Strokes After TAVR: Perspectives from the US CoreValve Trials

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1 Strokes After TAVR: Perspectives from the US CoreValve Trials Jeffrey J. Popma, MD Professor of Medicine Harvard Medical School Director, Interventional Cardiology Clinical Services Beth Israel Deaconess Medical Center Boston, MA

2 Conflict of Interest Statement Over the past year, I have received the following: Research Grants: Medtronic, Boston Scientific, Abbott Vascular, Covidien, Cook Medical Advisory Board: Boston Scientific, Abbott Vascular, GE Healthcare, Covidien

3 Stroke After TAVR Neurologic Definitions Neurologic Assessment Extreme Risk Findings High Risk Findings Predictors of Stroke Popma TVT 2014 Stroke After TAVR

4 Rankin Modified Scale 0 No symptoms at all 1 No significant disability despite symptoms; able to carry out all duties and activities 2 Slight disability; unable to carry out all previous activities but able to look after own activities without assistance 3 Moderate disability; requiring some help but able to walk without assistance 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 Severe disabiliy; bedridden, incontinent, and requires constant nursing care and attention 6 Death Leon et al J Am Coll Cardiol 2011;57:253 69

5 Stroke After TAVR Neurologic Definitions Neurologic Assessment Extreme Risk Finding High Risk Findings Predictors of Stroke Popma TVT 2014 Stroke After TAVR

6 Protocol Mandated Neuro Assessment Before and Immediately Post-Procedure Popma TVT 2014 Stroke After TAVR Extreme Risk Study Iliofemoral

7 Stroke After TAVR Neurologic Definitions Neurologic Assessment Extreme Risk Findings High Risk Findings Predictors of Stroke Popma TVT 2014 Stroke After TAVR

8 Pivotal Trial Design Popma JACC 2014 March 19 (epub ahead of print) Extreme Risk Study Iliofemoral Pivotal 8

9 Study Disposition Popma JACC 2014 March 19 (epub ahead of print) Extreme Risk Study Iliofemoral Pivotal 9

10 Major Stroke Popma JACC 2014 March 19 (epub ahead of print) Extreme Risk Study Iliofemoral Pivotal 10

11 Neurologic Events Event 1 Month N=471 1 Year N=471 Any Stroke, % Major Stroke, % Minor Stroke, % TIA, % Popma JACC 2014 March 19 (epub ahead of print) Extreme Risk Study Iliofemoral Pivotal 11

12 Number of Strokes (n) Major and Minor Stroke (1 Month) 9 8 Minor Stroke Major Stroke Days to Stroke Popma JACC 2014 March 19 (epub ahead of print) Extreme Risk Study Iliofemoral Pivotal 12

13 All-Cause Mortality By Major Stroke Popma TVT 2014 Stroke After TAVR Extreme Risk Study Iliofemoral Pivotal 13

14 Stroke After TAVR Neurologic Definitions Neurologic Assessment Extreme Risk Findings High Risk Findings Predictors of Stroke Popma TVT 2014 Stroke After TAVR

15 Pivotal Trial Design Adams NEJM 2014 March 29 (epub ahead of print) 15

16 All Stroke Adams NEJM 2014 March 29 (epub ahead of print)

17 Major Stroke Adams NEJM 2014 March 29 (epub ahead of print) 17

18 All-Cause Mortality or Major Stroke Adams NEJM 2014 March 29 (epub ahead of print) 18

19 Stroke After TAVR Neurologic Definitions Neurologic Assessment Extreme Risk Finding High Risk Findings Predictors of Stroke Popma TVT 2014 Stroke After TAVR

20 Predictors of Stroke-I Variable Age Patients KM (%) 1-Yr (95% CI) (2.9, 10.0) Rate of All-Stroke (6.7%) P Value > (4.8, 12.7) Logistic EuroSCORE < (4.1, 10.7) (3.5, 12.8) STS Score < (4.9, 12.4) (vs. <10) (2.8, 12.9) >15 (vs. <10) (1.1, 14.5) Diabetes (2.0, 9.4) Hypertension (5.1, 10.9) PVD (5.2, 16.0) TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study Iliofemoral Pivotal 20

21 Predictors of Stroke-II KM (%) 1-Yr Rate of All Stroke Variable Patients (95% CI) (6.7%) P Value Prior Stroke (1.3, 16.9) Prior TIA (2.1, 23.3) History of A-fib / A- flutter Post-TAVR Valvuloplasty Performed More than 1 Valve Implanted (3.0, 10.5) (2.2, 14.5) (0.9, 35.0) TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study Iliofemoral Pivotal 21

22 Conclusions The US CoreValve Screening Committee used conventional and non-conventional risk factors to determine extreme surgical risk The High Risk showed a numeric reduction in the rate of all stroke at 30 days and one year compared with surgery The majority of strokes occurred within the 1 st 72 hours, but the risk persisted to 14 days No predictors of strokes were identified Post-TAVR balloon post-dilation did not increase the stroke risk TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study Iliofemoral Pivotal 22

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