AVCCriptogénico:Está na altura dealterar as
guidelines?
ClaudiaJorgeUniversityHospitalofSantaMaria
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Cryptogenic strokeremainsamajorchallenge
§ PFO-relatedstrokes,i.e.duetoparadoxicalembolism,havebeenstronglyimplicatedasapossiblecause
1-Hartetal.LancetNeurology20142-Wolfetal.CerebrovascularDis2015
3-Lechatetal.NEJM19884-Kissela,etal,Neurology2012
§ ~25%ofallischemicstrokesare“cryptogenic”1
§ 34-46%ofischemicstrokesoccurbetween18-60years2
§ PFOpresentin40-50%ofcryptogenic strokepatients3
§ YoungandmiddleagedpatientshavecontinuedexposuretoPFO-relatedrecurrencerisk
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Normal appearing atrial septum
Septum Secundum Septum
Primum
Agitated saline study demonstrating right to leftshunting through the PFO
Blood clot passing through the PFO becoming a paradoxical embolism
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
CLOSURETrial2012 PCTrial2013 RESPECTtrial2013
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Multicenter, randomized, open-label
PFOpercutaneousclosure(C)(n=447)
5.5%PFOCvs 6.8%MT,p=0.37
86%effectivePFOclosure3.2%majorvascularcomplications
Medicaltherapy(MT)(n=462)
Recurrentstroke:2.9%closurevs 3.1%MT,riskdifference– 0.13%
PrimaryendpointstrokeorTIA(2years)deathfromanycause (first30days)deathfromneurologiccauses(31daysand2years)
AF:5.7%PFOCvs 0.7%MT,p<0.001
Starflex device(NMTMedical,Boston,MA)2yearsfollow-up
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
PrimaryendpointComposite ofdeathfromanycausenon-fatalstroke,TIAperipheralembolism
Multicenter, randomized, open-label
PFOpercutaneousclosure(C)(n=204)
Medicaltherapy(MT)(n=210)
AF:2.9%PFOCvs 1.0%MT,p=0.16Bleeding:3.9%PFOCvs 5.7%MT,p=0.4
3.4%PFOCvs 5.2%MT
Recurrentstroke:0.5%closurevs 2.4%MT,p=0.14
AMPLATZERPFO(St.JudeMedical,Inc,St.Paul,MN)
4yearsfollowup
AVCCriptogénico:Está na altura dealterar asguidelines?
Multicenter, randomized, open-label
PFOpercutaneousclosure(C)(n=449)
Medicaltherapy(MT)(n=481)
AF:3.0%PFOCvs 1.5%MT,p=0.13
Claudia Jorge, Hospital de Santa Maria
3/9 device group patients did not have adevice at timeof endpoint stroke
72.7% risk reduction of stroke in favor of device
Bleeding:1.6%PFOCvs 1.9%MT,p=0.8
Recurrentstroke1.8%PFOCvs3.3%TM,p=0.08
AMPLATZERPFO(St.JudeMedical,Inc,St.Paul,MN)
2.5yearsfollow-up
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
RESPECT protocol required follow-up until Food and Drug Administration (FDA)regulatory decision (data lock, August 2015)
FDA Advisory Panel in May 2016 requested a final analysis of long-termoutcomes using updated data (data lock, May 2016)
In the ITT population, early and medium-term results in in RESPECT showed pointestimates in favor of closure but did notreach statistical significance
Loweventratesincreaseimportanceoflonger follow-up
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
IntheRESPECTtrial,forpatientswithcryptogenicstrokeandPFO,closurewiththeAMPLATZERPFOOccluder isanappropriatetreatmentoptionthatreducestheriskof
recurrentstroke,with very low risk
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
RESPECTTRIALAugust 14,2015,
Primary events18PFOClosure vs 24MTevents
Dropout rate18.2%PFOClosure vs 30.1%MT
Atrial fibrillation4.2%PFOClosure vs 1.9%MT
DVTor pulmonary embolism18PFOClosure vs 3MT
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
GORE®HELEX®Septal Occluder /GORE®Septal Occluder + antiplatelet medical vsantiplatelet medicalmanagement alone
Population:PFOand cryptogenic stroke or imaging-confirmed TIA
https://clinicaltrials.gov/ct2/show/NCT00738894
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
Primary objective
assess whether chronic anticoagulation on the one hand and endovasculartreatment on the other hand are superior to chronic antiplatelet therapy
https://clinicaltrials.gov/ct2/show/NCT00562289?term=close+pfo&rank=2
AVCCriptogénico:Está na altura dealterar asguidelines?
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
“Forthosewhobelieve,noexplanationisnecessary;forthosewhodon't,noexplanationispossible.“JosephDunninger
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?
AVCCriptogénico:
Está na altura devoltar a alterar asguidelines!
RecentpublicationsandresearchonCTO Claudia Jorge, Hospital de Santa Maria
Obrigada!
• Nunca em doentes assintom.ticos !• •Encerramento em alguns doentes comAVCcriptog.nico
• •Melhor selec..odosdoentes criptog.nico (estudocompleto doAVC)e
• identifica..odecaracter.sticas derisco• •Discuss.o benef.cio /risco individualizada• •Aguardar novos estudos eresultados defollow-upmais longo dosj.
• existentes• •Novos dispositivos (endotelizáveis /biodegrad.veis)
Claudia Jorge, Hospital de Santa MariaAVCCriptogénico:Está na altura dealterar asguidelines?