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Axel Linke University of Leipzig Heart Center, Leipzig, Germany
Johan Bosmans University Hospital Antwerp, Antwerp Belgium
Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany
Peter Wenaweser University Hospital Bern, Bern, Switzerland
Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy
Stephen Brecker St. George’s Hospital, London, United Kingdom
(on behalf of the ADVANCE Investigators)
UC201300511 EE
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ADVANCE
| Background
• It has been shown that the female gender is an
independent predictor of survival in patients over 79
years undergoing surgical aortic valve replacement
(SAVR)1.
• Female patients represent approximately 50% of the
patient population treated with transcatheter aortic
valve implantation (TAVI).
• Limited evidence has been published on the clinical
benefits of TAVI by gender.
1
Fuchs C. Heart. 2010.
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ADVANCE
| Objectives
• CoreValve ADVANCE Study Objective
– 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’.
• Gender Objective
– To evaluate the gender differences in outcomes.
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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
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ADVANCE
| Study Oversight
• 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
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ADVANCE
| Baseline Characteristics
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ADVANCE
| Baseline Characteristics
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ADVANCE
| Valve Performance
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ADVANCE
| Symptom Status
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ADVANCE
| 30-day Outcomes
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ADVANCE
| 6-Month Survival
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ADVANCE
| 6-Month Survival
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ADVANCE
| 6-Month Stroke
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Summary & Conclusions
• Females receiving Medtronic CoreValve System are
significantly older, have higher mean/peak gradients,
and are prescribed less cardiovascular medications.
• Females experienced more strokes and TIAs, major
vascular complications, and major bleeding events.
• However, despite these differences females benefited
the same as males from CoreValve with regard to
improved hemodynamics and reduced symptoms.
• Low mortality was reported for both genders out to
6-months.
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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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