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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Heart failure
Guidelines
Lymphedema prevention
L-Dex detection limit
Validation studies
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Andrew J. Accardi, MD, James Thomas Heywood, MD, FACC, Anne Daleiden-Burns, ACNP

Bioimpedance Spectroscopy: a Predictor of Compensated Versus Decompensated Heart Failure in the Emergency Room

ECF%TBW has been shown to be a marker of fluid overload in patients presenting with dyspnea. Median ECF%TBW for decompensated, compensated, and control were 52.1%, 49.0%, and 44.8%, respectively. Statistically significant ECF%TBW differences were shown. This bedside BIS device provides instantly useful quantitative fluid status data at the point-of-care. When coupled with physical exam and traditional markers, BIS may provide additional value to assist in ER evaluation and triage, as well as other settings in which fluid status is monitored.

Open access: YES
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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
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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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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
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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
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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
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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.

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