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Lymphedema

Groundbreaking new data from the NIH: Pre-operative clinical assessment can lead to earlier detection, and treating it promptly could lead to preventing progression.

Recognizing lymphedema early and treating it promptly is the best way to manage the condition. Without appropriate and timely treatment, lymphedema can lead to pain, recurrent infection, reduced mobility and impaired function1.

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Lymphedema: the Condition

Characterized by excess protein and edema in the tissues, lymphedema can be the result of radiation therapy or surgery and may occur in one or both arms or legs. "Studies show from 20% to 45% of patients who are at risk for lymphedema will eventually develop it." Wall Street Journal 20042.

Lymphedema may be extremely debilitating and although it cannot be cured, treatments often involving exercise, compression bandaging and massage can arrest the condition. Early detection and therefore early treatment are critical to providing the best patient outcome.

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Objective and Standardized Results: A Better Way

Until recently, techniques involving measuring limbs with a tape measure or immersing limbs in water have been favored for the diagnosis of lymphedema. These techniques, in addition to being cumbersome and time consuming, are diagnostically unreliable 3.

An individual's arms may naturally differ in size simply due to handedness. Consequently bioimpedance, which measures the subclinical changes in extracellular fluid (ECF), is a significantly superior method with respect to simplicity, accuracy and reproducibility. Figure 1 shows a lack of overlap between the affected and unaffected patient groups in the study obtained when using BIS. In contrast, the volumetric approach, which has a low inter-operator reliability, shows an overlap between the patient groups.

ImpediMed's application of bioimpedance to the clinical management of lymphedema gives the clinician objective and standardized information to aid their clinical assessment of a patient at risk of lymphedema.

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Groundbreaking New Data from the National Institutes of Health Demonstrates that Early Diagnosis and
Treatment are Effective in Controlling Lymphedema

Breast Cancer Pelvic Cancer
In Spite of Advances, Lymphedema Remains a Significant Problem Even With the Adoption of More Conservative Breast Treatment
Early detection has always been a key goal in successfully treating cancer. Improved surgical techniques and targeted therapies have also extended 5 year survival rates. Yet even with such new techniques as sentinel lymph node biopsy, incidence rates of lymphedema in 4-17% are cited in the literature for breast cancer patients5,6,7,8,9,10,11.

Today, most lymphedema is not diagnosed until it is visually apparent. By this point, fibrotic changes and lipid deposition caused by protein rich extracellular fluid stasis have already begun. Following the medical model, emerging new solutions now demonstrate that early assessment, diagnosis and intervention prevents progression and helps protect your patient’s quality of life.

NIH study confirms pre-operative clinical assessment and ongoing surveillance, can lead to early detection and early intervention, to successfully treat lymphedema.

Note: this study used a standardized volumetric measurement and not a bioimpedance device for assessment.

Mean Affected
Gergich N, Pfalzer L, Soballe P, Washington F. and McGarvey C: “Preoperative Assessment Improves early Diagnosis and Treatment of Lymphedema” Poster , Society of Surgical Oncology, Washington DC, 15-18 Mar 2007.[Poster] http://www.wcpt.org/abstracts2007/Abstracts/29-05.htm
New data from a five year, prospective NIH study demonstrate that it is possible to prevent the progression of lymphedema in patients at risk.13 This research supports the findings of lymphedema researchers around the globe.14,15,16 In addition, there is a growing international consensus among professional organizations in support of the prospective (pre-surgical) assessment of newly diagnosed cancer patients to identify and manage those patients at high risk for lymphedema.

Pre-surgical baselines establish what is “normal’ for your patient in terms of fluid levels in their arms. Periodic post-operative clinical assessment can detect significant changes from pre-surgical levels. An off-the-shelf compression garment has been demonstrated to be an effective intervention. In the NIH study, all women diagnosed with subclinical lymphedema returned to their pre-surgical baseline arm volume after an average of 4.4 weeks.12,13 None (0%) progressed to a Stage 2 or Stage 3 lymphedema.

Early Stage to Late Stage


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A New Paradigm for Aiding Medical Professionals in the Clinical Assessment and Management of Lymphedema

 




Everyone’s A Winner!
Physicians may now potentially reduce the severity of lymphedema and its physiological and psychological impact.

Patients can now potentially return to the quality of life they enjoyed prior to their breast cancer treatment knowing that their physician can clinically assess and treat the early signs of lymphedema.

Health providers potentially benefit from reduced costs and a preventative approach to an otherwise chronic, life-long condition with associated medical risks. Quality of life can be protected in these women.






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A Non-invasive, Fluid-specific Break Through:
The Lymphedema Index (L-Dex®)

ImpediMed's L-Dex® technology utilizes the characteristics of frequency dependent current flow to quantify changes in extra-cellular fluid in the patient's limb. These changes can assist the surgeon and oncologist in clinically assessing patients for the early signs of lymphedema. L-Dex technology is specific for extra-cellular fluid. As fluid accumulates, L-Dex values increase on this scale. The device provides an immediate result and is provided with software for tracking changes in patient's L-Dex values over time.

For more information, please visit www.L-Dex.com.

 

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Theory Behind Bioimpedance: The Science

Bioimpedance Analysis (BIA) was first used over 30 years ago to measure the total water content of the body. More recently, however, BIA has been applied to the quantification of unilateral lymphedema 22,23,24. BIA involves passing an extremely small electrical current through the body and measuring the opposition to the flow of this current (defined as impedance). At low frequencies, current passes through the ECF space and does not penetrate the cell membrane, characterized by the theoretical resistance at zero frequency (R0). At high frequencies, however, the current passes through both the intracellular fluid (ICF) and ECF (Figure 1: Biological Current Flow).

Based on this concept, together with the fact that the impedance of a geometrical system is related to conductor length, cross sectional area and signal frequency, a value of impedance can be calculated from a current passed through the body. The measured impedance is inversely proportional to the amount of fluid. By appropriate choice of signal frequency, this can be made specific for ECF or for total fluid determination.

The ImpediMed L-Dex® U400 is specifically designed for segmental bioelectrical impedance analysis to measure the ECF of the arms in which a small alternating current of 200uA RMS at a frequency of approximately 4kHz to 1000kHz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes is used to calculate the impedance value.

Bioelectrical impedance basics, simple mathematics, bioelectrical and anthropometric parameters from peer-reviewed published journal articles are used to convert measured impedance to a corresponding estimate of the extracellular fluid ratio (lymphedema index - referred to as L-Dex), and differences between the arms. These estimates can be used as alternatives to the current circumferential measurements and water immersion methods, to indicate trends toward the potential development of lymphedema.

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References
  1. Casely-Smith JR, and Casely Smith JR (1989) Physical therapy for lymphedema. Med. J. Aust. 15:542-3.
  2. Parker-Pope, T. (2004), Efforts mount to combat lymphedema, Wall Street Journal, 1 June.
  3. Ward LC, et al. (1992) Multi-frequency bioelectrical impedance augments the diagnosis and management of lymphedema in post-mastectomy patients. Eur. J. Clin. Invest. 22:751-4.
  4. Warren A, Brorson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery • Volume 59, Number 4, 2007
  5. Francis WP , Abghari P , Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg 2006;192(5):636-9. Available from http://www.ncbi.
  6. Armer J, Fu MR, Wainstock JM, Zagar E, Jacobs LK. Lymphedema following breast cancer treatment, including sentinel lymph node biopsy. Lymphology 2004;37(2):73-91. Available from PM:15328760
  7. Leidenius M, Leivonen M, Vironen J, von Smitten K. The consequences of long-time arm morbidity in node-negative breast cancer patients with sentinel node biopsy or axillary clearance. J.Surg.Oncol. 2005;92(1):23-31. Available from PM:16180231
  8. Langer I, Guller U, Berclaz G, Koechli OR, Schaer G, Fehr MK, et al. Morbidity of sentinel lymph node biopsy (SLN) alone versus SLN and completion axillary lymph node dissection after breast cancer surgery: a prospective Swiss multicenter study on 659 patients. Ann Surg 2007;245(3):452- 61. Available from http://www.ncbi..nlm.nih.gov/entrez/query.fcgi?cmd= Retrieve&db=PubMed& dopt=Citation&list_uids=17435553
  9. Clark B, Sitzia J, Harlow W. Incidence and risk of arm oedema following treatment for breast cancer: a three-year follow-up study. QJM. 2005;98(5):343-48. Available from PM:15820971
  10. Umberto Veronesi, M.D., Giovanni Paganelli, M.D., Giuseppe Viale, F.R.C.Path., Alberto Luini, M.D., Stefano Zurrida, M.D., Viviana Galimberti, M.D., Mattia Intra, M.D., Paolo Veronesi, M.D., Chris Robertson, Ph.D., Patrick Maisonneuve, Eng., Giuseppe Renne, M.D., Concetta De Cicco, M.D., Francesca De Lucia, M.D. and Roberto Gennari, M.D.: A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer . N Engl J Med Volume 349;6:546-553 August 7, 2003
  11. Haid et al: Morbidity of Breast Cancer Patients Following Complete Axillary Dissection or Sentinel Node Biopsy Only: A Comparative Evaluation. Breast Cancer Research and Treatment Volume 73, Number 1 / May, 2002
  12. Gergich N, Pfalzer L, Soballe P , Washington F. and McGarvey C: Early Diagnosis and Treatment Intervention for Lymphedema. World Confederation of Physical Therapy: Vancouver , British Columbia. June 2007. [poster]
  13. Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol 2005;3(4):208-17. Available from http://www.ncbi..nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list _uids=16379589
  14. Box R, Reul-Hirche H, Bullock-Saxton J, and Furnival C: Physiotherapy after breast cancer surgery: results of a randomized study to minimise lymphoedema. Breast Cancer Research and Treatment 75: 51-64, 2002
  15. Johansson K, Ohlsson K, Ingvar C, Albertsson M, Ekdahl C. Factors associated with the development of arm lymphedema following breast cancer treatment: a match pair case-control study. Lymphology 2002;35(2):59-71. Available from PM:12081053
  16. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology 2003;36(2):84-91.
  17. Harris, Susan R., Hugi, Maria R., Olivotto, Ivo A., Levine, Mark Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema CMAJ 2001 164: 191-199
  18. Werngren-Elgstrom M, Lidman D. Lymphedema of the lower extremities after surgery and radiotherapy for cancer of the cervix. Scand J Plast Reconstr Surg Hand Surg 1994;28:289-93.
  19. Nunns D, Williamson K, Swaney L, et al. The morbidity of surgery and adjuvant radiotherapy in the management of endometrial carcinoma. Int J Gynecol Cancer 2000;10:233-8.
  20. Fujiwara K, Kigawa J, Hasegawa K, et al. Effect of simple omentoplasty and omentopexy in the prevention of complications after pelvic lymphadenectomy. Int J Gynecol Cancer 2003;13:61-6.
  21. Carlson J, Kauderer J, Walker J, Gold M, O’Malley D, Tuller E, Clarke-Pearson D. Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. The 38th Annual Meeting on Women’s Cancer . March 3-7, 2007. San Diego, CA. Abstract #228.
  22. Cornish BH, et al. (2001) Early diagnosis of lymphedema using multiple frequency Bioimpedance. Lymphology. 34:2-11.
  23. Cornish BH, et al. (1996) Bioelectrical impedance for monitoring the efficacy of lymphedema treatment programmes. Breast Cancer Res. Treat. 38:169-76.
  24. Cornish BH, et al. (2000) Early diagnosis of lymphedema in post surgery breast cancer patients. Ann. NY Acad. Sci. 904:571-5.


* Note: L-Dex®values that lie outside the normal range may indicate the early signs of lymphedema and values that have changed +10 L-Dex units from baseline may also indicate early lymphedema. The L-Dex scale is a tool to assist in the clinical assessment of lymphedema by a medical provider. The L-Dex scale is not intended to diagnose or predict lymphedema of an extremity.

 

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