Medical Device Daily Contributing Writer

LAS VEGAS, Nevada — The sound of coins hitting slot machine trays was heard in the background as more than 900 attendees at the 19th annual Interdisciplinary Breast Center Conference of the National Consortium of Breast Care Centers (Warsaw, Indiana) filed into the conference areas where the newest technologies for diagnosis and treatment of breast cancer were presented.

Advances in medical technology have extended the survival rate for breast cancer, especially when diagnosed early, to more than 90% at five years; although other co-morbidities related to the treatment of the cancer still exist.

One such condition is lymphedema, where extracellular fluid builds up in the arm where lymph nodes were removed or irradiated. Studies have shown that anywhere from 4% to 49% (see Table 1) of breast cancer patients will develop lymphedema and if not diagnosed early or managed appropriately, it can become an irreversible condition.

Breast cancer-related lymphedema is a chronic condition that diminishes quality of life and contributes to impairments in limb range of motion, loss of strength, and functional limitations with activities such as lifting and reaching.

To compound this already ugly story is the fact that until not too long ago there was no way to determine who might be at risk for developing this condition and no remedy if diagnosed.

In a breakfast symposium at the NCBC conference, Steven Schonholz, MD, director of the Breast Center at Mercy Medical Center (Springfield, Massachusetts) presented "Prospective Assessment and Management of Lymphedema in Breast Cancer Patients using Bioimpedence Spectroscopy."

He shared groundbreaking data from the National Institutes of Health (NIH; Bethesda, Maryland) that "demonstrated periodic assessment and early intervention at subclinical stages of lymphedema is effective in returning breast cancer patients to a pre-surgical baseline."

While bioimpedence was not used in the NIH study, the technology has been validated in peer-reviewed literature as being capable of detecting early-onset lymphedema typically three to four months prior to total limb volume changes.

ImpediMed (San Diego) has developed a simple, inexpensive in-office test to determine pre-clinically those patients who have begun to collect fluid in their treated arm.

Using bioimpedence, extracellular fluid is measured in both arms pre-surgically and post-surgically and patients are followed at three-month intervals usually for up to three years, since most cases of lymphedema develop in that timeframe. However, it does remain a lifelong risk.

If detected, a $60 off-the-shelf compression sleeve has been shown to be an effective intervention, with all the women diagnosed with subclinical lymphedema returning to their pre-surgical baseline after an average of one month wearing the sleeve. None of the women progressed to stage 2 or 3 lymphedema.

Up until 2007, when Impedimed's first-generation device was cleared by the FDA, most surgeons were reluctant to discuss lymphedema with their patients because there was no way to detect it early and after it goes untreated, the extracellular fluid becomes irreversible.

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