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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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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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.

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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Kilgore, L.J., et al.

Reducing Breast Cancer-Related Lymphedema (BCRL) Through Prospective Surveillance Monitoring Using Bioimpedance Spectroscopy (BIS) and Patient Directed Self-Interventions.

Our results demonstrated that early conservative intervention for breast cancer patients high risk for BCRL who were prospectively monitored by utilizing BIS significantly lowers rates of BCRL. These findings support early prospective screening and intervention for BCRL. Early detection with patient-directed interventions improves patient outcomes and decreases the risk of persistent BCRL.

Open access: No
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Whitworth, P.W. et al.

Preventing Breast Cancer-Related Lymphedema in High-Risk Patients: The Impact of a Structured Surveillance Protocol Using Bioimpedance Spectroscopy.

The results of this analysis underscore previously published data on the efficacy of prospective BCRL surveillance and early intervention using BIS. Of the 93 high-risk patients prospectively followed and managed in this structured BCRL protocol, only 11% required CDP and only 3% required continued therapy. These excellent outcomes are superior to contemporary studies of conventional measures reporting BCRL rates in similarly treated high-risk patients.

Open access: Yes
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National Accreditation Program for Breast Centers (NAPBC)

2018 NAPBC Standards Manual

STANDARD 2.15 – Support and Rehabilitation

Supportive services may include:
• Lymphedema management and risk reduction practices

RESOURCES
National Accreditation Program for Breast Centers (NAPBC) Accreditation Resources,
facs.org/quality-programs/napbc/accreditation/resources
Resource links to NLN guidelines

Open access: Yes
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Kaufman, D.I., et al.

Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema.

In summary, BIS represents a valuable and practical tool for the early detection of subclinical BCRL in patients undergoing prospective monitoring. In this prospective surveillance study, use of BIS allowed for early intervention and a reduction in the predicted rate of chronic BCRL compared to historical controls (no cases of persistent, chronic BCRL were observed after early intervention even in the highest risk patients). Such an approach represents not only a valuable strategy to address the recent NCCN guidelines on survivorship for monitoring for BCRL but also a cost-effective strategy to prevent and manage the potentially devastating effects of chronic BCRL.

Open access: Yes
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Whitworth, P.W. and A. Cooper

Reducing chronic breast cancer-related lymphedema utilizing a program of prospective surveillance with bioimpedance spectroscopy.

In summary, prospective surveillance of breast cancer patients (most of whom were considered high risk) for the development of BCRL using BIS permitted the detection and simple pre-emptive management of subclinical disease resulting in a very low rate of chronic lymphedema compared to the established, expected range. These findings (which represent the largest group of patients monitored in a structured, program for early detection of BCRL using BIS) support the cost-effective allocation of resources for prospective, BIS assisted, BCRL surveillance within guidelines-based breast cancer survivorship programs. For women at risk for BCRL, this protocol represents a useful option to meet NCCN guidelines for the education, monitoring and treatment of BCRL.

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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