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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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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Ridner, S.H., et al.

A Prospective Study of L-Dex Values in Breast Cancer Patients Pretreatment and Through 12 Months Postoperatively.

At the time of breast cancer diagnosis, L-Dex values are similar to normative values. Identified maximum changes in L-Dex values 12 months postoperatively suggest that frequent L-Dex measurements during that time frame are of potential clinical benefit. Our findings are consistent with research supporting an L-Dex value of >7 as indicative of clinical lymphedema with subclinical lymphedema logically occurring at somewhat lower likely, near >6.5.

Open access: No
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Accardi, A. et al.

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

Preliminary findings demonstrated excellent correlations with BIS measurements and IVC size, right atrial pressure and pulmonary artery systolic pressure measurements which suggest a possible alternative method to detect fluid overload despite the small sample size. Trending a patient’s impedance using the SOZO device at home or the practitioner’s office may assist clinicians in providing more accurate, individualized HF care.

Open access: Yes
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Accardi, A. et al.

Utilization of bioimpedance spectroscopy in lieu of invasive monitoring for monitoring fluid overload.

The total body impedance measured from the SOZO unit correlated with PAD with a correlation coefficient of 0.876. The findings from this case suggest that BIS may provide an additional noninvasive tool to detect extracellular fluid excess and impending congestion before hospitalization. BIS correlates well with diastolic PA pressures and may prove a useful adjunct in the management of HF. Further research is needed in a larger more diverse group of patients to assess the role BIS plays in the management of HF.

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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