cdi subcutâneo: vantagens e resultados · s-icd pooled data* 90.1% 98.2% altitude first shock...

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FRANCISCO BELLO MORGADO HOSPITAL DE SANTA CRUZ, HOSPITAL DOS L USÍADAS L ISBOA IX Congresso – Novas fronteiras em medicina Cardiovascular CDI Subcutâneo: Vantagens e Resultados

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Page 1: 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%

FRANCISCO BELLO MORGADOHOSPITAL DE SANTA CRUZ,HOSPITAL DOS LUSÍADAS

LISBOA

IXCongresso– NovasfronteirasemmedicinaCardiovascular

CDISubcutâneo:VantagenseResultados

Page 2: 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%

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

Page 3: 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%

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%

Page 4: 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%

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:

Page 5: 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%
Page 6: 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%

Growing Need for Managing Leads5% Estimated Annual Incidence

Page 7: 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%

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.

Page 8: 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%

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.

Page 9: 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%

LimitaçõesCDI/Pacing Transvenosos

CDIePMconvencionaléumcompromissoparaavida

- Extraçãoprocedimentoderiscoconsiderável- Impossíveldescontinuarmesmoquesemodifiquemasindicações

- Desenvolvimentodetratamentosalternativos

- ImportânciaCDI“menosdefinitivo”

Page 10: 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%

CDIsubcutâneo

Ultrapassar problemas

• Acesso vascularou acesso ao

VDdifícil ou ausente

• Complicações da implantação

• Infecção comenvolvimento

endocardico

• Insuficiência tricúspide

• Extracção commenor risco

Page 11: 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%

CDI subcutâneo

Eléctrodo tripolar

Gerador activo

Longevidade esperada 7,3anosMonitorização à distânciaCompatível comRMN80Jenergia máxima

Sem pacingbradicardiaSem pacinganti-taquicardiaPoucos “diagnósticos”

Page 12: 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%

Implantação totalmente extra-vascularRX=0

Page 13: 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%

S-ICDPooledAnalysisCohort

EFFORTLESSN=568*

BothStudiesN=13

IDEN=308

TotalPooledN=889

Meanfollow-up22months TotalImplantedN=882

NotImplantedN=7

Page 14: 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%

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

Page 15: 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%

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)

Page 18: 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%

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

Page 19: 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%
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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)

Page 21: 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%

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)

Page 23: 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%
Page 24: 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%

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).

Page 25: 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%

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

Page 26: 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%

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)

Page 27: 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%

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)

Page 28: 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%

Motivosparanãoimplantar

• Hábito/resistênciamudança• Medodatécnica(muitocirúrgica)• Receiodequeodoentevenhaanecessitardepacing,CRT

• Receiochoquesinapropriados• Necessidadedetestededesfibrilhação• Preço

Page 29: 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%

ScorePRAETORIAN

Knops RE, Heart Rhythm (2018)

Page 30: 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%

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%

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%

• EstáadecorreroensaioPRAETORIANDFT• NofuturoserápossívelimplantarsemDFT?• Nãoéumasoluçãoperfeita...ORXéfeitodepoisdoimplante...

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Knops R, J Am Coll Cardiol EP 2017;3:1487–98

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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%

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