Coverage Policy Manual
Policy #: 2012008
Category: DME
Initiated: January 2012
Last Review: February 2019
  Pneumatic Compression Device, Intermittent, for Home Use following Hip and Knee Arthroplasty, Hip Fracture Repair

Description:
Deep vein thrombosis (DVT) is a significant cause of morbidity and mortality after major orthopedic surgery.  Between 40% and 60% of patients develop a DVT after hip or knee arthroplasty. Anticoagulants such as aspirin, low-molecular-weight heparin, warfarin, Lovenox and other anticoagulants are commonly used to reduce the incidence of DVT after surgical procedures.
 
Pneumatic compression devices have been evaluated for their capacity to reduce DVT after hip and knee surgery. These devices use air pumps and inflatable chambers to apply waves of pressure. To maintain normal blood flow into the leg, pneumatic compression systems have cycles of inflation and deflation of the air chambers.  Depending on the device used, the full cycle of pumping takes between 20 seconds and 2 minutes at pressures ranging from 25 to 130 mmHg.
 
Numerous devices, including but not limited to the following, have received approval through the FDA 510(K) process:
    • ActiveCare® System (Medical Compression Systems Ltd.) approved March 8, 2006
    • WalkCare™ P200 System (Medical Dynamics LLC) approved May 20, 1999
    • Act-One™ System (New Dimension in Medicine Inc.) approved December 27, 1994
    • Aircast VenaFlow® System (Aircast, a subsidiary of DJO Global Inc.) approved October 25, 1993
    • A-V Impulse System™ (Novamedix Services Ltd.) approved April 15, 1992
    • SCD™ System (Kendall Brands, a subsidiary of Covidien) approved May 19, 1989
    • Venowave VW5 (Venowave Inc.; Stouffville, Ontario, Canada): The device is a portable unit that is strapped to the leg below the knee. Different models are available that have a different maximum number of wave plate cycles per minute.
    • 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.
 
 

Policy/
Coverage:
Effective June 2014
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Intermittent Pneumatic Compression Device for home use for prevention of deep vein thrombosis following hip or knee arthroplasty or hip fracture repair, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for those patients who are not candidates for, or who have a contraindication for the use of chemical prophylaxis (e.g., low molecular weight heparin, Lovenox or other anticoagulants) due to bleeding risks as listed in the AACP guidelines:
    • Previous major bleeding (and previous bleeding risk similar to current risk)
    • Severe renal failure
    • Concomitant antiplatelet therapy (e.g.,clopidogrel, prasugrel, ticagrelor)
*Note: Aspirin may be considered concomitant antiplatelet therapy only if the patient was on aspirin therapy prior to surgery and must continue therapy after surgery)
    • Surgical factors: history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery
 
Intermittent Pneumatic Compression Devices will be limited to a maximum of 14 days per arthroplasty.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Intermittent pneumatic compression device for home use for prevention of deep vein thrombosis for any indication other than those listed above do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, intermittent pneumatic compression device for home use for prevention of deep vein thrombosis for any indication other than those listed above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective December 2013 through May 2014
Intermittent Pneumatic Compression Device for home use for prevention of deep vein thrombosis following hip or knee arthroplasty or hip fracture repair, meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for those patients who are not candidates for, or who have a contraindication for the use of chemical prophylaxis (e.g., low molecular weight heparin, Lovenox or other anticoagulants) due to bleeding risks as listed in the AACP guidelines:
    • 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
 
Intermittent Pneumatic Compression Devices will be limited to a maximum of 14 days per arthroplasty.
 
 
Effective prior to November 2013
Intermittent Pneumatic Compression Device for home use for prevention of deep vein thrombosis following hip or knee arthroplasty meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in those patients who are not candidates for, or who have a contraindication for, the use of chemical prophylaxis (e.g., low molecular weight heparin, Lovenox or other anticoagulants).
 
Intermittent Pneumatic Compression Devices will be limited to a maximum of 14 days per arthroplasty.

Rationale:
VTE prophylaxis in major orthopedic surgery patients
 
Patients without a contraindication to prophylaxis with pharmaceutical agents
Anticoagulation is the mainstay of deep vein thrombosis (DVT) prophylaxis after major surgery and is sometimes continued into the outpatient setting. Treatment with pneumatic compression devices may offer addition benefit when used in conjunction with anticoagulation in the inpatient setting but is not commonly used in the outpatient setting. The ideal study design to evaluate whether there is benefit in the outpatient setting would be a randomized controlled trial (RCT) comparing outpatient anticoagulation alone to anticoagulation plus pneumatic compression devices. Key health outcomes include incidence of DVT and pulmonary embolism (PE), as well as measures of functional status and/or quality of life associated with these outcomes.
 
Randomized controlled trials (RCT): No RCT with the above design was identified. In 2012, Kakkos and colleagues published a meta-analysis of RCTs evaluating combined use of anticoagulation and mechanical DVT prophylaxis following joint replacement surgery; however, the study focused on inpatient thromboprophylaxis (Kakkos, 2012). The authors identified 4 trials that compared anticoagulation alone to anticoagulation plus use of pneumatic compression devices. Three of the 4 studies used pneumatic compression devices only until discharge from the hospital. In the fourth study, the article did not clearly state that that pump use was limited to the inpatient setting, but inpatient use was implied e.g., the article stated that staff checked several times a day to ensure correct use of the pump system. Meta-analyses found statistically significantly lower incidences of DVT in the group that used compression pumps in addition to anticoagulation compared to anticoagulation-only. In a pooled analysis of 4 trials on hip replacement, the incidence of DVT was 9.7% in the anticoagulation-only group and 0.9% in the combined treatment group (risk ratio [RR]: 0.17; 95% confidence interval [CI]: 0.06 to 0.46). Similarly, when findings from 2 trials on knee replacement were pooled, the incidence of DVT was 18.7% in the anticoagulation-only group and 3.7% in the combined treatment group (RR: 0.27; 95% CI: 0.08 to 0.89).
 
There are several reasons why the benefit of pneumatic compression devices in the hospital setting may not extrapolate to benefit in the outpatient setting. First, the level of mobility is necessarily less in the hospital than in the outpatient setting, indicating a different risk for DVT. Also, the use of pneumatic compression devices in the hospital can be more highly controlled and monitored. In the outpatient setting, there are questions about the degree of compliance with the devices, including the ability to correctly use them in the absence of professional supervision. No comparative studies were identified that focused on compliance with pneumatic compression devices in the outpatient setting.
 
Case series: A 2006 case series by Giannoni and colleagues in Italy included both inpatient and outpatient DVT prophylaxis with pneumatic compression devices and anticoagulants (Giannoni, 2006).  The study included 34 patients who underwent total knee replacement (4 patients had bilateral replacements). All patients used a pneumatic compression device (A-V Impulse foot pump system) for 15 days. The mean hospital stay was 7 days, and the range was 5 to 12 days. The compression devices were worn for an average of 14 hours per day (range 8 to 18 hours). Patients were also treated with LMWH, beginning after surgery and continuing until the operated leg was completely weight bearing (15-30 days). Ultrasonography detected DVTs in 3 of 34 (8.8%) patients; all were distal DVTs. One symptomatic DVT developed on the 4th post-operative day, and there were 2 subclinical DVTs detected at the routine 1 month ultrasonographic examination. This study did not include a comparison group of patients who did not use a pneumatic compression device. In addition, given the range of length of hospital stay, some patients received their entire course of prophylactic treatment as inpatients. Compliance with pneumatic compression devices was not reported.
 
Patients with a contraindication to prophylaxis with pharmaceutical agents
Patients with contraindications to anticoagulants need to be treated with non-pharmacologic measures. The ideal study design for this question would be an RCT comparing prophylaxis with pneumatic compression devices alone in the outpatient setting to no prophylaxis or to alternative methods of prophylaxis.
 
Randomized controlled trials: No RCTs using this design were identified. However, one recent RCT provided data that might be useful for answering the question of whether outpatient use of pneumatic compression devices are beneficial in the absence of outpatient anticoagulant use. The study, reported on in 2 publications, one in 2010 and the other in 2011, was conducted at multiple centers in the United States and included 395 patients undergoing total hip replacement (Colwell, 2010; Hardwick, 2011).  Individuals with a previous history of thrombosis, known coagulation disorder, solid malignant tumor, peptic ulcer disease or mental disorder were excluded. Patients were randomized to 10 days of DVT prophylaxis using either low-molecular-weight heparin (LMWH) or a mobile pneumatic compression device (ActiveCare+SFT). Treatment continued until 10 days after surgery in both groups; patients received a variable portion of their treatment after hospital discharge. Patients in the compression device group could also receive aspirin if recommended by their doctor. Patients were examined with bilateral duplex ultrasound on day 10-12 following surgery. The mean length of hospital stay was 3.2 days in both groups. Length of hospital stay ranged from 2 days to 10 days; thus, patients had between 0 days and 8 days of outpatient use of their assigned method of prophylaxis. According to ultrasound findings, 8 of 196 (4.1%) in the pneumatic compression group and 8 of 190 (4.2%) in the LMWH group had a DVT. In addition, 2 pulmonary emboli were detected in each group. The incidence of venous thromboembolic events did not differ significantly between groups. However, the rate of major bleeding was significantly higher in the LMWH group. A total of 11 (6%) of patients in the LMWH group had a major bleeding event compared to no patients in the pneumatic compression group (p=0.0004). Rates of minor bleeding were similar in the 2 groups; 78 (40%) in the LMWH group and 74 (37%) in the pneumatic compression group. In addition, compliance with the mobile compression devices was monitored using internal timers in the device. According to these data, patients used the device for a mean of 11 days (range 1 to 15 days) and for a mean of 20 hours per day. Mean use of the device was 83% of possible usable time. Findings on compliance were not reported separately for inpatient and outpatient use of the devices.
 
Conclusions in patients undergoing major orthopedic surgery: There is very little published evidence on the efficacy of outpatient use of limb pneumatic compression devices for deep vein thrombosis prophylaxis after major orthopedic surgery. There are no RCTs that evaluate outpatient use of pneumatic compression as an adjunct to pharmacologic prophylaxis in patients without a contraindication to anticoagulants. Some RCTs have evaluated the inpatient use of pneumatic compression as an adjunct to pharmacologic agents, but the results of these trials might not be able to be extrapolated to the outpatient setting. There is also a lack of evidence on compliance with limb pneumatic compression devices in the outpatient setting. National clinical guidelines support the use of pneumatic compression devices DVT prophylaxis after major orthopedic surgery in patients who are not candidates for pharmacologic prophylaxis due to a high risk of bleeding. In addition, one RCT that reported similar rates of post-operative DVT in patients who received pneumatic compression devices or low-molecular-weight evidence provides some evidence in support of pneumatic compression devices as the sole intervention in the outpatient setting. This study was limited in that much of the treatment occurred in the hospital, and patients with a known coagulation disorder were excluded from participation.
 
ACCP recommendations on use of limb compression devices in orthopedic surgical patients (Falck-Ytter, 2012):
    • “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).”
    • “2.1.2 In patients undergoing hip fracture surgery (HFS), we recommend use of one of the following rather than no antithrombotic prophylaxis for a minimum of 10 to 14 days: LMWH, fondaparinux, LDUH, adjusted-dose VKA, aspirin (all Grade 1B) , or an 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).”
 
For all of the above recommendations related to pneumatic compression pumps, the ACCP recommended only portable, battery-powered devices be used and stated that efforts should be made to ensure devices are worn for 18 hours per day. The authors noted that compliance is the biggest challenge associated with use of pneumatic compression devices.
 
2017 Update
A literature search conducted through December 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
There is a meta-analysis of RCTs comparing IPC use with placebo in hospital. The metaanalysis was published in 2013 by Ho and colleagues (Ho, 2013). It included RCTs comparing IPC to no prophylaxis or another type of prophylaxis in hospitalized surgical and nonsurgical patients. As with the meta-analyses reviewed above, there was heterogeneity of participants and interventions. Studies using a no prophylaxiss control group may have been conducted in lower-risk patients and, in higher-risk patients, some studies also included pharmacologic prophylaxis in both groups. A pooled analysis of 40 RCTs found a significantly lower rate of DVT with IPCs (7.3%) versus placebo (16.7%) (RR=0.43; 95% CI, 0.36 to 0.52). Similarly, a pooled analysis of 26 trials found a significantly lower rate of PE with IPCs (1.2%) than placebo (2.8%) (RR=0.48; 95% CI, 0.33 to 0.69). Results of the Ho et al meta-analysis suggest that IPCs can be beneficial for VTE prophylaxis in patients with a contraindication to medication.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2016 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2018 Update
A literature search conducted through February 2018 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
 

CPT/HCPCS:
A4600Sleeve for intermittent limb compression device, replacement only, each
E0650Pneumatic compressor, nonsegmental home model
E0651Pneumatic compressor, segmental home model without calibrated gradient pressure
E0652Pneumatic compressor, segmental home model with calibrated gradient pressure
E0660Nonsegmental pneumatic appliance for use with pneumatic compressor, full leg
E0666Nonsegmental pneumatic appliance for use with pneumatic compressor, half leg
E0667Segmental pneumatic appliance for use with pneumatic compressor, full leg
E0669Segmental pneumatic appliance for use with pneumatic compressor, half leg
E0671Segmental gradient pressure pneumatic appliance, full leg
E0673Segmental gradient pressure pneumatic appliance, half leg
E0676Intermittent limb compression device (includes all accessories), not otherwise specified

References: Ahmed AB, Koster A, Lance M, et al.(2018) European guidelines on perioperative venous thromboembolism prophylaxis: Cardiovascular and thoracic surgery. Eur J Anaesthesiol. Feb 2018;35(2):84-89. PMID 29112541

Boutwell A, Hwu S.(2009) Effective Interventions to Reduce Rehospitalizations: A Survey of the Published Evidence Institute for Healthcare Improvement. 2009

Colwell CW, Froimson MI, Mont MA et al.(2010) Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with LMWH. J Bone Joint Surg Am 2010;92(3):527:535.

Colwell CW.(2009) The ACCP guidelines for thromboprophylaxis in total hip and knee prophylaxis. Orthopedics. 2009 Dec;32(12 Suppl):67-73.

Edwards J, Pulido P, Colwell C, et al.(2008) Portable Compression Device and LMWH compared with LMWH for thromboprophylaxis after total joint arthroplasty. J Arthroplasty 2008;23(8): 1122-1127.

Faraoni D, Comes RF, Geerts W, et al.(2018) European guidelines on perioperative venous thromboembolism prophylaxis: Neurosurgery. Eur J Anaesthesiol. Feb 2018;35(2):90-95. PMID 29112542

Froimson M, Murray T, Fazekas A.(2009) Venous thromboembolic disease reduction with a portable pneumatic compression device. J Arthroplasty 2009;24(2):310-316.

Geerts WH, Bergqvist D, Pineo GF, et al.(2008) American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):381S-453S. Available online at: http://chestjournal.chestpubs.org/content/133/6_suppl/381S.long. Last accessed January 25, 2012.

Gelfer Y, Tavor H, Oron A, et al.(2006) Deep vein thrombosis prevention in joint arthroplasties: continuous enhanced circulation therapy vs LMWH. J Arthroplasty 2006;21(2):206-214.

Giannoni MF, Ciatti R, Capoccia L et al.(2006) 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.

Guyatt GH, Akl EA, Crowther M, et al.(2012) 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. PMID 22315255

Hardwick ME, Pulido PA, Colwell CW, Jr.(2011) 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.

Ho KM, Tan JA.(2013) 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. PMID 23852609

Kakkos SK, Caprini JA, Geroulakos G et al.(2008) Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism in high-risk patients. Cochrane Database Syst Rev 2008; (4):CD005258.

Kakkos SK, Caprini JA, Geroulakos G, et al.(2016) Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev. Sep 07 2016;9:CD005258. PMID 27600864

Kakkos SK, Warwick D, Nicolaides AN et al.(2012) 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.

Kearon C, Akl EA, Ornelas J, et al.(2016) Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. Feb 2016;149(2):315-352. PMID 26867832

Kozek-Langenecker S, Fenger-Eriksen C, Thienpont E, et al.(2018) 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. PMID 28901992

National Institute for Health and Clinical Excellence (NICE).(2010) Venous thromboembolis: reducing the risk. Developed by the National Collaborating Centre for Acute and Chronic Conditions. London, UK: National Institute for Health and Clinical Excellence;2010. NICE Clinical Guideline No. 92. Available at: http://www.nice.org.uk/nicemedia/live/12695/47195/47195.pdf. Last accessed January 25, 2012.

Venclauskas L, Maleckas A, Arcelus JI, et al.(2018) European guidelines on perioperative venous thromboembolism prophylaxis: Surgery in the obese patient. Eur J Anaesthesiol. Feb 2018;35(2):147-153. PMID 29112546


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.