• 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 ? 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 Potential conflicts of interest ? ? ? First TAVI performed by Alain Cribier in 2002 CE-Mark approval of the Edwards SAPIEN™ THV in 2007 The „SOURCE“ Post Approval Registry included 2300+ 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 Edwards SAPIEN™ THV 23 mm and 26 mm Stainless Steel Frame Bovine Pericardial Tissue Stainless Steel Frame Equine Pericardial Tissue Cribier-Edwards™ THV 23mm Edwards SAPIEN XT ™ THV 23 mm, 26 mm, and 29mm Cobalt-Chromium Frame Bovine Pericardial Tissue Semi-closed leaflets Reduced crimped profile 2004 2007 2010 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 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 Subclavian 0.3% 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“ * VARC definitions /CEC Adjudicated p <.0001 p <.0001 AVA(cm2) Mean Gradient (mm Hg) EF (%) *Site reported, Paired observation analysis Baseline 30 Days *Site reported 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 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

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