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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. All Rights Reserved.
Transcatheter Aortic Valve Implantation via the Direct Aortic Access Approach: Patient Characteristics and Short-term OutcomesInsights from the Medtronic CoreValve® ADVANCE study
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
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
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.
Subclavian9.6%
96/996 pts.
Direct Aortic2.1%
21/996 pts.
Transfemoral88.3%
879/996 pts.
ADVANCE | Results
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.
Subclavian9.6%
96/996 pts.
Direct Aortic (DA)2.1%
21/996 pts.
Transfemoral88.3%
879/996 pts.
ADVANCE | Access Sites
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CoreValve® Size 26 mm 29 mm 31 mm
Valve Height 55 mm 53 mm 52 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
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.
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
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
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
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
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
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
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.