PreventionandTreatmentofInfectionsDr.GeorgiosZervopoulosInfectionsAreIncreasinginFrequency&FasterThanImplants1ContributingFactorsforIncreaseOlderPatientsReceivingDevicesMorePatientComorbiditiesMixofCIEDsisChangingNumberofPulseGeneratorReplacements&UpgradesisIncreasingMoreResistantSaureus&Coagulase(-)StaphylococcusSpecies1.GreensponAetal.JAmCollCardiol201158(10)1001-1006.OverallInfectionRateat1Yearis3.1%

HighPowerRates>LowPowerRatesatAllTimePointsInfectionRateAcrossallProcedureTypes@1yearDataonFile–TruvenMarketscanResearchMortalitysignificantlyincreasesfollowingCIEDInfectionsinMedicareBeneficiariesPublishedinonNov.14,201111Sohailetal.ArchivesofInternalMedicine2011171(20),1821-18284.8to7.7FoldIncreaseInAdmissionMortality1.6to2.1FoldIncreasesLongTermMortality(27-36%@1Yr)P<0.001forallcomparisonsofwith/withoutinfectionClinicalNeed&StandardofCareClinicalNeed&StandardofCareClinicalProblemsCardiacImplantableElectronicDevice(CIED)relatedinfectionsareincreasinginfrequency&areexpensivetotreat1Specificpatientconditions&procedurecharacteristicssignificantlyincreasetheriskofCIEDinfections(e.g.,renalinsufficiency&failure,diabetesmellitus,multi-leaddevicepatients,replacement&revisionprocedures)2StandardtreatmentforCIEDinfectionrequiresadditionalhospitalstay,systemicantibiotics,&removalofallhardware,beforere-implantationcanoccur3CurrentStandardofCarehasImportantDeficiencies4Twomostcommonprophylacticantibiotics,IVcefazolin&ycin,areinadequate&havedistinctdeficienciesCefazolinhaspooractivityagainstCoagulase(-)Staphylococcus&MRSAycinhaspoortissuepenetration&noactivityagainstgram(-)rodsCurrentClinicalNeedAnadjunctiveprophylacticantibiotictherapyforCIEDimplantationGreensponAetal.JAmCollCardiol201158(10)1001-1006.Ellisetal.CombProdTher20111(1)003.WilkoffBetal.HeartRhythm20074(11)1467-1470.4.SanfordGuidetoAntimicrobialTherapy2012,42ndEditionSuggestedTreatmentforCIEDInfectionsCompleteextractionofallhardwareCompletedebridementoftheinfectedscartissueNoreimplantationatprimaryextractionprocedureSustainedantibiotictherapy(2to6weeks)ReimplantationatalternatesiteWilkoffBetal.HeartRhythm.2007;4(11):1467-1470CourtesyofSt.Luke’s-RooseveltHospitalCenterCourtesyofDr.RogerCarilloCourtesyofDr.RogerCarilloTreatingCIEDInfectionsisExpensiveTheestimatedmeancostofaCIEDinfectionis$50,0001

1.Ashanetal.Europace.2014.1-8.2.BasedonTYRXanalysisoftheMedicareStandardAnalyticFile(SAF)for2008inpatientclaims,performedinconjunctionwiththehealthcareconsultingfirmBraide-ForbesHealthResearch.

ClinicalExperienceInfectionPreventionMeasuresHeadCover*ShaveofthesurgicalareaScrubwithpuregasolineLocalDisinfection(Betadine)WayofSewingHeadCover*

HeadCover*WayofSewing

IPGmovedoutofplaceIPGmovedoutofplaceTheTYRX?Absorbable

AntibacterialEnvelopeTYRX?AbsorbableAntibacterialEnvelopeFeaturestheadvantagesoforiginalTYRXEnvelopeDesignedtostabilizeCIEDplacementMayhelppreventCIEDinfectionsAntibiotics(minocycline&rifampicin)eluteforaminimumof7daysSecondgenerationmultifilamentmeshsubstrateAbsorbsintothebodyin~9weeksNochangenecessaryinsurgicaltechniqueduringreplacement&revisionproceduresAfterabsorption,noforeignbodynidusforpotentialinfectionTimeSequenceSimulationDemonstratingElution&AbsorptionofTYRXAbsorbableEnvelope

AbsorbableEnvelopeafterimplantation:envelopeiselutingminocyclline&rifampicinAbsorbableEnvelopeat4weeks:envelopeisdissolvingintofragmentsAbsorbableEnvelopeat~9weeks:meshhasnophysicalpresenceandisfullyabsorbedMedtronicisGeneratingClinicalEvidenceMulti-CenterRetrospectiveRegistry(Completed)Single-CenterRetrospectiveStudy(Completed)Single-CenterRetrospectiveStudy(Completed)Multi-CenterProspectiveStudy(Closed)Multi-Center

RCTWRAP-IT(New)COMMANDVanderbiltValleyHealthPublished:PACEApril2014Citadel&CenturionClevelandClinic(Dr.BruceWilkoff,PI)642patients~900patients~2900patients~1000patients~7000patients10Centers1Center1Center~50centers~200centers1.05%vs3.56%(historicalcontrol)0.4%vs3.0%(control)1.1%vs3.7%

(control)0.1%vs1.67%&1.88%(historicalcontrol)TBDPublished:PACEFebruary2011Published:PACEMarch2013PresentedatHRS&EuroPaceLateBreakingTrials2013ToBeInitiatedVITATRONLEADS

ActiveFixationCRYSTALINEACTIFIX–ICQ09B/JBCRYSTALLINEACTFIX

ICFO9B/ICQ09BACTIVEFIXATIONLEADDownsizedleadbody

2.03mm/6F)ICF09B1.90mm/(5.7F)ICQ09BSteroideluting

collarPlatinumringPolyurethane(ICQ)orsilicone(ICF)outerinsulationExtendible/Retractable

helixCRYSTALLINEACTFIX

ICFO9B/ICQ09BCRYSTALCLEARSENSINGAshorttip-to-ringspacingreducesfar-fieldsensing,allowingbettertherapyanddiagnosticsforyourpatientsAllowsahighersensitivitysettingforimproveddetectionofatrialfibrillation10mmThehelix,orscrew,extendsintotheendocardialtissueAllowsforleadpositioninganywhereintheheart’schamberActivefixationleadsmaybeabetterchoicetopreventleaddislodgment.TheseleadsaresomewhateasiertoremoveTransvenousActiveFixationLeadsLeadExtensionConfirmation

25LocatingtheHisBundleforPacingIdentifytheHisbundlepotentialMappingwithEPcatheterMappingwiththe3830leadSeptumpacing2627PresentationTitle(EditonSlideMaster)|June1,2015|Confidential,forInternalUseOnlyTHANKYOUHis-BundlePacingLeads&CathetersHisbundlepacingclinicalevidenceLimitedDatawithnoLargeRandomizedClinicalTrialProcedureandFollow-Up

Procedureandfluorotimes~20minuteleadimplant&10minutefluoro1-4>75%ImplantSuccess1-4PacingCaptureThresholdsPacingCaptureThreshold1-2atimplant:SelectiveHis-BundlePacing:2.5V@0.5msNon-selectiveHis-BundlePacing:1.5V@0.5msAcuteInjuryCurrentpredictslowerchronicthresholds9Exitblock3.2-5.5%exitblock(PCT>5V@0.5ms)at20±10mF/U2SensingAcute2.9±2.0–6.8±5.3mV1-3esLimiteddatawithnolargerandomizedclinicaltrialNarrowPacedQRS3-7ImprovedandpreservedLVfunction3-6LowerHF-relatedhospitalizationinfrequentlypaced(>40%)patients3CorrectedLBBBincertainpatients7SuccessfullyPacedAVB(infra-nodalandintra-His)9Zanon,JCardiovascElectrophysiol.2006,17:29Huang.Europace.2015Zanon,PACE.2011,34:399Sharma,HeartRhythm.2015,305Deshmukh,Circulation.2000,101:869Catanzariti,Europace.2013,15:546Lustgarten,HeartRhythm.2015,12:1548Vijayaraman,PACE,2015,38:540Vijayaraman,JACC:EP,2015,1:571Note:Toviewthestudiesonline,gointopresentationmodeandclickonthestudyyou’dliketoview.30SelectSecureLeadOverviewModel3830leaddesign3830LeadSpecifications:4.1FRleadbodydiameterBipolarFixedscrewhelixSteroidelutingPolyurethaneouterinsulationCableinnerconductorCross-sectionalviewof3830lead3830Lead31C304GuideCatheterFamilyOverviewC304deflectablecatheterdesignC304DeflectableCatheterC304SpecsShapeDeflectableIntroducer9FrUsablelength30cm,40cm,and45cmInnerdiameter5.7FrOuterdiameter8.4FrIntegratedvalveNoManipulationArticulationhandleHydrophiliccoatingNoBraidYes,8x832PresentationTitle(EditonSlideMaster)|June1,2015|Confidential,forInternalUseOnlyC315CatheterFamilyOverviewShapeDescriptionCompatible3830lengthsLeadLocationH2020cm49cm

orlongerApex,triangleofKochforsmallerpatientsJ30cm59cm

orlongerBachmann’sbundle,highatrial