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

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Presentation on theme: "INTERNATIONAL. CAUTION: For distribution only in markets where CoreValve ® has been approved. The CoreValve ® System is not currently approved in the USA,"— Presentation transcript:

1 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

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. 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).

3 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

4 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).

5 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).

6 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

7 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

8 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).

9 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

10 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).

11 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

12 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

13 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

14 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

15 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.


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