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

TAVR Related Cerebral Embolism TAVR Related Cerebral Embolism

TAVR Related Captured EmboliTAVR Related Captured Emboli

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

Sources of EmbolismSources of Embolism

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.

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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

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