Flexitouch System for Lymphedema – pro

Lymphedema is condition that is difficult to treat. Flexotouch is a non-manual device. Guidelines on its appropriateness are discussed.

Lymphedema pumps (pneumatic compression devices) are generally considered medically necessary for home use for the treatment of lymphedema if the member has undergone a four-week trial of conservative therapy and the treating doctor determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb.

In such cases, a non-segmented device or segmented device without manual control of the pressure in each chamber is generally considered medically necessary to meet the clinical needs of the member. A segmented device with manual control of the pressure in each chamber is considered medically necessary only if there is clear documentation of medical necessity in the individual case. A segmented device with manual control of the pressure in each chamber is considered medically necessary only when there is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device with a segmented appliance/sleeve or a segmented device without manual control of the pressure in each chamber.

There is one randomized study. The results were published in the Canadian Medical Association Journal in 2001. It demonstrated a trend in favour of pneumatic compression pumps compared with no treatment. It concluded: “Further randomized trials are required to determine whether pneumatic compression provides additional benefit over compression garments alone”.

Flexitouch is a specific device. There is insufficient evidence in the peer-reviewed published medical literature that a 2-phase lymph preparation and drainage therapy device (Flexitouch Device, Tactile Systems Technology, Minneapolis, MN) provides superior outcomes to standard segmented pneumatic compression devices. According to the manufacturer, the 2-phase lymph preparation and drainage therapy device consists of an electronic controller unit and garments, worn on the trunk and upper and lower affected extremities and connected to the controller unit by tubing harnesses. The garment consists of 32 inflatable chambers that sequentially inflate and deflate and deflate at 1 to 3 second intervals, according to one of the 13 preprogrammed treatment patterns selected. Chamber pressure and treatment times can be adjusted. In essence it is an automated and more sophisticated version of the standard segmental compression pump. The manufacturer states that device’s sequential action evacuates lymph from the trunk and extremities and drains it into the venous system. The garments are made from stretch material and are fitted with Velcro enclosures, so custom fitting of garments is not required. There are no published studies comparing the effectiveness of this 2-phase lymph preparation and drainage therapy device to standard segmented pneumatic compression devices. It is also more expensive.

A 2009 review found that: “While numerous articles were reviewed noting that PCD has become standard of care in most countries, conclusive documentation of the benefits of this treatment modality are lacking. The opinion expressed by the Supportive Care Guidelines Group of Cancer CareOntario and the Ontario Ministry of Health and Long Term Care is illustrative of this dilemma when they state that “The lack of sufficient high quality evidence precludes definitive recommendations from being made.” While this statement was made in relation to treatment options for women with breast cancer and lymphedema, the document further states “There is some evidence which suggests that physical therapies such as compression therapy and manual lymphatic drainage may improve established lymphedema but further studies are needed.”

Gurdal SO, Kostanoglu A, Cavdar I, et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol. 2012; 10(3):129-135.Hammond T. Reduction of complications and costs associated with Flexitouch therapy for lymphedema. Open Rehabil J. 2009; 2:54-57.

Flexitouch can handle trunkal edema, which is an advantage. However, there are also dedicated devices specifically for trunkal edema, such as LymphoJacket and others.

Kligman L, Wong RK, Johnston M, Laetsch NS. The treatment of lymphedema related to breast cancer: A systematic review and evidence summary. Support Care Cancer. 2004;12(6):421-431.

Swedish Council on Technology Assessment in Health Care (SBU). Manual lymph drainage combined with compression therapy for arm lymphedema following breast cancer treatment (Alert). Stockholm, Sweden: SBU; 2005.

Tactile Systems Technology. Flexitouch Device. Physician Information [website]. Minneapolis, MN: Tactile Systems; 2005. Available at: http://www.tactilesystems.com/html/professionals.html.

Kligman L, Wong RK, Johnston M, Laetsch NS. The treatment of lymphedema relatedto breast cancer: a systematic review and evidence summary. Support Care Cancer.2004;12(6):421-31.

Szuba A, Achalu R, Rockson S. Decongestive lympatic therapy for patients with breastcarcinoma-associated lymphedema. Cancer 2002;95(11):2260-2267.Winifred S. Hayes (Hayes, Inc.). Pneumatic Compression Devices for Treatment ofPeripheral Lymphedema. Hayes Brief. June 6, 2005 and January 7, 2008.

Harris SR, Hugi MR, Olivotto I, Levine M for the Steering Committee for ClinicalPractice Guidelines for the Care and Treatment of Breast Cancer. Clinical PracticeGuidelines for the care and treatment of breast cancer: 11. Lymphedema. CanadianMedical Association Journal 2001;164(2):191-199.21

Harvey N. Mayrovitz, PhD, Dawn Brown-Cross, PT, EdD, CLT Nova Southeastern University Barbara L. Mayrovitz, RN, BA Home Health Service Alison H. Golla, MA, OTR/L, CLT Tactile Systems Technology, Inc.”Lymphedema: Role of Truncal Clearance as a Therapy Component”
Home Health Care Management Practice OnlineFirst. Feb 27, 2009

Tina Hammond,Can Truncal Edema Be Treated With Pneumatic Compression”
National Lymphedema Network’s  LymphLink,  Volume 21

Poage E, Singer M, Armer J, Poundall M, Shellabarger MJ. Demystifying lymphedema: development of the lymphedema putting evidence into practice card. Clin J Oncol Nurs. 2008 Dec;12(6):951-64. [61 references]

Manual lymphatic drainage for lymphedema following breast cancer treatment.Cochrane Database Syst Rev. 2015 May 21;(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.

Stuiver MM, ten Tusscher MR, Agasi-Idenburg CS, Lucas C, Aaronson NK, Bossuyt PM.Conservative interventions for preventing clinically detectable upper-limb lymphoedema in patients who are at risk of developing lymphoedema after breast cancer therapy.
Cochrane Database Syst Rev. 2015 Feb 13;(2):CD009765.

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