Clinical evidence | ImpediMed - Part 3

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.

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

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
eviCore healthcare

Clinical Guidelines – Physical and Occupational Therapy Services

Bioimpedance listed under Validated Clinical tools for Diagnosing Lymphedema

Open access: Yes
Accardi, A. et al.

Correlation of Limb Bioimpedance to Echocardiographic Indicators of Congestion in Patients with NYHA Class II/III Heart Failure.

The management of the chronic HF patient continues to challenge the primary care provider. Most HF patients are managed by body weight, physical examination findings, and intermittent diagnostics like echocardiography. These traditional methods of evaluation often fail to aid the practitioner in detecting fluid overload and impending decompensation. Staggering healthcare costs and financial penalties associated with 30-day readmission served as the impetus for this study. The use of SOZO is predicated on a correlation between impedance measurements and established measures of fluid. Despite the small study size, correlations of the SOZO device impedance measurements with IVC, RAP, and PAS suggest a possible alternative method to detect fluid overload. The results suggest that there is a relationship that could be used at low cost, is noninvasive, and easy to use. However, due to limitations to the study design, further research is needed to determine the utility of the SOZO device.

Open access: Yes
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
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
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
SOZO logo on tablet


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