Study: Limb compression device can reduce the annual occurrence of skin infections in lymphedema patients by nearly 80 percent

Wednesday, October 7, 2015

Media note: Watch study authors Alan T. Hirsch, M.D., and Pinar Karaca-Mandic, Ph.D., discuss their study findings here.

A new landmark national study published today in JAMA Dermatology found the use of an advanced pneumatic compression device (APCD) reduced the episodes of skin infections that occur annually in patients with lymphedema by nearly 80 percent.

Rates of cellulitis, the medical term for such skin infections, were lowered from 21 percent to 4.5 percent in the individuals with lymphedema due to cancer, and from 28.8 percent to 7.3 percent in individuals whose lymphedema was not due to cancer.

The research was conducted at the University of Minnesota Medical School and School of Public Health in collaboration with Vanderbilt University School of Nursing and Stanford University School of Medicine.

“It is a national goal, shared by patients, businesses, payers, and government, that we identify new treatments that preserve health, but that do so at a lower cost. It is essential that we collect data from real world settings and assess the effectiveness of devices,” said Pinar Karaca-Mandic, Ph.D., lead author and associate professor of health policy and management at the University of Minnesota School of Public Health.

Lymphedema is a common cardiovascular disease that causes limb and trunk swelling, decreases mobility, worsens function and quality of life, and leads to skin infections and hospitalizations. Lymphedema affects more than five million Americans and occurs in response to cancer, cancer treatment, infections, and from inherited causes. There is no cure and symptoms persist for a lifetime. Worse, awareness of the risk and cost of lymphedema is low among patients, physicians and payers.

The authors analyzed 718 lymphedema patients from across the United States over a 5-year period (2007-2013) from a large national administrative database, and evaluated clinical events and costs for a 12-month period prior to and during a 12-month period of treatment. After receiving a device, patients reduced their utilization of inpatient and outpatient clinic visits rapidly lowering healthcare costs.

The study also found the APCD:

  • Significantly improved the health of patients with lymphedema by reducing key adverse clinical events.
  • Decreased outpatient clinic and hospital visits and reduced the need for physical therapy.
  • Contributed to a decline in total lymphedema-related costs per patient. Excluding medical equipment, healthcare costs declined by 37% among cancer patients and declined by 36% in patients without cancer.
  • Contributed to reduced outpatient costs. Lymphedema-related outpatient costs per patient declined by 53% among cancer patients (from $1,500 to $700) and by 65% among patients without cancer (from $1,700 to 600).

The APCD studied was manufactured by Tactile Medical based in Minneapolis, Minnesota; it works by stimulating the body’s lymphatic system to carry protein rich fluid, called lymph, out of the tissue of the arms and legs. The Flexitouch® System APCD gently massages the skin with light “press and release” action. This massage simulates the muscle contractions and pressure on the skin that helps lymph to move through the body as it would in a person with a healthy lymphatic system.

“Cardiovascular diseases affect many families throughout the world. Healthy lymphatic vessels are a critical component of the cardiovascular system and are essential to good health. By studying a large group of patients, and carefully measuring the impact of this at-home treatment, we were extremely gratified to see these skin infections were lowered by nearly 80% within one year,” said Alan T. Hirsch, M.D., co-author and professor of medicine, epidemiology and community health in the Cardiovascular Division in the University of Minnesota Medical School. “This is amazing. Patients fear these infections, they suffer, and the costs to treat them are immense. Yet, a device used at home can provide amazing protection for the patient and for the health care system. This is the very definition of a public health success.”

The authors also noted that their analysis considered only direct healthcare costs, which represent only a fraction of the overall costs related to the lymphedema burden. “For example, when one takes into account the additional costs due to productivity loss, caretaker costs and other non-monetary costs, the availability of an effective home treatment that improves physical functioning would likely have a much larger impact than the one we could measure,” said Karaca-Mandic.

Additional information about lymphedema can be found at the Lymphatic Education and Research Network at www.lypmphaticnetwork.org or the National Lymphedema Network at www.lymphnet.org.

The study was supported in part by Tactile Medical to defray access costs for use of the Optum Health database and defrayed health economic analytical costs. 

Hirsch serves as chief medical officer at Tactile Medical and Karaca-Mandic received consultative reimbursement from Tactile Medical for her independent performance of health economic analyses. These relationships were reviewed and managed by the University of Minnesota in accordance with its Conflict of Interest policies. No other author had any conflicts of interest.