Transcatheter Aortic Valve Implantation:
Current Clinical Update
Dr Martyn ThomasDirector of Cardiac Services
Guys and St Thomas NHS Foundation TrustA Member of Kings Health Partners
London
Available systems: Edwards (TA and TF) and Corevalve.
Current IndicationsThe Edwards SAPIEN transcatheter heart valve is indicated for use in patients with symptomatic aortic stenosis (aortic valve area <0.8 cm2) requiring aortic valve replacement who have high risk for operative mortality, or are “non-operable”, as determined by one of the following risk assessments:
1) Logistic EuroSCORE >20%or2) STS Score>10
Inclusion Criteria (from 18F safety & efficacy study)
1. Aortic valve area: < 1 cm2 (<0.6 cm2/m2)
2. Aortic valve annulus diameter: ≥ 20 mm and ≤ 27 mm
3. Ascending aorta: ≤ 43 mm
4. Iliac/femoral vessel diameter: ≥ 6 mmAND
5c. Age ≥ 65 yrs and 1-2 comorbidities
5b. Logistic ES ≥ 15% OR
5a. Age ≥ 75 yrs OR
Homograft – 1962
Porcine valve – 1965
Pericardial tissue valve – 1969
1960 20021970 2004
First CoreValve Transcatheter AVR by Retrograde ApproachLaborde, Lal, Grube – July 12, 2004
First PVT Transcatheter AVR by Antegrade ApproachAlain Cribier - 2002
Mechanical heart valve – 1962
Surgery
Transvascular
Aortic Valve Replacement
2006
First CoreValve PERCUTANEOUS AVRby Retrograde Approach – Oct 12, 2006Serruys, DeJaegere, Laborde
First Edwards/PVT Transapical Beating Heart AVRWebb, Lichtenstein – Nov 29, 2005
20012000
First PVT animalimplantationA. Cribier
First Corevalve animal implantation JC. Laborde
First-in-Man
RECAST REVIVE
REVIVE I REVIVAL I
Procedural success
in humans
Feasibility
REVIVE II REVIVAL II IDE TRAVERCE
PARTNER EU
Demonstrate “reasonable” safety
& effectiveness
Randomized Control
PARTNER IDE
Effectiveness vs. control (AVR &
medical therapy)
Post-Market
SOURCE
Evaluate transition to commercial use
Procedural success & clinical outcomes
Edwards SAPIEN™ THV Most recent clinical Results.
> 1500 Patients treated with Edwards Valve
*Implant success = Successful device delivery and deployment resulting in an AVA>0.9cm² with AI <2+
PARTNER EU TF: Procedure Outcomes
Ventricular embolization (n = 1)
Aortic embolization (n=1)23 mm SAPIEN valve
N=25
26 mm SAPIEN valve
N=27
Implant failures
n = 2
Patients Implanted
n = 54
Successful Implants*
n = 52
Patients Planned
n = 60Implant aborted
n = 6
Vascular access (n = 3)
Unsucessfull BAV (n=2)
Active endocarditis (n=1)
96.3%
THV Learning Curve Percent Successful Implant
80
85
90
95
100
%
PARTNER EU TFVascular Events
Event Total Days to Event
Phlebitis and Pulmonary Embolism 1 11
Iliac Artery Dissection 7 0
False Aneurysm 1 1
Wound dehiscence 1 4
Iliac Perforation 1 0
Groin Hematoma 2 0, 3
Iliac Occlusion 1 92
15%
Freedom from death at 6M = 90%
PARTNER EU TF: primary safety outcome.Freedom from death at 6 months.
PARTNER EU Transfemoral Survival (As Treated)
Data Extracted: 01SEP2008Time (months)
Pro
ba
bilty
(e
ve
nt
fre
e)
0 1 2 3 4 5 6
0.0
0.2
0.4
0.6
0.8
1.0
30D: 0.92Nrisk: 54
6M: 0.9Nrisk: 33
PARTNER EU TFFreedom from Stroke
PARTNER EU Transfemoral (As Treated) Freedom from Stroke
Data Extracted: 01SEP2008Time (months)
Pro
ba
bilty
(e
ve
nt
fre
e)
0 1 2 3 4 5 6
0.0
0.2
0.4
0.6
0.8
1.0
30D: 0.97Nrisk: 52
6M: 0.95Nrisk: 31
Freedom from Stroke at 6 Mo = 95%
NY
HA
Unknown
Exp/Withd
I
II
III
IV
Dead
Visit
Baseline(n= 54)
30 Day(n= 54)
3 Months(n= 54)
6 Months(n= 54)
13%
2%
15%
56%
15%
26%
31%
31%
4%
7%
22%
35%
31%
2%
9%
20%
41%
26%
4%
9%
PARTNER EU TF: Efficacy endpoints NYHA Class
Bubble Plot of Transvalvular Leak/Severity over Time
Transfemoral Only
Tra
nsv
alv
ula
r le
ak/
Se
veri
ty
0 (None)
+1 Trace
+2 Mild
+3 Moderate
Visit
Baseline(n= 18)
Discharge(n= 48)
30 Day(n= 36)
3 Months(n= 34)
6 Months(n= 34)
28%
22%
44%
6%
71%
23%
6%
69%
19%
11%
65%
26%
9%
74%
21%
3%
3%
PARTNER EU TF: Efficacy endpoints Paravalvular Leak
SOURCE Registry Post CE Mark Commercial Experience
Purpose Evaluate the transition to commercial clinical
use under controlled market release conditions with a prescribed training and proctor program
Objective Multicenter, observational collection of acute
and early (30d) procedural success and short term (1 yr)clinical performance outcomes
Procedural Success definition used by Sponsor to assess training success in new commercial sites
Defined as successful valve deployment and delivery system removal, AVA > 0.9 cm2 and AR ≤ 2.
The SOURCE Registry & SAPIEN™ THV Commercial Experience
Acute Procedural Success
Transfemoral Success 96.9%
(n=254)
Transapical Success 94.9%
(n=316)
Aborted Procedure 2.3%
Malposition 0.3%
Valve-in-Valve Bailout 0.7%
Pericardial Tamponade 0.7%
Coronary Interventions 0.7%
Vascular Complications 6.9% (19/273)
Intraprocedural Deaths 0.3% (1/273)
The SOURCE Registry Procedural Complications
Transfemoral
Complication Transapical(n = 295)
Aborted Procedure 1.0%
Malposition 0.7%
Valve-in-Valve Bailout 2.4%
Pericardial Tamponade 0.3%
Coronary Interventions 0.3%
Vascular Complications Access Injury Related to Closure Device Aortic Dissections/Perforations
1.0%0%0%
1.0%
Intraprocedural Deaths 1.7%
Hemodynamic Support 3.7%
The SOURCE Registry Procedural Complications
Transapical
*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)
< 30 day TransfemoralSurvival*(n=204)
93.6%
NYHA(n=99)
Class I: 39.4% Class II: 50.5% Class III: 9.1% Class IV: 1.0%
MI(n=204)
1.0%
Stroke(n=204)
3.4%
Vascular Complications (n=204)
7.4%
The SOURCE Registry30 Day Results: Trans-femoral
*Population analyzed = Patients with Sapien in place and alive post-procedure (no conversion)
< 30 day TransapicalSurvival*(n=173)
89.6%
NYHA(n=55)
Class I: 38.2% Class II: 56.4% Class III: 5.5% Class IV: 0%
MI(n=173)
1.2%
Stroke(n=173)
0.6%
Vascular Complications (n=173)
0.6%
The SOURCE Registry (TA)30 Day Results
THV Learning Curve: TFPercent Successful Implant
80
85
90
95
100%
Pooled Transfemoral TAVIAll Cause Mortality
Months Post Procedure
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
0 2 4 6 8 10 12
Free
dom
fro
m D
eath
Revival
Canada
Revive
Partner
Source
90%93.6%
Generation 1
25FGeneration
221F
CoreValve Self-Expanding ReValving™ SystemTechnological Progress
Generation 3
18F
14 patients14 patients
65 patients**65 patients**
124 patients 124 patients
** including 10 in feasibility study and 2 ReDo
2004-2005
2004-2005
2005-2006
2005-2006
2006-2007
2006-2007 Apr Jun
AugOct
Dec Fe
bApr Ju
nAug
0
500
1000
1500
2000
2007 2008
> 1600 Cases
Post CE Mark Cumulative 18F ReValving PAVR Procedures
Updated 01-October-2008: ~100 sites in 20 countries
The CorevalveAortic Valve Replacement
Personnal contribution as ProctorBefore CE mark : N = 123Registry period : N = 495
Procedural Results
Series186%
88%
90%
92%
94%
96%
98%
100%
90.4%
94.4%
98.2%
Procedure Success
Series10
50
100
150
200
250
205.3
154.1
125.9
Procedure Mean Time ± SD
21F S&E
18F S&E
18F EE
Site reported data only in the case of registry & not monitored
PAVR Cases Post CE Mark
24
758
2106
457
1134
301
972
0
500
1000
1500
2000
25002
00
7-A
pr
Ma
y
Ju
n
Ju
l
Au
g
Se
p
Oc
t
No
v
De
c
20
08
-Jan
Fe
b
Ma
r
Ap
r
Ma
y
Ju
n
Ju
l
Au
g
Se
p
Oc
t
No
v
Total # of Cases
Total # of In-Training Cases
Total # of Certified Cases
Procedural Results
In-Training (N = 809)
Certified (N = 456)
Both(N = 1265)
25
97.5% 98.9% 98.0%
0%
20%
40%
60%
80%
100%
Procedural Success
130.9118.3
126.5
0
20
40
60
80
100
120
140
160
180
200
Procedure Mean Time SD (minutes)
Procedural Complications*
*Multiple events in same patients = data not cumulative
21F S&E Study
(N = 52)
18F S&E Study
(N = 124)
18F EE Registry
≤ 24-Hour Mortality 0.0% 3.2% 1.5%
Aortic dissection 9.6% 0.8% 0.4%
Major bleeding 13.5% 8.0% 2.3%
Cardiac tamponade 5.8%) 6.5% 2.3%
Conversion to surgery 5.8% 2.4% 0.6%
Access site complication 9.6% 4.8% 1.7%
Site reported data only in the case of registry & not monitored
≤ 30-Day Adverse Events*
* Multiple events in same patients = data not cumulative
† Includes 4 deaths where cause is not known
21F S&E Study
(N = 52)
18F S&E Study
(N = 124)
18F EE Registry
30-Day All Mortality 15.4% 14.5% 9.7%
Cardiac Deaths 7.7% 11.2% 4.9%†
Myocardial Infarction 3.8% 3.4% 0.7%
Major Arrhythmias 25.0% 18.5% 4.9%
Pacemaker 17.3% 25.8% 12.2%
Renal Failure 5.8% 4.8% 1.2%
Stroke 17.3% 6.5% 2.2%
TIA 0.0% 5.6% 0.3%
Structural Valve Dysfunction 0.0% 0.0% 0.0%
Valve Migration 0.0% 0.0% 0.0%
Site reported data only in the case of registry & not monitored
Paired NYHA Comparison Baseline to 30-Day Follow-up
28
74.9% 73.4% 74.3%
23.8% 25.2% 24.3%
1.3% 1.4% 1.3%0%
20%
40%
60%
80%
In-Training Certified Both
Improved (III-IV to I-II) Unchanged Worsened (I-II to III-IV)
Transfemoral approach362
Transapical * 5
Left Subclavian 26
Right Subclavian 1
Trans aorta * 2
Personnal contribution as ProctorRegistry period 04/01/08 - 30/09/08N = 397* Out of the Registry
PAVR by Femoral vs Subclavian Access
The PARTNER IDE TrialCo-principal Investigators:
Martin B. Leon, MD Interventional CardiologyCraig Smith, MD, Cardiac Surgeon
Columbia University
Population: High Risk/Non-Operable
Symptomatic, Critical Calcific Aortic Stenosis
No
Not in Study
No
VSTrans apical
AVR Control
1:1 Randomization
Cohort A TAPowered to be Pooled with TF
YesCohort B
NoASSESSMENT:
Operability
Cohort An= up to 690 pts
n=350 pts
Total n= 1040
ASSESSMENT: Transfemoral Access
Transfemoral
AVR Control VS
Yes
1:1 Randomization
Cohort A TFPowered
Independently
Primary Endpoint: All Cause Mortality(Non-inferiority)
Medical Management Control
ASSESSMENT: Transfemoral Access
VSTrans
femoral
1:1 Randomization
Yes
Primary Endpoint: All Cause Mortality(Superiority)
Two Trials: Individually Powered Cohorts(Cohorts A & B)
Conclusions (Personal)Primary success rate is improving and training can
“limit” the learning curve of a TAVI device.Patient selection remains a “learning” curve.
Technical success but a non-cardiac death at 1 year with not be cost effective.
The trans-apical approach is very simple BUT requires a minithoracotomy.
The transfemoral approach is technically more difficult but has advantages if the peripheral complication rate can be minimised.
This is a major technology breakthrough.............what, where, why and when remain the questions!!
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