GabrieleHesslingDepartmentofElectrophysiology

GermanHeartCenter,TechnicalUniversityMunich,Germany

PedirhythmVII,Thessaloniki,6thFebruary2017

Thenewleadlesspacemakers-whenwilltheybefeasibleinchildren?

PacemakerTherapy

1956 2013

Eachyearnearly1millionpersonsworldwidereceivetransvenouscardiacpacemakers.

SNllnopacemakersorleadsaredesignedspecificallyforchildren

WhyLeadlesspacing?

Lead-associatedcomplica8ons-Pneumothorax-CardiacperforaNon-Dislodgement-Venousocclusion-Fracture,insulaNonfailure

Pocket/Generator-relatedcomplica8ons

-Hematoma-SkinErosion-InfecNon-CosmeNcconcerns

Pacemakerrelatedadverseeventsin~1of10paNents

PotenNalbenefitsofleadlesspacing

1

2

3

Percutaneous,lesshardware,nocosmeNcissues

ReducNonofacuteandchroniccomplicaNons

ReducNonofcomplicaNonsShortin-hospitalstay

Onlysinglechamberpacing(VVI/R)possible

MMicra™

St.JudeMediaNanos8m™

Size

Longevity

Accesssite

FixaNon

RetrievalopNon

41,4mm,ø5.9mm 25.9mm,ø6.7mm

>9,3years 10years

V.femoralis(18Fr.) V.femoralis(23Fr.)

Screw-inHelix(1,3mm) 4self-expand.Ni8nolTines

Yes Yes

CEMark/FDAApproval

Oktober2013/No April2015/April2016

2Systems

MRIcompaNble 1.5and3Tesla1.5Tesla

Source:MedtronicInc,St.JudeInc

St.JudeMedical Medtronic

2Systems

Nanos8m™Micra™

Source:,St.JudeMedical,Medtronic

St.JudeMediaNanos8m™

41,4mm,ø5.9mm

>9,3years

V.femoralis(18Fr.)

Screw-inHelix(1,3mm)

Yes

Oktober2013

1.5Tesla

St.JudeMedical

28thOctober2016St.JudeMedicalhaspressedpauseonallimplantsofitsNanos8mleadlesscardiacpacemakersduetoaba_eryproblemthathasresultedinlossofpacingandtelemetryinafewdevices.Theissuehasbeenobservedinsevendevices(29-37monthsaaerimplant)outofapproximately1400implantsaroundtheworld—a0.5%rate.

Leadlesspacing-ImplantaNon

Catheterbaseddeliveryinthelowerrightventricularseptum

Removalseemspossible

RetrievaloftheLeadlessCardiacPacemakerAMul8centerExperienceCircArrhythmElectrophysiol2016,December;9(12)VivekY.Reddy,MarcA.Miller,ReinoudE.Knops,PetrNeuzil,PascalDefaye,WernerJung,RahulDoshi,MarkCastellani,AdamStrickberger,R.HardwinMead,HarishDoppalapudi,DhanunjayaLakkireddy,Ma_hewBenne_,JohannesSperzel• Overallleadlesspacemakerretrievalsuccessratewas94%:• Leadlesscardiacpacemakerimplanted6months• Noprocedure-relatedadverseeventsat30dayspostretrievalprocedure.

IndicaNons

Pa8entswithIndica8onforVVI(R)Pacing

• ChronicatrialfibrillaNonwith2or3°AVBlock

• Sinusrhythmwith2or3°AVorBBBblock,lowlevelofphysicalacNvityorpaNentswithalifespan<10years

• SinusBradycardiawithinfrequentpausesorunexplainedsyncope

Poten8alindica8ons?PhysicallyveryacNvepaNents(avoidpocket)?Venousaccessproblems?S/ppocketinfecNon?PaNentsatincreasedriskforleadfailureorinfecNon?Neurocardiogenicsyncopecardioinhibitorytype

Data

ReddyetalNEJM2015;373:1125

Nanostim n= 526 Micra n= 725

Reynoldsetal,NEJM2016;374:533

Efficacy

NanosNm Micra

Efficacyendpointreachedin>90%

Safety-NanosNm

At6months:Devicerelatedseriouseventsin6.7%;-CardiacperforaNonin1.3%-  Devicedislodgementin1.7%-  ThresholdelevaNonin1.3%-  VascularcomplicaNons1.3%

Safety-Micra

At6monthsAtotalof28eventsin25paNents(4%)-Cardiacinjuryin1.6%

Leadlesspacinginchildren

•  SafetyandfeasibilityofusingthisleadlesspacemakerinpaNentsyoungerthan18yearsofageunknown

•  Sizeoftheintroducersheath(18French/23French)maymakeitsuseinchildrenmoredifficult(complicaNonsrelatedtoeitherthefemoralaccesssiteorcathetermanipulaNonwithintherightventricle)

•  DevicesplacedinthesmallerrightventriclesofchildrenðTV-problems,proarrhythmia?

•  Furtherminiaturiza8onrequired;shorterba_erylife?•  Extractability(firstdatainhumansaboutremovalof

chronicallyimplantedsystems;riskoffibrosishigherinchildren?)

LeadlesspacinginadultswithCHD

•  SafetyandfeasibilityofusingthisleadlesspacemakerinadultCHDpaNentsunknown

•  IndicaNonsbasedonadultpopulaNonindicaNons;singlechamberpacing

UnsolvedIssues

•  Morphologicallyleaventricles(S/patrialswitch)withouttrabeculaNon?

•  Retrogradeplacementina(single)ventricle?

•  RiskofThrombosis-anNcoagulaNonmanagement?

Summary

•  LeadlesspacingseemsanexciNngnewdevelopment

•  Electricalperformancecomparablewithtransvenouspacemakers

•  AcutecomplicaNonssuchastamponadeorperforaNonneedtobeaddressedðsafe(r)implantaNontechniques

•  Long-termissues(thrombogenity,proarrhyhtmia,extractability)needtobeaddressed/solved

Systemsapplicableforchildrencurrentlylacking

Summary

•  LeadlesspacingseemsanexciNngnewdevelopment

•  Electricalperformancecomparablewithtransvenouspacemakers

•  AcutecomplicaNonssuchastamponadeorperforaNonneedtobeaddressedðsafe(r)implantaNontechniques

•  Long-termissues(thrombogenity,proarryhtmia,extractability)needtobeaddresed/solved

Systemsapplicableforchildrencurrentlylacking

What´snext?

Smallerdevices?Leadlessatrialdevices?

CommunicaNonwithventriculardevice?LeadlesspacerandsubcutaneousICD?

IntravascularICDs?

Thankyouforyoura_enNonandthankyouChristofKolb!

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