Report

Lymphedema is a swelling of soft tissues, especially in the limbs, due to the localized increase in the quantity of lymph that results from an impairment of the normal clearance by the lymphatic system and/or from an excessive production of lymph caused by obstruction of the venous vessels. Pneumatic compression devices were developed to aid in the mobilization of lymph from the extremity, to avoid the morbid consequences of uncontrolled lymphedema. These devices have varied designs, and all appear to be effective to some extent when used in conjunction with an elevation of the limb, manual massage, and an elastic "sleeve" or bandage. This review examines data on the relative effectiveness of single-chambered pneumatic devices vs. multichambered devices, with or without pressure calibrations.

Background

Pathophysiologically, the fluid accumulating in lymphedema represents an abnormal collection of proteins, water, and solute in the interstitial tissues. The stagnation of this protein-rich lymph may encourage infection and result in inflammatory reactions. Fibrosis and excessive formation of connective tissues represent further serious consequences that may present as elephantiasis or sclerodermatous changes. The extent to which the swelling has progressed toward these latter stages influences the effectiveness of the treatment of patients with lymphedema. For example, lymphedema following radical mastectomy and/or radiation theraphy may respond readily to the application of external pressures, whereas the response to the same treatment may be limited if the condition has progressed to the stage of fibrotic changes. Furthermore, the treatability of the lymphedema may also depend on the etiology of the condition --that is, whether the lymphedema is the result of a congenital absence of or abnormalities in the lymphatic system or is secondary to an identifiable cause such as trauma, surgery, radiation therapy, infection, or malignancy.

Early treatment for lymphedema consisted of the elevation of the limb and manual massage to encourage drainage of lymph from the limbs. Elastic bandages and sleeves aided drainage and were somewhat effective in preventing the accumulation of lymph.(1-3). Among the early compression devices used to facilitate the mobilization of fluid from the limbs was one type that consisted of a single inflatable chamber that applied relatively uniform pressure to the whole limb. The development of multichambered devices allowed the sequential application of pressure from the distal to proximal direction. This "milking" of the extremity was thought to be more effective in removing the lymph from the extremity. The latest modification to these pneumatic compression devices was the incorporation of a control mechanism to permit the delivery of calibrated pressure gradients with a multichambered device.

All pneumatic compression devices appear to be effective in patients with treatable lymphedema, the magnitude of such effects depending in part on the tissue changes that may hinder the drainage of lymph and thus the reduction of the swelling. The successful treatment of patients with lymphedema may require the use of elastic bandages or sleeves between treatments with these devices.

Published Literature

A computer search of the Medline data base (1966-1992) found 38 references that were relevant to the treatment of lymphedema with lymphedema pumps or pneumatic compression devices. Nine of these references presented data on the effects of the various pumps in the treatment of series of patients, each study including patients with lymphedema of varied etiology (Table 1). One study compared the effects of three different treatment modes: manual massage, single-chambered device, and multichambered (uncalibrated) compression device. Seven of the nine references reported data showing the extent of reduction in the volume of excess edema fluid (difference in measurements between the edematous limb and the normal, control limb) with treatment, and the remaining two reported volume or measurement changes with treatment only in the edematous extremity. The selection criteria for patients to be treated varied from study to study, and even within a study the characteristics of the lymphedema were not defined, so the treatability of the lymphedema may have varied from patient to patient. With two exceptions, the studies reported data only on the effect of a single, short-term application of the device on the reduction of lymphedema.

Table

Table 1. Treatment of lymphedema.

Zanolla et al(4). compared three different protocols for treating lymphedema in 60 patients who had radical mastectomies. Each group consisted of 20 women. Group 1 received intermittent pressure treatment with a single-chambered compression device for 6 hours per day for 1 week. Group 2 was treated with cyclical sequential pressure application via a multichambered device for 6 hours per day for 1 week. Group 3 received manual massage for 1 hour 3 days per week for 1 month. After the treatments, all patients wore elastic sleeves during the day and were given 60 mg of benzopyrone (purported macrophage activator) every day. The difference between the circumference of the edematous arm at the maximum edema point and that of the normal arm was determined before therapy, at the end of the therapy, and 3 months after therapy. Patients in all protocols showed significant reductions in lymphedema immediately after therapy, with little difference in the effectiveness of the three modes of therapy. The average reduction in the difference between the edematous and control limbs immediately after conclusion of the therapy was 21 in the women treated with the single-chambered device (group 1), 21 in the women treated with the sequential compression device (group 2), and 18 in the women treated by manual massage (group 3). Measurements taken 1 month after the cessation of the therapy sessions showed that the edema fluid appeared to have reaccumulated only in the women treated with the sequential compression device (percent reductions of the lymphedema were 21, 5, and 25 at 3 months in groups 1, 2, and 3, respectively).

Supporting evidence for the effectiveness of a single-chambered compression device was observed in other studies. Swedborg(5). found that the application of this device for 6 hours every day for 2 weeks (2 days off in the middle) reduced the lymphedema by an average of 17.7 in 54 postmastectomy patients. Bertelli et al(6). treated 68 postmastectomy patients with lymphedema for 6 hours every day and found that the edema was reduced, on the average, by about 16.5 at 2 months and about 18.9 at 6 months. Individual responses varied greatly such that about one half of the patients showed reductions of edema greater than 25, about 5 had a worsening of edema, and the remainder had a reduction of less than 25. In a study of 17 patients with lymphedema of various etiologies, Raines et al(7). found that intermittent pneumatic compression treatment for a 24-hour period resulted in the reduction of lymphedema by about 25 in the arms of 11 patients and by about 45 in the legs of 6 patients.

The treatment of lymphedema by the application of pressure sequentially from the distal to proximal direction with a multichambered device, without calibrated pressure gradients, also showed similar varied results. Richmand et al(8). treated 24 lymphedema patients (16 females and 8 males) with intermittent sequential pressure application for 24 hours and found that the treatment reduced the edema by 25-45 in the seven upper limbs and by 36-47 in the 18 lower limbs. Zelikovski et al(9). reported that the treatment of 20 patients over a 2-day period resulted in an average reduction in edema of 21.8, but observed that the individual responses varied from 0-63. Yamazaki et al(10). applied sequential pressure for 40-60 minutes every day or every other day to the edematous arm of 26 postmastectomy patients. They reported that 14 of the patients showed a significant reduction in lymphedema after 15 months of treatment, 7 showed no change, and 5 continued to accumulate edema fluid.

A multichambered device with a calibrated pressure gradient was used by Kim-Sing and Basco(11). and Klein et al. (12). King-Sing and Basco(11). reported that the treatment of 15 postmastectomy patients with intermittent calibrated pressure gradient application for 48 hours resulted in the reduction of lymphedema by an average of 49.4, with individual responses varying from 13-68.7. Klein et al(12). treated 73 patients with lower extremity lymphedema similarly for 48 hours and reported only the changes in circumferences of the treated limbs before and after the treatment. Although Klein et al(12). noted that these reductions in circumferences at five levels of the treated limb were significant, comparative measurements of the normal, control extremity were not made, thus calculation of the absolute reduction of lymphedema was not possible.

Discussion

The treatment of lymphedema by the application of external pressure to the extremity by manual massage, elastic sleeve or wrapping,(13,14). immersion in liquid tanks,(15). or pneumatic compression devices appears to be relatively effective. Whether any mode of pressure application is more or less effective in pushing the lymph out of the limb probably is dependent on a number of factors, including whether lymphatic channels or the venous vessels are obstructed. Thus manual massage with elevation of the limb and use of elastic sleeves or wrappings may suffice to control the lymphedema in mild or early cases, while more severe or longstanding lymphedema may benefit from the use of external pressure devices.

According to the studies reported in the literature, all modes of external pressure application effectively reduce lymphedema in most patients. Since none of the studies specified uniform criteria for the selection of patients or the characteristics of the lymphedema, comparison of the relative effectiveness of the various modes of external pressure therapies cannot be meaningfully done. Even in the case of postmastectomy patients, who may represent the most treatable group of patients, no attempt to define or control for uniformity in the severity, duration, or complexity (e.g., fibrotic changes) of the lymphedema among the patients was evident. In view of these uncertainties, one can only conclude from the data in the literature that manual massage, pressure applied with a single-chambered pneumatic device, and sequential pressure applied with a multichambered device, with or without a calibrated pressure gradient, all are effective to some degree in reducing lymphedema in some patients.

Multichambered devices which were developed for the intermittent application of pressure sequentially from the distal to proximal direction in an attempt to effect the mobilization of the lymph by a "milking" action, may be more effective than single-chambered devices in selected patients. However, which patients these are cannot be determined from the published information. The published studies have only demonstrated that the reductions of lymphedema in some patients treated with the multichambered devices appear to be similar to those obtained with the use of a single-chambered device and with manual massage.

A multichambered device with a mechanism to apply a calibrated pressure gradient that automatically adjusts the pressures to limb conditions was developed with the hope that this controlled pressure application would be more effective in the mobilization of the lymph. From the two studies that reported the results of using this device in patients, the advantages of applying calibrated pressure gradients are not apparent. Although the patients treated by Kim-Sing and Basco(11). appeared to have a greater average reduction in lymphedema, the responses appear to be comparable with those observed with the use of other modes of therapy. The number of patients in their study was small and the individual responses of their patients varied over a wide range, which was similar to that reported for other modes therapy. In the other study,(12). the reported indicated that the device decreased the circumferences of the treated limbs, but the significance of these changes are unknown because the authors did not report comparative measurements of the normal limbs.

The selection of patients who had failed to respond to one or another mode of therapy and the finding that some of these patients responded to the treatment under study would suggest that whether the lymphedema might be successfully treated by one or another mode of therapy may depend on the individual patient. It is conceivable that most uncomplicated lymphedema could be treated satisfactorily by any of the external pressure modes of therapy, while others may respond more favorably to one or another therapy. Lymphedema difficult to control by one mode of therapy may benefit by the use of another. Data that might be useful for the selection of the best candidates for treatment by a given mode of therapy are lacking at this time. These studies did not address important questions concerning the effectiveness of these pneumatic compression devices over the long-term and the most appropriate frequency and duration of use of these devices.

Pneumatic compression pumps were approved for marketing by the Food and Drug Administration (FDA) as devices that were substantially equivalent to similar devices marketed prior to the 1976 Medical Devices Amendments to the Federal Food, Drug and Cosmetic Act. The possible uniqueness or superiority of one pump vs. another was not a consideration for these approvals by the FDA. The National Institutes of Health has agreed with our findings that, although these pneumatic compression devices appear to be useful in the treatment of lymphedema, there is a lack of data to determine whether one device is more efficacious than another or to ascertain the best protocol for their use.

Patients have been reimbursed for the purchase and use of these pneumatic compression devices. The average allowed charges for purchase by Medicare in 1991 were $198. 15 for single-chambered lymphedema pumps, $535.01 for multichambered devices, and $1,437.39 for multichambered devices with calibrated pressure gradients. In 1991, Medicare patients purchased 8,299 single-chambered devices at a total cost of $1,644,448; 1,329 multichambered devices at a total cost of $711,030; and 9,989 multichambered devices with calibrated pressure gradients at a total cost of $14,358,094.

Summary

Lymphedema is the abnormal accumulation of lymph in the interstitial tissues that is usually the result of impairment of the normal clearance by the lymphatic system caused by therapy or disease. The application of external pressure represents a reasonable and successful method for the mobilization of lymph from the affected limb in some patients. Pneumatic compression devices consisting of a single inflatable chamber or multiple chambers have been developed and used in the successful reduction of lymphedema. Multichambered devices allow the application of pressure sequentially, starting from the distal chamber and progressing proximally, theoretically encouraging an effective, unidirectional flow of lymph out of the limb.

All pheumatic compression devices appear to be similarly effective in the treatment of lymphedema. Since the patients selected varied from study to study and the characteristics of the lymphedema among the patients were not defined, neither the criteria for the selection of patients to be treated with one or another device nor the difference in effectiveness of the devices could be ascertained.

References

1.

Pierson S, Pierson D, Swallow R, Johnson G Jr. Efficacy of graded elastic compression in the lower leg. JAMA. 1983;249:242–243. [PubMed: 6848811]

2.

Foldi E, Foldi M, Weissleder H. Conservative treatment of lymphoedema of the limbs. Angiology. 1985;36:171–180. [PubMed: 4025929]

3.

Brennan MJ. Lymphedema following the surgical treatment of breast cancer: A review of pathophysiology and treatment. J Pain Symptom Manage. 1992;7:110–116. [PubMed: 1573284]

4.

Zanolla R, Monzeglio C, Balzarini A, Martino G. Evaluation of the results of three different methods of post-mastectomy lymphedema treatment. J Surg Oncol. 1984;26:210–213. [PubMed: 6738072]

5.

Swedborg I. Effects of treatment with an elastic sleeve and intermittent pneumatic compression in post-mastectomy patients with lymphoedema of the arm. Scand J Rehabil Med. 1984;16:35–41. [PubMed: 6710094]

6.

Bertelli G, Venturini M, Forno G, et al. Conservative treatment of postmastectomy lymphedema: A controlled, randomized trial. Ann Oncol. 1991;2:575–578. [PubMed: 1793725]

7.

Raines JK, O'Donnell TF Jr, Kalisher L, Darling RC. Selection of patients with lymphedema for compression therapy. Am J Surg. 1977;133:430–437. [PubMed: 848678]

8.

Richmand DM, O'Donnell TF Jr, Zelikovski A. Sequential pneumatic compression for lymphedema: A controlled trial. Arch Surg. 1985;120:1116–1119. [PubMed: 4038053]

9.

Zelikovski A, Bair A, Haddad M, Reiss R. The mobile pneumatic arm sleeve: A new device for treatment of arm lymphedema. Lymphology. 1985;18:68–71. [PubMed: 4033195]

10.

Yamazaki Z, Idezuki Y, Nemoto T, Togawa T. Clinical experiences using pneumatic massage therapy for edematous limbs over the last 10 years. Angiology. 1988;39:154–163. [PubMed: 2964798]

11.

Kim-Sing C, Basco VE. Postmastectomy lymphedema treated with the Wright linear pump. Can J Surg. 1987;30:368–370. [PubMed: 3664393]

12.

Klein MJ, Alexander MA, Wright JM, et al. Treatment of adult lower extremity lymphedema with the Wright linear pump: Statistical analysis of a clinical trial. Arch Phys Med Rehabil. 1988;69:202–206. [PubMed: 3348722]

13.

Zhang T-S, Huang W-Y, Han L-Y, Liu W-Y. Heat and bandage treatment for chronic lymphedema of extremities. Report of 1,045 patients. Chin Med J (Engl). 1984;97:567–577. [PubMed: 6440743]

14.

Chang T-S, Han L-Y, Gan J-L, Huang W-Y. Microwave: An alternative to electric heating in the treatment of peripheral lymphedema. Lymphology. 1989;22:20–24. [PubMed: 2725053]

15.

Palmer A, Macchiaverna J, Braun A, et al. Compression therapy of limb edema using hydrostatic pressure of mercury. Angiology. 1991;42:533–542. [PubMed: 1863013]

AHCPR Pub. No. 93-0051