TheNextOISFron/er?PCIs,PacemakersandNext
Procedures
JeffreyG.Carr,MD,FACC,FSCAITylerCardiacandEndovascular
CenterTyler,Texas
DisclosureStatementofFinancialInterest
• Grant/ResearchSupport
• Consul/ngFees/Honoraria
• AstraZeneca,Novar/s,BostonScien/fic,RexMedical,Veryan,StJude
• Philips,Medtronic,Spectrane/cs,AbboR,Avinger,NCP-FreseniusVascular,CSI,AstraZeneca
Withinthepast12months,Iormyspouse/partnerhavehadafinancialinterest/arrangementoraffilia/onwiththeorganiza/on(s)listedbelow.
Affilia/on/FinancialRela/onship Company
Angioplasty• 40yearsAnniversary---Sept1977Dr.AndreasGruentzig
• Earlydays—Balloonangioplastyandfirstgenstents
• Heparin,Dextran,Dipyridamole,Aspirin,Warfarinloading�– 4-7daysinhospital
• Level1SurgicalORStandby
PacemakerandDeviceImplants
• EarlydaysofPMimplant– InOR– 1-2days+inhosp.– Althoughrare,leadorpocketinfec/onsareissueswithsignificant
clinicalandeconomicconsequences
PercutaneousCoronaryInterven/on(PCI)OfficeBased—SameDayInterven/on
(SDI)
CardiacRhythmManagement(CRM)-Pacemaker,ICDandBiventricularPacer
ImplantsinOffice
Safety
Safety
SafetyOutcomesStudiesforOfficeBasedInterven/ons
Office-basedendovascularsuiteissafeformostproceduresJain,K.,etal.J.VASCSURG2014Jan;59(1):186-916458pts. TotalComplica=onrate0.8%26/6458transfers 10/6458surgicalinterven=ons0Procedure-relatedDeaths 18Deathsin30d99%sa=sfac=on–wouldreturn
SafetyandEfficacyofPeripheralVascularProceduresPerformedintheOutpa=entSeOng
Oskui,P.,etal.JINVASIVECARDIOL2015;27(5):243-249500Procedures(335AVF,148PAD,17Misc)7/500Adverseevents 1/500emergenttransfers0reporteddeaths
Treatmentoutcomesandlessonslearnedfrom5134casesofoutpa=entoffice-basedendovascularproceduresinavascularsurgicalprac=ce
LinP.,etal.VASCULAR20165123pts. TotalComplica=onrate1.4%15/5123(0.29%)immediatehospitaliza=on/transfer 7/5123(0.13%)emergentsurgery0Procedurerelateddeaths 9Deathsin30d(0.18%)
MajorityASAI,II,III13.1%ASAIV(Alldialysispts)Comparedearlyvs.latercaseexperiencebyquin=les(n=1000foreachgrp)
CPORT-E18,867pa/entswithstableCADorACSunderwentnon-emergencyPCIatahospitalwith(n=4,718)orwithout(n=14,149)on-sitecardiacsurgeryfrom2006to2011.Conclusions:Elec/vepercutaneouscoronaryinterven/on(PCI)athospitalswithouton-sitecardiacsurgeryisnon-inferiortosimilarproceduresperformedathospitalswithsurgicalcapabili/es.
NEJM2012;366:1792-1802
9MonthOutcomes
Noon-sitesurgery(n=14,149)
On-sitesurgery(n=4,718)
Pvalue
Death 3.2% 3.2%TVR 6.5% 5.4% 0.01(for
superiority)MI 3.1% 3.1%MACE 12.1% 11.2% 0.01(fornon-
inferiority)
12
MASSCOMM3,691pa/entselec/vePCIinMassachuseRshospitalswithouton-sitesurgerybetween2006and2011.Pa/entswererandomizedin3:1fashiontoundergoPCIatini/alhospital(n=2,774)ortransferredtoanotherwithon-sitesurgicalback-up(n=917). NEJM2013;368:1498-1508Conclusion:Pa/entsundergoingnon-emergencyPCIexperiencesimilaroutcomeswhetherornottreatedathospitalsthatpossesson-sitecardiacsurgerycapabili/es.
30DayOutcomes 1YearOutcomes
Noon-sitesurgery(n=2,774)
On-sitesurgery(n=917)
Pvalue
MACE 9.5% 9.4% <0.001(fornon-inferiority)
DEATH 0.7% 0.3% 0.39
MI 6.5% 6.5% 1.00
Repeatrevasculariza/on
2.7% 3.5% 0.25
Stroke 0.4% 0.1% 0.21
Noon-sitesurgery(n=2,774)
On-sitesurgery(n=917)
Pvalue
MACE 17.3% 17.8% <0.001(fornon-inferiority)
DEATH 2.3% 2.4% 0.89
MI 8.6% 7.8% 0.55
Repeatrevasculariza/on
8.5% 9.9% 0.24
Stroke 1.0% 0.8% 0.83
OutcomesandTemporalTrendsofInpa/entPercutaneousCoronaryInterven/onatCentersWithandWithoutOn-siteCardiacSurgeryintheUnitedStatesGoel,et.alJAMACardiol.2017;2(1):25-33.
AU.S.na/onalinpa/entsample(N = 6,912,232)pa/entsunderwentinpa/entPCIfromJan2003toDec2012.OfthesePCIs,396,741(5.7%)wereperformedatcenterswithouton-sitecardiacsurgery.
Findings:• 7-foldincreaseinthepropor/onofPCIsatcenterswithouton-sitecardiacsurgery.
• Adjustedin-hospitalmortalityarerinpa/entPCIwassimilaratcenterswithandwithouton-sitecardiacsurgery.
Safety
SCAI/ACC/AHAExpertConsensusDocument2014UpdateonPercutaneousCoronaryInterven=onWithoutOn-Site
SurgicalBackup
CoronaryPCIisSafeinSiteswithoutSurgicalBackup
StudiesonSameDayDischargeforPCI
• EPOS• STRIDE• EASY
Safety
PrevalenceandOutcomesofSame-DayDischargeAcerElec=vePercutaneousCoronaryInterven=onAmong
OlderPa=entsSunil,R,etal.JAMA.2011
CoronaryisPCISafewithSameDayDischarge
AppropriatenessforOfficebasedPCI
• Caseselec/oncriteria– TypesA,B1,B2lesions.NoTypeClesions.– NoNSTEMI,STEMI,complexbifurca/onorthrombo/cladenlesions
– MCC’s,severeAS,LM,lowEF
– SCAIToolkitforPCIAppropriateness
! Creden/alingofOperators! PeerReview! Assessmentofhomesupportsystems
versus
SafetyNetforPCIandCRMinOfficeandSDD
Office-BasedSameDayPCIsandCRMs-Advantages
• Focusedanddedicatedteam• Efficientturnover• Noserviceinterrup/ons• Nonosocomialinfec/ons• Highpa/entsa/sfac/on,easyaccessandfamiliarity
• Con/nuityofcare• Costefficientcomparedtohospital(If50%PCIsSDD,est.savings$200-500M/yr)PopescuAM,etal.JACC
CardiovascInterv.2010;3(10):1020-1021.
AccesstoPCIwithoutonsitesurgeryhasincreaseddrama/callysince2007
ChangeintheavailabilityofPCIwithoutonsitesurgery20072013#Statesallowingbothprimaryandelec/veallowed 28 45#StatesallowingprimaryPCIonly 12 4Notallowed 10 1
Statesaremakingregulatorychangestoimproveoutpa/entaccessforPCI
Medicarepaymentpolicieshavenotkeptpacewithstatechangesandclinicalguidelines
PaymentCoverage• StatesregulatecoverageforPCIandCRMforsitesofficeandASCs
• CMShasencouragedoutpa/entandobserva/onstatusforPCI
• CMSdoesnotcurrentlycoverPCIorCRMinoffice(POS11)
• CMSdoescoverCRMinASCsCMShasnotkeptpacewithstateregsandclinicalguidelines
CMScommentsin2018FinalRuleforcoronaryinterven/onalproceduresinASC
MACRAEpisode-BasedCostMeasures
Fieldtes/ngunderwaynowtodevelopCostMeasuresfor:1. Elec/veOutpa/entPCI2. KneeArthroplasty3. Revasculariza/onforLEChronicCLI4. Rou/neCataractRemovalwithIntraocular
LensImplant5. Screening/surveillanceColonoscopy6. IntracranialHemorrhageorCerebralInfarc/on7. SimplePneumoniawithHospitaliza/on8. STEMIwithPCI
CommentperiodtoCMSthroughNov15,2017
Poten/alNextandFutureCardiacProcedures
• IschemicHeart– FFR– IVUS– GrarDisease– TypeClesions
• Noninvasive--TEE
• StructuralHeart– PFOClosure– LAAClosure– MitraClip– TAVR– TMVR
• Electrophysiology--DCCV--AFAbla/on
WhatisneededtoexpandnewproceduresintotheOfficeandSameDayDischarge?
OperatorexperienceandtrainingStaffexperienceandtraining
Creden/alingPeerreview
ReimbursementOutcomesrepor/ng
Specialconsidera/ons:• ExperiencedOperatorandNewDevice• InexperiencedOperatorandExis/ngDevice• InexperiencedOperatorandNewDevice• Newapplica/onsofexis/ngdevices
Conclusions• Office-basedPCIsandCRMdeviceimplantsaregrowingintheUSand
provideasafe,pa/ent–preferred,cost-efficientalterna/vetohospital-basedinterven/ons
• Demonstra/ngsafetyandappropriatenessinofficesewngis
paramount• Outcomesmeasuresandtransparencyisimportant– OEISNa/onalRegistryandotherRegistrieswillplayavitalroleasthereimbursementlandscapechanges
• Officebasedinterven/onsarehighlyregardedbypa/entand
providers• NewCardiacproceduresarelikelytobeperformedinofficesewng
oncesafety,transparencyandreimbursementissuesresolved
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