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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 UC201104698a_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 1 14182 years France II Registry 2 120336 months UK Registry 3 9161 year Italian Registry 4 88121 year Netherlands Experience 5 22130-days French Experience 6 17430-days 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011. 2. Gilard M. France 2 Registry. Presented at TCT 2011. 3. Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT 2011. 4. Laborde JC. TAVR Access Site Considerations. Presented at TVT 2011. 5. Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT 2011. 6. 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 N141918817 Age, years82.2 ±5.782.2 ±6.383 ±571 ±11 Female, %3930.439.853.8 Logistic EuroSCORE, % 26.5 ±15.12225.4 ±13.134 ±11 NYHA class III and IV, %72.3NR 40 LVEF, %51.1 ±13.3NR 52 ±14 Diabetes, %28.42523.920 Prior MI, %25.52526.1NR Baseline Patient Characteristics Subclavian NR= Not Reported 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011. 2. Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT 2011. 3. Laborde JC. TAVR Access Site Considerations. Presented at TVT 2011. 4. 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 2011. 2. Laborde JC. TAVR Access Site Considerations. Presented at TVT 2011. 3. Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT 2011. 4. 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 N14191882217 Major Vascular Complication,% 5.75.4NR9 Blood Transfusion / Major Bleeding,% 36.237.2NR Stroke,%2.14.33.400 Myocardial Infarction,%02.2NR50 Acute Renal Failure,%5.34.3NR 0 New Pacemaker, %24.122.1NR 1. Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011. 2. Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT 2011. 3. Laborde JC. TAVR Access Site Considerations. Presented at TVT 2011. 4. Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT 2011. 5. 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 2011. 2. Gilard M. France 2 Registry. Presented at TCT 2011. 3. Blackman D. UK Registry Comparison valve type and access approach. Presented at TCT 2011. 4. Verkroost MWA. TAVI Using Left Subclavian Route. Presented at TCT 2011. 5. 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 2011. 2. 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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