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

Boyages J, Vicini F, Shah C.

Bioimpedance Spectroscopy Monitoring Reduces Long-term Clinical Lymphedema Risk

The Kaplan–Meier analysis shows that patients with early detection using L-Dex and intervention have statistically significant higher rates of lymphedema progression free survival through three years compared to using tape measure. This reinforces the importance of monitoring patients for three years, since progression to chronic lymphedema occurred throughout the three-year follow up period.

Open access: Yes
Mary S. Dietrich, Katrina Gaitatzis, Louise Koelmeyer, John Boyages, Vandana G. Abramson, Sarah A. McLaughlin, Nicholas Ngui, Elisabeth Elder, James French, Jeremy Hsu, T. Michael Hughes, Deonni P. Stolldorf, Chirag Shah, and Sheila H. Ridner

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes

Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored.

Open access: Yes
Louise A. Koelmeyer PhD, OT,Katrina Gaitatzis Grad Dip(Psych),Mary S. Dietrich PhD, MS,Chirag S. Shah MD,John Boyages MD, PhD,Sarah A. McLaughlin MD,Bret Taback MD,Deonni P. Stolldorf PhD, RN,Elisabeth Elder MD, PhD,T. Michael Hughes MD,James R. French MD,Nicholas Ngui MD,Jeremy M. Hsu MD,Andrew Moore MD,Sheila H. Ridner PhD, RN

Risk Factors for Breast Cancer-Related Lymphedema in Patients Undergoing 3 Years of Prospective Surveillance with Intervention

The results confirm known BCRL risk factors such as axillary lymph node dissection, taxane-based chemotherapy, regional nodal irradiation, and obesity and provides novel data on the increased risk of BCRL in patients living in a rural areas as well as no increased risk from air travel.

Open access: Yes
Sheila H. Ridner, Mary S. Dietrich, John Boyages, Louise Koelmeyer, Elisabeth Elder, T. Michael Hughes, James French, Nicholas Ngui, Jeremy Hsu, Vandana G. Abramson, Andrew Moore, and Chirag Shah

A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Brease Cancer Lymphedema Prevention

This study compared rates of progression to chronic breast cancer-related lymphedema (defined as ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM).

Open access: Yes
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
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
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
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
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
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
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
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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