INTERMITTENT PNEUMATIC COMPRESSION. TO PUMP OR NOT TO PUMP. Joseph Feldman, M.D., CLT-LANA. Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. The central disturbance is a low output failure of the
TO PUMP OR NOT TO PUMP
Joseph Feldman, M.D., CLT-LANA
lymphatic system insufficiency and deranged lymph
The central disturbance is a low output failure of the
lymphvascular system, I.e., overall lymph transport
is reduced. This derangement arises either from
congenital lymphatic dysplasia or anatomical obliteration.
The lymphatic transport falls below the capacity needed
to handle the presented load of microvascular filtrate
including plasma protein. Swelling is produced by
accumulation in the extracellular space of excess water,
filtered/diffused plasma proteins, extravascular blood
cells and cell products. This process culminates in
proliferation of parenchymal and stromal elements with
excessive deposition of extracellular matrix substance.
The preclinical (latent) phase of lymphedema.
There is a reduced lymph transport capacity but it
remains sufficient to drain the normal lymphatic
protein load. Any further reduction in functional
reserve may result in lymphedema.
Protein-rich intersititial edema
Fibrosis of the subcutaneous tissue
Increased infection rate
Arthropathy and alterations of ligaments/tendons
Weissleder, et al: Lymphedema, 2008
Fibrosis = repair of connective tissue
Four components of fibrosis:
-Migration and proliferation of fibroblasts
-Deposition of extracellular matrix
-Maturation and organization of fibrous tissue
In chronic lymphedema, there are inflammatory cells in the
dermis – mast cells, polymorphonuclear leukocytes,
macrophages lymphocytes, plama cells and histiocytes.
The mononuclear cell inflitrate initiates the
cytokine cascade that accompanies the release of proteases
and local tissue destruction. Elastic fibers are damaged early
in these events. There is collagen phagocytosis.
Lipid clearance from the dermis is impaired in chronic
lymphedema, stored lipid droplets being a characteristic
feature of the macrophages.
The epidermis is acanthotic, the proliferation of the
keratinocyctes being influenced by cytokines released
from the cellular elements of chronic dermal infiltation,
hypertrophic vasuclar endothelial cells and epidermal
The intracellular spaces are expanded and filled with
protein-rich edema fluid.
Papillomatosis may develop in cases where there is
epidermal acanthosis, hyperkeratosis, proliferation of
connective tissue and increased newly formed blood
vessels. The papillomata contain a small number of dilated
From 11 major medical indices
IPC Search Used
(N =13 articles included)
(N = 646 articles excluded)
By Research Librarian
LE Search Terms Used
(N = 5,927 articles)
Phase 1 – Screen 1
Review of title and Abstracts
LE Research Domain
(N = 1,303 articles included)
(N = 4,624 articles excluded)
Phase 1 – Screen 2
Review of Abstracts
Inclusion/Exclusion LE Criteria Applied By Editors
(N = 659 articles included)
(N = 644 articles excluded)
Figure 1.Literature review process for IPC and lymphedema systematic review
ALFP Literature review process for IPC and lymphedema systematic review 2004-2011
IPC Search Used
Key Words including pneumatic compression device, intermittent compression therapy, IPC, pneumotherapy, compression pressure.
N=13 articles included
N=646 articles excluded
Phase 2 – Screen 4
Review of Full Text
Inclusion IPC Criteria Applied
(N = 13 articles included)
Inclusion Criteria: valid study design (RCT, CT) or literature review.
IPC was the intervention on patients with primary or secondary lymphedema.
Weight of Evidence category
Strong evidence from at least one published systematic review of multiple
well-designed randomized controlled trials. 2 articles
Strong evidence from at least one published properly-designed randomized
controlled trials of appropriate size and in an appropriate clinical setting.
Evidence from published well-designed trials without randomization, single
group, pre-post, cohort, time series or matched case-controlled studies.
IV Evidence from well-designed non-experimental studies from more than
one center or research group. 0 articles
Opinions of respected authorities, based on clinical evidence, descriptive
studies or reports of experts consensus committees. 3 articles
1948 – Conrad Jobst, an engineer from Toledo, Ohio, consulted with
Dr. Brock E. Brush at the Henry Ford Hospital, Detroit, because of a
chronically swollen leg caused by deep phlebitis. A compression stocking
was prescribed but the tightness varied at different levels and created
constricting bands. Mr. Jobst observed that when he swam and stood
in Lake Erie, his leg felt better if the water was up to his waist.
He realized that there was graduated pressure. He then designed
gradient pressure garments.
In 1955, Brush and Heldt published a paper on a apparatus for the reduction
of limb edema. The device was built with the aid of the Scientific Laboratory
of the Ford Motor Co. and the pump design was improved and the pump
manufactured by the Jobst Institute.
The Jobst apparatus utilized is comprised of three features:
A sleeve of special fabric in the length in which are incorporated two
inflatable rubber lubes of about 1-in. caliber. Thissleeve is laced on so
that it can be adjusted to anarm of any size. A nonelasticglove is used in
conjunction with the sleeve to prevent svvellingof the hand while the pump is in use.
2. A speciallyconstructed, electrically operated air pump with a
timing device permitting inflation of the rubbertubes for 45 seconds and a collapsing rest oithesetubes for 15 seconds of every minute that the
device is in operation. Pressure: 40-50 mmHg
3. A custom-measured pressure-gradient sleeve to be worn when
the pump is not in use.The arm measurements for ihis sleeve are taken
after a few days of pumping, when the arm has been reduced in size.
It has been our practice to begin the treatment 3-4 days, 6 to 8 hours/day.
Rest 15 minutes Q 2 hours.
Dimensions: 5.5 x 12 x 8 (H x W x D)
Weight: 6 lbs
Pressure Range: 0-125mm Hg
Electrical Rating: 120 VAC, 60 HZ, .5 A
Cycle Time: 18 secs per chamber
Deflation: 18 secs
Warranty: 3 years
Bilateral operation available
Used with 4 chamber garment.
Multi-Chamber segmented, calibrated HCPCS Code E0562
Gradient, sequential, pneumatic compression device, intended for the primary
or adjunctive treatment of primary or secondary Lymphedema
Use with 8 chamber garment. Bilateral treatment available.
Features & Benefits
Password Protected - Patients cannot change settings
Tracks Patient Use - Hour Meter –Tracks patient compliance
Digital Display - Pressure displayed for each cell for safety
Leak Detection - Smart device detects leaks
Bilateral Capabilities - Treat 2 extremities simultaneously
- 5 appliance cells. Can use 1 to 5 cells.
Pretherapy™: Treatment based on the principles of manual lymph drainage.
It starts proximally (near or over the torso, depending on the garment), to decongest
these areas prior to sequential compression therapy. and provides extra treatment
for lymphedema occurring at the upper arm or leg.
12-Zone Calibrated Gradient Sequential Compression: Treatment for lymphedema
and venous insufficiency, with the LymphaPress® short cycle time and 12 to 24
overlapping chambers. Pressures in each chamber can be set individually at the pump,
to adjust for focal pain, fibrosis, and other clinical situations.
Torso and abdominal garments: For treatment of lymphedema occurring in the trunk,
abdomen or genital areas. The Comfysleeve™ 1-75 and Lympha Pants II™ treat the
torso, trunk and abdominal areas, as well as the torso-limb juncture.
Individualized treatment: Pressure, treatment time, and mode are all adjustable
to meet individual patient needs and increase compliance.treatment application.
Patient Lock: Treatment pressure and modes are locked in, to maximize compliance
and prevent tampering, for safe and easy use at home.
Unlike traditional compression pumps that squeeze and hold the affected areas,
the Flexitouch system promotes natural movement of fluid through the lymphatic system
into healthy areas of the body. The mechanism of action of the Flexitouch system has
been clinically proven to stimulate the lymphatic system.
The Flexitouch system offers multiple treatment options to provide customized treatment
for your patient. These treatment options include limb only and limb and core treatment
along with supplemental treatment options to focus on specific body areas that may need
additional treatment. With multiple garment and accessory sizes and adjustable velcro,
the Flexitouch system offers both the treatment and sizing to provide effective treatment
for your patient.
This treatment option provides traditional distal to proximal treatment preceded by proximal clearing of the trunk, thigh, calf, and foot. Enhanced programming and the addition of a core accessory applies treatment that extends past the inguinal area into the trunk, providing comprehensive treatment to patients when clinically appropriate.
Approximate treatment time: 1 hour
HOW IT WORKS
TRUNK: directs fluid from the groin toward the waist; cycle repeats
THIGH: directs fluid from the knee toward the top of the thigh; cycle repeats
CALF: directs fluid from the ankle toward the knee; cycle repeats
FOOT: directs fluid from the foot toward the ankle; cycle repeats
FULL LEG AND TRUNK: directs fluid from the toes to the waist in one continuous motion; cycle repeats
Foldi: “Unlike CDT, pneumomassage is incompatible with anatomy, physiology and pathophysiology.” It exerts pressure on the extremity and shifts edema fluid into the root of the limb and into the adjacent trunk quadrant.
Pappas and O’Donnell: 49 inpatients treated with Lymph Press @ 80-90 mmHg maximum pressure for twice daily 8 hour periods of compression for 2-3 days and then fitted with compression garments. Patients with rapid reaccumulationcontinued with home treatment 4 hours/day. Others were treated 2-3 days/week as outpatients for 4-6 months.
26/43 had the limb return to normal size. 10/43 had a partial response and 7/43 no repsonse. Those with less fibrosis and more compliant tissues had a better response.
j VascSurg 1992, 16: 555-64
The pressure settings routinely used for IPC treatment are well in excess of the pressure within the skin lymphatic vessels which are in the range of
+/- 4 mmHg to 8 mmHg (Mayrovitz, 2007).
The pressure must be sufficient to overcome the resistive tissue forces.
In lymphatic obstruction, the subcutaneous tissue pressure can be
significantly elevated to 15 mmHg to 18 mmHg.
However, the pressure should not collapse the superficial lymphatics
and pumps should only be used as part of a CDT program
A peak inflation pressure of 25 mmHg to 50 mmHg is sufficient for patients
without significant fibrosis. Fibrotic skin requires higher pressure,
as high as 100mg (Olszewski).
Does IPC stimulate lymph collectors or the autonomic nervous system that
controls them, or is the edema reduction only due to shifting interstitial
fluid to prelymphatic channels and/or initial lymph vessel network or thru the
Miranda, et al reported on 11 patients with LE lymphedema before and after a
single 3 hour SIPC treatment. Subjects had LAS prior to and 48 hours after
LAS index scores based on appearance, density and number of lymphatics, dermal backflow and collateral lymphatics in the limb and visualization of intensity of popliteal and inguinal nodes.
There was a significant reduction in leg volumes but not in the LAS index scores indicating increased transport of water without comparable transport
of macromolecules ( protein). SPIC may have reduced lymphedema by
reducing blood capillary filtration (lymph formation) restoring balance in lymph
Miranda F, Perez CJ, et al: Lymphology 34 (2001) 135-141
The fluid mobility in subcutaneous pitting edematous tissue is significantly
greater than that of normal tissue.
Edematous fluid in the distal arm showed greater mobility than in proximal sites.
Improvement of edema due to pneumatic compression (Lympha Press)
was found to be greater at the distal sites than at the proximal sites. Pressure
80-130 mmHg for 5 days, 4 hours each treatment.
Edema recurred between treatments.
Mridha M, Ödman S Scand J Rehab Med 21, 1989
Normal leg subcutaneous tissue pressure is between 1.5 and 10 mmHg.
In the lower extremity, pneumatic compression generates tissue fluid pressures on the average 20% lower than in the inflated skin chambers in a study of Stage !! to IV
lymphedema(Olszewski). This variance may be attributed to skin rigidity (fibrosis), low hydraulic conductivity of the subcutis, and dissipation of the
applied force in the subcutus to the proximal non-compressed regions. IPC
produced unidirectional flow toward the groin without backflow.
The total proximally displaced volume from ankle to groin was up to
100 ml/cycle. Pump pressures were 50 to 125 mmHg, 50 sec inflation time
each chamber and 50 sec deflation when cycle completed.
No statistically significant association was found between reported
use pattern and age, gender, lymphedema severity, or time since
The usual recommendation is for 1 hour 6 or 7 days/week
Adherence: Use generally tapers off after months or years.
Ridner et al, OncolNurs Forum 35 (2008)
Boris, Weindorf, Lasinski: Reported on the occurrence of genital edema
in 128 patients with LE lymphedema.
75 patients– no pump therapy
53 patients – used a pump.
of the pump patients developed genital edema after pump therapy
The incidence of genital edema was not affected by age, sex, duration
or grade of LE, whether the lymphedema was primary or secondary.
Also, the incidence of genital edema was unaffected by the type of pump,
single chamber (37%) or sequential (63%), the pressure level applied or
duration of use.
Pressures: 13% < 40, 23% 40-80, 23% >80, 37% unknown.
The patients who had IPC treatment and developed genital edema
did not have genital edema prior to IPC treatment.
Lymphology 31 (1998) 15-20
50 y/o 146 lb female developed right developed bilateral leg edema in
her late 30s after the a heavy object fell on each foot at different times.
Both feet swelled and the swelling persisted with varying severity.
In November, 2011, there was incresed edema including the thighs,
Her podiatrist ordered a Biocompression Model 3004 sequential pump.
Instructed to use the pump BID for 20 minutes @60 mmHg.
The legs became numb and the patient reduced the pressure to 40 mmHg.
The podiatrist again recommended 60 mmHg but the patient set the pressure
to 50 mmHg. After 2 treatments, groin edema noted including labial edema.
Also became aware of buttock edema. The genital edema subsided
but the buttock edema persists.
Finally referred for CDT.
Has bilateral leg edema and Stemmer sign present each foot.
Use of IPC at home can reduce clinic treatments
The pumps are expensive but are DME and usually covered by commercial insurance.
CMS 2001: The following conditions must be met:
Refractory Primary and Secondary Lymphedema
1. The member has undergone a four-week trial of conservative therapy that must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb.
2. The treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial therapy.
3. The member has shown compliance in the previous treatment options and is capable of following instructions that accompany the use of the lymphedema pump.
For indications other than cited above.
When the medical guidelines shown above are not met.
Appliances used for pneumatic compression of the chest or trunk (E0656 and E0657)
will be denied as not medically necessary.
Reid sleeve- A non-elastic binder for an extremity (A4465) is non-covered for all
indications because it does not meet the definition of a surgical dressing.
- Increase total tissue pressure.
- Can soften the limb and squeeze out water.
- Relatively easy to use.
- Programmable pumps can simulate MLD.
- DME: usually covered by insurance.
- Do not mobilize protein effectively.
- If used as the sole treatment, fluid returns.
- May not decongest the adjacent trunk.
- Can cause swelling in the adjacent trunk.
- High cost: $ 1,000 to 9,000.
IPC can be effective promoting fluid upatke and alleviating swelling.
There is evidence to suggest fluid transport is not associated with
transport of macromolecules (proteins) from the interstitial tissue.
The Review supports a multi-modality approach when fluid uptake
is desired in an altered state of lymphatic dysfunction.
Level I-II evidence supports compression pressures in the range between
30 and 60 mmHg. IPC pressure is dissipated when applied to tissue.
Forces such as tissue resistance and blood pressure should be considered
when applying IPC.
There is no standard consensus for the frequency of IPC treatments.
None of the studies reported significant adverse events during or after the