1. Heart Valve Thrombosis & Neuro-Outcomes
George D. Dangas, MD, FACC
Professor of Medicine & Director, Cardiovascular Innovation
Mount Sinai Medical Center, New York, NY

2. Independent predictors of stroke after TAVR (day 0 to 10)
Iliofemoral access (HR: 0.67)
Prior TIA (HR: 1.85)
Prior CABG (HR: 0.61)
Angina (HR: 1.68)
BMI < 21 (HR: 2.14)
Falls in the past 6 months (HR: 1.56)
Time in OR (per min; HR: 1.003)
Time of delivery catheter in body (per min; HR: 1.01)
Rapid pacing during valvuloplasty (HR: 9.86)
Circ Cardiovasc Interv. 2016;9:e

3. Independent predictors of stroke after TF-TAVR
Higher pre-TAVR aortic valve peak gradient
Dementia
23-mm vs. 26-mm valve size
Independent predictors of stroke after TA-TAVR
Pure aortic stenosis withotu regurgitation
More postdilations
Race other than white
Lower LVEF
History of AF
Circ Cardiovasc Interv. 2016;9:e002981

4. Circulation Cardiovascular Intervention 2016; 9 e004307
Art and Science of Cerebrovascular Event Prevention After Transcatheter Aortic Valve Replacement
The evolving concepts of timing, risk factor contributions, and preventive strategies for cerebrovascular events (CVE) in patients undergoing transcatheter aortic valve replacement.
Dangas G and Giustino G
Circulation Cardiovascular Intervention 2016; 9 e004307

5. Strategies to prevent thrombo-embolic complications during TAVR
Giustino G. & Dangas G. – Eurointervention 2015

6. Strategies to prevent thrombo-embolic complications after TAVR
Giustino G. & Dangas G. – Eurointervention 2015

7. Neurological Outcomes With Embolic Protection Devices in TAVR A Systematic Review and Meta-Analysis of RCTs
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Interventions 2016; 9 (20):

8. Neuroimaging Endpoints
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Interventions 2016; 9 (20):

9. TLV between EP versus no EP by balloon-expandable versus self-expandable valves
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Interventions 2016; 9 (20):

10. Neurologic Clinical Endpoints
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Intervention 2016; 9 (20):

11. All-cause Mortality
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Intervention 9 (20):

12. Perspectives
WHAT IS KNOWN? Intraprocedural EP emerged as an attractive strategy to prevent intraprocedural stroke and mitigate the burden of subclinical cerebral embolization during TAVR. Previous RCTs evaluating EP devices were of small size and relatively underpowered to detect differences in neurological imaging and clinical endpoints.
WHAT IS NEW? In this meta-analysis of the available RCTs, use of EP seems to be associated with a significant reduction in imaging markers of cerebral infarction and improved early clinical neurological status.
WHAT IS NEXT? The safety and efficacy of routine EP during TAVR need to be established in prospective RCTs powered to detect differences in hard clinical endpoints.
Giustino G, Mehran R, Verklamp R, Faggioni M, Baber U, Dangas G
JACC Cardiovascular Interventions 2016; 9 (20):

13. Primary Efficacy Endpoint
The GALILEO Trial
Primary Efficacy Endpoint
Composite of Death, Stroke, MI, Symptomatic Valve Thrombosis, Systemic Thromboembolism, DVT and PE

14. - The ENVISAGE Trial - Successful TAVR Design Flow Chart
Patients with indication to chronic oral anticoagulation
RANDOMIZE 1:1
2-5 Days after the procedure
Background of single Antiplatelet Therapy
EDOXABAN 60 mg QD (30 mg QD in patients > 80 years of age, CrCl ml/min or weight < 60 kg).
N = 750
Warfarin (target INR 2-3)
N = 750
Minimum duration of randomized therapy 12 months
CLINIC FOLLOW-UP: 1, 6, 12 Months
Secondary Endpoints
All-cause Death, MI, Stroke or TIA, VARC-2 Life-threatening (LT) bleeding and Major bleeding
Primary Endpoint - NACE
[Composite of Death, MI, Stroke, TIA, systemic thromboembolism or VARC-2 Life-threatening (LT) or Major bleeding]
Substudies
MRI substudy
4D CT substudy
Cost-Effectiveness analysis
Neurocognitive function & QoL substudy