Bioimpedance devices or bioelectrical impedance spectroscopy devices are a non-invasive technology and have been proposed for use as a tool to diagnose lymphedema. Bioimpedance compares resistance to electrical current in different compartments as tissue impedance decreases with the accumulation of excess interstitial fluid.
Secondary lymphedema may develop following surgery for breast cancer. This condition results from lymphatic dysfunction or disruption and can be difficult to accurately diagnose and manage. One challenge is identifying the presence of clinically significant limb swelling through simple noninvasive methods. Many techniques have been used for documenting lymphedema including measuring differences in limb volume (volume displacement) and limb circumference. A number of newer techniques are being evaluated, including bioimpedance with use of bioimpedance spectroscopy (BIS) analysis (e.g., ImpediMed LDex® U400). BIS is based on the theory that the amount of opposition to flow of electric current (impedance) through the body is inversely proportional to the volume of fluid in the tissue.
Devices using bioimpedance (bioelectrical impedance spectroscopy) for use in the diagnosis, surveillance, or treatment of individuals with lymphedema, including use in subclinical secondary lymphedema, is considered investigational.
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There is a lack of scientific evidence to verify the technical and diagnostic performance of bioimpedance testing in the diagnosis of secondary lymphedema, especially for subclinical disease. There are no data from comparative clinical trials that demonstrate the impact of the test on clinical outcomes.
Agency for Healthcare Research and Quality. Technology Assessment Program. (2010, May). Diagnosis and treatment of secondary lymphedema. Retrieved September 26, 2013 from http://www.cms.gov.
Barrio, A., Eaton, A., & Frazier, T. (2015). A prospective validation study of bioimpedance with volume displacement in early-stage breast cancer patients at risk for lymphedema. Annals of Surgical Oncology, 22 (03), 370-375. (Level 3 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (1:2018). Bioimpedance devices for detection of lymphedema (2.01.82). Retrieved January 18, 2019 from http://www.evidencepositioningsystem.com. (8 articles and/or guidelines reviewed)
Fu, M., Axelrod, D., Guth, A., Cartwright, F, Qiu, Z., Goldberg, J., et. al. (2014) Proactive approach to lymphedema risk reduction: a prospective study. Annals of Surgical Oncology, 21 (11), 3481-3489. (Level 3 evidence)
Smoot, B., Zerzan, S., Krasnoff, J., Wong, J., Cho, M., & Dodd, M. (2014). Upper extremity bioimpedance before and after treadmill testing in women post breast cancer treatment. Breast Cancer Research and Treatment, 148 (2), 445-453. Abstract retrieved May 27, 2015 from PubMed database.
U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080825. Retrieved September 26, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2013, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130338. Retrieved September 27, 2013 from http://www.accessdata.fda.gov.
Vicini, F. A., Arthur, D., Shah, C., Anglin, B. V., Curcio, L. D., Laidley, A. L., et al. (2013). Multi-institutional analysis of bioimpedance spectroscopy in the early detection of breast cancer related lymphedema. Journal of Cancer Research & Therapy, 1 (1), 1-7. (Level 3 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2015, March; last update search March 2018). Bioelectrical impedance (Bioimpedance) analysis for assessment of lymphedema. Retrieved January 18, 2019 from www.Hayesinc.com. (60 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/12/2012
MOST RECENT REVIEW DATE: 3/28/2019
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