Lymphedema

Secondary lymphedema is a leading post-treatment complication for many cancer patients, costing the U.S. healthcare system an estimated $7 billion annually.1 Of the nearly 17 million cancer survivors in the U.S., roughly one in three treated for the cancers below will develop chronic lymphedema.2,3

Lymphedema is a risk for women and men treated with surgery, radiation or Taxane-based chemotherapy for multiple cancer types, including:

  • Breast cancer
  • Colorectal cancer
  • Melanoma
  • Genital cancers
  • Urinary cancers

Characteristics of lymphedema

Lymphedema is characterized by a buildup of lymphatic fluid that causes painful and sometimes debilitating tightness and swelling and can lead to infections and hospitalization. It is rarely diagnosed until it’s symptomatic, when fibrotic changes and lipid deposition caused by protein-rich extracellular fluid stasis have already begun. However, if the condition is diagnosed at Stage 0 (prior to patient symptoms), lymphedema is reversible and treatable with at-home intervention.4

Cancer Related video

Early assessment of lymphedema

Stanley G. Rockson, MD, director of the Stanford Center for Lymphatic and Venous Disorders at Stanford University, discusses early assessment of lymphedema and the clinical utility of BIS.

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L-Dex® for early detection

Previously, cancer survivors were not routinely monitored, but with a new technology called L-Dex, clinicians have a tool that aids in early detection of lymphedema. L-Dex is a measurement of fluid buildup in an at-risk limb compared to a healthy limb. It uses noninvasive bioimpedance spectroscopy (BIS), which is capable of detecting fluid changes as small as 2.4 tablespoons (36ml) and takes less than 30 seconds to complete.

At-risk patients receive a baseline measurement before treatment and then are measured regularly after treatment. An L-Dex increase of 6.5 or more is an indication that lymphedema is developing, and intervention is needed. Recently published interim results from the PREVENT Trial showed that this early detection combined with at-home intervention using standard compression therapy can reduce the progression of lymphedema by 95%.5

Impedimed 3D device

L-Dex clinical practice guidelines

ImpediMed’s proprietary L-Dex technology has been validated as a clinical tool for lymphedema assessment and is recommended in numerous clinical practice guidelines, including:

• eviCore Clinical Guidelines for Physical and Occupational Therapy Service
• National Accreditation Program for Breast Centers (NAPBC)
• National Lymphedema Network
• American Physical Therapy Association
• LE&RN Centers of Excellence

Read more about the L-Dex score

1 in 3

One third of cancer survivors will develop lymphedema.2,3

#1 cause

Secondary lymphedema is most commonly caused by cancer or its treatment.6

95% reduction

Bioimpedance spectroscopy (BIS) has demonstrated up to a 95% reduction in clinical breast cancer-related lymphedema.5

ImpediMed’s proven technology

SOZO®, the world’s most advanced BIS device, combines ImpediMed’s patented BIS and L-Dex technologies to detect as little as 36 ml (2.4 tablespoons) in limb fluid change. SOZO has been proven to detect subclinical lymphedema up to 10 months before a patient experiences symptoms, providing opportunities for early intervention and treatment7.

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95% Lymph prevention

PREVENT 12-month interim results

95% lymphedema prevention

PREVENT trial design:

  • Largest randomized controlled trial focused on lymphedema prevention
  • >1,100-patients
  • 1:1 randomization into tape measure or L-Dex arms
  • 10 centers across US and Australia
  • Enrolled breast cancer survivors at risk for lymphedema
  • L-Dex score change +6.5 from baseline triggered an intervention
  • >10% volume change required referral to complex decongestive physiotherapy (CDP)

12-month interim results:

  • Pre-specified 12-month interim analysis on first 50% of patients enrolled (n=508)
  • 109 (21%) triggered events in line with expected incidence rate within 12 months
    • 68 in tape measure arm
    • 41 in L-Dex arm
  • No evidence of over detection with L-Dex
  • Fewer patients progressed to CDP with L-Dex
    • 10 in tape measure arm
    • 2 in L-Dex arm
Impedimed Chart

Demonstrated real world outcomes

Large and small institutions with follow-up to 26 months

Clinical evidence

ImpediMed’s L-Dex and BIS technologies have demonstrated real-world lymphedema-related outcomes as published in more than 140 peer-reviewed studies on over 17,000 patients.

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References

  1. ImpediMed estimate.
  2. National Cancer Institute website: https://cancercontrol.cancer.gov/ocs/statistics/statistics.html Accessed April 30, 2019.
  3. Shaitelman SF, et al. Recent Progress in the Treatment and Prevention of Cancer-Related Lymphedema. CA Cancer J Clin 2015;65:55-81.
  4. ISL. The diagnosis and treatment of peripheral lymphedema: 2013 consensus document of the International Society of Lymphology. Lymphology. 2013;46(1):1-11. (To be confirmed)
  5. Ridner SH, et al. A randomized trial evaluating bioimpedance spectroscopy versus tape measurement for the prevention of lymphedema following treatment for breast cancer: interim analysis. Ann Surg Oncol 2019; https://doi.org/10.1245/s10434-019-07344-5
  6. Brayton K, et al. Lymphedema prevalence and treatment benefits in cancer: impact of a therapeutic intervention on health outcomes and costs. PLoS One. 2014; 9(12): e114597. Published online 2014 Dec 3. doi: 10.1371/journal.pone.0114597.
  7. Cornish et al, Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology. 2001 Mar;34(1):2-11.
  8. Kaufman DI, et al. Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema. Breast Can Res Treat. 2017;DOI 10.1007/s10549-017-4451-x.
  9. Koelmeyer LA, et al. Early surveillance is associated with less incidence and severity of breast cancer-related lymphedema compared with a traditional referral model of care. Cancer 2018;DOI: 10.1002/cncr.31873.
  10. Whitworth PW and Cooper A. Reducing chronic breast cancer-related lymphedema utilizing a program of prospective surveillance with bioimpedance spectroscopy. Breast J. 2017;1-4.
  11. Laidley A, Anglin B. The impact of L-Dex measurements in assessing breast cancer-related lymphedema as aprt of routine clinical practice. Frontiers in Oncology 2016;6(192).
  12. Kilgore L, at al. Reducing breast cancer-related lymphedema (BCRL) through prospective surveillance monitoring using bioimpedance spectroscopy (BIS) and patient direction self-interventions. Ann Surg Oncol 2018; doi.org/10.1245/s10434-018-6601-8.
  13. Soran A, et al. The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study. Lymph Res Bio. 2014;12(4):289-94.