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.

The management of the chronic HF patient continues to challenge the primary care provider. Most HF patients are managed by body weight, physical examination findings, and intermittent diagnostics like echocardiography. These traditional methods of evaluation often fail to aid the practitioner in detecting fluid overload and impending decompensation. Staggering healthcare costs and financial penalties associated with 30-day readmission served as the impetus for this study. The use of SOZO is predicated on a correlation between impedance measurements and established measures of fluid. Despite the small study size, correlations of the SOZO device impedance measurements with IVC, RAP, and PAS suggest a possible alternative method to detect fluid overload. The results suggest that there is a relationship that could be used at low cost, is noninvasive, and easy to use. However, due to limitations to the study design, further research is needed to determine the utility of the SOZO device.

Open access: Yes
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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
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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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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
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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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