1. Potential conflicts of interest
Speaker’s name: Alec Vahanian
 I have the following potential conflicts of interest to report:
 Research contracts  Consulting
 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. 30-day outcomes in a 2700 patient international clinical registry with a second generation balloon expandable transcatheter heart valve using multiple access techniques Alec Vahanian, MD Hopital Bichat Paris France on behalf of the SOURCE XT Investigators

3. Potential conflicts of interest
Speaker’s name: A. Vahanian
X I have the following potential conflicts of interest to report:
X Research contracts Edwards Lifesciences
X Consulting
Medtronic, Saint Jude Medical, Abbott Vascular, Valtech
 Employment in industry
 Stockholder of a healthcare company
 Owner of a healthcare company
 Other(s)
 I do not have any potential conflict of interest

4. Introduction
TAVI has demonstrated excellent clinical outcomes for patients with severe, symptomatic aortic stenosis.
Earlier generation transcatheter device designs have evolved to improve procedural performance and safety outcome profiles.
European commercial approval for the new generation Edwards Lifesciences SAPIEN XT™ THV, NovaFlex and Ascendra2 delivery systems was obtained in 2010.

5. SAPIEN XT™ Valve
SAPIEN XT™ - next generation balloon expandable THV featuring:
Open cell cobalt-chromium stent
Scalloped pericardial leaflet technology
Semi-closed leaflets
Reduced crimped profile
Extended valve sizes
23mm
26mm
29mm
Indication:
Symptomatic calcific aortic stenosis (AVA < 1.0cm²)
Estimated procedural/operative mortality risk ≥ 15%

6. The Delivery Systems Enhanced Delivery Systems NovaFlex Ascendra 2
18 Fr Profile
Tapered Catheter Tip
Steerable Catheter
Off-balloon Crimping
E sheath – 16Fr
Ascendra 2
Reduced Sheath 24Fr Profile
Greater Hemostatic Control
Single-handed Operation

7. SOURCE XT Post Approval Study
SOURCE XT is a multicenter, prospective, observational post approval study of real world experience with the new generation SAPIEN XT™ transcatheter valve platform.
Study objectives :
Observe the use of the device in the real world according to the label
Evaluate efficacy and safety of SAPIEN XT ™ in a real world setting
Incorporate VARC definitions/ measurement of frailty

8. Study Oversight SOURCE XT Executive Committee
Professor Dr. Helmut Baumgartner-Muenster, Germany
Professor Dr. Gino Gerosa-Padua, Italy
Dr. Marie-Claude Morice-Massy, France
Professor Dr. Patrick Nataf-Paris, France
Dr. Paolo Rubino-Mercogliano, Italy
Dr. Martyn Thomas- London, England, United Kingdom
Professor Dr. Alec Vahanian-Paris, France
Professor Dr. Thomas Walther, Bad Nauheim, Germany
Dr. Olaf Wendler-London, England, United Kingdom
Professor Dr. Stephan Windecker-Bern, Switzerland

9. Methods
2706 consecutively enrolled patients in 94 centres from 17 countries using transfemoral, transapical, transaortic and subclavian delivery access for 23mm, 26mm and 29mm SAPIEN XT ™ valves.
Enrollment period was from July 2010 to October 2011
Independent Clinical Event Committee
Data monitoring
Initial, interim analysis of baseline patient characteristics, acute procedural outcomes, and 30 day clinical and echocardiographic outcomes are presented.

10. Enrollment Per Country

11. Top 20 Enrolling Centers
1. Karlsruhe-Städtisches/ Herzzentrum, Germany
180
2. Massy- Jacques Cartier, France
142
3. Milano-Monzino, Italy
138
4. Mercogliano-Montevergine, Italy
135
5. Hamburg-University, Germany
109
6. Milano-San Raffaele, Italy 88
7. London Kings Health Partners,UK 80
8. Rouen-Charles Nicolle , France 78
9. Padova-University, Italy 77
10. Madrid-San Carlos, Spain 63
11. Toulouse-Rangueil, France 62
12. Bernau-Evangelisch, Germany 55
13. Paris-Bichat, France 54
14. Coruna-CHU, Spain 48
15. Regensburg-University, Germany 47
16. Tours-St Gatien, France 42
17. Würzburg-University, Germany 40
18. Brussels-St Luc, Belgium 39
19. Catanzaro-St Anna, Italy 37
20. San Sebastian-Gipuzkoa, Spain

12. Baseline Characteristics
Results
(n = 2706)
Age (years, mean± SD)
81.3 ± 6.6
Female - %
57.7
Logistic EuroSCORE (mean±SD)
20.5 ± 12.6
STS Score (mean±SD)
8.5 ± 7.0
Previous Stroke / TIA - %
8.4 / 4.6
COPD - %
20.1
Renal Insufficiency - %
28.0
Peripheral Vascular Disease - %
21.2
Frail Condition (Katz ADL) (mean±SD)
5.2 ± 1.4

13. Cardiac Characteristics
Results
(N = 2706)
Congestive Heart Failure - %
61.2
NYHA III/IV - %
76.7
LV Ejection Fraction (mean±SD)
54.6 ± 15.5
Coronary Artery Disease - %
44.8
Previous MI - %
15.1
Previous PCI - %
30.4
Previous CABG - %
16.2
Atrial Fibrillation - %
24.9
Previous Pacemaker - %
11.0
Previous Ao Bioprosthesis - %
2.5

14. Access Routes
Subclavian 0.3%

15. Procedural Information
Characteristics
Results
(N = 2706)
Total Procedure Time (minutes, mean± SD)
84.7 ± 54.1
General Anesthesia (%)
67.2
Pre-implant BAV (%)
96.8
Final Valve Position - Correct at Intended Site (%)
97.0
Valve Size Implanted: (%)
- 23 mm
- 26 mm
- 29 mm
42.7
48.5
8.8
Annular Diameter: (mm, mean± SD)
- 23 mm valve
- 26 mm valve
- 29 mm valve
20.5 ± 3.0
22.8 ± 3.3
25.2 ± 3.3

16. Procedural Complications
Events
Results
(N = 2706)
Aborted Procedures - %
0.6
Unable to Cross Native Valve - %
0.04
Conversion to Surgery - %
0.4
Annular Dissection - %
Coronary Occlusion - %
SAPIEN-in-SAPIEN (Bailout) - %
1.1
Valve Embolization - %
0.7
Cardiac Tamponade - %
0.5

17. Clinical Outcomes at 30 Days
* VARC definitions /CEC Adjudicated

18. Hemodynamics at 30 Days by Echo*
p <.0001
p <.0001
Baseline
30 Day
p <.0001
*Site reported
Paired observation analysis

19. Paravalvular Leak at 30 Days by Echo*
*Site reported

20. Conclusions
SAPIEN XT TAVI post approval study confirms high risk profile of treated patients.
Demonstrates new access approaches, valve sizes and delivery systems with a high rate of success.
Shows a good safety profile according to VARC benchmarks.
This large dataset will contribute to multivariable risk prediction models and the development of a TAVI risk score.

21. More SOURCE XT at PCR
LATE BREAKING SESSION – Thursday, 17 May 2012; 15:00-15:12 – Room 241
30 day Outcomes from the SOURCE XT Post-approval Study – learn about SOURCE XT transfemoral and transapical outcomes WENDLER O. , King‘s College Hospital/King‘s Health Partners, LONDON, UNITED KINGDOM
LATE BREAKING POSTER – Available 15 – 18 May 2012, Poster Area
Alternative access for second generation balloon expandable TAVI devices. Results from the SOURCE XT post-approval study in patients treated via transaortic approach ROMANO M. Institut Hospitalier Jacques Cartier, MASSY, FRANCE
Do women have a poorer outcome compared to men after TAVI? MORICE M.C. Institut Hospitalier Jacques Cartier, MASSY, FRANCE