INTERMITTENT PNEUMATIC COMPRESSION

1. INTERMITTENT PNEUMATIC COMPRESSION TO PUMP OR NOT TO PUMP Joseph Feldman, M.D., CLT-LANA

2. 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.

3. 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.

4. 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

5. 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)

6. 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.

7. 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.

8. 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

9. 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.

10. 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

11. 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.

13. 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.

15. 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. • .

17. 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.

18. 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.

19. 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.

20. 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.

21. Original Wright Linear Pump

22. Wright Linear Pump

23. 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.

24. 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

25. Early Lypha Press circa 1980s

26. Lympha Press Optimal

27. 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.

28. Flexitouch

29. 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.

30. 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

31. 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

32. 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).

33. 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

34. 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

35. 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.

36. 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)

37. 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

38. 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

39. 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

40. 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.

41. 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.

42. 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.

43. 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.

44. 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.