Tình hình thay van động mạch chủ qua đường ống thông ở hoa kỳ current status of TAVR in the US

TAVR Update 2014


Marvin H. Eng, MD FSCAI FACC
Assistant Professor of Medicine
Division of Cardiology
University of Texas Health Sciences Center
San Antonio, Texas
Disclosures
• Speakers Bureau for Edwards Lifesciences
• Consultant for NAVIGATE CSI
Goals of Percutaneous Valve Therapy
• No paravalvular leak
• Durable
• Safe
• Repositionable
• Low-Profile
– Transfemoral access
• Prevents myocardial
injury
– Heart block
• Easy to Implant

Edwards Balloon-Expandable Valves
Characteristics
Frame
SAPIEN
Stainless Steel
SAPIEN XT
Cobalt Chromium

S3
Cobalt Chromium
Annulus range
18-25 mm 18-29 mm 17-29 mm
Sizes
23,26 mm 23, 26, 29 mm 20, 23, 26, 29 mm
Sheath Size (ID)
22, 24Fr 16, 18, 20 Fr 14, 16Fr
Vascular
Complications (30D)
15.5% 9.5% 6.0%
Pacemaker (30D)
5.9 % 6.4% 13.3%
Stroke (30D)
3.0% 3.2% 2.7%
≥ Moderate
AR 12.2% 4.1 % 3.4%
Edwards Balloon-Expandable Valves
Access- XT
Sheath ID

Sheath OD

Sheath
OD
Expanded

Minimum
Vessel Diameter
23 mm

16Fr

6.7 mm

8.9 mm

6.0 mm

26 mm

18
Fr
7.2 mm

8.9 mm

6.5 mm

29 mm

20
Fr
8.0 mm

9.9 mm

7.0 mm

Balloon-Expandable Valves

Sapien 3 (S3)
Sheath ID

Sheath OD

Sheath
OD
Expanded

Minimum
Vessel Diameter
23 mm

14
Fr (4.6 mm)
6.0 mm

7.6 mm

5.5 mm

26 mm

14
Fr (4.6 mm)
6.0 mm

8.0 mm

5.5 mm

29 mm

16
Fr (5.3 mm)
6.7 mm

8.6 mm

6.0 mm

Binder R et al. JACC Int. 2013;6:301-7

PARTNER I-A
Leon MB ACC 2013
Edwards Sapien
PARTNER IB 5 Year data
PARTNER I-B
Kapadia S TCT 2014
S3 High-Risk Registry
30D
Clinical
Outcome TF
N=96
TA
N= 54
Overall
N= 150
Mortality
2 (2.1%) 6 (11.1%) 8 (5.3%)

CV Mortality
2 (2.1%) 5 (9.3%) 7 (4.7%)
Stroke
1 (1.0%) 3 (5.6%) 4 (2.7%)
Disabling
Stroke 0 (0.0%) 0 (0.0%) 0 (0.0%)
Major Vascular
Complications

5 (5.2%) 4 (7.4%) 9 (6.0%)
Major Bleeding
19 (19.8%) 11 (20.4%) 30 (20%)
Re
-Hospitalization 0 (0.0%) 0 (0.0%) 0 (0.0%)
Webb J TCT 2014
Washington D.C.
Self-Expanding
Medtronic CoreValve Series
Engager TA 23/26 mm
Annulus Range
18-29 mm 18-26 mm 21-26.7 mm
Sheath Size (ID)
18Fr 14Fr 29Fr
Access
TF, SC, TAo TF, SC, TAo TA, TAo
Pacemaker
rate 26.1% ? 16.9%
Medtronic CoreValve vs. SAVR
Increased Surgical Risk
Adams DH et al. NEJM 2014;370:

1790-1798.
CoreValve- Extreme Risk Registry
Paravalvular Leak
Popma, JJ et al. JACC 2014; 63:1972-81.
Balloon vs. Self-Expanding
CHOICE (Sapien XT vs MCV)
Balloon n=121

Self n=117

RR (95% CI)

P
-value
Device
Success

95.9%

77.5%

1.24 (1.12
-1.37)
<0.01

Final
AR (angio)

None/trace
62.0%

35.0%

1.77 (1.34
-2.35)


<0.001


Mild
33.9%

46.7%

0.73 (0.53
-0.99)

Moderate
3.3%

14.1%

0.23 (0.08
-0.67)

Severe
0.8%

4.2%

0.20 (0.02
-1.67)
30
-day
Death

4.1%

5.1%

0.81 (0.25
-2.57)
0.77

Stroke

5.8%

2.6%

2.26 (0.60
-8.52)
0.33

Major
Bleeding

8.3%

12.0%

1.31
(0.74-2.32)
0.36

Vascular

Complications

14.0%

12.8%

1.10 (0.57
-2.09)
0.78

Pacemaker

17.3%

37.6%

0.46 (0.28
-0.74)
0.001

Abdel-Wahab M et al. JAMA 2014;311: 1503-1514.
CHOICE

Aortic insufficiency
Abdel-Wahab M et al. TCT 2014
Washington D.C.
Self-Expanding Valves
Direct Flow
Schoafer J et al. JACC 2014;63: 763-8.
Bijuklic C et al. Eurointervention 2013;8:Q75-8.
• 23, 25, 27, 29 mm valves
– 19-28 mm annuli
– 18Fr
– Conformable polyester cuff
– Rings pressurized with saline and contrast
– Infuse polymer to solidify rings
Direct Flow
Inner Curve Technique
DeMarco F. et al. Eurointervention 2014;10
:400-402.
Direct Flow
Registry and DISCOVER Trial
Tuzcu EM TCT 2014 Washington D.C.
30
DAY Outcome Real World
(n=105)
DISCOVER
(n=75)
P-value
Death
1.9% (2) 1.3%(1) 0.768
MI
0% (0) 1.3% (1) 0.417

Stroke
1.9% (2) 4% (3) 0.651
Major Vascular
Complications

3.8% (4) 2.7% (2) 0.674
Composite
Safety
End
-Point
89.5% 91% (68) 0.801
17%
Self-Expanding Valves
Portico Valve
• Bovine Leaflets
– Porcine Cuff
• 23 mm 19-21 mm
• 25 mm 21-23 mm
• 27mm  23-25 mm
• 29mm  25-27 mm
• 18Fr
• Retrievable
Manohoran G. et al. Eurointervention
2012;8: Q97-Q101.
Portico Valve
CE mark Trial
N=103
30 day 1 year
Death
2.8% 8.7%

CV
Death 2.9% 5.8%
Stroke (major
+minor) 3.9% 5.8%
New pacemaker
9.7% 10.7%
MI
1.9% 1.9%
Major
Vascular
Complication

5.8% 6.8%
Major Bleeding
3.9% 3.9%
Manoharan G et al. TCT 2014
Washington D.C.
Self-Expanding Valves
Edwards Centera
⟩ 23, 26, 29 mm sizes
⟩ Bovine pericardium leaflets
⟩ PET skirt
⟩ Motorized deployment
⟩ Recapturable at 70%
deployment
⟩ Anticipate14Fr e-sheath
⟩ 4/15 (27%) pacemaker
implant
Binder R et al. JACC Int. 2013;6:301-7.
Kuck KH TCT 2014 Washington D.C.

0
2
4
6
8
10
12
14
None/Trace Mild Moderate Severe
Baseline Discharge
Paravalvular Leak
“Mechanical Expanding” Valve
Lotus Valve
• Neither self or balloon
expandable
– Mechanical expansion
• Repositionable
• Retrievable
• Adaptive Seal

Merideth, I et al. EuroIntervention
2014;9: 1264-1270.
Lotus Valve
“Mechanical” Deployment
Merideth, I et al. EuroIntervention 2014;9:
1264-1270.
Lotus Valve in High Risk Pts
REPRISE II- 1 Year (n=120)
Merideth, I et al. TCT 2014 Washington D.C.
Event

Discharge 7d

30 Days

1 Year

Death

3.3% (4/120)

4.2% (5/119)

10.9% (13/119)
CV Death

3.3%
(4/120)
4.2% (5/119)

6.7% (8/119)

Disabling

stroke
1.7% (2/120)

1.7%
(2/119)
3.4% (4/119)

Non
-disabling
stroke

4.2% (5/120)

4.2% (5/119)

5.9% (7/119)

Total stroke

5.9% (7/120)

5.9% (7/119)

9.3% (11/119)

31.9%
Self-Expanding Valve
VENUS A
• Nitinol frame
• Porcine Pericardium
• 23, 26, 29, 32 mm
– Rounded eyelets
– Enhanced inflow (20
mm) strength
– Tapered Inflow
– Radiopaque Markers

– Sheathless 19fr

Gao R el al. TCT 2014 Washington D.C.
Other Valves
Accurate, Jena, Innovare, Syntheon