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Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery March 4, 2011

Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

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Page 1: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Transcatheter Aortic Valve Implantation Outcomes

German Heart Center MunichDivision of Cardiac Surgery

March 4, 2011

Page 2: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

TransfemoralTAVI

Outcomes

TAVI registries

Randomized controlled

trials

Peer-reviewed

observational

Page 3: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Country-based TAVI registries

Belgium (n=328)

France (n=244)

Germany (n=697)

United Kingdom (n=872)

Italy (n=772)

Presented in Paris at EuroPCR 2010

Page 4: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011
Page 5: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Baseline characteristics

Page 6: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Baseline characteristicsDHZ

• Mean age - 80 years • Logistic EuroSCORE – 20%

Page 7: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Procedural success

83,1

91,2

97,2 98,2 98,1

77,8

86

94,1

90

95,2

90,5

50

55

60

65

70

75

80

85

90

95

100

S&E Sgb Eur Ital Spain Web6 Web7 Web9 Him Thom Rod

N=126

Büllesfeldsubmitted

N=136

GrubeCirc Interv

2008

N=646

PiazzaEuroInterv

2008

N=514

PetronioCirc Interv

2010

AvanzasRev Esp

Card 2010

N=108 N=18

WebbCirculation

2006

N=50

WebbCirculation

2007

N=113

WebbCirculation

2009

N=463

ThomasCirculation

2010

Rodés-CabauCirculation

2010

N=168

%

N=51

HimbertJACC 2009

CoreValve

Edwards Sapien

Page 8: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Procedural success with TAVIDHZ

> 98%

Page 9: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

AvanzasRevEspCard

2010

N=108

All-cause mortality at 30 Days

14,3

10,8

8

5,4

7,4

0

5

10

15

Safety & Efficacy

18F

Sg EU It

Medtronic CoreValve Edwards Sapien THV

N=136

GrubeCirc Interv

2008N=646

PiazzaEuroInterv

2008N=514

PetronioCirc Interv

2010N=126

Büllesfeldsubmitted

11,112

8

6,3

9,5

Web6 Web7 Web9 Th10 Rod10

%

N=18

WebbCirculation

2006

Rodés-CabauCirculation

2010

N=168N=50

WebbCirculation

2007

N=113

WebbCirculation

2009N=463

ThomasCirculation

2010

Page 10: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

0

2

4

6

8

10

12

14

Belgium France Germany UK Italy

%European registry results

30-day mortality

9%

12.7%

7.5% 7.2%6.9%

Page 11: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

30 day mortality with growing experience *

11.4 to 3.8%

* Patients were subcategorized into temporal quartiles (Q1 represents the first 105 patients and Q4 represents the last 105 patients of our experience)

Page 12: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Cumulative survival*

Q4 vs. Q1

HR (95% CI) p-value

0.49 (0.25-0.95) 0.035

6-month mortality

Q4 vs. Q1

HR (95% CI) p-value

0.33 (0.11-1.00) 0.053

30-day mortality

(3.8% vs. 11.4%) (12.4% vs. 22.4%)

* Patients were subcategorized into temporal quartiles (Q1 represents the first 105 patients and Q4 represents the last 105 patients of our experience)

Page 13: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Overall 3-year survival curve N = 554

Transfemoral, transaxillary, transapical, and transaorticCu

mul

ativ

e su

rviv

al (%

)

Days after TAVI

Page 14: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Stroke rate at 30 Days

CoreValveEdwards Sapien

9,6

2,9

1,9

1,8

2,8

0

4

5,3

6

2,4

3

0 2 4 6 8 10 12

S&E

Sg

EU

It

Ger

Web6

Web7

Web9

Him

Thom

Rod

N=136Grube Circ Interv 2008

N=646

Piazza EuroInterv 2008

N=514

Petronio Circ Interv 2010

N=126

Büllesfeld 18F S & E

Zahn EHJ In press

N=588

N=18Webb Circulation 2006

Rodés-CabauCirculation 2010N=168

N=50Webb Circulation 2007

N=113Webb Circulation 2009

N=463

Thomas Circulation 2010

Himbert JACC 2009N=51

CoreValveEdwards Sapien

Page 15: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Stroke at 30 days

6.7 to 1.0%

* Patients were subcategorized into temporal quartiles (Q1 represents the first 105 patients and Q4 represents the last 105 patients of our experience)

Page 16: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Pacemaker implantation% CoreValve

Edwards Sapien

26,2

33,3

9,3

16,3

35,2

42,5

0

4 4,46 6,7

3,6

0

5

10

15

20

25

30

35

40

45

S&E Sgb Eur Ital Spai Germ Web6 Web7 Web9 Him Thom Rod

N=126

Büllesfeldsubmitted

N=136

GrubeCirc Interv

2008

N=646

PiazzaEuroInterv

2008

N=514

PetronioCirc Interv

2010

AvanzasRev Esp

Card 2010

N=108 N=18

WebbCirculation

2006

N=50

WebbCirculation

2007

N=113

WebbCirculation

2009

N=463

ThomasCirculation

2010

Rodés-Cabau

Circulation2010

N=168N=51

HimbertJACC 2009

ZahnEHJ

Inpress

N=588

Page 17: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

0

10

20

30

40

50

Belgium France Germany UK Italy

European Registry ResultsPacemaker implantation

MDT CoreValve

Edwards SAPIEN

23

5

27

5

41

2119

26

7

Page 18: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Pacemaker ImplantationDHZ

24.8 to 18.6%

Page 19: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Vascular complications

%

16

1,9 1,8

5,6

19,5

13

9,5

7,5 8

12

17,9

13,1

0

2

4

6

8

10

12

14

16

18

20

Mu Eur It Sp Ger Net Tch Fr Web9 Him Thom Rod

N=646

PiazzaEuroInterv

2008

N=103

BleizifferEurJCVSurg

2009

N=514

PetronioCirc Interv

2010

AvanzasRev Esp

Card2010

N=108

ZahnEHJ

In press

N=588

v.MieghemEuroInt

2010

N=99

EltchaninoffEHJ

in press

N=21

TchetcheEuroInt

2010

N=21 N=113

WebbCirculation

2009

N=51

HimbertJACC 2009

N=463

ThomasCirculation

2010

Rodés-CabauCirculation

2010

N=168

CoreValve

Edwards Sapien

Page 20: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Vascular complications

26.7 to 9.5%

* Patients were subcategorized into temporal quartiles (Q1 represents the first 105 patients and Q4 represents the last 105 patients of our experience)

Page 21: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

PF=physical functioning; RP=role physical; BP=bodily pain; GH=general health; VT=vitality; SF=social functioning; RE=role emotional; MH=mental health

Marked improvement in all 8 domains of the SF12 questionnaire at early and intermediate-term follow-up.

5-month follow-up

1. Ussia et al. EHJ 2009;30:1790-1796

12-month follow-up

Edwards2CoreValve1

Quality of Life

2. Pooled REVIVE and REVIVAL data

Page 22: Transcatheter Aortic Valve Implantation Outcomes - DHM · Transcatheter Aortic Valve Implantation Outcomes German Heart Center Munich Division of Cardiac Surgery. March 4, 2011

Quality of Life at 1 year follow-upDHZ (n=186)

Improvement in physical quality of life maintained at 1 year follow-up