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Postsurgical Home Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis

Policy Number: MP-515

Latest Review Date: March 2021

Category:  DME                                                                    

Policy Grade:  A

POLICY:

Major Orthopedic Surgery

Postsurgical home use (no more than 14 days) of limb compression devices for venous thromboembolism prophylaxis after major orthopedic surgery (e.g. total hip arthroplasty, total knee arthroplasty, or hip fracture surgery) may be considered medically necessary in patients with a documented contraindication to pharmacological agents (i.e., at high-risk for bleeding*).

Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis after major orthopedic surgery (e.g. total hip arthroplasty, total knee arthroplasty, or hip fracture surgery) is considered not medically necessary in patients without a contraindication to pharmacological prophylaxis.

*The ACCP guidelines on prevention of VTE in orthopedic surgery patients list the following general risk factors for bleeding:

  • Previous major bleeding (and previous bleeding risk similar to current risk)
  • Severe renal failure
  • Concomitant antiplatelet agent
  • Surgical factors: history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery

Major Non-orthopedic Surgery

Postsurgical home use (no more than 14 days) of limb compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery (e.g. open abdominal and open-pelvic procedures) may be considered medically necessary in patients who are at moderate or high risk of venous thromboembolism with a documented contraindication to pharmacological agents (i.e., at high-risk for bleeding**).

Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis after major non-orthopedic surgery (e.g. open abdominal and open-pelvic procedures) is considered not medically necessary in patients who are at moderate or high risk of venous thromboembolism without a contraindication to pharmacological prophylaxis and in patients who are at low-risk of venous thromboembolism.

**The American College of Obstetricians and Gynecologists (ACOG) proposed the following risk classification for VTE in patients undergoing major gynecological surgery:

  • Low: Surgery lasting less than 30 minutes in patients younger than 40 years with no additional risk factors.
  • Moderate: Surgery lasting less than 30 minutes in patients with additional risk factors; surgery lasting less than 30 minutes in patients age 40-60 years with no additional risk factors; major surgery in patients younger than 40 years with no additional risk factors.
  • High: Surgery lasting less than 30 minutes in patients older than 60 years or with additional risk factors; major surgery in patients older than 40 years or with additional risk factors.
  • Highest: Major surgery in patients older than 60 years plus prior venous thromboembolism, cancer, or molecular hypercoagulable state.

Other Surgery

Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis after all other surgeries other than those indicated above is considered not medically necessary.

**Clinical documentation must be specific to patient and list contraindication to pharmacological prophylaxis (see ACCP guidelines).

DESCRIPTION OF PROCEDURE OR SERVICE:

Antithrombotic prophylaxis is recommended for surgical patients who are at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), based on the surgical procedure and/or patient characteristics. For some types of surgery (e.g., major orthopedic surgery), there is a particularly high risk of VTE due to the nature of the procedure and the prolonged immobility during and after surgery. Common patient risk factors include increasing age, prior VTE, malignancy, pregnancy, and significant comorbidities. Increased risk of bleeding is a contraindication to anticoagulation as are adverse events and allergic reactions. Limb compression devices have been used as an adjunct or alternative to anticoagulation in the home setting for patients in the postoperative period as a method to reduce VTEs.

Risk of Venous Thromboembolism

Orthopedic Surgery

Antithrombotic prophylaxis is recommended for surgical patients at moderate-to-high risk of postoperative venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients may be classified as moderate-to-high risk of VTE based on the surgical procedure and/or patient characteristics. For some types of surgery, such as major orthopedic surgery, there is a particularly high risk of VTE due to the nature of the procedure and the prolonged immobility during and after surgery. The specific orthopedic procedures of concern are total knee arthroplasty, total hip arthroplasty, and hip fracture surgery. For these surgeries, all patients undergoing the procedure are considered at high risk for VTE.

Other surgeries with increased risk of VTE include abdominal surgery, pelvic surgery, cancer surgery, and surgery for major trauma. For these types of surgeries, the risk varies. There are numerous patient-related risk factors such as increasing age, prior VTE, malignancy, pregnancy, and significant comorbidities that can be used in conjunction with the type of surgery to determine risk. There are tools for assessing VTE risk in surgical patients, such as the Modified Caprini Risk Assessment Model that was used in developing the 2012 American College of Chest Physicians (ACCP) guidelines on VTE prevention. However, in clinical practice, this and similar instruments are not regarded as definitive for assessment of individual patient risk. Pharmacologic prophylaxis is indicated for patients at moderate-to-high risk for VTE.As described in the ACCP guidelines, there are preferred antithrombotic prophylaxis regimens according to procedure and patient risk characteristics.

Pharmacologic Prophylaxis

Pharmacologic prophylaxis is effective at reducing postoperative VTE, but also has risks. The main risk is bleeding, although other adverse effects such as allergic reactions and development of heparin antibodies can occur. Contraindications to pharmacologic prophylaxis include previous intolerance to these agents and increased risk of bleeding. Most patients undergoing major surgery will not have an increased risk of bleeding precluding use of anticoagulants, because these patients would also likely have had a contraindication to the surgery itself and thus are likely to avoid the procedure. However, there are some cases in which patients with a high bleeding risk will undergo major surgery, such as patients with severe renal failure who require an essential procedure. Other patients may develop contraindications during the episode of care. For example, patients who have excessive bleeding during or after surgery, or patients who develop bleeding complications such as a GI bleed, will subsequently have a contraindication to anticoagulants. There are a few surgeries for which anticoagulants are contraindicated or avoided, most notably some neurosurgery procedures. Assessment and quantitation of bleeding risk can be performed using instruments such as HAS-BLED scoring system, although these tools were not developed specifically for the post-operative period.

Major orthopedic surgeries have high risk of DVT due to venous stasis of the lower limbs as a consequence of immobility during and after surgery. In addition, direct venous wall damage associated with the surgical procedure itself may occur. DVTs are frequently asymptomatic and generally resolve when mobility is restored. However, some episodes of acute DVT can be associated with substantial morbidity and mortality. The most serious adverse consequence of acute DVT is PE, which can be fatal; this occurs when the DVT detaches and migrates to the lungs. In addition, DVT may produce long-term vascular damage that leads to chronic venous insufficiency. Without thromboprophylaxis, the incidence of venographically detected DVT is approximately 42% to 57% after total hip replacement, and the risk of PE is approximately 1% to 28%. Other surgical patients may be at increased risk of VTE during and after hospitalization. For example, it is estimated that rates of VTE without prophylaxis after gynecologic surgery are 15% to 40%.

Thus, antithrombotic prophylaxis is recommended for patients undergoing major orthopedic surgery and other surgical patients at increased risk of VTE. For patients undergoing major orthopedic surgery, clinical practice guidelines published in 2012 by the American College of Chest Physicians (ACCP) recommend that one of several pharmacologic agents or mechanical prophylaxis be provided rather than no thromboprophylaxis. The guidelines further recommend the use of pharmacologic prophylaxis during hospitalization, whether or not patients are using a limb compression device. A minimum of 10 to 14 days of prophylaxis is recommended, a portion of which can be post-discharge home use.

Limb Compression Prophylaxis

The ACCP guidelines have also noted that compliance is a major issue with the home use of limb compression devices for thromboprophylaxis and recommended that, if this prophylactic option is selected, use should be limited to portable, battery-operated devices. Moreover, ACCP recommended that devices be used for 18 hours a day. A 2009 nonrandomized study found that there was better compliance with a portable battery-operated limb compression device than with a nonmobile device when used by patients in the hospital following hip or knee replacement surgery.

Non-Orthopedic Surgery

Pharmacologic and Limb Compression Prophylaxis

ACCP also issued guidelines (2012) on VTE prophylaxis in non-orthopedic surgery patients. For patients undergoing general or abdominal-pelvic surgery who have a risk of VTE of 3% or higher, the ACCP recommends prophylaxis with pharmacologic agents or intermittent pneumatic compression rather than no prophylaxis. For patients at low risk for VTE (about 1.5%), the guidelines suggest mechanical prophylaxis. Unlike the guidelines on major orthopedic surgery which recommends a minimum of 10-14 days of VTE prophylaxis, the guideline on non-orthopedic surgery patients does not include a general timeframe for prophylaxis. They do, however, define “extended duration” pharmacologic prophylaxis as lasting four weeks; the latter is recommended only for patients at high risk for VTE, undergoing abdominal or pelvic surgery for cancer who not otherwise at high risk for major bleeding complications.

National clinical guidelines have not specifically recommended the use of limb compression devices in the posdischarge home setting. However, given the availability of portable, battery-operated devices, there is interest in the home use of limb compression devices for VTE prevention following discharge from the hospital for major orthopedic and nonorthopedic surgery.

Also see Policy #123 Lymphedema Pumps/Pneumatic Compression Devices

KEY POINTS:

The most recent literature review was updated with a search of the MEDLINE database through January 25, 2021.

SUMMARY OF EVIDENCE:

For individuals who have a moderate-to-high postsurgical risk of VTE and no contraindication to pharmacologic prophylaxis who receive home use of an intermittent pneumatic compression (IPC) device as an adjunct to anticoagulation, there are no randomized controlled trials (RCTs) assessing the incremental benefit of home use of an IPC device. Multiple meta-analyses of RCTs have compared medication plus an IPC device with medication alone in surgical patients in the hospital setting. Relevant outcomes are overall survival,symptoms, morbid events, and treatment-related morbidity. Results of these meta-analyses suggest that in-hospital addition of an IPC device to pharmacologic management improves VTE prophylaxis. Limitations of these meta-analyses include: not distinguishing between asymptomatic and symptomatic deep vein thrombosis; sparse data on pulmonary embolism;and results generally not stratified by patient risk or specific intervention(s). Moreover, these trials do not permit inferences to the post-discharge home setting, since the post discharge setting differs in important respects from the hospital setting. Discharged patients tend to be healthier than those in the hospital. Factors such as treatment consistency, duration, and application errors in use differ in the home. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a moderate-to-high postsurgical risk of VTE and a contraindication to pharmacologic prophylaxis who receive home use of an IPC device, there are no RCTs assessing the incremental benefit of home use of an IPC device. Meta-analyses of RCTs have compared VTE prophylaxis with an IPC device to no prophylaxis in surgical patients inthe hospital setting, and 1 RCT evaluated the feasibility of post discharge home use of an IPC device. Relevant outcomes are overall survival, symptoms, morbid events, and treatment-related morbidity. Results from meta-analyses suggest that in-hospital use of an IPC device improves VTE prophylaxis over no prophylaxis. Limitations include heterogeneity of participants and interventions; studies using a no prophylaxis control group might have included lower risk patients and some studies involving higher risk patients also included pharmacologic prophylaxis across groups. Nonetheless, the inference is supported that in patients with a contraindication to pharmacologic prophylaxis, post discharge use of an IPC device is superior for VTE prophylaxis compared with no prophylaxis. A study of the post discharge use of an IPC device combined with home visits showed that home use is feasible.With post discharge planning and support, home use of an IPC device in moderate-to-high risk patients who have a contraindication to pharmacologic prophylaxis is likely to improve VTE prevention. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Guidance on Determining High Risk for Bleeding

The ACCP guidelines on prevention of VTE in orthopedic surgery patients list the following general risk factors for bleeding :

  • Previous major bleeding (and previous bleeding risk similar to current risk);
  • Severe renal failure;
  • Concomitant antiplatelet agent;
  • Surgical factors: history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery.

The guidelines note, however, that “...specific thresholds for using mechanical compression devices or no prophylaxis instead of anticoagulant thromboprophylaxis have not been established.”

The 2016 ACCP guidelines addressing antithrombotic therapy for VTE disease outlined risk factors for bleeding with anticoagulant therapy and estimated the risks of major bleeding for patients in various risk categories.

Risk factors include (1 point per risk factor):

  • Age >65 y
  • Age >75y
  • Previous bleeding
  • Cancer
  • Metastatic cancer
  • Renal failure
  • Liver failure
  • Thrombocytopenia
  • Previous stroke
  • Diabetes
  • Anemia
  • Antiplatelet therapy
  • Poor anticoagulant control
  • Comorbidity and reduced functional capacity
  • Recent surgery
  • Alcohol abuse
  • Nonsteroidal anti-inflammatory drug

Table PG1: Guidelines for Risk of Bleeding

Risk Factors                                                 Estimated Absolute Risk of Major Bleeding

 

Low Risk ( 0 Risk Factors)

Moderate Risk (1 Risk Factor)

High Risk (≥2 Risk Factors)

Anticoagulation 0-3mo

Baseline Risk (%)

0.6

1.2

4.8

Increased Risk (%)

1.0

2.0

8.0

Total Risk (%)

1.6

3.2

12.8

Anticoagulation after first 3 mo.

Baseline Risk (%/yr.)

0.3

0.6

≥2.5

Increased Risk (%/yr.)

0.5

1.0

≥4.0

Total Risk (%/yr.)

0.8

1.6

≥6.5

Adapted from Kearon et al (2016).

Clinical guidelines from the American Academy of Orthopaedic Surgeons have indicated that:

"Patients undergoing elective hip or knee arthroplasty are at risk for bleeding and bleeding-associated complications. In the absence of reliable evidence, it is the opinion of this work group that patients be assessed for known bleeding disorders like hemophilia and for the presence of active liver disease which further increase the risk for bleeding and bleeding-associated complications. (Grade of Recommendation: Consensus) Current evidence is not clear about whether factors other than the presence of a known bleeding disorder or active liver disease increase the chance of bleeding in these patients and, therefore, the work group is unable to recommend for or against using them to assess a patient's risk of bleeding. (Grade of Recommendation: Inconclusive)"

Guidance on Duration of Use

In patients with contraindications to pharmacologic prophylaxis who are undergoing major orthopedic surgery (THA, TKA or HFS), the ACCP guidelines are consistent with use of intermittent limb compression devices for 10-14 days after surgery. The ACCP suggestion on extended prophylaxis (up to 35 days) was a weak recommendation that did not mention limb compression devices as an option.

In the ACCP guideline on VTE prophylaxis in patients undergoing non-orthopedic surgery, the length of standard duration or “limited duration” prophylaxis was not defined. However, “extended duration” pharmacologic prophylaxis was defined as four weeks; this was recommended only for patients at high risk for VTE undergoing abdominal or pelvic surgery for cancer and not otherwise at high risk for major bleeding complications.

Guidance on Risk Level for Patients Undergoing Non-Orthopedic Surgery

The ACCP guidelines on prevention of VTE in non-orthopedic surgery patients included the following discussion of risk levels:

“In patients undergoing general and abdominal-pelvic surgery, the risk of VTE varies depending on both patient-specific and procedure-specific factors. Examples of relatively low-risk procedures include laparoscopic cholecystectomy, appendectomy, transurethral prostatectomy, inguinal herniorrhaphy, and unilateral or bilateral mastectomy. Open abdominal and open-pelvic procedures are associated with a higher risk of VTE. VTE risk appears to be highest for patients undergoing abdominal or pelvic surgery for cancer...

Patient-specific factors also determine the risk of VTE, as demonstrated in several relatively large studies of VTE in mixed surgical populations. Independent risk factors in these studies include: age at least 60 years, prior VTE, and cancer; age >60 years, prior VTE, anesthesia at least two hours, and bed rest at least 4 days; older age, male sex, longer length of hospital stay, and higher Charlson comorbidity score; and sepsis, pregnancy or postpartum state, central venous access, malignancy, prior VTE, and inpatient hospital stay more than 2 days. In another study, most of the moderate to strong independent risk factors for VTE were surgical complications, including urinary tract infection, acute renal insufficiency, postoperative transfusion, perioperative myocardial infarction, and pneumonia.”

In 2007 (reaffirmed in 2018), the American College of Obstetricians and Gynecologists revised its risk classification for VTE in patients undergoing major gynecologic surgery:

  • Low: Surgery lasting less than 30 minutes in patients younger than 40 years with no additional risk factors.
  • Moderate: Surgery lasting less than 30 minutes in patients with additional risk factors; surgery lasting less than 30 minutes in patients age 40-60 years with no additional risk factors; major surgery in patients younger than 40 years with no additional risk factors.
  • High: Surgery lasting less than 30 minutes in patients older than 60 years or with additional risk factors; major surgery in patients older than 40 years or with additional risk factors.
  • Highest: Major surgery in patients older than 60 years plus prior venous thromboembolism, cancer, or molecular hypercoagulable state.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American College of Chest Physicians

In 2016, the American College of Chest Physicians (ACCP) updated its 2012 evidence-based guideline on antithrombotic therapy and prevention of thrombosis. The 2016 update, which addressed antithrombotic therapy for venous thromboembolism (VTE), outlined risk factors for bleeding with anticoagulant therapy and estimated the risks of major bleeding for patients in various risk categories (see Table 2).

Risk factors include (1 point per factor):

  • Age >65 y
  • Age>75y
  • Previous bleeding
  • Cancer
  • Metastatic cancer
  • Renal failure
  • Liver failure
  • Thrombocytopenia
  • Previous stroke
  • Diabetes
  • Anemia
  • Antiplatelet therapy
  • Poor anticoagulant control
  • Comorbidity and reduced functional capacity
  • Recent surgery
  • Alcohol abuse
  • Nonsteroidal anti-inflammatory drug

Table 2: Guidelines for Risk of Bleeding

Estimated Absolute Risk of Major Bleeding

Risk Factor

Low Risk ( 0 Risk Factors)

Moderate Risk (1 Risk Factor)

High Risk (≥2 Risk Factors)

Anticoagulation 0-3mo

Baseline Risk (%)

0.6

1.2

4.8

Increased Risk (%)

1.0

2.0

8.0

Total Risk (%)

1.6

3.2

12.8

Anticoagulation after first 3 mo.

Baseline Risk (%/yr.)

0.3

0.6

≥2.5

Increased Risk (%/yr.)

0.5

1.0

≥4.0

Total Risk (%/yr.)

0.8

1.6

≥6.5

Adapted from Kearon et al (2016)

In a 2017 review of ACCP 2012 and American Academy of Orthopaedic Surgeons 2011 guidelines on antithrombotic therapy and prevention of VTE in patients undergoing orthopedic and non-orthopedic surgery, ACCP recommended use of limb compression devices in orthopedic surgical patients:

  •  “2.1.1 In patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA), we recommend use of one of the following for a minimum of 10 to 14 days rather than no antithrombotic prophylaxis: low-molecular-weight heparin (LMWH), fondaparinux, apixaban, dabigatran, rivaroxaban, low-dose unfractionated heparin (LDUH), adjusted-dose vitamin K antagonist(VKA), aspirin (all Grade 1B) , or an intermittent pneumatic compression device (IPCD) (Grade 1C).”
  •  “2.5. In patients undergoing major orthopedic surgery, we suggest using dual prophylaxis with an antithrombotic agent and an IPCD during the hospital stay (Grade 2C).
  • “2.6. In patients undergoing major orthopedic surgery and increased risk of bleeding, we suggest using an IPCD or no prophylaxis rather than pharmacologic treatment (Grade 2C).”

“The efficacy of mobile mechanical compression devices alone has not been compared with any

chemoprophylaxis agent in an appropriately powered randomized trial. In addition, concerns have arisen with regard to patient compliance after hospital discharge and the high cost of these devices.”

In 2012, ACCP recommendations on use of limb compression devices in non-orthopedic general and abdominal-pelvic surgical patients, stratified by patient risk of VTE and risk of bleeding are listed in Table 3.

Table 3. Recommendations on Limb Compression Device Use in Non-orthopedic General and Abdominal-Pelvic Surgical Patients

Patient Risk Group

Recommendation

GOR

Very low risk (<0.5%)

“[W]e recommend that no specific pharmacologic or mechanical prophylaxis be used other than early ambulation.”

1B

2C

Low risk for VTE (~ 1.5%)

“[W]e suggest mechanical prophylaxis, preferably with intermittent pneumatic compression (IPC), over no prophylaxis.”

2C

Moderate risk for VTE (~3%) and not at high risk of bleeding

“[W]e suggest low-molecular-weight heparin (LMWH), low-dose unfractionated heparin, or mechanical prophylaxis with IPC over no prophylaxis.”

2B

2B

2C

Moderate risk for VTE (~3%) and high risk for major bleeding complications or in whom bleeding consequences would be particularly severe

“We suggest mechanical prophylaxis, preferably with IPC, over no prophylaxis.”

2C

High risk for VTE (~6.0%) and not at high risk of bleeding

“[W]e recommend pharmacologic prophylaxis with LMWH or low-dose unfractionated heparin over no prophylaxis. In these patients, we suggest adding mechanical prophylaxis with elastic stockings or IPC to pharmacologic prophylaxis.”

1B

1B

2C

 

High risk for VTE (~6.0%) and high risk for major bleeding complications or in whom bleeding consequences would be particularly severe

“[W]e suggest use of mechanical prophylaxis, preferably with IPC, over no prophylaxis until the risk of bleeding diminishes and pharmacologic prophylaxis may be initiated.”

2C

High risk for VTE, both LMWH and unfractionated heparin contraindicated or unavailable and not at high risk for major bleeding complications:

“[W]e suggest low-dose aspirin, fondaparinux, or mechanical prophylaxis, preferably with IPC, over no prophylaxis.”

2C

High risk for VTE, undergoing abdominal or pelvic surgery for cancer and not otherwise at high risk for major bleeding complications

“[W]e recommend extended-duration, postoperative, pharmacologic prophylaxis (4 weeks) with LMWH over limited-duration prophylaxis.”

1B

GOR: grade of recommendation VTE: venous thromboembolism.

Note that a standard duration of prophylaxis was not defined. An “extended-duration” prophylaxis was defined as lasting 4 weeks.

American Academy of Orthopaedic Surgeons

In 2011, the American Academy of Orthopaedic Surgeons (AAOS) published an updated guideline on prevention of venous thromboembolism in patients undergoing elective hip and knee arthroplasty. The guideline included the following recommendations relevant to this policy:

  • “The work group suggests the use of pharmacologic agents and/or mechanical compressive devices for the prevention of venous thromboembolism in patients undergoing elective hip or knee arthroplasty, and who are not at elevated risk beyond that of the surgery itself for venous thromboembolism or bleeding. (Grade of Recommendation: Moderate) Current evidence is unclear about which prophylactic strategy (or strategies) is/are optimal or suboptimal. Therefore, the work group is unable to recommend for or against specific prophylactics in these patients. (Grade of Recommendation: Inconclusive)
  • In the absence of reliable evidence about how long to employ these prophylactic strategies, it is the opinion of this work group that patients and physicians discuss the duration of prophylaxis. (Grade of Recommendation: Consensus)
  • In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who have also had a previous venous thromboembolism, receive pharmacologic prophylaxis and mechanical compressive devices. (Grade of Recommendation: Consensus)
  • In the absence of reliable evidence, it is the opinion of this work group that patients undergoing elective hip or knee arthroplasty, and who also have a known bleeding disorder (e.g., hemophilia) and/or active liver disease, use mechanical compressive devices for preventing venous thromboembolism. (Grade of Recommendation: Consensus)”

American College of Obstetricians and Gynecologists

In 2007, (reaffirmed in 2018), the American College of Obstetricians-Gynecologists (ACOG) published a practice bulletin on prevention of DVT and PE after gynecologic surgery.  As with the ACCP recommendations, described above, prophylaxis recommendations varied according to patient risk level. For patients at moderate and high risk of DVT, intermittent pneumatic compression was one of the recommended options for DVT prophylaxis. For patients at highest risk i.e., older than 60 years plus prior VTE, cancer or molecular hypercoagulable state, IPC or graduated compression stockings plus LDUH or LMWH was recommended as a prophylaxis option. For all but the highest risk patients, the practice bulletin stated that, when IPC devices were used, “the devices should be used continuously until ambulation and discontinued only at the time of hospital discharge.” For the highest risk patients, the document stated that continuing prophylaxis for 2-4 weeks after discharge should be considered.

American Orthopaedic Foot and Ankle Society

In 2020, the American Orthopaedic Foot and Ankle Society reapproved a position statement on VTE prophylaxis after foot and ankle surgery which stated the following: “There is currently insufficient data for the American Orthopaedic Foot & Ankle Society (AOFAS) to recommend for or against routine VTE prophylaxis for patients undergoing foot and ankle surgery. Further research in this field is necessary and is encouraged.”

American Society of Hematology

In 2019, the American Society of Hematology issued guidelines for the prevention and management and of venous thromboembolism in surgical hospitalized patients. Following are 2 suggestions for patients undergoing major surgery: Recommendation 3: For those "who receive mechanical prophylaxis,...[use] intermittent compression devices over graduated compression stockings (conditional recommendation based on very low certainty in the evidence of effects)." Recommendation 4: For those "who receive pharmacologic prophylaxis,...[use] combined prophylaxis with mechanical and pharmacological methods over prophylaxis with pharmacological agents alone (conditional recommendation based on very low certainty in the evidence of effects). Remark: For patients considered at high risk of VTE, combined prophylaxis is particularly favored over mechanical or pharmacological prophylaxis alone."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Limb pneumatic compression devices, Venowave VW5, ActiveCare+SFT® System, ActiveCare+SFT® System, Kendall SCD™ 700 Sequential Compression System, Intermittent pneumatic compressing device, IPCD, VenaPro Vascular Therapy System VP-3111, Plasmaflow, Restep DVT system, AIROS 6, Plexus RP100, AeroDVxTM

APPROVED BY GOVERNING BODIES:

A large number of pneumatic and peristaltic limb compression devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510 (k) process for indications including prevention of deep vein thrombosis. Portable devices cleared by FDA include:

  • AIROS 6 Sequential Compression Device (AIROS Medical, Inc.): This device is safe for both home and hospital use.
  • Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device (Alleva Medical (D.G.) Ltd: This device is for home or clinical settings and is powered by an internal rechargeable battery.
  • AeroDVxTM System (Sun Scientific Inc): This device is for hospital or outpatient use.
  • VenaPro™ Vascular Therapy System (Innovamed Health, LLC, San Antonio, TX: battery-powered.
  • Venowave VW5 (Venowave, Stouffville, ON): The device is battery powered strapped to the leg below the knee.
  • ActiveCare+SFT® System (Medical Compression Systems LTD, Or Akiva, Israel): The device applies sequential pneumatic compression to the lower limb; it has the option of being battery-operated. Foot compression is achieved with use of a single-celled foot sleeve. Calf and thigh compression requires use of a 3-celled cuff sleeve.
  • Restep® DVT System (Stortford Medical LLC, West Windsor, NJ): This is a lightweight device that utilizes single chamber pressure cuffs attached to the patient’s lower legs.
  • Kendall SCD™ 700 Sequential Compression System (Covidien, Mansfield, MA): This pneumatic compression device can be used in the clinic or at home. It has a 2-pronged plug and is not battery-operated.
  • PlasmaFlow™ (ManaMed): This system is portable, to be used at home or in a clinical setting.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

HCPCS Codes :

E0650

Pneumatic compressor; non-segmental home model

E0651

Pneumatic compressor; segmental home model without calibrated gradient pressure

E0652

; with calibrated gradient pressure

E0660

Non-segmental pneumatic appliance for use with pneumatic compressor; full leg

E0666

; half leg

E0667

Segmental pneumatic appliance for use with pneumatic compressor; full leg

E0669

; half leg

E0671

Segmental gradient pressure pneumatic appliance; full leg

E0673

; half leg

E0676

Intermittent limb compression device (includes all accessories), not otherwise specified

REFERENCES:

  1. Afshari A, Fenger-Eriksen C, Monreal M, et al. European guidelines on perioperative venous thromboembolism prophylaxis: Mechanical prophylaxis. Eur J Anaesthesiol. Feb 2018; 35(2):112-115.
  2. Ahmed AB, Koster A, Lance M, et al. European guidelines on perioperative venous thromboembolism prophylaxis: Cardiovascular and thoracic surgery. Eur J Anaesthesiol. Feb 2018; 35(2):84-89.
  3. Alliance FC. Hospital Discharge Planning: A Guide for Families and Caregivers. //www.caregiver.org/hospital-discharge-planning-guide-families-and-caregivers.
  4. American Academy of Orthopaedic Surgeons (AAOS). Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. Available online at: www.guideline.gov.
  5. American Orthopaedic Foot & Ankle Society (AOFAS). Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery. 2013; //www.aofas.org/medical-community/health-policy/Documents/VTED-Position-Statement-approv-7-9-13-FINAL.pdf. Assessed January 23, 2020.
  6. American Orthopaedic Foot & Ankle Society (AOFAS). Position Statement: The Use of VTED Prophylaxis in Foot and Ankle Surgery. 2020; https://www.aofas.org/docs/default-source/research-and-policy/vted-prophylaxis-in-foot-and-ankle-surgery-position-statement.pdf?sfvrsn=21490028_2. Accessed February 22, 2021.
  7. 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 Dec;3(23).
  8. Boutwell A, Hwu S. Effective Interventions to Reduce Rehospitalizations: A Survey of the Published Evidence Institute for Healthcare Improvement. 2009.
  9. Colwell CW, Jr., Froimson MI, Anseth SD, et al. A mobile compression device for thrombosis prevention in hip and knee arthroplasty. J Bone Joint Surg Am. Feb 5 2014; 96(3):177-183.
  10. Colwell CW, Jr., Froimson MI, Mont MA et al. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am 2010; 92(3):527-35.
  11. Committee on Practice Bulletins--Gynecology ACoO, Gynecologists. ACOG Practice Bulletin No. 84: Prevention of deep vein thrombosis and pulmonary embolism. Obstet Gynecol 2007; 110(2 Pt 1):429-40.
  12. Domeij-Arverud E, Labruto F, Latifi A, et al. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilization: a prospective randomized trial of acute ruptures of the Achilles tendon. Bone Joint J. May 2015; 97-B (5):675-680.
  13. Falck-Ytter Y, Francis CW, Johanson NA et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 Suppl):e278S-325S.
  14. Family Caregiver Alliance. Hospital Discharge Planning: A Guide for Families and Caregivers. 2009; //www.caregiver.org/hospital-discharge-planning-guide-families-and-caregivers. Accessed March 1, 2017.
  15. Fan C, Jia L, Fang F, et al. Adjunctive Intermittent Pneumatic Compression in Hospitalized Patients Receiving Pharmacologic Prophylaxis for Venous Thromboprophylaxis: ASystematic Review and Meta-Analysis. J Nurs Scholarsh. 2020;52(4):397-405. doi:10.1111/jnu.12566
  16. Faraoni D, Comes RF, Geerts W, et al. European guidelines on perioperative venous thromboembolism prophylaxis: Neurosurgery. Eur J Anaesthesiol. Feb 2018; 35(2):90-95.
  17. Fisher WD. Impact of venous thromboembolism on clinical management and therapy after hip and knee arthroplasty. Can J Surg 2011; 54(5):344-51.
  18. Froimson MI, Murray TG, Fazekas AF. Venous thromboembolic disease reduction with a portable pneumatic compression device. J Arthroplasty 2009; 24(2):310-6.
  19. Giannoni MF, Ciatti R, Capoccia L et al. Total knee replacement: prevention of deep-vein thrombosis using pharmacological (low-molecular-weight heparin) and mechanical (intermittent foot sole pump system) combined prophylaxis. Preliminary results. Int Angiol 2006; 25(3):316-21.
  20. Gould MK, Garcia DA, Wren SM et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed.: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 Suppl):e227S-77S.
  21. Guyatt GH, Akl EA, Crowther M, et al. Introduction to the ninth edition: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. Feb 2012; 141(2 Suppl):48S-52S
  22. Hardwick ME, Pulido PA, Colwell CW, Jr. A mobile compression device compared with low-molecular-weight heparin for prevention of venous thromboembolism in total hip arthroplasty. Orthop Nurs 2011; 30(5):312-6.
  23. HAS-BLED Score for Major Bleeding Risk. //www.mdcalc.com/has-bled-score-for-major-bleeding-risk/.
  24. Haykal T, Zayed Y, Dhillon H, et al. Meta-Analysis of the Role of Intermittent Pneumatic Compression of the Lower Limbs to Prevent Venous Thromboembolism in Critically IllPatients. Int J Low Extrem Wounds. Jun 11 2020: 1534734620925391
  25. Ho KM, Tan JA. Stratified meta-analysis of intermittent pneumatic compression of the lower limbs to prevent venous thromboembolism in hospitalized patients. Circulation. Aug 27 2013; 128(9):1003-1020.
  26. Kakkos SK, Caprini JA, Geroulakos G, et al. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. Sep 07 2016; 9:CD005258.
  27. Kakkos SK, Warwick D, Nicolaides AN et al. Combined (mechanical and pharmacological) modalities for the prevention of venous thromboembolism in joint replacement surgery. J Bone Joint Surg Br 2012; 94(6):729-34.
  28. Kakkos SK, Caprini JA, Geroulakos G et al. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism in high-risk patients. Cochrane Database Syst Rev 2008; (4):CD005258.
  29. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. Feb 2016; 149(2):315-352.
  30. Kozek-Langenecker S, Fenger-Eriksen C, Thienpont E, et al. European guidelines on perioperative venous thromboembolism prophylaxis: Surgery in the elderly. Eur J Anaesthesiol. Feb 2018; 35(2):116-122.
  31. Lieberman JR, Heckmann N. Venous Thromboembolism Prophylaxis in Total Hip Arthroplasty and Total Knee Arthroplasty Patients: From Guidelines to Practice. J Am Acad Orthop Surg. 2017 Dec;25(12):789-798.
  32. MD+CALC. HAS-BLED Score for Major Bleeding Risk. n.d.; http://www.mdcalc.com/has-bled-score-for-major-bleeding-risk/. Accessed January 25, 2021.
  33. Mont MA, Jacobs JJ, Boggio LN, et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg. Dec 2011; 19(12):768-776.
  34. O'Connell S, Bashar K, Broderick BJ, et al. The use of intermittent pneumatic compression in orthopedic and neurosurgical postoperative patients: a systematic review and meta-analysis. Ann Surg. May 2016; 263(5):888-889.
  35. Rahn DD, Mamik MM, Sanses TV et al. Venous thromboembolism prophylaxis in gynecologic surgery: a systematic review. Obstet Gynecol 2011; 118(5):1111-25.
  36. Sobieraj DM, Coleman CI, Tongbram V, et al. Comparative effectiveness of combined pharmacologic and mechanical thromboprophylaxis versus either method alone in major orthopedic surgery: a systematic review and meta-analysis. Pharmacotherapy. Mar 2013; 33 (3):275-283.
  37. Sobieraj-Teague M, Hirsh J, Yip G et al. Randomized controlled trial of a new portable calf compression device (Venowave) for prevention of venous thrombosis in high-risk neurosurgical patients. J Thromb Haemost 2012; 10(2):229-35.
  38. Venclauskas L, Maleckas A, Arcelus JI, et al. European guidelines on perioperative venous thromboembolism prophylaxis: Surgery in the obese patient. Eur J Anaesthesiol. Feb 2018; 35(2):147-153.
  39. Wang X, Zhang Y, Fang F, et al. Comparative efficacy and safety of pharmacological prophylaxis and intermittent pneumatic compression for prevention of venousthromboembolism in adult undergoing neurosurgery: a systematic review and network meta-analysis [published online ahead of print, 2020 Apr 16]. Neurosurg Rev.2020;10.1007/s10143-020-01297-0. doi:10.1007/s10143-020-01297-0
  40. Zareba P, Wu C, Agzarian J, et al. Meta-analysis of randomized trials comparing combined compression and anticoagulation with either modality alone for prevention of venous thromboembolism after surgery. Br J Surg. Aug 2014; 101 (9):1053-1062.

POLICY HISTORY:

Medical Policy Panel, December 2012

Medical Policy Group, March 2013 (2): New policy created with literature search through November 2012. Outpatient use of limb pneumatic compression devices after major orthopedic surgery is considered medically necessary (for 14 days) in patients with a contraindication to pharmacological agents i.e., at high-risk for bleeding. Outpatient use is considered medically necessary after major non-orthopedic surgery in patients who are at moderate or high risk of venous thromboembolism with a contraindication to pharmacological agents. Other outpatient uses are investigational.

Medical Policy Administration Committee, April 2013

Available for comment April 18 through June 5, 2013

Medical Policy Group, August 2013 (2):  Added information for the Kendal SCD™ 700 Sequential Compression System.  Added Key Words Kendall SCD™ 700 Sequential Compression System, Intermittent pneumatic compressing device, IPCD

Medical Policy Group, May 2014 (5):  Approved by Governing Bodies-Added information for the VenaPro VP-3111 Pneumatic Compression Device.  Added Key Words VenaPro VP-3111 Vascular Therapy System

Medical Policy Panel, December 2014

Medical Policy Group, December 2014 (5): Updates to Key Points and References. Added policy statement to include “outpatient use of limb compression devices for VTE after all other surgeries” is considered investigational. Removed “pneumatic” from title and added “Postsurgical” to title, policy statement, and as applicable throughout policy. 

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6):  Updates to Description, Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6): Updates to Title, Description, Key Points and References; no change to policy statement.

Medical Policy Group, June 2016 (6): Clarification of Policy Statement, changed wording of outpatient to home use; no change to policy intent.

Medical Policy Panel, March 2017

Medical Policy Group, April 2017 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies and References. No change to policy statement.

Medical Policy Group, March 2018 (6): Clarified policy statement requirement for contraindication for anticoagulant. “Clinical documentation must be specific to patient and list contraindication to pharmacological prophylaxis (see ACCP guidelines).”

No change to policy intent.

Medical Policy Panel, March 2018

Medical Policy Group, April 2018 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Panel, March 2019

Medical Policy Group, March 2019 (6): Updates to Description, Key Points, Approved by Governing Bodies and References, added Key Words Plasmaflow, Restep DVT system . No change in policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points, Practice Guidelines, Key Words (AIROS 6, Plexus RP100, AeroDVxTM), Governing Bodies and References. Updated policy title to replace “home” with “outpatient”.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Description, Key Points, Governing Bodies and References. Policy statement updated to remove “investigational” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.