The Evidence and Clinical Need Justifies the Widespread ... · Prior CVA . Cleveland Clinic Summary...
Transcript of The Evidence and Clinical Need Justifies the Widespread ... · Prior CVA . Cleveland Clinic Summary...
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Cleveland Clinic
Samir Kapadia, MDProfessor of Medicine
Section head, Interventional CardiologyDirector, Cardiac Catheterization Laboratories
Cleveland Clinic
The Evidence and Clinical Need Justifies the Widespread Use of Embolic Protection During TAVR
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Cleveland Clinic
Disclosure• Co PI for Sentinel Trial
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Questions
• Is Stroke a Problem with TAVR in 2017?• How Common is Stroke in Comparison With SAVR?• Does Cerebral Protection Work?
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Questions
• Is Stroke a Problem with TAVR in 2017?• How Common is Stroke in Comparison With SAVR?• Does Cerebral Protection Work?
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Stroke Rates in Randomized Trials
•1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol Intv 2015;8:1797-806; 3Smith, et al., N Engl J Med 2011;364:2187-98; 4Leon, et al., N Engl J Med 2016;374:1609-20; 5Popma, et al., J Am Coll Cardiol 2014;63:1972-81; 6Adams, et al., N Engl J Med 2014;370:1790-8;;
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•1Manoharan, et al., J Am Coll Cardiol Intv 2015; 8: 1359-67; 2Moellman, et al., presented at PCR London Valves 2015; 3Linke, et al., presented at PCR London Valves 2015; 4Kodali, et al., Eur Heart J 2016; doi:10.1093/eurheartj/ehw112; 5Vahanian, et al., presented at EuroPCR 2015; 6Webb, et. al. J Am Coll Cardiol Intv 2015; 8: 1797-806; 7DeMarco, et al, presented at TCT 2015; 8Meredith, et al., presented at PCR London Valves 2015; 10Falk, et al., presented at EuroPCR 2016; 11Kodali, presented at TCT 2016; Reardon, M Published in NEJM March 2017
•Weighted average (n=5,952)~3.1%
Stroke Rates with Contemporary Devices
•71% BE (S3+XT)•29% SE (EvolutR+CV)
• 95% of SENTINEL patients were evaluated prospectively by neurologists.
• Clinical Events Committee included 2 stroke neurologists.
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Stroke Risk With Second Generation TAVR valves
Athappan, et al. A systematic review on the safety of second-generation transcatheter aortic valves. EuroIntervention 2016; 11:1034-1043
• Meta-analysis of ~20 non-randomized, mostly FIM, valve-company sponsored studies
• 2.4% major stroke at 30-days
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Cleveland Clinic
TVT Stroke Rate
2.6 2.6 2.62.4
00.5
11.5
22.5
3
2012 2013 2014 2015
% 30 Day Stroke
PCI
0.15%
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Mortality After StrokeTF TAVR – PARTNER Trial
Kapadia et al, Circ Int 2016
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No. at Risk
Major Stroke 15 10 5 2
No Major Stroke
376 368 329 217
•10
Mortality after StrokeCoreValve High Risk Trial
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Cleveland Clinic
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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% of TAVI patients with new cerebral lesions on DW-MRI
MRI Lesions After TAVR
•10. Lansky, et al. London Valves 2015
•11. Sacco et al., Stroke 2013
•12. Vermeer et al., Stroke 2003
•13. Vermeer et al., New Engl J Med
2009
•1. Rodes-Cabau, et al., JACC 2011; 57(1):18-28
•2. Ghanem, et al., JACC 2010; 55(14):1427-32
•3. Arnold, et al., JACC:CVI 2010; 3(11):1126 –32
•4. Kahlert, et al., Circulation. 2010;121:870-878
•5. Astarci, et al., EJCTS 2011; 40:475-9
•6. Lansky, et al., EHJ 2015; May 19
•7. Bijuklic, et al., JACC: CVI 2015
•8. Linke, et al., TCT 2014
•9. Vahanian, TCT 2014
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Overt Stroke – Size, Number, LOCATION
Size Number Location
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Lesion Volume, All Territories, P=0.0015
0 1 2 3 4
log10totvolpp_allT
-1.0
-0.5
0.0
0.5
1.0
Change in O
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95% Prediction Limits95% Confidence LimitsFit
Fit Plot for chgzOverall
Neurocognitive Changes and Lesions
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Cleveland Clinic
Stroke Risk Summary
Stroke risk is decreased compared to early feasibility trials (but not much) and is still a significant clinical problem
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Questions
• Is Stroke a Problem with TAVR in 2017?• How Common is Stroke in Comparison With SAVR?• Does Cerebral Protection Work?
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Cleveland Clinic
Stroke : TAVR versus SAVR
4.4
2.6
5.56.1
2.7
6.1
3.4
5.6
0
2
4
6
8
30 DaysTAVR SAVR TAVR SAVR TAVR SAVR
P1A S3iP2A
TAVR SAVR
SURTAVI
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TAVR and SAVR Stroke
• Risk of stroke with TAVR is not higher than risk of stroke with SAVR
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Cleveland Clinic
Questions
• Is Stroke a Problem with TAVR in 2017?• How Common is Stroke in Comparison With SAVR?• Does Cerebral Protection Work?
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Cerebral Protection
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Claret Medical™Sentinel™ Cerebral Protection System
•CAUTION: Investigational Device. Limited to investigational use by United States law.
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•Fully Protected •74% brain volume
•Partially Protected •24% brain volume
•Unprotected •2% brain volume
Sentinel Filters Protection
Zhao M, et al. Regional Cerebral Blood Flow Using Quantitative MR Angiography. AJNR 2007;28:1470-1473
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Cleveland Clinic
30-Day MACCE Sentinel vs. Control (ITT)
7.3%
9.9%
0%
5%
10%
15%
20%
Sentinel (Safety + Test) (N=234)
Control (N=111)
N=17 N=11
% of Patients with an Event
Error bars represent upper bound of the 95% Upper CI
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SENTINEL Study: Procedural Stroke
•SENTINEL trial. Data presented at Sentinel FDA Advisory Panel, February 23, 2017
•95% of SENTINEL patients were evaluated by neurologists•Clinical Events Committee included 2 stroke neurologists
•*Fisher Exact Test
•63% Reduction
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Type of Tissue Identified
Organizing
Acute + organizing thrombus Arterial wall + thrombus Valve tissue
Calcium nodules Foreign material + thrombus Myocardium + thrombus
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Morphometric Analysis:Embolic Material by Particle Size
14%
55%
91%
99%
0% 100%
>=150 um
>= 500 um
>= 1000 u
>=2000 um
20% 40% 60% 80%
Percent of Patients with at Least One Particle of Given Size
≥0.15 mm
≥0.5 mm
≥1 mm
≥2 mm
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Patient Level Meta-analysis: CLARETLesion Volume in Protected Territories
Data presented at Sentinel FDA Advisory Panel, February 23, 2017
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Ulm Sentinel study
Wörhle J, Seeger J, et al. DGK Mannheim 2017; CSI-Ulm-TAVR Study clinicaltrials.gov NCT02162069
• 802 all-comer consecutive TAVR patients at University of Ulm were prospectively enrolled • A propensity-score analysis was done matching the 280 patients protected with Sentinel to 280 control patients
• In multivariable analysis, TAVR without cerebral emboli protection (p=0.044) was the only independent predictor for stroke at 7-days• TAVR without cerebral emboli protection (p=0.028) and STS score (<8 vs. >8) (p=0.021) were the only independent predictors for
mortality and stroke at 7-days
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Predictors of Stroke, Neuro events or MRI findings
Author N Event rate Approach Clinical predictorsAnatomical
predictors
Tay et al 2011 253 9% TA/TF H/O stroke/TIA Carotid stenosis*
Nuis et al 2012 214 9% TF New onset AF Baseline AR >3+
Amat Santos et al 2012 138 6.5% TA/TF New onset AF None
Franco et al 2012 211 4.7% TA/TF None Post-dilation
Miller et al 2012 344 9% TA/TFHistory of stroke
Non TF-TAVR candidateSmaller AVA
Cabau et al 2011 60 68% (MRI) TA/TF Male, History of CAD Higher AVG
Fairbairn et al 2012 31 77% (MRI) TF Age Aortic atheroma
Nombela-Franco et al
20121061 5.1% TA/TF
Balloon postdilatation,
valve dislodgement,
New onset AF, PVD,
Prior CVA
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Summary• There is benefit of emboli prevention
• Clinical benefit• “Covert” stroke benefit
• We can’t reliably identify patients at risk and 99% patients have embolic material in filter
• Device is safe• Emboli prevention devices should be considered in
all patients undergoing TAVR
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TAVR in 2018Conscious sedation, TTE
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One Perclose and Same Side Sheath
•Valve Access
•Pigtail Access
•Pacer
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Sentinel
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Valve Deployment
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Final Picture
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Procedural Log
8:47 to 9:15 = 28 minutesAccess, temp wire, Sentinel, Valve deployment
Closure of groin
Fluorotime 11 miutesRadiation 159 mGy