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.

Contact Us
All
Heart failure
Guidelines
Lymphedema prevention
L-Dex detection limit
Validation studies
Economics quality of life
Filter

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
View
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
View
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
View
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
View
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
View
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
View
ONS Guidelines™

ONS Guidelines for Cancer Treatment-Related Lymphedema

Early diagnosis and treatment of lymphedema may mitigate symptoms.

Open access: Yes
View
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
View
Academy of Oncologic Physical Therapy of APTA

Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guidelines From the Academy of Oncologic Physical Therapy of APTA

From the American Physical Therapy Association, recent guidelines include a prospective surveillance model and early, preventative intervention for patients at risk of cancer-related lymphedema.

Open access: Yes
View
Lymphatic Education & Research Network

Centers of Excellence Program Description and Application

Bioimpedance spectroscopy as a tool for serial measurement and risk assessment

Open access: Yes
View
Coroneos, C.J., et al.

Correlation of L-Dex Bioimpedance Spectroscopy with Limb Volume and Lymphatic Function in Lymphedema

The L-Dex ratio correlated with limb volume and clinical assessment of pitting edema, and physiologic measures of lymphatic function, and demonstrated face, construct, and criterion validity in response to intervention. These findings support the adjunctive use of the L-Dex ratio with limb volume measurements for objective diagnosis, evaluation of lymphedema severity, longitudinal serial evaluation of lymphedema, and response to conservative and surgical interventions.

Open access: No
View
Ridner, S.H., et al.

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

The results of this interim analysis demonstrate that patients undergoing surveillance with BIS had reduced but non-statistically significant reductions in the rates of progression requiring CDP compared with TM. These results are currently supportive of the need for subclinical detection and early intervention for patients with BCRL, with a 10% absolute reduction and 67% relative reduction in the rates of CDP. Further data with a longer follow-up than in this study is expected in the years to come and will strengthen these early, positive, practice-changing results.

Open access: Yes
View
SOZO logo on tablet

SOZO®

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.

Discover SOZO