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

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

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

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.

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%

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

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

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

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.

Enrollment Per Country

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

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

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

Access Routes Subclavian 0.3%

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

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

Clinical Outcomes at 30 Days * VARC definitions /CEC Adjudicated

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

Paravalvular Leak at 30 Days by Echo* *Site reported

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.

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