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
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