Cierre de Orejuela Izquierda.

Juan Carlos Rama Merchán MD, PhD
FIBRILACIÓN AURICULAR
• 
FAeslaarritmiamásfrecuente
• 
FAafectaal0.5%delapoblacióngeneralyal3-5%delapoblación>65años
• 
FAesresponsabledel15-20%delosinfartoscerebralesisquémicos
REC. 2014; 67(4): 259-269
FIBRILACIÓN AURICULAR: STROKE
Marini et al, Stroke 2005
FIBRILACIÓN AURICULAR: STROKE
*Severedisabilitywasdefinedasascoreof≤40inthemodifiedBarthelIndex
Lin et al, Stroke 1996
PREVENCIÓN
Reducciónrela\variesgoinfartocerebral
Meta-análisis:29estudios,28044pacientes,seguimientomedio1.5años
70
60
50
40
30
20
10
0
WARFARINAvsCONTROL
AASvsCONTROL
WARFARINAvsAAS
Ann Intern Med. 2007; 146:857-86
WARFARINA / ACENOCUMAROL
•  Contraindicadosenel14-47%delospacientes
•  Hemorragiaintracraneal1.8%enpacientes>75años
•  Tasadeabandono38%/año(sangrados,interacciones,controles,dieta…)
Circula\on.2011;123:2363-2372
WARFARINA / ACENOCUMAROL
ALTERNATIVAS
NACOs
OCLUSIÓNOREJUELA
NACOs
Ruffetal.Lancet,2013
RateofMajorBleedinginNOACTrials
4
MajorBleedingRate(%/year)
3.3
3.6
3.4
3.1
3
2
2.1
NOAC
Warfarin
1
0
1Connolly,
3.6
RE-LY 1
ROCKETAF 2
ARISTOTLE 3
(Dabigatran)(Rivaroxaban)(Apixaban)
S. NEJM 2009; 361:1139-1151 – 2 yrs f-up (Corrected) 150 mg 2Patel, M. NEJM 2011; 365:883-891 – 1.9 yrs f-up, ITT 3Granger, C NEJM 2011; 365:981-992 – 1.8 yrs f-up
NACOs
CARTAEMAYAEMPS*
• 
Losepisodiosdesangradomayor,algunosdeellosmortales,noselimitanalos
antagonistasdelavitaminaKsinoquetambiénconsVtuyenunriesgosignificaVvopara
losnuevosACOs
• 
Ademáslasno\ficacionespost-comercializaciónindicanquenotodoslosprescriptores
Venensuficientementeencuentalainformacióndecadaunodeestosmedicamentos
enloquerespectaalmanejodelosriesgodesangrado
*CartarevisadayaprobadaporlaAgenciaEuropeayEspañoladeMedicamentosyProductosSanitarios,2013
NACOs & IRC
Dabigatran
Rivaroxaban
Apixaban
eGFR>60ml/min
110and150mgbid
20mg
5or2.5mgbid
StageIII
eGFR50-59ml/min
eGFR30-49ml/min
110and150mgbid
110and150mgbid
20mg
15mg
5or2.5mgbid
5or2.5mgbid
StageIV
eGFR15-30ml/min
Nodata
15mg
2.5mgbid
StageVand/orESRD
eGFR<15ml/min
Nodata
Nodata
Nodata
Hemodyalisis
Nodata
Nodata
Nodata
“Nodata”indicatesnodatafromsuitablypoweredrandomizedtrials
EuropeanHeartJournal,2012
NACOs & HIC
Avoidanceoflong-termanVcoagulaVonwithwarfarin
asatreatmentfornonvalvularatrialfibrilla\on
isprobablyrecommendedaqerwarfarin-associated
spontaneouslobarICHbecauseoftherela\velyhigh
riskofrecurrence(ClassIIa;LevelofEvidenceB).
Theusefulnessofdabigatran,rivaroxaban,orapixaban
inpa\entswithatrialfibrilla\onandpastICH
todecreasetheriskofrecurrenceisuncertain(Class
IIb;LevelofEvidenceC).
CIERRE DE OREJUELA IZQUIERDA
CIERRE OREJUELA IZQUIERDA
Heart1999;82:547-54
9MESES
1MES
2DIAS
INMEDIATO
CIERRE DE OREJUELA
CIERRE DE OREJUELA
“Sin” contraindicación para ACO
“Con” contraindicación para ACO
PROTECT AF
•  First randomized trial comparing LAA occlusion to warfarin
•  707 subjects with nonvalvular AF and CHADS2 score > 1
• 
59 centers in the US
• 
Follow-up with TEE at 45 days, six months and one year
• 
87% were able to stop warfarin therapy at 45-day follow-up
•  Primary Efficacy Endpoint
• 
All stroke (ischemic and hemorrhagic), CV or unexplained death, systemic embolism
•  Primary Safety Endpoint
• 
Device embolization requiring retrieval
• 
Pericardial effusion requiring drainage
• 
Cranial, GI or other significant bleed
Lancet 2009;374:534-42
PROTECT AF
Stroke, Death, Systemic embolism
Cierre de orejuela izquierda no inferior a Warfarina
PROTECT AF (4 años)
Cierre de orejuela izquierda superior a Warfarina
¡¡ Reduce mortalidad !!
JAMA.2014;312:1988-1998
PREVAIL
•  SecondrandomizedtrialcomparingLAAclosuretowarfarin
•  407randomizedpa\entsfrom41U.S.centers
•  IntendedtoconfirmresultsofPROTECTAFanddemonstrateimprovedacutesafetyprofile
•  Inclusionofnewcentersandnewoperatorstodocumentthatenhancementstothe
trainingprogramareeffec\ve
•  Threeco-primaryendpoints:
•  Rateofdeath,ischemicstroke,systemicembolismandcomplica\ons,requiringmajor
cardiovascularorendovascularinterven\onatsevendayspostimplantordischarge
•  Comparisonofthecompositeofstroke,systemicembolismandcardiovascular/unexplained
deathat18months
•  Comparisonofischemicstrokeandsystemicembolismoccurringgreaterthansevendays
postrandomiza\on(followedto18months)
JACC2014;64:1-12
PREVAIL
18 months
JACC2014;64:1-12
META-ANÁLISIS
2406 pacientes
Holmes et al. JACC. 2015
META-ANÁLISIS
Holmes et al. JACC. 2015
CIERRE DE OREJUELA
“Sin” contraindicación para ACO
“Con” contraindicación para ACO
Multicenter experience
§  Retrospec\ve,single-armmul\centerclinicalevalua\onoftheACPforstroke
preven\oninatrialfibrilla\onpa\ents
TotalPaVents
NumberofCenters
1,047
22
PaVentyearsfollow-up
1,349
CHA2DS2-VASc(Mean)
4.5
HAS-BLED(Mean)
3.1
Age(Mean)
74.9
PriorStroke/TIA
37%
PreviousMajorBleeding
47%
TakingOACatVmeofimplant
29.5%
ConcomitantprocedurestoLAAO
20.6%
Source:Tzikas,etal.(2014,May).MulIcenterexperiencewiththeAmplatzerCardiacPlug(ACP).PresentedatEuroPCR2014,Paris.Slidesavailableat
hsp://www.pcronline.com/Lectures/2014/Leq-atrial-appendage-occlusion-for-stroke-preven\on-in-atrial-fibrilla\on-mul\centre-experience-with-the-Amplatzer-cardiac-plug
Multicenter experience
Effectiveness in Stroke
Reduction vs. Estimated
6%
Effectiveness in Bleeding
Reduction vs. Estimated
6%
5,62%
-59%
4%
2%
5,34%
-61%
4%
2%
2,30%
0%
2,08%
0%
Estimated based on CHA2DS2-VASc Score
Estimated based on HAS-BLED Score
Observed rate in Study
Observed rate in Study
Total Patients
Total Patient
Years
CHA2DS2-VASc
Score
Total Patients
Total Patient
Years
HAS-BLED Score
1001
1349
4.43
1001
1349
3.12
Estimated Stroke Rate per
CHA2DS2-VASc
Actual Annual Stroke Rate
(N strokes + TIA)
Estimated Bleeding Rate
per HAS-BLED
Actual Annual Bleeding
Rate (N major bleeds)
5.62%
2.30% (31)
5.34%
2.08% (28)
Source:Tzikas,etal.(2014,May).MulIcenterexperiencewiththeAmplatzerCardiacPlug(ACP).PresentedatEuroPCR2014,Paris.Slidesavailableat
hsp://www.pcronline.com/Lectures/2014/Leq-atrial-appendage-occlusion-for-stroke-preven\on-in-atrial-fibrilla\on-mul\centre-experience-with-the-Amplatzer-cardiac-plug
Coste eficacia
Calidad de vida
JAmCollCardiol.2013
ESC Guidelines
“Interven\onalpercutaneousLAAclosuremaybeconsideredin
pa\entswithveryhighstrokeriskandcontraindica\onsforlong-term
an\coagula\on.”
RecommendaVonsforLAAclosure/occlusion/excision
RecommendaVons
Class
Level
ClassesofrecommendaVon
ClassIIb
Interven\onalpercutaneousLAA
closuremaybeconsideredin
pa\entswithveryhighstrokerisk
andcontraindica\onsforlong-term
an\coagula\on
IIb
B
Usefulness/efficacyisless
wellestablishedby
evidence/opinion
Maybe
considered
Levelsofevidence
Levelof
evidenceB
Dataderivedfromasinglerandomized
clinicaltrialorlargenon-randomized
studies
Source:Camm,A.,Lip,G.,DeCaterina,R.,Savelieva,I.,Atar,D.,Hohnloser,S.H.,.ESCCommiseeforPrac\ceGuidelines(CPG).(2012).2012focusedupdateoftheESCGuidelinesforthe
managementofatrialfibrilla\on.EuropeanHeartJournal,33,2719-2747.Accessedonlineat:
Perpectivas futuras
Take-Home message
- Contraindicación pa
ra ACO
es o alto
v
ra
g
s
e
n
io
c
a
c
li
p
m
o
-C
on ACO
riesgo de sangrado c
ACV hemorrágico
xtenso (< 6 m)
e
o
ic
m
é
u
q
is
V
C
A
• 
vo recurrente
•  Sangrado digesti
is
•  IRC terminal-Diális
zada (Child B-C)
n
a
v
a
a
ti
a
p
to
a
p
e
H
• 
• 
Cruz-GonzálezI,Rama-MerchanJC.Left atrial appendage closure devices for cardiovascular
risk reduction in atrial fibrillation patients. Research Reports in Clinical Cardiology, 2015