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Percutaneous Approach to Aortic Valve Repair. William W. O’Neill, M.D. Executive Dean Clinical Affairs Miller School of Medicine University of Miami. CAD Circa 1950. Coronary Heart Disease Deaths in the U.S. 1973 - 1998 "A Shift to the Right". Source: www:BBHQ.com. 5.

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percutaneous approach to aortic valve repair

Percutaneous Approach to Aortic Valve Repair

William W. O’Neill, M.D.

Executive Dean Clinical Affairs

Miller School of Medicine

University of Miami

at least 30 40 of cardiologists as patients go untreated
At least 30-40% Of Cardiologists’ AS Patients Go Untreated

Severe Symptomatic Aortic StenosisPercent of Cardiology Patients Treated

No AVR

AVR

Under-treatment especially prevalent among patients managed by Primary Care physicians

Update May 2008

  • Bouma B J et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999;82:143-148
  • Iung B et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients)
  • Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 2005
  • Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:312-321
the problem is urgent treatment options and timing matter
The Problem Is Urgent Treatment Options and Timing Matter

“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

Survival

Percent

Onset severe symptoms

100

Angina

Latent Period (Increasing Obstruction, Myocardial Overload)

80

Syncope

Failure

2

4

6

0

60

Avg. survivalYears

40

20

AgeYears

0

40

50

60

70

80

Aortic stenosis is life-threatening and progresses rapidly

Update May 2008

Sources: 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.

slide14
Natural History of Candidates for Balloon Aortic Valvuloplasty, O’Keefe et al:Mayo Clinic Proceedings 62:986-991, 1987

50 Patients, mean age 77 yrs., operation declined in 28 and deferrred in 22

slide15

Predictors of Long Term Survival After Percutaneous Aortic Valvuloplasty: Report of the Mansfield Scientific Balloon Aortic Valvuloplasty Registry: O’Neill et al. JACC Vol.17, No.1, Jan 1991:193-8

hemodynamic comparison bav vs avr
Hemodynamic Comparison:BAV vs. AVR

*One year post-operation. Jin et al. Ann Thor Surg. 2001 May; 71(5 Suppl):S311-4

slide21

Clinical Trial Update

Edwards SAPIENTM Transcatheter Heart Valve1

It’s What You Leave Behind That Matters

Update May 2008

1. CAUTION – Investigational device. Limited by United States law to investigational use.

slide22

2

1,8

Mean Gradient (mm Hg)

AVA (cm²)

80

1,6

70

p = .0076

p = .0076

1,4

1.69

60

1,2

1

50

0,8

40

43

0,6

30

0,4

20

0,2

0.56

0

10

8.5

0

Pre

Post

Pre

Post

PROCEDURAL RESULTS

edwards sapien transcatheter delivery systems
Edwards SAPIEN® Transcatheter Delivery Systems

Pulmonic

Transfemoral

Transapical

Update SEPT 2008

cc mark

Lenox Hill

Heart and Vascular

Institute

Of New York

-

CC Mark

Edwards-Sapien

ReValvingⓇ System CoreValve

  • Single layer porcine pericardium
  • Tri-leaflet configuration
  • Nitinol frame self-expandable - Inflow: 26 and 29 mm – 20 to 27 mm annulus
  • Delivery system 18F / 12F (OD)
  • Bovine pericardium
  • Tri-leaflet configuration
  • Mounted on a 14 mm long x 23 mm or 26 mm diameter highly resistant stainless steel balloon expandable stent
  • Delivery system 24F - 26F (ID)
slide25

25

1/9/2009 11:21 AM

slide26

26

1/9/2009 11:21 AM

slide27

ASSESSMENT: Operability

No

Yes

n=350 pts

Cohort B

n= up to 690 pts

Cohort A

Total n= 1040

ASSESSMENT: Transfemoral Access

ASSESSMENT: Transfemoral Access

No

Yes

No

Yes

Cohort A TA

Powered to be Pooled with TF

Cohort A TF

Powered Independently

1:1 Randomization

Not in Study

1:1 Randomization

1:1 Randomization

Trans apical

AVR Control

Trans

femoral

Medical Management Control

Trans

femoral

AVR Control

VS

VS

VS

Primary Endpoint: All Cause Mortality

(Superiority)

Primary Endpoint: All Cause Mortality(Non-inferiority)

The PARTNER IDE Trial

Co-principal Investigators:Martin B. Leon, MD Interventional CardiologyCraig Smith, MD, Cardiac SurgeonColumbia University

Population: High Risk/Non-Operable

Symptomatic, Critical Calcific Aortic Stenosis

Two Trials: Individually Powered Cohorts(Cohorts A & B)

Update SEPT 2008

slide28

n = 1975

n = 456

n = 723

n = 121

n = 253

n = 95

n = 172

n = 106

n = 25

n = 24

CAUTION: Investigational device.

Limited by Federal (USA)

law to Investigational use only.

This product has not been approved for

marketing in the United States, and is not

available for sale in the United States.