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