THE PREVENT TRIAL
Stopping Lymphedema Starts with PREVENT - Final 3-Year Primary Endpoint Results Published

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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THE PREVENT TRIAL
STOPPING LYMPHEDEMA STARTS WITH PREVENT

Final 3-Year Primary Endpoint Results Published

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

ONS Guidelines for Cancer Treatment-Related Lymphedema

Early diagnosis and treatment of lymphedema may mitigate symptoms.

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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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
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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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eviCore healthcare

Clinical Guidelines – Physical and Occupational Therapy Services

Bioimpedance listed under Validated Clinical tools for Diagnosing Lymphedema

Open access: Yes
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Koelmeyer, L.A., et al.

Early surveillance is associated with less incidence and severity of breast cancer-related lymphedema compared with a traditional referral model of care.

Scholars and guidelines have advocated for the routine implementation of early lymphedema surveillance and intervention after breast cancer treatment. Regular clinic visits to monitor extracellular fluid present an opportunity for therapists to provide risk management education, psychological support, physical rehabilitation, empowerment, and survivorship care. The findings from the current study support the use of BIS as part of an early prospective surveillance model of care that results in significantly earlier detection of lymphedema over time. Furthermore, the earlier detection of lymphedema will lead to lower health care costs if it results in the effective management of symptoms and prevents progression to severe clinical lymphedema.

Open access: Yes
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New England Journal of Medicine - Clincial Practice Vignette

Lymphedema after Breast Cancer Treatment Stanley G. Rockson, M.D.

This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the author’s clinical recommendations.

I would recommend a surveillance program that includes quarterly assessment of bioimpedance during this first year after treatment, which is when the majority of cases appear. There should also be prompt use of compression garments and, as necessary, use of decongestive physiotherapy for symptoms or for worrisome changes in bioimpedance.

Open access: No
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National Lymphedema Network

NLN Position Paper – Screening and Measurement for Early Detection of Breast Cancer-Related Lymphedema

Bioelectrical spectroscopy (BIS) or infrared perometry are suggested as alternative or adjunct methods to circumferential measurement. Specific protocols describing standard positions and measurements for these procedures should be in place.

BIS reading outside normal limits for equipment being used (e.g., L-Dex reading >10) warrant immediate referral for further evaluation by a professional trained in lymphedema assessment and management.

Open access: Yes
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National Lymphedema Network

NLN Position Paper – Diagnosis and Treatment of Lymphedema

BIS has been shown to provide reliable data to be used in the diagnosis of breast cancer-related lymphedema. BIS can detect early changes associated with lymphedema.

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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