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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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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.

Bilir, S.P., M.P. DeKoven, and J. Munakata, Economic benefits of BIS-aided assessment of post-BC lymphedema in the United States. Am J Manag Care, 2012. 18(5): p. 234-41.

Open access: Yes
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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.

Stout, N.L., et al., Breast cancer-related lymphedema: comparing direct costs of a prospective surveillance model and a traditional model of care. Phys Ther, 2012. 92(1): p. 152-63

Open access: Yes
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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.

Ward, L., et al., Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphedema by bioelectrical impedance spectroscopy. Lymphatic Research and Biology, 2011. 9(1): p. 47-51

Open access: No
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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.

Ward, L., et al., Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphedema by bioelectrical impedance spectroscopy. Lymphatic Research and Biology, 2011. 9(1): p. 47-51.

Open access: No
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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.

Ward, L., et al., Reference ranges for assessment of unilateral lymphedema in legs by bioelectrical impedance spectroscopy. Lymphatic Research and Biology, 2011. 9(1): p. 43-46

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.

Ribas, N., et al., Longitudinal and Transversal Bioimpedance Measurements in Addition to Diagnosis of Heart Failure. Journal of Physics: Conference Series, 2010. 224.

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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