Benefits of Compression in Lymphedema Patients:...

Benefits of Compression in Lymphedema Patients:

Experience With Routine Use

Thomas S. Maldonado MDProfessor of Surgery

New York University Langone Medical CenterDivision of Vascular and Endovascular Surgery

Division of Vascular and Endovascular Surgery

Interstitial accumulation of protein-enriched fluid

• Affects over 90 million worldwide

• Chronic disfiguring disease secondary to excessive fluid and protein accumulation in the interstitium as a result of lymphatic system stasis or obstruction

Lymphedema


Lymphedema

•Primary lymphedema: •congenital malformation•lymphedema praecox•lymphedema tarda

•Secondary lymphedema:•surgery•lymphatic trauma •Obesity•radiation therapy


Edema Formation

Increased Capillary Hydrostatic Pressure

- venous pressures gravitational forces, heart failure, venous obstruction

Decreased Plasma Oncotic Pressures (hypoproteinemia)

Increased Capillary Permeability caused by pro-inflammatory mediators

Histamine, bradykinindamage to structural integrity of capillary:

Tissue trauma, burns, severe inflammation

Lymphatic Obstruction (Filariasis, primary/secondary lymphedema)

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Lymphatic function and how CVI turns to lymphedemaa

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• Continuous over use and high luminal pressure permanently damage the lymphatic system, further reducing transport capacity, causing mechanical insufficiency, also resulting in edema.

• Patients with CVI display lymphatic damage in dermal biopsies even at early stages of CVI


High-input FailureVenous edema

• Capillary pressure : interstitial fluid


Low-output FailurePathologic process compromises lymphatic flow


Signs/symptoms•Edema

• Expansion of the interstitial space• Swelling extends to the toes: Stemmer’s sign• Swelling is initially soft with “pitting edema”• Induration and Fibrosis

•Pain

• Rare• Aching/heaviness of the limb

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Skin Changes

•Hyperkeratosis•Lichenification•Peau d/orange•Verrucae•Frank ulcerations are rare

Presentation Title Goes Here 9

Division of Vascular and Endovascular Surgery10

Pneumatic Compression Improves QOL in LE Lymphedema

Clinical presentation


Imaging:•Venous duplex: look for treatable venous insufficiency

•Lymphoscintigraphy: assessment of lymphatic function and visualization of major lymphatic trunks

•CT scan/MRI: •Lymphedema is confined to the epifascial space, sparing muscle•Characteristic honeycomb distribution of edema in the epifascialstructures and thickening of skin

•Venous edema effects both the epifascial and fascial compartments•Lipidema = fat accumulation without fluid

•Direct contrast lymphangiography: Limited to specialized center• Direct injection of iodine-based, lipid-soluble agent into subcut. lymphatics• Technically difficult• May exacerbate lymphatic dysfunction

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MRI findings:

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Lymphscintigraphynormal


abnormal

Dermal backflowLymphatic hypertension

Colloid RefluxValvular Incompetence


Why is lymphedema the orphan of the medical profession?



While there is currently no Cure…

We must understand the treatment options andWe must empower patients…


Traditional treatment approachMAINTENANCE NOT CURE

•Mainstays of treatment for lymphedema: •Skin hygiene•Diet and Exercise •Pressure and trauma avoidance•Manual lymphatic drainage •Compression wraps and elevation•Pneumatic Compression• (Surgery?)

17Pneumatic Compression Improves QOL in LE Lymphedema


Manual reduction of limb swelling

•Complex Decongestive Thearapy: comprehensive reduction program•Elevation•Manual lymph drainage/massage•Therapeutic exercise•Compression wraps

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After 6 months of complex wrapping and exercise: 42% volume reduction

19Cronenwett JL. Rutherford s Vascular Surgery. 8th ed, Philadelphia, PA, Saunders/Elsevier, 2014.

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Elevation

•Easiest way to reduce early lymphedema•Elevation of 30-45 degrees•Maximal reduction is usually achieved in 3-5 days

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Pneumatic compression•Concept dates back to the early 1800s with the first single chamber device introduced in 1934

•Flexitouch® pneumatic compression is unique: • 32 curved chambers• self inflate and deflate sequentially, mimicking a functional drainage system

•targets major lymphatic beds and venous drainage system simultaneously

•Treatment sessions are approximately 45 mins



• Truncal stimulation + extremity stimulation

• Mild, dynamic pressure delivered in 1-3 second intervals

• Gentle “work and release” action

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Traditional PCD10 “Press and Hold”Flexitouch System10 “Work and Release”

10. Mayorvitz H.N. et al. (I2007) Interface Pressures Produced by Two Different Types of Lymphedema Treatment Devices. Physical Therapy. 007;Vol.87(10)1379-1388.

• Extremity stimulation only

• High pressure delivered over longer periods of time

• “Press and hold” action

Not all PCDs are the same: The physiologic mechanisms applied are distinct

http://www.google.com/url?sa=i&rct=j&q=e0651+pneumatic+compression+garments&source=images&cd=&cad=rja&docid=Y1v0xzBcliow6M&tbnid=U_-gtR83Js3LsM:&ved=0CAUQjRw&url=http://magnusson12.nazata.com/chan-7315943/all_p1.html&ei=nMvyUbmWIdHbqQGVroDACw&bvm=bv.49784469,d.aWM&psig=AFQjCNEfeWZV8CNTXhdNKSMRMLN8RPVcWA&ust=1374952687648222


Evidence of Improved Lymphatic Function with the Flexitouch System

Study Results:• Breast cancer-related lymphedema patients

• 4 of 6 arms showed proximal movement of lymph toward the axilla with Flexitouch System use

Pre Post

Evidence of lymph movement toward

axilla

Adams, K.E. et al. (2010) Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. Biomed Opt. Express. 2010 Jul15; 1(1): 114-125.


How do you define long term success?


Best Treatment of Lymphedema

“Best defense, don’t be there”

PREVENTION


Scelsi R, et al. Morphologic changes of dermal bloodand lymphatic vessels in chronic venous insufficiency of the leg ; Int Angiol. 1994 Dec;13(4):308-11


•Stage of lymphedema Stage II or greater included

•196 total limbs

•The cohort was characterized by more female patients (68%)

• Individuals with secondary lymphedema accounted for nearly 80% of the study population

•The follow-up clinical assessment : 60+/- 27 days (range 17-242; median 55.5)

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• 90% of APCD-treated patients experienced a significant reduction in limb volume

• 35% had a limb volume reduction >10%

Percent Change in Limb Volume From Baseline


Figure 1. Boxplots for multiple patient subsets, displaying paired pre-treatment versus post-treatment limb volume (LV).



Body Mass Index


Conclusions from this study:

•90% of APCD-treated patients experienced a significant reduction in limb volume

•35% had a limb volume reduction >10%

•Mean limb volume reduction reduction was 1,150 mL or 8% (p < .0001)

•Greater baseline limb volume and BMI were strong predictors of LV reduction (p < .0001)



Ann Vasc Surg. 2016 Jan;30:40-4. doi: 10.1016/j.avsg.2015.07.004. Epub 2015 Aug 7.

https://www.ncbi.nlm.nih.gov/pubmed/26256706


Study Objective•Primary objective:

•To demonstrate improved quality of life in patients with lower extremity lymphedema with PC treatment

•Secondary objectives: •To demonstrate reduced infectious complications of lymphedema with PC treatment•To determine the incidence of concomitant venous insufficiency in patients with lymphedema

•Pneumatic Compression Improves QOL in LE Lymphedema 35


•Consecutive patients with lower extremity lymphedema presenting for treatment from 2012 to September 2014

•Inclusion criteria: •Age 18 or older •Presence of lymphedema in the lower extremity for at least 14 days

•Exclusion criteria: •Pregnant women•Previous use of the pneumatic compression device •Class IV congestive heart failure

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Methods



•Pneumatic compression device was given to all patients for a minimum of 3 months

•Venous duplex ultrasound obtained at initial visit

•Pre- and post-PC data collected on cellulitis, venous insufficiency, ulcers and limb-girth

•Quality of life questionnaire (CIVIQ-2 QOL) administered to all patients at 3, 6 and 12 month follow up.

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Methods


Division of Vascular and Endovascular Surgery38Pneumatic Compression Improves QOL in LE Lymphedema


Methods: Questionaire


P


Results: Venous insufficiency



Results: Limb Girth Changes after PC


Results: Venous reflux & Patient Reported Outcomes


p=0.257


Results: Quality of Life



Ongoing VA multcenter study….

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Title of Study

Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients using an Advanced Pneumatic Compression Device at Home.

Protocol Date

15Dec2015

Protocol Version

2.0

Name of Sponsor

Tactile Medical™

Investigational Product

Flexitouch system

Primary Endpoint

QOL, symptom assessment

Secondary Endpoint

Limb Circumference Changes, Compliance, skin changes

METHODOLOGY

Study Design

Multi-center, single arm, observational clinical trial

Treatments

The subjects will be instructed to use the Flexitouch as prescribed and will be followed for 52 weeks. The subjects will be seen in clinic weeks 4, 8, 12, 24 and 52 after completion of the baseline visit. The subject will also be asked to participate in a phone follow up visits 1 week after device training and 18 weeks after the baseline visit.

Treatment Duration

As prescribed

SUBJECT POPULATION

Number Planned

300

Major Inclusion/ Exclusion Criteria

Inclusion Criteria:

1.1.1.1 Age 18 or older

2.0 Diagnosis of primary or secondary, unilateral or bilateral LE lymphedema

Exclusion Criteria:

· Class IV congestive heart failure

· Previous use of the study PCD

· Pregnant women or women of childbearing potential not on contraception

· Any condition where increased venous and lymphatic return is undesirable

ASSESSMENTS

Efficacy

Assessment of QOL, tissue and limb circumference changes

Safety

Adverse Event monitoring

Division of Vascular and Endovascular SurgeryPresentation Title Goes Here 45


Study Purpose:To investigate whether Flexitouch Advanced PCD use is associated with improved clinical outcomes and health economic costs in a large representative national population.

Study Design:• Analyzed health insurer administrative database of 34 million individuals

• Identified patients with lymphedema who received the Flexitouch System (total n = 718)

• Examined health outcomes and costs for cancer-related (n = 374) and non-cancer-related (n = 344) lymphedema patients

Karaca-Mandic, P. et al. (2015) JAMA – Dermatology, Oct. 2015.

Follow-Up Ends

Baseline Period(12 months continuous insurance

eligibility)

Follow-Up Period(12 months after device use

initiated)

Follow-Up Starts

Jan 2007

Baseline Begins

Nov 2013

First receipt of a PCD (Index Date)

Lymphedema diagnosis

Cancer-Related LE (N = 374)

Non-Cancer-Related LE (N = 344)


BEFORE and AFTER Flexitouch….

JAMA Dermatol. 2015;151(11):1187-1193. doi:10.1001/jamadermatol.2015.1895

Division of Vascular and Endovascular SurgeryJAMA Dermatol. 2015;151(11):1187-1193. doi:10.1001/jamadermatol.2015.1895


Flexitouch Demonstrated Reductions in Key Adverse Events, Health Care Utilization & Costs


Conclusions : keys to longterm success

•Lymphedema is a prevalent disease and often neglected disease … adopt the orphan!

•Accurate diagnosis is key

•Empower the patient

• Treatment options are multi-dimensional and should be used together

• Skin hygiene• Diet and Exercise • Manual lymphatic drainage • Compression wraps and elevation• Pressure and trauma avoidance


•Pneumatic compression works

•90% of patients experience a significant reduction in limb volume• Greater baseline limb volume and BMI may serve as predictors

of LV reduction

• Improves symptoms and quality of life in patients with lower extremity lymphedema

• Decreases the number of infectious and wound healing complications

• Significant decrease in Lymphedma-related cost per patient (37%)In-patient VisitsOut-patient VisitsClinic VisitsEpisodes of Cellulitis

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• Prevention is key• Treat Early• Recognize that CVI and lymphedema are part of the same continuum

• Don’t wait until patients have reached late stage Lymphedema to treat

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Benefits of Compression in Lymphedema Patients: Experience With Routine UseLymphedemaLymphedemaEdema Formation Lymphatic function and how CVI turns to lymphedemaaHigh-input FailureLow-output FailureSigns/symptomsSkin ChangesClinical presentation Imaging:MRI findings:Lymphscintigraphy�normalabnormalWhy is lymphedema the orphan of the medical profession?Slide Number 16Traditional treatment approach�MAINTENANCE NOT CURE�Manual reduction of limb swellingAfter 6 months of complex wrapping and exercise: 42% volume reduction Elevation Pneumatic compressionSlide Number 22Evidence of Improved Lymphatic Function with the �Flexitouch SystemSlide Number 24Best Treatment of Lymphedema�Slide Number 26Slide Number 27Slide Number 28Slide Number 29Slide Number 30Figure 1. Boxplots for multiple patient subsets, displaying paired pre-treatment versus post-treatment limb volume (LV). �Slide Number 32Conclusions from this study:Slide Number 34Study Objective Methods Methods Slide Number 38Methods: QuestionaireResults: Venous insufficiencySlide Number 41Results: Venous reflux & Patient Reported Outcomes Results: Quality of Life�Ongoing VA multcenter study….Slide Number 45Slide Number 46BEFORE and AFTER Flexitouch….Slide Number 48Flexitouch Demonstrated Reductions in Key Adverse Events, Health Care Utilization & CostsSlide Number 50Conclusions : �keys to longterm successSlide Number 52Slide Number 53Slide Number 54

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