ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
.pdf
Role of 3D TEE
Annular Measurements
Advantages of 3D:
1.Ensures on-axis measurements of orthogonal views
2. Allows 3D assessment of annulus
Case Study: Determining
Appropriate THV Size
Aortic Complex Check List:
Annulus
Aortic Root Length
Sinotubular Junction (STJ)
LM distance
LVOT anatomy
Aorta Measurements
26 mm SAPIEN Valve |
23 mm SAPIEN Valve |
26 |
23 |
mm |
mm |
16 |
14 |
mm |
mm |
Annulus = 22.5 mm |
|
|
Aortic Root Length 17 mm |
23 mm THV chosen |
|
STJ = 20.5 mm |
||
|
||
LM distance = 12.6 mm |
|
|
LVOT = sigmoid septum |
|
Role of Imaging
23 mm THV positioned on the annulus
23 mm THV Final Position: slightly HIGH
Annulus = 23 mm
Aortic Root Length 17 mm
STJ = 20.5 mm
Lmain distance = 12.6 mm
Sigmoid Septum
Transcatheter AVR
Next Generation
Technology…
Edwards SAPIEN vs SAPIEN XT Transcatheter Heart Valves
NEW FRAME GEOMETRY |
SAPIEN THV |
SAPIEN XT THV |
|
Stainless Steel |
Cobalt-chromium |
||
• Less metal content |
|||
|
|
||
• Lower crimp profile |
|
|
NEW FRAME MATERIAL
•Cobalt-chromium
•Greater tensile and yield strength
NEW LEAFLET GEOMETRY
• Partially closed
RetroFlex 3 |
NovaFlex |
The PARTNER II Trial
Study Design
|
|
Symptomatic Severe Aortic Stenosis |
|
|
|
|
ASSESSMENT by Heart Valve Team |
|
|
n = 2000 |
Operable |
Two Parallel |
n = 560 |
|
Randomized |
Inoperable Randomized |
|||
(STS ≥4) |
Randomized Trials |
|||
Patients |
Patients |
|||
|
+6 Nested Registries |
|||
|
|
|
|
ASSESSMENT: |
|
|
Yes |
No |
||
Transfemoral |
|||
|
|
||
|
Access |
|
Transfemoral (TF) |
Transapical (TA) / |
|
TransAortic (TAo) |
||
|
||
1:1 Randomization |
1:1 Randomization |
TF TAVR |
|
Surgical |
TAVR: |
|
Surgical |
|
|
TA / TAo |
|
||||
SAPIEN XT |
|
AVR |
|
AVR |
||
VS |
SAPIEN XT |
VS |
||||
|
|
|
Primary Endpoint: All-Cause Mortality +
Disabling Stroke at Two Years
(Non-inferiority)
ASSESSMENT:
Transfemoral
Access
Yes
|
|
|
6 Nested |
Sample |
|
1:1 Randomization |
Registries |
Size |
|||
|
|
|
NR1 (Sm Vessel) |
100 |
|
|
|
|
NR2 (Transapical) |
100 |
|
TF TAVR |
|
TF TAVR |
NR3 (ViV) |
100 |
|
SAPIEN XT |
VS |
SAPIEN |
|||
|
|
||||
|
|
|
|
||
|
|
|
NR4 (TAo) |
100 |
|
Primary Endpoint: All-Cause |
|
|
|||
Mortality + Disabling Stroke + |
NR5 (29 mm TF) |
50 |
|||
Repeat Hospitalization at One Year |
|
|
|||
(Non-inferiority) |
NR6 (29 mm TA) |
50 |
|||
All-Cause Mortality (ITT)
All-Cause Mortality
70%
60%
50%
40%
30%
20%
10%
0%
SAPIEN
SAPIEN XT
HR [95% CI] =
0.93 [0.66, 1.33] p (log rank) = 0.706
5.1%
3.5%
23.7%
22.5%
|
0 |
3 |
6 |
9 |
12 |
No. at Risk |
|
Months post Randomization |
|
|
|
SAPIEN |
276 |
246 |
227 |
213 |
137 |
SAPIEN XT |
284 |
255 |
242 |
232 |
147 |
Vascular Complication Categories:
At 30 Days (AT)
SAPIEN |
SAPIEN XT |
(n=271) |
(n=282) |
Events |
n |
% |
n |
% |
p-value |
|
|
|
|
|
|
Perforation |
13 |
4.8 |
2 |
0.4 |
0.003 |
Dissection |
25 |
9.2 |
12 |
4.3 |
0.03 |
Hematoma |
16 |
5.9 |
10 |
3.6 |
0.23 |
CoreValve® Design
Outflow
Orientation
Constrained
Portion
Valve Function
Inflow
Portion
Sealing
Low Radial Force
Low Radial Force
High Hoop Strength
High Radial Force
High Radial Force
1.Sits in ascending aorta
2.Orientation during deployment
1.Supra-annular valve function
2.Avoid coronaries
1.Intra-annular anchoring
2.Mitigates paravalvular aortic regurgitation