Presentation is loading. Please wait.

Presentation is loading. Please wait.

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011.

Similar presentations


Presentation on theme: "INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011."— Presentation transcript:

1 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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 Axel Linke University of Leipzig Heart Center, Leipzig, Germany (on behalf of the ADVANCE Investigators) UC201300513 EE

2 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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. ADVANCE | Background

3 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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

4 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. The objectives of the CoreValve ADVANCE study is to evaluate the safety efficacy clinical outcomes 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’. ADVANCE | Objective

5 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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 VARC As-treated analysis

6 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 100% of all Patients were monitored All Primary Endpoint Events Adjudicated by an Independent Clinical Events Committee 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 ECGs and procedural angiograms ADVANCE | Study Oversight

7 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. 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 ADVANCE | Endpoint

8 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Baseline Characteristics

9 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Baseline Characteristics

10 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | EuroSCORE by Country

11 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 30-day Outcomes

12 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | 30-day Outcomes

13 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Valve Performance

14 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Symptom Status

15 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. Patients receiving a new pacemaker within 30-days of TAVI had significantly more conduction disturbances at baseline such as; RBBB, AV block, and Left Anterior Fascicular Block (LAFB). New pacemaker implantation rates varies by country ranging from 15% to 39% (p-value = 0.031). Use of AccuTrak reduced rate of new pacemaker implants by 10%. ADVANCE | Pacemaker Implantation

16 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Pacemaker Implantation

17 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. ADVANCE | Mortality Risk Factors

18 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. Summary and Conclusions Prior MI, history of AF, logistic EuroSCORE, and baseline peak gradient are predictors of all-cause mortality. History of AF and logistic EuroSCORE are predictors of cardiovascular mortality.

19 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. Summary and Conclusions Medtronic CoreValve ADVANCE is the largest, multicenter, prospective, fully monitored TAVI study, of ‘real world’ inoperable, and frail high-risk patients with the CoreValve that shows: – Improvement in aortic valve function – Reduction of symptoms – Low stroke and mortality rates at 30-days and 6-months post CoreValve implantation

20 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011. All Rights Reserved. CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. For more information and a complete list of adverse events, warning and contraindications reference CoreValve ® IFU.


Download ppt "INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2011."

Similar presentations


Ads by Google