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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3751_Библиотеки_им_академика_М_И_Перельмана

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FIGURE6.4 TheValiantthoracicstantgraft.
Reprintedwithpermissionfrom
FairmanRM ,T uchekJM,LeeWA,etal.PivotalresultsforthemedtronicvaliantthoracicstentgraftsystemintheVALORIItrial.JVascSurg.
2012;56:1222-1231.e1221.
2.Thegraftisavailableinstraightortaperedversions,withdiametersrangingfrom24to46mm,and
lengths up to22.7 cm. Itis compressed and preloaded into the Xcelerant deliverysystem (Medtronic Vascular),whichconsistsofasingle-usedisposablecatheterwithanintegratedhandle.
33
3.Valiantendograftefficacywasevaluatedinaretrospectivestudywith180patients,
34
treatingvarious
descending aortic pathologies (66 patients with thoracic aneurysms, 22 with thoracoabdominal aneurysms,19withanacuteaorticsyndrome,52withaneurysmaldegenerationofachronicdissection, and21patientswithtraumaticaortictransection).Overall30-daymortalityfortheserieswas7.2%,with astrokerateof3.8%andaparaplegiarateof3.3%.Mortalityratesdifferedaccordingtotheindication, with the highestrate for thoracoabdominal aneurysms (27.3%) and lowest for acute traumatic rupture (0%).
4.TheVALORIItrial(EvaluationoftheClinicalPerformanceoftheValiantThoracicStentGraftSystem
in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are CandidatesforEndovascularRepair)hasledtotheapprovaloftheCaptiviaDeliverySystem(Medtronic vascular) in the United States.
33,35
A cohort of 160 patients with degenerative DTAs and
thoracoabdominalaneurysmswerefollowedupfor5years.Technicalsuccessratewas96.3%,andthe 30-daymortalitywas3.1%.38.1%ofpatientshad≥1majoradverseeventat30days,while48.7%of patientshad≥1majoradverseeventat12months.
5.Five-yearsurvivalwas64%,with5%aneurysm-relatedmortality.Secondaryinterventionoccurredin
6.8%ofpatients.
D.Relay
1.TheRelaythoracicstent-graftsystem(BoltonMedical)iscomposedofaself-expandingnitinolstent,
suturedtoapolyesterfabricgraft,withacurvedlongitudinalnitinolwireforthepurposeofproviding longitudinalstrength(Fig.6.5).Twodifferentproximalstandardconfigurationsareavailable,theRELAY, withtheproximalbarestent,andanon-bare-stentmodel(RELAY-NBS).Onlyonedistalconfigurationis present.
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FIGURE6.5 IntheRelaystent-graft,thecurvednitinolwirestartsbelowthesecondrowofproximalcovered
stentsandendsclosetothedistalstent,allowingforsufficientcolumnstrengthwhileatthesametimeproviding
flexibilityandtorqueresponse.A,Relayhasanalignmentzone(dottedarrow)toprovideoptimalalignmentwith
aorticanatomyandallowproximalcaptureofthestent-graftforaccurateplacement.B,InRelay-NBS,theproximal
endiscoveredwithpolyestervasculargraftfabric(solidarrow)tooptimizeappositionoftheproximalendofthe
grafttothelumenwallwhileminimizingtraumatotheintimaandriskoffabricinfolding.
Reprintedwithpermissionfrom
ZipfelB,CzernyM,FunovicsM ,etal.EndovasculartreatmentofpatientswithtypesAandBthoracicaorticdissectionusingRelaythoracicstent-
grafts:resultsfromtheRESTOREPatientRegistry.JEndovascTher.2011;18:131-143.
2.Itisavailable instraightandtapered configurations,withdiametersrangingfrom 22 to46mm,and
lengthsfrom10to25cm.Thedeliverysheathrangesfrom20to26French,dependingonthediameterof thedevice.
3.TheEuropeanexperiencewithRelaywasdemonstratedintheRESTOREregistry,withasuccessrate
of97.3%.37A cohortof150 patients were prospectivelyaccrued,inwhom thoracic aortic aneurysms was treatedin64.7%,andDescADin19.3%.Paraplegiaratewas 3.3%,recoveredparaparesis3.3%, andstrokeonly 0.6%.Reinterventionswerenecessaryin8.7% ofthe cases. The30-daymortalityrate was 10%.Reinterventionrateduring2-year follow-upwas8.9%, owing totwo stentgraftmigrations, three proximal type I endoleak, four type III endoleak, and five distal type I endoleaks. No open conversionwasneededduringfollow-up.
4.TheuseofRelaysysteminDescADwasevaluatedinanotherstudyofthe RESTOREregistry,
38
in
whichthe majorityofpatientshadtypeBAD(84%). Thetechnical successratewas 95%.Thirty-day mortalitywas8%,andthetypeIendoleakratewas7%.The2-yearsurvivalratewas82%intheoverall population,and84%inpatientswithtypeBAD.
5. Bolton Medical’s next generation device, the (Relay Pro), is currently being developed, offering
diametersassmallas19French,inbothstentedandNBSconfigurations. Thepivotaltrialsprovidingevidenceregardingthethoracicdeviceshavebeensummarized(Tables6.2 and6.3).
Table6.2
SummaryofEvidenceAboutVariousThoracicDevicesinAorticDissection
Study Year Device Aim Number
of Patients
Typeof Dissection
Success Results Mortality
INSTEAD trial
17
2009 Talent
graft
Compare TEVAR+OMT toOMTalonein uncomplicated typeBAD
140 Uncomplicated
chronictypeB AD
Accessobtained in70/72cases randomizedto TEVAR+OMT (97.2%)
Aorticremodeling occurredin91.3% withTEVARvs
19.4%inOMT group(P<0.01)
Nodifferencein2-y all-causemortality
INSTEAD­XLtrial
18
2013 Talent
graft
Long-term follow-upofthe INSTEADtrial
140 Uncomplicated
chronictypeB AD
Accessobtained in97.2%of cases
Landmarkanalysis suggestedabenefit ofTEVARforall endpoints (mortalityand progression) between2and5y
■All-cause
mortalitywas lowerin TEVAR group:11.1% vs19.3% (P=0.13)
■Aorta-
specific mortalitywas lowerin
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TEVAR group(6.9% vs19.3%; P=0.04)at 5y
ADSORB trial
26
2014 Gore
TAG
Compare OMT+TAG devicetoOMT alonein uncomplicated typeBAD
61 Uncomplicated
acutetypeB
Accessobtained in100%of cases
■Incomplete
FL thrombosis: 43%inTAG groupvs 97%in OMTgroup
■FL
decreased andTL increasedin TAGgroup and increasedin theOMT group (P<00.1)
■No
mortality within30d
■Onedeath
inthe TAG+OMT groupduring follow-up dueto cardiac arrest,butno autopsywas performed
STABLE trial
32
2012 Proximal
Zenith TX2and distal BMS
Evaluatethe compositeTX2 devicein complicated typeBAD
40 Complicated
acutetypeB AD
Technical success:100%
CompleteFL thrombosis:31%at 1y
1-ysurvival:90%
RESTORE trial
37
2008 Relay Evaluatethe
efficacyofthe Relaygraftin DTAand DescAD
150 Acute
uncomplicated typeBAD
Technical success:97.3%
Aneurysmwasthe mostcommon pathologytreated (64.7%)followed bydissections (19.3%)
30-dmortalitywas 10%
Zipfeletal382011 Relay Toevaluatethe
safetyand performanceof Relaystent­graftsinpatients withacuteor chronicaortic dissections
91 Acuteand
chronic uncomplicated typeAand typeBAD
Technical success:95% (97%inacute, 95%inchronic, and93%intype Bdissections)
Relaystentgraft showedfavorable outcomesin treatmentof thoracicaortic dissections
■30-d
mortalitywas 8%(13%in acuteand 5%in chronic dissections); alldeaths occurredin patientswith typeB
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dissections
■2-y
survival:
■Overall:
82%
■TypeB
AD:84%
AD,aorticdissection;ADSORB,acutedissectionstentgraftorbestmedicaltreatment;BMS,baremetal stent;DTA,descendingthoracicaneurysm;FL,falselumen;INSTEAD,investigationofstentgraftin aorticdissection;OMT,optimizedmedicaltreatment;RESTORE,EuropeanexperienceintheRELAY endovascularregistryforthoracicdiseaseSTABLE,studyofthoracicaortictypeBdissectionusing endoluminalrepair;TEVAR,thoracicendovascularaorticrepair;TL,truelumen.
Table6.3
SummaryofEvidenceAboutVariousThoracicDevicesinDescendingThoracicAneurysms
Study Year Device
Used
AimofStudy No.of
Patients
Results
Choetal
25
2006 Gore
TAG
CompareendovascularrepairofDTAs usingtheTAGdevice,toopenrepair
142
■Technicalsuccess:98%(139/142)
■Operativemortality:2.1%inTAG
groupvs11.7%insurgicalgroup
■MAEat1y:(42%vs77%)
■Aneurysm-relatedsurvivalat5y:
(98%vs88%)
Farberetal
135
2012 CTAG ToevaluateCTAGdeviceinBAT 51
■Technicalsuccess:100%
■30-dmortality:7.8%
■MAE:35.3%
Matsumuraet al
30
2008 Zenith
TX2
ComparetheTX2devicetoopenrepair 230
■Perioperativemorbiditywaslower
forTX2device(compositeindex1.3 vs2.9)
■Neurologiccomplicationswerenot
significantlydifferent
■Aneurysmsgrowthat12mointhe
TX2groupwas7.1%
Thompsonet al
34
2007 Valiant
endograft
EvaluatetheefficacyofValiantendograft inmultipledescendingaorticpathologies
180
■30-dmortality:7.2%
■Stroke:3.8%
■Paraplegia:3.3%
■Mortalityratedifferedwith
indication:
■Thoracoabdominalaneurysm:
27.3%
■BAT:0%
VALORII trial
33
2012 Valiant
endograft
EvaluationoftheValiantgraftin degenerativeDTAs
160
■Technicalsuccess:96.3%
■30-dmortality:3.1%
■MAE:38.1%:
■Paraplegia:0.6%
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■Paraparesis:1.9%
■Stroke:2.5%
■1-yaneurysm-relatedmortality:4%
■Graftmigration:2.0%
■Endoleaks:13%
VALORII long-termtrial
35
2017 Valiant
endograft
Long-termoutcomesoftheVALORIItrial 160
■5-ysurvival:64%
■Aneurysm-relateddeathat5y:5%
■Secondaryintervention:6.8%
■Averageaorticdiameterdecreased
in48%
BAT,bluntaortictrauma;DTA,descendingthoracicaneurysm;MAE,majoradverseevents;VALOR, evaluationoftheclinicalperformanceoftheValiantthoracicstentgraftsysteminthetreatmentof descendingthoracicaneurysmsofdegenerativeetiologyinsubjectswhoarecandidatesforendovascular repair.
VI.InvestigationalDevices
ThesedevicesarecurrentlybeinginvestigatedbuthavenotyetbeenapprovedintheUnitedStates.These include the LeMaitre TAArget device, the JOTEC E-Vita stent-graft system, and the Streamliner MultilayerFlowModulator.
A.TAArget
1. TheTAArgetthoracicstent-graft(previouslylabeledEndoFit, LeMaitre Vascular)iscomposed ofa
nitinolskeletonofZ-shapedstentsthatareencapsulatedbetweentwothinsheetsofexpandedePTFE.The Z-shapedstentsaimatprovidinglongitudinalsupportwithoutasupportbar.Thedevicecanbestraightor tapered, and the proximal endis available with and without externalfixation witha bare metal stent, allowingfordifferentconfigurationsofthedevice.
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2. The graftis available indiameters from30 to42 mm, with lengths from 7to 22 cm. The graft is
deployedthrougha22or24Frenchsheathdependingonthediameterofthedevice.
40
3.Inastudywith41patientswithvariousdescendingaorticpathologies,whoweremanagedusingthe
TAArgetdevice,thegraftwassuccessfullydeployedinall41patients.In-hospitalmortalitywas7.3%, andthreepatientsdevelopedendoleaks,withonlyonepatientrequiringintervention.Onepatientsuffered fromspinalcordischemia.Two-yearmortalitywas17%,with11%aneurysm-relatedmortality.
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4.Anotherstudywith46aneurysmpatientsand41withDescAD,managedusingtheTAArgetdevice,
40
showed100%deploymentsuccessrate.In-hospitalmortalitywas9.2%,andneurologicalcomplications occurred in 9.3% of patients, including five strokes (two fatal) and three cases of paraplegia. Five patientshadimmediateproximaltypeIendoleak.Mortalityrateoverafollow-upperiodof5.2months was11.4%butwasnotfelttobeaneurysmorstent-graftrelated.
5. The DEDICATED registry has beenestablishedand aims atevaluating the use andefficacyof the
TAArgetstentgraftforthetreatmentofacuteandchronicaortictypeBAD.
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B.E-Vita
1. The E-Vitastent graftsystem(CryoLife JOTEC, Kennesaw, GA) has beenon the European market
since May 2004. Itis composed of a low porosity wovenpolyester graft with nitinol springssupport
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structure,suturedtoinnersideofthegraftinatip-to-tipfashion.Thedevicehasnolongitudinalsupport, makingitveryflexible.Itisavailablein24-44mmdiameters,andin12,15,17,and23cminlength.
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Multiplegraftconfigurationsareavailableforthisdevice.
2. Safety and efficacyof theE-Vita device were evaluatedina review of 126 patientswith multiple
descendingaorticpathologies.Graftwassuccessfullydeployedin77%ofpatients.Overallperioperative mortality within 30 days was 12.3%. Stroke occurred in 2.8% of cases, and transient spinal cord dysfunctionwasobservedintwocases.
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C.StreamlinerMultilayerFlowModulator
1.TheStreamlinerMultilayerFlowModulator(SMFM;Cardiatis)isaself-expandingstent,composed
ofcobaltalloywiresthatareinterconnectedinfivelayers.43Itisdesignedtoallowbloodflowthrough the stent to maintain patency of branch vessels, which may be an alternative the hybrid technique, especiallywhenappliedintheaorticarch(Fig.6.6).TheSMFMwasapprovedinEuropein2010.
FIGURE6.6 Computationalfluiddynamicsworkflowfrommedicaldatatobloodflowsimulationsetup.A,Aortic
Archthree-dimensionalgeometryrepresentedbyavolumeenclosedinatriangulatedsurface.B,SMFM(Cardiatis,
Isnes,Brussels,Belgium)device;spatialrepresentationasfittedthroughadiseasedaorticarch.
Reprintedwithpermissionfrom
StefanovF,MorrisL,ElhelaliA,etal.Insightsfromcomp lexaorticsurgerywithaStreamlinerdeviceforaorticarchrepair(STAR).JThorac
CardiovascSurg.2016;152:1309-1318.e1305.
2. Evidence regarding the SMFM is limited.
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In a nonrandomized trial (STRATO), 23 high-risk
surgicalpatientswithCrawfordtypeIIorIIIthoracoabdominalaneurysmsweremanagedwiththeSMFM device.47Stableaneurysmthrombosiswasachievedin15outof20patientsat1year.Therateofbranch patencywas96%at1year,100%at2years,and97%at3years.Ninepatientshadendoleaksrequiring 11interventions.
VII.PreproceduralPlanning
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A.Imaging
1. Precise imaging of the entire aorta and its branches is essential before planning an endovascular
repair. Computed tomograpic angiography (CTA) with three-dimensional reformatting of the chest, abdomen,andpelvisisthemethodofchoice.Assessmentoftheexternalandendoluminaldiameterofthe aorta is vital to appropriatelychoose thediameter andlength ofthe endograft andthe locationofthe landingzones. Furthermore,assessmentof theburdenof calcification, angulation,andtortuosity of the aortaisrequiredtoplantheperfectdeploymenttechnique
48,49
andtoassessthelikelihoodofendoleaks.
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CTAalsohelpstoidentifytheimportantsidebranchesanddiametersoftheiliacarteriestobetterchoose thedeliverydevice.Generally,an8mmexternaliliacartery—whichhasapproximately24Frenchouter diameters—shouldaccommodatea22Frenchsheath.
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2. Magneticresonanceangiography(MRA)can also beused; however,itdoes notdemonstratevessel
wallcalcification,whichhasimplicationsforvascularaccess.
B.LandingZones
1.Tightsealofthegrafttotheaorticwallisrequiredtoexcludebloodflowfromathoracicaneurysm
sac.Theendograftmustprovideanadequatesealproximally—attheaneurysmneck—anddistally,which are calledthe “landingzones.” A minimum seal zone of 2 cm is recommendedinthe thoracic aortato preventmigrationandendoleak.
2. Proximally, the landing above the neck of the aneurysm mayinvolve the aortic arch.When device
deploymentinvolvesthearch,theproximalendofthegraftmustcloselyapposetotheinnercurveofthe archinordertoavoidmigrationordevicecollapse.
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Further,deploymentinthearchcanjeopardize
the blood flow to the branch vessels, namely the left subclavian, left common carotid, and the brachiocephalictrunk.Earliergenerationstentsfacedtheproblemofnotbeingabletoconformtothearch anatomy,leadingto“birdbeaking”(Fig.6.7),andincreasingtheriskofgraftfailure.Currentdevicesare characterizedbyimprovedflexibilityanddesignatproximalgraftthatpermitbetterconformationtothe aorticarch.Carefulplanningisessentialtoassesstheneedfor“debranchingprocedures,”whichinvolve “moving”thebranchvesselstoamoreproximallocationtopreservebloodflowafterstentdeployment (hybridapproaches).
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FIGURE6.7 Imageobtainedinan84-year-oldwomanwhounderwentTEVARforanatheroscleroticaortic
aneurysmshowbird-beakconfigurationresultingintypeIaendoleak.Thin-slabmaximumintensityprojectionshows
bird-beakconfiguration(arrowhead)—imperfectappositionatproximalendofstent-grafttolessercurveofaortic
arch—resultinginwedge-shapedgapbetweenundersurfaceofthestent-graftandaorticwall.Length(two-headed
arrow)andangleofthebird-beakweremeasuredwiththree-dimensionalworkstationfunctions.Scallopedflares
(smallarrows)attheproximalendofthedevicewereexcludedfrommeasurementofbird-beaklength.Leakageof
contrastmediumisobservedflowingcontinuouslyfromthebird-beakintotheaneurysmalsac,signifyingtypeIa
endoleak(bigarrow).
Reprintedwithpermissionfrom
UedaT,FleischmannD,DakeMD,RubinGD,SzeDY.Incompleteendograftappositiontotheaorticarch:bird-beakconfigurationincreasesriskof
endoleakformationafterthoracicendovascularaorticrep air.Radiology.2010;255:645-652.
3.Distalsealzonemustalsobeatleast2cminlength,whichinsomecasesmightnecessitatecoveringof
theceliactrunk.Visceralarteriesbypassproceduresmightberequiredtopreservethebloodflowtothe gut.
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