DESCRIPTION
End-diastolic pneumatic compression boot (e.g., The Circulator Boot™) has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. Timed, sequential inflation during the end-diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic. Therapy is typically offered in a series of 40-minute sessions in an office setting. The end-diastolic compression device is distinctly different from single and multi-chambered lymphedema devices (used in the presence of significant lymphedema) and intermittent compression pumps (used for DVT prevention). The latter two devices do not require synchronization with the cardiac cycle; whereas the end diastolic pump relies on EKG input to apply timed compression just prior to the next QRS complex thereby reducing afterload and cardiac work. This same synchronized compression technology is used under direct supervision by a physician to increase cardiac output, and in that setting is known as enhanced external counterpulsation.
The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the electrocardiogram (EKG) and to appropriately time boot compressions in the end portion of the heart cycle; a rapid action valve assembly capable of both pressurizing and exhausting the boots; rigid, adjustable long boots to enclose the leg from groin to toes; and double-walled plastic bags to enclose the treated portion of the leg and to contain the compressed air.
NOTE: Lymphedema devices, intermittent compression pumps and enhanced external counterpulsation intended to treat decreased cardiac output are NOT addressed by this policy.
POLICY
End-diastolic pneumatic compression boots (e.g., Circulator boot) for the treatment of vascular diseases and related conditions, including but not limited to lymphedema, claudication pain, venous stasis ulcers, and ischemic lesions are considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Well-designed studies that evaluate the clinical importance of end-diastolic pneumatic compression devices for the treatment of vascular disease and related conditions continue to be lacking. The available evidence is limited to small case series which are outdated, and no randomized controlled trials are available that assess this technology.
SOURCES
Dillon, R.S. (1980). Effect of therapy with the pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease. Angiology, 31 (9), 614-638. Abstract retrieved July 8, 2019 from PubMed database.
Dillon, R.S. (1986). Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by local antibiotic injections and the end-diastolic pneumatic compression boot. Annals of Surgery, 204 (6), 643-649. (Level 4 evidence)
Dillon, R.S. (1997). Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the circulator boot. Results of treatments with the circulator boot. Angiology, 48 (5 Pt 2), S17-S34. Abstract retrieved July 8, 209 from PubMed database.
Flip, J.R., & Dillon, R.S. (2008). Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology, 59 (2), 214-219. Abstract retrieved July 8, 2019 from PubMed database.
U. S. Food and Drug Administration (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082134. Retrieved April 18, 2011 from http://www.accessdata.fda.gov.
Vella, A., Carlson, L.A., Blier, B., Felty, C., Kuiper, J.D., & Rooke, T.W. (2000). Circulator boot therapy alters the natural history of ischemic limb ulceration. Vascular Medicine, 5 (1), 21-25. Abstract retrieved July 8, 2019 from PubMed database.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 3/9/2023
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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