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

University of Cincinnati Cancer Institute (UCCI) Breast Cancer Center

Lymphedema: Improving Screening and Treatment Among At-Risk Breast Cancer Survivors

A protocol for BIS via the L-Dex device should be established in clinical practice; this provides APNs with a consistent, objective approach to detect subclinical lymphedema, assists the APN with evidence-based decision making for PT referral, and provides improved lymphedema education from the APN for at-risk survivors. The protocol could decrease clinical lymphedema incidence, improving functional ability and quality of life among survivors by decreasing arm edema and reducing joint and muscle aches, limb tightness, infection rates, and overall medical costs for chronic lymphedema treatment.

Open access: No
Laidley, A., Anglin B.

The Impact of L-Dex Measurements in Assessing Breast Cancer-Related Lymphedema as Part of Routine Clinical Practice.

The results of this retrospective study demonstrate that L-Dex assessments can be incorporated into routine breast cancer programs as part of follow-up. This is critically important given the recent changes in the NCCN survivorship guidelines for post-treatment follow-up care for breast cancer patients establishing that health-care providers “educate, monitor, and refer for lymphedema management.” Additionally, the analyses suggest that L-Dex assessments can identify subclinical BCRL and subsequently monitor the return to baseline following conservative interventions. Further studies are required to demonstrate the long-term benefits of early detection and subsequently early intervention predicated upon subclinical detection of BCRL.

Open access: Yes
The Breast Journal

Bioimpedance Spectroscopy for Breast Cancer Related Lymphedema Assessment: Clinical Practice Guidelines

With increasing data supporting early detection and treatment of BCRL, BIS has emerged as an important diagnostic modality due to its ability to detect subclinical lymphedema. BIS can be utilized as part of routine breast cancer clinical care starting with measurements prior to locoregional therapy and continued as part of survivorship using an increase of 10 to trigger early herapy for BCRL.

Open access: No
Dylke, E.S., et al.,

Diagnosis of upper limb lymphedema: development of an evidence-based approach.

This is the first study to establish evidence-based diagnostic criteria for LE against an appropriate reference standard. The two thresholds with the highest sensitivity, as well as good specificity, for detection of mild LE were determined from a normative population, accounting for normal inter-limb variations as well as limb dominance. These findings support the adoption of a more liberal diagnostic threshold set at 2SD above the mean, instead of the previously suggested 3SD threshold.

Open access: Yes
Cancer Medicine

The impact of early detection and intervention of breast cancer-related lymphedema: a systematic review

Breast cancer-related lymphedema (BCRL) has become an increasingly important clinical issue as noted by the recent update of the 2015 NCCN breast cancer guidelines which recommends to “educate, monitor, and refer for lymphedema management.” The purpose of this review was to examine the literature regarding early detection and management of BCRL.

Several studies were identified that demonstrate that newer diagnostic modalities (bioimpedance spectroscopy, perometry) have increased sensitivity allowing for the earlier detection of BCRL. Current data support the development of surveillance programs geared toward the early detection and management of BCRL in part due to newer, more sensitive diagnostic modalities.

Open access: Yes
Basta, M.N., et al.

Complicated breast cancer-related lymphedema: evaluating health care resource utilization and associated costs of management.

Complicated lymphedema was defined as any hospital admission within 2 years for a diagnosis of lymphedema or related complications based on prior research.
This study demonstrates a 2.3% incidence of complicated lymphedema after breast cancer surgery. Increased health care utilization for these patients resulted in hospital charge accrual of more than $180 million in 2 years or approximately $140,000 per patient. Although limitations must be taken into consideration, the significant burden of lymphedema underscored here mandates further investigation into targeted, anticipatory management strategies for BCRL

Open access: No
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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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