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"
250000
1973
1998
# Deaths
200000
150000
100000
50000
0
< 35
35-44
45-54
55-64
65-74
Age at Death
75-84
85+
Source: www:BBHQ.com
5
8
ACC/AHA 2006 Practice Guidelines JACC 2006;48:598-6
At least 30-40% Of Cardiologists’
AS Patients Go Untreated
Severe Symptomatic
Aortic Stenosis
100
AVR
Percent of Cardiology Patients Treated
90
41
32
30
31
60
70
45
48
60
50
40
68
30
70
69
59
Under-treatment
especially
prevalent among
patients
managed by
Primary Care
physicians
55
52
40
20
10
0
Boum a 1999
Iung* 2004
Pellikka 2005
Charlson 2006
Bach
Spokane
(prelim )
Vannan (Pub.
Pending)
1. 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 Journal
2003;24:1231-1243 (*includes both Aortic Stenosis and Mitral Regurgitation patients)
3. Pellikka, Sarano et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. Circulation 2005
4. Charlson E et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis2006;15:312-321
2.
Update May 2008
80
No AVR
The Problem Is Urgent
Treatment Options and Timing Matter
Aortic stenosis is life-threatening and progresses rapidly
100
Latent
Period
(Increasing
Obstruction
,
Myocardial
Overload)
80
60
40
20
0
Sources:
40
1
50
Onset
severe
symptoms
Angina
Syncope
Failure
0
2
4
“Survival after onset
of symptoms is 50%
at two years and
20% at five years.”1
6
“Surgical intervention
[for severe AS] should
be performed promptly
once even … minor
Age
2
80
Years symptoms occur.”
Avg. survival
Years
60
70
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.
Update May 2008
Survival
Percent
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
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
Death at 5 Years
100
90
80
Survival (%)
70
60
50
40
30
20
10
0
0
26
52
78
104
130
Weeks
156
182
208
234
260
Hemodynamic Comparison:
BAV vs. AVR
EOA (cm2)
Mean Gradient
(mmHg)
BAV O’NeillSurvivors
0.85
30.0
BAV O’NeillNon-survivors
0.78
28.2
BAV Kuntz et al
0.9
30
Surgical- porcine*
2.1
6.5
Surgical- pericardial*
2.07
5.8
Procedure
*One year post-operation. Jin et al. Ann Thor Surg. 2001 May; 71(5 Suppl):S311-4
Bittl et al. NEJM 1996;335:1290
Clinical Trial Update
Edwards SAPIEN Transcatheter
1
Heart Valve
It’s What You Leave Behind That Matters
1. CAUTION – Investigational device. Limited by United States law to investigational use.
Update May 2008
TM
PROCEDURAL RESULTS
Mean Gradient (mm Hg)
80
AVA (cm²)
2
p = .0076
p = .0076
1,8
70
1.69
1,6
60
1,4
50
40
1,2
43
1
0,8
30
0,6
20
0.56
0,4
8.5
10
0
Pre
Post
0,2
0
Pre
Post
Update SEPT 2008
Edwards SAPIEN® Transcatheter
Delivery Systems
Transfemoral
Transapical
Pulmonic
- Mark
CC
Lenox Hill
Heart and Vascular
Institute
Of New York
Edwards-Sapien
•
•
•
ReValvingⓇ System CoreValve
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




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)
25
1/9/2009
11:21 AM
26
1/9/2009
11:21 AM
The PARTNER IDE Trial
Co-principal Investigators:
Population: High
Risk/Non-Operable
Symptomatic, Critical
Calcific Aortic Stenosis
Martin B. Leon, MD Interventional Cardiology
Craig Smith, MD, Cardiac Surgeon
Columbia University
ASSESSMENT:
Operability
Yes
No
Cohort B
Cohort A
n= up to
690 pts
n=350 pts
Total n= 1040
ASSESSMENT:
Transfemoral Access
ASSESSMENT:
Transfemoral Access
Yes
Cohort A TF
Powered Independently
Two Trials: Individually
No
Yes
Cohort A TAPowered Cohorts
Powered to be(Cohorts A & B)
No
Pooled with TF
1:1 Randomization
Update SEPT 2008
1:1 Randomization
Trans
femoral
VS
AVR
Control
Not in Study
1:1 Randomization
Trans
apical
VS
AVR
Control
Primary Endpoint: All Cause Mortality
(Non-inferiority)
Trans
femoral
VS
Medical Management
Control
Primary Endpoint: All Cause Mortality
(Superiority)
n = 1975
n = 456
n = 723
n = 121
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.
n = 253
Update SEPT 2008
Edwards Lifesciences RetroFlex® II
Transfemoral Delivery Kit