30-day outcomes in a 2700 patient international clinical registry with a second generation balloon expandable transcatheter heart valve using multiple access techniques
? 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 Potential conflicts of interest
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 Potential conflicts of interest
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™ - 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%
Enhanced Delivery Systems NovaFlex 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 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
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
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.
N = 2706 * VARC definitions /CEC Adjudicated
*Site reported Paired observation analysis p <.0001 p <.0001 p <.0001 Baseline 30 Day
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.