The most common symptoms of PAD are leg pain (intermittent claudication - leg pain when walking and disappears after a few minutes of rest), tingling, numbness, and weakness in the legs. Walking can be greatly impaired. Severe cases of PAD (i.e., critical limb ischemia) can lead to nonhealing ulcers on the legs or feet, and ultimately, gangrene (dead tissue) or amputation.

Treatment for peripheral artery disease has two major goals. The first is to manage symptoms, such as leg pain, so that one can resume physical activities. The second is to stop the progression of atherosclerosis throughout the body to reduce the risk of heart attack or stroke. Treatment of PAD may include lifestyle changes (e.g., quitting smoking, lowering blood pressure, lowering high blood cholesterol, lowering blood sugar in diabetic patients, being physically active), pharmacologic (medicines), and surgical procedures (e.g., bypass surgery, balloon angioplasty ) for the more severe cases such as critical limb ischemia. Intermittent pneumatic or mechanical (nonpneumatic) compression devices are being investigated as a treatment option for PAD symptoms by improving blood circulation..

A typical intermittent pneumatic compression device consists of pneumatic compression cuffs that are wrapped around the legs and attached to a portable device that signals the cuffs to compress. The foot and ankle are compressed first, followed a second later by the calf. The purpose is to empty the veins of the foot, ankle, and calf so that the arteries can more easily deliver blood to those areas. The device is portable and can be used by the patient in the home without the assistance of medical personnel. A treatment session may last up to four hours. A mechanical compression device provides compression by tugging and releasing a disposable sleeve placed around the calf muscle, thus exerting repetitive cycles of external pressure build-up on the tissue, and a subsequent release.

Regulatory Status
An example of an intermittent pneumatic compression device is the ArterialFlow Sequential Compression System by Aircast, Inc. and an example of a mechanical compression device is the FM220 System by Flowmedic, Inc.. Both were cleared for marketing by the U.S. Food and Drug Administration under the 510(k) approval process and are intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Related Policies

• Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers (Policy #013 in the DME Section)

The use of intermittent pneumatic or mechanical compression devices in the management of peripheral artery disease is considered investigational.


Medicare Coverage:
There is no National Coverage Determination (NCD) for intermittent pneumatic or mechanical compression devices for the management of peripheral artery disease. In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Noridian Healthcare Services, LLC, the Local DME Medicare Carrier for jurisdiction JA, has determined that Intermittent Pneumatic or Mechanical Compression Devices for Peripheral Artery Disease is not covered. For additional information, refer to LCD L33829 Pneumatic Compression Devices. Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

[RATIONALE:

Literature Review

The current evidence available in the published, peer-reviewed medical literature supporting the use of compression devices in the management of peripheral artery disease is limited primarily to small controlled studies including pilot and feasibility studies with short-term follow up.

A study by de Haro et al. (2010) tested the feasibility of using a new portable non-pneumatic mechanical compression device for the treatment of claudication. Thirty patients were enrolled in a randomized controlled single study. Fourteen were assigned to active intermittent mechanical compression (IMC) and sixteen control patients continued with medical treatment alone. The investigators concluded that the use of IMC of the calf for three months increased claudication distances and led to objective improvements in ABI-pe (ankle-brachial index at rest and post-exercise). Intermittent mechanical compression may be a useful approach to patients with continued claudication despite standard medical treatment.

A study by Chang et al. (2012) investigated the effects of intermittent pneumatic compression (IPC) in patients with symptomatic peripheral arterial obstructive disease (PAOD), especially for those with infrapopliteal diffuse peripheral obstructive disease. Thirty one patients with infrapopliteal diffuse or multiple segmental lesions were enrolled in the study. Based on receipt of IPC therapy (3 hours daily for 3 months), patients were allocated to a study group (N=23) or control group (n=8). The investigators concluded that patients at high risk for amputation with infrapopliteal diffuse or multiple segmental lesions can improve their walking ability, transcutaneous oxygen tension of the target limb and quality of life after IPC therapy.

A study by Kakkos et al. (2005) compared the effect of unsupervised exercise, supervised exercise and intermittent pneumatic foot and calf compression (IPC) on the claudication distance, lower limb arterial haemodynamics and quality of life of patients with intermittent claudication. Thirty-four eligible patients with stable intermittent claudication were randomized to IPC (n = 13, 3h/d for 6 months), supervised exercise (n = 12, three hourly sessions/week for 6 months) or unsupervised exercise (n = 9). The investigators concluded that IPC, by augmenting leg perfusion, achieved improvement in walking distance comparable with supervised exercise. Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication.

The aim of a pilot study by Ramaswami et al. (2005) was to determine the usefulness of rapid, high-pressure, intermittent pneumatic calf and foot compression (IPCFC) in patients with stable intermittent claudication, with reference to the end points of improvement in initial claudication distance (ICD) (distance at which patient feels pain or discomfort in the legs), and improvement in absolute claudication distance (ACD) (distance at which patient stops walking because the pain or discomfort becomes severe). Thirty male patients presenting with stable, intermittent claudication (ACD between 50 and 150 meters on treadmill testing at 3.8 km/h, 10 degrees gradient) were recruited into this pilot study from a single center. Fifteen patients were randomized to treatment with IPCFC (applied for 1 hour twice daily in the sitting position) and were also advised to have daily exercise, and 15 patients served as controls, who were advised exercise alone. According to the investigators, the results of the pilot study showed that IPCFC improves walking distance in patients with stable intermittent claudication. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future.

This retrospective controlled study by Kavros et al. (2008) evaluated the clinical efficacy of intermittent pneumatic compression (IPC) in patients with chronic critical limb ischemia, tissue loss, and nonhealing wounds of the foot after limited foot surgery (toe or transmetatarsal amputation) on whom additional arterial revascularization had been exhausted. This study was comprised of 2 groups. Group 1 (IPC group) consisted of 24 consecutive patients, median age 70 years, who received IPC for tissue loss and nonhealing amputation wounds of the foot attributable to critical limb ischemia in addition to wound care. Group 2 (control group) consisted of 24 consecutive patients, median age 69 years, who received wound care for tissue loss and nonhealing amputation wounds of the foot due to critical limb ischemia, without use of IPC. Group allocation of patients depended solely on their willingness to undergo IPC therapy. The investigators concluded that IPC used as an adjunct to wound care in patients with chronic critical limb ischemia and nonhealing amputation wounds/tissue loss improves the likelihood of wound healing and limb salvage when established treatment alternatives in current practice are lacking. This controlled study adds to the momentum of IPC clinical efficacy in critical limb ischemia set by previously published case series, compelling the pursuit of large scale multicentric level 1 studies to substantiate its actual clinical role, relative indications, and to enhance our insight into the pertinent physiologic mechanisms.

A systematic review conducted by Moran et al. (2014) on the use of intermittent pneumatic compression (IPC) for critical limb ischemia identified two controlled before-and-after CBA) studies and six case series studies. All studies had a high risk for bias. The authors concluded that the limited available results suggest that IPC may be associated with improved limb salvage, wound healing and pain management. However, in the absence of additional well-designed analytical studies examining the effect of IPC in critical limb ischaemia, this treatment remains unproven.

Summary

There is insufficient published evidence supporting the use of intermittent pneumatic or non-pneumatic mechanical compression devices in the treatment of peripheral artery disease. Published evidence consists of small controlled studies including feasibility and pilot studies with short-term follow up Therefore, their use is considered investigational.

Practice Guidelines and Position Statements

The 2005 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for the management of patients with peripheral artery disease and the 2011 focused update of the guidelines do not mention the use of intermittent compression devices in their treatment recommendations.

The 2012 American College of Chest Physician's (ACCP) evidence- based clinical practice guidelines for antithrombotic therapy and prevention of thrombosis do not include any recommendations for the use of intermittent compression devices in the treatment of patients with peripheral artery disease (PAD) including asymptomatic PAD, intermittent claudication and critical limb ischemia.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Intermittent Pneumatic or Mechanical Compression Devices for Peripheral Artery Disease
Intermittent Pneumatic Compression Devices for Peripheral Artery Disease
Mechanical Compression Devices for Peripheral Artery Disease
Pneumatic Compression Devices for Peripheral Artery Disease
Compression Devices for Peripheral Artery Disease
Peripheral Artery Disease

References:
1. Rooke TW, Hirsch AT, Hertzer et al. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011 Nov 1;58(19):2020-45. Epub 2011 Oct 6.

2. Hirsch AT, Haskal ZJ, Hertzer NR et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation.

J Am Coll Cardiol. 2006 Mar 21;47(6):1239-312.

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