cdi subcutâneo: vantagens e resultados · s-icd pooled data* 90.1% 98.2% altitude first shock...
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FRANCISCO BELLO MORGADOHOSPITAL DE SANTA CRUZ,HOSPITAL DOS LUSÍADAS
LISBOA
IXCongresso– NovasfronteirasemmedicinaCardiovascular
CDISubcutâneo:VantagenseResultados
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Date of download: 6/1/2013
Copyright © The American College of Cardiology. All rights reserved.
From: 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008
J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033
Annual Number of PM and ICD Implantations: 1993 to 2008Between 1993 and 2008, overall cardiac implantable electrophysiological device (CIED) implantation increased by 96% (an average of 4.7%/year). Pacemaker (PM) implantation increased by 45%, whereas implantable cardioverter-defibrillator (ICD) implantation increased by 504%.
Figure Legend:
1993 – 2008
96% aumento de implantações de dispositivos cardíacos
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Date of download: 6/1/2013
Copyright © The American College of Cardiology. All rights reserved.
From: 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008
J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033
Rate of CIED InfectionThe annual rate of cardiac implantable electrophysiological device (CIED) infection remained fairly constant until 2004 when there was a marked increase. The infection rate increased from 1.53% in 2004 to 2.41% in 2008 (p < 0.001).
Figure Legend:
…De 2004 a 2008Risco de Infecção aumentou
de 1,53% para 2,41%
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Date of download: 6/1/2013
Copyright © The American College of Cardiology. All rights reserved.
From: 16-Year Trends in the Infection Burden for Pacemakers and Implantable Cardioverter-Defibrillators in the United States: 1993 to 2008
J Am Coll Cardiol. 2011;58(10):1001-1006. doi:10.1016/j.jacc.2011.04.033
Incidence of Comorbidities in Patients With CIED InfectionThe incidence of 4 major comorbidities (renal failure, respiratory failure, heart failure, and diabetes) remained fairly constant until 2004 when a marked increase was observed. This paralleled both the observed increase in implantable cardioverter-defibrillator implantation and the increased infection rate. CIED = cardiac implantable electrophysiological device.
Figure Legend:
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Growing Need for Managing Leads5% Estimated Annual Incidence
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LimitaçõesCDITransvenosoCOMPLICAÇÕES• Naimplantação:pneumotórax,hemotórax,infecção sistema,
hematoma,disfunção deeléctrodos,deslocação…• Noseguimento:disfunção deeléctrodos,problemas
relacionados comgerador,infecções (endocardite),choquesinapropriados,choques apropriados masevitáveis…
Circulation. 2012;125:57-64.
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LimitaçõesCDITransvenoso
• Electrodo noseguimento ou o“elo mais fraco”
- Disfunção/deslocação electrodo comnecessidade dereintervenção:10anos:16.4%
50%
60%
70%
80%
90%
100%
0 1 2 3 4 5 6 7 8 9 10Year
Patie
ntSurvival&
TVLead
Survival
Borleffs-TVleadfailure(n=2,145)Borleffs-All-causeTVleadremovalorcappingKleemann-TVeadfailure(n=990)Altitude-Patientsurvival(n=47,032)
Maisal,W.,&Kramer,D.(2008).Implantable cardioverter defibrillator lead performance.Circulation,117(21),2721–2723.
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LimitaçõesCDI/Pacing Transvenosos
CDIePMconvencionaléumcompromissoparaavida
- Extraçãoprocedimentoderiscoconsiderável- Impossíveldescontinuarmesmoquesemodifiquemasindicações
- Desenvolvimentodetratamentosalternativos
- ImportânciaCDI“menosdefinitivo”
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CDIsubcutâneo
Ultrapassar problemas
• Acesso vascularou acesso ao
VDdifícil ou ausente
• Complicações da implantação
• Infecção comenvolvimento
endocardico
• Insuficiência tricúspide
• Extracção commenor risco
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CDI subcutâneo
Eléctrodo tripolar
Gerador activo
Longevidade esperada 7,3anosMonitorização à distânciaCompatível comRMN80Jenergia máxima
Sem pacingbradicardiaSem pacinganti-taquicardiaPoucos “diagnósticos”
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Implantação totalmente extra-vascularRX=0
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S-ICDPooledAnalysisCohort
EFFORTLESSN=568*
BothStudiesN=13
IDEN=308
TotalPooledN=889
Meanfollow-up22months TotalImplantedN=882
NotImplantedN=7
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S-ICD Pooled ResultsS-ICD and TV-ICD Spontaneous Conversion Efficacy
Spontaneous ShockEfficacy
FirstShock FinalShock inepisodeS-ICDPooledData* 90.1% 98.2%
ALTITUDEFirstShockStudy1 90.3% 99.8%SCD-HeFT2 83%PainFree RxII2 87%MADIT-CRT3 89.8%LESSStudy4 97.3%*ExcludedVT/VFStormevents
1ChaYMetal.HeartRhythm2013;10:702–708.2Swerdlow CDetal.PACE 2007;30:675–700.3Kutyifa V,etal.JCardiovasc Electrophysiol 2013;24:1246-52.4GoldMRetal.Circulation 2002;105:2043-2048.
S-ICDPooledData100%Clinicalconversiontonormalsinus
rhythm
Oftwo “unconverted” episodes• Onespontaneously terminated afterthe5thshock• Intheotherepisode, thedeviceprematurelydeclaredtheepisode ended.Anewepisode was
immediately reinitiated andtheVFwassuccessfully terminated with oneshock
WhenevaluatingTV-ICDstudies1-4,S-ICDwasaseffectiveasTV-ICDintreatingspontaneousarrhythmias
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S-ICD Pooled ResultsMortality Compared to TV-ICD Studies
1BurkeMCetal.PooledAnalysisoftheEFFORTLESSandIDERegistry.JACC April 20th 2015 2MossAJetal.MADITRITStudyNEJM 2012;367;2275-2283.3HealyJSetal.SIMPLEStudyHeartRhythm 2014;LBCT01;LB01-01.
The1.6%annual mortalityratewiththeS-ICDwasdeemed“provocative”bytheauthorsasitislowerthanobservedinTV-ICDstudies.
Study Mortality(At2years)
AverageAge
10Prevention Ischemic NYHA LVEF
S-ICDPooled* 3.2% 50 70% 38% 37.5%class
II-IV 39%
MADITRIT15-7%
HighrateandDelayedTherapy
Arms
63 100% 53% 98%classIIorIII 26%
SIMPLE2 11% 64 70% 63%classIIorIII 32%
S-ICDhada2yearmortalityratethatcomparedfavorablywithmortalityratesinstudieswithTV-ICDs
*Thisanalysiswasnotdesignedorpoweredtoassessmortalityandcareshould betakenasthepopulationinthisanalysismaydifferfromthepatientpopulation inTV-ICDstudies.
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S-ICD Pooled ResultsComplications
Zero endovascularinfectionsorelectrodefailures
1. Peterson PNetal.JAMA.2013;309(19):2025-2034.2. VanReesJBetal.JACC 2011;58:995-10003. Tarakji KG,Wazni OM,Wilkoff BLetal.Europace 2014;16:490-495
Theacutemajorcomplication ratewaslowerwhencomparedtostudieswithTV-ICD,likelybecauseS-ICDdoesn’t require
vascularaccess1,2
Therewerezeroendovascularinfectionsorelectrodefailureswhichcouldbea
factorintheobservedlowmortalityrate3
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CDIsubcutâneo
Choquesinapropriados/Oversensing daondaT
- Dependentesdascaracterísticasbasaisdodoente- Incidênciamáximanoiníciodoseguimento
ChoquesdoCDIconvencional
- Relaçãocomdisfunçãodoelectrodo earritmiasauriculares- Aumentodaincidênciadedisfunçãodoelectrodo earritmiasauricularesaolongo de
seguimento- Maischoques inapropriados alongoprazo
GoldMR,Theuns DA,Knight BPet al. Head-to-headcomparison ofarrhythmiadiscrimination performance ofsubcutaneousandtransvenous ICDarrhythmia detectionalgorithms:theSTARTstudy.JCardiovasc Electrophysiol. 2012Apr;23(4):359-66Kooiman etal.Inappropriate subcutaneous implantablecardioverter-desfibrillator shocksduetoT-waveoversensing canbeprevented:implication formanagement.HeartRhythm2014.PooleJE,GoldMR.Whoshouldreceivethesubcutaneousimplanted defibrillator?: Thesubcutaneous implantablecardioverter defibrillator (ICD)shouldbeconsidered inallICDpatients whodonotrequire pacing.Circ Arrhythm Electrophysiol. 2013Dec;6(6):1236-44
50%
60%
70%
80%
90%
100%
0 1 2 3 4 5 6 7 8 9 10Year
Patie
ntSurvival&
TVLead
Survival
Borleffs-TVleadfailure(n=2,145)Borleffs-All-causeTVleadremovalorcappingKleemann-TVeadfailure(n=990)Altitude-Patientsurvival(n=47,032)
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Propensity matched case(S-ICD)-control (TV-ICD)Study:
i)safety/efficacy– long-term follow-up
ii)cost-efficacyanalysis (aretheinitial implant costs balanced by the long-termeconomic impact of device-related complications?)
*Device-related complication rateswith TV-ICDs arehigher*nosignificant difference ininappropriate shock rates*Significant difference inunit cost of the S-ICD,overall S-ICDcosts maybemitigatedversusTV-ICDover alonger period of follow-up.
Int JCardiol 228(2017)280–285
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SICDhasaclassIrecommendationforpatientsathigherriskofinfection
2017 AHA/ACC/HRS Guideline for Management ofPatients With Ventricular Arrhythmias and the Prevention ofSudden Cardiac Death (online advance
published October 2017)
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S-ICD(até31Agosto2018)
HospitalSantaCruz- n=100- Idade:40,2±16,8anos- Prevençãoprimária:71%- Seguimento:665dias
Porquê apreferência?
Idade 41
Acesso vascular 10
Infecção CDIprévia 7
Disfunção prévia CDI 4
2018 – Estimado 31 dispositivos (aumento 50%)
Indicação n
Miocardiopatiahipertrófica 21
Miocardiopatia isquémica(Fej.<35%) 19
Miocardiopatiadilatada(Fej.<35%) 16
FVventricularidiopática 12
SíndromedeBrugada 8
DisplasiaarritmogénicadoVD 6
Ventrículoesquerdonãocompactado 6
Outrascausas 12
0
5
10
15
20
25
2009201020112012201320142015201620172018Terapêutica apropriada:19in7patients(19%)Tempoaté choque:22±4,6sTerapêutica inapropriada– 16%- (2zonas 6%)
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EstruturalEléctrico
Estrutural
Eléctrico
HOSPITAL SANTA CRUZ – EVOLUÇÃO SICD
Até2014n=37
Até2018n=100
9,7%totalCDIuni(n=163)
17%totalCDIuni(n=157)
S-ICD(até31Agosto2018)
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Experiencia doHStaCruz
• follow-up2.6±1.9years• 6patients(11%)died• Noneduetosuddencardiacdeath• Sixpatients(11%)receivedappropriatetherapies• Allventriculartachycardiaandfibrillationepisodeswereadequately
treated• Ninepatients(17%)hadinappropriateshocks:
– 6withouttiered-therapyvs3withpreviouslyprogrammedtiered-therapy(p=0.001).
– Theyearlyrateofinappropriateshockswas17%/yearwithsinglezonedetectionvs4%/yearwithtiered-therapyprogramming(p=0.007).Single-zonedetectionprogrammingwasanindependentpredictorofinappropriateshockdelivery(HR1.49,IC95%:1.05-18.80,p=0.04).
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Quantos são potenciais candidatos?
Doentes consecutivos seguidos em consulta de CDI“screening” para CDI-SC (ECG com derivações xifóide-V6; manúbrio-V6 e xifóide-manúbrio)“screening tool”
Pelo menos 1 vector apropriado (em pé e deitado) em todos os complexos de ECG 10-20 seg
213(93%)doentes passaram oscreening17(7%)doentes falharam oscreening
Vectorprimário/secundário – onda TgrandeVectoralternativo – onda Rpequena13%detodos vectores medidos comdiscrepância pé/deitado
JCardiovascElectrophysiol,Vol.25,pp.494-499,May2014
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Quem são os candidatos?• Doentes jovens (> 30 kg)
– Elevado tempo de seguimento previsto (risco de complicações maior)– Síndrome Brugada, miocardiopatia hipertrófica– Cardiopatias congénitas operadas sem acesso às cavidades direitas
(Fontan)• Insuficientes renais em HD (elevado risco de infecção dos sistemas
convencionais)• Sobreviventes de FV, sem cardiopatia estrutural• Prevenção primária em geral, desde que não candidatos a CRT
(duração QRS) e sem necessidade de pacing• Doentes não dependentes de pacing que já tiveram infecções de
sistemas convencionais
• (possível implantar em doentes com sistemas de pacing bipolar)
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Limitações• Pacing (taquicardia/bradicardia)• Screening• Gerador ainda grande (difícil de ser utilizado em
crianças < 30 kg)• Duração menor que CDI convencional (vamos
saber com o tempo)
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Motivosparanãoimplantar
• Hábito/resistênciamudança• Medodatécnica(muitocirúrgica)• Receiodequeodoentevenhaanecessitardepacing,CRT
• Receiochoquesinapropriados• Necessidadedetestededesfibrilhação• Preço
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ScorePRAETORIAN
Knops RE, Heart Rhythm (2018)
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Hospital de Santa Cruz
Podemo saplicar oscore?Coil acimadoapêndicexifóide eabaixodomanúbrioTopodogeradornasombracardíaca(2projeções)
![Page 31: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/31.jpg)
Hospital de Santa Cruz
Step1– 30(espessuragorduraabaixoesternobaixa)Step2– x1(geradorposterior)Step3– x1(espessuragorduraabaixogeradorbaixa)
SCORE=30– riscobaixo
![Page 32: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/32.jpg)
• EstáadecorreroensaioPRAETORIANDFT• NofuturoserápossívelimplantarsemDFT?• Nãoéumasoluçãoperfeita...ORXéfeitodepoisdoimplante...
![Page 33: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/33.jpg)
Knops R, J Am Coll Cardiol EP 2017;3:1487–98
![Page 34: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/34.jpg)
![Page 35: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/35.jpg)
Indicações futuras??
ICDindication
CRTIndication
CRT-D
PacingIndication
TV-ICD
ATPforSMVT
TV-ICD
S-ICDunless…
• 1.LBoersma.ICDfromreallifetothefuture:ICDinnovations.ESC2014
![Page 36: CDI Subcutâneo: Vantagens e Resultados · S-ICD Pooled Data* 90.1% 98.2% ALTITUDE First Shock Study 1 90.3% 99.8% SCD-HeFT2 83% PainFree Rx II2 87% MADIT-CRT3 89.8% LESS Study4 97.3%](https://reader033.vdocuments.mx/reader033/viewer/2022053004/5f08b10d7e708231d4234165/html5/thumbnails/36.jpg)
Conclusões• Dispositivossem eléctrodos intracavitários fazem
seguramente partedofuturo dotratamento debradi etaquiarritmias
• Já possuem hoje vantagens indiscutíveissobre sistemas dequedispomos
• Alenta adopção datecnologia é multifactorial• É necessário identificar em cada centro quais os factores
princiapais queestão atornar lenta aadopção doSICD