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

Conflict of Interest for A Pichard

Proctor for Edwards Lifesciences.

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

Multiple Options for Vascular Access

directaortic

subclavian/axillary

transapical

transfemoral

carotid

Common IliacRPA

IVC to Aorta Entry

Transeptal

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

US TVT Registry.Mack et al. JAMA 2013;310: 2069-77

• Trans-femoral: 64%• Trans Apical 29%• Trans Aortic 4%• Percutaneous Access: 36%

.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

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%

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%

Procedural Success.CoreValve EU Registries. Ruiz, TVT 2012

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.

Worldwide TAVI Distribution2012-2013

28%

61%

11%

Western Europe

United States

Rest of the World

Courtesy of BIBA Medtech

11 European Countries Registry TAVI: 2007 to 2012

Registry data

TAVI Centres

Registry data

TAVI Implants per Annum

Registry data

BIBA Marketing

Annual Implants each Country

National Reimbursement Systems2012-2013

Implants in Europe 2009-2013

Cumulative implants in Europe 2009-2013

Courtesy of Patrick Serruys

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

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

% Patients undergoing conventional AVR vs TAVI

konventionell Katheterbasiert

(Quelle: DGTHG Statistik 2010)

Germany :TAVI – a Game Changer in AVR

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.

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.

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

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

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

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)

Learning Curve Partner I. 2621 patients

33

TF p for trend<0.001

TATF

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

TATF

P<0.004

P<0.34

Learning Curve2621 patients in Partner 1

Major Bleeding Vasc Complic.

P<0.04

P<0.04

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.

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

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

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

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

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

Survival Data

• Partner Trials and Corevalve Extreme risk have proven Survival Benefit.

• We are learning on who not to do TAVR, “Cohort C”.

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

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

Inoperable Patients, Partner 1B.Makkar et al. JACC 2014;63:901-11

Techn. Inoperable

Clin. Inoperable

Standard Therapy

Technical InoperabilityPartner Trial. Makkar et al. JACC 2014;63:901-911

85 (23%) of 369 patients

Clinically Inoperable.Partner 1B. Makkar et al. JACC 2014;63:901-11

284 of 369 patients

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.

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)

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.

Thank you