1. TAVR Medtronic CoreValve® Subclavian Approach Clinical Data
Carlos E. Ruiz M.D., Ph.D., FACC
Director, Congenital, Valvular and Structural Heart Disease Program
North Shore Long Island Jewish System
Lenox Hill Heart and Vascular Institute of New York

2. Subclavian/Axillary: Right or Left
Access Routes
Most appropriate access route selected by MDT based on patient anatomical characteristics
Direct Aortic
Transfemoral
Subclavian
Right Antererior
Minithoracotomy
Upper
Ministernotomy
Subclavian/Axillary: Right or Left
Left preferred (versus right) due to delivery pathway’s typically better alignment with native aortic valve anatomy and less obstructive interaction with cranial perfusion

3. Access Selection Criteria
Subclavian artery luminal diameter and calcification
Presence of ipsilateral IMA graft
Aortic root angulation
Approach
Left Subclavian / Axillary
Right Subclavian / Axillary
Iliofemoral
Aortic Root Angle*
>70°
>30°
* Aortic root angle = angle between plane of aortic valve annulus and horizontal plane

4. Room Setup O1 O2 Option A Option B OR Key: O1 = Operator 1

5. Clinical Data Baseline Characteristics Procedural Outcomes
Mid/Long-Term Outcomes
Subclavian vs. Transfemoral

6. Clinical Data Baseline Characteristics Procedural Outcomes
Mid/Long-Term Outcomes
Subclavian vs. Transfemoral

7. 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. Clinical Data Baseline Characteristics Procedural Outcomes
Mid/Long-Term Outcomes
Subclavian vs. Transfemoral

9. 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).

10. 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

11. Clinical Data Baseline Characteristics Procedural Outcomes
Mid/Long-Term Outcomes
Subclavian vs. Transfemoral

12. Anna Sonia Petronio MD, FESC University of Pisa, Italy
CoreValve Subclavian: A Single Center Propensity-Case-Controlled Registry of Transcatheter Aortic Valve Implantation via Subclavian vs. Transfemoral Access
Anna Sonia Petronio MD, FESC
University of Pisa, Italy
Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011

13. Propensity Score Matching
Propensity score matching was performed in order to derive a comparable group of transfemoral patients
141 TAVR Trans-subclavian
141 TARI Trans-femoral
matched
PAD
85%
21%
P<0.0001
The propensity score was calculated for each patient using a logistic regression model which included the following variables:
CAD
Diabetes
Pulmonary Hypertension
Prior aortic Valvuloplasty
Prior pulmonary edema
Prior stroke
LVEF
Chronic renal failure
Fragility
To account fo potential differeences between transfemoral and trans-subclavian TAVI regarding the main clinical predictors of procedural success a propensity analysis was performed.
Petronio AS. Italian Experience Subclavian vs. Transfemoral. Presented at TCT 2011

14. Results
Overall Survival – 2 years
(A.S.Petronio et al. TCT 2011)

15. Conclusions Subclavian access is safe and effective
First alternative access route to PAD
Reduced distance to aortic valve results in more direct catheter response
Similar acute and 2-year results compared to femoral approach
Less bleeding complications

16. Thank you CRuiz@NSHS.edu

17. CoreValve® System Subclavian Clinical Experience
Study
Subclavian Study Size
Number of Centers
Follow-up
Italian Experience1
141 8
2 years
France II Registry2
120 33
6 months
UK Registry3 91 6
1 year
Italian Registry4 88 12
Netherlands Experience5 22 1
30-days
French Experience6 17 4
Key Message:
The CoreValve® System has significant global experience, and more than patients have been studied in independent registries.
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).