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INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012.

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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. 2012."— 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. 2012. All Rights Reserved. Stephen Brecker St. George’s Hospital, London, United Kingdom 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 Axel Linke University of Leipzig Heart Center, Leipzig, Germany (on behalf of the ADVANCE Investigators) UC201302336 EE

2 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. 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

3 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. Subclavian 9.6% 96/996 pts. Direct Aortic 2.1% 21/996 pts. Transfemoral 88.3% 879/996 pts. ADVANCE | Results

4 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. Subclavian 9.6% 96/996 pts. Direct Aortic (DA) 2.1% 21/996 pts. Direct Aortic (DA) 2.1% 21/996 pts. Transfemoral 88.3% 879/996 pts. ADVANCE | Access Sites

5 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. CoreValve ® Size 26 mm 29 mm 31 mm Valve Height55 mm53 mm52 mm ADVANCE | DA Pre-operative Planning A pre-operative CT scan is essential to guide in the selection of the: Thoracic Access Location Determine anatomy posterior to sternum (e.g., grafts, distance to aorta) to guide puncture placement Delivery trajectory should optimize coaxial alignment with native valve and avoid critical vessels Aortic Access Site – Site should be free of calcification and greater than 6 cm from the basal plane to facilitate valve deployment

6 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. ADVANCE | Direct Aortic Procedure Right Anterior Mini-Thoracotomy 76% 16/21 pts. Upper Mini-Sternotomy 24% 5/21 pts.

7 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. Perform aortography with forceps placed directly on the intended access site and use graduated pigtail to confirm ≥ 6 cm distance from the basal plane Place two standard double purse-string sutures and gain arterial access via the Seldinger technique or direct cannulation via scalpel puncture. Courtesy of Dr. Giuseppe Bruschi ADVANCE | DA Procedure

8 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. ADVANCE | Direct Aortic Procedure

9 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. ADVANCE | Baseline Demographics

10 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. All Rights Reserved. ADVANCE | 30-day Outcomes

11 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. 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. 2012. All Rights Reserved. Transcatheter Aortic Valve Implantation (TAVI) via the direct aortic approach appears to be a safe and feasible alternative in a very high risk patients with very good early outcomes. Prior CABG and porcelain aorta are not contraindications for the Direct Aortic approach. More accurate placement from this approach may reduce complications and enable implants in challenging aortic anatomy ADVANCE | Conclusions

13 INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve® is approved. Not for distribution in U.S., Canada or Japan. Medtronic, Inc. 2012. 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.


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