Medical Policy: 07.01.76
Original Effective Date: September 2017
Reviewed: September 2020
Revised: September 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Lymphedema, a less common form of edema, is a result of an abnormality of the lymphatic system. It is divided into two broad classes according to etiology, primary and secondary. Primary lymphedema is further divided into three categories of primary causes for lymphedema, which vary by their age at onset. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as lymph node dissection or radiation, malignant obstruction, and infection. The goal of treatment is to control limb swelling, since the underlying disease cannot usually be corrected.
Lymphedema is usually staged by observing a patient’s physical condition. The International Society of Lymphology uses the following 3-stage scale for classification of a lymphedematous limb:
An increasing number of lymphologists recognize an earlier stage of lymphedema, termed Stage 0, which refers to a latent or subclinical condition where swelling is not evident despite impaired lymphatic transport. Stage 0 may exist for months or years before the onset of overt lymphedema.
Early and ongoing treatment of lymphedema is necessary. Conservative therapy may consist of several features depending on the severity of the lymphedema. Patients are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by patients designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all of the previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in patients who have difficulty performing self-manual lymphatic drainage. In patients with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.
Operations for lymphedema are classified in two main categories: excisional operations and lymphatic reconstruction. Surgical management of lymphedema is categorized into two general approaches: physiologic techniques and reductive/ablative techniques. Physiologic procedures are proposed for individuals with early stage lymphedema prior to deposition of excess fat and extensive tissue fibrosis. Reductive/ablative techniques are proposed for individuals who present with more advanced lymphedema after fat deposition and tissue fibrosis has occurred. Individuals with more advanced lymphedema have been treated with physiologic techniques, however, the results are variable, and only limited numbers of patients have been analyzed. Surgery may be used as an adjunct to conservative therapy. Conservative therapy is multimodal. It involves meticulous skin hygiene and care, exercise, compression therapy, and physical therapy (manual lymphatic drainage). Complete decongestive therapy and pneumatic compression pumps are also used as adjuncts to conservative therapy. There is no consensus regarding the role of surgery, the optimal surgical approach, or the timing of an operative procedure for extremity lymphedema.
Suction-assisted lipectomy in combination with excision of skin excess (SALCESE) is a procedure that combines the benefits of bulk reduction from lipectomy with the benefits of facilitated wound healing from the skin excision.
This procedure uses microsurgery to build tiny bridges between the lymphatic vessels and the veins, so that the lymph fluid has a new pathway out of the arm. However, it hasn’t been proven effective in the small research studies available.
In this approach, the surgeon "harvests" lymph nodes and their attached blood vessels from another area of the body — such as the abdomen or groin — and then connects them to the lymph vessels and blood vessels under the arm. Another technique involves implanting the nodes into the wrist of the arm affected by lymphedema. Some small, early studies have found that the procedure can offer relief from severe swelling, heaviness in the limb, and infections, although it doesn’t cure the lymphedema. There is some concern that the procedure could cause lymphedema in the other area of the body from which the lymph nodes were taken.
The greater omentum is supplied by the right, middle, and left omental arteries, which arise from the right and left gastroepiploic arteries. All or part of the greater omentum can be harvested based on this blood supply for free tissue transfer. It has stimulated new interest in its use as the donor site in the treatment of lymphedema.
The purpose of lymphatic physiologic microsurgery simultaneous to lymphadenectomy for breast cancer (ie, the Lymphatic Microsurgical Preventing Healing Approach [LYMPHA]) is to prevent lymphedema in individuals who are being treated for breast cancer. LYMPHA is a preventive LVA procedure performed during nodal dissection or reconstructive surgery that involves anastomosing arm lymphatics to a collateral branch of an axillary vein.
The National Comprehensive Cancer Network Guidelines on Breast Cancer and Breast Cancer Survivorship (Version 6.2020) does not specifically mention surgical treatments for lymphedema. The guideline recommends educating patients on lymphedema, monitoring for lymphedema, and referring for lymphedema management as needed.
National Cancer Institute (NCI): The NCI Health Professional Version [Physician Data Query (PDQ®)] on lymphedema states that “Surgery is rarely performed on patients who have cancer-related lymphedema. The primary surgical method for treating lymphedema consists of removing the subcutaneous fat and fibrous tissue with or without creation of a dermal flap within the muscle to encourage superficial-to-deep lymphatic anastomoses. These methods have not been evaluated in prospective trials, with adequate results for only 30% of patients in one retrospective review. In addition, many patients face complications such as skin necrosis, infection, and sensory abnormalities. The oncology patient is usually not a candidate for these procedures. Other surgical options include the following: Microsurgical lymphaticovenous anastomoses in which the lymph is drained into the venous circulation or the lymphatic collectors above the area of lymphatic obstruction; liposuction; superficial lymphangiectomy; fasciotomy” (2019).
This consensus document does not offer any recommendations or statements related to LVA for preventing lymphedema. However, for LVA treatment of existing lymphedema, the document states:
Lymphaticvenous (or lymphovenous) anastomoses (LVA) are currently in use at multiple centers around the world. These procedures have undergone confirmation of long-term patency (in some cases more than 20 years) and some demonstration of improved lymphatic transport (by objective physiologic measurements of long-term efficacy). Multiple lymphaticvenous anastomoses in a single surgical site with both the superficial and deep lymphatics, allow the creation of a positive pressure gradient (lymphatic-venous) and evade the phenomenon of gravitational reflux without interrupting the distal peripheral superficial lymphatic pathways. Some centers also practice lymph nodal-venous shunts as a derivative method.
U.S. Food and Drug Administration (FDA) The FDA does not regulate surgical procedures. Any medical devices, drugs, biologics, or tests used as a part of this procedure may be subject to FDA regulation.
The surgical treatment of lymphedema, including but not limited to, microsurgical lymphatico-venous anastomosis, lymphovenous bypass, omental lymph node flap, suction assisted lipectomy or liposuction and vascularized lymph node transfer techniques is considered investigational alone or in combination of another procedure.
Surgical treatment of lymphedema of the genetalia is considered investigational alone or in combination of another procedure.
Preventive surgical treatment Lymphatic physiologic microsurgery performed during nodal dissection or breast reconstruction to prevent lymphedema (including, but not limited to, the Lymphatic Microsurgical Preventing Healing Approach) in individuals who are being treated for breast cancer is considered investigational.
Operative management of primary and secondary lymphedema is typically reserved for localized primary malformations, failed medical management, or recurrent cellulitis in affected extremities. There is no consensus regarding the role of surgery, the optimal surgical approach, or the timing of an operative procedure for extremity lymphedema. Outcome data for reductive/ablative techniques for the treatment of lymphedema are from retrospective reviews, small case series and case reports. Currently there are not randomized trials to determine the optimal reductive procedure to treat lymphedema outside of 1 nonrandomized controlled trial after breast cancer treatment. All available studies had high risk of bias including the following considerations single-center focus, retrospective design, small size, and lack of randomization, blinding, and parallel controls. Although some early results are promising and the changes to quality of life have been documented, surgery is considered investigational and isn’t widely available or considered standard of care. High-quality RCTs are required to further clarify the effectiveness of surgical interventions in the prevention and treatment of lymphedema. Surgery is not curative and the long-term efficacy cannot be proven with the available literature at this time.
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