Will Cerebral Emboli Protection Will Cerebral Emboli Protection Devices Reduce Stroke After TAVRDevices Reduce Stroke After TAVR
E Murat Tuzcu, MDE Murat Tuzcu, MDCleveland ClinicCleveland Clinic
• Murat TuzcuMurat Tuzcu• No financial disclosuresNo financial disclosures• Member of PARTNER Trial Member of PARTNER Trial executive executive
committeecommittee
Major Stroke (n=15)Major Stroke (n=15)No Major Stroke (n=164)No Major Stroke (n=164)
Mor
talit
y (%
)M
orta
lity
(%)
MonthsMonths
p (log rank) <0.0001p (log rank) <0.0001
27.7%27.7%
66.7%66.7%
PARTNER–B: Impact of Major Stroke on Survival
100100
8080
6060
4040
2020
0000 66 1212 1818 2424
Stro
ke (%
)S
troke
(%)
Months Post ProcedureMonths Post Procedure
Stroke after TAVR and AVRStroke after TAVR and AVR
3.2%3.2%6.06.0%%
4.9%4.9%7.77.7%%
HR HR [95% CI] =[95% CI] =1.22 [0.67, 2.23]1.22 [0.67, 2.23]
p (log rank) = 0.517p (log rank) = 0.517
Numbers at RiskTAVR 348 287 249 224 162 65 28AVR 351 246 230 211 160 62 31
30 Day Stroke Rate30 Day Stroke RateTAVR – 4.6%TAVR – 4.6%
AVR – 2.4% AVR – 2.4%
7070
6060
5050
4040
3030
2020
1010
0000 66 1212 1818 2424 3030 3636
TAVRTAVRAVRAVR
PARTNER-A: Timing of Neurological EventsPARTNER-A: Timing of Neurological Events
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
AV
RA
VR
TAV
RTA
VR
31-36431-36411-3011-30 >730>730365-730365-730
nn
0-20-2 3-53-5 6-106-10ICU stay (d)ICU stay (d)
Timing of Neurological Event After TAVR Timing of Neurological Event After TAVR
Tay et al, J Am Coll Cardiol Intv 2011;4:1290 –7Tay et al, J Am Coll Cardiol Intv 2011;4:1290 –7
HemorrhagicHemorrhagicTIATIAIschemicIschemic
1414
1212
1010
88
66
44
22
00
Num
ber o
f Pat
ient
sN
umbe
r of P
atie
nts
11 2-302-30 31-6031-60 61-9061-90 91-12091-120 >120>120DaysDays
Lost to follow-upLost to follow-up 00 00 44 44 55 1010DeadDead 66 2323 2828 3232 3636 4545AliveAlive 247247 230230 221221 217217 212212 198198
Silent Cerebral Embolism after TAVRSilent Cerebral Embolism after TAVR
Ghanem et al JACC Ghanem et al JACC 2010;55:1427-322010;55:1427-32
68% 69% 73%
84%
68%
Percentage of Patients (%)
Rodes-Cabau JACC 2011
(n=60)
Astarci EJCTS 2011
(n=80)
Ghanem JACC 2010
(n=30)
Rodes-Cabau JACC 2011
(n=25)
Rodes-Cabau JACC 2011
(n=32)
Diffusion Weighted MRI Diffusion Weighted MRI
Silent Cerebral Embolism after TAVRSilent Cerebral Embolism after TAVR
HIT
SH
ITS
Adapted from Szeto et al, J CAdapted from Szeto et al, J Card Surg 2011;26:348-354ard Surg 2011;26:348-354
Timing of Emboli: TCDTiming of Emboli: TCD
Edwards SAPIEN valveEdwards SAPIEN valveN=28N=28
Wire inWire inArchArch
BAVBAV ValveValveInsertionInsertion
ValveValveDeployedDeployed
140140
120120
100100
8080
6060
4040
2020
00
TFTFTATA
Timing of Emboli: TCDTiming of Emboli: TCD
Adapted from Kahlert, AHA 2010Adapted from Kahlert, AHA 2010
Medtronic CoreVavleMedtronic CoreVavleEdwards SAPIEN-TFEdwards SAPIEN-TFEdwards SAPIEN-TAEdwards SAPIEN-TA
700700
600600
500500
400400
300300
200200
100100
00ValveValve
PassagePassageStiffStiffWireWire
BAVBAVBalloonBalloon
BAVBAV DeliveryDeliverySystemSystem
PositioningPositioning ImplantImplant TotalTotal
HIT
SH
ITS
Cerebral MRI Studies Cerebral MRI StudiesStudyStudy
Kahlert et al.Kahlert et al.Circulation 2010Circulation 2010
Ghanem et al.Ghanem et al.JACC 2010JACC 2010
Rodés-Cabau et al.Rodés-Cabau et al.JACC 2011JACC 2011
Fairbairn et al.Fairbairn et al.Heart 2011Heart 2011
Arnold et al.Arnold et al.JACC Int 2010JACC Int 2010
nn
3232
2222
6060
3131
2525
Valve typeValve type
ES (n=22)ES (n=22)CV (n=10)CV (n=10)
CVCV
ESES
CVCV
ESES
ApproachApproach
TFTF
TFTF
TF (n=29)TF (n=29)TA (n=31)TA (n=31)
TFTF
TATA
Ischemic Ischemic defectsdefects
ES: 86%ES: 86%CV: 80%CV: 80%
73%73%
TF: 66%TF: 66%TA: 71%TA: 71%
77%77%
68%68%
Median number of Median number of lesionslesions
ES: 4 (2.1-6.0)ES: 4 (2.1-6.0)CV: 2.6 (0.3-4.9)CV: 2.6 (0.3-4.9)
2.5 (1.0-5.5)2.5 (1.0-5.5)
TF: 3 (1-7)TF: 3 (1-7)TA: 4 (2-9)TA: 4 (2-9)
2 (1-5)2 (1-5)
NANA
ES : Edward Sapien CV: CoreValveES : Edward Sapien CV: CoreValve Adapted from Josep Rodés-CabauAdapted from Josep Rodés-Cabau
MRI Findings - Cognitive/Neurological Status
StudyStudy
Kahlert et al.Kahlert et al.Circulation 2010Circulation 2010
Ghanem et al.Ghanem et al.JACC 2010JACC 2010
Rodés-Cabau et al.Rodés-Cabau et al.JACC 2011JACC 2011
Fairbairn et al.Fairbairn et al.Heart 2011Heart 2011
Arnold et al.Arnold et al.JACC: Cardio JACC: Cardio Interv 2010Interv 2010
Cognitive/Neurological Cognitive/Neurological statusstatus
NIHSS, MMSE, mRSNIHSS, MMSE, mRS
NIHSSNIHSS
NIHSS, MMSENIHSS, MMSE
NIHSSNIHSS
Standardized clinical Standardized clinical assessmentassessment
ResultsResults
No changeNo change
Neurological impairment: 3 Neurological impairment: 3 (10%)(10%)
No changeNo change
No changeNo change
Neurological impairment: 5 Neurological impairment: 5 (20%)(20%)
StrokeStroke
00%%
3.6%3.6%
3.3%3.3%
6.0%6.0%
4.0%4.0%
Adapted from Josep Rodés-CabauAdapted from Josep Rodés-Cabau
Predictors of DefectsStudyStudy
Kahlert et al.Kahlert et al.Circulation 2010Circulation 2010
Ghanem et al.Ghanem et al.JACC 2010JACC 2010
Rodés-Cabau et Rodés-Cabau et al.al.JACC 2011JACC 2011
Fairbairn et al.Fairbairn et al.Heart 2011Heart 2011
Arnold et al.Arnold et al.JACC: Cardio JACC: Cardio Interv 2010Interv 2010
UnivariateUnivariate
Hyperlipidemia Hyperlipidemia Renal dysfunctionRenal dysfunctionLower aortic atheroma thicknessLower aortic atheroma thicknessPorcelain aortaPorcelain aortaIncreased left atrial appendage velocity Increased left atrial appendage velocity Reduced aortic valve areaReduced aortic valve area
Cerebrovascular diseaseCerebrovascular diseasePeripheral artery diseasePeripheral artery diseaseAortic atheromaAortic atheroma
Male genderMale genderCoronary artery disease Coronary artery disease Higher transvalvular aortic gradientHigher transvalvular aortic gradient
AgeAgeFluoroscopy timeFluoroscopy timeCatheterisation timeCatheterisation timeArch and descending aortic atheromaArch and descending aortic atheroma
--
MultivariateMultivariate
--
--
--
Age, Aortic arch Age, Aortic arch atheromaatheroma
--
Potential Variables Impacting of Stroke RiskPotential Variables Impacting of Stroke Risk
• Patient variablesPatient variables– Aortic atheromaAortic atheroma– AF (old and new)AF (old and new)– Carotid Carotid stenosisstenosis
• Procedural variablesProcedural variables– Device manipulation in archDevice manipulation in arch– Crossing the native valveCrossing the native valve– Deployment of the prosthesisDeployment of the prosthesis– Postdilation of the valvePostdilation of the valve– Access related Access related
(TA/TAo/subclavian/carotid)(TA/TAo/subclavian/carotid)
• Device related variablesDevice related variables– Stasis behind the valveStasis behind the valve– Stent or valveStent or valve– Self expanding versus balloon Self expanding versus balloon
expandingexpanding
• Post procedural variablesPost procedural variables– Antiplatelet therapy Antiplatelet therapy– Anticoagulation therapy Anticoagulation therapy– Use of protamineUse of protamine– Bridging of anticoagulationBridging of anticoagulation
• Operator Experience Operator Experience
Cerebral Protection Cerebral Protection Devices and Post TAVR StrokeDevices and Post TAVR Stroke
• There is clear evidence that embolization There is clear evidence that embolization occur at the various stages of TAVR.occur at the various stages of TAVR.
• Cerebral protection devices may very well Cerebral protection devices may very well prevent the emboli reaching the brain.prevent the emboli reaching the brain.
• However the risk associated with the use of However the risk associated with the use of these devices are unknown.these devices are unknown.
• The hypothesis “Cerebral emboli protection The hypothesis “Cerebral emboli protection devices will reduce incidence of stroke after devices will reduce incidence of stroke after TAVR” should be tested in a RCT.TAVR” should be tested in a RCT.
When We See it Coming – When We See it Coming – What do we do in US? What do we do in US?
RICA EPDRICA EPD LLICA EPDICA EPD
LLSSCA BalloonCA Balloon
RSCA BalloonRSCA Balloon
6F/45 Shuttle6F/45 Shuttleww RSCA balloon RSCA balloon
6F/80 Shuttle6F/80 Shuttleww RICA Filter RICA Filter
6F/80 Shuttle6F/80 Shuttleww LICA Filter LICA Filter
5F RFV sheath5F RFV sheath
8F IMA Guide w8F IMA Guide wCrossover wireCrossover wire
5F LFV sheath5F LFV sheathww TPM TPM
23F SAPIEN23F SAPIENDelivery sheathDelivery sheath 6F/45 Shuttle6F/45 Shuttle
ww LSCA balloon LSCA balloon
How to Accomplish This – Just Work Hard!How to Accomplish This – Just Work Hard!