one year outcomes in real world patients treated with transcatheter aortic valve implantation the...

One Year Outcomes in Real World Patients Treated with Transcatheter Aortic Valve Implantation

The ADVANCE StudyAxel 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) UC201403656 EE

Disclosure Statement of Financial Interest

• Grant/Research Support• Consulting Fees/Honoraria• Major Stock Shareholder/Equity• Royalty Income• Ownership/Founder• Intellectual Property Rights• Other Financial Benefit

• 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. 2013. 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


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


• 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


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


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


CoreValve ADVANCE | Baseline Characteristics


*measured by angiography

CoreValve ADVANCE | Procedural Results


*Kaplan-Meier Estimates

CoreValve ADVANCE | Primary Endpoint


CoreValve ADVANCE | 1-Year Stroke


*Kaplan-Meier Estimates†New AKI that occurred outside of the 72 hr post-TAVI window are included

CoreValve ADVANCE | Additional VARC I Endpoints


CoreValve ADVANCE | 1-Year Survival


CoreValve ADVANCE | Survival by Logistic EuroSCORE


CoreValve ADVANCE | NYHA Symptom Status


CoreValve ADVANCE | Valve Performance


CoreValve ADVANCE | Aortic Regurgitation


CoreValve ADVANCE | Paravalvular Leak


CoreValve ADVANCE | Transvalvular Regurgitation


*At discharge

CoreValve ADVANCE | Survival by AR*

2-Year Survival


CoreValve ADVANCE | 2-Year Survival


• 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


Thank YouCoreValve ADVANCE Study Centers

CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l. © 2013.

one year outcomes in real world patients treated with transcatheter aortic valve implantation the...

Documents

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valve sizes

cautionfor distribution

destin au

level of valve function

university of catania

georges hospital