Perc. Ao Valve

thomas.marie50

Perc. Ao Valve

Indications and Results

of the Ballooon

Expandable

Aortic Valve ( Edwards )

Eulogio Garcia MD

Hospital Clínico San Carlos

Madrid

Monday, December 7, 2009


Perc. Ao Valve

Aortic stenosis is life-threatening and

progresses rapidly

Source:

1

S.J. Lester et al., “The Natural History and Rate of Progression of Aortic Stenosis,” Chest 1998

2

C.M. Otto, “Valve Disease: Timing of Aortic Valve Surgery,” Heart 2000

Chart:: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.

Monday, December 7, 2009


Perc. Ao Valve

The Problem Is Serious

Aortic stenosis is life-threatening and

progresses rapidly

Survival after onset of

symptoms is 50% at two

years and 20% at five

years 1

“Surgical intervention [for

severe AS] should be

performed promptly once

even…minor symptoms

occur” 2

Source:

1

S.J. Lester et al., “The Natural History and Rate of Progression of Aortic Stenosis,” Chest 1998

2

C.M. Otto, “Valve Disease: Timing of Aortic Valve Surgery,” Heart 2000

Chart:: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.

Monday, December 7, 2009


Perc. Ao Valve

Balloon Valvuloplasty with and without Aortic Valve Replacement

Monday, December 7, 2009


Perc. Ao Valve

Survival of Severe Aortic Stenosis Patients

Balloon Valvuloplasty with and without Aortic Valve Replacement

Monday, December 7, 2009


At least 30-40% of patients

with degenerative and symptomatic AS are

Monday, December 7, 2009


At least 30-40% of patients

with degenerative and symptomatic AS are

Severe Symptomatic Aortic Stenosis

Percent of Cardiology Patients Treated

No AVR

AVR

32 30

60

48

31

45

68 70

69

Bouma

1999

Iung

2004

Pellika

2005

40

Charlson

2006

Charlson

2006

Iung* 2004 Pellikka 2005 Charlson 2006 Bach Spokane (prelim) Vannan (Pub. Pending)

52

Bach

2006

Spokane

prelim.

Vannan

Pub.

Pending

55

Monday, December 7, 2009


At least 30-40% of patients

with degenerative and symptomatic AS are

Severe Symptomatic Aortic Stenosis

Percent of Cardiology Patients Treated

No AVR

AVR

32 30

60

48

31

45

68 70

EuroHeart Survey, 200452

Bouma

1999

Iung

Pellika

40

Charlson

Bach

50012004

Patients 2005 in 92 2006 centers at 2006 25

Charlson

countries

2006

No operation in 31.8%

Monday, December 7, 2009

Iung* 2004 Pellikka 2005 Charlson 2006 Bach Spokane (prelim) Vannan (Pub. Pending)

69

Spokane

prelim.

Vannan

Pub.

Pending

55


At least 30-40% of patients

with degenerative and symptomatic AS are

Severe Symptomatic Aortic Stenosis

Percent of Cardiology Patients Treated

32 30

68 70

EuroHeart Survey, 200452

Bouma

1999

Iung

Pellika

50012004

Patients 2005 in 92 2006 centers at 2006 25

Charlson

countries

2006

No operation in 31.8%

60

40

Charlson

Iung* 2004 Pellikka 2005 Charlson 2006 Bach Spokane (prelim) Vannan (Pub. Pending)

Monday, December 7, 2009

48

Bach

31

69

Spokane

prelim.

No AVR

AVR

Vannan

Pub.

Pending

55

45

« Survival after onset

of symptoms

50% at 2 years and

20% at 5 years »

« Need for AVR

as soon as possible

after the onset of

Symptoms »

Ross J Jr, Braunwald E.

Aortic stenosis, Circulation 1968


Monday, December 7, 2009

Perc. Ao Valve


Perc. Ao Valve

So an alternative to the

standard surgical

approach would be

useful……there is a huge

hidden patient population.

Monday, December 7, 2009


Perc. Ao Valve

?

Monday, December 7, 2009


Perc. Ao Valve

Very old

age

?

Monday, December 7, 2009


Perc. Ao Valve

Very old

age

?

Severe

LV

dysfunctio

n

Monday, December 7, 2009


Perc. Ao Valve

Very old

age

?

Severe

LV

dysfunctio

n

Comorbidities

Monday, December 7, 2009


Perc. Ao Valve

Renal

disease

Severe

Very old LV

age

? dysfunctio

n

COPD

Comorbidities

Porcelain

Aorta

Previous thoracic surg.

Monday, December 7, 2009


Monday, December 7, 2009

Perc. Ao Valve


Monday, December 7, 2009

Perc. Ao Valve

PVT-Edwards

Percutaneous Heart Valve


Perc. Ao Valve

PVT-Edwards

Percutaneous Heart Valve

First generation – polyurethane

Monday, December 7, 2009


Perc. Ao Valve

PVT-Edwards

Percutaneous Heart Valve

First generation – polyurethane

Second generation – bovine pericardium

Monday, December 7, 2009


Perc. Ao Valve

PVT-Edwards

Percutaneous Heart Valve

Cribier-Edwards Device

First generation – polyurethane

Second generation – bovine pericardium

• equine pericardial valve

• stainless steel stent

• 23mm and 26mm diameters

• balloon-expandable

• AVA = 1.7-1.9 cm 2

Monday, December 7, 2009


Seminal events,

from BAV

to THV

1985

2000

1999

1994

1987

2002

2000-02

2002-03

Large series of animal implantation

First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


1985

Seminal events,

from BAV

to THV

2000

1999

1994

1987

2002

2000-02

2004

2002-03

Large series of animal implantation

First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


Seminal events,

from BAV

to THV

Transfemoral retrograde

Cribier‐Edwards

23mm

1985

2000

1999

1994

1987

Equine

pericardium

2002

2000-02

2004

2002-03

Edwards SAPIEN

23mm, 26mm

Large series of animal implantation

First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Bovine pericardium Ascendra

Concept An2‐Ca of« stented Tfx valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

Edwards Lifesciences

Technological improvements

Retroflex

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Transapical

Monday, December 7, 2009


Seminal events,

from BAV

to THV

Transfemoral retrograde

Cribier‐Edwards

23mm

1985

Transfemoral

Retrograde

2000

1999

1994

1987

Equine

pericardium

2002

2000-02

2004

2002-03

Transapical

Edwards SAPIEN

23mm, 26mm

J. Webb F. Mohr

T. Walter

Large series of animal implantation

M. Mack

First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Bovine pericardium Ascendra

Concept An2‐Ca of« stented Tfx valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

Edwards Lifesciences

Technological improvements

Retroflex

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Transapical

Monday, December 7, 2009


1985

1987

1994

2002

2000-02

2004

2002-03

2000

Large series of animal implantation

1999 First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


1985

1987

1994

2002

2000-02

2004

2002-03

2005-07

2000

Large series of animal implantation

1999 First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

2007

CE mark

commercialization

International TF and TA

Feasibility Studies

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


THV development

A long road:

20 Years

from concept

to real world

1985

1987

1994

2002

2000-02

2004

2002-03

2005-07

2000

Large series of animal implantation

1999 First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

2007

CE mark

commercialization

International TF and TA

Feasibility Studies

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


THV development

A long road:

20 Years

from concept

to real world

1985

1987

1994

2002

2000-02

2004

2002-03

2005-07

20 years

2000

Large series of animal implantation

1999 First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

2007

CE mark

commercialization

International TF and TA

Feasibility Studies

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Monday, December 7, 2009


THV development

A long road:

20 Years

from concept

to real world

1985

1987

1994

2002

2000-02

2000

2004

2002-03

2005-07

20 years

1999 First animal implantation (sheep)

« Percutaneous Valve Technology » (prototypes)

Post-mortem studies of intra-valvular stenting

Sketches of stented valve

Concept of« stented valve », to rule out post-BAV valvular restenosis

F.I.M. Balloon Aortic Valvuloplasty

2007

2009 > 9000 THV

CE mark

commercialization

International TF and TA

Feasibility Studies

Edwards Lifesciences

Technological improvements

Feasibility Studies (antegrade)

F.I.M. PHV implantation

Large series of animal implantation

implanted worldwide

Monday, December 7, 2009


Monday, December 7, 2009

Perc. Ao Valve


Monday, December 7, 2009

Perc. Ao Valve


Perc. Ao Valve

Vessel dilators : 16, 18, 20 y 22F

Monday, December 7, 2009


Perc. Ao Valve

Arterial sheath 24F ( Edwards )

Monday, December 7, 2009


Perc. Ao Valve

200

100

0

Monday, December 7, 2009


Perc. Ao Valve

200

100

0

Monday, December 7, 2009


Monday, December 7, 2009

Perc. Ao Valve


Monday, December 7, 2009

Perc. Ao Valve


Monday, December 7, 2009

UPDATED RESULTS


Edwards THV Clinical Trial Sites

Columbia University (NY)

- REVIVE II

- REVIVAL II

Aarhus

Frankfurt

Essen

Vancouver

Detroit (MI)

Med City Dallas

Cleveland Clinic

Rouen

Madrid

San Carlos &

Gregorio Maranon

Paris

Paris

Institute &

Bichat

Monday, December 7, 2009


Monday, December 7, 2009

Perc. Ao Valve


Perc. Ao Valve

Edwards THV Clinical Studies Program

Monday, December 7, 2009


Perc. Ao Valve

Edwards THV Clinical Studies Program

Monday, December 7, 2009


Perc. Ao Valve

REVIVE

REVIVAL

PARTNER EU TF

SOURCE TF

N = 106

N= 55

N=61

N = 463

Mean Euroscore (%) 28.9 ± 13.4 34.1 ± 18.0 25.7 ± 11.5 25.7

Procedure time (min) 158 ±-138 138.0 ± 63.6 145.3 ± 61.3 NA

Fluoroscopy time (min) 30.56 ±7.6 NAV 28.1 ± 17 NA

Acute procedure success NA NA NA 95.6%

Device success composite incl. AR


Perc. Ao Valve

All SAPIEN ® Studies, Transfemoral

REVIVE

REVIVAL

PARTNER EU TF

SOURCE TF

N = 106

N= 55

N=61

N = 463

Mean Euroscore (%) 28.9 ± 13.4 34.1 ± 18.0 25.7 ± 11.5 25.7

Procedure time (min) 158 ±-138 138.0 ± 63.6 145.3 ± 61.3 NA

Fluoroscopy time (min) 30.56 ±7.6 NAV 28.1 ± 17 NA

Acute procedure success NA NA NA 95.6%

Device success composite incl. AR


Perc. Ao Valve

PARTNER EU TA

REVIVALTA

TRAVERCE TA

SOURCE TA

N = 69

N = 40

N = 172

N = 575

Mean Euroscore (%) 33.8 ± 14.7 36.2 ± 15.7 26.7 ± 12.7 29.2%

Procedure time (min) 131.6 ±-59.3 87.1 ± 62.7 119 ± 77 NA

Fluoroscopy time (min) 14 ±7.4 NAV 28.1 ± 17 NA

Acute procedure success NA NA NA 92.9%

Device success composite incl.

AR


Perc. Ao Valve

All SAPIEN ® Studies, Transapical

PARTNER EU TA

REVIVALTA

TRAVERCE TA

SOURCE TA

N = 69

N = 40

N = 172

N = 575

Mean Euroscore (%) 33.8 ± 14.7 36.2 ± 15.7 26.7 ± 12.7 29.2%

Procedure time (min) 131.6 ±-59.3 87.1 ± 62.7 119 ± 77 NA

Fluoroscopy time (min) 14 ±7.4 NAV 28.1 ± 17 NA

Acute procedure success NA NA NA 92.9%

Device success composite incl.

AR


Perc. Ao Valve

Vascular Access

Complication Rate,

by patient

January 2006 – June

2006

30%

P = .006

Monday, December 7, 2009


REVIVE Learnings

Perc. Ao Valve

Matter

– and Drive Improvement

Vascular Access

Complication Rate,

by patient

January 2006 – June

2006

30%

P = .006

Monday, December 7, 2009


REVIVE Learnings

Perc. Ao Valve

Matter

– and Drive Improvement

Vascular Access

Complication Rate,

by patient

January 2006 – June

2006

30%

Vascular Screening with

Columbia University

Medical Center

Core Lab

INSTITUTED

(in coordination with DSMB)

Vascular Access

Complication Rate,

by patient

August 2006 –

December 2007

5.8%

P = .006

Monday, December 7, 2009


Perc. Ao Valve

Acute procedure

success

TF (n=463) TA (n=575) Total (n=1038)

436/95.6%

523/92.9%

959/94.1%

n=456

n=563

n=1019

Device success comp* 428/92.4% 522/90.8% 950/91.5%

Conversion to sAVR 8/1.7% 20/3.5% 28/2.7%

AR >+2** 15 (3.2%) 34 (5.9%) 49 (4.7%)

Valve MigraWon 0(0.0%) 3(0.5%) 3(0.3%)

Valve MalposiWon 8(1.7%) 8 (1.4%) 16(1.5%)

Coronary obstrucWon 3(0.7%) 3(0.5%) 6 (0.6%)

*Device success is a composite including AR


Perc. Ao Valve

Implantation Success

Acute procedure

success

TF (n=463) TA (n=575) Total (n=1038)

436/95.6%

523/92.9%

959/94.1%

n=456

n=563

n=1019

Device success comp* 428/92.4% 522/90.8% 950/91.5%

Conversion to sAVR 8/1.7% 20/3.5% 28/2.7%

AR >+2** 15 (3.2%) 34 (5.9%) 49 (4.7%)

Valve MigraWon 0(0.0%) 3(0.5%) 3(0.3%)

Valve MalposiWon 8(1.7%) 8 (1.4%) 16(1.5%)

Coronary obstrucWon 3(0.7%) 3(0.5%) 6 (0.6%)

*Device success is a composite including AR


Perc. Ao Valve

Implantation Success

Acute procedure

success

TF (n=463) TA (n=575) Total (n=1038)

436/95.6%

523/92.9%

959/94.1%

n=456

n=563

n=1019

Device success comp* 428/92.4% 522/90.8% 950/91.5%

Conversion to sAVR 8/1.7% 20/3.5% 28/2.7%

AR >+2** 15 (3.2%) 34 (5.9%) 49 (4.7%)

Valve MigraWon 0(0.0%) 3(0.5%) 3(0.3%)

Valve MalposiWon 8(1.7%) 8 (1.4%) 16(1.5%)

Coronary obstrucWon 3(0.7%) 3(0.5%) 6 (0.6%)

*Device success is a composite including AR


Perc. Ao Valve

Implantation Success

Acute procedure

success

TF (n=463) TA (n=575) Total (n=1038)

436/95.6%

523/92.9%

959/94.1%

n=456

n=563

n=1019

Device success comp* 428/92.4% 522/90.8% 950/91.5%

Conversion to sAVR 8/1.7% 20/3.5% 28/2.7%

AR >+2** 15 (3.2%) 34 (5.9%) 49 (4.7%)

Valve MigraWon 0(0.0%) 3(0.5%) 3(0.3%)

Valve MalposiWon 8(1.7%) 8 (1.4%) 16(1.5%)

Coronary obstrucWon 3(0.7%) 3(0.5%) 6 (0.6%)

*Device success is a composite including AR


Perc. Ao Valve

With No

Vascular

ComplicaWons

With All

Vascular

ComplicaWons

With Major

Vascular

ComplicaWons

P‐value

Survival Transfemoral

94.1%

92.2%

88.6%

NS

Survival Transapical

90.7%

72.7%

61.1%


Perc. Ao Valve

Vascular/Access complications and

With No

Vascular

ComplicaWons

With All

Vascular

ComplicaWons

With Major

Vascular

ComplicaWons

P‐value

Survival Transfemoral

94.1%

92.2%

88.6%

NS

Survival Transapical

90.7%

72.7%

61.1%


Perc. Ao Valve

Vascular/Access complications and

With No

Vascular

ComplicaWons

With All

Vascular

ComplicaWons

With Major

Vascular

ComplicaWons

P‐value

Survival Transfemoral

94.1%

92.2%

88.6%

NS

Survival Transapical

90.7%

72.7%

61.1%


Perc. Ao Valve

TF (n=463) TA (n=575) Total (n=1038)

Death 29 (6.3%) 59 (10.3%) 88 (8.5)

Stroke 11 (2.4%) 16 (2.6%) 27 (2.5%)

Renal failure

requiring dialysis

23(5.0%) 69 (11.7%) 92 (8.7%)

Permanent

Pacemaker

31 (6.7%) 42 (7.3%) 73 (7.0%)

29

Data Snapshot

Monday, December 7, 2009

12/07/09


Perc. Ao Valve

Major Complications (< 30 days)

TF (n=463) TA (n=575) Total (n=1038)

Death 29 (6.3%) 59 (10.3%) 88 (8.5)

Stroke 11 (2.4%) 16 (2.6%) 27 (2.5%)

Renal failure

requiring dialysis

23(5.0%) 69 (11.7%) 92 (8.7%)

Permanent

Pacemaker

31 (6.7%) 42 (7.3%) 73 (7.0%)

29

Data Snapshot

Monday, December 7, 2009

12/07/09


Perc. Ao Valve

Major Complications (< 30 days)

TF (n=463) TA (n=575) Total (n=1038)

Death 29 (6.3%) 59 (10.3%) 88 (8.5)

Stroke 11 (2.4%) 16 (2.6%) 27 (2.5%)

Renal failure

requiring dialysis

23(5.0%) 69 (11.7%) 92 (8.7%)

Permanent

Pacemaker

31 (6.7%) 42 (7.3%) 73 (7.0%)

29

Data Snapshot

Monday, December 7, 2009

12/07/09


Perc. Ao Valve

Major Complications (< 30 days)

TF (n=463) TA (n=575) Total (n=1038)

Death 29 (6.3%) 59 (10.3%) 88 (8.5)

Stroke 11 (2.4%) 16 (2.6%) 27 (2.5%)

Renal failure

requiring dialysis

23(5.0%) 69 (11.7%) 92 (8.7%)

Permanent

Pacemaker

31 (6.7%) 42 (7.3%) 73 (7.0%)

29

Data Snapshot

Monday, December 7, 2009

12/07/09


Perc. Ao Valve

Major Complications (< 30 days)

TF (n=463) TA (n=575) Total (n=1038)

Death 29 (6.3%) 59 (10.3%) 88 (8.5)

Stroke 11 (2.4%) 16 (2.6%) 27 (2.5%)

Renal failure

requiring dialysis

23(5.0%) 69 (11.7%) 92 (8.7%)

Permanent

Pacemaker

31 (6.7%) 42 (7.3%) 73 (7.0%)

29

Data Snapshot

Monday, December 7, 2009

12/07/09


Perc. Ao Valve

49% 48%

30%

37%

Transapical

Transfemoral

16% 12%

6% 3%

● As EuroSCORE gets higher, ratio of TA to TF is greater

30

Monday, December 7, 2009


Perc. Ao Valve

Risk Analysis: Logistic EuroSCORE

Baseline EuroSCORE - The SOURCE Registry

49% 48%

50

38

25

13

0

30%

37%

16% 12%

Transapical

Transfemoral

6% 3%

Percent of Patients

< 20 20 - 40 41 - 60 > 60

● As EuroSCORE gets higher, ratio of TA to TF is greater

30

Monday, December 7, 2009


Perc. Ao Valve

Survival

TF (n=459)

TA (n=571)

30 day 93.7% 89.7%

EuroSCORE20 93.3%

SOURCE 30 Day All Cause Mortality -- Transfemoral Approach

Stratified by Logistic EuroSCORE

1

(Mean 33.7)

63% of pts

93.4%

(Mean 12.4)

88.1%

(Mean 36.3)

70% of pts

SOURCE 30 Day All Cause Mortality -- Transapical Approach

Stratified by Logistic EuroSCORE

1

0.95

0.95

0.9

0.9

Survival

0.85

0.8

0.75

0.7

0.65

< 20 >= 20

Survival

0.85

0.8

0.75

0.7

0.65

p=0.068

< 20 >= 20

0.6

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

0.6

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

Survival of TA pts with ES< and >20 show a strong trend toward a difference.

Why?.....Hypothesis generating……..patient demographics?

Monday, December 7, 2009


Survival

Perc. Ao Valve

The SOURCE Registry “Cohort 1”

Outcome related to Euroscore

TF (n=459)

TA (n=571)

30 day 93.7% 89.7%

EuroSCORE20 93.3%

SOURCE 30 Day All Cause Mortality -- Transfemoral Approach

Stratified by Logistic EuroSCORE

1

(Mean 33.7)

63% of pts

93.4%

(Mean 12.4)

88.1%

(Mean 36.3)

70% of pts

SOURCE 30 Day All Cause Mortality -- Transapical Approach

Stratified by Logistic EuroSCORE

1

0.95

0.95

0.9

0.9

Survival

0.85

0.8

0.75

0.7

0.65

< 20 >= 20

Survival

0.85

0.8

0.75

0.7

0.65

p=0.068

< 20 >= 20

0.6

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

0.6

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

Survival of TA pts with ES< and >20 show a strong trend toward a difference.

Why?.....Hypothesis generating……..patient demographics?

Monday, December 7, 2009


Perc. Ao Valve

Last patient enrolled:

• REVIVE - Dec 07

• REVIVAL - Dec 07

• PARTNER EU - Jan 08

• SOURCE - Jan 09

Revive TF

Revival TF

Partner EU TF

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

Source TF

Monday, December 7, 2009


Perc. Ao Valve

Edwards SAPIEN® Transcatheter Aortic Heart

Valve: Transfemoral Survival, All Studies 30D

1.0000

THV Mortality Transfemoral

0.9250

0.8500

0.7750

0.7000

Last patient enrolled:

0

• REVIVE - Dec 07

• REVIVAL - Dec 07

1.0000

• PARTNER Months post EU implant - Jan 08

• SOURCE - Jan 09

Revive TF

Revival TF

Partner EU TF

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

Source TF

Monday, December 7, 2009


Perc. Ao Valve

SOURCE

TRAVERCE

Last patient enrolled:

• REVIVAL II - Feb 08

• PARTNER EU - Jan 08

• TRAVERCE - Apr 08

• SOURCE - Jan 09

REVIVAL

PARTNER EU

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

33

Data Snapshot

Monday, December 7, 2009

12/07/09


Edwards SAPIEN® Transcatheter Perc. Ao Valve Aortic Heart Valve:

Transapical Survival, All Studies 30D

1.0000

THV Mortality Transapical

0.9250

Survival

0.8500

SOURCE

TRAVERCE

0.7750

0.7000

Last patient enrolled:

• REVIVAL II - Feb 08

PARTNER EU

• PARTNER EU - Jan 08

• TRAVERCE - Apr 08

0 • SOURCE - Jan 09

1.0000

Months post implant

REVIVAL

0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0

33

Data Snapshot

Monday, December 7, 2009

12/07/09


Monday, December 7, 2009

Perc. Ao Valve


Monday, December 7, 2009


Perc. Ao Valve

N= 132

Mortality 6

Implantation

Success

128

Vascular

complications 10

Monday, December 7, 2009


Perc. Ao Valve

Personal Experience

N= 132

Mortality 6

Implantation

Success

128

Vascular

complications 10

Monday, December 7, 2009


Perc. Ao Valve

# Patients

Surgery

THV

No THV

Risk

REVIVE REVIVAL PARTNER EU

SOURCE

Mean Euroscore (%) 29.8 ± 13.4 34.1 ± 18.0 25.7 ± 11.5 25.7

PARTNER EU REVIVAL TRAVERCE SOURCE

Mean Euroscore (%) 33.8 ± 14.7 36.2 ± 15.7 26.7 ± 12.7 29.2%

Monday, December 7, 2009


Perc. Ao Valve

Edwards SAPIEN ® THV treats an unprecedented high risk

# Patients

Surgery

THV

No THV

Risk

REVIVE REVIVAL PARTNER EU

SOURCE

Mean Euroscore (%) 29.8 ± 13.4 34.1 ± 18.0 25.7 ± 11.5 25.7

PARTNER EU REVIVAL TRAVERCE SOURCE

Mean Euroscore (%) 33.8 ± 14.7 36.2 ± 15.7 26.7 ± 12.7 29.2%

Monday, December 7, 2009


Perc. Ao Valve

Source: Millennium Research Group 2008

Monday, December 7, 2009


Perc. Ao Valve

Heart Valve Market Forecast . . .

Source: Millennium Research Group 2008

Monday, December 7, 2009


The PARTNER IDE Trial

Population: High Risk/

Non-Operable

Symptomatic, Critical

Calcific Aortic Stenosis

Co-principal Investigators:

Martin B. Leon, MD Interventional Cardiology

Craig Smith, MD, Cardiac Surgeon

Columbia University

Yes

ASSESSMENT:

Operability

No

n= up to

690 pts

Cohort A

Total n= 1040

Cohort B

n=350 pts

Yes

Cohort A TF

Powered Independently

ASSESSMENT:

Transfemoral

Access

No

Cohort A TA

Powered to be

Pooled with TF

Two Trials: Individually

Powered Cohorts

(Cohorts A & B)

Yes

ASSESSMENT:

Transfemoral

Access

No

1:1 Randomization

1:1 Randomization

1:1 Randomization

Not in Study

Trans

femoral

VS

AVR

Control

Trans

apical

VS

AVR

Control

Trans

femoral

VS

Medical Management

Control

Primary Endpoint: All Cause Mortality

(Non-inferiority)

Primary Endpoint: All Cause Mortality

(Superiority)

39

Data Snapshot

Monday, December 7, 2009

12/07/09


Monday, December 7, 2009

Perc. Ao Valve


Conclusions

Perc. Ao Valve

Transcatheter balloon expandable aortic valve

implantation is a major breackthrough in the treatment of

valvular disease.

Both transfemoral and transapical implantation have

demonstrated a rapid growing rate of inmediate success

and very good midterm outcome.

In my opinion transfemoral approach is the preferred one

when there is adequate vascular access

Technical advance and adequate patient selection will

result in the best clinical benefit for patients

Monday, December 7, 2009

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