INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA,

Slides:

Advertisements

Similar presentations

Transcatheter aortic valve implantation

Advertisements

” سبحانك لا علم لنا إلا ما علمتنا إنك أنت العليم الحكيم “

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA or Japan. ©Medtronic, Inc All.

STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic.

INTERNATIONAL. CAUTION—For distribution only in markets where CoreValve has been approved. Not approved in the USA, Canada or Japan. The information in.

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

Georg Nickenig, Universitatsklinikum Bonn, Germany Jan-Malte Sinning, Universitatsklinikum Bonn, Germany Jan Kovac, Glenfield Hospital, Leicester, UK Peter.

Three-year clinical and echocardiographic follow-up of aortic stenosis patients implanted with a self-expending bioprosthesis Sabine Bleiziffer German.

ACC 2015 Michael J Reardon, MD, FACC On Behalf of the CoreValve US Investigators A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic.

Lessons from TAVR Randomized Trials and Registries E Murat Tuzcu, MD Professor of Medicine Cleveland Clinic Financial disclosures: None PARTNER Executive.

Long-Term Outcomes Using a Self- Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-Year Results From.

THE RISE OF NEW TECHNOLOGIES FOR AORTIC VALVE STENOSIS: A PROPENSITY-SCORE ANALYSIS FROM TWO MULTICENTER REGISTRIES COMPARING SUTURELESS AND TRANS-CATHETER.

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

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

University Heart Center Hamburg

Dr Martyn Thomas Director of Cardiac Services Guys and St Thomas NHS Foundation Trust A Member of Kings Health Partners London.

Corrado Tamburino, MD, PhD; Davide Capodanno, MD; Angelo Ramondo, MD; Anna Sonia Petronio, MD; Federica Ettori, MD; Gennaro Santoro, MD; Silvio Klugmann,

The Risk and Extent of Neurological Events Are Equivalent for High-Risk Patients Treated With Transcatheter or Surgical Aortic Valve Replacement Thomas.

Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III.

Axel Linke University of Leipzig Heart Center, Leipzig, Germany Sabine Bleiziffer German Heart Center, Munich, Germany Johan Bosmans University Hospital.

A Contemporary Analysis of Pulmonary Hypertension in Patients Undergoing Mitral Valve Surgery: Is this a Risk Factor? Thank you to the society and panel.

Trancatheter Aortic Valve Implantation (TAVI)

TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.

TCT 2015 | San Francisco | October 15, 2015 Transcatheter Aortic Valve Replacement for Failed Surgical Bioprostheses Danny Dvir, MD John G. Webb, MD and.

The Impact of Prior Stroke on the Outcome of Patients with Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Romain Didier, MD;

GENDER DISPARITIES AMONG PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT Michael A. Gaglia, Jr.; Michael J. Lipinski; Rebecca Torguson; Jiaxiang.

UC c EN. Through Medtronic sponsored research, the Transcatheter Aortic Valves clinical portfolio is studying over 11,000 subjects at over 125.

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

Alberto Repossini, Thierry A Folliguet

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

Longest Follow-up After Implantation of a Self-Expanding Repositionable Transcatheter Aortic Valve: Final Follow-up of the Evolut R CE Study Stephen Brecker,

G. Michael Deeb, MD On Behalf of the CoreValve US Investigators

The Impact of Preoperative Renal Dysfunction on the Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement Andres M. Pineda MD, J. Kevin.

TAVR in Patients With Chronic Kidney Disease

TriGuard Device for Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Multicenter Real-World Experience Masieh Abawi, Ermela.

Outcomes in the CoreValve US High-Risk Pivotal Trial in Patients with a Society of Thoracic Surgeons Predicted Risk of Mortality Less than or Equal to.

Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve replacement for severe symptomatic aortic valve stenosis.

Trans- catheter aortic valve replacement vs

A Review of Medtronic CoreValve TAVI Clinical Results:

TAVR Medtronic CoreValve® Subclavian Approach Clinical Data

Are we ready to perform TAVI in Intermediate Risk Patients?

Ganesh Manoharan Consultant Cardiologist

Updates From NOTION: The First All-Comer TAVR Trial

TAVR – The Trans-carotid Approach

MedStar Washington Hospital Center Cardiac Catheterization Conference

30-Day Safety and Echocardiographic Outcomes Following Transcatheter Aortic Valve Replacement with the Self-Expanding Repositionable Evolut PRO System.

Predictors of Pacemaker Implantation With a Self-Expanding Repositionable Transcatheter Aortic Valve Ian T. Meredith AM, MBBS, PhD, FRACP FACC, FCSANZ,

First Report of Three-Year Outcomes With the Repositionable and Fully Retrievable Lotus™ Aortic Valve Replacement System: Results From the REPRISE I.

Early Outcomes with the Evolut R Repositionable Self-Expanding Transcatheter Aortic Valve in the United States Mathew Williams, MD, For the Evolut R US.

University of Pennsylvania

5th Meeting on Acute Cardiac Care and Emergency Medicine, 2016 Vilnius

Giuseppe Tarantini MD, PhD

Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement Harold L. Dauerman, MD; Michael J. Reardon,

Review of the Data from the Subclavian Approach Clinical Trials

Direct Flow Medical Experience with a Conformable, Repositionable Retrievable Percutaneous Aortic Valve Reginald Low MD University of California, Davis.

TAVI „Catch me if you can!“

The Impact of Live Case Transmission on Patient Outcomes during Transcatheter Aortic Valve Replacement: Results from the VERITAS Study Dr. Ron Waksman.

Michael Mack, M.D. Dallas, TX

Insights from the NCDR® STS/ACC TVT Registry.

CoreValve Continued Access Study Shows Continued Improvement in 1-Year Outcomes With Self-Expanding Transcatheter Aortic Valve Replacement Steven J. Yakubov,

Ganesh Manoharan Consultant Cardiologist

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

University Heart Center Hamburg

Balloon-Expandable Transcatheter Valve System : OUS Data

Six-month–adjusted survival after aortic valve replacement (AVR) for severe aortic stenosis (AS) stratified by procedure and preoperative ejection fraction.

Late Follow-Up from the PARTNER Aortic Valve-in-Valve Registry

Samir R. Kapadia, MD On behalf of The PARTNER Trial Investigators

Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes Thomas Modine, MD, PhD, Jean François.

Transcutaneous aortic valve implantation using the axillary/subclavian access with patent left internal thoracic artery to left anterior descending artery:

Transcatheter versus medical treatment of symptomatic severe tricuspid regurgitation: a propensity score matched analysis Maurizio Taramasso MD, PhD from.

Presentation transcript:

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Medtronic CoreValve ® System Subclavian Approach Summary of Clinical Experience UC a_EE1P

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Rationale for Subclavian Approach Subclavian implantation expands patient access to TAVISubclavian implantation expands patient access to TAVI –A subclavian approach provides an alternative for TAVI for patients whose iliofemoral anatomy is compromised due to atherosclerosis, calcifications, or tortuosity –Subclavian arteries are often viable in patients with compromised femoral and/or iliac arteries Modine T, Obadia JF, Choukroun E, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. 2011; 141(2).

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Baseline Characteristics Procedural Outcomes Mid/Long-Term Outcomes Subclavian vs. Transfemoral

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. CoreValve ® System Subclavian Clinical Experience StudySubclavian Study SizeNumber of CentersFollow-up Italian Experience years France II Registry months UK Registry year Italian Registry year Netherlands Experience days French Experience days 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Gilard M. France 2 Registry. Presented at TCT Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Laborde JC. TAVR Access Site Considerations. Presented at TVT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Italian Experience 1 UK Registry 2 Italian Registry 3 French Experience 4 N Age, years82.2 ± ±6.383 ±571 ±11 Female, % Logistic EuroSCORE, % 26.5 ± ± ±11 NYHA class III and IV, %72.3NR 40 LVEF, %51.1 ±13.3NR 52 ±14 Diabetes, % Prior MI, % NR Baseline Patient Characteristics Subclavian NR= Not Reported 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Laborde JC. TAVR Access Site Considerations. Presented at TVT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Baseline Characteristics Procedural Outcomes Mid/Long-Term Outcomes Subclavian vs. Transfemoral

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. CoreValve ® System Procedure Success Subclavian 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Laborde JC. TAVR Access Site Considerations. Presented at TVT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2). Note: Procedure success definition varies among publications

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. CoreValve ® System Procedural Results Subclavian NR= Not Reported Italian Experience 1 UK Registry 2 Italian Registry 3 Netherlands Experience 4 French Experience 5 N Major Vascular Complication,% NR9 Blood Transfusion / Major Bleeding,% NR Stroke,% Myocardial Infarction,%02.2NR50 Acute Renal Failure,%5.34.3NR 0 New Pacemaker, % NR 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Laborde JC. TAVR Access Site Considerations. Presented at TVT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Baseline Characteristics Procedural Outcomes Mid/Long-Term Outcomes Subclavian vs. Transfemoral

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. 30-Day Survival Subclavian 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT Gilard M. France 2 Registry. Presented at TCT Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT Modine T. TAVI using Axillary/subclavian Access. J Thorac Cardiovasc Surg. 2011; 141(2).

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Long-term Survival Subclavian 1. Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Baseline Characteristics Procedural Outcomes Mid/Long-Term Outcomes Subclavian vs. Transfemoral

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. CoreValve Subclavian: A Single Center Propensity-Case-Controlled Registry of Transcatheter Aortic Valve Implantation via Subclavian vs. Transfemoral Access Anna Sonia Petronio MD, FESC Head of Cardiac Catheterization Laboratory Cardiothoracic and Vascular Department University of Pisa, Italy Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. CAD Diabetes Pulmonary Hypertension Prior aortic Valvuloplasty Prior pulmonary edema Prior stroke LEVF Chronic renal failure Fragility CAD Diabetes Pulmonary Hypertension Prior aortic Valvuloplasty Prior pulmonary edema Prior stroke LEVF Chronic renal failure Fragility 141 TAVI using trans- subclavian approach 141 TAVI using transfemoral access Propensity score matching was performed in order to derive a comparable group of transfemoral patients The propensity score was calculated for each patient using a logistic regression model which included the following variables: Propensity Score Matching Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011

INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA, Japan or Canada. Overall Survival 2-Years Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011 CoreValve® is a registered trademark of Medtronic CV Luxembourg S.a.r.l.