1 pneumatic compression devices
TRANSCRIPT
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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
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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
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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
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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.
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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.
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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.
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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
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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'
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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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'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 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
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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
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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
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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
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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
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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.
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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.
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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.
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$ccessed "une 2I! 200A at &ttp:66www.(ymp&net.or6pd'Docs6n(ntreatment.pd' bert
D. oover! "r.! #D! #P! F$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
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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'
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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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'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 m