leadless devices who should receive one - dcri · • leadless pacemakers represent new leap...
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#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