Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital Antwerp, Antwerp, Belgium Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany Peter Wenaweser University Hospital Bern, Bern, Switzerland Stephen Brecker St. George’s Hospital, London, United Kingdom Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy (on behalf of the ADVANCE Investigators) Speaker's name- Axel Linke, MD ? I have the following potential conflicts of interest to report- Consultant- Medtronic, Inc. and St. Jude Medical Medtronic is the sponsor of the CoreValve ADVANCE study, and provided all statistical analyses and assisted in the graphical display of the data. The CoreValve ADVANCE study evaluated the clinical benefits of TAVI using the CoreValve system in a fully monitored, “real world” trial. This presentation reports for the first time the complete 1-year patient outcomes from the ADVANCE study. ADVANCE | Background Medtronic CoreValve® System Porcine pericardial tissue valve sutured to a self expanding nitinol frame Supra-annular valve position preserves circularity at level of valve function 18F catheter delivery system, with AccuTrak Stability Layer available in later cases 2 valve sizes were used in this study- 26 mm and 29 mm 1,015 patients enrolled from March 2010 to July 2011 5 year follow-up 44 centres - 12 countries in Western Europe, Asia and South America All centres had conducted at least 40 TAVI procedures prior to the study and had a Heart Team in place Clinical endpoints reported according to VARC I As-treated analysis MACCE defined as a composite of All-cause Mortality Myocardial Infarction (Q-wave and non-Q-wave) Emergent Cardiac Surgery or Percutaneous Re-intervention Stroke Additional Clinical Endpoints (VARC I) Cardiovascular Mortality Bleeding Vascular Complications Acute Kidney Injury New Pacemaker Implantation ADVANCE | Endpoints All primary endpoint events adjudicated by an independent clinical events committee consisting of TAVI-experienced interventional cardiologists and cardiac surgeons using VARC I definitions All cerebrovascular events adjudicated by an independent neurologist Adjudication of events utilized all available relevant source documents, including neuroimaging and systematic NIH Stroke Scale assessments Core laboratory for systematic review and assessment of EKGs and procedural angiograms Site reported echocardiographic data ADVANCE | Study Oversight *measured by angiography *Kaplan-Meier Estimates *Kaplan-Meier Estimates †New AKI that occurred outside of the 72 hr post-TAVI window are included NYHA ADVANCE | Aortic Regurgitation ADVANCE | Paravalvular Leak ADVANCE | Transvalvular Regurgitation *At discharge

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