TAVR Medtronic CoreValve® Subclavian Approach Clinical Data

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Presentation transcript:

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

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

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

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

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

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

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

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

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).

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

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

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

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

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

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

Thank you CRuiz@NSHS.edu

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 2000 patients have been studied in independent registries. 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).