#AHA16

LeadlessDevices:WhoShouldReceiveOne?

KevinP.Jackson,MD

Background

RisksAssociatedwithTraditionalPacemakers• 350,000pacemakersannuallyintheU.S.andnearly1millionworldwide• Acutetraumaticcomplication(pneumothorax,tamponade)in2.8%ofimplants• 11%leadcomplicationrateat5years• 8%pocketcomplicationrateat5years• Complicationrequiringreoperation in8%ofimplants

UdoEO,etal.HeartRhythm2012May;9(5):728-35

LeadlessPacemakers

Imagesfrom:http://www.medtronic.com/us-en/about/news/micra-fda-approval.html andhttp://www.medicalexpo.com/prod/st-jude-medical/product-70886-569901.html

• Single-chamber,programmableVVIRdevice• Capsulecontainsbatteryandelectronics• Insertedintorightventricleviafemoralveincatheter

LeadlessPacemakers- Advantages

• Simplifiedimplantprocedure• Smallerelectrodetipallowsshorterimpulseduration(pulsewidth)andprolongsbatterylife• MRIconditional• Noreported infections

HeartRhythm. 2016Oct;13(10):2056-63

LeadlessIIstudy

• Implantsuccessfulin289/300patients(96%)• Devicemetpre-specifiedefficacyandsafetyendpoints:Ø90%ofpatientshadadequatecapturethresholdandsensinginITTanalysis

Ø7%majoradverseeventat6months

NEngl JMed2015;373:1125-35.

Micra Transcatheter PacingStudy

N Engl J Med. 2016 Feb 11;374(6):533-41

Primaryefficacy outcomemet:Stablepacingcapturethresholdatfollow-up

Primarysafety outcomemet:freedomfrommajorcomplication96%at6months

ComplicationRates:Micra versusHistoricControls

0%

1%

2%

3%

4%

5%

6%

7%

8%

MajorComplication

Device/leaddislocation

Infection Cardiacinjury

3.4%

0.0% 0.0%

1.5%

7.5%

1.6%

0.2%

1.1%

Micra Control

Adaptedfrom:N Engl J Med. 2016 Feb 11;374(6):533-41

51%reductioninmajorcomplications

2012ACCF/AHA/HRSFocusedUpdateforDevice-BasedTherapyofCardiacRhythmAbnormalities

MajorClassIIndications• Sinusnodedysfunction• Chronotropicincompetence• High-degreeAVblock

ØSymptomsØPause>3secondsØRate<40ØInfra-Hisian escaperhythm

J Am Coll Cardiol 2013;61:e6–75.

Trialimplantindication:

ChronicAFwithbradycardia

64%

Sinusnodedysfunction

17%

AVblock15%

Other4%

Adaptedfrom:N Engl J Med. 2016 Feb 11;374(6):533-41 andNEngl JMed2015;373:1125-35.

ChronicAFwithAVblock56%

Sinusnodedysfunction

35%

AVblock9%

LeadlessIIMicra

SingleversusDual-chamberDevice

J Am Coll Cardiol 2013;61:e6–75.

• PermanentAFwithpacingindication

• IntermittentpacingneedØ SinusnodedysfunctionØ Post-conversionpauses

• Completeheartblock?

PacemakerselectioninCHB

NEnglJMed2005;353:145-55.

PacemakerselectioninCHB

NEnglJMed2005;353:145-55.

• Nodifferenceinincidenceofatrialfibrillationorstroke

Meta-analysis:Dual-chamberpacingmayreduceincidenceofAFandstroke

Circulation.2006;114:11-17.

WhentoconsiderLeadlessPacemakerImplantation• StandardVVIpacemakerindication:

ØPermanentAFwithpacingindicationØSinusnodedysfunction(intermittentpacingindication)ØCompleteheartblock(>70yearsold,limitedfunction)

•Uniqueindication:ØPriordeviceinfectionØVascularaccessissue(dialysis,Porta-cath)

LimitationstoLeadlessPacemakers

• Single-chamberdevices(<10%ofimplants)• Developmentofpacemakersyndrome• Largeperipheralaccesscatheter• LackofcompatibilityforupgradetoICDorCRT• UnclearmanagementatbatteryEnd-of-Life

ManagementofLeadlessDevicesatEndofBatteryLife

PacingClin Electrophysiol.2016Apr;39(4):393–397; Clin ResCardiol 2015)

Conclusion

• Leadlesspacemakersrepresentnewleapforwardintechnology•Mayaddressthe“Achilles’heel”oftraditionalpacemakerdevice• Appropriatepatientsincludethosecurrentlyindicationforsingle-chamberdevice•Maysee“creep”insinglechamberimplantsforotherindicationsuntiltechnologycatchesup