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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

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slide1

INTERMITTENT PNEUMATIC COMPRESSION

TO PUMP OR NOT TO PUMP

Joseph Feldman, M.D., CLT-LANA

slide2

Lymphedema is an external manifestation of

lymphatic system insufficiency and deranged lymph

transport.

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.

slide3

Lymphostasis

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.

slide4

Consequences of chronic lymphostasis/

lymphedema

Protein-rich intersititial edema

Fibrosis of the subcutaneous tissue

Increased infection rate

Lymphostatichemangiolymphangiopathy

Lipogenesis

Arthropathy and alterations of ligaments/tendons

Weissleder, et al: Lymphedema, 2008

slide5

Fibrosis

Fibrosis = repair of connective tissue

Four components of fibrosis:

-Angiogenesis

-Migration and proliferation of fibroblasts

-Deposition of extracellular matrix

-Maturation and organization of fibrous tissue

(remodeling)

slide6

Inflammation

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.

slide7

Epidermal Changes

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

cells.

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

lymphatics.

slide8

Initial Literature Search

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

slide9

Phase 2 – Screen 3

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.

slide10

TABLE 3 Bandolier Ranking System

Weight of Evidence category

Description

I

Strong evidence from at least one published systematic review of multiple

well-designed randomized controlled trials. 2 articles

II

Strong evidence from at least one published properly-designed randomized

controlled trials of appropriate size and in an appropriate clinical setting.

3 articles

III

Evidence from published well-designed trials without randomization, single

group, pre-post, cohort, time series or matched case-controlled studies.

5 articles

IV Evidence from well-designed non-experimental studies from more than

one center or research group. 0 articles

V

Opinions of respected authorities, based on clinical evidence, descriptive

studies or reports of experts consensus committees. 3 articles

slide11

IPC History

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.

slide13

Brush BE, Wylie JH, Beninson J, et al. Arch Surgery 77(4), 1958

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.

slide15

Characteristics of IPC devices

  • IPC Device
  • Unique Characteristics
  • Single Chamber HCPCS E0650 – non-segmental
  • Single cuff that expands and contracts applying pressure against the limb.
  • No manual control over pressure distribution.
  • No pressure gradient exists.
  • Not optimal for lymphedema management.
  • .
slide17

Multi-Chamber segmented without manual control HCPCS Code E0651

  • Commonly have 3-4 chambers which inflate sequentially from distal to
  • proximal until all are inflated and then all deflate together.
  • May have limited pressure programming options and are not
  • independentlyadjustable.
  • May be constructed so that each chamber has the same pressure and
  • pressure gradient is achieved by virtue of the limb contours.
  • These pumps can treat one or two legs or arms.
slide18

Sequential Circulator SC-2004

E0651

Specifications:

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

Inflation:72 secs

Deflation: 18 secs

Warranty: 3 years

Bilateral operation available

Used with 4 chamber garment.

slide19

Multi-Chamber segmented, calibrated HCPCS Code E0562

  • Gradient pressure exists; higher pressure in the distal chambers
  • and lower pressures in the proximal chambers
  • Exhibit at least three zones of pressure; some pumps allow adjustment of
  • each chamber.
  • Typically manually programmable, enabling adjustment of the level and
  • location of compression.
  • May have from 4 to up to 36 chambers.
slide20

Sequential Circulator

SC-3004

E0652

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.

slide23

Wright Linear Pump

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.

slide24

Advanced compression systems HCPCS Code E0652

  • Enable digital programming.
  • May simulate, through adjacent pneumatic truncal applications, the action of clearing the proximal trunk and extremity.
  • The truncal and proximal chambers enable clearing of the lymphatic pathways.
  • Only 1 to 2.5 chambers at a time are active as compression progresses in a distal-to-proximal direction, simulating the action of manual lymphatic drainage
slide27

Features:

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.

slide29

Flexitouch

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.

slide30

Full Leg and Core

PROGRAM L1

.................................................................

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

slide31

Contrasting Views of IPC.

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

slide32

Pressure Level

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

(Szolnoky, 2009).

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).

slide33

Physiology

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

venous circulation?

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

SPIC treatment.

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

kinetics.

Miranda F, Perez CJ, et al: Lymphology 34 (2001) 135-141

slide34

Physiology

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

slide35

Physiological Changes

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.

slide36

Treatment Times and Frequency

No statistically significant association was found between reported

use pattern and age, gender, lymphedema severity, or time since

diagnosis.

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)

slide37

Contraindications to ICT

  • Acute Skin Infection
  • Phlebitis – SVT/DVT
  • Bone mets to treated area – a relative contraindication
  • Unhealed fractures
  • CHF
  • Generalized edema
  • Ischemic vascular disease. ABI >0.8
slide38

Use Caution for the Following Conditions

  • Peripheral Neuropathy, especially with significant sensory loss
  • Open Wounds
  • Fragile Skin
  • Significant Limb Asymmetry
  • Pregnancy – no proximal compression
  • Adjacent trunk, genital edema
slide39

Genital Edema Is Not A Myth

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

(p=.0001).

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

slide40

Case Report

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.

slide41

Cost Considerations

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.

slide42

WHEN COVERAGE WILL NOT BE APPROVED by CMS (Medicare)

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.

slide43

IPC

Advantages:

- 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.

Disadvantages:

- 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.

slide44

Conclusions

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

IPC treatments.