1 Pneumatic Compression Devices

7/25/2019 1 Pneumatic Compression Devices

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1 Pneumatic Compression Devices Literature Review February 2009 Prepared by:

Ro1 Pneumatic Compression Devices Literature Review February 2009 Prepared

by: Robert D. oover! "r.! #D! #P! F$CP Purpose %&e purpose o' t&is (iterature

review is to consider t&e scienti)c evidence 'or t&e use o' pneumatic compression

devices *PCD+ in t&e treatment o' (ymp&edema. %&e review wi(( attempt to

determine: 1. Does t&e medica( (iterature support t&e use o' one type o' PCDcompared to anot&er, 2. -' t&e medica( (iterature supports t&e use o' one type o'

PCD compared to anot&er! are t&ere speci)c patient popu(ations or disease

conditions t&at support t&e medica( necessity o' one type o' PCD *e..! PCD wit&

manua((y/contro((ed pressures vs. wit&out manua( contro(+, %ypes o' Pneumatic

Compression Devices and $pp(iances *s(eeves+ %&ere are basic types o' PCDs: 1. $

non/semented pneumatic compressor *ea(t&care Common Procedure Codin

ystem *CPC+ code 0340+ is a device w&ic& &as a sin(e out5ow port on t&e

compressor. %&is out5ow port may be connected to a s(eeve6app(iance wit& mu(tip(e

compartments or sements *0371/037+ and may ac&ieve a se8uentia( pressure

radient t&rou& t&e desin o' t&e tubin and6or air c&ambers in t&e

s(eeve6app(iance. 2. $ semented pneumatic compressor wit&out ca(ibrated

radient pressure *0341+ is a device w&ic& &as mu(tip(e out5ow ports on t&e

compressor w&ic& (ead to distinct sements on t&e app(iance w&ic& in5ate

se8uentia((y. %&ese devices ac&ieve se8uentia( compression by eit&er *a+ app(ication

o' t&e same pressure in eac& sement or *b+ app(ication o' a predetermined

pressure radient in successive sements but no abi(ity to individua((y set or adust

pressures in eac& o' one or severa( sements. -n t&ese devices! t&e pressure is

usua((y set by a sin(e contro( on t&e dista( sement. %&ey are used wit&

s(eeves6app(iances *0337/0339+ t&at are mu(ti/c&ambered t&us a((owin 'or

se8uentia(! radient compression. . $ semented device wit& ca(ibrated radient

pressure *0342+ is c&aracteried by a manua( contro( on at (east t&ree out5ow

ports w&ic& can de(iver an individua((y determined pressure to eac& sementa( unit.

%&ese PCDs are a(so used wit& a mu(tic&ambered s(eeve6app(iance to ac&ievese8uentia(! radient compression. vidence Review Criteria $ P; and =compression> combined wit&

=(ymp&edema.> ?n(y n(is& (anuae 'u(( te@t artic(es were reviewed. %&e searc&

was (imited to artic(es pub(is&ed 'rom 19A0 to 200A. %&e re(ative strent& o' t&e

evidence presented in t&e c(inica( studies was assessed accordin to t&e uidance

provided by t&e Centers 'or #edicare B #edicaid ervices *C#+ to contractor

medica( directors 'or deve(opin (oca( coverae determinations *LCDs+.1 2

$ccordin to C# instructions! coverae po(icies s&ou(d be based on: 1. Pub(is&ed

aut&oritative evidence derived 'rom de)nitive randomied c(inica( tria(s or ot&er

de)nitive studies and! 2. enera( acceptance by t&e medica( community *standard

o' practice+! as supported by sound medica( evidence based on: a. cienti)c data orresearc& studies pub(is&ed in peer/reviewed medica( ourna(s or! b. Consensus o'

e@pert medica( opinion *i.e.! reconied aut&orities in t&e )e(d+ or! c. #edica(

opinion derived 'rom consu(tations wit& medica( associations or ot&er &ea(t& care

e@perts. %&e instructions continue by statin: $cceptance by individua( &ea(t& care

providers or even a (imited roup o' &ea(t& care providers norma((y does not

indicate enera( acceptance by t&e medica( community. %estimonia(s indicatin suc&

(imited acceptance! and (imited case studies distributed by sponsors wit& )nancia(


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interest in t&e outcome! are not suEcient evidence o' enera( acceptance by t&e

medica( community. %&e broad rane o' avai(ab(e evidence must be considered and

its 8ua(ity s&a(( be eva(uated be'ore a conc(usion is reac&ed. &i(e t&is review is not

conducted to deve(op an LCD! its purpose wi(( support coverae decisions made by

t&e contractor medica( director. Conse8uent(y! t&e review wi(( be conducted in

accordance wit& uidance provided by C#. -n addition to artic(es and position

papers retrieved by t&e searc& described above! severa( manu'acturers o' PCDs

were asGed 'or c(inica( materia( supportin PCD use. vidence va(uation &i(e

numerous artic(es were reviewed notin t&at PCD &as become standard o' care in

most countries! conc(usive documentation o' t&e bene)ts o' t&is treatment moda(ity

are (acGin. %&e opinion e@pressed by t&e upportive Care uide(ines roup o'

Cancer Care ?ntario and t&e ?ntario #inistry o' ea(t& and Lon %erm Care is

i((ustrative o' t&is di(emma w&en t&ey state t&at =%&e (acG o' suEcient &i& 8ua(ity

evidence prec(udes de)nitive recommendations 'rom bein made.>2 &i(e t&is

statement was made in re(ation to treatment options 'or women wit& breast cancer

and (ymp&edema! t&e document 'urt&er states =%&ere is some evidence w&ic&

suests t&at p&ysica( t&erapies suc& as compression t&erapy and manua(

(ymp&atic drainae may improve estab(is&ed (ymp&edema but 'urt&er studies are

needed.> uba et.a(. conducted a randomied! prospective study at t&e tan'ord

Center 'or Lymp&atic and Henous Disorders c(inic comparin deconestive

(ymp&atic t&erapy *DL%+ a(one or DL% wit& adunctive intermittent compressive

t&erapy. %&e study uti(ied a e8uentia( Circu(ator 200I *! inc(uded 27 women w&o &ad

comp(eted an initia( one mont& o' intensive DL% but &ad (ess t&an one year o' DL%e@perience. $(( patients were )tted wit& and wore a C(ass -- compression arment. -n

tudy 1 *-nitia( %reatment+! 12 patients were randomied to DL% p(us PCD *roup 1+

and 11 to DL% a(one *roup 2+. $'ter two weeGs o' treatment! t&ere was a

statistica((y sini)cant vo(ume reduction in t&e aJected e@tremity o' I4.K vs. 23K

'or roup 1 compared to roup 2! respective(y. $t t&e end o' I0 days! vo(ume

reduction was 0.K 'or roup 1 and 27.1K 'or roup 2. %&e diJerence in vo(ume

reduction between t&e two roups at I0 days was not statistica((y sini)cant nor

was t&e c&ane 'rom t&e time o' t&e two weeG eva(uation &owever! it did

demonstrate t&at t&e eJects o' treatment are durab(e. -n tudy 2 *#aintenance

%reatment+! 27 patients were recruited and 24 comp(eted t&e study. Patients were

'o((owed 'or one mont& and were randomied to receive se('administeredmaintenance t&erapy wit& DL% a(one versus DL% p(us PCD. imi(ar to tudy 1! t&ere

was a statistica((y sini)cant reduction in (imb vo(ume in t&e roup randomied to

t&e DL% p(us PCD roup. %wenty/'our patients were 'o((owed 'or subse8uent 3 mont&

period wit& 19 e(ectin to continue use o' a PCD. %&ese patients e@perienced an

additiona( reduction in (imb vo(ume compared to t&e )ve patients e(ectin to

discontinue pump use. ubas study was sma(( and on(y inc(uded patients wit&

(ymp&edema subse8uent to breast cancer treatment. %&ere was no description o'


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t&e randomiation process and 'o((ow/up time was re(ative(y s&ort. -n addition! (iGe

many studies! patients used a compression arment or compression bandae

systems between treatments. ince aut&ors do not comment on t&e comp(iance

wit& arment use! its impact on t&e resu(ts o' PCD use are uncertain. Comp(iant use

o' a compression arment between sessions cou(d c(ear(y impact t&e vo(ume

reductions attributed to PCD use. %aGin t&at caveat into consideration! t&is study

did demonstrate t&at t&e use o' an 0341 PCD was eEcacious in reducin upper

e@tremity edema. RocGson and co((eaues conducted a randomied! prospective!

cross/over study o' massae versus PCD *F(e@itouc& / %acti(e ystems! -nc.+ in 10

patients wit& uni(atera( breast cancer/associated (ymp&edema o' t&e arm.I %&e

F(e@itouc& system uti(ies a arment t&at e@tends onto t&e t&oracic wa(( or

pe(vic6abdomina( reion! t&e bene)t purported to be encouraement o' e@cess 5uid

to 'o((ow e@istin pat&ways o' (ymp& movement 'rom t&e trunG to t&e centra(

circu(ation. $(( patients used se('/administered massae and compression arments

prior to randomiation. %&e study was conducted 'or 1I days a'ter a 1 weeG

was&out w&ere on(y compression arments were used *no massae+. %&e F(e@itouc&

arm ac&ieved statistica((y sini)cant reduction in vo(ume compared to t&e massae

a(one co&ort. %&e aut&ors observed t&at even in s&ort term use! I t&e device

con'ers t&erapeutic bene)t over t&at w&ic& can be attained t&rou& standard

t&erapies. owever! t&ey a(so note t&at t&is was a sma(( study o' (imited (ent& and

t&e protracted use o' t&is device must be considered in re(ations&ip to t&e retai( cost

o' between M10!A00 and M12!I00 *2004 pricin+. $dditiona( weaGnesses are t&e (acG

o' comparison to standard arments t&at encirc(e t&e (imb on(y and t&e 'ai(ure to

speci'y treatment pressures. Dini et.a(.4 *199A+ conducted t&e most wide(y cross/

re'erenced randomied study e@aminin t&e impact o' treatment wit& pneumatic

compression versus no treatment on post/mastectomy patients wit& (ymp&edema.

%&is study randomied A0 post/mastectomy women to eit&er intermittent

pneumatic compression or no treatment. omen in t&e treatment roup underwent

a two/weeG cyc(e o' )ve pump sessions per weeG! 'o((owed by a )ve/weeG breaG intreatment and t&en anot&er two/weeG cyc(e o' treatment. %&ere was no statistica((y

sini)cant diJerence in response rates between t&e two roups. %&e aut&ors

conc(uded t&at pneumatic compression pumps &ave a (imited ro(e in t&e

manaement o' patients wit& (ymp&edema. $ weaGness o' t&is study is t&e (acG o'

detai(ed in'ormation about t&e pump system used. %&e aut&ors state t&at PCD

sessions &ad cyc(e pressures o' 30 mm &owever! t&ere is no description o' t&e

system used or w&et&er a se8uentia( radient app(iance was used. "o&ansson and

co((eaues3 prospective(y compared manua( (ymp& drainae *#LD+ uti(iin t&e

Hodder tec&ni8ue to se8uentia( pneumatic compression app(ied to t&e upper

e@tremity in 2A women wit& post/surica( arm (ymp&edema 'o((owin breast cancer

and a@i((ary node dissection. Pneumatic compression was app(ied wit& t&e Lymp&a/Press device *0341 N 0337+ uti(iin I0/30 mm o' pressure 'or 2 &ours per day.

Compression arments were used in bot& t&e #LD and PCD patients between

treatments. Fo((owin a two weeG run/in usin a standard compression s(eeve

*arment+! 2I patients were randomied. $t t&e two weeG 'o((ow/up! t&ere was no

sini)cant diJerence between t&e two treatments *#LD vs. PCD+ in eit&er abso(ute

vo(ume reduction or in percent reduction in (ymp&edema. %&e aut&ors note t&at t&e

poorer resu(t 'or t&e PCD patients compared to ot&er studies *10! 14+ may be due to


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t&e s&ort duration o' treatment *2 &ours per day+. $ruin aainst t&is &ypot&esis is

t&e comparison o' t&e #LD and PCD demorap&ics. %&e PC roup &ad an averae

edema duration o' 3.4 mont&s versus 1I.0 mont&s in t&e #LD roup. tudies &ave

s&own t&at t&e duration o' t&e edema can sini)cant(y impact t&e success o'

(ymp&edema treatment due to scarin and )brous c&anes in t&e under(yin

tissues t&ere'ore! t&e PCD patients wit& t&e s&orter duration s&ou(d &ave &ad an

=advantae> towards improved 5uid reduction over t&e #LD patients. %&is was not

seen.


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&ome. $(( patients used compression stocGins between treatments. Patients were

'o((owed up at I 3 mont& interva(s over a mean time o' 24 N I mont&s. $ tota( o'

30K o' patients &ad a reduction to (imb irt& at t&e nine (eve(s o' (e w&ic& were

measured and 20K &ad reduction 'rom t&e dista( ca(' to t&e toe on (on/term 'o((ow/

up. Qineteen percent &ad minima( (imb irt& reduction. %&ere appeared to be no

eJect o' ender! duration o' (ymp&edema! type o' (ymp&edema! nor w&ic& (imb was

invo(ved on predictin t&e outcome o' t&e treatment. Pappas conc(uded t&at t&e

deree o' tissue comp(iance or subcutaneous )brosis as we(( as t&e mec&anics o'

t&e e@terna( pneumatic device itse(' *suc& as peaG pressure! compression cyc(e!

se8uence! and distribution o' 3 compression+ are t&e predictive measures in

(owerin edema by compression tec&ni8ues. For t&e best eJect t&ey proposed

compression o' t&e (imb not e@ceed t&e systo(ic pressure and used va(ues around

A0/90 mm. Four o' t&e participants! a(( 'rom t&e poor response roup!

e@perienced in'ection durin t&e 'o((ow/up period in spite o' institutin e@tra sGin

care measures. eaGness in t&is study desin is evident in t&e e@c(usion o' non/

responders and t&ose wit& arm edema. Qo comparison was made amonst t&e

cateories o' t&ose usin t&e device dai(y and t&ose c&oosin not to use it. %&ere is

diversity o' participants in t&e type! duration and amount o' (ymp&edema! ender!

amount o' pressure used and duration o' eac& treatment in t&e &ome settin. S(ein

et a(.9 e@amined t&e ri&t Linear Pump! speci)ca((y in t&e (ower e@tremity.

@c(usion criteria consisted o' presence o' in'ection! metastasis! c&ronic &eart

'ai(ure and rena( disease. eventy/t&ree subects were treated over a IA/&our period

wit& a radient! t&ree compartment device app(ied to t&e (ower (imb 'or 2/&ours.

$'ter a one &our rest period t&e device wou(d be app(ied wit& increasin duration to

a ma@imum o' A &ours. %&e protoco( was dependent on patient to(erance o' pain.

%&e dista( pressure was determined by t&e mean o' t&e systo(ic and diasto(ic wit&

t&e ot&er two ce((s diminis&in in pressure by 20 mm eac&. %&e tota( treatment

cyc(e was 120 seconds wit& 90 seconds o' pressure dista((y! 70 seconds 'or t&e

midd(e ce(( and 40 seconds pro@ima((y. %&e (imb was e(evated and wrapped betweentreatments. -n t&e IA/&our treatment protoco(! measurements were taGen at 4 (eve(s

o' t&e (e. Qinety percent o' patients s&owed a decrease in circum'erence at t&e

anG(e and mid/ca(' area! ranin 'rom 1.3 2.1 cm. $(( patients &ad some

improvement a'ter t&e IA &ours post/treatment. %&eir resu(ts suested t&at men

responded better t&an women. $(t&ou& S(ein noted t&at t&e reduction in

circum'erence at t&e )ve (eve(s o' t&e treated (imb were sini)cant! comparative

measurements o' t&e norma(! contro( e@tremity were not made t&us ca(cu(ation o'

t&e abso(ute reduction in (ymp&edema was not possib(e. $s wit& t&e ot&er studies

cited above! t&ere was variabi(ity in t&e participants deree o' (ymp&edema!

etio(oy! duration and amount o' compression pressure. -n 19A4 Ric&mand et.a(.10

e@amined t&e impact o' se8uentia( compression usin a Lymp&a/Press mu(ti/compartmenta( s(eeve *0341 N 0337+ on 2I patients. %&e study was prospective

but not randomied. %&ere was &eteroeneity wit& respect to t&e etio(oy o' t&e

(ymp&edema *primary vs. secondary+! duration o' (ymp&edema! (ocation o' edema

*upper vs. (ower e@tremity+ and prior t&erapies inc(udin one patient wit& previous

surery *C&ar(es Procedure+ 'or (ymp&edema. -n addition! t&e patients were studied

in an inpatient settin! con)ned to bed wit& t&e aJected e@tremity e(evated. Resu(ts

were on(y presented 'or (ower e@tremity vo(ume reduction despite 7 o' 2I patients


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enro((ed 'or upper e@tremity conditions. Lower e@tremity vo(ume was reduced by

appro@imate(y I4K. Fo((ow/up at /3 mont&s to determine t&e e@tent o' treatment

persistence was comp(icated by subect drop out. ?n(y I o' 7 patients in t&e upper

e@tremity and A o' 1A in t&e (ower e@tremity co&ort were avai(ab(e 'or 'o((ow/up

data. $ut&ors note t&at a(( patients compu(sive(y wore we((/)tted e(astic s(eeves and

aunt(ets to &e(p maintain vo(ume reduction. %&is study is poor(y desined and &as

sini)cant met&odo(oic s&ortcomins. %&e (acG o' data on upper e@tremity

treatment success! t&e (are number o' patients (ost to 'o((ow/up and t&e s&ort

duration o' treatment *1/2 days 7 inpatient+ maGe enera(iation o' t&e resu(ts to

(on term treatment diEcu(t. #oreover! as many aut&ors point out in various

reviews! t&e use o' compression arments between PCD treatments is critica( to

ac&ievin sustained resu(ts. Te(iGovsGi11 and co((eaues reported t&eir e@perience

wit& 232 patients usin t&e Lymp&a/Press PCD on bot& upper and (ower e@tremity

edema. From t&e description o' t&e device used! it appears to be an 0341. %&ey

conc(uded t&at resu(ts were encourain and noted 3/70K reduction o'

(ymp&edema in AAK o' patients wit& upper (imb (ymp&edema w&i(e (ower e@tremity

(ymp&edema =a(most comp(ete(y disappeared.> %&is was not a randomied tria( and

contained very (itt(e statistics detai(in t&e patients treated! etio(oies o'

(ymp&edema or t&e met&ods used to measure 5uid reduction. #oreover! w&i(e t&ey

note 232 patients were treated! t&e reductions noted above were 'or 112 patients

*I2K+! main(y post/mastectomy (ymp&edema. %&ere is no detai( provided on t&e

outcomes o' t&e ot&er 140 patients. Fina((y! it s&ou(d be noted t&at Te(iGovsGi

deve(oped t&e Lymp&a/Press device and &as a )nancia( interest in t&e outcome o'

any study. vidence Reviews6#eta/$na(ysis $ systematic review o' t&e common

conservative t&erapies 'or arm (ymp&edema secondary to breast cancer treatment

was conducted by #ose(y et a(. *2007+.12 %&e review inc(uded t&e 'o((owin

treatments: comp(e@ p&ysica( t&erapy! manua( (ymp&atic drainae! pneumatic

pumps! ora( p&armaceutica(s! (ow (eve( (aser t&erapy! compression bandain and

arments. %&e review 'ound t&at t&e more intensive and &ea(t& pro'essiona( basedt&erapies! suc& as comp(e@ p&ysica( t&erapy! manua( (ymp&atic drainae!

pneumatic pump and (aser t&erapy enera((y yie(ded t&e reater vo(ume reductions.

e('/initiated t&erapies suc& as compression arment wear! e@ercise and (imb

e(evation were 'ound to yie(d a (esser vo(ume reduction. %&e review inc(uded

randomied! contro((ed! para((e( and cross/over! case/contro( and co&ort studies. $

metaana(ysis cou(d not be per'ormed due to t&e treatment and data &eteroeneity.

Five studies were inc(uded t&at e@amined pneumatic pump t&erapy and most are

detai(ed individua((y above &owever! t&e Te(iGovsGi study 'rom 19A0 was reviewed

'or t&is ana(ysis but e@c(uded because t&e pressures used were sini)cant(y &i&er

t&an w&at is now recommended. -n addition as noted above! Te(iGovsGi is t&e

deve(oper o' t&e Lymp&aPress device and &as a potentia( bias due to )nancia(interest in researc& outcomes. %wo o' t&ese studies *Dubois and Te(iGovsGi+

demonstrated t&at vo(ume reduction cou(d be ac&ieved 'rom pump t&erapy a(one!

a(t&ou& one study uti(ied &i&er pressure t&at was usua((y recommended. %&ree

studies *"o&ansson! Dubois! wedbor+ demonstrated t&at better resu(ts in vo(ume

reduction were ac&ieved w&en t&e pneumatic pump was used in combination wit&

ot&er treatments! inc(udin: manua( (ymp&atic drainae! compression arments and

se(' massae. -n addition! it was noted t&at t&ree studies demonstrated t&at


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continuin pump t&erapy or wearin a compression arment were bene)cia( in

maintainin t&e reduction in vo(ume *Dubois! wedbor! Te(iGovsGi+. %&e review

conc(uded t&at! =Despite t&e rane o' positive outcomes identi)ed in t&is review!

t&e A evidence to support t&em is! in some instances! poor. %&ere'ore! t&ere is sti(( a

need 'or (are sca(e! &i& (eve( c(inica( tria(s in t&is area.= -n 2001 ricGson and

co((eaues reviewed t&e researc& (iterature re(ated to manaement o' arm edema

in women wit& breast cancer.1 %&e aut&ors review t&e evidence 'or t&e various

moda(ities o' a compre&ensive treatment proram and address pneumatic

compression! wit& and wit&out p&ysica( t&erapy! as eJective in reducin

(ymp&edema. owever! t&ey a(so maGe t&e 'o((owin conc(usion: $(t&ou&

intermittent compression is o'ten used! a number o' issue about its use remain to

be reso(ved! inc(udin t&e optimum amount o' pressure! t&e most eEcacious

treatment sc&edu(e and w&et&er maintenance t&erapy is needed a'ter t&e initia(

reduction o' edema. -n 199A t&e $merican Cancer ociety *$C+ conducted a

(ymp&edema worGs&op t&at attempted to summarie t&e evidence surroundin t&e

manaement o' (ymp&edema.1I Qumerous topics were covered inc(udin p&ysica(

t&erapy! surica( options! various moda(ities o' deconestive t&erapy and

compressive t&erapy. %wo sections speci)ca((y addressed compressive t&erapy wit&

pneumatic compression devices. and =no comparative studies assessin t&e re(ative eEcacy o'

pumps are avai(ab(e.> %&ey contrast con5ictin studies w&ere a mu(ti/c&amber

device was 'ound superior to a sin(e/c&amber device *S(ein study+ wit& Tano((as

)ndin13 notin e@ce((ent reduction in swe((in 'rom a sin(e/c&amber device

compared to a mu(ti/c&amber product. %&e proceedins o' a worGroup at t&e $C

meetin! (ead by Dr. tan(ey RocGson! addressed t&e dianosis and manaement o'

(ymp&edema. %&e purpose o' t&e worGroup was to derive a consensus statementreardin t&e dianosis and treatment o' (ymp&edema 'o((owin breast cancer

surery. $ccordin to t&e worGroups consensus! treatment o' (ymp&edema is best

ac&ieved t&rou& mu(tip(e moda(ities and we((/)tted compression arments must be

used to contro( onoin edema between p&ysica( t&erapy or intermittent

compression sessions. peaGin speci)ca((y about intermittent compression pumps!

t&e consensus o' t&e roup was t&ey may warrant a ro(e in t&erapy w&en used in

concert wit& deconestive (ymp&atic t&erapy and ot&er estab(is&ed treatments suc&

as (ow/stretc& bandain! e@ercise and manua( (ymp&atic t&erapy. $s an adunct!

t&e aut&ors state t&at: UV-Wntermittent compression pumps! w&ic& are most

eJective w&en used adunctive(y in manua( (ymp&atic t&erapy. %&e use o' t&ese

se8uentia( radient pumps in t&e absence o' a mu(tidiscip(inary treatment prorams&ou(d be avoided. Despite t&e compre&ensive nature o' t&e worGs&op and mu(tip(e

(iterature reviews and re'erences to intermittent compression! t&ere was no

reconition or discussion o' se8uentia( radient compression uti(iin manua(

contro( o' pressures in individua( 9 c&ambers! t&e type o' PCD represented by

ea(t&care Common Procedure Codin ystem *CPC+ code 0342. -n 199 t&e

$ency 'or ea(t& Care Po(icy and Researc& ?Ece o' %ec&no(oy $ssessment17

conducted a tec&no(oy review o' (ymp&edema pumps. %&e review concentrated on


8/36

sin(e/c&ambered pneumatic devices vs. mu(tic&ambered devices! wit& or wit&out

pressure ca(ibrations. %&e review encompassed pub(is&ed medica( (iterature 'rom

1933/1992 and &i&(i&ted 9 studies! a(( inc(uded in t&is review. %&e report

summaried t&e evidence as 'o((ows: $(( pneumatic compression devices appear to

be simi(ar(y eJective in t&e treatment o' (ymp&edema. ince t&e patients se(ected

varied 'rom study to study and t&e c&aracteristics o' t&e (ymp&edema amon t&e

patients were not de)ned! neit&er t&e criteria 'or se(ection o' patients to be treated

wit& one or anot&er device or t&e diJerence in eJectiveness o' t&e devices cou(d be

ascertained. ayes! -nc.! a subscription/based tec&no(oy assessment company!

reviewed PCDs 'or t&e treatment o' perip&era( (ymp&edema in 2004 and updated

t&e review in "anuary 200A.1A %&is evidence/based medicine review conc(uded! in

part! t&at 1+ t&ere is no consensus in t&e scienti)c (iterature on pump se(ection and

use 2+ %&e evidence supportin t&e use o' pneumatic compression t&erapy as a

so(itary treatment moda(ity 'or perip&era( (ymp&edema is e@treme(y (imited and o'

poor 8ua(ity + no comparative studies &ave been pub(is&ed to determine t&e most

eJective pumpin times! pressure (eve(s6ranes! in5ation6de5ation cyc(es! (ent&

and 're8uency o' individua( pumpin sessions! or type o' pump 'or patients wit&

perip&era( edema and I+ t&ere is some evidence to suest t&at se8uentia(

mu(tic&ambered pumps are more eJective t&an sin(e/c&ambered pumps. %&e

%reatment o' Lymp&edema Re(ated to


9/36

re'erence 4 in bibi(iorap&y+. &i(e t&e Dina study was t&e on(y (iterature re'erence

t&at met t&e criteria o' a randomied! contro((ed tria(! t&e uide(ines did review t&e

resu(t o' a number o' ot&er (ess riorous pub(is&ed studies. %&ey note mi@ed resu(ts

and (imitations due to sma(( samp(e sie! mi@ed popu(ations! (acG o' contro( roups

and (acG o' outcome measures t&at assessed symptoms suc& as pain and

&eaviness. %&e aut&ors 'urt&er note t&at no comparative studies &ave been

pub(is&ed to determine optima( treatment times! pressure (eve(s or type o' pump.

%&ey note t&at t&e (iterature is suestive but not unanimous t&at se8uentia(!

mu(tic&ambered pumps are more eJective t&an sin(e/c&amber pumps but do not

speci)ca((y address manua((y/contro((ed pressure radient pumps *0342+. Co&en!

et.a(. pub(is&ed Lymp&edema trateies 'or #anaement in a 2001 supp(ement to

t&e ourna( Cancer. 21 %&is supp(ement contained mu(tip(e sections addressin t&e

care o' breast cancer patients. -n t&e section on manaement o' (ymp&edema! t&e

aut&ors state: $(t&ou& at one time pneumatic compression pumps represented t&e

standard treatment 'or (ymp&edema in t&e ;nited tates! controversy about t&eir

use e@ists today. ome studies corroborate t&eir use'u(ness in t&e treatment o'

(ymp&edema w&i(e anot&er randomied study discounts t&eir eJectiveness...-n

s&ort! no c(ear uide(ines e@ist in t&e se(ection or use o' pumps. $ variety o' pumps!

wit& sin(e or mu(tip(e c&ambers and various ma@ima( pressures! (ent&s o'

pumpin times and 're8uency o' use! &ave been recommendedU$(t&ou& some

patients report onoin bene)t in t&e use o' a pump as part o' a &ome proram!

ot&ers e@perience (itt(e bene)t. $ supp(ier o' pneumatic compression devices

provided an additiona( document t&at is reported(y unpub(is&ed entit(ed

=Compre&ensive %reatment uide(ines stab(is&in Disease #anaement

uide(ines 'or Lymp&edema.> %&e aut&or! Cyndi ?rti! is a (ymp&edema

compression t&erapist wit& numerous citins and contributions on t&e internet to

(ymp&edema b(os! 're8uent(y asGed 8uestions and patient support sites. %&e

document out(ines t&e t&ree diJerent types o' pumps *one c&amber intermittent!

se8uentia( non/radient! radient se8uentia(+ and recommends t&e use o' aradient se8uentia( pump as t&is more c(ose(y mimics t&e bodys pressure radient

system. %&ere 11 is no discussion or distinction in &er uide(ines between

se8uentia( radient pumps wit& or wit&out manua( contro(. Position tatements

-nternationa( ociety o' Lymp&o(oy Consensus document o' t&e -nternationa(

ociety o' Lymp&o(oy entit(ed =%&e Dianosis and %reatment o' Perip&era(

Lymp&edema> was pub(is&ed in 200.22 $ccordin to t&e -L! t&e document

=attempts to ama(amate t&e broad spectrum o' protoco(s advocated wor(dwide 'or

t&e dianosis and treatment o' perip&era( (ymp&edema into a coordinated

proc(amation representin a Yconsensus o' t&e internationa( community.> %&e

consensus document inc(udes intermittent pneumatic compression or

=pneumomassae> as a non/surica( treatment option &owever! t&e documentdoes not recommend any type o' compression pump *i.e.! sin(e or mu(tic&amber!

se8uentia( radient! etc.+! 're8uency or pressure settin. Qationa( Lymp&edema

QetworG $ccordin to t&eir web site! t&e Qationa( Lymp&edema QetworG *QLQ+ is

an internationa((y reconied non/pro)t oraniation 'ounded in 19AA to provide

education and uidance to (ymp&edema patients! &ea(t&care pro'essiona(s and t&e

enera( pub(ic by disseminatin in'ormation on t&e risG reduction and manaement

o' primary and secondary (ymp&edema. %&e QLQ is described as a =drivin 'orce


10/36

be&ind t&e movement in t&e ;.. to standardie 8ua(ity treatment 'or (ymp&edema

patients nationwide.> %&e QLQ &as deve(oped position papers on various topics

re(ated to t&e dianosis and manaement o' (ymp&edema. %&e QLQ states t&at

=QLQ position papers are dra'ted by t&e QLQ #edica( $dvisory Committee *#$C+ to

re5ect pro'essiona( positions on Gey issues re(ated to (ymp&edema and (ymp&o(oy.

%&ese documents are reviewed every two years or w&en new scienti)c advances

re(ated to t&e topic occur.> %&e most recent position statement by t&e QLQ #$C

re(ated to treatment o' (ymp&edema was approved by t&e QLQ -n5ation cyc(e time or

duration! number o' treatments and duration o' treatment are not discussed. 12

ummary %&is review o' t&e scienti)c (iterature attempts to determine i' t&ere is

diJerentiation between t&e diJerent types o' pneumatic compression devices and i'

so! are t&ere speci)c patient c&aracteristics or disease conditions w&ic& merit t&e

use o' one device over anot&er. $ccordin to instructions issued to #edicare

contractors by C#! one must consider t&e broad rane o' avai(ab(e evidence and

eva(uate t&e 8ua(ity o' t&e evidence. %&is e@ercise reviewed peer/reviewed!

pub(is&ed c(inica( tria(s! uide(ines and consensus statements 'rom c(inica( e@pertsand medica( associations! position statements 'rom oraniations wit& e@pertise in

t&e subect o' (ymp&edema treatment and ot&er eva(uations o' pneumatic

compression tec&no(oy. it& reard to t&e 8ua(ity o' t&e evidence! numerous

aut&ors commented t&at t&e studies supportin t&e use o' pneumatic compression

devices are universa((y poor. %&ere are 'ew randomied! prospective! contro((ed

tria(s and t&e ones t&at were reviewed &ad con5ictin resu(ts. #ost c(inica(

uide(ines and position statements re(ied upon e@pert opinion and consensus

&owever! a(( were (acGin in speci)city wit& respect to t&e 8uestions at &and.

$pp(yin t&e C# instructions 'or t&e evidence basis 'or coverae decisions to t&e

8uestions posed! one can summarie t&e scienti)c (iterature as 'o((ows: Zuestion 1:

Does t&e pub(is&ed medica( (iterature support t&e use o' one type o' pneumaticcompression device compared to anot&er, $. Pub(is&ed aut&oritative evidence

derived 'rom de)nitive randomied c(inica( tria(s or ot&er de)nitive studies $nswer:

Qo. %&ere is a enera( trend towards support o' a mu(ti/c&amber device over a

sin(e c&amber device t&ou& evidence is con5ictin.


11/36

enera( acceptance o' one type o' pneumatic compression device over anot&er.

%&ere is a trend towards support o' a mu(ti/c&amber device over a sin(e c&amber

device. 2+ Consensus o' e@pert medica( opinion *i.e.! reconied aut&orities in t&e

)e(d+ $nswer: Qo. %&ere is no consensus o' t&e e@pert medica( opinions reviewed

t&at one type o' pump is more eEcacious t&an anot&er. + #edica( opinion derived

'rom consu(tations wit& medica( associations or ot&er &ea(t& care e@perts. $nswer:

Qo. Review o' medica( association statements and position papers 'rom &ea(t& care

e@perts in t&e treatment o' (ymp&edema &ave no 1 statements reardin t&e

superiority o' one type o' pump over anot&er &owever! Cyndi ?rti did recommend

use o' a se8uentia( radient pump since! in &er opinion! it better mimics t&e bodys

own (ymp&atic drainae mec&anism. Zuestion 2: $re t&ere speci)c patient

c&aracteristics and6or disease conditions t&at 'avor one type o' pneumatic

compression devices over anot&er, $. Pub(is&ed aut&oritative evidence derived

'rom de)nitive randomied c(inica( tria(s or ot&er de)nitive studies $nswer: Qo.

&i(e t&ere is a enera( trend towards support o' a mu(ti/c&amber device over a

sin(e c&amber device! in'ormation on patient se(ection *ot&er t&an &avin

(ymp&edema+! 're8uency o' treatment! treatment duration and pressures uti(ied

are (acGin.


12/36

i(burn ?! i(burn P! RocGson . $ pi(ot! prospective eva(uation o' a nove(

a(ternative 'or maintenance t&erapy o' breast cancer/associated (ymp&edema.


13/36

Pneumatic Compression Devices Literature Review February 2009 Prepared by:

Robert D. oover! "r.! #D! #P! F$CP Purpose %&e purpose o' t&is (iterature review is

to consider t&e scienti)c evidence 'or t&e use o' pneumatic compression devices

*PCD+ in t&e treatment o' (ymp&edema. %&e review wi(( attempt to determine: 1.

Does t&e medica( (iterature support t&e use o' one type o' PCD compared to

anot&er, 2. -' t&e medica( (iterature supports t&e use o' one type o' PCD compared

to anot&er! are t&ere speci)c patient popu(ations or disease conditions t&at support

t&e medica( necessity o' one type o' PCD *e..! PCD wit& manua((y/contro((ed

pressures vs. wit&out manua( contro(+, %ypes o' Pneumatic Compression Devices

and $pp(iances *s(eeves+ %&ere are basic types o' PCDs: 1. $ non/semented

pneumatic compressor *ea(t&care Common Procedure Codin ystem *CPC+

code 0340+ is a device w&ic& &as a sin(e out5ow port on t&e compressor. %&is

out5ow port may be connected to a s(eeve6app(iance wit& mu(tip(e compartments or

sements *0371/037+ and may ac&ieve a se8uentia( pressure radient t&rou&

t&e desin o' t&e tubin and6or air c&ambers in t&e s(eeve6app(iance. 2. $

semented pneumatic compressor wit&out ca(ibrated radient pressure *0341+ is a

device w&ic& &as mu(tip(e out5ow ports on t&e compressor w&ic& (ead to distinct

sements on t&e app(iance w&ic& in5ate se8uentia((y. %&ese devices ac&ieve

se8uentia( compression by eit&er *a+ app(ication o' t&e same pressure in eac&

sement or *b+ app(ication o' a predetermined pressure radient in successive

sements but no abi(ity to individua((y set or adust pressures in eac& o' one or

severa( sements. -n t&ese devices! t&e pressure is usua((y set by a sin(e contro( on

t&e dista( sement. %&ey are used wit& s(eeves6app(iances *0337/0339+ t&at are

mu(ti/c&ambered t&us a((owin 'or se8uentia(! radient compression. . $

semented device wit& ca(ibrated radient pressure *0342+ is c&aracteried by a

manua( contro( on at (east t&ree out5ow ports w&ic& can de(iver an individua((y

determined pressure to eac& sementa( unit. %&ese PCDs are a(so used wit& a

mu(tic&ambered s(eeve6app(iance to ac&ieve se8uentia(! radient compression.

vidence Review Criteria $ P; and =compression> combined wit& =(ymp&edema.> ?n(y n(is&

(anuae 'u(( te@t artic(es were reviewed. %&e searc& was (imited to artic(es

pub(is&ed 'rom 19A0 to 200A. %&e re(ative strent& o' t&e evidence presented in t&e

c(inica( studies was assessed accordin to t&e uidance provided by t&e Centers 'or

#edicare B #edicaid ervices *C#+ to contractor medica( directors 'or deve(opin

(oca( coverae determinations *LCDs+.1 2 $ccordin to C# instructions! coverae

po(icies s&ou(d be based on: 1. Pub(is&ed aut&oritative evidence derived 'rom

de)nitive randomied c(inica( tria(s or ot&er de)nitive studies and! 2. enera(

acceptance by t&e medica( community *standard o' practice+! as supported by

sound medica( evidence based on: a. cienti)c data or researc& studies pub(is&ed in

peer/reviewed medica( ourna(s or! b. Consensus o' e@pert medica( opinion *i.e.!reconied aut&orities in t&e )e(d+ or! c. #edica( opinion derived 'rom consu(tations

wit& medica( associations or ot&er &ea(t& care e@perts. %&e instructions continue by

statin: $cceptance by individua( &ea(t& care providers or even a (imited roup o'

&ea(t& care providers norma((y does not indicate enera( acceptance by t&e medica(

community. %estimonia(s indicatin suc& (imited acceptance! and (imited case

studies distributed by sponsors wit& )nancia( interest in t&e outcome! are not

suEcient evidence o' enera( acceptance by t&e medica( community. %&e broad


14/36

rane o' avai(ab(e evidence must be considered and its 8ua(ity s&a(( be eva(uated

be'ore a conc(usion is reac&ed. &i(e t&is review is not conducted to deve(op an

LCD! its purpose wi(( support coverae decisions made by t&e contractor medica(

director. Conse8uent(y! t&e review wi(( be conducted in accordance wit& uidance

provided by C#. -n addition to artic(es and position papers retrieved by t&e searc&

described above! severa( manu'acturers o' PCDs were asGed 'or c(inica( materia(

supportin PCD use. vidence va(uation &i(e numerous artic(es were reviewed

notin t&at PCD &as become standard o' care in most countries! conc(usive

documentation o' t&e bene)ts o' t&is treatment moda(ity are (acGin. %&e opinion

e@pressed by t&e upportive Care uide(ines roup o' Cancer Care ?ntario and t&e

?ntario #inistry o' ea(t& and Lon %erm Care is i((ustrative o' t&is di(emma w&en

t&ey state t&at =%&e (acG o' suEcient &i& 8ua(ity evidence prec(udes de)nitive

recommendations 'rom bein made.>2 &i(e t&is statement was made in re(ation to

treatment options 'or women wit& breast cancer and (ymp&edema! t&e document

'urt&er states =%&ere is some evidence w&ic& suests t&at p&ysica( t&erapies suc&

as compression t&erapy and manua( (ymp&atic drainae may improve estab(is&ed

(ymp&edema but 'urt&er studies are needed.> uba et.a(. conducted a

randomied! prospective study at t&e tan'ord Center 'or Lymp&atic and Henous

Disorders c(inic comparin deconestive (ymp&atic t&erapy *DL%+ a(one or DL% wit&

adunctive intermittent compressive t&erapy. %&e study uti(ied a e8uentia(

Circu(ator 200I *! inc(uded 27 women w&o &ad comp(eted an initia( one

mont& o' intensive DL% but &ad (ess t&an one year o' DL% e@perience. $(( patients

were )tted wit& and wore a C(ass -- compression arment. -n tudy 1 *-nitia(%reatment+! 12 patients were randomied to DL% p(us PCD *roup 1+ and 11 to DL%

a(one *roup 2+. $'ter two weeGs o' treatment! t&ere was a statistica((y sini)cant

vo(ume reduction in t&e aJected e@tremity o' I4.K vs. 23K 'or roup 1 compared

to roup 2! respective(y. $t t&e end o' I0 days! vo(ume reduction was 0.K 'or

roup 1 and 27.1K 'or roup 2. %&e diJerence in vo(ume reduction between t&e

two roups at I0 days was not statistica((y sini)cant nor was t&e c&ane 'rom t&e

time o' t&e two weeG eva(uation &owever! it did demonstrate t&at t&e eJects o'

treatment are durab(e. -n tudy 2 *#aintenance %reatment+! 27 patients were

recruited and 24 comp(eted t&e study. Patients were 'o((owed 'or one mont& and

were randomied to receive se('administered maintenance t&erapy wit& DL% a(one

versus DL% p(us PCD. imi(ar to tudy 1! t&ere was a statistica((y sini)cantreduction in (imb vo(ume in t&e roup randomied to t&e DL% p(us PCD roup.

%wenty/'our patients were 'o((owed 'or subse8uent 3 mont& period wit& 19 e(ectin

to continue use o' a PCD. %&ese patients e@perienced an additiona( reduction in (imb

vo(ume compared to t&e )ve patients e(ectin to discontinue pump use. ubas

study was sma(( and on(y inc(uded patients wit& (ymp&edema subse8uent to breast

cancer treatment. %&ere was no description o' t&e randomiation process and

'o((ow/up time was re(ative(y s&ort. -n addition! (iGe many studies! patients used a


15/36

compression arment or compression bandae systems between treatments. ince

aut&ors do not comment on t&e comp(iance wit& arment use! its impact on t&e

resu(ts o' PCD use are uncertain. Comp(iant use o' a compression arment between

sessions cou(d c(ear(y impact t&e vo(ume reductions attributed to PCD use. %aGin

t&at caveat into consideration! t&is study did demonstrate t&at t&e use o' an 0341

PCD was eEcacious in reducin upper e@tremity edema. RocGson and co((eaues

conducted a randomied! prospective! cross/over study o' massae versus PCD

*F(e@itouc& / %acti(e ystems! -nc.+ in 10 patients wit& uni(atera( breast cancer/

associated (ymp&edema o' t&e arm.I %&e F(e@itouc& system uti(ies a arment t&at

e@tends onto t&e t&oracic wa(( or pe(vic6abdomina( reion! t&e bene)t purported to

be encouraement o' e@cess 5uid to 'o((ow e@istin pat&ways o' (ymp& movement

'rom t&e trunG to t&e centra( circu(ation. $(( patients used se('/administered

massae and compression arments prior to randomiation. %&e study was

conducted 'or 1I days a'ter a 1 weeG was&out w&ere on(y compression arments

were used *no massae+. %&e F(e@itouc& arm ac&ieved statistica((y sini)cant

reduction in vo(ume compared to t&e massae a(one co&ort. %&e aut&ors observed

t&at even in s&ort term use! I t&e device con'ers t&erapeutic bene)t over t&at

w&ic& can be attained t&rou& standard t&erapies. owever! t&ey a(so note t&at t&is

was a sma(( study o' (imited (ent& and t&e protracted use o' t&is device must be

considered in re(ations&ip to t&e retai( cost o' between M10!A00 and M12!I00 *2004

pricin+. $dditiona( weaGnesses are t&e (acG o' comparison to standard arments

t&at encirc(e t&e (imb on(y and t&e 'ai(ure to speci'y treatment pressures. Dini et.a(.4

*199A+ conducted t&e most wide(y cross/re'erenced randomied study e@aminin

t&e impact o' treatment wit& pneumatic compression versus no treatment on post/

mastectomy patients wit& (ymp&edema. %&is study randomied A0 post/

mastectomy women to eit&er intermittent pneumatic compression or no treatment.

omen in t&e treatment roup underwent a two/weeG cyc(e o' )ve pump sessions

per weeG! 'o((owed by a )ve/weeG breaG in treatment and t&en anot&er two/weeG

cyc(e o' treatment. %&ere was no statistica((y sini)cant diJerence in response ratesbetween t&e two roups. %&e aut&ors conc(uded t&at pneumatic compression

pumps &ave a (imited ro(e in t&e manaement o' patients wit& (ymp&edema. $

weaGness o' t&is study is t&e (acG o' detai(ed in'ormation about t&e pump system

used. %&e aut&ors state t&at PCD sessions &ad cyc(e pressures o' 30 mm

&owever! t&ere is no description o' t&e system used or w&et&er a se8uentia(

radient app(iance was used. "o&ansson and co((eaues3 prospective(y compared

manua( (ymp& drainae *#LD+ uti(iin t&e Hodder tec&ni8ue to se8uentia(

pneumatic compression app(ied to t&e upper e@tremity in 2A women wit& post/

surica( arm (ymp&edema 'o((owin breast cancer and a@i((ary node dissection.

Pneumatic compression was app(ied wit& t&e Lymp&a/Press device *0341 N 0337+

uti(iin I0/30 mm o' pressure 'or 2 &ours per day. Compression arments wereused in bot& t&e #LD and PCD patients between treatments. Fo((owin a two weeG

run/in usin a standard compression s(eeve *arment+! 2I patients were

randomied. $t t&e two weeG 'o((ow/up! t&ere was no sini)cant diJerence between

t&e two treatments *#LD vs. PCD+ in eit&er abso(ute vo(ume reduction or in percent

reduction in (ymp&edema. %&e aut&ors note t&at t&e poorer resu(t 'or t&e PCD

patients compared to ot&er studies *10! 14+ may be due to t&e s&ort duration o'

treatment *2 &ours per day+. $ruin aainst t&is &ypot&esis is t&e comparison o'


16/36

t&e #LD and PCD demorap&ics. %&e PC roup &ad an averae edema duration o'

3.4 mont&s versus 1I.0 mont&s in t&e #LD roup. tudies &ave s&own t&at t&e

duration o' t&e edema can sini)cant(y impact t&e success o' (ymp&edema

treatment due to scarin and )brous c&anes in t&e under(yin tissues t&ere'ore!

t&e PCD patients wit& t&e s&orter duration s&ou(d &ave &ad an =advantae> towards

improved 5uid reduction over t&e #LD patients. %&is was not seen.


17/36














care measures. eaGness in t&is study desin is evident in t&e e@c(usion o' non/

responders and t&ose wit& arm edema. Qo comparison was made amonst t&e

cateories o' t&ose usin t&e device dai(y and t&ose c&oosin not to use it. %&ere is

diversity o' participants in t&e type! duration and amount o' (ymp&edema! ender!

amount o' pressure used and duration o' eac& treatment in t&e &ome settin. S(ein

et a(.9 e@amined t&e ri&t Linear Pump! speci)ca((y in t&e (ower e@tremity.

@c(usion criteria consisted o' presence o' in'ection! metastasis! c&ronic &eart

'ai(ure and rena( disease. eventy/t&ree subects were treated over a IA/&our period

wit& a radient! t&ree compartment device app(ied to t&e (ower (imb 'or 2/&ours.

$'ter a one &our rest period t&e device wou(d be app(ied wit& increasin duration to

a ma@imum o' A &ours. %&e protoco( was dependent on patient to(erance o' pain.

%&e dista( pressure was determined by t&e mean o' t&e systo(ic and diasto(ic wit&

t&e ot&er two ce((s diminis&in in pressure by 20 mm eac&. %&e tota( treatment

cyc(e was 120 seconds wit& 90 seconds o' pressure dista((y! 70 seconds 'or t&e

midd(e ce(( and 40 seconds pro@ima((y. %&e (imb was e(evated and wrapped between

treatments. -n t&e IA/&our treatment protoco(! measurements were taGen at 4 (eve(so' t&e (e. Qinety percent o' patients s&owed a decrease in circum'erence at t&e

anG(e and mid/ca(' area! ranin 'rom 1.3 2.1 cm. $(( patients &ad some

improvement a'ter t&e IA &ours post/treatment. %&eir resu(ts suested t&at men

responded better t&an women. $(t&ou& S(ein noted t&at t&e reduction in

circum'erence at t&e )ve (eve(s o' t&e treated (imb were sini)cant! comparative

measurements o' t&e norma(! contro( e@tremity were not made t&us ca(cu(ation o'

t&e abso(ute reduction in (ymp&edema was not possib(e. $s wit& t&e ot&er studies

cited above! t&ere was variabi(ity in t&e participants deree o' (ymp&edema!

etio(oy! duration and amount o' compression pressure. -n 19A4 Ric&mand et.a(.10

e@amined t&e impact o' se8uentia( compression usin a Lymp&a/Press mu(ti/

compartmenta( s(eeve *0341 N 0337+ on 2I patients. %&e study was prospectivebut not randomied. %&ere was &eteroeneity wit& respect to t&e etio(oy o' t&e

(ymp&edema *primary vs. secondary+! duration o' (ymp&edema! (ocation o' edema

*upper vs. (ower e@tremity+ and prior t&erapies inc(udin one patient wit& previous

surery *C&ar(es Procedure+ 'or (ymp&edema. -n addition! t&e patients were studied

in an inpatient settin! con)ned to bed wit& t&e aJected e@tremity e(evated. Resu(ts

were on(y presented 'or (ower e@tremity vo(ume reduction despite 7 o' 2I patients

enro((ed 'or upper e@tremity conditions. Lower e@tremity vo(ume was reduced by


18/36

appro@imate(y I4K. Fo((ow/up at /3 mont&s to determine t&e e@tent o' treatment

persistence was comp(icated by subect drop out. ?n(y I o' 7 patients in t&e upper

e@tremity and A o' 1A in t&e (ower e@tremity co&ort were avai(ab(e 'or 'o((ow/up

data. $ut&ors note t&at a(( patients compu(sive(y wore we((/)tted e(astic s(eeves and

aunt(ets to &e(p maintain vo(ume reduction. %&is study is poor(y desined and &as

sini)cant met&odo(oic s&ortcomins. %&e (acG o' data on upper e@tremity

treatment success! t&e (are number o' patients (ost to 'o((ow/up and t&e s&ort

duration o' treatment *1/2 days 7 inpatient+ maGe enera(iation o' t&e resu(ts to

(on term treatment diEcu(t. #oreover! as many aut&ors point out in various

reviews! t&e use o' compression arments between PCD treatments is critica( to

ac&ievin sustained resu(ts. Te(iGovsGi11 and co((eaues reported t&eir e@perience

wit& 232 patients usin t&e Lymp&a/Press PCD on bot& upper and (ower e@tremity

edema. From t&e description o' t&e device used! it appears to be an 0341. %&ey

conc(uded t&at resu(ts were encourain and noted 3/70K reduction o'

(ymp&edema in AAK o' patients wit& upper (imb (ymp&edema w&i(e (ower e@tremity

(ymp&edema =a(most comp(ete(y disappeared.> %&is was not a randomied tria( and

contained very (itt(e statistics detai(in t&e patients treated! etio(oies o'

(ymp&edema or t&e met&ods used to measure 5uid reduction. #oreover! w&i(e t&ey

note 232 patients were treated! t&e reductions noted above were 'or 112 patients

*I2K+! main(y post/mastectomy (ymp&edema. %&ere is no detai( provided on t&e

outcomes o' t&e ot&er 140 patients. Fina((y! it s&ou(d be noted t&at Te(iGovsGi

deve(oped t&e Lymp&a/Press device and &as a )nancia( interest in t&e outcome o'

any study. vidence Reviews6#eta/$na(ysis $ systematic review o' t&e common

conservative t&erapies 'or arm (ymp&edema secondary to breast cancer treatment

was conducted by #ose(y et a(. *2007+.12 %&e review inc(uded t&e 'o((owin

treatments: comp(e@ p&ysica( t&erapy! manua( (ymp&atic drainae! pneumatic

pumps! ora( p&armaceutica(s! (ow (eve( (aser t&erapy! compression bandain and

arments. %&e review 'ound t&at t

more intensive and &ea(t& pro'essiona( based t&erapies! suc& as comp(e@ p&ysica(

t&erapy! manua( (ymp&atic drainae! pneumatic pump and (aser t&erapy enera((y

yie(ded t&e reater vo(ume reductions. e('/initiated t&erapies suc& as compression

arment wear! e@ercise and (imb e(evation were 'ound to yie(d a (esser vo(ume

reduction. %&e review inc(uded randomied! contro((ed! para((e( and cross/over!

case/contro( and co&ort studies. $ metaana(ysis cou(d not be per'ormed due to t&e

treatment and data &eteroeneity. Five studies were inc(uded t&at e@amined

pneumatic pump t&erapy and most are detai(ed individua((y above &owever! t&e

Te(iGovsGi study 'rom 19A0 was reviewed 'or t&is ana(ysis but e@c(uded because t&e

pressures used were sini)cant(y &i&er t&an w&at is now recommended. -n

addition as noted above! Te(iGovsGi is t&e deve(oper o' t&e Lymp&aPress device and

&as a potentia( bias due to )nancia( interest in researc& outcomes. %wo o' t&ese

studies *Dubois and Te(iGovsGi+ demonstrated t&at vo(ume reduction cou(d be

ac&ieved 'rom pump t&erapy a(one! a(t&ou& one study uti(ied &i&er pressure t&at

was usua((y recommended. %&ree studies *"o&ansson! Dubois! wedbor+

demonstrated t&at better resu(ts in vo(ume reduction were ac&ieved w&en t&e

pneumatic pump was used in combination wit& ot&er treatments! inc(udin: manua(

(ymp&atic drainae! compression arments and se(' massae. -n addition! it was


19/36

noted t&at t&ree studies demonstrated t&at continuin pump t&erapy or wearin a

compression arment were bene)cia( in maintainin t&e reduction in vo(ume

*Dubois! wedbor! Te(iGovsGi+. %&e review conc(uded t&at! =Despite t&e rane o'

positive outcomes identi)ed in t&is review! t&e A evidence to support t&em is! in

some instances! poor. %&ere'ore! t&ere is sti(( a need 'or (are sca(e! &i& (eve(

c(inica( tria(s in t&is area.= -n 2001 ricGson and co((eaues reviewed t&e researc&

(iterature re(ated to manaement o' arm edema in women wit& breast cancer.1

%&e aut&ors review t&e evidence 'or t&e various moda(ities o' a compre&ensive

treatment proram and address pneumatic compression! wit& and wit&out p&ysica(

t&erapy! as eJective in reducin (ymp&edema. owever! t&ey a(so maGe t&e

'o((owin conc(usion: $(t&ou& intermittent compression is o'ten used! a number o'

issue about its use remain to be reso(ved! inc(udin t&e optimum amount o'

pressure! t&e most eEcacious treatment sc&edu(e and w&et&er maintenance

t&erapy is needed a'ter t&e initia( reduction o' edema. -n 199A t&e $merican Cancer

ociety *$C+ conducted a (ymp&edema worGs&op t&at attempted to summarie t&e

evidence surroundin t&e manaement o' (ymp&edema.1I Qumerous topics were

covered inc(udin p&ysica( t&erapy! surica( options! various moda(ities o'

deconestive t&erapy and compressive t&erapy. %wo sections speci)ca((y addressed

compressive t&erapy wit& pneumatic compression devices. and =no comparative studies

assessin t&e re(ative eEcacy o' pumps are avai(ab(e.> %&ey contrast con5ictin

studies w&ere a mu(ti/c&amber device was 'ound superior to a sin(e/c&amber

device *S(ein study+ wit& Tano((as )ndin13 notin e@ce((ent reduction in swe((in

'rom a sin(e/c&amber device compared to a mu(ti/c&amber product. %&e

proceedins o' a worGroup at t&e $C meetin! (ead by Dr. tan(ey RocGson!

addressed t&e dianosis and manaement o' (ymp&edema. %&e purpose o' t&eworGroup was to derive a consensus statement reardin t&e dianosis and

treatment o' (ymp&edema 'o((owin breast cancer surery. $ccordin to t&e

worGroups consensus! treatment o' (ymp&edema is best ac&ieved t&rou&

mu(tip(e moda(ities and we((/)tted compression arments must be used to contro(

onoin edema between p&ysica( t&erapy or intermittent compression sessions.

peaGin speci)ca((y about intermittent compression pumps! t&e consensus o' t&e

roup was t&ey may warrant a ro(e in t&erapy w&en used in concert wit&

deconestive (ymp&atic t&erapy and ot&er estab(is&ed treatments suc& as (ow/

stretc& bandain! e@ercise and manua( (ymp&atic t&erapy. $s an adunct! t&e

aut&ors state t&at: UV-Wntermittent compression pumps! w&ic& are most eJective

w&en used adunctive(y in manua( (ymp&atic t&erapy. %&e use o' t&ese se8uentia(radient pumps in t&e absence o' a mu(tidiscip(inary treatment proram s&ou(d be

avoided. Despite t&e compre&ensive nature o' t&e worGs&op and mu(tip(e (iterature

reviews and re'erences to intermittent compression! t&ere was no reconition or

discussion o' se8uentia( radient compression uti(iin manua( contro( o' pressures

in individua( 9 c&ambers! t&e type o' PCD represented by ea(t&care Common

Procedure Codin ystem *CPC+ code 0342. -n 199 t&e $ency 'or ea(t& Care

Po(icy and Researc& ?Ece o' %ec&no(oy $ssessment17 conducted a tec&no(oy


20/36

review o' (ymp&edema pumps. %&e review concentrated on sin(e/c&ambered

pneumatic devices vs. mu(tic&ambered devices! wit& or wit&out pressure

ca(ibrations. %&e review encompassed pub(is&ed medica( (iterature 'rom 1933/1992

and &i&(i&ted 9 studies! a(( inc(uded in t&is review. %&e report summaried t&e

evidence as 'o((ows: $(( pneumatic compression devices appear to be simi(ar(y

eJective in t&e treatment o' (ymp&edema. ince t&e patients se(ected varied 'rom

study to study and t&e c&aracteristics o' t&e (ymp&edema amon t&e patients were

not de)ned! neit&er t&e criteria 'or se(ection o' patients to be treated wit& one or

anot&er device or t&e diJerence in eJectiveness o' t&e devices cou(d be

ascertained. ayes! -nc.! a subscription/based tec&no(oy assessment company!

reviewed PCDs 'or t&e treatment o' perip&era( (ymp&edema in 2004 and updated

t&e review in "anuary 200A.1A %&is evidence/based medicine review conc(uded! in

part! t&at 1+ t&ere is no consensus in t&e scienti)c (iterature on pump se(ection and

use 2+ %&e evidence supportin t&e use o' pneumatic compression t&erapy as a

so(itary treatment moda(ity 'or perip&era( (ymp&edema is e@treme(y (imited and o'

poor 8ua(ity + no comparative studies &ave been pub(is&ed to determine t&e most

eJective pumpin times! pressure (eve(s6ranes! in5ation6de5ation cyc(es! (ent&

and 're8uency o' individua( pumpin sessions! or type o' pump 'or patients wit&

perip&era( edema and I+ t&ere is some evidence to suest t&at se8uentia(

mu(tic&ambered pumps are more eJective t&an sin(e/c&ambered pumps. %&e

%reatment o' Lymp&edema Re(ated to


21/36

provides additiona( bene)t over compression arments a(one *Dina study

re'erence 4 in bibi(iorap&y+. &i(e t&e Dina study was t&e on(y (iterature re'erence

t&at met t&e criteria o' a randomied! contro((ed tria(! t&e uide(ines did review t&e

resu(t o' a number o' ot&er (ess riorous pub(is&ed studies. %&ey note mi@ed resu(ts

and (imitations due to sma(( samp(e sie! mi@ed popu(ations! (acG o' contro( roups

and (acG o' outcome measures t&at assessed symptoms suc& as pain and

&eaviness. %&e aut&ors 'urt&er note t&at no comparative studies &ave been

pub(is&ed to determine optima( treatment times! pressure (eve(s or type o' pump.

%&ey note t&at t&e (iterature is suestive but not unanimous t&at se8uentia(!

mu(tic&ambered pumps are more eJective t&an sin(e/c&amber pumps but do not

speci)ca((y address manua((y/contro((ed pressure radient pumps *0342+. Co&en!

et.a(. pub(is&ed Lymp&edema trateies 'or #anaement in a 2001 supp(ement to

t&e ourna( Cancer. 21 %&is supp(ement contained mu(tip(e sections addressin t&e

care o' breast cancer patients. -n t&e section on manaement o' (ymp&edema! t&e

aut&ors state: $(t&ou& at one time pneumatic compression pumps represented t&e

standard treatment 'or (ymp&edema in t&e ;nited tates! controversy about t&eir

use e@ists today. ome studies corroborate t&eir use'u(ness in t&e treatment o'

(ymp&edema w&i(e anot&er randomied study discounts t&eir eJectiveness...-n

s&ort! no c(ear uide(ines e@ist in t&e se(ection or use o' pumps. $ variety o' pumps!

wit& sin(e or mu(tip(e c&ambers and various ma@ima( pressures! (ent&s o'

pumpin times and 're8uency o' use! &ave been recommendedU$(t&ou& some

patients report onoin bene)t in t&e use o' a pump as part o' a &ome proram!

ot&ers e@perience (itt(e bene)t. $ supp(ier o' pneumatic compression devices

provided an additiona( document t&at is reported(y unpub(is&ed entit(ed

=Compre&ensive %reatment uide(ines stab(is&in Disease #anaement

uide(ines 'or Lymp&edema.> %&e aut&or! Cyndi ?rti! is a (ymp&edema

compression t&erapist wit& numerous citins and contributions on t&e internet to

(ymp&edema b(os! 're8uent(y asGed 8uestions and patient support sites. %&e

document out(ines t&e t&ree diJerent types o' pumps *one c&amber intermittent!se8uentia( non/radient! radient se8uentia(+ and recommends t&e use o' a

radient se8uentia( pump as t&is more c(ose(y mimics t&e bodys pressure radient

system. %&ere 11 is no discussion or distinction in &er uide(ines between

se8uentia( radient pumps wit& or wit&out manua( contro(. Position tatements

-nternationa( ociety o' Lymp&o(oy Consensus document o' t&e -nternationa(

ociety o' Lymp&o(oy entit(ed =%&e Dianosis and %reatment o' Perip&era(

Lymp&edema> was pub(is&ed in 200.22 $ccordin to t&e -L! t&e document

=attempts to ama(amate t&e broad spectrum o' protoco(s advocated wor(dwide 'or

t&e dianosis and treatment o' perip&era( (ymp&edema into a coordinated

proc(amation representin a Yconsensus o' t&e internationa( community.> %&e

consensus document inc(udes intermittent pneumatic compression or=pneumomassae> as a non/surica( treatment option &owever! t&e document

does not recommend any type o' compression pump *i.e.! sin(e or mu(tic&amber!

se8uentia( radient! etc.+! 're8uency or pressure settin. Qationa( Lymp&edema

QetworG $ccordin to t&eir web site! t&e Qationa( Lymp&edema QetworG *QLQ+ is

an internationa((y reconied non/pro)t oraniation 'ounded in 19AA to provide

education and uidance to (ymp&edema patients! &ea(t&care pro'essiona(s and t&e

enera( pub(ic by disseminatin in'ormation on t&e risG reduction and manaement


22/36

o' primary and secondary (ymp&edema. %&e QLQ is described as a =drivin 'orce

be&ind t&e movement in t&e ;.. to standardie 8ua(ity treatment 'or (ymp&edema

patients nationwide.> %&e QLQ &as deve(oped position papers on various topics

re(ated to t&e dianosis and manaement o' (ymp&edema. %&e QLQ states t&at

=QLQ position papers are dra'ted by t&e QLQ #edica( $dvisory Committee *#$C+ to

re5ect pro'essiona( positions on Gey issues re(ated to (ymp&edema and (ymp&o(oy.

%&ese documents are reviewed every two years or w&en new scienti)c advances

re(ated to t&e topic occur.> %&e most recent position statement by t&e QLQ #$C

re(ated to treatment o' (ymp&edema was approved by t&e QLQ -n5ation cyc(e time or

duration! number o' treatments and duration o' treatment are not discussed. 12

ummary %&is review o' t&e scienti)c (iterature attempts to determine i' t&ere is

diJerentiation between t&e diJerent types o' pneumatic compression devices and i'

so! are t&ere speci)c patient c&aracteristics or disease conditions w&ic& merit t&e

use o' one device over anot&er. $ccordin to instructions issued to #edicare

contractors by C#! one must consider t&e broad rane o' avai(ab(e evidence and

eva(uate t&e 8ua(ity o' t&e evidence. %&is e@ercise reviewed peer/reviewed!pub(is&ed c(inica( tria(s! uide(ines and consensus statements 'rom c(inica( e@perts

and medica( associations! position statements 'rom oraniations wit& e@pertise in

t&e subect o' (ymp&edema treatment and ot&er eva(uations o' pneumatic

compression tec&no(oy. it& reard to t&e 8ua(ity o' t&e evidence! numerous

aut&ors commented t&at t&e studies supportin t&e use o' pneumatic compression

devices are universa((y poor. %&ere are 'ew randomied! prospective! contro((ed

tria(s and t&e ones t&at were reviewed &ad con5ictin resu(ts. #ost c(inica(

uide(ines and position statements re(ied upon e@pert opinion and consensus

&owever! a(( were (acGin in speci)city wit& respect to t&e 8uestions at &and.

$pp(yin t&e C# instructions 'or t&e evidence basis 'or coverae decisions to t&e

8uestions posed! one can summarie t&e scienti)c (iterature as 'o((ows: Zuestion 1:Does t&e pub(is&ed medica( (iterature support t&e use o' one type o' pneumatic

compression device compared to anot&er, $. Pub(is&ed aut&oritative evidence

derived 'rom de)nitive randomied c(inica( tria(s or ot&er de)nitive studies $nswer:

Qo. %&ere is a enera( trend towards support o' a mu(ti/c&amber device over a

sin(e c&amber device t&ou& evidence is con5ictin.


23/36

ourna(s $nswer: Qo. %&ere is no scienti)c data or pub(is&ed researc& supportin

enera( acceptance o' one type o' pneumatic compression device over anot&er.

%&ere is a trend towards support o' a mu(ti/c&amber device over a sin(e c&amber

device. 2+ Consensus o' e@pert medica( opinion *i.e.! reconied aut&orities in t&e

)e(d+ $nswer: Qo. %&ere is no consensus o' t&e e@pert medica( opinions reviewed

t&at one type o' pump is more eEcacious t&an anot&er. + #edica( opinion derived

'rom consu(tations wit& medica( associations or ot&er &ea(t& care e@perts. $nswer:

Qo. Review o' medica( association statements and position papers 'rom &ea(t& care

e@perts in t&e treatment o' (ymp&edema &ave no 1 statements reardin t&e

superiority o' one type o' pump over anot&er &owever! Cyndi ?rti did recommend

use o' a se8uentia( radient pump since! in &er opinion! it better mimics t&e bodys

own (ymp&atic drainae mec&anism. Zuestion 2: $re t&ere speci)c patient

c&aracteristics and6or disease conditions t&at 'avor one type o' pneumatic

compression devices over anot&er, $. Pub(is&ed aut&oritative evidence derived

'rom de)nitive randomied c(inica( tria(s or ot&er de)nitive studies $nswer: Qo.

&i(e t&ere is a enera( trend towards support o' a mu(ti/c&amber device over a

sin(e c&amber device! in'ormation on patient se(ection *ot&er t&an &avin

(ymp&edema+! 're8uency o' treatment! treatment duration and pressures uti(ied

are (acGin.


24/36

breast carcinoma/associated (ymp&edema. Cancer 200294*11+:2230/2237. I

i(burn ?! i(burn P! RocGson . $ pi(ot! prospective eva(uation o' a nove(

a(ternative 'or maintenance t&erapy o' breast cancer/associated (ymp&edema.


25/36

$ccessed "une 2I! 200A at &ttp:66www.(ymp&net.or6pd'Docs6n(ntreatment.pd' bert

D. oover! "r.! #D! #P! F$CP Purpose %&e purpose o' t&is (iterature review is to

consider t&e scienti)c evidence 'or t&e use o' pneumatic compression devices *PCD+

in t&e treatment o' (ymp&edema. %&e review wi(( attempt to determine: 1. Does t&e

medica( (iterature support t&e use o' one type o' PCD compared to anot&er, 2. -' t&e

medica( (iterature supports t&e use o' one type o' PCD compared to anot&er! are

t&ere speci)c patient popu(ations or disease conditions t&at support t&e medica(

necessity o' one type o' PCD *e..! PCD wit& manua((y/contro((ed pressures vs.

wit&out manua( contro(+, %ypes o' Pneumatic Compression Devices and $pp(iances

*s(eeves+ %&ere are basic types o' PCDs: 1. $ non/semented pneumatic

compressor *ea(t&care Common Procedure Codin ystem *CPC+ code 0340+ is

a device w&ic& &as a sin(e out5ow port on t&e compressor. %&is out5ow port may

be connected to a s(eeve6app(iance wit& mu(tip(e compartments or sements

*0371/037+ and may ac&ieve a se8uentia( pressure radient t&rou& t&e desin

o' t&e tubin and6or air c&ambers in t&e s(eeve6app(iance. 2. $ semented

pneumatic compressor wit&out ca(ibrated radient pressure *0341+ is a device

w&ic& &as mu(tip(e out5ow ports on t&e compressor w&ic& (ead to distinct sements

on t&e app(iance w&ic& in5ate se8uentia((y. %&ese devices ac&ieve se8uentia(

compression by eit&er *a+ app(ication o' t&e same pressure in eac& sement or *b+

app(ication o' a predetermined pressure radient in successive sements but no

abi(ity to individua((y set or adust pressures in eac& o' one or severa( sements. -n

t&ese devices! t&e pressure is usua((y set by a sin(e contro( on t&e dista( sement.

%&ey are used wit& s(eeves6app(iances *0337/0339+ t&at are mu(ti/c&ambered

t&us a((owin 'or se8uentia(! radient compression. . $ semented device wit&

ca(ibrated radient pressure *0342+ is c&aracteried by a manua( contro( on at

(east t&ree out5ow ports w&ic& can de(iver an individua((y determined pressure to

eac& sementa( unit. %&ese PCDs are a(so used wit& a mu(tic&ambered

s(eeve6app(iance to ac&ieve se8uentia(! radient compression. vidence Review

Criteria $ P; and=compression> combined wit& =(ymp&edema.> ?n(y n(is& (anuae 'u(( te@t

artic(es were reviewed. %&e searc& was (imited to artic(es pub(is&ed 'rom 19A0 to

200A. %&e re(ative strent& o' t&e evidence presented in t&e c(inica( studies was

assessed accordin to t&e uidance provided by t&e Centers 'or #edicare B

#edicaid ervices *C#+ to contractor medica( directors 'or deve(opin (oca(

coverae determinations *LCDs+.1 2 $ccordin to C# instructions! coverae

po(icies s&ou(d be based on: 1. Pub(is&ed aut&oritative evidence derived 'rom

de)nitive randomied c(inica( tria(s or ot&er de)nitive studies and! 2. enera(

acceptance by t&e medica( community *standard o' practice+! as supported by

sound medica( evidence based on: a. cienti)c data or researc& studies pub(is&ed in

peer/reviewed medica( ourna(s or! b. Consensus o' e@pert medica( opinion *i.e.!reconied aut&orities in t&e )e(d+ or! c. #edica( opinion derived 'rom consu(tations

wit& medica( associations or ot&er &ea(t& care e@perts. %&e instructions continue by

statin: $cceptance by individua( &ea(t& care providers or even a (imited roup o'

&ea(t& care providers norma((y does not indicate enera( acceptance by t&e medica(

community. %estimonia(s indicatin suc& (imited acceptance! and (imited case

studies distributed by sponsors wit& )nancia( interest in t&e outcome! are not

suEcient evidence o' enera( acceptance by t&e medica( community. %&e broad


26/36

rane o' avai(ab(e evidence must be considered and its 8ua(ity s&a(( be eva(uated

be'ore a conc(usion is reac&ed. &i(e t&is review is not conducted to deve(op an

LCD! its purpose wi(( support coverae decisions made by t&e contractor medica(

director. Conse8uent(y! t&e review wi(( be conducted in accordance wit& uidance

provided by C#. -n addition to artic(es and position papers retrieved by t&e searc&

described above! severa( manu'acturers o' PCDs were asGed 'or c(inica( materia(

supportin PCD use. vidence va(uation &i(e numerous artic(es were reviewed

notin t&at PCD &as become standard o' care in most countries! conc(usive

documentation o' t&e bene)ts o' t&is treatment moda(ity are (acGin. %&e opinion

e@pressed by t&e upportive Care uide(ines roup o' Cancer Care ?ntario and t&e

?ntario #inistry o' ea(t& and Lon %erm Care is i((ustrative o' t&is di(emma w&en

t&ey state t&at =%&e (acG o' suEcient &i& 8ua(ity evidence prec(udes de)nitive

recommendations 'rom bein made.>2 &i(e t&is statement was made in re(ation to

treatment options 'or women wit& breast cancer and (ymp&edema! t&e document

'urt&er states =%&ere is some evidence w&ic& suests t&at p&ysica( t&erapies suc&

as compression t&erapy and manua( (ymp&atic drainae may improve estab(is&ed

(ymp&edema but 'urt&er studies are needed.> uba et.a(. conducted a

randomied! prospective study at t&e tan'ord Center 'or Lymp&atic and Henous

Disorders c(inic comparin deconestive (ymp&atic t&erapy *DL%+ a(one or DL% wit&

adunctive intermittent compressive t&erapy. %&e study uti(ied a e8uentia(

Circu(ator 200I *! inc(uded 27 women w&o &ad comp(eted an initia( one

mont& o' intensive DL% but &ad (ess t&an one year o' DL% e@perience. $(( patients

were )tted wit& and wore a C(ass -- compression arment. -n tudy 1 *-nitia(%reatment+! 12 patients were randomied to DL% p(us PCD *roup 1+ and 11 to DL%

a(one *roup 2+. $'ter two weeGs o' treatment! t&ere was a statistica((y sini)cant

vo(ume reduction in t&e aJected e@tremity o' I4.K vs. 23K 'or roup 1 compared

to roup 2! respective(y. $t t&e end o' I0 days! vo(ume reduction was 0.K 'or

roup 1 and 27.1K 'or roup 2. %&e diJerence in vo(ume reduction between t&e

two roups at I0 days was not statistica((y sini)cant nor was t&e c&ane 'rom t&e

time o' t&e two weeG eva(uation &owever! it did demonstrate t&at t&e eJects o'

treatment are durab(e. -n tudy 2 *#aintenance %reatment+! 27 patients were

recruited and 24 comp(eted t&e study. Patients were 'o((owed 'or one mont& and

were randomied to receive se('administered maintenance t&erapy wit& DL% a(one

versus DL% p(us PCD. imi(ar to tudy 1! t&ere was a statistica((y sini)cantreduction in (imb vo(ume in t&e roup randomied to t&e DL% p(us PCD roup.

%wenty/'our patients were 'o((owed 'or subse8uent 3 mont& period wit& 19 e(ectin

to continue use o' a PCD. %&ese patients e@perienced an additiona( reduction in (imb

vo(ume compared to t&e )ve patients e(ectin to discontinue pump use. ubas

study was sma(( and on(y inc(uded patients wit& (ymp&edema subse8uent to breast

cancer treatment. %&ere was no description o' t&e randomiation process and

'o((ow/up time was re(ative(y s&ort. -n addition! (iGe many studies! patients used a


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compression arment or compression bandae systems between treatments. ince

aut&ors do not comment on t&e comp(iance wit& arment use! its impact on t&e

resu(ts o' PCD use are uncertain. Comp(iant use o' a compression arment between

sessions cou(d c(ear(y impact t&e vo(ume reductions attributed to PCD use. %aGin

t&at caveat into consideration! t&is study did demonstrate t&at t&e use o' an 0341

PCD was eEcacious in reducin upper e@tremity edema. RocGson and co((eaues

conducted a randomied! prospective! cross/over study o' massae versus PCD

*F(e@itouc& / %acti(e ystems! -nc.+ in 10 patients wit& uni(atera( breast cancer/

associated (ymp&edema o' t&e arm.I %&e F(e@itouc& system uti(ies a arment t&at

e@tends onto t&e t&oracic wa(( or pe(vic6abdomina( reion! t&e bene)t purported to

be encouraement o' e@cess 5uid to 'o((ow e@istin pat&ways o' (ymp& movement

'rom t&e trunG to t&e centra( circu(ation. $(( patients used se('/administered

massae and compression arments prior to randomiation. %&e study was

conducted 'or 1I days a'ter a 1 weeG was&out w&ere on(y compression arments

were used *no massae+. %&e F(e@itouc& arm ac&ieved statistica((y sini)cant

reduction in vo(ume compared to t&e massae a(one co&ort. %&e aut&ors observed

t&at even in s&ort term use! I t&e device con'ers t&erapeutic bene)t over t&at

w&ic& can be attained t&rou& standard t&erapies. owever! t&ey a(so note t&at t&is

was a sma(( study o' (imited (ent& and t&e protracted use o' t&is device must be

considered in re(ations&ip to t&e retai( cost o' between M10!A00 and M12!I00 *2004

pricin+. $dditiona( weaGnesses are t&e (acG o' comparison to standard arments

t&at encirc(e t&e (imb on(y and t&e 'ai(ure to speci'y treatment pressures. Dini et.a(.4

*199A+ conducted t&e most wide(y cross/re'erenced randomied study e@aminin

t&e impact o' treatment wit& pneumatic compression versus no treatment on post/

mastectomy patients wit& (ymp&edema. %&is study randomied A0 post/

mastectomy women to eit&er intermittent pneumatic compression or no treatment.

omen in t&e treatment roup underwent a two/weeG cyc(e o' )ve pump sessions

per weeG! 'o((owed by a )ve/weeG breaG in treatment and t&en anot&er two/weeG

cyc(e o' treatment. %&ere was no statistica((y sini)cant diJerence in response ratesbetween t&e two roups. %&e aut&ors conc(uded t&at pneumatic compression

pumps &ave a (imited ro(e in t&e manaement o' patients wit& (ymp&edema. $

weaGness o' t&is study is t&e (acG o' detai(ed in'ormation about t&e pump system

used. %&e aut&ors state t&at PCD sessions &ad cyc(e pressures o' 30 mm

&owever! t&ere is no description o' t&e system used or w&et&er a se8uentia(

radient app(iance was used. "o&ansson and co((eaues3 prospective(y compared

manua( (ymp& drainae *#LD+ uti(iin t&e Hodder tec&ni8ue to se8uentia(

pneumatic compression app(ied to t&e upper e@tremity in 2A women wit& post/

surica( arm (ymp&edema 'o((owin breast cancer and a@i((ary node dissection.

Pneumatic compression was app(ied wit& t&e Lymp&a/Press device *0341 N 0337+

uti(iin I0/30 mm o' pressure 'or 2 &ours per day. Compression arments wereused in bot& t&e #LD and PCD patients between treatments. Fo((owin a two weeG

run/in usin a standard compression s(eeve *arment+! 2I patients were

randomied. $t t&e two weeG 'o((ow/up! t&ere was no sini)cant diJerence between

t&e two treatments *#LD vs. PCD+ in eit&er abso(ute vo(ume reduction or in percent

reduction in (ymp&edema. %&e aut&ors note t&at t&e poorer resu(t 'or t&e PCD

patients compared to ot&er studies *10! 14+ may be due to t&e s&ort duration o'

treatment *2 &ours per day+. $ruin aainst t&is &ypot&esis is t&e comparison o'


28/36

t&e #LD and PCD demorap&ics. %&e PC roup &ad an averae edema duration o'

3.4 mont&s versus 1I.0 mont&s in t&e #LD roup. tudies &ave s&own t&at t&e

duration o' t&e edema can sini)cant(y impact t&e success o' (ymp&edema

treatment due to scarin and )brous c&anes in t&e under(yin tissues t&ere'ore!

t&e PCD patients wit& t&e s&orter duration s&ou(d &ave &ad an =advantae> towards

improved 5uid reduction over t&e #LD patients. %&is was not seen.


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1 Pneumatic Compression Devices

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