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