Stopping Lymphedema Starts with PREVENT - Final 3-Year Primary Endpoint Results Published

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

Anne Daleiden-Burns, ACNP, Andrew Accardi, MD, J. Thomas Heywood, MD, FACC

Time-to-Decongestion Following Heart Failure Hospitalization as Measured by Extracellular Fluid Nadir Using Bioimpedance Spectroscopy

The time required to achieve clinical decongestion is highly variable and often takes longer than may be anticipated; in our study it took an average of 16.9 days. Our results show that ECF is more sensitive than weight when tracking post-discharge decongestion. Noninvasive BIS measurements may assist clinicians with tracking fluid status in HF patients. ECF monitoring during the weeks following heart failure hospitalization may provide a more accurate measure of fluid status than weight alone.

Open access: Yes
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
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
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
Weyer, S., et al.

Bioelectrical impedance spectroscopy as a fluid management system in heart failure.

Peripheral edema could be detected with a sensitivity of 100% and a specificity of 90%. BIS presents the possibility of an automatic decision making process to detect an upcoming edema, as an early indicator of worsening of a HF condition. BIS can detect and follow changes in lung impedance in patients and is sensitive to ECF volume. Since most patients with acute HF suffer not only from pulmonary edema but also from edema in the limbs, a combination of different segmental BIS measurements offers the best option to manage the course of disease.

Open access: No
Ribas, N., et al.

Longitudinal and Transversal Bioimpedance Measurements in Addition to Diagnosis of Heart Failure

This preliminary study suggests that in HF longitudinal bioimpedance measurement in leg segment provides additional information to clinical examination and could even reflect sub-clinical hyper-hydration.

Open access: Yes
Beckmann, L., et al.

Monitoring of body fluid in patients with chronic heart failure using Bioimpedance-Spectroscopy

BIS offers a good possibility to monitor the water content of a person. This can be used in monitoring decompensated CHF patients. Since most patients with acute heart failure suffer not only from lung edema, but also from edema in limbs a combination of segmental and whole body BIS measurements offers the best options to supervise the course of diseases. In this paper, both BIS measurements show a strong correlation with the water balance and weight loss.

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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