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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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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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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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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