Axel Linke University of Leipzig Heart Center, Leipzig, Germany

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Presentation transcript:

Treatment of High Risk Aortic Stenosis Patients with Transcatheter Medtronic CoreValve Implantation Axel Linke University of Leipzig Heart Center, Leipzig, Germany Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany Peter Wenaweser University Hospital Bern, Bern, Switzerland Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy Johan Bosmans University Hospital Antwerp, Antwerp Belgium Stephen Brecker St. George’s Hospital, London, United Kingdom Robert Bauernschmitt ISAR Heart Center, Munich, Germany (on behalf of the ADVANCE Investigators) This slide deck focuses on the CoreValve® (Medtronic, Inc., Minneapolis, MN) Percutaneous Aortic Valve Replacement System and provides a summary of the clinical experience regarding its benefits, risks, and potential use as an alternative to surgical aortic valve replacement.

CoreValve ADVANCE | Background Transcatheter Aortic Valve Implant (TAVI) enables treatment of aortic valve stenosis without open-heart surgery. Balloon-expandable TAVI - superior to standard medical therapy in inoperable patients - non-inferior to surgical AVR in high-risk patients with AS in a randomized controlled trial. Neither balloon-expandable or self expanding TAVI have been studied in a rigorous, monitored, independently adjudicated, ‘real world’ study.

CoreValve ADVANCE | Background Medtronic CoreValve® System Porcine pericardial tissue valve sutured into a self expanding nitinol frame Supra-annular valve position preserves circularity at level of valve function 18Fr catheter delivery system 3 valve sizes 3 3 3

CoreValve ADVANCE | Objective The objective of the CoreValve ADVANCE study is to evaluate the safety efficacy clinical outcome according to VARC of percutaneous aortic valve implantation using the Medtronic CoreValve System in consecutive ‘real world’ patients with severe aortic stenosis considered inoperable or high risk for conventional AVR by the local ‘HEART TEAM’.

CoreValve ADVANCE | Methods 1,015 patients enrolled from March 2010 to July 2011 5 year follow-up 44 centers - 12 countries in Western Europe, Asia and South America All centers had conducted at least 40 TAVI procedures prior to the study and had Heart Team in place Clinical endpoints reported according to Valve Academic Research Consortium (VARC)

CoreValve ADVANCE | Primary Endpoint Primary Endpoint- Major Adverse Cardiac & Cerebrovascular Events (MACCE) at 30-days post procedure. 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 Clinical endpoints reported according to VARC All-cause and Cardiovascular Mortality Myocardial Infarctions Life Threatening Bleeding Major Vascular Complications Acute Kidney Injury

CoreValve ADVANCE | Study Oversight 100% of all Patients were monitored All Primary Endpoint events adjudicated by an Independent Clinical Events Committee (CEC) Consisting of TAVI-experienced Interventional Cardiologists and Cardiac Surgeon 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 Systematic review and assessment of ECG’s and Procedural Angiograms

CoreValve ADVANCE | Baseline Characteristics

CoreValve ADVANCE | Procedural Results

CoreValve ADVANCE | Valve Performance

CoreValve ADVANCE | Symptom Status

CoreValve ADVANCE | 30-day Outcomes

CoreValve ADVANCE | 6-month Survival

CoreValve ADVANCE | 6-month Survival

CoreValve ADVANCE | 6-month Survival

CoreValve ADVANCE | 6-month Stroke

Summary and Conclusions The CoreValve ADVANCE study, which is the largest, multicenter, prospective, fully monitored TAVI study, shows that treatment of ‘real world’ inoperable and frail, high-risk patients with the Medtronic CoreValve is: Safe Associated with: an improvement in aortic valve function low stroke and mortality rates at 1 month and 6 months follow-up

Thank You CoreValve ADVANCE Study Centers