transcatheter aortic valve implantation outcomes - dhm · transcatheter aortic valve implantation...
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Transcatheter Aortic Valve Implantation Outcomes
German Heart Center MunichDivision of Cardiac Surgery
March 4, 2011
TransfemoralTAVI
Outcomes
TAVI registries
Randomized controlled
trials
Peer-reviewed
observational
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
Baseline characteristics
Baseline characteristicsDHZ
• Mean age - 80 years • Logistic EuroSCORE – 20%
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
Procedural success with TAVIDHZ
> 98%
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
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%
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)
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)
Overall 3-year survival curve N = 554
Transfemoral, transaxillary, transapical, and transaorticCu
mul
ativ
e su
rviv
al (%
)
Days after TAVI
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
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)
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
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
Pacemaker ImplantationDHZ
24.8 to 18.6%
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
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)
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
Quality of Life at 1 year follow-upDHZ (n=186)
Improvement in physical quality of life maintained at 1 year follow-up
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