A New Paradigm of Lymphedema Management
Click here to see the NLN Position Paper regarding the diagnosis and treatment of lymphedema
• Physicians can now treat women earlier to help reduce the severity of lymphedema and its physiological and
• psychological impact.
• Patients may return to the quality of life they enjoyed prior to their breast cancer treatment
• knowing that their physician can clinically assess and treat the lymphedema in all stages of their care.
• Health insurance providers may benefit from reduced costs associated with preventative care
• for an otherwise chronic, life-long condition with associated medical risks.
*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.
Lymphedema background incidence rates
Lymphedema is a common morbidity following primary treatment for breast cancer. This impairment
is typically not diagnosed until visual swelling of the arm is present. By the time the clinical diagnosis
is established, usually at Stage II, fibrotic changes and lipid deposition caused by stasis of protein
rich extracellular fluid has occurred resulting in an advanced and difficult to manage condition.2
Incidence rates vary depending on type of primary medical intervention and method/timing of
extremity measurement. Secondary lymphedema has been estimated to occur in a range of 8–56%
at 2 years post surgery.3 While recent surgical advances such as sentinel lymph node biopsy have
decreased incidence rates to 4–17%4–6 (See Figure 1), nearly 36% of these procedures go on to
axillary lymph node dissection due to positive nodes.4 Risk factors such as number of nodes
removed and BMI may be helpful but are not sufficiently predictive. Of those diagnosed with
lymphedema, 80% of patients experience onset within 3 years of surgery and the remainder
develop lymphedema at the rate of 1% a year.7
Early Intervention — The NIH Model
Compelling clinical evidence of the importance of prospective assessment of patients at risk for lymphedema was recently demonstrated in a 5 year clinical trial sponsored by the National
Institutes of Health (NIH) and published in the journal CANCER (Stout-Gergich, 2008).1Early treatment resulted in optimal outcomes. An off-the-shelf compression garment proved to be an effective intervention. In the study, all women diagnosed with lymphedema returned to their pre-surgical baseline arm volume after an average of 4.4 weeks of treatment. (See Figure Left)
This research supports the findings of lymphedema researchers around the globe.12–15 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 risk for lymphedema.15–19Although an optoelectronic infrared device was used in this trial, subsequent studies have demonstrated high correlation between this method andBIS.20 Additionally, BIS has been independently validated in the peer-reviewed literature and shown capable of assisting physicians in the clinical assessment of lymphedema in women.8 Pre-surgical baselines establish the patient’s baseline L-Dex value allowing for comparison to post-operative measurements to measure changes in extracellular fluid levels to aid a clinician to assess lymphedema in women.
Bioimpedance spectroscopy (BIS) provides sensitive and objective measurement of changes in extracellular fluid indicative of early physiological signs of lymphedema.8 BIS is a direct measure of electrical resistance through extracellular fluid and provides patient specific values which are compared between limbs and over time. L-Dex values represent the ratio of impedance in the normal limb compared to that of the at-risk limb.
Recently BIS has been proposed as the new gold standard for measuring extracellular fluid changes lymphedema based on its specificity, accuracy, precision, repeatability both within and between testing centers, limits of detection, sensitivity, practicability and applicability under normal conditions of use.9 L-Dex devices are cleared for aiding in the clinical assessment of extracellular fluid volume differences between arms and legs in women and legs in men.
Physicians typically establish a clinical diagnosis of lymphedema after visible changes in girth and volume of the patient’s limbs are apparent and as confirmed by a 2 centimeter circumferential girth measurement difference using a tape measure.10–11 While the tape measure provides a gross and indirect measure of total limb volume change, there are issues related to measurement time, reproducibility, accuracy and standardization that negatively impact on the use and quality of the measure.
These limitations make it difficult for health insurance providers to have confidence in the efficacy of the services for which they are reimbursing. BIS allows providers the ability to identify extracellular fluid differences well in advance of current methods used to aid in the clinical assessment of unilateral arm and leg lymphedema in women and leg lymphedema in men. (See Figure 2)
The diagnosis of lymphedema often requires referral for specialized and protracted treatment by physical therapists including complex decongestive therapy (CDT), compression bandages, custom fitted sleeves and in some cases, procurement of expensive pneumatic compression devices or pumps.21
The cost of these interventions is significant to patient and payer (government and third party). A recent study published in the Journal of Clinical Oncology of 1,877 breast cancer patients by Shih, et al (2009)22 identified a $14,877 to $23,167 increased overall cost of medical treatment for those patients with a documented history of lymphedema compared to those without lymphedema over a two year period. (See Figure Left) The study employed an economic analysis method based on medical claims reviewed. Further, as there is no current “cure” for chronic lymphedema, intensive care and associated cost must be maintained for the remainder of the survivor’s life. For this reason, early treatment appears to be highly desirable compared to current methods of caring for these patients