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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3751_Библиотеки_им_академика_М_И_Перельмана
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FIGURE14.3 CSICardiovascularSystem,INC.Diamondback360PeripheralOrbitalAtherectomySystem.A,
Depictsthecathetersetup,(B)showsamagnifiedimageoftheorbitalatherectomycathetertip.
©2019CardiovascularSystems,Inc.CSI®,Diamondback360®,GlideAssist®,ViperWireAdvance®andViperSlide®are
registeredtrademarksofCardiovascularSystems,Inc.,andusedwithpermission.
2.DB360utilizescentrifugalforceanddifferentialsandingtomodifycalcifiedandfibroticplaquewhile
protecting the vessel media.
16,17
As the crown’s rotational speed increases, the centrifugal force is
amplifiedcreatingalargerorbitdiameter.Healthy compliantarterialtissuesflexawayfromthe crown
whilediseasedfibrocalcificandcalcificplaquesremainadherenttothespinningcrown.Cross-sectional
histological analysis of porcinearteries postDB360treatment showedminimal damageto theinternal
elasticlamina,media,andexternalelasticlamina,whichisthoughttoreducearterialrestenosisrates.
16
The unique orbital motion of the crown also allows for continuous blood andsaline flow across the
lesion,maintainingcontinuousperfusiontothedistallimbandconstantheatdissipation.Therearealsoa
varietyofcrownsizesandshapes(solid,classic,andmicrocrown)availabletofacilitatetreatingvessels
ofdifferentcaliberaswellasmorphologicallesions.
3.Becausethedebriswasheddownstreamfromtheatherectomysitehasanaveragediameterthatismuch
smallerthanthatoftheaveragecapillarysize(2-3vs9.5μm),thevastmajorityofparticlesareflushed
through thecapillarybed and ultimatelyabsorbed by the bodyvia the reticuloendothelial system.The
combination of strict treatment intervals of 20-30 seconds with alternating rest periods of similar
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duration, smaller crowns,andliberaladministrationofvasodilatorspreventsprocedural complications
suchasslowflow,vesselclosure,andspasm.18Nevertheless,itisourpracticetoutilizeadistalembolic
protectiondevicewhenutilizingorbitalatherectomyabovethepoplitealartery.
B.OrbitalAtherectomyforPopliteal,Peroneal,and/orTibialArteriesinCLI
CALCIUM 360 was a multicenter study that comprised 50 patients with Rutherford classification 4-6
limbischemiarandomized1:1toOAwithballoonangioplasty(BA)versusBAalone.Thevesselstreated
included popliteal, peroneal, and/or tibial arteries that had an angiographic stenosis >50%,
fluoroscopicallyvisiblecalcium>25%oftreatedsegment, anda maintargetvessel reference diameter
>1.5mm. The averagelesionlength in the DB360arm was greater than theBA arm (9.1 vs 6.9 cm).
Primaryendpointswererestorationofnormallumendefinedasaresidualstenosis<30%withnobailout
stenting or dissection. The OA group had numerically less dissections, bailout stenting, and residual
stenosis,butnonereachedstatisticalsignificance.
19
C.OrbitalAtherectomyforAbove-the-KneePAD
TheCOMPLIANCE360trialcomparedtreatmentofcalcifiedfemoropoplitealdiseasewithOAwithBA
andBAonly.ThehypothesisforperformingOAbeforeBAisthatareductionincalcificationburdenmay
translateintomorecompliantvesselsresultinginfewerdissectionsandhopefullylessadjunctivestenting.
When compared with BA alone, OA plus BA yielded greater luminal gain. The primary endpoint of
freedomfromTLR(includingadjunctivestenting)orrestenosiswasachievedin77.1%oflesionsinthe
OA groupversusonly 11.5% inthe BA group(P <.001) at6 months, butthere was nodifference at
12monthswhenadjunctivestenting wasexcludedfrombeingconsidered aTLRevent(81%vs78.3%,
P>.99).20AlthoughtheoccurrenceofTLRat12monthswasthesame,therewasasignificantlylower
numberofstentsdeployedintheOAgroup.
VI.DirectionalAtherectomy(Table14.4)
Table14.4
DAKeyPoints
■Slowpassesandfrequentinterruptionofpassesfordecreasedembolizationrates.
■TheuseofDAresultedinsimilar12-moprimarypatencyratescomparedwithotherrevascularizationtechniques(BMS,DES,
DCB)butwithauniquebenefitofbeingabletoavoidstentplacement.
■DiabeticshavenoninferiorprimarypatencyratescomparedwithnondiabeticswhenrevascularizedwithDA.
■DAiseffectiveandsafeforfemoropopliteallesionswithmoderateandseverecalcificationsbutshouldbeusedwithadistal
embolicprotectiondevice,wheneverpossible.
A.DADevicesandTrials
1. TheMedtronic (Fridley,MN)SilverHawkandTurboHawk(Fig. 14.4) are forward-cutting devices
utilizingahigh-speedcuttingbladetoshredobstructingarterialatheromaintoribbonsofplaquethatare
thencollectedintothecatheternosecone.Multiplepassesaretakenthroughthelesionduringwhichthe
bladeisredirectedsequentiallyinallquadrantsintoobtainfullcircumferentialcoverageandmaximize
plaquedebulking.Both DA devices are produced inmultiple sizes so thatfemoropopliteal and tibialperonealarteriescanbeaccommodated.
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FIGURE14.4 Medtronic.HawkOneDirectionalAtherectomySystem.AtherectomyofPeripheralVasculature.
Medtronic.UsedwithpermissionbyMedtronic©2019.
2.DEFINITIVELEisaprospective,multicenternonrandomizedstudytestingthesafetyandefficacyof
Medtronic’s SilverHawk and TurboHawk DA catheters. There were 800 subjects enrolled with
claudication/chronic limb-threatening ischemia(CLI) and atleast a 50% stenosis orocclusion in their
femoropoplitealand/ortibial-peronealvessels.21Multilevellesionswithinthetargetlegwereincluded
as long aseachdiscretelesionlengthwas <20 cm,butseverelycalcified vesselswere excluded.The
averagelengthofthelongestlesionineachindividualwas8.3+5.5cm.Prespecifiedendpointsincluded
primary patency in claudicants and freedom from major unplanned amputation in CLI patients at
12months.Theoverallprimarypatencyinclaudicants at12 months was 78%(95% CI: 74%-80.6%),
which is similar to and even better than the outcomes of BMS, DES, and DCB for lower extremity
revascularization.The12-monthlimbsalvagerateof95%achievedintheCLIgroupwashigherthanthe
75%patencyrateachievedwithDESinACHILLES.
21,22
Althoughpriorsmall,single-centerstudieshad
demonstrated lower patency rates in diabetics, the authors’ showed that diabetic claudicants who
underwent DA have noninferior 12-month primary patency rates compared with their nondiabetic
counterparts.PeriproceduralcomplicationsfromDAincludedembolization(3.8%),perforation(5.3%),
abruptclosure(2.0%),andneedforbailoutstenting(3.2%).DAobjectivelyincreasesthevesseldiameter
andhasanaddedadvantageofbeingabletoavoidimplantationofaforeignintravascularscaffoldwhile
maintainingsimilarandevensuperiorefficacycomparedwithotherrevascularizationtechniques.
B.DAforModerate-to-SevereVesselCalcification
1. The majority ofatherectomystudies, includingthe DEFINITIVE LE, excluded patients with severe
arterial calcification in part to avoid lesion morphologies that are prone to complications such as
dissections, vessel perforation, and atherosclerotic embolization. Balloon angioplasty of severely
calcifiedlesionshasbeenshowntobeassociatedwithearlyelasticrecoilandbothpooracuteandlongterm outcomes. Stenting severe calcified lesions can result in suboptimal stent expansion ultimately
jeopardizingstentpatency.
23
2. The DEFINITIVE CA
++
registry demonstrated that directional atherectomy when used with the
SpiderFXdistalembolicprotectiondevice wassafeandeffectiveinthosewithmoderatelytoseverely
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calcifiedfemoropopliteal lesionsandRutherfordclinicalcategory2-4ischemia.15Thetreatedlesion’s
meanlengthwas short measuring3.9 +2.6 cmwith 17.9%oflesionsoccluded and 81%classified as
severely calcified. The 30-day freedom from MAE rate was 93.1% and a <50% residual diameter
stenosiswasachievedin92%oflesions.TheidealSpiderFXfilterpositionwasinthepoplitealartery
just proximal to the anterior tibial take-off. Debris was recovered in 88.4% of filters with a 2.3%
embolicratethatiscomparabletostentingandPTAdata.
24
VIIPhoenixAtherectomyDevice(Table14.5)
Table14.5
PhoenixAtherectomyDeviceKeyPoints
■ThePhoenixatherectomydeviceisafront-cuttingatherectomydevicethatisavailableinthreesizes.
■Size1.8and2.2mmcanbeusedforbothabove-andbelow-the-kneeinterventionswhile2.4mmisonlyforfemoropopliteal
interventions.
■Usageof2.4mmcatheterforbelow-the-kneewasassociatedwithincreasedriskofdissectionandperforation.
■Phoenixatherectomydeviceshowedanacceptablesafetyandefficacyinaprospective,single-arm,nonrandomizedtrial.
A.ThePhilips(VolcanoCorporation,SanDiego,California)Phoenixatherectomysystem(Fig.14.5) is
anover-the-wirefront-cutting device that hasametal element atthe tip ofthe catheterfortreatment of
peripheral arterial diseases.Thedeviceisavailableinmultiplesizesincluding1.8 mm5F,2.2mm6F,
and 2.4 mm 7F sheath. Both 1.8 and 2.2-mm catheters are used for below- and above-the-knee
intervention,whereas the 2.4-mm catheter is only usedfor femoropopliteal interventions. There are 2
versions of the 2.4 mm catheter, the tracking catheter (130 cm in length) and the deflection catheter
(127 cm in length). The latter is the only Phoenixatherectomy device that has the directional cutting
abilitythatallowsdebulkingofarterialdiametersthatarelargerthanthecatheter’sdiameter.
25
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FIGURE14.5 Phoenixatherectomysystem
CourtesyofRoyalPhilips.
B.ThePhoenixatherectomysystemwasstudiedintheprospective,multicenter,nonrandomized,single-
arm Endovascular Atherectomy Safety and Effectiveness Study (EASE) trial inthe United States and
Germany.25ThetrialwasintendedtostudythesafetyandefficacyofthePhoenixdeviceintreatmentof
thebelow-the-kneeperipheralarterialdisease.Onehundredandtwenty-eightpatientswereenrolledwith
abnormalrestingorexerciseankle-brachialindexwithRutherfordclass2-5and≥70%stenosisforatotal
treated lesion length ≤10 cm. The primary efficacy endpoint was technical success defined as postatherectomy stenosis ≤50%, whereas the secondary efficacy endpoint included procedure success,
definedastheproportionoftargetlesionswithresidualstenosis≤30%,andclinicalsuccess,definedas
≥1Rutherfordgradeimprovementat30daysand6months.Theprimarysafetyendpointwasabsenceof
MAE at 30 days. The study showed 95.1% (117/123) technical success. The residual stenosis postatherectomywas≤30%in99.2%(122/123).Theclinicalsuccesswasachievedin74.5%ofpatientsat
30 days and for 80% at 6 months. MAEs occurred in 5.7% (6/105) through 30 days, and 16.8% at
6monthswith1%rateofdissectionandsymptomaticdistalembolizationand2%rateofperforation.Of
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importancedistalprotectionwasusedin4.7%ofproceduresintheperprotocolgroup,butnoneofthese
embolicprotection devices were usedinthe treatmentoftarget lesions.The6-monthfreedomoftarget
vesselrevascularizationandtarget lesion revascularizationwas 88.0%and86.1%, respectively. In the
subgroup analysis, patientswithout CLIachieveda significant clinical success comparedwith patients
withCLI.
25
References
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femoropoplitealdisease:twelve-monthZilverPTXrandomizedstudyresults.CircCardiovascInterv.2011;4(5):495-504.
2.DakeMD,AnselGM,JaffMR,etal.Durableclinicaleffectivenesswithpaclitaxel-elutingstentsinthefemoropoplitealartery:5-year
resultsoftheZilverPTXrandomizedtrial.Circulation.2016;133(15):1472-1483.
3.ZellerT,LanghoffR,Rocha-SinghKJ,etal.Directionalatherectomyfollowedbyapaclitaxel-coatedballoontoinhibitrestenosisand
maintainvesselpatency:twelve-monthresultsoftheDEFINITIVEARstudy.CircCardiovascInterv.2017;10(9).pii:e004848.
4.DasTS.Excimerlaser-assistedangioplastyforinfrainguinalarterydisease.JEndovascTher.2009;16(2suppl2):II98-II104.
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6.BosiersM,PeetersP,ElstFV,etal.Excimerlaserassistedangioplastyforcriticallimbischemia:resultsoftheLACIBelgiumstudy.Eur
JVascEndovascSurg.2005;29(6):613-619.
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multicentertrial.JEndovascTher.2006;13(1):1-11.
8.DaveRM,PatlolaR,KollmeyerK,etal.Excimerlaserrecanalizationoffemoropopliteallesionsand1-yearpatency:resultsofthe
CELLOregistry.JEndovascTher.2009;16(6):665-675.doi:10.1583/09-2781.1.
9.RastanA,SixtS,SchwarzwälderU,etal.InitialexperiencewithdirectedlaseratherectomyusingtheCLiRpathphotoablation
atherectomysystemandbiassheathinsuperficialfemoralarterylesions.JEndovascTher.2007;14(3):365-373.
10.SchmidtA,ZellerT,SievertH,etal.Photoablationusingtheturbo-boosterandexcimerlaserforin-stentrestenosistreatment:twelve-
monthresultsfromthePATENTstudy.JEndovascTher.2014;21(1):52-60.
11.DippelEJ,MakamP,KovachR,etal.Randomizedcontrolledstudyofexcimerlaseratherectomyfortreatmentoffemoropoplitealin-
stentrestenosis:initialresultsfromtheEXCITEISRtrial(EXCImerLaserRandomizedControlledStudyforTreatmentof
FemoropopliTEalIn-StentRestenosis).JACCCardiovascInterv.2015;8(1PtA):92-101.
12.ZellerT,KrankenbergH,SteinkampH,etal.One-yearoutcomeofpercutaneousrotationalatherectomywithaspirationininfrainguinal
peripheralarterialocclusivedisease:themulticenterpathwayPVDtrial.JEndovascTher.2009;16(6):653-662.
13.CBoiangiu,MFissha,KKaid,etal.AnalysisofRetrievedParticulateDebrisAfterSuperficialFemoralArtery(SFA)AtherectomyUsing
thePathwayJetstreamG3Device.Paperpresentedat:SCAI2011ScientificSessions;Baltimore,Maryland.
14.MaeharaA,MintzGS,ShimshakTM,etal.IntravascularultrasoundevaluationofJETSTREAMatherectomyremovalofsuperficial
calciuminperipheralarteries.EuroIntervention.2015;11(1):96-103.
15.RobertsD,NiaziK,MillerW,etal.Effectiveendovasculartreatmentofcalcifiedfemoropoplitealdiseasewithdirectionalatherectomy
anddistalembolicprotection:finalresultsoftheDEFINITIVECa++trial.CatheterCardiovascInterv.2014;84(2):236-244.
16.AdamsGL,KhannaPK,StaniloaeCS,etal.OptimaltechniqueswiththeDiamondback360Systemachieveeffectiveresultsforthe
treatmentofperipheralarterialdisease.JCardiovascTranslRes.2011;4(2):220-229.
17.SotomiY,ShlofmitzRA,ColomboA,SerruysPW,OnumaY.Patientselectionandproceduralconsiderationsforcoronaryorbital
atherectomysystem.IntervCardiol.2016;11(1):33-38.
18.DasT,MustaphaJ,IndesJ,VorhiesR.Techniqueoptimizationoforbitalatherectomyincalcifiedperipherallesionsofthelower
extremities:theCONFIRMseries,aprospectivemulticenterregistry.CatheterCardiovascInterv.2014;83(1):115-122.
19.ShammasNW,LamR,MustaphaJ,etal.Comparisonoforbitalatherectomyplusballoonangioplastyvs.balloonangioplastyalonein
patientswithcriticallimbischemia:resultsoftheCALCIUM360randomizedpilottrial.EndovascTher.2012;19(4):480-488.
20.DattiloR,HimmelsteinSI,CuffRF.TheCOMPLIANCE360°Trial:arandomized,prospective,multicenter,pilotstudycomparingacute
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2014;26(8):355-360.
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C H A P T E R 1 5
CurrentUseandAvailabilityofReentryDevices
SamitM.ShahMD,PhD
CarlosMenaMD,FACC,FSCAI
I.ChronicTotalOcclusions
II.PioneerPlusCatheter
A.FirstReentryDevice
III.OutbackRe-EntryCatheter
IV.BostonScientificOffroadReentryCatheterSystem
V.MantarayBalloonCatheter
VI.Conclusion
I.ChronicTotalOcclusions
II.PioneerPlusCatheter
A.FirstReentryDevice
III.OutbackRe-EntryCatheter
IV.BostonScientificOffroadReentryCatheterSystem
V.MantarayBalloonCatheter
VI.Conclusion
KeyPoints
■Chronic total occlusions of the superficial femoral artery are a common presentation of
peripheral arterial disease, and subintimalcrossinghasbecome a mainstayofinfrainguinal
intervention. However, failure to reenter the true lumen is the primary limitation to
proceduralsuccess.
■True lumen reentry devices have been shown in multiple trials to facilitate true lumen
reentry and increase initial procedural success, but these devices are associated with
increasedfinancialcostandriskofvesselinjury.
I.ChronicTotalOcclusions
1.Chronictotalocclusions(CTO)arepresentinnearly50%ofpatientswithperipheralarterialdisease
andmostcommonlyaffectthesuperficialfemoralartery(SFA).
1
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2. Revascularization of CTO lesions can be technically challenging, and the presence of a CTO is
associatedwithdecreasedproceduralsuccess.2Specifically, CTOreferstoocclusivelesionsthathave
beenpresentforgreaterthanorequaltothreemonthsorstablelesionsthatcompletelypreventcontrast
opacificationofthedistal vessel.
3,4
These lesions arecomposed ofaproximal anddistalfibrocalcific
cap,mixedluminalplaquewiththrombinandfibrin,andlocalizedinflammationintheadjacentvascular
wall.
5
3. Thegoalofendovascular intervention for CTOistocross the proximalcap, traverse theoccluded
lumen,andreenterthedistalvesseltoreestablishantegradeflow.6However,theproximalcap may be
heavilycalcified,andlesionsaffectingtheSFAmayspanover20cminlength.7Inmanycases,crossing
the truelumenmaynotbe possible anda subintimal methodcanbe used. This was firstdescribed by
AmmanBolia in1987 when an iatrogenic popliteal arterydissectionwas used to circumventa 10cm
occlusionwithrecanalizationofthetruelumendistaltothelesion.
8
4.Thekeyaspectsofthesubintimalapproachincludeaccessingthesubintimalspacewithahydrophilic
wire,crossingthelesionwith awire loop,andreenteringthetruelumenbeyondtheoccludedsegment.
Angioplastyisperformedinthesubintimalspacetocreateaneolumenbetweentheintimalandadventitial
layersofthevessel.Thesuccessofthesubintimalapproachhingesontheabilityoftheoperatortoreenter
thetruelumendistaltoanocclusivelesion.Failuretoreenterthetruelumenhasbeencitedastheprimary
limitationtoproceduralsuccessinupto15%ofcases.
9–11
5.Truelumenreentryandthespecializeddevicesthathavebeendevelopedforthispurposearethefocus
ofthischapter.
II.PioneerPlusCatheter
A.FirstReentryDevice
ThefirstreentrydevicethatwasusedinclinicalpracticewastheCrossPoint.
A.TransVascularSystems(PaloAlto,CA)wassubsequentlypurchasedbyMedtronicInc.(Minneapolis,
MN)in2003,andthedevicewasrenamedthePioneercatheter.
B.In2013,the devicewaspurchased bythePhilips-VolcanoCorporation(RanchoCordova,CA)and
rereleasedasthePioneerPluscatheter(Fig.15.1A).
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FIGURE15.1 A,ThePhilips-VolcanoPioneerPlusrentrycatheterisshownwithadistal20MHzIVUS
(intravascularultrasound)transducer,nitinolneedleforintimalplanepuncture,andcontrolhandle.B,PioneerPlus
devicewithneedleextendedandhandonthecontrolwheel.
CourtesyofRoyalPhilips.
1.Thisdual-lumencatheterusesintravascularultrasound(IVUS)tolocalizethetruelumenofthevessel,
andanextendablehollow24Gnitinolneedleupto7mmlongisdeployedthroughthesubintimaltissueto
facilitateplacementofanoncoated0.014″guidewire inthetruelumenofthe vessel.
12,13
Notably, the
devicewasrecalledbyMedtronicin2011owingtofailureofthenitinolneedletoretractbackintothe
device.
14
2.Thedevicehasanouterdiameterof6Frandisadvancedoveramonorail0.014″guidewireintothe
subintimalspace(Fig.15.1B).A20MHzIVUStransduceratthetipofthedeviceisusedtoorientthetrue
lumen of the vessel at “12 o’clock” (Fig.15.2) and the nitinol hypotube is then deployed to a fixed
distance(from 3 to7 mm). A second0.014 ″ can then be advanced into thetrue lumenof thevessel,
allowingfortheretractionoftheneedle,removalofPioneercatheter,andsubsequentangioplastyofthe
subintimalspace.Thismethodhasbeenusedsuccessfullyinbothiliac15andfemoropopliteal lesions
16
withareportedsuccessrategreaterthan95%.
17,18
Thelengthofthecatheteris120cmwhichlimitsuse
ofthedeviceininfrapoplitealdisease.
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