strokes after tavr: perspectives from the us corevalve trials · 2016. 2. 17. · popma tvt 2014...
TRANSCRIPT
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Jeffrey J. Popma, MD Professor of Medicine
Harvard Medical School Director, Interventional Cardiology
Clinical Services Beth Israel Deaconess Medical Center
Boston, MA
Strokes After TAVR: Perspectives from the US
CoreValve Trials
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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
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Stroke After TAVR
• Neurologic Definitions
• Neurologic Assessment
• Extreme Risk Findings
• High Risk Findings
• Predictors of Stroke
Popma TVT 2014 Stroke After TAVR
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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
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Stroke After TAVR
• Neurologic Definitions
• Neurologic Assessment
• Extreme Risk Finding
• High Risk Findings
• Predictors of Stroke
Popma TVT 2014 Stroke After TAVR
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Extreme Risk Study | Iliofemoral
Protocol Mandated Neuro Assessment
Popma TVT 2014 Stroke After TAVR
Before and Immediately Post-Procedure
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Stroke After TAVR
• Neurologic Definitions
• Neurologic Assessment
• Extreme Risk Findings
• High Risk Findings
• Predictors of Stroke
Popma TVT 2014 Stroke After TAVR
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Pivotal Trial Design
8 Extreme Risk Study | Iliofemoral Pivotal Popma JACC 2014 March 19 (epub ahead of print)
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Study Disposition
9 Extreme Risk Study | Iliofemoral Pivotal Popma JACC 2014 March 19 (epub ahead of print)
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Major Stroke
10 Extreme Risk Study | Iliofemoral Pivotal Popma JACC 2014 March 19 (epub ahead of print)
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Neurologic Events
11 Extreme Risk Study | Iliofemoral Pivotal
Event
1 Month
N=471
1 Year
N=471
Any Stroke, % 4.0 7.0
Major Stroke, % 2.3 4.3
Minor Stroke, % 1.9 3.2
TIA, % 0.6 1.1
Popma JACC 2014 March 19 (epub ahead of print)
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0
1
2
3
4
5
6
7
8
9
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 25 26 27 28 29 30
Days to Stroke
Minor StrokeMajor Stroke
Major and Minor Stroke (1 Month) N
um
ber
of
Str
okes (
n)
12 Extreme Risk Study | Iliofemoral Pivotal Popma JACC 2014 March 19 (epub ahead of print)
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All-Cause Mortality By Major Stroke
13 Extreme Risk Study | Iliofemoral Pivotal Popma TVT 2014 Stroke After TAVR
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Stroke After TAVR
• Neurologic Definitions
• Neurologic Assessment
• Extreme Risk Findings
• High Risk Findings
• Predictors of Stroke
Popma TVT 2014 Stroke After TAVR
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Pivotal Trial Design
15 Adams NEJM 2014 March 29 (epub ahead of print)
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All Stroke
Adams NEJM 2014 March 29 (epub ahead of print)
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Major Stroke
17 Adams NEJM 2014 March 29 (epub ahead of print)
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All-Cause Mortality or Major Stroke
18 Adams NEJM 2014 March 29 (epub ahead of print)
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Stroke After TAVR
• Neurologic Definitions
• Neurologic Assessment
• Extreme Risk Finding
• High Risk Findings
• Predictors of Stroke
Popma TVT 2014 Stroke After TAVR
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Predictors of Stroke-I
Variable Patients
KM (%) 1-Yr
(95% CI)
Rate of All-Stroke
(6.7%) P Value
Age
≤85 222 5.4 (2.9, 10.0)
>85 249 7.8 (4.8, 12.7) 0.268
Logistic EuroSCORE
<22 291 6.6 (4.1, 10.7) 0.897
≥22 180 6.8 (3.5, 12.8)
STS Score
<10 263 7.8 (4.9, 12.4)
10-15 (vs. <10) 125 6.1 (2.8, 12.9) 0.552
>15 (vs. <10) 83 4.2 (1.1, 14.5) 0.286
Diabetes 200 4.4 (2.0, 9.4) 0.110
Hypertension 424 7.4 (5.1, 10.9) 0.071
PVD 165 9.2 (5.2, 16.0) 0.116
20 TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study | Iliofemoral Pivotal
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Variable Patients
KM (%) 1-Yr
(95% CI)
Rate of All Stroke
(6.7%) P Value
Prior Stroke 65 4.7 (1.3, 16.9) 0.627
Prior TIA 44 7.3 (2.1, 23.3) 0.844
History of A-fib / A-
flutter 222 5.6 (3.0, 10.5) 0.344
Post-TAVR
Valvuloplasty
Performed
99 5.7 (2.2, 14.5) 0.689
More than 1 Valve
Implanted 17 5.9 (0.9, 35.0) 0.909
Predictors of Stroke-II
21 TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study | Iliofemoral Pivotal
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Conclusions
22 TCT 2013 Predictors of Mortality and Stroke Extreme Risk Study | Iliofemoral Pivotal
• 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 1st 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