Clinical Evidence

ImpediMed’s bioimpedance spectroscopy (BIS) devices have been studied and clinically validated in the areas of lymphedema, heart failure, body composition and veterinary BIS research.

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Final 3-Year Primary Endpoint Results Published

Heart failure
Lymphedema prevention
L-Dex detection limit
Validation studies
Economics quality of life

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

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

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
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

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

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
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

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

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
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

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

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

Open access: Yes
Anne Daleiden-Burns, ACNP, Andrew Accardi, MD, J. Thomas Heywood, MD, FACC

Time-to-Decongestion Following Heart Failure Hospitalization as Measured by Extracellular Fluid Nadir Using Bioimpedance Spectroscopy

The time required to achieve clinical decongestion is highly variable and often takes longer than may be anticipated; in our study it took an average of 16.9 days. Our results show that ECF is more sensitive than weight when tracking post-discharge decongestion. Noninvasive BIS measurements may assist clinicians with tracking fluid status in HF patients. ECF monitoring during the weeks following heart failure hospitalization may provide a more accurate measure of fluid status than weight alone.

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

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

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
National Comprehensive Cancer Network

NCCN Clinical Practice Guidelines in Oncology for Breast Cancer and Survivorship

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

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

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

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

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

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
ONS Guidelines™

ONS Guidelines for Cancer Treatment-Related Lymphedema

Early diagnosis and treatment of lymphedema may mitigate symptoms.

Open access: Yes
Sheila H. Ridner, Chirag Shah, John Boyages, Louise Koelmeyer, Nicolas Ajkay, Sarah M. DeSnyder, Sarah A. McLaughlin, Mary S. Dietrich

L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery

These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.

Open access: Yes
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SOZO, the world’s most advanced, noninvasive BIS device, incorporates L-Dex technology to aid in the assessment of secondary lymphedema and delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds.

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