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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Final 3-Year Primary Endpoint Results Published

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

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
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
American Physical Therapy Association (APTA)

Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association.

Practice Recommendations Based on Patient Presentation At Risk/Early Upper Extremity Lymphedema (ILS Stage 0-I)

Bioimpedance analysis (BIA) should be used to detect subclinical/early stage lymphedema (Grade B)
– Cutpoint of >7.1 L-Dex score should be used for diagnosis of breast cancer–related lymphedema when preoperative baseline measures are not available (Grade B)
– Cutpoint of >10 L-Dex score above preoperative baseline should be used for diagnosis of breast cancer–related lymphedema (Grade B)
– Preoperative assessment using BIA may enhance the ability to detect changes in tissue fluid earlier indicating lymphedema (Grade B)

Open access: Yes
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
Zink, M.D., et al.

Feasibility of Bioelectrical Impedance Spectroscopy Measurement before and after Thoracentesis.

A significant increase in impedance was observed using the low frequency domain for the “Transthoracic” vector after thoracentesis. There was a moderate correlation between the amount of removed PE and the change in impedance using the “Foot to Hand” vector in the low frequency domain. Demonstrated feasibility of measuring fluid shifts by BIS in thoracentesis. Use as an adjunct diagnostic tool to evaluate PEs and monitor patients after thoracentesis. BIS measurement was safe, noninvasive, and easy to handle.

Open access: Yes
Soran, A., Ozmen, T. et al.

The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study.

To our knowledge, this is the first prospective study of patients who underwent ALND for breast cancer in which BIS technology was used to detect LE and evaluate the benefits of early diagnosis and treatment interventions objectively. We demonstrated that periodic monitoring of women at high risk for LE, with BIS technology, allowed detection of subclinical LE and timely intervention for treatment, resulting in a reduction of clinical LE from 36.4% to 4.4%. Future studies will determine whether this translates into reduced total health care costs and improved quality of life for patients with breast cancer.

Open access: No
Skrabal, F., et al.

Adding “hemodynamic and fluid leads” to the ECG. Part I: the electrical estimation of BNP, chronic heart failure (CHF) and extracellular fluid (ECF) accumulation.

The discrimination of healthy subjects from patients with heart failure on the basis of the ECF/ICF ratio of the legs is especially impressive, since there is little overlap between the groups (Fig. 8) and since part of the patients was on diuretics and had little or no visible or palpable edema. This parameter alone could become helpful for the diagnosis and management of CHF in the future.

Open access: No
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