Cancer Treatment

Flexitouch System for Lymphedema

Lay Summary: 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. That is assumed to have beend one in this case since the therapy was delivered by a physical therapist.

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 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.

TriCenturion, LLC. Pneumatic compression devices (used for lymphedema). Policy No. LYPH20021201. Medicare Local Medical Review Policy. DMERC Region A. Columbia, SC: TriCenturion; April 1, 2002.

Tiwari A, Cheng KS, Button M, et al. Differential diagnosis, investigation, and current treatment of lower limb lymphedema. Arch Surg. 2003;138(2):152-161.
International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003;36(2):84-91.

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.

Anticoagulation in cancer patients - guidelines

Pulmonary emboli is an indication for long term anticoagulation. Although generally oral warfarin is used, it is now recognized that it is not as effective in patients with thromboses secondary to cancer as are the low molecular weight heparins, such as Lovenox.

Low Molecular Weight Heparins are used for the prophylaxis or treatment of deep vein thrombosis. The decision to use LMWH instead of standard heparin or warfarin will depend upon the clinical scenario and individual patient factors such as risk of bleeding or availability of venous access.

Several studies have shown that patients with malignancy and thrombosis do not respond well to warfarin and many of them have recurrent DVT on warfarin. The National Comprehensive Cancer Network has issued its first guidelines for how to prevent deep vein thrombosis (DVT) in cancer patients and how to treat a DVT. The guidelines listed the following agents for anticoagulation:

Unfractionated heparin: 5,000 units subcutaneously three times a day.
Low molecular weight heparin, dosed according to standard operating procedures of individual institutions, with either dalteparin, enoxaparin or tinzaparin.
Pentasaccharide, fondaparinux, 2.5 mg subcutaneous daily.

The guidelines were revealed at the 11th annual conference of the NCCN -- a consortium of 19 of the leading cancer centers in the country. They included recommendations for prophylaxis of venous thromboembolism in cases of patients with cancer or who are suspected of cancer. If they do not have contraindication for anticoagulation, then therapy was suggested with or without sequential compression devices. If there is a contraindication for anticoagulant therapy then use of compression devices, including graduated compression stocking, were considered.

For initial treatment of DVT or PE, either UFH or LMWH should be administered. For postoperative patients, an agent such as UFH, which has a short half life and is readily reversible, may be preferable. For more stable patients who are not at high risk for bleeding, LMWH is probably the treatment of choice.

Chronic VTE therapy with anticoagulants in cancer patients is a challenge. Many anticancer medications interact with oral anticoagulants (eg, warfarin), he added, and make it difficult to control the level of anticoagulation, particularly in cancer patients with more extensive disease. In a study of patients with and without cancer receiving oral anticoagulants, the VTE recurrence rate and risk of bleeding were substantially higher in patients with advanced cancer, particularly in the first 2 months of therapy. Recent results from the CLOT trial showed that the incidence of VTE recurrence was significantly lower in patients with advanced cancer receiving dalteparin (Fragmin) versus those receiving oral anticoagulation therapy over a 6-month period. The bottom line is that LMWH should be strongly considered in patients who have advanced metastatic cancer (Lee AY et al. N Engl J Med 2003;349:146–153).New guideline recommendations have been released for the use of anticoagulation in the prevention and treatment of venous thromboembolism (VTE) in patients with cancer. The guidelines, which were prepared by an international panel of researchers and are published in the October 29 Early Release Articles issue and were published in the December 1, 2007 issue of the Journal of Clinical Oncology.
The ASCO panel was a mix of world-famous experts in thrombosis and methodology, he added, and the resulting guidelines underwent extensive internal and external review by other leading experts before further review by the ASCO board of directors and their own reviewers.

Their guideline recommendations included the following:

Patients with cancer who are hospitalized should be considered candidates for VTE prophylaxis with anticoagulants in the absence of bleeding or other contraindications to anticoagulation.

Routine prophylaxis with an antithrombotic agent is not recommended for ambulatory patients during systemic chemotherapy, but patients receiving thalidomide or lenalidomide with chemotherapy or dexamethasone are at high risk for thrombosis and warrant prophylaxis.

All patients undergoing major surgical intervention for malignant disease should be considered for thromboprophylaxis.

Low molecular weight heparin (LMWH) represents the preferred agent for both the initial and continuing treatment of patients with cancer who have established VTE.

The impact of anticoagulants on survival of patients with cancer requires additional study and cannot be recommended at present.

Patients with cancer should be encouraged to participate in clinical trials designed to evaluate anticoagulant therapy as an adjunct to standard anticancer therapies.

INNOHEP is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP were established in hospitalized patients. It is an FDA approved indication.

:146–153).

The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):627S-644S.
   
N.L. Rymes Outpatient management of DVT using low molecular weight heparin and a hospital outreach service Clinical & Laboratory Haematology Volume 24 Page 165  - June 2002 Volume 24 Issue 3

Richard Schreiber, Regarding clinical practice guidelines on the use of warfarin, Journal of the American Geriatrics Society Volume 49 Page 96  - January 2001 Volume 49 Issue 1

Highlights of the NCCN 11th Annual Conference: Clinical Practice Guidelines & Quality Cancer Care™, published as a supplement to The Oncology Report by Elsevier Oncology. © 2006 NCCN.