BREAST CANCER AWARENESS MONTH
Early detection matters. Revolutionize your lymphedema care.

Clinical Evidence

Extensive clinical evidence shows that using ImpediMed’s bioimpedance spectroscopy (BIS) technology for early detection and intervention reduces the impact of chronic lymphedema on breast cancer patients.

It is Well Established that Breast Cancer Related Lymphedema (BCRL) can be Resolved with Early Detection and Intervention

Opportunity for Prevention is Before Noticeable Swelling Occurs

Lymphedema develops in stages, and a university of Kansas study found that when lymphedema is detected at stage 0 or stage 1 it is reversible, but in stages 2 and 3 it is not. These findings demonstrate how early conservative intervention and prospective monitoring with BIS can significantly lower rates of BCRL and persistent BCRL (pBCRL).¹

It is Well Established that Breast Cancer Related Lymphedema (BCRL) can be Resolved with Early Detection and Intervention

ImpediMed’s BIS Technology is Most Effective Method for Early Lymphedema Detection

The PREVENT Trial involved 10 centers across the US and Australia and was the largest randomized controlled trial (RCT) to assess lymphedema prevention in breast cancer patients.

Learn More About PREVENT

Triggers and Interventions

ImpediMed’s BIS technology is more precise and reliable than tape measure in detecting lymphedema (LE), as there are statistically significantly fewer triggers and interventions for those assessed with BIS compared to tape measure (p=0.011)2.

Progression to Chronic Lymphedema

Additionally, with early detection using BIS technology and intervention there is significantly lower progression to chronic lymphedema compared to using tape measure (p=0.016), which is the primary endpoint result2.

RESOURCES

Review the Strong Literature Included in our Clinical Evidence Summaries for Lymphedema Prevention Program.

RESOURCES

Read More About L-Dex in our Clinical Evidence Summaries.

RESOURCES

Discover PREVENT, the Largest Randomized Trial to Assess Lymphedema Prevention!

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Guidelines
Lymphedema prevention
L-Dex detection limit
Validation studies
Economics quality of life
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LYMPHEDEMA PREVENTION

Bioimpedance spectroscopy for breast cancer‑related lymphedema assessment: clinical practice guidelines

Chirag Shah, Pat Whitworth, Stephanie Valente, Graham S. Schwarz, Megan Kruse, Manpreet Kohli, Kirstyn Brownson, Laura Lawson, Beth Dupree & Frank A. Vicini

These clinical practice guidelines present clinicians with a standardized evidence-based approach to BCRL surveillance to detect subclinical BCRL, allowing for early intervention and low rates of chronic BCRL.

Open access: Yes
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LYMPHEDEMA PREVENTION

The prevention and treatment of breast cancer- related lymphedema: A review

Maureen P. McEvoy, Ameer Gomberawalla, Mark Smith, Francesco M. Boccardo, Dennis Holmes, Risal Djohan, Paul Thiruchelvam, Suzanne Klimberg, Jill Dietz and Sheldon Feldman

American Society of Breast Surgeons (ASBrS) Lymphatic Surgery Working Group Agrees: Evidence Supports Programs for Early Detection and Intervention to Prevent Chronic Lymphedema.

Open access: Yes
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LYMPHEDEMA PREVENTION

Bioimpedance Spectroscopy Monitoring Reduces Long-term Clinical Lymphedema Risk

Boyages J, Vicini F, Shah C. Icon Cancer Care; GenesisCare; Cleveland Clinic

The Kaplan–Meier analysis shows that patients with early detection using L-Dex and intervention have statistically significant higher rates of lymphedema progression free survival through three years compared to using tape measure. This reinforces the importance of monitoring patients for three years, since progression to chronic lymphedema occurred throughout the three-year follow up period.

Open access: Yes
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LYMPHEDEMA PREVENTION

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes

Mary S. Dietrich, Katrina Gaitatzis, Louise Koelmeyer, John Boyages, Vandana G. Abramson, Sarah A. McLaughlin, Nicholas Ngui, Elisabeth Elder, James French, Jeremy Hsu, T. Michael Hughes, Deonni P. Stolldorf, Chirag Shah, and Sheila H. Ridner

Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored.

Open access: Yes
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LYMPHEDEMA PREVENTION

Risk Factors for Breast Cancer-Related Lymphedema in Patients Undergoing 3 Years of Prospective Surveillance with Intervention

Louise A. Koelmeyer PhD, OT,Katrina Gaitatzis Grad Dip(Psych),Mary S. Dietrich PhD, MS,Chirag S. Shah MD,John Boyages MD, PhD,Sarah A. McLaughlin MD,Bret Taback MD,Deonni P. Stolldorf PhD, RN,Elisabeth Elder MD, PhD,T. Michael Hughes MD,James R. French MD,Nicholas Ngui MD,Jeremy M. Hsu MD,Andrew Moore MD,Sheila H. Ridner PhD, RN

The results confirm known BCRL risk factors such as axillary lymph node dissection, taxane-based chemotherapy, regional nodal irradiation, and obesity and provides novel data on the increased risk of BCRL in patients living in a rural areas as well as no increased risk from air travel.

Open access: Yes
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LYMPHEDEMA PREVENTION

A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Brease Cancer Lymphedema Prevention

Sheila H. Ridner, Mary S. Dietrich, John Boyages, Louise Koelmeyer, Elisabeth Elder, T. Michael Hughes, James French, Nicholas Ngui, Jeremy Hsu, Vandana G. Abramson, Andrew Moore, and Chirag Shah

This study compared rates of progression to chronic breast cancer-related lymphedema (defined as ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM).

Open access: Yes
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GUIDELINES

Considerations for Clinicians in the Diagnosis, Prevention, and Treatment of Breast Cancer-Related Lymphedema: Recommendations from a Multidisciplinary Expert ASBrS Panel

Sarah A. McLaughlin, MD , Alicia C. Staley, MBA, MS, BS , Frank Vicini, MD, FACR, FABS , Paul Thiruchelvam, BSc, MD, PhD, FRCS , Nancy A. Hutchison, MD, CLT-LANA , Jane Mendez, MD , Fiona MacNeill, FRCS, MD, FEBS , Stanley G. Rockson, MD , Sarah M. DeSnyder, MD , Suzanne Klimberg, MD, PhD , Michael Alatriste, LMT, CLT , Francesco Boccardo, MD, PhD, FACS , Mark L. Smith, MD, FACS , and Sheldon M. Feldman, MD, FACS

Part 1: Definitions, Assessments, Education, and Future Directions

Open access: Yes
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GUIDELINES

Is bioimpedance spectroscopy a useful tool for objectively assessing lymphovenous bypass surgical outcomes in breast cancer-related lymphedema?

Sutherland, A., Wagner, J.L., Korentager, S. et al. Breast Cancer Research and Treatment

This is the first study to utilize BIS measurements to assess response to LVB surgical intervention for BCRL. BIS measurements demonstrated clinically significant improvement after LVB, providing objective evidence in support of this surgical treatment for BCRL. BIS changes should be reported as key objective data in future studies assessing BCRL interventions, including response to LVB.

Open access: No
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GUIDELINES

NCCN Clinical Practice Guidelines in Oncology for Breast Cancer and Survivorship

National Comprehensive Cancer Network

The NCCN Guidelines® are consistent with regard to the necessity to educate patients about lymphedema and monitor for the early development of lymphedema.

Open access: Yes
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GUIDELINES

The Risk of Subclinical Breast Cancer–Related Lymphedema by the Extent of Axillary Surgery and Regional Node Irradiation: A Randomized Controlled Trial

John Boyages, MBBS(Hons), FRANCZR PhD, Frank A. Vicini, MD, Chirag Shah, MD, Louise A. Koelmeyer BAppSc, Jerrod A. Nelms PhD, MPH, Sheila H. Ridner, PhD, RN, FAAN

The lower triggering rates with BIS and its better discrimination of the risk of sBCRL by receipt and type of RNI compared with TM support its use for post treatment surveillance to detect sBCRL and to initiate early intervention. The risk of sBCRL increased with more extensive axillary treatment. Patients having ALND or extensive RNI require close surveillance for BCRL. Longer follow-up is required to determine rates of progression to clinical lymphedema.

Open access: YES
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GUIDELINES

The impact of monitoring techniques on progression to chronic breast cancer‑related lymphedema: a meta‑analysis comparing bioimpedance spectroscopy versus circumferential measurements

Chirag Shah, MD, April Zambelli-Weiner, Nicole Delgado, Ashley Sier, Robert Bauserman, Jerrod Nelm

Evidence suggests that monitoring with BIS allowing for early intervention significantly reduces the relative risk of chronic BCRL with a 69% and 81% reduction compared to background and circumference, respectively. Circumference monitoring did not appear to provide a benefit with respect to chronic BCRL incidence. Based on these results, BIS should be considered for BCRL screening in order to detect subclinical BCRL and reduce rates of chronic BCRL, particularly in high-risk patients.

Open access: YES
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VALIDATION STUDIES

Body Positional Effects on Bioimpedance Spectroscopy Measurements for Lymphedema Assessment of the Arm

Louise A. Koelmeyer, Leigh C. Ward, Catherine Dean, John Boyages

The findings support impedance measurements being made reliably using either the lead or stand- on device, representing supine and upright measurement positions, respectively. Data between devices were, however, not directly interchangeable.

Open access: Yes
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References

  1. 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;http://doi.org/10.1245/s10434-018-6601-8.
  2. Ridner SH, et al. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphatic Research and Biology 2022.