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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Sheila H. Ridner, Chirag Shah, John Boyages, Louise Koelmeyer, Nicolas Ajkay, Sarah M. DeSnyder, Sarah A. McLaughlin, Mary S. Dietrich

L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery

These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.

Open access: Yes
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Ridner, S.H., et al.

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

The results of this interim analysis demonstrate that patients undergoing surveillance with BIS had reduced but non-statistically significant reductions in the rates of progression requiring CDP compared with TM. These results are currently supportive of the need for subclinical detection and early intervention for patients with BCRL, with a 10% absolute reduction and 67% relative reduction in the rates of CDP. Further data with a longer follow-up than in this study is expected in the years to come and will strengthen these early, positive, practice-changing results.

Open access: Yes
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Koelmeyer, L.A., et al.

Early surveillance is associated with less incidence and severity of breast cancer-related lymphedema compared with a traditional referral model of care.

Scholars and guidelines have advocated for the routine implementation of early lymphedema surveillance and intervention after breast cancer treatment. Regular clinic visits to monitor extracellular fluid present an opportunity for therapists to provide risk management education, psychological support, physical rehabilitation, empowerment, and survivorship care. The findings from the current study support the use of BIS as part of an early prospective surveillance model of care that results in significantly earlier detection of lymphedema over time. Furthermore, the earlier detection of lymphedema will lead to lower health care costs if it results in the effective management of symptoms and prevents progression to severe clinical lymphedema.

Open access: Yes
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Kilgore, L.J., et al.

Reducing Breast Cancer-Related Lymphedema (BCRL) Through Prospective Surveillance Monitoring Using Bioimpedance Spectroscopy (BIS) and Patient Directed Self-Interventions.

Our results demonstrated that early conservative intervention for breast cancer patients high risk for BCRL who were prospectively monitored by utilizing BIS significantly lowers rates of BCRL. These findings support early prospective screening and intervention for BCRL. Early detection with patient-directed interventions improves patient outcomes and decreases the risk of persistent BCRL.

Open access: No
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Whitworth, P.W. et al.

Preventing Breast Cancer-Related Lymphedema in High-Risk Patients: The Impact of a Structured Surveillance Protocol Using Bioimpedance Spectroscopy.

The results of this analysis underscore previously published data on the efficacy of prospective BCRL surveillance and early intervention using BIS. Of the 93 high-risk patients prospectively followed and managed in this structured BCRL protocol, only 11% required CDP and only 3% required continued therapy. These excellent outcomes are superior to contemporary studies of conventional measures reporting BCRL rates in similarly treated high-risk patients.

Open access: Yes
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Kaufman, D.I., et al.

Utilization of bioimpedance spectroscopy in the prevention of chronic breast cancer-related lymphedema.

In summary, BIS represents a valuable and practical tool for the early detection of subclinical BCRL in patients undergoing prospective monitoring. In this prospective surveillance study, use of BIS allowed for early intervention and a reduction in the predicted rate of chronic BCRL compared to historical controls (no cases of persistent, chronic BCRL were observed after early intervention even in the highest risk patients). Such an approach represents not only a valuable strategy to address the recent NCCN guidelines on survivorship for monitoring for BCRL but also a cost-effective strategy to prevent and manage the potentially devastating effects of chronic BCRL.

Open access: Yes
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Whitworth, P.W. and A. Cooper

Reducing chronic breast cancer-related lymphedema utilizing a program of prospective surveillance with bioimpedance spectroscopy.

In summary, prospective surveillance of breast cancer patients (most of whom were considered high risk) for the development of BCRL using BIS permitted the detection and simple pre-emptive management of subclinical disease resulting in a very low rate of chronic lymphedema compared to the established, expected range. These findings (which represent the largest group of patients monitored in a structured, program for early detection of BCRL using BIS) support the cost-effective allocation of resources for prospective, BIS assisted, BCRL surveillance within guidelines-based breast cancer survivorship programs. For women at risk for BCRL, this protocol represents a useful option to meet NCCN guidelines for the education, monitoring and treatment of BCRL.

Open access: Yes
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Laidley, A., Anglin B.

The Impact of L-Dex Measurements in Assessing Breast Cancer-Related Lymphedema as Part of Routine Clinical Practice.

The results of this retrospective study demonstrate that L-Dex assessments can be incorporated into routine breast cancer programs as part of follow-up. This is critically important given the recent changes in the NCCN survivorship guidelines for post-treatment follow-up care for breast cancer patients establishing that health-care providers “educate, monitor, and refer for lymphedema management.” Additionally, the analyses suggest that L-Dex assessments can identify subclinical BCRL and subsequently monitor the return to baseline following conservative interventions. Further studies are required to demonstrate the long-term benefits of early detection and subsequently early intervention predicated upon subclinical detection of BCRL.

Open access: Yes
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Soran, A., Ozmen, T. et al.

The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study.

To our knowledge, this is the first prospective study of patients who underwent ALND for breast cancer in which BIS technology was used to detect LE and evaluate the benefits of early diagnosis and treatment interventions objectively. We demonstrated that periodic monitoring of women at high risk for LE, with BIS technology, allowed detection of subclinical LE and timely intervention for treatment, resulting in a reduction of clinical LE from 36.4% to 4.4%. Future studies will determine whether this translates into reduced total health care costs and improved quality of life for patients with breast cancer.

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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