Clinical Evidence | ImpediMed

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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Andrew J. Accardi, Bradley S. Matsubara, Richelle L. Gaw, Anne Daleiden-Burns, James Thomas Heywood

Clinical Utility of Fluid Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy

Clinical trial compares BIS measurements from patients with heart failure (HF) to those from healthy adults, and describe how these point-of-care fluid volume assessments may be applied to HF management

Open access: Yes
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Andrew J. Accardi, MD, James Thomas Heywood, MD, FACC, Anne Daleiden-Burns, ACNP

Bioimpedance Spectroscopy: a Predictor of Compensated Versus Decompensated Heart Failure in the Emergency Room

ECF%TBW has been shown to be a marker of fluid overload in patients presenting with dyspnea. Median ECF%TBW for decompensated, compensated, and control were 52.1%, 49.0%, and 44.8%, respectively. Statistically significant ECF%TBW differences were shown. This bedside BIS device provides instantly useful quantitative fluid status data at the point-of-care. When coupled with physical exam and traditional markers, BIS may provide additional value to assist in ER evaluation and triage, as well as other settings in which fluid status is monitored.

Open access: YES
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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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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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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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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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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
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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
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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®

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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