Debulking Below the Knee: Devices & Techniques · 2019-06-20 · Sources: Endovascular Today...
Transcript of Debulking Below the Knee: Devices & Techniques · 2019-06-20 · Sources: Endovascular Today...
DebulkingBelowtheKnee:Devices&Techniques
JihadA.Mustapha,MD,FSCAI,FACCAdvancedCardiac&VascularCentersforAmputationPrevention
GrandRapids,MI
DisclosuresBardPeripheralVascular– ConsultantBostonScientific– Consultant,ScientificAdvisory Board,ResearchCardioFlow – Equity,ResearchCardiovascularSystems,Inc.– Consultant,ResearchMedtronic– ConsultantMicromedical Solutions – ChiefMedicalOfficerPhilips– ConsultantPQBypass– ResearchReflowMedical– ChiefMedicalOfficerTerumo - Consultant
AtherectomyDevices
Jetstream™Atherectomy
System(BostonScientific)
PeripheralRotablator™Rotational
AtherectomySystem(BostonScientific)
Diamondback360™,Stealth
360™Atherectomy
System(CardiovascularSystems,Inc)
SilverHawk™,TurboHawk™PlaqueExcision
System(Covidien)
Turbo-Elite™Laser
AtherectomyCatheter
(Spectranetics)
Front-Cutting ü ü N/A
Differential Cutting ü ü ü N/A
ActiveAspiration ü
ConcentricLumens ü ü ü
LesionMorphology:
Calcium ü ü ü ü ü
Soft/FibroticPlaque
ü ü ü
Thrombus ü ü
Sources:EndovascularTodayBuyer’sGuide2014.JETSTREAMSystemBrochure,BostonScientificWebsite,2014.PeripheralRotablator productwebsite,BostonScientific,2014.Diamondback360productwebsite,CSI,2014.Covidienwebsite,DirectionalAtherectomyproducts,2014.Turbo-EliteLaserAtherectomyCatheterInstructionsforUse,May2014.
TheLACIStudies
TheLACITrial:6MonthResults• Lairdetal• 145pt,155criticalischemiclimbs• 423lesions• 41%SFA,15%Popliteal,41%Infrapop• 70%ofPtshadcomboocclusionandstenosis• 29%RutherfordClass4• 71%RutherfordClass5or6• Limbsalvage92%at6months
DEFINITIVELE• StudyDesignandOversight:
• Prospective,non-randomized,globalstudy• 800subjectsenrolledat47centers• CECandSteeringCommitteeoversightandCECadjudicaiton• AngiographicandDuplexcorelaboratoryanalyses
• InclusionCriteria• RCC1-6• ≥50%stenosis• Lesionlengthsupto20cm• ReferenceVessel≥1.5mmand≤7.0mm
• ExclusionCriteria• Severecalcification• In-stentrestenosis• Aneurysmal targetvessel
LesionAssessment
Characteristic Claudication (RCC 1-3)
CLI(RCC 4-6)
All Subjects (RCC 1-6)
Number of Patients 598 201 799Number of Lesions 743 279 1022Mean Length (cm) 7.5 7.2 7.4Baseline Stenosis (%) 73 76 74 Occlusions (%) 17 30 21
Anatomic location based on proximal edge of lesion treatment, % (N)SFA 72% (536) 48% (135) 66% (671)Popliteal 15% (114) 17% (48) 16% (162)Infrapopliteal 13% (93) 34% (96) 18% (189)
CorelabreportedMcKinseyJFetalJACCInterv 2014
PrimaryPatencyinSubgroupsSubgroup Claudicants (n=743) CLI (n=279)
Patency(PSVR < 2.4)
Lesion Length (cm)
Patency(PSVR < 2.4)
Lesion Length (cm)
All (n=1022) 78% 7.5 71% 7.2
Lesion type
Stenoses (n=806) 81% 6.7 73% 5.8
Occlusions (n=211) 64% 11.1 66% 10.3Lesion LocationSFA (n=671) 75% 8.1 68% 8.6
Popliteal (n=162) 77% 6.0 68% 5.4
Infrapopliteal (n=189) 90% 5.5 78% 6.0
PrimaryPatencyinSubgroupsSubgroup Claudicants (n=743) CLI (n=279)
Patency(PSVR < 2.4)
Lesion Length (cm)
Patency(PSVR < 2.4)
Lesion Length (cm)
All (n=1022) 78% 7.5 71% 7.2
By Lesion Length< 4 cm (n=318) 81% 2.2 84% 2.3
4-9.9 cm (n=418) 83% 6.5 62% 6.6≥ 10 cm (n=283) 67% 14.4 65% 15.1SFA Only By Lesion Length< 4 cm (n=184) 78% 2.3 82% 2.3
4-9.9 cm (n=253) 83% 6.5 60% 6.9≥ 10 cm (n=232) 65% 14.6 63% 15.5
JetstreamSystemOverview
ControlPOD ConsoleOver-the-Wire
ApprovedforusewithBSC0.014”300cmThruwayGuidewire
ApprovedforusewithAtherectomyLubricants,suchasRotaglide
XC2.1/3.0mm
XC2.4/3.4mm SC1.85mm
JETSTREAMXCCatheters JETSTREAMSCCatheters
(TibialSizes)(SFA&PoplitealSizes)
SC1.6mm
PatientCharacteristics• 241patients(258lesions)
Overall(N=241)
Age(years),mean± SD 67.1± 9.8Male 66.0%MedicalHistory
Hypertension 82.6%Hypercholesterolemia 66.8%Smoking 50.6%HeartDisease 47.7%Diabetes 41.1%
RaceCaucasian 80.1%AfricanAmerican 16.6%NativeAmerican 2.1%Other 1.2%
LesionCharacteristicsOverall
(N=258lesions)Non-Stenta
(N=165lesions)Stenta
(N=93lesions)Lesionlocation
SuperficialFemoral 75.6% 72.1% 81.7%CommonFemoral 10.9% 15.2% 3.2%Popliteal 13.6% 12.7% 15.1%
Lesionlength,mean± SD 16.4± 13.6cm 14.1± 12.6cm 20.5± 14.4cmCalciumGradeb
0 10.0% 10.2% 9.5%1 16.2% 14.6% 19.0%2 24.1% 17.8% 35.7%3 28.2% 31.8% 21.4%4 19.5% 21.0% 16.7%
LesionRVD,mean± SD 5.7± 0.9mm 5.5± 0.9mm 5.9± 0.9mmOcclusion(100%stenosis) 36.1% 28.7% 50.0%Pre-treatmentstenosisestimate,mean± SD 91.1%± 9.8% 90.2%± 10.0% 92.7%± 9.4%
aPost hocanalysisofpatientswhoreceivedanddidnot receiveadjunctivestents.bCalcium grading:0=novisiblecalcification;1=one individual segmentofvesselcalcificationrepresenting<25%ofthelengthoftheentiresegment;2=aggregatecalcificationrepresenting<50%ofthesegmentlength;3=aggregatecalcificationrepresenting>50%ofthesegmentlength;4=densecircumferentialcalcificationalong thesegmentlength.
Procedures• 98.3%proceduralsuccess(≤30%residualdiameterstenosispost-procedure)
• 84patients(35%)receivedadjunctivestents
• Stentplacementperformedatoperator’sdiscretion
• Embolicprotectionusedin22.4%ofcases
Post-treatmentstenosisestimate,mean± SDOverall
(N=258lesions)Non-Stent
(N=165lesions)Stent
(N=93lesions)Post-Jetstream 44.4%± 20.0% 38.5%± 16.2% 54.8%± 22.0%PostAdjunctiveTreatment 9.8%± 11.4% 11.6%± 11.7% 6.6%± 10.2%
Proceduretime: 73.4± 37.5minTotalJetstreamruntime: 4.7± 3.5 min
NumberofPassesBladesDown: 2.0± 1.5BladesUp: 1.8± 1.4
UniqueMechanismofActionPreferential Sanding
• Elastichealthytissue“gives”andisnotaffectedbydiamond grit
• Diseasedtissueprovides resistanceandallowsgritto“sand”theplaque
Compliant TissueDiseased TissueDiamond Grit
No detrimental effectEffective plaque removal
• 6monthdata• 124patientsforinfrapopliteal revascularization(201lesions)• Claudicants55%• CLI45%• TreatmentOAeitherstandaloneorwithadjuctive Rx
`
LIBERTY360• Prospective,observational,multi-centerclinicalstudytoevaluateacuteandlong-termclinical,functionalandeconomicoutcomesofendovasculardeviceinterventioninpatientswithdistaloutflowperipheralarterialdisease(PAD)
• Noinclusionandexclusion• Independentcorelaboratoryanalysesandadjudications
• Angiographic• DuplexUltrasound• SixMinuteWalkTest• HealthEconomics
• Includesseparateanalysesfor• Claudicants• Criticallimbischemia(RB4and5)• Criticallimbischemia(RB6)
DeviceUsagebyLesionBalloonand/oratherectomywerepreferreddevices.
*BailoutstentgroupisasubsetofStentgroup.Bailoutstentdefinedasstentplacedduetoanangiographiccomplicationorsub-optimalresult(>50%stenosis).CoreLabreportedlesions.Patientswithreportedvaluesmaybelessthantotalnumberofpatientsenrolledineacharm.
ComparisonbetweenRutherfordcategoriessignificant(p<0.05)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Balloon Atherectomy Stent Bailoutstent*
Rutherford2-3(N=599) Rutherford4-5(N=754) Rutherford6(N=145)
MajorAdverseEvents(MAEs)to6MonthsHighfreedomfrom6-MonthMajorAdverseEvents(MAE),indicatingevenRC6subjectscanbetreatedwithPVI.
Kaplan-MeiermethodusedtoobtainestimateoffreedomfromMAE.Greenwood’smethodusedtoobtainthe95%confidenceintervalfortheestimate.PairwiseLog-RankP-valuesat180-Days:RC2-3vs.RC4-5,P<0.0001;RC2-3vs.RC6,P<0.0001;RC4-5vs.RC6,P=0.0453
MajorAdverseEventdefinedas:
v Death(within30daysoftheindexprocedure)
v Unplannedmajoramputationofthetargetlimb(abovetheankle)
v Clinically-drivenTVR(inclusiveofTLR)ofthetargetlimb
499 484 450 414589 554 479 40699 87 67 54
0 30 90 180
Time to MAE (Days)
0.5
0.6
0.7
0.8
0.9
1.0
Surv
ival
Pro
babi
lity
2-3: Claudicants4-5: CLI
6: CLI
6: CLI4-5: CLI2-3: ClaudicantsBaseline Rutherford Classification
Product-Limit Survival EstimatesWith Number of Subjects at Risk and 95% Confidence Limits
499 484 450 414589 554 479 40699 87 67 54
0 30 90 180
Time to MAE (Days)
0.5
0.6
0.7
0.8
0.9
1.0
Surv
ival
Pro
babi
lity
2-3: Claudicants4-5: CLI
6: CLI
6: CLI4-5: CLI2-3: ClaudicantsBaseline Rutherford Classification
+ Censored
Product-Limit Survival EstimatesWith Number of Subjects at Risk and 95% Confidence Limits
6-MonthFreedomfromMAEs
(PointEstimateand95%ConfidenceIntervals)Kaplan-MeiermethodusedtoobtainestimateoffreedomfromMAE.Greenwood’smethodusedtoobtainthe95%confidenceintervalfortheestimate.
60% 65% 70% 75% 80% 85% 90% 95% 100%
Rutherford6
Rutherford4-5
Rutherford2-3
73.7%
81.2%
92.6%
AtRisk 54
Events 23
Censored 22
AtRisk 406
Events 102
Censored 81
AtRisk 414
Events 35
Censored 50
6-Month RC2-3vs.RC4-5 RC2-3vs.RC6 RC4-5 vs.RC6
Hazard Ratio P Hazard Ratio P Hazard Ratio P
MAE 0.40[0.29,0.56] <0.0001 0.26[0.16,0.41] <0.0001 0.63[0.42,0.95] 0.0271
6-MonthFreedomfromMAEComponents
PointEstimateand95%ConfidenceIntervalsKaplan-MeiermethodusedtoobtainestimateoffreedomfromMAE.Greenwood’smethodusedtoobtainthe95%confidenceintervalfortheestimate.
RC2-3 RC4-5 RC6
Atrisk 445 485 61
Events 1 18 11
Censored 53 86 27
70% 80% 90% 100% 70% 80% 90% 100% 70% 80% 90% 100%
85.1%
95.3%
97.1%
87.1%
96.8%
99.8%
85.1%
83.1%
93.0%
ForcalculationofMAErate,deathcappedat30days.
Death MajorAmputation TVR
RC2-3
RC2-3 RC4-5 RC6
Atrisk 446 498 66
Events 14 26 13
Censored 39 65 20
RC2-3 RC4-5 RC6
Atrisk 414 411 59
Events 33 91 12
Censored 52 87 28
RC4-5
RC6
CoxproportionalhazardsmodelidentifiesnodifferencebetweenanyRCgroup/armat6months.
Phoenixcatheter• 5Fr,OTW,frontcuttingatherectomy
• Rotationalspeed10000RPM
• DebriswithdrawnthroughArchimedesscrewsystem
• EASEtrial>100patients,0.8%embolicevents
Pantheris
• VISIONtrial• 130pts• 55(24monthresults)
• 91.4%treatedstandalonePantheris
• 9.6%DCB• 5.1%stent
• 82%freedomfromTLRat24months
DEFINITIVEARStudyDesign
GeneralandAngiographicCriteria
Assessment
Lesionseverelycalcified?
Guidewirepassage,enrollment&Randomization
DAART*(N=48)
DCB(N=54)
GuidewirePassage&Enrollment
DAART*(N=19)
No
Yes
Registryarmforseverelycalcifiedlesionscreatedtolimitbail-outstenting(andthereforevariables)inrandomizedarm.
*DirectionalAtherectomy+Anti-RestenoticTherapy
Purpose:assessandestimatetheeffectoftreatingavesselwithdirectionalatherectomy +DCB(DAART)comparedtotreatmentwithDCBalone
ClinicalLimitations&UnmetNeeds
CalciumasaBarrier LongerLesionLengthCalcium Limits Vessel Expansion1
Calcium May Limit Drug Effect2Increasedlesionlengthisanindependent
predictorofdecreasedpatency5.
1FreedMS,ManualofInterventionalCardiology,2FanelliDEBELLUM,3Laird,CCI,June2010,4SMARTControlIFU,5Matusumura,DURABILITYIIJVS,July2013,6Davaine,
EuropeanJournalofVascularandEndovascularSurgery44(2012)
BaselineLesionCharacteristicsPerCoreLab
BaselineCharacteristics DAART(N=48)
DCB(N=54)
p-Value* DAARTSevereCa++Arm
(N=19)
LesionLength(cm) 11.2 9.7 0.05 11.9
DiameterStenosis 82% 85% 0.35 88%
Referencevesseldiameter(mm) 4.9 4.9 0.48 5.1
Minimumlumendiameter(mm) 1.0 0.8 0.34 0.7
Calcification 70.8% 74.1% 0.82 94.7%
Severecalcification 25.0% 18.5% 0.48 89.5%
*p-valueforDAARTandDCBgroups
KeyStudyOutcomeat12Months- AngiographicPatencyshowssimilarpattern
82.490.9
58.3
71.8 68.8
42.9
0102030405060708090
100
AllPatients Lesions>10cm AllSevereCa++
DAART
DCB
N=34N=39 N=22N=16 N=24N=7
Resultsforallpatientswhoreturnedforangiographicfollow-up
What’soutthereandwhattochoose?• Severaldevicesnowavailablefordebulking
• Criticalquestionremainsisdebulkingpartofvesselprep“all”or“some”ofthetime
• Eachdevicehascompellingdata
• Somebetterforcalcificdisease
• Somebetterforeaseofuse
• ThereisnoquestionthatinsomecaseseitherforDCBorstentingadebulkingstrategyiscriticaltoobtainbestinitialandprobablylong-termoutcomes
• Combinedtherapyappearcompellingthoughnotfullytested