1. The SOURCE Family of Registries
1 Year Results from Cohort 1 of the SOURCE Registry
The European Registry of Transcatheter
Aortic Valve Implantation using the
Edwards SAPIEN Valve
Martyn Thomas, MD , Gerhard Schymik, MD, Thomas Walther, MD, Dominique
Himbert, MD, Thierry Lefèvre, MD, Hendrik Treede, MD, Holger Eggebrecht, MD,
Paolo Rubino, MD, Iassen Michev, MD, Rüdiger Lange, MD and Olaf Wendler,
MD on behalf of the SOURCE investigators
2. Potential Conflicts of Interest
Speaker’s name: Dr Martyn Thomas
I have the following potential conflicts of interest to report:
Research contracts
Consulting for Edwards Lifesciences
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
2
3. Background
• Trans-catheter Aortic Valve Implantation (TAVI) is an
alternative to open surgery in patients considered to be
at high risk for the standard procedure.
• Cohort 1 of The SOURCE Registry describes the
outcomes in a consecutive group of patients treated in
32 European centres during the first year of
commercialisation of the Edwards SAPIEN Valve from
Nov 07 to Jan 31st 09.
3
4. The SOURCE Family of Registries
Timeline
2009 2010 2011
Nov 07
SOURCE COHORT 1
SOURCE COHORT 2
PREVAIL
SOURCE XT EU
SOURCE XT Global
4
5. Methods: EuroPCR 09
34 Centres Initially Participating in
Commercial Launch
1123 patients
Excluded: Included:
2 Centres / 85 patients 32 centres
• Unable to obtain Ethic Cte approval
• Unable to secure administrative support
1038 patients
• One missing patient due to admin. error
We now present 1 year data
that represents systematic
follow-up on 98% of
EuroPCR The SOURCE Registry has
100% procedure data implanted patients.
99.9% 30 Day Data
98% 30 day data
2010 All consecutively enrolled
5
6. The SOURCE Registry Enrollment
Site Name Pts Site Name Pts
Karlsruhe/Städisches Klinikum + Herzklinik – 89 Rouen/CHU – H Eltchaninoff, JP Bessou 31
G Schymik, H Schroefel
Leipzig/Herzzentrum - T Walther, G Schuler 87 Madrid/S Carlos – C Macaya, E Rodriguez 31
London/St Thomas’ + King’s -M Thomas, O Wendler 75 Bern/Inselspital- P Wenaweser, T Carrel 31
Paris/Bichat – D Himbert, P Nataf 56 Münster – H Baumgartner, H Reinecke 30
Massy/Jacques Cartier - T Lefèvre, M Romano 51 Jena/Uniklinik – K Hekmat, M Ferrari 26
Hamburg/Uniklink- H Treede, O Franzen 48 Lund/Universitetssjukhuset – G Olivecrona, P Johnsson 23
Essen/Uniklinik – H Eggebrecht, M Thielmann 47 Bruxelles/St Luc – P Astarci, J Kefer 21
Mercogliano/Clinica Montevergine-P Rubino, G Sorrogpago 47 San Sebastian/Gipuzkoa – J Goiti, M Larman 20
Milan/S Raff – I Michev, F Maisano 41 Leuven/Gasthuisberg – C Dubois, P Herijgers 17
Munich/DHZ – R Lange 41 Frankfurt/Uniklinik –V Schächinger, M Doss 15
Athens/Onassis – K Spargias, G Stavridis 36 London/Brompton – M Mullen, N Moat 12
Milan/Monzino – P Bigliogli, M Fusari 35 Innsbruck/Uniklinik – L Mueller, T Bartel 10
Paris/HEGP – D Blanchard, JN Fabiani 34 Lübeck/Uniklinik – ED Kraatz, H Sier 8
Aarhus/Skejby- HR Andersen, KE Klaaborg 34 Cambridge/Papworth – C Densem, P Calvert 8
Zurich/KlinikimPark+Hirslanden- W Amann, F Bernet 34
TOTAL 1038
6
8. Major Complications (≤ 30 Days)
To give Context of Early v Late Events
TF (n=463) TA (n=575) Total (n=1038)
Death 6.3% 10.8% 8.8%
Stroke 2.6% 2.4% 2.5%
Renal Failure 1.3% 7.0% 4.4%
Requiring
Dialysis
Permanent 6.0% 7.7% 6.9%
Pacemaker
8 Data Snapshot 5/03/10
11. All Data as KM Curves
Cohort 1: 1 YR (Events: Late)
Freedom From: Stroke, PM, MI
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12. SOURCE vs Normal Elderly Population
Cause of Late Stroke (30 Days to 1 Year)
Type of Stroke (Total =19 patients) n/%
SOURCE HEMORRHAGIC (n=4/19) 4/21.1%
Mean (days to adverse event ) 176
Median (days to adverse event ) 167
NORMAL ELDERLY POPULATION* 13%
SOURCE NON-HEMORRHAGIC (n=13/19) 13/68.4%
Mean (days to adverse event ) 163
Median (days to adverse event )
117
NORMAL ELDERLY POPULATION* 87%
SOURCE UNKNOWN (n=2) 2/10.5%
Mean (days to adverse event) 158
Median (days to adverse event ) 158
*Lloyd-Jones D, et al. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart
Association. Circulation. 2010 Feb 23;121(7):948-54. Erratum in: Circulation. 2010 Mar 30;121(12):e259.
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13. All Data as KM Curves
Cohort 1: 1 YR (Events: Late)
Freedom From: Vascular Complication, Endocarditis, and Re-Operation
13
14. Early Vascular Access Complications
Relationship to 1 Year Mortality (NB 22/24F Device)
% Survival in Pts who did % Survival in Pts who did
Approach not have vascular access have vascular access P-Value
complications complications
TF 83.9% 72.2% 0.0121
TA 73.2% 47.4% 0.0188
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15. ALL
179
Causes of Death
30 Days to 1 Year
Cardiac
45 (25.1%)
Non Cardiac
88 (49.2%)
Unknown
46 (25.7%) ALL
Heart Failure Pulmonary*** Sudden Death
28 (62.2%) 21 (23.9%) 18 (39.1%)
Myocardial
Renal Failure Unknown
Infarction
11 (12.5%) 18 (39.1%)
6 (13.3%)
Endocarditis Cancer Other
3 (6.7%) 10 (11.4%) 10 (21.7%)
Other* Stroke Other * = Arrhythmia, cardiac arrest
8 (17.8%) 9 (10.2%) Other** = Sepsis, vascular access related, major
bleeding, infection, suicide, and multiple organ failure
Pulmonary***= Respiratory Failure, Pulmonary
Gastrointestinal Embolism and Pneumonia
5 (5.6%)
Other**
32 (36.4%)
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22. 30 Day Survival 1 Year Survival
SOURCE TA ES>20 87.4% 69.3%
(Mean 36.1%)
SOURCE TF ES>20 93.1% 81%
(Mean 33.5%)
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23. Historical Comparison –
TAVI Studies Included
The data/outcomes of all historical monitored EW THV clinical
studies were pooled to provide a comparator to The
SOURCE Registry
“Monitored EW THV clinical trials” means 100% source data
monitored, Core lab read and CEC adjudicated studies.
No. of TA TF
Study Dates of Study Principal Investigators
Sites n= n=
REVIVE 9 _ 106 Jan 2006 - Dec 2007 H Eltchaninoff
REVIVAL 4 55 40 Dec 2005 - Feb 2008 W O’Neill, M Leon, C Smith
T Walther, F Mohr, G Wimmer-
TRAVERCE 3 172 _ Feb 2007 – Apr 2008
Greinecker, E Wollner
PARTNER EU 9 69 61 Apr 2007- Jan 2008 T Lefèvre, G Wimmer-Greinecker
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29. TF and TA
Outcomes in “lower risk” patients
SOURCE-TA SOURCE-TF
I Yr Survival 78.4% 80.9%
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30. Are we learning in terms of the
who should and who should
not have TAVI?
A glimpse into COHORT 2 of the
SOURCE Registry
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31. The SOURCE Registry
Timeline
2009 2010 2011
Nov 07
SOURCE COHORT 1
Feb 09 Dec 09
SOURCE COHORT 2
N = 1301 (482 TF/819TA) from 38 centers
PREVAIL
SOURCE XT EU
SOURCE XT Global
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32. Baseline Demographics and Risk Factors:
All Cohort 1 vs. All Cohort 2
ALL ALL
COHORT 1 COHORT 2
(n=1038) (n=1301) P-Value
Age (yrs) 81.2 81.0 NS
Female 576/55.5% 767/59.0% 0.05
Pulmonary Disease 286/27.6% 309/23.8% 0.03
Renal Dysfunction 305/29.4% 365/28.1% NS
Logistic EuroSCORE 1035/27.6 1297/25.4 0.006
Peripheral Vascular Disease 210/20.2% 255/19.6% NS
Carotid Artery Stenosis (>50%) 132/12.7% 150/11.5% NS
Incidence of CAD 537/51.7% 694/53.3% NS
Porcelain Aorta 86/8.3% 101/7.8% NS
Prior CABG 236/22.7% 262/20.1% NS
Mitral valve disease 257/24.8% 450/34.6% <0.0001
32 Data Snapshot 5/03/2010
33. Conclusions
• Outcomes at 1 year for COHORT 1 of The SOURCE
Registry show an improvement compared to
historical controls.
• Survival for the TF approach is now >80%.
• There has been a marked improvement in the TA
outcomes with survival now similar to historical
TF results.
• Lower risk TA (<20% euroscore) patients have the
same 1 year outcome as TF.
• Univariant and multivariant analysis of the
COHORT 1 dataset should allow work to start on
the development of a TAVI risk score.
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34. Conclusions
• COHORT 1 outcomes provide a benchmark against
which future TAVI cohorts may be measured.
• The lower risk profile of COHORT 2 patients may
lead to further improvement in 1 year outcomes.
• If the lower profile SAPIEN XT delivery systems
result in lower vascular complications this should
result in further improvement in 1 year survival.
This will be tested in The SOURCE XT Registry.
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