tavr. global and us data. a.pichard, l. satler, r waksman, i ben-dor, n bernardo, p corso, s boyce,...
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TAVR. Global and US Data.
A. Pichard,
L. Satler, R Waksman, I Ben-Dor, N Bernardo,
P Corso, S Boyce, S Goldstein, H Cooper, Z Wang,
F Asch, J Weidel, T. Weddington, G Weissman,
G Weigold, T Fuisz, S Minha, Marco Magalhaes,
P Okubagzi, J Lindsay, A. Taylor
Medstar Washington Hospital Center.
Washington, DC
Snowmass, March 2014
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Conflict of Interest for A Pichard
Proctor for Edwards Lifesciences.
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Self Expanding
Edwards CENTERA Valve
Balloon Expandable
Edwards SAPIEN 3 Valve
Designed to further reduce PV leaks.
TF delivery through a 14 Fr eSheath. Dramatically reduced TA profile: 18 F.
Discrete valve anchors in the annulus.
Edwards’ bovine pericardial tissue leaflets.
Motorized delivery system for stable deployment and single operator use.Repositionable & pre-loaded.Delivered through a 14 Fr eSheath.Discrete valve anchors in the annulus.Edwards’ bovine pericardial tissue leaflets.
Binder et al. JACC Interv 2013;6:301
CE Approved
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Multiple Options for Vascular Access
directaortic
subclavian/axillary
transapical
transfemoral
carotid
Common IliacRPA
IVC to Aorta Entry
Transeptal
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Implants by Access SiteEurope 2010 to 2012
Q4CY10 Q1CY11 Q2CY11 Q3CY11 Q4CY11 Q1CY12 Q2CY12 Q3CY12 Q4CY120%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
DA SC TA TF
Transfemoral
Trans Apical Subcl
Trans Aortic
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US TVT Registry.Mack et al. JAMA 2013;310: 2069-77
• Trans-femoral: 64%• Trans Apical 29%• Trans Aortic 4%• Percutaneous Access: 36%
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.05 .2 .5 1 2 5 20Odds Ratio
More likely after TF
More likely after TA
Prolonged LOS
Hospital death
Renal failure
Bleeding
Pacemaker
Stroke
Shorter LOS
Propensity-Matched Comparison of Outcomes after TA vs. TF (501 patient pairs).
Eugene Blackstone, TCT 2013
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Procedural Factors.23 TAVR Centers in 8 European Countries
• Hybrid room: 12%• TAVR in the Cath Lab: 96%• Cardiac surgeon participate in the
procedure: 83%• CPB machine in Cath lab: 48%• TEE used routinely: 70%• General anesthesia: 61%• Percutaneous Access: 70%
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US TVT Registry.Mack et al. JAMA 2013;310: 2069-77
Hybrid OR: 57%
Hybrid Cath Lab: 28%
Cath Lab 14%
Cardio pulmonary bypass: 4%
Conscious Sedation: 2%
Percutaneous Access: 36%
Cross Over to Open Heart surgery: 1%
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Procedural Success.CoreValve EU Registries. Ruiz, TVT 2012
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Death (%) 6.6Annulus Rupture(%) 0.4Valve migration(%) 1.3Coronary obstruction(%) 0.4Tamponade(%) 1.2Surgery(%) 0.6Stroke with sequelae (%) 2Vascular complication(%) 6.6Pacemaker (%) Edw: 8.1/ MCV: 21
France TAVI 2013. 30 day Results.41 centres 64% of 3707 TAVI
Success rate: 94.1%
Bataille et al.
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Worldwide TAVI Distribution2012-2013
28%
61%
11%
Western Europe
United States
Rest of the World
Courtesy of BIBA Medtech
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11 European Countries Registry TAVI: 2007 to 2012
Registry data
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TAVI Centres
Registry data
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TAVI Implants per Annum
Registry data
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BIBA Marketing
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Annual Implants each Country
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National Reimbursement Systems2012-2013
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Implants in Europe 2009-2013
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Cumulative implants in Europe 2009-2013
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Courtesy of Patrick Serruys
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2010 2011 2013N= 1555 2364 3707
Age(yr) 82±7 83± 7 83 ± 9
LES (%) 23 ± 14 21 ± 14 19 ± 13
General Anesthesia(%)
73 66 62
TA (%) 19 17 7
Length of stay (d)
12 11 11
Trends in TAVI. France
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2007 2008 2009 2010
1.2% 6.5% 13% 20%TAVI
SAVR
# o
f p
roced
ure
s
49459 73000
Number of AVR’s in Europe Before and After TAVI
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% Patients undergoing conventional AVR vs TAVI
konventionell Katheterbasiert
(Quelle: DGTHG Statistik 2010)
Germany :TAVI – a Game Changer in AVR
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0
500
1000
1500
2000
2500
1055
2035
2006 2007 2008 2009 2010
All Aortic Valve Interventions in patients aged 80 or over
UK SATIRE Registry. Moat et al.
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0
1000
2000
3000
4000
5000
6000
7000
8000
6217
7252
2006 2007 2008 2009 2010
All Surgical Aortic Valve Interventions (AVR + AVR & CABG)
7548
UK SATIRE Registry. Moat et al.
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May June july Aug Sept oct Nov Dec Jan Feb Mar Apr May June July Aug Sept Oct0
50
100
150
200
250
300
29
5976
89
117134
149160164
191201213223
236244245249250
Cumulative TVT Sites EnrolledMay 2012-Oct 2013 250
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May June July Aug Sept Oct Nov Dec Jan Feb MarchApril May June July Aug Sept Oct 0
2000
4000
6000
8000
10000
12000
13 20 100 333683
12831825
24613116
3583
4551
5417
6437
72107862 8108
958410133
Cumulative TVT RecordsMay 2012-Oct 2013
10, 133
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114
85
189 6
0
20
40
60
80
100
120
<25 25-49 50-74 75-99 100+
Volume per Site (2012q3-2013q2)
# of sites ineach volumegroup
Source: STS/ACC TVT Registry data warehouse 7/1/2012-6/30/2013
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New Trials/Registries
• UK Satire (TAVR vs SAVR).• NORDIC Trial (Corevalve vs AVR).• Activation Trial (PCI or not in TAVI with CAD).• Simplify TAVI (BAV pre vs no BAV).• CHOICE (CoreValve vs Edwards)• Clean TAVI, Sentinel is US (Claret device).• TAO EmbolX (EmbolX cerebral protection).• Cooling and Brain Oxygenation (Rhino-chill device).• BRAVO 2/3 (Bivalirudine).• AUREA (DAPT vs Oral Anticoagulation)
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Learning Curve Partner I. 2621 patients
33
TF p for trend<0.001
TATF
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Learning Curve Partner I. 2621 patients
TA p for trend<0.05
TF p for trend<0.05
Successful device deployment.
Asymptote at around 40-50 cases
TATF
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TATF
P<0.004
P<0.34
Learning Curve2621 patients in Partner 1
Major Bleeding Vasc Complic.
P<0.04
P<0.04
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The Association of Transcatheter Aortic Valve Replacement (TAVR) Availability, Surgical AVR Case Volume, and
In-hospital Mortality in the United States
A Report from the STS National Database and the STS/ACC TVT RegistryJ. Matthew Brennan, MD, MPH
Assistant Professor of MedicineInterventional Cardiology
Duke University Medical Center
J. Matthew Brennan, Fred Edwards, Sarah Milford-Beland, John Carroll, Fred Grover, Ralph Brindis, Dave Shahian, Murat Tuczu, Sean O’Brien, Cynthia Shewan, Kathleen Hewitt,
Eric Peterson, James Gammie, John Rumsfeld, David Holmes, Michael MackOn Behalf of the TVT Registry Participants
Primary STS Discussant: Joseph E. Bavaria, M.D.
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2008 2009 2010 2011 20120
10,000
20,000
30,000
40,000
50,000 AVR Case Volume in USA
Overall (SAVR + TAVR) Overall SAVR Low Risk SAVRIntermediate Risk SAVR High Risk SAVR TAVR
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TAVR Centers (n=230)
2008 2009 2010 2011 20120
5,000
10,000
15,000
20,000
25,000
AVR
Case
Vol
ume
‘No TAVR’ Centers (n=571)
2008 2009 2010 2011 2012
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0
0.5
1
1.5 Adjusted Mortality [(o:e) Ratio]
*o:e Ratio calculated using STS PROM calibrated for yr2007
Surgical AVR Risk 2008 – 2009 2010 – 2011Q2 2011Q3 – 2013Q2Low 0.60 (0.53, 0.68) 0.56 (0.49, 0.65) 0.50 (0.44, 0.57)Intermediate 0.76 (0.68, 0.85) 0.66 (0.58, 0.76) 0.62 (0.55, 0.70)High 0.86 (0.78, 0.94) 0.74 (0.66, 0.82) 0.62 (0.55, 0.69)
*p<0.0001 across intervals
2008 2009 2010 2011 2012 20130%
5%
10%
15% Observed Mortality
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High Risk (S+T) AVRLow Risk AVR
0
2000
4000
6000
8000
10000
TAVR
Cas
e Vo
lum
e (Q
uart
erly
)
2008
2008Q4
2009Q3
2010Q22011
2011Q4
2012Q3
2013Q20
0.2
0.4
0.6
0.8
1
1.2
Obs
erve
d:Ex
pect
ed
(o:e
) Rati
o
*o:e Ratio calculated using STS PROM calibrated for yr2007
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Surgical AVR- STS Database 2006-2010 n=100,031
0%
10%
20%
30%
40%
50%
60%
50%
27%
16%
7%<2% 2-4% 4-8% >8%
Risk of Mortality
Mean 2.9%
PARTNER 2ASURTAVI
PARTNER 1Corevalve US
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Survival Data
• Partner Trials and Corevalve Extreme risk have proven Survival Benefit.
• We are learning on who not to do TAVR, “Cohort C”.
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Long Term Outcomes of TAVIRodes-Cabau et al. JACC 2012;60:1864-75
23% Cardiac
17.8% Un-known
59.2% Non Cardiac• Pulmonary 26.9%• Kidney Failure 7.9%• Stroke 5.9%• Major Bleeding 4.6%• Cancer 5.3%• Other 8.6%
• CHF 15.1%• Sudden
Death 2.6%• MI 3.9%• Endocarditi
s 0.7%• MVR 0.7%
339 patients, 52% TA, 3.5 years median f/u
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Dea
th In
cid
ence
(%
)
Months
0 6 12 18 240%
20%
40%
60%
80%
100%
STS 5-14.9
Numbers at Risk
STS <5
Months
0 6 12 18 240%
20%
40%
60%
80%
100%
28 26 25 24 16
12 8 7 6 5
Standard Rx TAVR
STS ≥15
0 6 12 18 240%
20%
40%
60%
80%
100%
Months
43 32 23 19 15
47 29 19 14 8
108 80 76 67 52
119 84 59 42 29
Mortality and STS Score (ITT)(Society Thoracic Surgery Score)
44
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Inoperable Patients, Partner 1B.Makkar et al. JACC 2014;63:901-11
Techn. Inoperable
Clin. Inoperable
Standard Therapy
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Technical InoperabilityPartner Trial. Makkar et al. JACC 2014;63:901-911
85 (23%) of 369 patients
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Clinically Inoperable.Partner 1B. Makkar et al. JACC 2014;63:901-11
284 of 369 patients
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ESC/EACTS Guidelines - 2012
Class I: Inoperable• Heart Team required• On-site cardiac surgery
Class IIa: High-risk for surgery.• Heart team decides.
USA: Same as Partner 1 Trial Inclusion Criteria.
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USA Requirements for TAVR Program.AATS, ACCF, SCAI, STS Consensus
• Interventional Cardiology– Hospital: 1,000 caths/400 PCIs per year– Operators: 100 structural procedures lifetime
or 30 L-sided structural procedures per year (60% should be BAV).
• Surgery– Hospital: 50 AVR per year, of which > 10 high-
risk (STS ≥ 6%)– Operators: 100 AVR career, of which at least 10
are high-risk (STS ≥ 6%) or 25 AVR per year or 50 AVR in 2 years (at least 20 in the last year before initiating TAVR)
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TVT U.S. National Registry
• Comprehensive prospective observational database (7-page).
• FU includes 30-days, 1-year (incl. QOL measures).
• TVT Registry entry linked to reimbursement.
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Thank you