1. 30 Day Outcomes from the SOURCE XT TAVI Post Approval Study
Olaf Wendler MD PhD FRCS
Professor of Cardiac Surgery
King's College Hospital/King’s Health Partners, London, UK
on behalf of the SOURCE XT Investigators

2.    Potential conflicts of interest Speaker’s name: Olaf Wendler
 I have the following potential conflicts of interest to report:
 Research contracts Edwards Lifesciences
 Consulting
Medtronic, JenaValve, Edwards Lifesciences, SJM
 Employment in industry
 Stockholder of a healthcare company
 Owner of a healthcare company
 Other(s)
 I do not have any potential conflict of interest   

3. Introduction First TAVI performed by Alain Cribier in 2002
CE-Mark approval of the Edwards SAPIEN™ THV in 2007
The „SOURCE“ Post Approval Registry included patients treated using the SAPIEN™ THV
Data generated provided important information for new product and clinical development
Next generation SAPIEN XT™ THV and its delivery systems are assessed in the „SOURCE XT“ Post Approval Study

4. Edwards SAPIEN XTTM Evolution
Stainless Steel Frame
Equine Pericardial Tissue
Stainless Steel Frame
Bovine Pericardial Tissue
Cobalt-Chromium Frame
Bovine Pericardial Tissue
Semi-closed leaflets
Reduced crimped profile
2004
2007
2010
Cribier-Edwards™ THV
23mm
Edwards SAPIEN™ THV
23 mm and 26 mm
Edwards SAPIEN XT ™ THV
23 mm, 26 mm, and 29mm 4

5. SOURCE - SOURCE XT
Multicenter, prospective, observational, post-approval studies to
Observe use of the SAPIEN/SAPIEN XT™ THV in the real world
Evaluate long-term safety of SAPIEN/SAPIEN XT™ THV
SOURCE was further aimed to
Develope physician training
Optimize patient screening and selection
SOURCE XT is further aimed to
Incorporate VARC definitions
Include assessment of frailty
Develop a TAVI risk prediction model

6. Design and Execution SOURCE Registry SOURCE XT Post Approval Study
Patients
2307
2706
Enrollment
Nov 2007 – Dec 2009
July 2010 – Oct 2011
Centers 37 94
Countries 14 17
Access Routes
TF, TA
TF, TA, TAO, SC
THV
SAPIEN™
23mm, 26mm
SAPIEN XT™
23mm, 26mm, 29mm
Adverse Event Adjudication
Principal Investigators
Independent Clinical Endpoint Committee, VARC Guidelines
Monitored No
Yes
Follow-up
30 Days, annually to 2 Years
30 Days, annually to 5 Years

7. Executive Committee Prof. Dr. Helmut Baumgartner - Muenster, Germany
Prof. Dr. Gino Gerosa - Padua, Italy
Dr. Paolo Rubino - Mercogliano, Italy
Prof. Dr. Patrick Nataf - Paris, France
Dr. Martyn Thomas - London, United Kingdom
Prof. Dr. Alec Vahanian - Paris, France
Prof. Dr. Thomas Walther - Bad Nauheim, Germany
Prof. Dr. Olaf Wendler-London - United Kingdom
Prof. Dr. Stephan Windecker-Bern, Switzerland

8. Access Routes
Subclavian 0.3%

9. Methods Focus on quality of data
Centers participating had to submit consecutive group of their patient experience using the Edwards SAPIEN XT™
Decision of access route made by the individual center
Cardiologists and Cardiac Surgeons as PI‘s in participating centers to support the „Heart Team“ approach
„We present the interim analysis of the 30 day outcomes
with a focus on TF and TA access routes“

10. Baseline Characteristics - Cardiac
Transfemoral
N = 1694
Transapical
N = 906 P
NYHA III/IV (%)
77.2
75.9
0.5
LV Ejection Fraction (mean ±SD)
55.3 ±17.0
53.5 ± 12.4
<.0001
Coronary Artery Disease (%)
40.2
51.8
Previous MI (%)
12.2
20.9
Previous PCI (%)
27.2
36.7
Previous CABG (%)
12.3
24.4
Atrial Fibrillation (%)
22.8
29.9
Previous Pacemaker (%)
10.0
12.7
0.03
Previous Ao Bioprosthesis (%)
1.8
4.0
0.001

11. Baseline Characteristics
Transfemoral
N = 1694
Transapical
N = 906 P
Age (years, mean ±SD)
81.9 ±6.6
80.2 ±6.4
<.0001
Female (%)
64.5
45.6
Previous Stroke (%)
7.3
10.6
0.005
Renal Failure (%)
24.9
35.2
Peripheral Vascular Disease (%)
14.6
33.0
Diabetes Mellitus (%)
26.8
33.7
0.0003
Porcelain Aorta (%)
4.4
10.7
Frail condition (mean±SD)
5.2 ±1.4
0.7
COPD (%)
19.6
21.9
0.2
Logistic EuroSCORE (mean±SD)
19.9 ±12.0
21.8 ±13.8
0.0004
STS Score (mean±SD)
8.4 ±7.0
8.7 ±7.2
Logistic
EuroSCORE TF TA
≤40
92.3
88.5
>40
6.7
10.8
Missing
0.9
0.8

12. Procedural Information
Characteristic
Transfemoral
N = 1694
Transapical
N = 906 P
Total Procedure Time (min, mean ±SD)
79.7 ±51.7
90.7 ±56.3
<0.0001
Fluoroscopy Time (min, mean ±SD)
15.0 ±20.8
7.4 ±19.3
Contrast Volume (ml, mean ±SD)
141.1 ±104.0
95.0 ±81.8
General Anesthesia (%)
50.1
96.0
Pre-implant BAV (%)
98.5
93.4
Annular Diameter (mm, mean ± SD)
21.7 ± 3.5
22.5 ± 3.4
Valve size implanted
23 mm (%)
26 mm (%)
29 mm (%)
NA (%)
47.8
51.8 --
0.3
33.0
41.8
23.8
1.4

13. Procedural Complications
Adverse Events
Transfemoral
N = 1694
Transapical
N = 906 P
Conversion to Surgery (%)
0.3
0.6
Cardiac Tamponade (%)
0.7
0.1
0.04
Annular Dissection (%)
0.4
Coronary Occlusion (%)
1.0
SAPIEN-in-SAPIEN (Bailout) (%)
0.8
1.7
0.07
Valve Embolization (%)
0.9
0.2
Aborted Procedure (%)
1.1
Unable to Cross Native Valve (%) --

14. Clinical Outcomes at 30 Days
Transfemoral
N = 1694
Transapical
N = 906
All-cause Mortality (%)*
4.3
9.9
Any Stroke (%)*
2.3
2.1
TIA (%)
0.6
0.7
Myocardial Infarction (%)
0.5
New Pacemaker (%)
8.0
10.9
Vascular Complication – Major (%)*
7.3
3.6
Renal Failure with Temporary Dialysis) (%)
1.2
4.0
Major Bleeding (%)
5.0
11.4
* VARC definitions /CEC Adjudicated

15. Subanalyses Mortality
Stratified LES
Transfemoral
N = 1694
Transapical
N=906
≤40
4.0
8.4
>40
7.0
22.4
SAPIEN XTTM Size
Transfemoral
N = 1694
Transapical
N=906
23mm (%)
4.3
8.9
26mm (%)
4.1
11.9
29mm (%)
N/A
6.0
Missing (%)
0.6
0.06

16. Echo at 30 Days*: TF – TA Mean Gradient (mm Hg) EF (%) AVA(cm2)
p <.0001
EF (%)
p <.0001
Baseline
30 Days
*Site reported, Paired observation analysis

17. Paravalvular Leak at 30 Days*: TF - TA
*Site reported

18. Conclusions (I)
Mortality in TF (4.3%) is one of the lowest ever reported for TF registries
One third of patients were selected for a TA approach
Mortality in TA has decreased but remains higher in the very high-risk patient group
For 29 mm TA prostheses (not available for TF, no selection bias) mortality for TA is only 6%
Compared to SOURCE, mean log EuroSCORE has decreased but stays within the label indication of 15 for the SAPIEN XTTM
TA patients continue to present with more co-morbidities

19. Conclusions (II)
Major vascular complications were more common after TF and bleeding more often seen after TA
Procedural complications were rare and early hemodynamic function excellent using the SAPIEN XT™
LV ejection fraction was improved significantly using both access routes
The number of patients with no/trace paravalvular leakage is high and it remains to be seen which effect this may has on the 1-year survival
It remains to be seen which effect frailty has on 1-year survival