One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation The ADVANCE Study Axel Linke University of Leipzig Heart.

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Presentation transcript:

One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation The ADVANCE Study Axel Linke University of Leipzig Heart Center, Leipzig, Germany Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital Antwerp, Antwerp, Belgium Ulrich Gerckens Gemeinschaftskrankenhaus Bonn, Bonn, Germany Peter Wenaweser University Hospital Bern, Bern, Switzerland Stephen Brecker St. George’s Hospital, London, United Kingdom Corrado Tamburino Ferrarotto Hospital, University of Catania, Catania, Italy (on behalf of the ADVANCE Investigators) UC EE

Disclosure Statement of Financial Interest Grant/Research Support Grant/Research Support Consulting Fees/Honoraria Consulting Fees/Honoraria Major Stock Shareholder/Equity Major Stock Shareholder/Equity Royalty Income Royalty Income Ownership/Founder Ownership/Founder Intellectual Property Rights Intellectual Property Rights Other Financial Benefit Other Financial Benefit Medtronic, Inc. Medtronic, Inc. Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. Transcatheter aortic valve implant (TAVI) enables treatment of aortic valve stenosis without open-heart surgery. The CoreValve ADVANCE study evaluated the clinical benefits of TAVI using the CoreValve system in a fully monitored, “real world” trial. This presentation reports for the first time the complete 1-year patient outcomes from the ADVANCE study. CoreValve ADVANCE | Background

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. Medtronic CoreValve ® System Porcine pericardial tissue valve sutured to a self expanding nitinol frame Supra-annular valve position preserves circularity at level of valve function 18F catheter delivery system, with AccuTrak ® Stability Layer available in later cases 2 valve sizes were used in this study: 26 mm and 29 mm CoreValve ADVANCE | Background

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. 1,015 patients enrolled from March 2010 to July 2011 –5 year follow-up 44 centres - 12 countries in Western Europe, Asia and South America All centres had conducted at least 40 TAVI procedures prior to the study and had a Heart Team in place Clinical endpoints reported according to VARC As-treated analysis CoreValve ADVANCE | Methods

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Endpoints 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 Additional Clinical Endpoints (VARC) Cardiovascular Mortality Bleeding Vascular Complications Acute Kidney Injury New Pacemaker Implantation

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve 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 surgeons using VARC I definitions 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 for systematic review and assessment of EKGs and procedure angiograms Site reported echocardiographic data

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Baseline Characteristics

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. *measured by angiography CoreValve ADVANCE | Procedural Results

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. *Kaplan-Meier Estimates CoreValve ADVANCE | Primary Endpoint

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 1-Year Stroke

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. *Kaplan-Meier Estimates †New AKI that occurred outside of the 72 hr post-TAVI window are included CoreValve ADVANCE | Additional VARC I Endpoints

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 1-Year Survival

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Survival by Logistic EuroSCORE

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | NYHA Symptom Status

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Valve Performance

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Aortic Regurgitation

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Paravalvular Leak

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | Transvalvular Regurgitation

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. *At discharge CoreValve ADVANCE | Survival by AR*

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. CoreValve ADVANCE | 2-Year Survival

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. Medtronic CoreValve ADVANCE is one of the largest “real world” TAVI trials performed in multiple experienced centres. 1-year outcomes demonstrate –low stroke rates at 1-year –low rates of AR and PVL at 1-year –mild AR with the same low mortality rate as those patients with no AR –improved valve performance 2-year patient survival rates continues to remain high CoreValve ADVANCE | Summary and Conclusions

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. Non destiné au marché français. ©Medtronic, Inc All Rights Reserved. Thank You CoreValve ADVANCE Study Centers CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. © 2013.