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洛和会病院医学雑誌 Vol.30:86−91,2019
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Incidence of Filter Slow flow in Patient with Acute Coronary Syndrome Using Distal Protection Device
PhyoHtetOo¹,KoKoSoe¹,AyumuFujioka²,ToshihiroIwasaku²,TakeyaMinami²,HiroakiFujie²,NaofumiOyamada²,IchiroHamanaka²,KinzoUeda²
¹No.(2),DefenceServicesGeneralHospital,Naypyidaw,Myanmar²RakuwakaiKyotoCardiovascularInterventionCenter,RakuwakaiMarutamachiHospital
【Abstract】Aim: Effectiveness of distal protection device in primaryPCI has been controversial.Actually, in dailypracticewesometimesexperiencefilterslow-flowafterstentingandsometimesnot.Soweassumedthatthosecaseswhichfilterslowflowoccurredshouldbethesubsetswhichwouldreceivethebenefitsbyusingdistalprotectiondevicesforavoidingno-flow/slow-flowinACScircumstances.Method:Thesubjects consistedof 273consecutiveACSpatientswhounderwentprimaryPCIusingdistalprotectiondevice(Filtrap,NIPRO)betweenMay2009andJanuary2018.Theyweredivided into 2groupsdepending on the occurrence of filter slow-flowafter stenting; the filterslow-flow (FS)group (n=129)andno filter slow-flow (nFS)group (n=144).Patient’s characteristics, lesionandproceduralcharacteristicswereanalyzedbetweenthetwogroups.Results:Therewerenosignificantdifferencesinpatientcharacteristicsregardingcardiovascularriskfactors(Hypertension,Diabetes,HemodialysisandSmoking),exceptdyslipidemia(65.9%vs42.3%,p<0.01).Thetotalocclusion lesion on controlCAGwas significantly common inFSgroup thannFSgroup (69.8%vs 57.6%,p<0.05).Moreover, the largeamountof thrombusburden justafterwiringweremore likely found inFSgroupthannFSgroup(44.1%vs2.1%,p<0.01).Theexistenceofcalcificationandtortuosityof lesionwerefewerinFSgroupthannFSgroup(67.4%vs85.3%,p<0.01),whichshowedthelesionsinFSgrouphavemorefragileatherosclerosisor thrombus.Asaresult, aspiration thrombectomy justafterwiring (64.3%vs27.1%,p<0.01)andpredilatationprocedures(61.2%vs21.3%,p<0.01)werehigherinFSgroup.Conclusion:Theseresultsdemonstrate that the selectiveuseofdistalprotectiondevice in the fragileandhighthrombusburdenlesionwhicharemorelikelyfoundinFSgroupisthekeytoavoidslowflow/noreflowphenomenonandseriousadversecardiaceventsafterrevascularization.
【Introduction】
Itisevidentthattheoccurrenceofdistalembolization
and associated slow-flow/no-reflowphenomenon after
percutaneous coronary intervention (PCI) for acute
coronary syndrome (ACS) result in poor prognosis.
However, theeffectivenessofdistalprotectiondevice in
primaryPCIhasbeen controversial.Actually, in daily
practicewesometimesexperience filter slow-flowafter
stentingandsometimesnot.Soweassumed that those
caseswhichfilterslowflowoccurredshouldbethesubsets
whichwillreceivethebenefits foravoidingno-flow/slow-
flowinACSrecanalizationtreatment.
【Methods】
Study Population
BetweenMay2009andJanuary2018,273consecutive
ACSpatientswhounderwentprimaryPCIusingdistal
protectiondevice (Filtrap,NIPRO)wereenrolled in this
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study.Theyweredividedinto2groupsdependingonthe
occurrenceoffilterslow-flowafterstenting:thefilterslow-
flow(FS)group(n=129)andnofilterslow-flow(nFS)group
(n=144).
Procedures
Weretrospectivelyanalyzedthepatient’sclinicaldata,
procedures andangiographic findingsby twodifferent
observers.All patientswere pre-medicated 200mg of
aspirinandbolus injectionof5000IUheparinatERand
5000IUofheparin intracoronaryof theculpritvesselat
controlCAG. Inaddition,allpatientswereprescribeda
loadingdoseofClopidogrelorPrasugrelatER.PCIwas
performedaccording to thestandardclinical techniques
withradialor femoralarteryapproaches. Culprit lesions
wereclassifiedaccordingtotheAHA/ACCclassification.
Severityoflesionstenosiswasdividedintothreecategories
according topercentageof stenosisoncontrolCAG: (1)
Mild;stenosis<75%(2)Moderate;Stenosisbetween75and
99% (3)Severe; stenosis>99%orTotalocclusion lesion.
Thrombusburdenwasdefinedas: (1) Small;Only intra
luminal staining (2)Moderate;Other fillingdefectsnot
associatedwithcalcification, lesionhaziness, irregularity
withill-definedborders(3)Large;Intraluminal,roundfilling
defect,visibleintwoviews,largelyseparatedfromvessel
wall.Severityofcalcificationwascategorizedas: (1)Mild;
Arterialwallcalcificationseenas thin line (2)Moderate;
fillingdefect in lesionnotassociatedwiththrombusseen
evenbeforeandaftercontrast injection (3)Severe;heavy
easily seen calcification.Target lesion tortuositywas
definedas (1)Mild;straightsegmentoronlyonebendof
60degreeormore (2)Moderate; twobendsof60degree
ormore (3)Severe; threeormorebendsof60degreeor
more. Intra-arterial flowwasgradedas0-3according to
theThrombolysis inMyocardial Infarction trial (TIMI)
classification.Collateral flowwasgraded according to
Rentrop’sscore.Afterthecontrolangiogram,7Frguiding
catheterwasused forall of thepatients, and the lesion
wascrossedwith0.014 inch floppyguidewire.Usageof
thrombus aspirationprocedurewasdepended on each
operator’s choice.Thenwe evaluated IVUS findings
inmost cases except fromhemodynamically unstable
patients. In severe organic stenotic or calcified lesions
dilatationbyballoon(<3mm)wasadded.Accordingtothe
IVUS findingandangiographic information, theoperator
deployedFiltrap.Thenweimplantedadrug-elutingstent.
The Basic Principle of Filtrap
Details ofFiltrap (NIPRO, Japan)havealreadybeen
describedelsewhere. Inbrief, the filter isattachedto the
distalendofa0.014-inchguidewire.The filtermembrane
isattachedtohalfofthefilterbasket.Thefiltermembrane
ismadeofpolyurethaneandhasapproximately1800holes.
Eachholesizeisapproximately100μm,andthemembrane
is40μmthick.
Statistical Analysis
SPSSversion21.0(SPSSInc.,Chicago,IL)wasusedfor
allanalyses.Categoricaldatawasexpressedasabsolute
frequenciesandpercentage.Thedatewascomparedusing
aChiSquare testorFisher’sexact test, asappropriate.
Continuousvariables,whichareexpressedasthemean±
standarddeviation (SD),werecomparedusingeitheran
unpairedStudent’st-testortheMann-WhitneyUtest.Ap
valueof<0.05wasconsideredstaticallysignificant.
【Results】
Baseline Demographic
Filter slow-flowoccurred in129patients (Table1).
Although therewereno significantdifferences inother
basicbackgroundofpatient’scharacteristicbetweentwo
groups, patients in theFSgroup showed significantly
higherLDLcholesterollevelatadmissionthanthoseinthe
n-FSgroup.
Lesion Characteristics
Themorphological characteristics of the lesions in
twogroupsareshowninTable2andTable3.Asforpre-
IncidenceofFilterSlowflowinPatientwithAcuteCoronarySyndromeUsingDistalProtectionDevice
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proceduralangiographicfinding,target lesionsweremore
commoninRCAandLADthanLCXandtargetsegment
weredetected inproximalandmidsegmentsmorethan
distal segments,whichwerenosignificantdifferences in
bothgroups.Regarding the lesion characteristics, total
occlusionlesiononcontrolCAGwascommoninFSgroup
thannFSgroup(69.8%vs57.6%,p<0.05).Inaddition,the
FSgrouphad significantly larger amount of thrombus
burdenjustafterwiringcomparedwithnFSgroup(44.1%
vs2.1%,p<0.01).InFSgroup,mildcalcifiedlesionswere
significantlyhigher thannFSgroup (85.3%vs 67.4%,p
<0.001).On theotherhand, the lesionswithmoderate
calcification inFSgroupwere less thannFSgroup (9.3%
vs22.9%,p<0.01)
Variable Total(n = 273)
FS group(n= 129)
n-FS group(n= 144) P value
Age (years) 70.2 ±12.1 70.1±11.9 70.3±12.3 0.89
Males 213(78.1%) 105(81.3%) 108(75.2%) 0.24
Hypertension 175(64.1%) 78(60.1%) 97(67.2%) 0.25
Diabetes Mellitus 101(37.0%) 51(40.3%) 50(35.1%) 0.45
Smoking 132(48.4%) 62(48.1%) 70(49.3%) 1.00
Hemodialysis 10(3.7%) 3(2.1%) 7(5.3%) 0.34
Dyslipidemia 80(29.3%) 51(65.9%) 29(42.3%) <0.01*
Systolic Blood ressure (mmHg) 146.7±29.3 144.1±29.7 149.1±28.8 0.53
LVEF (%) 53.8±12.2 51.7±11.6 55.7±12.6 0.12
Variable Total(n = 273)
FS group(n= 129)
n-FS group(n= 144) P value
Lesion Location
LAD 120(43.1%) 58(45.1%) 62(43.4%) 1.00
LCX 14(5.1%) 6(4.8%) 8(5.2%) 0.41
RCA 139(51.2%) 65(50.1%) 74(51.4%) 0.76
Target Lesion Segment
Proximal(Seg.1, 5, 6, 11) 147(53.8%) 71(55.0%) 76(52.8%) 1.20
Mid(Seg.2, 7, 9, 12, 13) 115(41.1%) 52(40.4%) 63(43.8%) 1.21
Distal(Seg.3, 4, 8) 11(4.1%) 6(4.6%) 5(3.4%) 1.00
Table 1. Baseline patient characteristics
Table 2. Pre-procedural morphological characteristics of target vessels
Continuous data is presented as mean ± standard deviation; categorical data is presented as a number (%) LVEF left ventricular ejection fraction
Categorical data is presented as a number (%)
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IncidenceofFilterSlowflowinPatientwithAcuteCoronarySyndromeUsingDistalProtectionDevice
Procedural Characteristics
Regardingproceduralcharacteristics, therewereno
significantdifferences inpredilatationballoonsize (2.8±
0.6mmvs2.9±0.5mm,p=0.54),stentdiameter (3.4±0.4
mmvs3.4±0.3mm,p=1.0)andstentlength(25.1±7.0mm
vs24.4±6.4mm,p=0.23)betweenbothgroups. (Table4)
Moreover,therewasalsonosignificantdifferenceinsingle
stent procedure (75.9%vs 82.7%, p=0.24) andmultiple
stentprocedure (24.1%vs17.3%,p=0.45)betweenboth
groups (Table 4).The rate of thrombusaspiration just
afterwiringweresignificantlyhigher inFSgroup than
nFSgroup(64.3%vs27.1%,p<0.01).Inaddition,therateof
predilatationwithballoon(POBA)wassignificantlyhigher
inFSgroupthannFSgroup(61.2%vs24.3%,p<0.01).
【Discussion】
Incomparisonwith lesions found instablecoronary
arterydiseases, coronary lesions responsible for acute
coronarysyndromes (ACS)consistsofdisruptedplaques
with superimposed thrombus, and disrupted plaques
which tend to have larger necrotic cores andgreater
plaque inflammation (1).Distalembolizationof thrombus
or atheromatous gruel from epicardial culprit lesion
is common inACSandmightbe further triggeredby
percutaneouscoronary interventions (PCIs) (2,3).Factors
thatincreasetheriskofdistalembolizationwhichinturn
manifestas slow/noreflowphenomenon includePCI to
lesions containing large amounts of friable atheroma,
PCI to culprit lesions containing thrombus responsible
forACS,anduseofatherectomy. (4-6).Accordingtothis
study, thepatientswithdyslipidemiawerehigher inFS
group. So thesepatientshadmore chance of slow/no
flowafterprocedureforACS.Inthelesioncharacteristics,
total occlusion lesion on controlCAGand lesionwith
Variable Total(n = 273)
FS group(n= 129)
n-FS group(n= 144) P value
% Stenosis Control CAG
<75% 46(17.0%) 16(12.4%) 30(20.1%) 0.17
75-99% 54(19.7%) 23(17.8%) 31(22.2%) 0.33
100% 173(63.3%) 90(69.8%) 83(57.6%) <0.05
Thrombus Burden just after wiring
Small 150(55.0%) 45(34.9%) 105(72.9%) <0.01
Moderate 63 (23.1%) 27(21.0%) 36(25.0%) 0.42
Large 60 (21.9%) 57(44.1%) 3(2.1%) <0.01
Calcification
Mild 207(75.8%) 110(85.3%) 97(67.4%) <0.001
Moderate 45(16.5%) 12(9.3%) 33(22.9%) <0.01
Severe 21(7.7%) 7(5.4%) 14(9.7%) 0.33
Target Lesion Tortuosity
Mild 178(65.2%) 75(58.1%) 103(71.5%) <0.05
Moderate 60(21.9%) 39(30.2%) 21(14.6%) <0.05
Severe 35(12.8%) 15(11.6%) 20(13.9%) 1.00
Table 3. Lesion characteristic on CAG
Continuous data is presented as mean ± standard deviation; categorical data is presented as a number (%)
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large thrombusburden justafterwiringwerehigher in
FSgroup thannFSgroup. Inaddition, theexistenceof
calcificationand tortuosityof lesionswere fewer inFS
groupthannFSgroup.Theseresults indicatethe lesions
inFS group have fragilemassive atherosclerosis and
thrombus.Asresult, aspiration thrombectomy justafter
wiringandpredilatationproceduresbyPOBAwereused
frequentlyinFSgroup.
Theeffectivenessofdistalprotectiondevice inprimary
PCIhasbeencontroversialso far.That isbecausethose
populationhavewidevariationsinbothpatientbackground
andlesioncharacterbackground.So,weneedtoselectthe
patientswhowouldgetmorebenefitofdistalprotection
device.Our studywas retrospective study fromsingle
centerexperience,howeveritcouldbeamilestoneforthe
beneficialuseofdistalprotectiondevicesinprimaryPCI.
【Limitations】
Thisstudyhasseveralpotentiallimitations.Firstthis
studywasa retrospective single-centerexperience ina
limitednumberofpatients. Second,wecannot analyze
lesionsmorphologiesinallpatientsbyIVUSstudybecause
ofhemodynamic instability in somepatients.However,
even under these conditions,we can exhibit that the
fragileatherosclerosis, totallyoccluded lesionsand large
thrombusburden lesions indyslipidemiapatientswere
associatedwithhigh frequencyoffilterslowflowduring
theprocedure.
【Conclusion】
This studydemonstrated thepatients, lesions and
proceduralcharacteristics that increasetheriskofdistal
embolization bymean of filter slow flow. So, selected
use of distal protection device in these patients and
lesioncategoriesare importantduringrevascularization
procedureinprimaryPCI.
【Acknowledgments】
Apartofthisworkwaspresentedatthe27thAnnual
Meetingof the JapaneseAssociation ofCardiovascular
InterventionandTherapeutics.
【Conflicts of Interest】
The authors report no financial relationships or
conflictsofinterestregardingthecontentherein.
Variable Total(n = 273)
FS group(n= 129)
n-FS group(n= 144) P value
Predilatation balloon size(mm) 2.9±0.5 2.8±0.6 2.9±0.5 0.54
Stent diameter (mm) 3.4±0.4 3.4±0.4 3.4±0.4 1.00
Stent Length(mm) 24.8±19.4 25.1±7.0 24.4±6.4 0.23
Number of Stent
One stent 217(79.4%) 98(75.9%) 119(82.7%) 0.24
Two or More Stents 56(20.6%) 31(24.1%) 25(17.3%) 0.45
Aspiration Thrombectomy Just after wiring 122(44.6%) 83(64.3%) 39(27.1%) <0.01
Predilatation (POBA) 114(41.7%) 79(61.2%) 35(24.3%) <0.01
Table 4.Procedural Characteristics
Continuous data is presented as mean ± standard deviation; categorical data is presented as a number (%)
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IncidenceofFilterSlowflowinPatientwithAcuteCoronarySyndromeUsingDistalProtectionDevice
【References】
1)ShahP.K. (2003)Mechanismsofplaquevulnerability
andruptured.JAmCollCardio41(SupplS):15S-22S.
2)AngeliniA.,RubartelliP.,MistrorigoF.,etal(2004)Distal
protectionwithafilterdeviceduringcoronarystenting
inpatientswithstableandunstableangina.Circulation
110:515-512.
3)RogersC,HuynhR,SeifertPA,etal.Embolicprotection
with filteringorocclusionballoonsduringsaphenous
veingraft stenting retrieves identical volumes and
sizesofparticulatedebris.Circulation2004;109:1735-40.
4)KotaniJ.,NantoS.,MintzG.S.,etal.(2002)Plaquegruel
ofatheromatouscoronarylesionmaycontributetothe
no-reflowphenomenoninpatientswithacutecoronary
syndrome.Circulation106:1672-1677.
5)Mehran R., Dangas G., Mintz G.S. , et al . (2000)
Atherosclerotic plaqueburden andCK-MBenzyme
elevationafter coronary interventions: intravascular
ultrasoundstudyof2256patients.Circulation101:604-
610.
6)HenriquesJP,ZijlstraF,OttervangerJP,deBoerMJ,
van’tHofAW,HoorntjeJC,SuryapranataH.Incidence
andclinical significanceofdistalembolizationduring
primaryangioplasty foracutemyocardial infarction.
EurHeartJ.2002;23:1112-1117
7)RoffiM,MukherjeeD.Currentroleofemboliprotection
devices in percutaneous coronary and vascular
interventions.AmHeartJ.2009;157:263-270
8)Morishima I, SoneT,OkumuraK,TsuboiH,Kondo
J,MukawaH,MatsuiH,TokiY, ItoT,HayakawaT.
AngiographicNo-ReflowPhenomenonasaPredictorof
AdverseLong-TermOutcomeinPatientsTreatedWith
PercutaneousTransluminalCoronaryAngioplasty for
FirstAcuteMyocardial Infarction.JAmCollCardiol.
2000;36:1202-1209
9)StoneGW,Webb J, CoxDA, Brodie BR,Qureshi
M,KalynychA,TurcoM,SchultheissHP,DulasD,
RutherfordBD,AntoniucciD,KrucoffMW,Gibbons
RJ, Jones D, Lansky AJ, Mehran R, Enhanced
MyocardialEfficacyandRecoverybyAspiration of
LiberatedDebris (EMERALD) InvestigatorsDistal
Microcirculatory ProtectionDuring Percutaneous
CoronaryInterventioninAcuteST-SegmentElevation
MyocardialInfarction.JAMA.2005;293:1063-1072
10)GickM,JanderN,BestehornHP,KienzleRP,Ferenc
M,WernerK,CombergT,PeitzK,ZohlnhöferD,
BassignanaV,BuettnerHJ,NeumannFJ.Randomized
evaluationoftheeffectsoffilter-baseddistalprotection
onmyocardialperfusionandinfarctsizeafterprimary
percutaneous catheter intervention inmyocardial
infarctionwith andwithout ST-segment elevation.
Circulation.2005;112:1462-1469