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
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The SOURCE Family of Registries1 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
Speaker’s name: Dr Martyn Thomas
I have the following potential conflicts of interest to report:
Research contractsConsulting for Edwards LifesciencesEmployment in industryStockholder of a healthcare companyOwner of a healthcare companyOther(s)
I do not have any potential conflict of interest
Potential Conflicts of Interest
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• 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.
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Background
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SOURCE COHORT 1
SOURCE COHORT 2
PREVAIL
SOURCE XT EU
SOURCE XT Global
2009 2010 2011
Nov 07
The SOURCE Family of RegistriesTimeline
34 Centres Initially Participating in Commercial Launch1123 patients
Included:32 centres
1038 patients
The SOURCE Registry has 100% procedure data
98% 30 day dataAll consecutively enrolled
Excluded:2 Centres / 85 patients
• Unable to obtain Ethic Cte approval• Unable to secure administrative support• One missing patient due to admin. error
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99.9% 30 Day DataEuroPCR
2010
Methods: EuroPCR 09
We now present 1 year data that represents systematic
follow-up on 98% of implanted patients.
Site Name Pts Site Name Pts
Karlsruhe/Städisches Klinikum + Herzklinik –
G Schymik, H Schroefel
89 Rouen/CHU – H Eltchaninoff, JP Bessou 31
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
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 Requiring Dialysis
1.3% 7.0% 4.4%
Permanent Pacemaker
6.0% 7.7% 6.9%
5/03/10Data Snapshot8
Major Complications (≤ 30 Days)
To give Context of Early v Late Events
SOURCE: COHORT 11 Year Survival (All Approaches)
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All Data as KM CurvesCohort 1: 1 YR (Events: Late)
Freedom From: Stroke, PM, MI
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SOURCE vs Normal Elderly PopulationCause 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.
All Data as KM CurvesCohort 1: 1 YR (Events: Late)
Freedom From: Vascular Complication, Endocarditis, and Re-Operation
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Early Vascular Access Complications Relationship to 1 Year Mortality (NB 22/24F Device)
Approach% Survival in Pts who did not have vascular access
complications
% Survival in Pts who didhave vascular access
complicationsP-Value
TF 83.9% 72.2% 0.0121TA 73.2% 47.4% 0.0188
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Causes of Death30 Days to 1 Year
ALL
ALL179
Cardiac45 (25.1%)
Heart Failure28 (62.2%)
Myocardial Infarction6 (13.3%)
Endocarditis3 (6.7%)
Other*8 (17.8%)
Non Cardiac88 (49.2%)
Pulmonary***21 (23.9%)
Renal Failure11 (12.5%)
Cancer10 (11.4%)
Stroke9 (10.2%)
Gastrointestinal5 (5.6%)
Other**32 (36.4%)
Unknown46 (25.7%)
Sudden Death18 (39.1%)
Unknown18 (39.1%)
Other10 (21.7%)
Other * = Arrhythmia, cardiac arrestOther** = Sepsis, vascular access related, major bleeding, infection, suicide, and multiple organ failurePulmonary***= Respiratory Failure, Pulmonary Embolism and Pneumonia
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Influence of EuroSCORE - Cohort 1 –EuroSCORE as predictor of 30 Day Mortality
Baseline Demographics and Risk Factors:All Cohort 1 vs. All Cohort 2
• 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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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.