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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3751_Библиотеки_им_академика_М_И_Перельмана
.pdf
1.
A systematic review of seven small trials investigating the use of non–drug-eluting BRS in lower
extremities demonstrated high procedural success. However, mean primary patency rates were not
encouragingat 61.6% in femoral arteries after 6-12 months compared with 50.3% in below-the-knee
lesions.43Currently,twoBRSstentscarrytheCEmarkforuseinthe lowerextremity,theIgaki-Tamai
stent(KyotoMedicalPlanningCo.,Kyoto,Japan)andtheREMEDYstent(KyotoMedicalPlanningCo.,
Kyoto, Japan). Both, however, have been shown to be inferior compared with nitinol stents.
44,45
An
unsuccessful attempt to improve performance using drug-coated balloon deployment before BRS
implantationwasstudiedinasmallcohortof20patients,withalowrateofprimarypatencyandhighrate
oftargetlesionrevascularization.
44
2.
Giventhese suboptimal results, the use of non–drug-coated BRS stents has been limited, with a shift
toward using antiproliferative coated BRS. The ESPRIT scaffold system (everolimus-eluting PLLA
scaffold) was testedin35 patients withlesionslocatedin thesuperficial femoral artery(88.6%) and
external iliac artery (11.4%). At 1 and 2 years, binary restenosis rates were 12.1% and 16.1%,
respectively.46 The Absorb everolimus-eluting bioresorbable vascular scaffold was the only FDA-
approvedBRSincoronaryarterydisease.Thefeasibilityandefficacyoftheiruseinarteriesbelowthe
kneewastestedin33patientswithexcellent12-monthprimarypatencyof96%and84.6%at24months.
47
C.Summary
BRSsareapromisingarenaforendovasculartherapyinPAD,despitethetechnicalchallengestheypose
forendovascularoperators. Currently,noBRSisFDAapprovedforclinical useinperipheralvessels.
Thismaychangeinthenearfuturewithpromisingdatafromeverolimus-elutingBRSstents.Withnewer
generationBRSswiththinnerstrutsandprovidingmoreradialstrength,thesescaffoldsmayreshapethe
futureofendovascularintervention.
References
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32.KrogerK,SantosaF,GoyenM.Biomechanicalincompatibilityofpoplitealstentplacement.JEndovasTher.2004;11:686-694.
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36.DakeMD,VanAlstineWG,ZhouQ,RaghebAO.Polymer-freepaclitaxel-coatedZilverPTXstents–evaluationofpharmacokinetics
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37.DakeMD,AnselGM,JaffMR,etal.Paclitaxel-elutingstentsshowsuperioritytoballoonangioplastyandbaremetalstentsin
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38.DakeMD,AnselGM,JaffMR,etal.Durableclinicaleffectivenesswithpaclitaxel-elutingstentsinthefemoropoplitealartery:5-year
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C H A P T E R 1 4
AtherectomyforPeripheralArterialDisease
BennettCuaMD
FACC,MahmoudAbdelghanyMD
RobertR.AttaranMD,FACC,FASE,FSCAI,RPVI
I.Introduction
A.PercutaneousInterventionsforPeripheralArteryDisease
B.ZilverPTXDES
C.Treatment
II.PrinciplesofAtherectomy
III.ExcimerLaserAtherectomy
A.ELASystemMechanics
B.ELAforCriticalLimbIschemia
C.ELAinClaudicants
D.ELAforIn-StentRestenosis
IV.RotationalAtherectomy
A.RADevice:JetstreamXC
B.RotationalAtherectomyforInfrainguinalPAD
VOrbitalAtherectomy
A.OADevice:Diamondback360
B.OrbitalAtherectomyforPopliteal,Peroneal,and/orTibialArteriesinCLI
C.OrbitalAtherectomyforAbove-the-KneePAD
VI.DirectionalAtherectomy
A.DADevicesandTrials
B.DAforModerate-to-SevereVesselCalcification
VIIPhoenixAtherectomyDevice
KeyPoints
■The principles and goals of atherectomy include plaque modification, debulking, vessel
preparation,andminimizingtheneedforstentdeployment.
■The mechanisms of atherectomy by excimer laser include plaque debulking by
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photochemical,photothermal,andphotomechanicalforplaqueablation.
■Orbital atherectomy, directional atherectomy, and forward-cutting atherectomy are other
FDA-approvedmethodsofatherectomy.
I.Introduction
A.PercutaneousInterventionsforPeripheralArteryDisease
Percutaneous interventions for peripheral arterydisease (PAD)continuetorapidlyevolve providing a
varietyoftoolstorestorelowerextremitybloodflow.However,thepaucityofrandomizedcontroltrials
comparingthesedifferentrevascularizationtechniqueshasleftuswithoutanevidence-basedroadmapto
guidetreatment.Althoughthe adventofnitinolstentshasgreatly reducedearlyrestenosis afterballoon
angioplastyby addressing complications such as vessel dissection and elastic recoil during theindex
procedure,itslong-termsuccessremainshamperedbyin-stentrestenosis(ISR).Drug-coatedtechnology
including stents and balloons, scoring balloons, and atherectomy devices are all potential tools for
prevention andtreatment ofISR.Currentpracticesare basedpredominantlyonevidencegatheredfrom
smallsafetytrialsandsingle-centerexperienceswithafewselectiverandomizedcontroltrials.
B.ZilverPTXDES
TheZilverPTXpaclitaxel-coatednitinoldrug-elutingstent(DES)(CookMedical,Bloomington,IN)has
gainedpopularityforthetreatmentoffemoropoplitealarterialstenoseswithaprovensuperior12-month
event-free survival and patency rates compared with balloon angioplasty with provisional bare metal
stent(BMS),butitisimportanttonotethattheaveragelesionlengthwasonly6.5cm.1Morerecently,5-
yearfollow-updatawerepublished2comparingZilverPTXwithballoonangioplasty. TheZilverPTX
DES demonstrated sustained superiority in freedom from reintervention compared with balloon
angioplasty.
C.Treatment
Nevertheless,theoptimaltreatmentstrategyforlongerlesionsthataremorefrequentlyseeninreal-world
practiceremainsunclear,andtheroleforatherectomyremainstobeseen.
II.PrinciplesofAtherectomy
Thefundamentalaimofatherectomyis(1)plaquemodificationtofacilitatepassageofotherendovascular
equipment and balloon expansion, (2) debulking of atherosclerotic and calcium burden to maximize
luminal diameter gain, (3) vessel preparation to avoid suboptimal balloon angioplasty, and (4) to
minimizetheneedforstentdeployment.Thereareseveraldifferenttypesofatherectomydevicesdesigned
to cut, shave, sand, or vaporize plaques in diseased arteries. Current data do not support use of
atherectomydevicesaloneindenovolesionsbutinsteadmaybe ahelpfuladjuncttorevascularization.
Forexample,vesselpreparationbydirectionalatherectomy(DA)beforeballoonangioplastywithdrugcoated balloon (DCB) was effective and safe. Although the DEFINITIVE AR study (Directional
AtherectomyFollowedbyaPaclitaxel-CoatedBalloontoInhibitRestenosisandMaintainVesselPatency
—A PilotStudyofAnti-Restenosis Treatment)did notshowa significant difference betweenDA plus
DCBincomparisonwithDCBonlyforthetreatmentoffemoropoplitealarterydiseaseat1year;patients
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treatedwithDAplusDCBhadhighertechnicalsuccessrate(89.6%vs64.2%;P=.004)andlowerflowlimitingdissectionrate(2%vs19%;P=.01)comparedwithDCBonly.
3
III.ExcimerLaserAtherectomy
Spectranetics is the manufacturer of four excimer laser atherectomy devices for infrainguinal lower
extremityarteries:(1)Turbo-Elite(previouslyCliRpath),(2)Turbo-Booster,(3)Turbo-Tandem,and(4)
Turbo-Power(Fig.14.1).Thefirstdeviceisusedforbothabove-andbelow-the-kneearteries,whereas
thelatterthreedevicesareforabove-the-kneelesions.
FIGURE14.1 Turbo-EliteLaserAtherectomyCatheter.
CourtesyofRoyalPhilips.
A.ELASystemMechanics
TheSpectranetics(MapleGrove,MN)excimerlaseratherectomydevicesemitaxenonchloride(XeCl)
ultravioletlightfromthefiberopticcathetertipatawavelengthof308nm,ablatingatheroscleroticplaque
andvaporizingthrombiatapenetrationdepthof50µmbyacombinationofphotochemical,photothermal,
andphotomechanicaleffectswhileminimizingdamagetosurroundingtissue.4Throughthephotochemical
process,thehigh-energy,monochromaticlaserbeamsdirectlybreakthemolecularcarbon-carbonbonds
ofatheroscleroticplaqueorthrombuswithsubsequentdissipationofenergy.Thereleasedenergy,through
the photomechanical effect, evaporates the intracellular water ahead of the tip of the laser catheter,
producinga steam bubble that rapidlyexpands and contracts resultingintissue breakdown. The laser
emission is pulsed rather than continuous like its Argon predecessors, minimizing the photothermal
processasexcessiveheatingpromotesaneurysmformation,lateperforations,andahighrestenosisrate.
Each pulse is 125 ns with 80 pulses delivered per second. This calculates to less than 1 mm of
atheroscleroticplaqueablatedpersecondnecessitatingslowadvancementofthelasertoensurethatthe
advancement ratedoes notexceedthe tissue removal rateintomaximizeluminal diameter gainof the
vessel.Theresidualparticlesmeasurelessthan10micronsindiameterconferringminimalriskofdistal
embolization.5Thelasershouldonlybeactivatedaftersalineflushtoremoveiodinatedcontrastmaterial
fromthetargetbloodvessel,becausecontrastandhemoglobinabsorbtheexcimerlaserlightat308nm,
yielding cavitation bubbles, vapor bubbles, and percussive waves, which can lead to dissections or
perforations.
6
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B.ELAforCriticalLimbIschemia
1. The Laser Angioplasty in Critical Limb Ischemia (LACI) Belgium trial published in 2005
demonstrated the safety and efficacyofthe Turbo-Elite (previouslyCliRpath) for treatment ofcritical
limbischemia(definedasRutherfordcategory4,5,or6)inpoorsurgicalbypasscandidates.6Therewas
fairlyevendistribution of lesions betweenfemoropopliteal, infrapopliteal, and multilevel lesions.The
standardendovascularmethodofcrossingthelesionwithaguidewirefollowedbyover-the-wirelasing
was successfullyexecuted in 84% (43 of 51) ofcases with the remainder 16% (8 of 51) of lesions
requiring a step-by-step technique to achieve recanalization. The step-by-step technique involves
sequentialadvancementoftheguidewireandactivationofthelasercatheterinatelescopingfashionuntil
theentirelength ofthe occlusion is crossed. Adjunctive PTA, stenting, andacombinationofPTA with
stenting were used in33%, 6%, and47%, respectively. Limbsalvage ofthetreatedlimb at6 months
(studyprimaryendpoint)was90.5%andfreedomfromcriticallimbischemiawas86%.
2. The LACI Phase 2 trial also studied the Turbo-Elite enrolling patients in the United States and
GermanywiththesameinclusionandexclusioncriteriaasLACIBelgiumbutcomparativelyresultedina
cohortwithahigherincidenceofdiabetesandnonhealingulcers(Rutherfordcategory5-6).Reflectiveof
thecohorts’poorprotoplasm,therewasa10%mortalityrateat6monthsalmostexclusivelyfromcardiac
causes.Theprimaryendpointof6-monthlimbsalvagewasachievedin93%ofsurvivinglegs.Thestepby-steptechniquewasusedin17%(26of145)ofcaseswithminimaladditionalriskwhilesignificantly
increasing the success rate of crossing total occlusions. Adjunctive PTA and stent placement were
requiredin96%and45%ofcases,respectively.
7
C.ELAinClaudicants
1. TheTurbo-Elite laser catheter’s enface, concentriclaser orientationlimited itsabilitytooptimally
treatfemoral-popliteallesionsasitwasunabletocreatealumenmuchlargerthanthenominaldiameter
of the ablation catheter.8 Directional lasing allowed for more complete removal of atherosclerotic
plaque,neointimalhyperplasia,andthrombusbyoff-axislasing,whichwasincorporatedintotheTurboElitewiththeadditionofabiasguidecatheter.9Thisfirstdirectionallasingcatheterwasknownasthe
Turbo-Booster. The Turbo-Tandem followed as the second-generation directional ELA catheter. The
Turbo-PoweristhenewestgenerationELAcatheterthathasremovedthebiasguidecatheterwhilestill
preservingitsdirectionalfunctionalitywithanewlydesignedeccentrictip.
2.CliRpathExcimerLaserSystemtoEnlargeLumenOpenings(CELLO)wasasingle-arm,prospective
registry published in 2009studyingthe efficacyandsafetyofusing the Turbo-Boosterwiththe TurboElitetoincreaseluminaldiameterofthesuperficialfemoralandpoplitealarteryabovethekneejointin
patientswithintermittentclaudication.Theaveragelesionlengthwas5.6cmwith61.5%withmoderateto-severecalcification.ThetandemuseofTurbo-ElitefollowedbyTurbo-Boosterachievedbothefficacy
and safety primary endpoints with a reduction in index lesion percent diameter stenosis prior to any
adjunctivetherapyfrom77%+15%atbaselineto34.7%+17.8%withnomajoradverseevents(MAEs)
at 6 months. Intravascular ultrasound (IVUS) data from CELLO showed that luminal diameter gain
achievedwithELAhadequalcontributionfrom plaquedebulkingandvesselenlargementdemonstrated
byanincreaseinexternalelasticmembranecircumference.
8
D.ELAforIn-StentRestenosis(Table14.1)
Table14.1
ELAandIVUSKeyPoints
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■ThethreemainmechanismsbywhichELAworksarephotochemical,photothermal,andphotomechanical.
■TheTurbo-TandemandTurbo-PoweraretheonlytwoFDA-approvedatherectomydevicesapprovedfortreatmentof
femoropoplitealISRwithlevel1clinicaldata.
■LimiteddistalembolizationwithratescomparabletoangioplastyandstentingbutwithrateslowercomparedtoSilverHawk
directionalatherectomy.
■IVUSstudiesshowthatincreaseinvesselluminaldiameterwithELAisequallyattributedtoplaquedebulkingandexpansionof
vesselwallcircumference.
1.TheTurbo-Booster,Turbo-Tandem,andTurbo-Poweraretheonlyatherectomydevicesapprovedfor
treatmentoffemoral-poplitealISRlesions(level1clinicalevidence).
2. ThePhotoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment
(PATENT)studyin2014usedtheTurbo-Elitetocreateapilotchannelfollowedbyameanof5.7passes
with the Turbo-Booster to treat symptomatic femoropopliteal ISR, which achieved a high procedure
successratebutwithonlyprimarypatencyat6and12monthsof64.1%and37.8%,respectively.
10
3. The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent
Restenosis (EXCITE-ISR) trial in 2015 is the first large, prospective, randomized control trial that
demonstratessuperiorityintermsofproceduralsuccess(93.5%vs82.7%;P=.01)withsignificantlyless
procedural complications (major dissections, residual stenosis >30%, or need for bailoutstenting), 6monthfreedomfromtargetlesionrevascularization(TLR)(73.5%vs51.8%;P<.005),and30-dayMAE
rates(5.8% vs20.5%;P <.001) when usingELAinadditiontopercutaneoustransluminalangioplasty
(PTA)versusPTAalonetotreatbarenitinolin-stentrestenosis.11Theaveragelesionlengthwas19.6cm
in theELAplus PTA group and 19.3 cm inthe PTA-only group. There was a statisticallysignificant
differenceinthepresenceofseverecalcificationwith27.1%and9.1%intheELAplusPTAandPTAonly group,respectively. The combinationofELAandPTA offers a 52%reductioninTLR (HR0.48;
95%CI:0.31-0.74).SimilartothePATENTstudy,ELAwasperformedusingtheTurbo-Elitetocreatea
pilot channelifneededandthenfollowedwith 4 quadrant passes with theTurbo-Tandem for maximal
plaquedebulking.PriortreatmentforISRinthetargetlimb,increasedlesionlength,decreasedreference
vessel diameter,andtreatmentwithPTAalonewithout ELA were associatedwithanincrease inTLR
occurrence with lesion length as the only significant interaction term. There were no reported stent
fracturesduetolaser-stentinteractions.IVUSstudieshavedemonstrateda35%reductioninstenosisand
a112%luminalareagain,60%ofwhichisattributedtovesselexpansionwiththeTurbo-Tandem.
ClinicalPearls
■Lasingshouldneverbeinitiateduntilsalineflushisusedtoremoveiodinatedcontrastand
bloodfromthetargetvessel.
■Slow advancement of the laser to ensure that the advancement rate does not exceed the
tissueremovalrateintomaximizeluminalgainofthevessel.
■TheTurbo-EliteistheonlyELAdevicethatcanbeusedtocrossocclusionswiththestep-
by-steptechnique.
■After a pilot channel has been made in a difficult-to-cross lesion with the Turbo-Elite,
followupwiththeTurbo-PowerorTurbo-Tandemtoobtainmaximalluminaldiameter.
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IV.RotationalAtherectomy(Table14.2)
Table14.2
RAKeyPoints
■TheJetstreamprovidesconcomitantatherectomyandcontinuousaspiration.
■Despitehavingacontinuousaspirationfeature,distalemboliremainaconcernandembolicprotectiondevicesmustbeconsidered.
■TheJetstreamhasbeenshowntobesafeandeffectiveinshort,calcifiedfemoral-popliteallesions.
■Increaseinvessellumensizeispredominantlyduetoatherosclerosisandcalciumdebulking.
■Theroleforrotationalatherectomybelowthekneeremainsunclear.
A.RADevice:JetstreamXC
TheBostonScientific(Marlborough,MA)Jetstream(Fig.14.2)isarotational,front-cuttingatherectomy
devicethatoffers(1)differential-cuttingtargetingplaquewhileavoidingdamagetonormalendothelium
and(2) continuousactiveaspirationtoreduceembolizationpotentially allowingforbettertreatment of
lesionswithmixedmorphologysuchascalcium,softplaque,fibrousplaque,andthrombus.TheJetstream
XCcatheter made for above-the-knee lesions hasanexpandable blade technologythatcancreatetwo
lumensizeswiththesameatherectomydevicewhiletheJetstreamSCforbelow-the-kneelesionsonlyhas
onebladesize.Theexpandableblademodesareknownasbladesdown(BD;minimaltip)andbladesup
(BU;maximumtip).
FIGURE14.2 MedicalEXPOBostonScientific.CuttingAtherectomyCatheter/ArterialJetstream.
ImageprovidedcourtesyofBostonScientific.©2019BostonScientificCorporationoritsaffiliates.Allrightsreserved.
B.RotationalAtherectomyforInfrainguinalPAD
1.TheMulticenterPathwayPVDtrial
12
publishedin2009studiedthesafetyandefficacyofthePathway
PVsystemutilizedbytheBostonScientific’sJetstream.Thestudyincluded172patientswithRutherford
Class 1-5 lower limb ischemia. This trial’s cohort had a higher proportion of diabetic patients and
vessels with smaller reference diameters compared withthe SilverHawk atherectomy cohorts. Lesion
inclusion criteria included an atherosclerotic stenosis >70% and up to 10 cm lesion length in the
femoropoplitealsegmentorupto3cmlesionlengthininfrapoplitealvessels.Ninetytwopercentofthe
lesionswere located in the SFA or popliteal artery, whereas only8% were in the tibial arteries. The
averagetreatedlesionlengthwasonly2.7cm,51%ofpatientshadmoderate-to-highcalciumscores,and
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31% had total occlusions.Despite having a continuous active aspiration component,there were 9.9%
(n = 17) reported distal embolic events. A separate small study by Boiangiu et al13 comprising 22
participants undergoingJetstream atherectomy with a distal embolic device showed that macroscopic
debris was recovered in 95.4% (21 of 22). Debris analysis revealed collagen material, fibrin,
macrophages,calcificationandcholesterol-richmaterialmeasuring1to10mminsize,whichiscapable
ofoccludingtibialvesselsthatare1to3mminsize.ComparedwiththeSilverHawkatherectomycohort,
Jetstreamatherectomywasassociatedwithahigheroccurrenceofclinicallysignificantdistalemboliat
72.7%versus46.7%.
2.TheMulticenterPathwayPVDtrial’s
12
primarystudyendpointofMAEratesat1and6monthswere
1%and20%,respectively,whicharecomparabletotheuncontrolledstudiesofSilverHawkatherectomy.
MAEwasprimarilydrivenbyrestenosisrateswitha1-yearrateof38.2%,andthiswasalsosimilarto
SilverHawkatherectomy’s1-yearrestenosisratesof35.4%and37.8%.The1-yearlimbsalvageratewas
100%despite15%ofthecohorthavingRutherfordclass4-5limbischemia.Atherectomywasperformed
asstand-alonetherapyin33%ofpatientswithadjunctiveballoonangioplastyin59%andstentingin7%.
Basedonthese limited data,the Jetstream seemstobeeffective andsafeinthose withshort,calcified
femoral-popliteallesions.12Inaseparatestudy,theJetstreamwasshowntosuccessfullyincreaselumen
dimensionsinmoderatelytoseverelycalcified femoral-popliteal lesions from an averagearea of6.6-
10.0mm2(P=.001)byIVUS.Debulkingofcalciumisthemainmechanismbywhichluminalareagain
wasachievedincontrasttoELA.14Todate,therearenorandomizedtrialsavailablecomparingtheuseof
Jetstream atherectomy with balloon angioplasty or drug-coated technologies including stenting. These
atherectomydeviceshavebeenshowntobesafeandhighly effectivein reducing embolicevents when
usedinconjunctionwithadistalembolicprotectiondevice.
15
VOrbitalAtherectomy(Table14.3)
Table14.3
OAKeyPoints
■Orbitalatherectomy(DB360)canbeusedformodificationofcalcifiedlesionsintodecreasetheneedforbailoutstentingwhen
balloonangioplastyiscomplicatedbydissection,vesselclosure,orspasm.
■Adheretostricttreatmentintervalswithequalresttime,usesmallercrownsizes,andadministervasodilatorsliberallytoprevent
slowflow,vesselclosure,orspasm.
■DB360shouldnotbeusedforin-stentrestenosis,bypassgrafts,andwhenthrombusordissectionispresent.
■Atherectomydebrismeasuresontheof2μmandisflushedthroughthecapillarysystemultimatelybeingabsorbedbythe
reticuloendothelialsystem.
A.OADevice:Diamondback360
1.CSI(StPaul,MN) Diamondback360(DB360)(Fig.14.3)isanorbitalatherectomydevicewithan
eccentrically mounted diamond-coated crown that sits on a flexible drive shaft and rotates over a
proprietary0.014-inguidewire(ViperWire)totreatdenovo,calcifiedlowerextremitylesions.
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