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AHCPR Health Technology Reviews. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1995. 

                        - This publication is provided for historical reference only and the information may be out of date.

**This publication is provided for historical reference only and the information may be out of date.**

## AHCPR Health Technology Reviews.

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Agency for Health Care Policy and Research (US)

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#  4Lymphedema Pumps: Pneumatic Compression Devices

S Steven Hotta, MD, PhD and Thomas V Holohan, MD.

Published: August 1993.

## 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

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Bookshelf ID: NBK63969

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