medical individuals (Schunemann, 2018). For hospitalized acutely or critically ill medical individuals, ASH prefers pharmacological prophylaxis when it can be used; mechanical VTE prophylaxis, including IPC devices, is reserved for individuals who cannot receive pharmacological prophylaxis. The guideline strongly recommends against extending VTE prophylaxis beyond hospitalization for acutely or critically ill medical individuals. For chronically ill medical individuals, including nursing home residents, ASH suggests against using VTE prophylaxis of any kind. For medical outpatients with minor risk factors such as immobility, minor injury, illness, or infection, ASH similarly suggests against VTE prophylaxis. Notably, ASH identifies “utility of outpatient use of mechanical prophylaxis in medical outpatients at risk of VTE” as an unresolved research gap.

ASH published companion guidelines in 2019 addressing VTE prevention for individuals who receive surgery as inpatients (Anderson, 2019). These guidelines conditionally recommend IPC for these individuals, with a preference for IPC over graduated compression stockings when mechanical prophylaxis is chosen. However, all recommendations are limited to the perioperative and inpatient hospital setting. The guideline panel explicitly identified “lack of information regarding out-of-hospital use of pneumatic compression” as a limitation of this modality and stated that they “would also welcome high-quality studies to determine the effectiveness of mechanical prophylaxis administered outside the hospital setting.”

The American College of Chest Physicians (CHEST) guideline on antithrombotic therapy for VTE disease, updated in 2021, addresses pharmacological treatment of established VTE disease and does not recommend IPC or mechanical prophylaxis for VTE prevention in any setting (Stevens, 2021). The only compression-related recommendation in the guideline suggests against routinely using compression stockings to prevent post-thrombotic syndrome after acute DVT.

Systematic Review and Clinical Trial Evidence for Intermittent Pneumatic Compression

The most comprehensive systematic review evidence on IPC comes from a 2022 Cochrane Review evaluating combined IPC and pharmacological prophylaxis for VTE prevention (Kakkos, 2022). This update included 34 studies with 14,931 participants, all in hospitalized surgical or trauma populations. Adding IPC to pharmacological prophylaxis reduced the incidence of both PE (odds ratio [OR], 0.46; 95% confidence interval [CI], 0.30 to 0.71) and DVT (OR, 0.38; 95% CI, 0.21 to 0.70) compared with pharmacological prophylaxis alone, without increasing bleeding risk. Adding pharmacological prophylaxis to IPC reduced PE and DVT but significantly increased bleeding risk (OR, 6.02; 95% CI, 3.88 to 9.35). The review’s conclusions align with current guideline recommendations supporting combined modalities in hospitalized individuals at risk of VTE. Neither the Cochrane Review nor the published guidelines it references address the use of IPC devices in the outpatient setting or following ambulatory surgical procedures.

Recent evidence from high-risk inpatient populations does not demonstrate meaningful incremental benefit from pneumatic compression when added to standard thromboprophylaxis. A post hoc analysis of the Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT) trial (Al-Dorzi, 2025) found that adjunctive pneumatic compression did not improve outcomes and no subgroup of critically ill individuals derived benefit beyond pharmacologic prophylaxis. Similarly, randomized trial data in postoperative neurosurgical individuals (Zhang, 2025) showed no significant reduction in venous thromboembolism with the addition of intermittent compression devices to low-molecular-weight heparin. Taken together, these findings suggest limited clinical value of pneumatic compression even in higher-risk inpatient settings, and there is little evidence-based rationale to expect improved outcomes with use of these devices in lower-risk outpatient or home settings.

A very large retrospective study enrolled 30,824 medically ill individuals in critical care and examined whether use of intermittent compression devices reduced the incidence of VTE (Dhakal, 2019). During hospitalization, 67 individuals (0.22%) developed VTE (55 DVTs and 12 PEs). Risk-adjusted analysis revealed no significant difference in VTE incidence between individuals who received compression devices (n=20,018) and those who did not (n=10,819; p=0.74). This large cohort study of medically ill individuals casts further doubt on the efficacy of compression devices for the prevention of thrombotic events in nonsurgical populations.

Compliance With Home-Use Mechanical Compression Devices

A systematic review of adherence to mechanical thromboprophylaxis following surgical procedures found that up to one-fourth of hospitalized individuals were non-adherent with compression devices (Craigie, 2015). While no studies were identified that followed individuals post-discharge, it is unlikely that adherence would improve in the unsupervised outpatient setting.

In a cross-sectional study, 388 individuals who had undergone major orthopedic surgery were surveyed regarding thromboprophylaxis use after hospital discharge (Giuliano, 2019). A total of 94% reported being prescribed a pharmacologic agent at discharge, whereas 56% reported mechanical compression therapy. Of those prescribed mechanical compression, 86.6% received graded compression stockings and only 13.4% received IPC. Of the 122 respondents who reported their compliance with mechanical compression, 18% reported wearing their device less than 50% of the time and 63% reported wearing it at least 75% of the time. The investigators concluded that duration of thromboprophylaxis and rates of IPC therapy use after hospitalization for major orthopedic surgery are suboptimal and that more research on home IPC use is needed.

A prospective cohort study followed 102 individuals after total joint arthroplasty who were prescribed daily aspirin in conjunction with mobile IPC devices worn for 2 weeks postoperatively (Dietz, 2020). Compliance was highest on postoperative day 1 at 34.7%, and by day 14 compliance fell to 14.8%. Difficulty using the pumps and discomfort related to heat were significantly associated with noncompliance; 1 individual developed blistering from the device. During the 90-day follow-up period, 1 DVT and 1 nonfatal PE were confirmed in 2 separate participants. The investigators noted that even with poor IPC compliance, the incidence of VTE was low after total joint arthroplasty.

In summary, studies have not conclusively shown that home use of pneumatic compression devices reduces the incidence of thromboembolism. The evidence base for IPC efficacy remains confined to hospitalized populations; major clinical practice guidelines recommend against extending mechanical or pharmacological prophylaxis beyond the inpatient setting, and compliance with home-use compression devices is poor. Home use of these devices for DVT prevention is not a generally accepted medical practice.

American Society of Anesthesiologists (ASA) Physical Status Classifications: A standardized method used to assess and communicate an individual’s preoperative health status. It categorizes individuals based on the presence and severity of systemic disease and is commonly used to estimate perioperative risk. The ASA classification does not account for the specific type of surgery or procedural risk, but rather reflects the individual’s overall medical condition at the time of evaluation (American Society of Anesthesiologists, 2026).

• ASA I: A normal healthy patient
• ASA II: A patient with mild systemic disease
• ASA III: A patient with severe systemic disease
• ASA IV: A patient with severe systemic disease that is a constant threat to life
• ASA V: A moribund patient who is not expected to survive without the operation
• ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes.

Deep vein thrombosis (DVT): Formation of a blood clot within the deep venous system, most commonly in the lower extremities.

Embolus: Material such as a blood clot, air, or fat carried in the bloodstream and capable of obstructing a blood vessel at a site distant from its point of origin.

Intermittent pneumatic compression (IPC): A mechanical method of thromboprophylaxis that uses inflatable garments wrapped around the limbs to periodically apply pressure, promoting venous blood flow.

Mechanical thromboprophylaxis: Use of physical methods (such as intermittent pneumatic compression or compression stockings) to reduce the risk of venous thromboembolism without pharmacologic agents.

Outpatient (ambulatory) setting: Medical care provided without an overnight hospital stay, including same-day surgical procedures and home-based care.

Pharmacologic thromboprophylaxis: Use of medications (such as anticoagulants) to prevent venous thromboembolism.

Prophylaxis: Treatment or intervention intended to prevent disease or a medical condition.

Pulmonary embolism (PE): Obstruction of one or more pulmonary arteries by an embolus, most commonly a thrombus originating from the deep veins.

Thrombus: A blood clot that forms within a blood vessel or the heart and remains attached to its site of origin.

Venous thromboembolism (VTE): A condition encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE).

Peer Reviewed Publications:

1. Alaia MJ, Patel D, Levy A, et al. The incidence of venous thromboembolism (VTE)--after hip arthroscopy. Bull Hosp Jt Dis (2013). 2014; 72(2):154-158.
2. Al-Dorzi HM, Arishi H, Al-Hameed FM, et al. Performance of risk assessment models for VTE in patients who are critically ill receiving pharmacologic thromboprophylaxis: a post hoc analysis of the Pneumatic Compression for Preventing VTE trial. Chest. 2025; 167(2):598-610.
3. Colorectal Writing Group for Surgical Care and Outcomes Assessment Program-Comparative Effectiveness Research Translation Network (SCOAP-CERTAIN) Collaborative, Nelson DW, Simianu VV, et al. Thromboembolic complications and prophylaxis patterns in colorectal surgery. JAMA Surg. 2015; 150(8):712-720.
4. Craigie S, Tsui JF, Agarwal A, et al. Adherence to mechanical thromboprophylaxis after surgery: a systematic review and meta-analysis. Thromb Res. 2015; 136(4):723-726.
5. Day JS, Ramsey ML, Lau E, Williams GR. Risk of venous thromboembolism after shoulder arthroplasty in the Medicare population. J Shoulder Elbow Surg. 2015; 24(1):98-105.
6. Dhakal P, Wang L, Gardiner J, et al. Effectiveness of sequential compression devices in prevention of venous thromboembolism in medically ill hospitalized patients: a retrospective cohort study. Turk J Haematol. 2019; 36(3):193-198.
7. Dietz MJ, Ray JJ, Witten BG, et al. Portable compression devices in total joint arthroplasty: poor outpatient compliance. Arthroplast Today. 2020; 6(1):118-122.
8. Giuliano KK, Pozzar R, Hatch C. Thromboprophylaxis after hospitalization for joint replacement surgery. J Healthc Qual. 2019; 41(6):384-391.
9. Huang HF, Tian JL, Yang XT, et al. Efficacy and safety of low-molecular-weight heparin after knee arthroscopy: a meta-analysis. PLoS One. 2018; 13(6):e0197868.
10. Kaye ID, Patel DN, Strauss EJ, et al. Prevention of venous thromboembolism after arthroscopic knee surgery in a low-risk population with the use of aspirin. A randomized trial. Bull Hosp Jt Dis (2013). 2015; 73(4):243-248.
11. Maletis GB, Inacio MC, Reynolds S, Funahashi TT. Incidence of symptomatic venous thromboembolism after elective knee arthroscopy. J Bone Joint Surg Am. 2012; 94(8):714-720.
12. Martín-Ferrero MA, Faour-Martín O, Simon-Perez C, et al. Ambulatory surgery in orthopedics: experience of over 10,000 patients. J Orthop Sci. 2014; 19(2):332-338.
13. Matthews JH, Terrill AJ, Barwick AL, Butterworth PA. Venous thromboembolism in podiatric foot and ankle surgery. Foot Ankle Spec. 2018; 11(5):444-450.
14. Mauck KF, Froehling DA, Daniels PR, et al. Incidence of venous thromboembolism after elective knee arthroscopic surgery: a historical cohort study. J Thromb Haemost. 2013; 11(7):1279-1286.
15. Mohtadi NG, Johnston K, Gaudelli C, et al. The incidence of proximal deep vein thrombosis after elective hip arthroscopy: a prospective cohort study in low risk patients. J Hip Preserv Surg. 2016; 3(4):295-303.
16. Zhang Z, Marcano A, Huisman MV, et al. Intermittent compression devices as antithrombotic strategy in neurosurgical interventions: a prospective randomized controlled trial (Trial In Prevention of Post-Operative ThromboEmbolic Events). J Thromb Haemost. 2025; 23(11):3561-3568.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Society of Anesthesiologists (ASA). Statement on ASA physical status classification system. 2026. Available at: https://www.asahq.org/standards-and-practice-parameters/statement-on-asa-physical-status-classification-system. Accessed on May 15, 2026.
2. 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/view/ncd.aspx?ncdid=225. Accessed on May 15, 2026.
3. Anderson DR, Morgano GP, Bennett C, et al. American Society of Hematology 2019 guidelines for management of venous thromboembolism: prevention of venous thromboembolism in surgical hospitalized patients. Blood Adv. 2019; 3(23):3898-3944.
4. Kakkos SK, Kirkilesis G, Caprini JA, et al. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. 2022; 1(1):CD005258.
5. Schunemann HJ, Cushman M, Burnett AE, et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. Blood Adv. 2018; 2(22):3198-3225.
6. Stevens SM, Woller SC, Kreuziger LB, et al. Antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report. Chest. 2021; 160(6):e545-e608.
7. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Venowave VW5. Summary of safety and effectiveness. 510(k) No. K232640. Rockville, MD: FDA. June 25, 2024. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232640. Accessed on May 15, 2026.

1. National Library of Medicine. Medical encyclopedia: blood clots. Updated December 29, 2023. Available at: https://medlineplus.gov/bloodclots.html. Accessed on May 15, 2026.

Deep Vein Thrombosis
Home Setting
Intermittent Pneumatic Compression
Pneumatic Compression Devices
Venous Thromboembolism
Venowave VW5

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