Breast cancer-related lymphedema (BCRL) is a chronic, debilitating disorder that is frequently misdiagnosed, treated too late or not treated at all. Being able to quantitively follow it or predict its onset or severity would be clinically useful. Bioimpedance is one method of obtaining scores that may prove predictive with followup and over time.

 The L-Dex XCA is a bioimpedance analyzer designed to assist in the clinical assessment of unilateral lymphedema of the arm. The L-Dex XCA utilizes a simple linear scale called the L-Dex (lymphedema index). The L-Dex ranges from -10 to +10 and defines the normal range of L-Dex values for a patient without lymphedema. The presence or absence of lymphedema is assessed by comparing the patient’s L-Dex to this range.

ImpediMed LDex™ U400 (ImpediMed Limited, San Diego, CA) was approved for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process in 2008. Thus, the manufacturer was not required to provide the evidence of clinical efficacy that is necessary to support a premarket approval (PMA). According to the FDA clearance letter, the device is “to aid in the clinical assessment of unilateral lymphedema of the arm in women.”  The FDA labeling states that the device is “not intended to diagnose or predict lymphedema of an extremity.” One grequnetly quoted study to support L-DEX is Stout Gergich et al (2008) is a report of a case-control study but ti used a different technology, perometry, in the diagnosis and management of subclinical lymphedema in patients with early-stage breast cancer. The article states that “further research is needed” to validate bioimpedance in the context of a surveillance tool.

There are no unequivocally supportive guidelines.

The National Lymphedema Network position statement, Screening and Measurement for Early Detection of Breast Cancer Related Lymphedema, updated April 2011, states that circumferential tape measurements are acceptable means of measuring limb volume. The current position statement states “bioelectrical spectroscopy (BIS) or infrared perometry are suggested as alternative or adjunctive methods to circumferential measurement.”

A technology assessment of the diagnosis and management of secondary lymphedema prepared for the Agency for Healthcare Research and Quality (Oremus et al, 2010) concluded: “There is consistent evidence to indicate that lymphedema can be reliably measured using circumferential measures or volume displacement … There is too little evidence to draw conclusions about the reliability of other tests such as tonometry, ultrasound, lymphoscintigraphy, or bioimpedance.”

The Northern Ireland CREST Committee guidelines for lymphedema (2008) recommend circumferential limb volume measurement for assessing limb volume. Bioimpedance measurement is described as promising, noting that it should be considered over the next 5 years. Presumably, an updates statemetns will soon be issued.

The National Cancer Institute Physician Data Query (PDQ) on lymphedema (NCI, 2011) states that circumferential upper-extremity measurement is the most widely used method to diagnose upper-extremity lymphedema. Bioimpedance is listed among several other options for evaluating limb volume. The PDQ also stated that a study comparing various methods of assessing upper-limb lymphedema did not show any superiority of any one method; for support, the PDQ cited a study by Ridner, et al. (2007) comparing circumferential limb measurements to bioimpedance and perometry.

On the balance, there is some support in guideliens for the concept of testing for the risk of lymphedema over time, but specifically bioimpedance appears not to be well supported.

 International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2009 consensus document of the International Society of Lymphology. Lymphology. 2009;42:51-60. Available at: http://www.solarismed.com/rr/journal.pdf. Accessed on May 5, 2010.

Oremus M, Walker K, Dayes I, Raina P. Diagnosis and treatment of secondary lymphedema. Draft Technology Assessment. Prepared for the Agency for Healthcare Research and Quality (AHRQ) by the McMaster University Evidence-based Practice Center. Rockville, MD: AHRQ; October 19, 2009. Available at: http://www.cms.gov/determinationprocess/downloads/id66aTA.pdf. .

U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). ImediMed L-Dex U400 and optional Lymphedema Analysis PC Software. 510(k) No. K080825. Rockville, MD: FDA; October 3, 2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080825.pdf.

Ward LC, Czerniec S, Kilbreath SL. Quantitative bioimpedance spectroscopy for the assessment of lymphoedema. Breast Cancer Res Treat. 2009;117(3):541-547.

Ward LC, Czerniec S, Kilbreath SL. Operational equivalence of bioimpedance indices and perometry for the assessment of unilateral arm lymphedema. Lymphat Res Biol. 2009;7(2):81-85.

Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: A systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-859.

Canadian Agency for Drugs and Technologies in Health (CADTH), Health Technology Inquiry Service. Manual lymph drainage or intermittent pneumatic compression for adult patients with secondary lymphedema: Clinical effectiveness. Health Technology Assessment. Ottawa, ON: CADTH; April 8, 2010.

Cormier JN, Askew RL, Mungovan KS, et al. Lymphedema beyond breast cancer: A systematic review and meta-analysis of cancer-related secondary lymphedema. Cancer. 2010 Jul 27.

For Lay version see here

The ReidSleeve® (Peninsula Medical, Inc., Scotts Valley, CA) is a custom-fitted, non-elastic sleeve that provides compression to assist in flow of lymphatic fluid. According to the manufacturer’s website, the sleeve contains a foam insert and works by applying high and low pressure to different parts of the affected area. The high-pressure zones force excess fluid into the areas under lower pressure, forming channels by which the lymphatic fluid can be removed through the lymphatic and venous system. The Contour® and Optiflow® sleeves are made by the same manufacturer as the ReidSleeve and use the same technology but are lighter sleeves that are intended for patients with mild to moderate lymphedema. ArmAssist® and LegAssist® (MedAssist Group, Tampa, FL) are other custom-fabricated, non-elastic compression sleeves. CircAid® (CircAid Medical Products Inc., San Diego, CA) is a non-elastic compression sleeve that is available prefabricated and custom-fitted. THe FDA approval was based on the original study that demonstrated that edema in the hands of affected patients was reduced by an average of 80%. U.S. Food and Drug Administration (FDA): The FDA has classified compression sleeves as Class I devices, therapeutic medical binders. They are exempt from the premarket notification procedure. Such devices meet a much lower burden of proof to be considered medically necessary.

Brennan MJ, Miller LT. Overview of treatment options and review of the current role and use of compression garments, intermittent pumps, and exercise in the management of lymphedema. Cancer 1998; 83:2821.

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]

Read the Layperson version here.

Cervantes, C., and Orphey, S. Pneumatic Compression for Venous Stasis Ulcers and the Implications of Lymphedema on Delayed Wound Healing. Today’s Wound Clinic, November 2010. However, this coverage decision is not specific to Pneumatic Pumps and is not binding on other entities and many insurers are not covering this service, insisting on manual massage, or on leasing rather than purchasing a pump.

Adams, K., Rasmussen J., et al. Direct evidence of lymphatic function improvement after advanced pneumatic compression device treatment of lymphedema, 2 August 2010/Vol. 1, No.1/Biomedical Optics Express.

Oremus M, Dayes I, et al. Diagnosis and treatment of secondary lymphedema.McMasterUniversityEvidence-basedPracticeCenterunder contract to the Agency for Healthcare Research and Quality Technology Assessment, Blue Cross of Idaho MP 1.01.18 Pneumatic Compression Pumps for Treatment of Lymphedema, 2009

CMS, Decision Memo for Pneumatic Compression Pumps for Venous Insufficiency (CAG-00075N)

Read the Layperson version here.