update on update on transcathetertranscatheter aortic...
TRANSCRIPT
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Update on Update on TranscatheterTranscatheter
Aortic Valve ReplacementAortic Valve Replacement
VinodVinod H. H. ThouraniThourani, MD, MD
Associate Professor of Cardiothoracic SurgeryAssociate Professor of Cardiothoracic Surgery
Associate Director, Structural Heart CenterAssociate Director, Structural Heart Center
Associate Director, CTS Clinical Research UnitAssociate Director, CTS Clinical Research Unit
Associate Director, CT Surgery Residency ProgramAssociate Director, CT Surgery Residency Program
Emory University School of MedicineEmory University School of Medicine
American Association for Thoracic SurgeryAmerican Association for Thoracic Surgery
April 28, 2012April 28, 2012EMORY
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• During the past 12 months, I have received research grants,
advisory boards, consultation fees/honoraria, and/or travel
expenses from:
– Edwards LifeSciences: Emory Co-PI, National Steering and Publications
Committee
– St Jude Medical
EMORY
Disclosures
– St Jude Medical
– DirectFlow
– Sorin Medical
– Co-Founder and IP (via Emory University): Apica Cardiovascular
• Some of the products are investigational and/or not FDA-
approved or available for sale in the US (Corevalve, Sapien non-
TF, DirectFlow, Portico, Apica). Some products have only been
tested in non-humans
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Transcatheter Aortic Devices
• Current-
– Edwards Sapien
– Medtronic Corevalve
• Future-
– St. Jude Portico
– Sadra
– Direct Flow
– Symetis
– Medtronic Engager (Ventor)
– JenaValve
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EMORY
TAVR: Transfemoral (TF) and
Transapical (TA)
TransfemoralTransfemoral TransapicalTransapical
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4885051400
59390 61000
50000
60000
70000
TAVI SAVR
# of procedures
Number of T-AVR and S-AVR in Europe
6093510
900012000
48850
0
10000
20000
30000
40000
50000
1 2 3 42007 2008 2009 2010
# of procedures
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EMORYEMORY
Tests to Assist in Decision MakingTests to Assist in Decision Making
n TTE/TEE (3D echo beneficial in some)
n Determine accurate annulus sizing
nn Cardiac Catheterization within past 6 monthsCardiac Catheterization within past 6 months
nn Iliac vessel angiogramIliac vessel angiogram
CT SCANCT SCANnn CT SCANCT SCAN
nn Chest/Chest/abdabd/pelvis/through the mid thigh with 1.5 mm /pelvis/through the mid thigh with 1.5 mm
cuts and 3D cuts and 3D reconstructionreconstruction
nn Without contrast in those with Without contrast in those with creatininecreatinine > 1.5> 1.5
nn Evaluate the ascending aorta for calcificationEvaluate the ascending aorta for calcification
nn Evaluate femoral and iliac arteries for Evaluate femoral and iliac arteries for
calcificationcalcification
nn Pulmonary function testsPulmonary function tests
nn Carotid duplexCarotid duplex
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• Annular diameter: 18-21mm
• Use 23mm Valve
EMORYEMORY
TTE/TEE MeasurementsTTE/TEE Measurements
• Annular diameter: >21-
24.5mm
•Use 26mm Valve
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EMORY
CT Imaging for TAVR
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EMORYEMORY
Potential Transapical PatientPotential Transapical Patient
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EMORY
CT Imaging for TAVR
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EMORYEMORY
Our First Patient at Emory: 2007Our First Patient at Emory: 2007
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EMORYEMORY
The Patient Population with AS
74 yo primary AVR 90 yo redo AVR
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• Background
• Preoperative Assessment
• Intraoperative Technical Aspects
• Postoperative Complications
EMORY
Outline
• Postoperative Complications
• Outcomes
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Innovative Catheter Tip Design
Sapien XT/Novaflex
RF3New shorter
softer tip
New balloon
Processing for
Smooth transition
To valve NF - Original
RF3
NF - Original
NF - Improved
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TAVI Approaches
Transfemoral
+++• Less invasive
• Percutaneous
• Local anesthesia
- - -• Delivery more difficult
than TA
• More stroke?
• Delivery profile matters
• Not for all patients
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Access/Closure
Preclosure with 2-3 Proglides
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EMORY
Retroperitoneal Iliac Exposure
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EMORY
Transapical AVR
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EMORY
Transapical AVR
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EMORY
Transapical AVR
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CoreValve ReValving®
System
• Self Expandable•
Available in Europe: > 3000 cases
Medtronic CoreValve
• Self Expandable• Nitinol Frame• Porcine Pericardium• Size: 26 and 29 mm• CE Mark in Europe• 18F sheath• NOT retrievable• Porcine
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CoreValve Bioprosthesis: Two Sizes
“Small” “Large”
40 mm 43 mmOutflow
55 mm 53 mmHeight
26 mm 29 mmInflow
24 mm22 mmConstrained
20 mm to
23 mm
23 mm to 27
mm
Accomodates
Annulus of:
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CoreValve Delivery Step 1
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CoreValve Delivery Step 2
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CoreValve Delivery Step 3
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CoreValve Delivery Completed
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Procedural Success. Corevalve.Percent of Patients (%)
83.1%
96.8% 98.1% 97.0% 98.0% 98.7% 99.0% 98.1%
40%
60%
80%
100%
*
Procedure Success is not defined consistently across all studies.* Technical Success is reported here.
1. Medtronic Data on File. COR 2006-02: 18 Fr Safety & Efficacy Study Re-Analysis, August 14, 2009. 2. Meredith IT. A Snapshot from the Ongoing Australia-New Zealand Medtronic CoreValve® Registry. Transcatheter Cardiovascular Therapeutics 2009,
September 21-25, 2009. San Francisco, CA.3. Avanzas P, Munoz-Garcia AJ, Segura J, et al. Percutaneous implantation of the CoreValve® self-expanding aortic valve prosthesis in patients with severe
aortic stenosis: early experience in Spain. Rev Esp Cardiol. 2010;63:141-148.4. Eltchaninoff. French Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.5. Bosmans. Belgian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.6. Zahn. German Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.7. Ludman. UK Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
8. Petronio. Italian Registry, TAVI Facts, Figures and National Registries. EuroPCR 2010, Paris, France.
N = 126 N = 62 N = 108 N = 78 N = 141 N = 588 N = 460 N = 772
Percent of Patients (%)
0%
20%
18 Fr S&E1 ANZ2 Spain3 French4 Belgian5 Germany6 UK7 Italian8
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CoreValve Pacemaker Rates
(high, but vary by center)
35.2%
26.9%
42.5%
26%
31.3%
40%
30%
40%
50%
60%
Percent of Patients (%)
Weighted Average 28.5%
35.2%
26.9%
42.5%
26%
31.3%
40%
30%
40%
50%
60%
Percent of Patients (%)
Weighted Average 28.5%
35.2%
26.9%
42.5%
26%
31.3%
40%
30%
40%
50%
60%
Percent of Patients (%)
Weighted Average 28.5%
26.9%23%
26%
18.5%
0%
10%
20%
30%
18 Fr S&E1
N = 125 ANZ2
N = 118 Spain3
N = 108French4
N = 66Belgian5
N = 119German6
N = 588UK7
N = 460Italian8
N = 772
Percent of Patients (%)
26.9%23%
26%
18.5%
0%
10%
20%
30%
18 Fr S&E1
N = 125 ANZ2
N = 118 Spain3
N = 108French4
N = 66Belgian5
N = 119German6
N = 588UK7
N = 460Italian8
N = 772
Percent of Patients (%)
26.9%23%
26%
18.5%
0%
10%
20%
30%
18 Fr S&E1
N = 125 ANZ2
N = 118 Spain3
N = 108French4
N = 66Belgian5
N = 119German6
N = 588UK7
N = 460Italian8
N = 772
Percent of Patients (%)
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CoreValve US Pivotal Trial Design
Medtronic CoreValve Medtronic CoreValve U.S. Pivotal TrialU.S. Pivotal Trial
“Extreme Risk”“Extreme Risk”Patient GroupPatient Group
“High Risk”“High Risk”Patient GroupPatient Group
40 Sites in the US40 Sites in the US
National CoNational Co--PIs:PIs:
Jeff Jeff PopmaPopma, MD, MD
David Adams, MDDavid Adams, MD
Patient GroupPatient Group
IliofemoralIliofemoral access?access?
CoreValveCoreValveObservationalObservational
CoreValveCoreValveSingle ArmSingle Arm
Up to 100Up to 100
Patient GroupPatient Group
Randomization 1:1Randomization 1:1
CoreValveCoreValve SAVRSAVR
395*395* 395395
790790
Yes 487Yes 487
NoNo
*Includes iliofemoral and alternative access patientsNote: 3 roll-in patients per study site equates to a maximum of 1,497 patients enrolled
Alternative AccessAlternative Access
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EMORY
Complications
• Severe transvalvular or paravalvular AR
• Major bleeding
• Aortic rupture or dissection
• Coronary artery obstruction• Coronary artery obstruction
• Severe MR
• Arrhythmias/Bradycardia
• Pericardial effusion
• VSD
• Valve misdeployment
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• Successful CoreValveimplantation
• Collapsed on ICU on 1st POP day
H.S., 83 y, male
EMORY
Aortic Dissection
POP day
• Resuscitationunsuccessful
• Autopsy performed
• Aortic wall perforation
Courtesy of R. Langer, et al, Munich
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EMORYEMORY
Ventricular DeploymentVentricular Deployment
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EMORYEMORY
Valve Positioning SoftwareValve Positioning Software
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EMORYEMORY
Left Main OcclusionLeft Main Occlusion
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EMORYEMORY
LV BleedingLV Bleeding
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Transapical Closure Devices
“In Development”
• Apica
• Entourage CardioClose• Entourage CardioClose
• MID Permaseal
• Novogate
• SpirX Closure
• Cardiapex
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EMORYEMORY
Iliac RuptureIliac Rupture
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EMORYEMORY
All Cause All Cause Mortality: Mortality:
TF TF vsvs Med Med TxTx (PARTNER 1B)(PARTNER 1B)Freedom from Death (%) Standard Rx
TAVI
69.3%
Months
Freedom from Death (%)
∆ at 1 yr = 20.0%
NNT = 5.0 pts
Numbers at RiskNumbers at Risk
TAVITAVI 179179 138138 122122 6767 2626
Standard RxStandard Rx 179179 121121 8383 4141 1212
49.3%
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EMORYEMORYNeuro events at 30D & 1Y: PARTNER 1B
Major Stroke All Stroke or TIA
P = 0.06P = 0.18
6.7
10.6
1.74.5
30 Days 1 Year
P = 0.03P = 0.04
TAVR (n=179) Standard Rx (n=179)
per cent
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EMORYEMORYMajor Vascular Complications: PARTNER 1B
16.8%17.4%
30 Daysp < 0.001
1 YearP<0.001
1.1%2.2%
TAVR
n=30
Std Tx
n=2
TAVR
n=31
Std Tx
n=4
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EMORYEMORY
PARTNER 1A: 2 YEARPARTNER 1A: 2 YEAR
Kodali, NEJM, 2012
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EMORYEMORY
PARTNER 1A: 2 YEARPARTNER 1A: 2 YEAR
Kodali, NEJM, 2012
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EMORYEMORY
PARTNER 1A: 2 YEARPARTNER 1A: 2 YEAR
Kodali, NEJM, 2012
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DW-MRI after TAVI
Valve New
lesions
Strokes
lesions
Ghanem CoreValve 73% 10%
Knipp SAPIEN 58% 4%
Kahlert Both 84% 0%
Astarci Both 91% 0%
Rodes, Webb SAPIEN 68% 3.3%
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Embrella• Deflector• Radial access• Canadian/German feasibility study
SHEF• Deflector• Femoral access• Femoral access• German feasibility
study
Claret• Dual carotid filter• German feasibility study
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EMORYEMORY
PV Aortic Regurgitation: PARTNER 1APV Aortic Regurgitation: PARTNER 1A
P < 0.001 P < 0.001 P < 0.001
Patients %
60
80
100
1 Year6 Months30 Days
Patients %
None Trace Mild Moderate Severe
0
20
40
60
TAVR AVR TAVR AVR TAVR AVR
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EMORYEMORY
PARTNER 1A: 2 YEARPARTNER 1A: 2 YEAR
Kodali, NEJM, 2012
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EMORYEMORY
Additional Experience ThroughAdditional Experience Through
NonNon--Randomized Continued AccessRandomized Continued Access
600
700
800
900
1000Continued Access PeriodRandomized Clinical Trial
PMA-TA = 104
AVR = 103NRCA-TA = 843
0
100
200
300
400
500
600
May
2007
Sep
2009
PMA
# of
Patients
Enrolled
Sep 21, 2011
PMA Data Lock
April 2008
Dewey, STS, 2012
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30 Days 1 Year
OutcomeOutcomePMAPMA--TATA
(n (n = = 104)104)
AVRAVR
(n (n = = 92)92)
NRCANRCA--TATA
(n (n = = 822)822)
PMAPMA--TATA
(n (n = = 104)104)
AVRAVR
(n (n = = 92)92)
NRCANRCA--TATA
(n = 822)(n = 822)
Clinical OutcomesClinical Outcomes
at 30 Days and 1 Year (AT)at 30 Days and 1 Year (AT)
All percents are KM
estimates.
AllAll--Cause Mortality Cause Mortality –– pts. (%)pts. (%) 9 (8.7%) 7 (7.6%) 66 (8.2%) 30 (29.1%) 23 (25.3%) 148 (23.6%)
Stroke – pts. (%) 7 (7.0%) 5 (5.5%) 16 (2.0%) 10 (10.8%) 6 (7.0%) 22 (3.7%)
Death or Stroke – pts. (%) 16 (15.4%) 11 (12.0%) 80 (9.9%) 36 (34.8%) 27 (29.7%) 163 (25.7%)
Note: p-values between NRCA-TA vs PMA-TA and NRCA-TA vs AVR are all not significant.
Dewey, STS, 2012
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20%
30%
40%
Cause M
ortality
AVR
PMA-TA
NRCA-TA
AllAll--Cause Mortality (AT)Cause Mortality (AT)
23.6%25.3%
29.1%
0%
10%
0 3 6 9 12
All-Cause M
ortality
Months Post Procedure
AVRAVR 9292 7676 7171 7070 6767
PMAPMA--TATA 104104 8787 8282 7676 7373
NRCANRCA--TATA 822822 571571 370370 297297 126126
No. at Risk
∆ at 1 yr:
AVR - PMA-TA = –3.8%
AVR - NRCA-TA = +1.7%
PMA-TA - NRCA-TA = +5.5%
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20%
30%
40%
Stroke
AVR
PMA-TA
NRCA-TA
Stroke (AT)Stroke (AT)
∆ at 1 yr:
AVR - PMA-TA = –3.8%
AVR - NRCA-TA = +3.3%
PMA-TA - NRCA-TA = +7.1%
0%
10%
0 3 6 9 12
Stroke
Months Post Procedure
AVRAVR 9292 7272 6767 6666 6363
PMAPMA--TATA 104104 8181 7777 7070 6767
NRCANRCA--TATA 822822 563563 365365 291291 123123
No. at Risk
3.7.%
7.0%
10.8.%
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ConclusionsConclusions
• Additional experience in The PARTNER Trial NRCA-TA (n=843)
further supports transapical as a safe and effective treatment option
for high risk patients not eligible for transfemoral access:
– Mortality: – Mortality:
• PMA-TA 29.1%,
• AVR 25.3%
• NRCA-TA 23.6%
– Stroke:
• PMA-TA 10.8%
• AVR 7.0%
• NRCA-TA 3.7%
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• Self expanding stent designed to be:
– Fully re-sheathable
– Repositionable* (antegrade and
retrograde) at the implant site
– Retrieveable
– TF and TA
St. Jude Medical Portico™
Transcatheter Valve Program
– TF and TA
• Bovine and porcine pericardial valve
with Linx™ anti-calcification technology
• Cuff tissue and stent geometry designed
to minimize PV leak
• Leaflet/cuff position within the frame, and
stent length, designed for minimal
protrusion into LVOT, potentially
minimizing conduction system and mitral
valve apparatus interference
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Portico First-in-Human
Deployment: Vancouver
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First-in-Human
Deployment
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Positioning
Wires
Direct Flow Medical: Valve Concept
Aortic Ring
Check ValvesVentricular Ring
Investigational device not for sale in or outside the United States
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FIM 18F DFM Valve: Final angiogram FIM 18F DFM Valve: Final angiogram (after (after
polymer exchange)polymer exchange)
Investigational device not for sale in or outside the United States
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Access For TAVI
Subclavian– Minimally Diseased Vessel
– Less Invasive Than TA
– Local Anesthesia Possible
– Crosses Arch But Less – Crosses Arch But Less
Traumatic ?
– Direct Access To Valve
Direct Aortic– Most Direct Access
– Less Invasive Than TA
– Surgeons More Comfortable
With Access
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EMORYEMORY
The Future: ValveThe Future: Valve--inin--Valve Valve
DeploymentDeployment
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EMORYEMORY
The Future: The Future: TAoTAo
DeploymentDeployment
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Two T-AVRs in One Patient..
TransTrans--apicalapical
AVRAVR
Courtesy of Dr. John WebbCourtesy of Dr. John Webb
TransTrans--apicalapical
MVRMVR
(valve(valve--inin--valve)valve)
SapienSapien
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25th percentile
=STS 3.8
10th percentile
EMORYEMORY
The Creep for TAVRThe Creep for TAVR
• PARTNER II
• SUR TAVI10th percentile
= STS 8%• SUR TAVI
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Symptomatic Severe Aortic Symptomatic Severe Aortic StenosisStenosisSymptomatic Severe Aortic Symptomatic Severe Aortic StenosisStenosis
ASSESSMENT: OperabilityASSESSMENT: Operability
ASSESSMENT:
Transfemoral Access
ASSESSMENT:
Transfemoral Access
ASSESSMENT:
Transfemoral Access
ASSESSMENT:
Transfemoral Access
Total = 2000 patientsTotal = 2000 patients
2 Parallel Trials:
Individually Powered
2 Parallel Trials:
Individually PoweredOperableOperableOperableOperablen= 2000n= 2000 InoperableInoperableInoperableInoperable n=500n=500
The PARTNER II Study DesignThe PARTNER II Study Design
TransapicalTransapicalTransapicalTransapical
Transfemoral AccessTransfemoral Access
tAVRtAVR
TransTrans
femoral
tAVRtAVR
TransTrans
femoral
Surgical Surgical
AVRAVR
Surgical Surgical
AVRAVR
TransfemoralTransfemoralTransfemoralTransfemoral
Primary Endpoint: All Cause Mortality, Major Primary Endpoint: All Cause Mortality, Major
StrokeStroke
Primary Endpoint: All Cause Mortality, Major Primary Endpoint: All Cause Mortality, Major
StrokeStroke
tAVRtAVR
TransTrans
apicalapical
tAVRtAVR
TransTrans
apicalapical
Surgical Surgical
AVRAVR
Surgical Surgical
AVRAVR
1:1 Randomization1:1 Randomization1:1 Randomization1:1 Randomization
VSVStAVR tAVR
SAPIEN XTSAPIEN XT
tAVR tAVR
SAPIEN XTSAPIEN XT
Transfemoral AccessTransfemoral Access
Nested Registry
Transapical
Nested Registry
Transapical
tAVR tAVR
SAPIENSAPIEN
tAVR tAVR
SAPIENSAPIEN
Primary Endpoint: All Cause Primary Endpoint: All Cause Mortality, Major Mortality, Major
Stroke and Stroke and RehospitalizationRehospitalization
Primary Endpoint: All Cause Primary Endpoint: All Cause Mortality, Major Mortality, Major
Stroke and Stroke and RehospitalizationRehospitalization
1:1 Randomization1:1 Randomization
VS
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• Qualified multi-disciplinary team
– Surgeon
• Open surgical AVR experience (especially in high risk AVR patients)
• Catheter-based experience
– Interventional cardiologist (skilled in structural heart disease)
– Experienced surgical OR team
EMORY
Integral Components
– Experienced surgical OR team
– Experienced transcatheter OR team
– Vascular surgeon accessible for aorto-iliac disease complications
– Perfusionist and CPB circuitry present in the OR
• Fixed-imagining fluoroscopic capability
• Minimum requirements for sterile OR environment
• Discuss and prepare for all catastrophic events with specific roles
for each member of the team.
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EMORYConclusionsConclusions
nn TAVR is here!!! ARE WE READY????TAVR is here!!! ARE WE READY????
nn Results are superior to medical Results are superior to medical txtx and comparable to and comparable to
open surgeryopen surgery
nn The patient population who does not benefit from The patient population who does not benefit from nn The patient population who does not benefit from The patient population who does not benefit from
TAVR needs to be further refinedTAVR needs to be further refined
nn Techniques to prevent embolization (via imaging), Techniques to prevent embolization (via imaging),
vascular complications (via sizing), vascular complications (via sizing), paravalvularparavalvular
leaks (via imaging), and stroke (via catching of leaks (via imaging), and stroke (via catching of
emboli) need to be further refinedemboli) need to be further refined
nn Success Success can only be achieved with a collaborative and can only be achieved with a collaborative and
dedicated teamdedicated team
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EMORYEMORY
The Team: Cardiologist and Cardiac The Team: Cardiologist and Cardiac
SurgeonSurgeon
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CoreValve US Pivotal Trial Design
Medtronic CoreValve Medtronic CoreValve U.S. Pivotal TrialU.S. Pivotal Trial
“Extreme Risk”“Extreme Risk”Patient GroupPatient Group
“High Risk”“High Risk”Patient GroupPatient Group
40 Sites in the US40 Sites in the US
National CoNational Co--PIs:PIs:
Jeff Jeff PopmaPopma, MD, MD
David Adams, MDDavid Adams, MD
Patient GroupPatient Group
IliofemoralIliofemoral access?access?
CoreValveCoreValveObservationalObservational
CoreValveCoreValveSingle ArmSingle Arm
Up to 100Up to 100
Patient GroupPatient Group
Randomization 1:1Randomization 1:1
CoreValveCoreValve SAVRSAVR
395*395* 395395
790790
Yes 487Yes 487
NoNo
*Includes iliofemoral and alternative access patientsNote: 3 roll-in patients per study site equates to a maximum of 1,497 patients enrolled
Alternative AccessAlternative Access
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EMORY
Impact of TAVR at Emory
AVR
TAVR
AVR