Lymphedema Patients Benefit from Pneumatic Compression Devices

NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.

"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.

"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.

Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.

Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.

Lymphedema-related outcomes had either primary or secondary diagnosis codes.

The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.

As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).

The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.

Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).

The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).

Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.

"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.

Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.

Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."

"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."

Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."

"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.

"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.

"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of

treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.

"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.

Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.

NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.

"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.

"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.

Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.

Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.

Lymphedema-related outcomes had either primary or secondary diagnosis codes.

The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.

As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).

The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.

Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).

The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).

Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.

"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.

Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.

Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."

"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."

Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."

"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.

"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.

"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of

treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.

"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.

Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.

NEW YORK - Patients with lymphedema may reduce their risk of cellulitis, as well as the number of outpatient visits, by using an advanced pneumatic compression device (APCD), according to a new study.

"Our study demonstrates, for the first time, that receipt of an advanced pneumatic compression device is associated with significant improvements in key clinical endpoints for lymphedema patients, both for those with cancer and those without," Dr. Pinar Karaca-Mandic of the University of Minnesota School of Public Health in Minneapolis said by email.

"This finding has important implications for the patients who suffer from the disease, especially for those who have high rates of cellulitis. These devices serve as a viable self-management option and can reduce the need for more intensive outpatient care in rehabilitative settings," she added.

Advanced devices have more garment chambers and greater adjustability than earlier devices, the researchers wrote.

Dr. Karaca-Mandic and colleagues used a commercial insurance claims database to compare outcomes for 12 months before and 12 months after APCD purchase (Flexitouch System, Tactile Medical) by 718 patients (374 with cancer) between 2008 and 2012.

Lymphedema-related outcomes had either primary or secondary diagnosis codes.

The patients' mean age was 54.2, 84.8% were female, and 71.6% were non-Hispanic white. Just over half (52.2%) had hypertension, and breast cancer (39.6%) was the predominant disease in the cancer group.

As reported online October 7 in JAMA Dermatology, the adjusted rate of cellulitis diagnoses fell from 21.1% before APCD use to 4.5% afterward (p<0.001), a 79% decline. The noncancer group had a 75% decline, from 28.8% to 7.3% (p<0.001).

The noncancer group also had a 54% decline in adjusted rate of hospitalizations, from 7.0% to 3.2% (p=0.02), the authors reported.

Both groups had declines in receipt of manual therapy, from an adjusted rate of 35.6% before APCD use to 24.9% afterward for cancer patients (p<0.001) and from 32.3% to 21.2% for noncancer patients (p<0.001).

The adjusted rate of outpatient visits fell from 58.6% to 41.4% in the cancer cohort and from 52.6% to 31.4% in the noncancer group (p<0.001 for both).

Total costs per patient, excluding medical equipment, declined from $2597 to $1642 for cancer patients (p=0.002) and from $2937 to $1883 (p=0.007) for noncancer patients.

"While our findings are based upon the outcomes from one specific device, it is possible other such devices may also reduce patient burden. This warrants explorations in future studies. In addition, our study was not designed to assess the long term effectiveness of the device. That should be studied in future work," Dr. Karaca-Mandic explained.

Also, she pointed out, her team didn't look at nonmonetary expenses such as productivity loss and caretaker costs. "To the extent that device use improves physical functioning and lowers such costs as well, the impact is likely much larger than we can measure," she added.

Dr. Peter J. Franks, of the Center for Research and Implementation of Clinical Practice in London, UK, said by email, "We have these devices that appear to work. The problem is that the evidence on efficacy and cost effectiveness is so poor. The article gave some retrospective observational data that implied that the incidence of infection (cellulitis) was reduced. This is important, as infections lead to further deterioration of the lymphatic system, making the situation worse for the patient and increasing the risk of further infections."

"It is hard to say how generalizable the results are to other devices, though fundamentally they all work in similar ways," said Dr. Franks, who coauthored an accompanying editorial. "I think that this is an important step in how we consider the use of medical devices."

Cynthia Shechter, an occupational therapist in New York City who is a lymphedema specialist for cancer patients, said by email, "When looking for the right device, look for a pump that contains multiple chambers, operates on a short thirty-second cycle time, and applies graduated compression."

"The body operates on a pressure gradient system, so it is imperative to obtain a gradient or graduated compression pump. Pressure at the feet or hand is greater than the thigh or shoulder," she added.

"Clinicians practicing in the treatment of lymphedema need to be open-minded regarding less traditional treatment options for this insidious condition, including the use of traditional and advanced pneumatic compression devices," Shechter said.

"This study indicates that use of an APCD reduces the necessity for therapy. However, rehabilitation therapy for primary and secondary lymphedema, at least a short course of

treatment, is important, especially in order to ensure patients are adequately educated in lymphedema care, management, and precautions," she said.

"There should be a follow-up study performed to discuss a patient's ability to sustain use of the APCD versus a traditional pneumatic pump, and the long-term success in both preventing infection and in reduction of therapy visits," Shechter said.

Tactile Medical partially supported this research and employs one coauthor as chief medical officer. Dr. Karaca-Mandic, Dr. Franks, and his coauthor reported consulting for the company.