Bệnh tim cấu trúc và bệnh lý van tim có gì mới trong năm 2015-2016

Structural and Valvular
interventions 2015-2016
A/Prof Michael Nguyen
Fiona Stanley Hospital
Australia


Overview
•
•
•
•
•

Mitral valve interventions
Aortic valve interventions
Lef atrial appendage occlusion
Heart Failure interventions
Patent Foramen Ovale closure


Mitral Valve Interventions


How th e d evice works


EVEREST 2


A. Freedom From Death, MV Surgery or Reoperation

B. Freedom From Death

1.0

1.0

L.,..

0.8

,_

....

c:

0.8

~

0.6

i:::;:-::;-

0.6

~

'-

---

::;

~

~

0.4

0.4

0.2

0.2
evice (n = 178)
rgery (n = 80)

0.0

0.0
0

6

12

24

Patients At Risk

48
- 36 RCT Device (n = 178)
Months

Device Group

178

Control Group

80

136

128

117

75

69

63

c

·

60

RCT Surgery (n = 80)

-

109
54

0

6

12

24

Patients At Risk

98

45

49

21

Freedom From MV Surgery or Reoperation

36

Months

48

-

RCT D

-

RCT Su

Device Group

178

165

158

143

133

Control Group

80

76

70

65

57

60

119

58

52

24

D. Landmark Analysis of Freedom From MV Surgery or
Reoperatton Beyond 6 Months

1.0

0.8

:; I

\:

.,

0.6

0.4

0.2
-

0.0
0

6

12

24

136

128

117

Control Group

RCT Device (n = 178)

-

RCT Surgery (n

36

48

=

80)

178
80

75

Feldman, T. et al. J Am Coll Cardiol. 2015; 66(25):2844-54.

69

63

RCT Device (n = 136)

-

24

Months

Patients At Risk

Device Group

-

RCT Surgery (n

36

=

75)

48

60

45

Months
109
54

98

117

109

98

49

63

54

49

21


A

p=0.11

p=0.004

p=0.01

12 Months

5 Years

100%
90%
80%
70%
........

-. #.
c:

·..:::;
Q)
ro

..

V I

c..

60%
50%
40%
30%
20%
10%
0%

Baseline

B

p=0.99

p=0.03

p=0.19

100%
90%

80%
70%
........

-.

#.

c:
·..::
V I
Q)

..

c..

:;

60%
50%
40%
30%

ro
20%
10%
0%

Baseline

12 Months

5 Years


EVEREST II trial results.

Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc
Interv. 2015;8:e001943


Table 3.

EVEREST II Trial: 5-Year Follow-Up Data Accordingto MR Etiology
Degenerative MR
MitraClip (n=130)

Functional MR
Surgery (n=62)

MitraClip (n=48)

Surgery (n=18)

Freedom from mortality

89% [78%-95%]

86% [60%-96%]

60% [32%-79%]

55% [27%-76%]

Freedom from MV surgery or reoperation

69% [55%-80%]

96% [62%-1 00%]

90% [43%-99%]

81 % [33%-96%]

MR grade ~2+

81%

100%

86%

86%

NYHA class ~2

95%

97%

76%

100%

lVEDV reduction, ml

-31.7

-49.2

-23.8

-13.2

lVESV reduction, ml

-5.6

-8.8

-4

-5.2

lVEDV indicates left ventricular end-diastolic volume; lVESV, left ventricular end-systolic volume; MR, mitral regurgitation; MV, mitral valve; and NYHA, New York
Heart Association functional class.


Percutaneous

Maria Del Trigo, and Josep Rodés-Cabau Circ Cardiovasc
Interv. 2015;8:e001943

mitral annuloplasty

devices.


TITAN 2 : Carillon Mitral Device


Percutaneous Mitral Valve
Replacement


Atrial skirt
Posterior

"-,.

anchor

•

.;)

•

\

)

CardiaQ

Anterior

.---------------i
anc

-

....

hors

'<

.\

/

.

'>-/'
'

I

>..._

I

-

~

,

...

-..I.,

-

Medtronic device

_.,..

-

Edwards FORTIS

.;

'


CardiAQ valve.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409

Tiara valve.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


Tendyne valve.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


Medtronic transcatheter mitral valve.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


Valtech’s Cardiovalve is a transcatheter mitral valve replacement system designed to be
implanted using the transfemoral route.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


HighLife transcatheter mitral valve replacement system.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


MitrAssist’s valve-in-valve: a valve that assists the existing valve.

Ole De Backer et al. Circ Cardiovasc Interv. 2014;7:400-409


TAVR


'
'

'\

I

.

\/

~

XT™

Sapien

CoreValve™

3™

~

I

I"

"

CoreValve Evolut™

Portico™

1\1 I
,..

I

·.
,
Direct

Flow™

Lotus TM

Accurate TM

Jenavalve™

'
f

r
\/

Sapien

I
\/

Engager™

I
I.


TAVR outcomes


US outcomes


Partners 2 – Intermediate
A

Intention-to-Treat Population

50
100

B

50

Hazard ratio, 0.89 (95% Cl, 0. 73-1.09)

P=0.25

40

risk (STS 4% to 8%)

As-Treated Population

100

80
0

70

v,

U"- '""

21.l

0

50
60

0

ec:

30

70

2

cu

o=

21.0

0

60
50

E ~
~

30

80

::::,<(

40

90

90
~~

ratio, 0.87 (95% Cl, 0.71-1.07)

Hazard

P=0.18

30
40

1
3

6

9

12

15

18

21

24

3

6

12

9

15

18

21

24

40

..0

20

.

c

:

1 ua

:::

~ 0

30

10
0-+-~~~~~~~~~~~~~~~~~~~~~~~

20
0

3

6

12

9

15

18

24

21

Months since Procedure

10

Surgery

C

Transfemoral-Access Cohort, Intention-to-Treat Analysis
0
3
6

50
No. at Risk

TAVR
Surgery

TAVR
9

12

15

18

21

24

D

838

917

826
900

870

807
842

100

901

870

783

812

770

842

825

747

779

825

50

Months since Procedure
Hazard ratio, 0.79 (95% Cl, 0.62-1.00)

40
1011 918

90
1021
80

994

801

811

735

717

766

801

811

774

695

40

80

30

15.9

20.0
16.3

1

1
3

40

6

9

40

12
15

18

21

24

6

9

15

6

9

12

15

Months since Procedure

18

21

3

6

24

24

9

12

15

18

21

24

Months since Procedure
Surgery

722

636

No. at Risk
No. at Risk

21

0-+-~~~~~~~~~~~~~~~~~~~~~~~
0

3

18

10~::::::======::::::======-~~~

0-+-~~~~~~~~~~~~~~~~~~~~~~~
0

12

20

===

j_,c

3

30

:::::::::::::::=================

20

301

10

15.8

0

60
50

50

694

ratio, 0.78 (95% Cl, 0.61-0.99)

Hazard

70

20.4
0
20

715

P=0.04

20

70

731

90

30

60

743

774

Transfemoral-Access Cohort, As-Treated Analysis

P=0.05

100

944

No. at Risk

0-+-~~~~~~~~~~~~~~~~~~~~~~~

TAVR

762

717

708

685

624
663

652

600
644

591
634

612

573

565

555

537