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

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
Fu, M.R., et al.

L-dex ratio in detecting breast cancer-related lymphedema: reliability, sensitivity, and specificity.

Giving that all the women who were treated for breast cancer are at life-time risk for lymphedema, using assessment methods that can accurately identify true lymphedema cases among at-risk breast cancer survivors is of the ultimate importance for clinical practice. Perhaps, the most important contribution of our study was that it has provided evidence that, using a cutoff point of L-Dex ratio of >+7.1, cross-sectional assessment of BIA was able to discriminate at-risk breast cancer survivors and those with lymphedema.

Open access: Yes
Billr SP, DeKoven MP, Munakata J.

Economic Benefits of BIS-Aided Assessment of post-BC Lymphedema in the United States.

Economic analysis demonstrating that BIS utilization would lead to a cost savings which is magnified when considering sequelae of BCRL.
Over 1 year, BIS-aided assessment of lymphedema for patients following treatment for BC results in cost savings, even without considering potential cost savings associated with averted downstream sequelae.

Open access: Yes
Stout, N.L., et al.

Breast cancer-related lymphedema: comparing direct costs of a prospective surveillance model and a traditional model of care.

Early intervention may reduce the need for intensive rehabilitation and may be cost saving. This perspective article compares a prospective surveillance model with a traditional model of impairment-based care and examines direct treatment costs associated with
each program.
The prospective surveillance model includes the cost of screening all women plus the cost of intervention for early-stage BCRL. The TM group comprised women referred for BCRL treatment using a traditional model of referral based on late-stage lymphedema. The
traditional model cost includes the direct cost of treating patients with advancedstage lymphedema. The cost to manage early-stage BCRL per patient per year using a prospective surveillance model is $636.19. The cost to manage late-stage BCRL per patient per year using a traditional model is $3,124.92. The prospective surveillance model is emerging as the standard of care in breast cancer treatment and is a potential cost-saving mechanism for BCRL treatment.

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

Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphedema by bioelectrical impedance spectroscopy.

The choice of the mean + 3 SD as the criterion value may be questioned as being too conservative compared to a criterion of the mean + 2 SD more common in diagnostic testing. This threshold value was originally proposed by Cornish et al. but without supporting explanation for its choice. Its use in the present study was based upon this historical precedent.

Open access: No
Ward LC, Dylke E, Czerniec S, et al.

Confirmation of the Reference Impedance Ratios Used for Assessment of Breast Cancer-Related Lymphedema by Bioelectrical Impedance Spectroscopy.

Study of 172 healthy females indicates that impedance ratio thresholds are consistent with those previously identified.
In summary, new criterion thresholds for the assessment of BCRL by BIS have been determined. Although statistically different to the established reference values, the magnitude of the difference is sufficiently small to be of no practical clinical consequence. It is concluded that, in accord with the observations of Ridner et al., the present reference thresholds may be used with confidence as markers for lymphedema.

Open access: No
Ward LC, Dylke E, Czerniec S, et al.

Reference ranges for assessment of unilateral lymphedema in legs by bioelectrical impedance spectroscopy

The impedance ratio thresholds for lymphedema of the legs have been established, opening the way for BIS to become established clinically for the early detection and assessment of lower limb lymphedema.

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
Shih YC, Xu Y, Cormier JN, et al.

Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-Year follow-up study.

Claims study of 1,877 patients for 2 years after the start of cancer treatment. 10% of patients developed lymphedema with ALND and chemotherapy associated with development. Higher medical costs associated with BCRL diagnosis ($23, 167 vs. $14,877) with higher rates of cellulitis/lymphangitis noted.
Although the use of claims data may underestimate the true incidence of lymphedema, women with BCRL had a greater risk of infections and incurred higher medical costs. The substantial costs documented here suggest that further efforts should be made to elucidate reduction and prevention strategies for BCRL.

Open access: Yes
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