1. Options for Intervention in a Patient who has a TAVR Stroke
L. Nelson Hopkins MD FACS
Distinguished Professor of Neurosurgery
Professor of Radiology
Founder, Gates Vascular Institute
And Jacobs Institute

2. Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship
Company
Grant/Research Support
Consulting Fees/Honoraria
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit1
Toshiba, Medtronic, Microvention
None
Claret, Boston Scientific, Medina, Ostial, Apama, Ocular, Silk Road, TSP
TSP

3. First and most important Option…
Prevent Strokes !!

4. TAVR and Stroke Knowing the risk factors for stroke after TAVR
Female gender8
Chronic Kidney Disease (CKD)8
TAVR at center in first half of experience8
Post-procedural new onset atrial fibrillation8,9
Valve-in-Valve higher risk than native valve TAVR9
Trans Apical patients
8Auffret V, Regueiro A, Del Trigo M, et al. Predictors of Early Cerebrovascular Events in Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement. JACC (7)
9Davidson LJ and Davidson CJ. Editorial Comment: Stroke Prevention: Let’s Prepare for Generation X TAVR. Catheter Cardiovasc Interv (4):

5. Strokes Post TAVR Multi-Factorial
Embolic material -Debris released during the procedure Atrial fibrillation (new onset) Hypo-perfusion Hemorrhage
First priority should first be to prevent stroke by using embolic protection, but stroke is multi-factorial

6. Preventable Strokes During TAVR
Embolic material released during TAVR
-Atheromatous Material
-valve tissue
-calcium
-thrombus
-foreign material
First priority should first be to prevent stroke by using embolic protection, but stroke is multi-factorial

7. Clinical stroke Post TAVR under-recognized Other Trans Aortic Arch Left Heart Procedures ??
AHA/ASA consensus definition of stroke includes imaging evidence of a CNS infarction with or without acute neurological dysfunction1
Most studies do not use routine MRI imaging post op
Studies using discharge DETAILED exam by neurologists report much higher clinical stroke rates2 (Messé, et al., e.g.)
Rates of new neurological deficit with positive imaging evidence of brain ischemia
vs.
Sacco R, et al., Stroke. 2013;44:
Messé S, et al., Circulation. 2014;129:

8. Most Ischemic Injury in TAVR Unrecognized
Major/disabling stroke
Transient ischemic attack (TIA)
Minor/non-disabling stroke
Neurocognitive decline
“Silent” cerebral infarcts
cognitive changes can go unnoticed initially but can be devastating long term
….but can have far-reaching effects

9. New cerebral lesions found in most patients following TAVR Mounting evidence MRI lesions associated with delayed problems with cognition
Ghanem, et. al, JACC 2010
68-100% of TAVI patients affected1-12
Most patients have multiple infarcts
“Silent” infarcts associated with13-15
2-4-fold risk of future stroke
>3-fold risk of mortality
>2-fold risk of dementia
Cognitive decline
Dementia
(Control Arm)
(Control Arm)
1. Rodes-Cabau, et al., JACC 2011; 57(1):18-28
2. Ghanem, et al., JACC 2010; 55(14):
3. Arnold, et al., JACC:CVI 2010; 3(11):1126 –32
4. Kahlert, et al., Circulation. 2010;121:
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, et al., TCT 2014
10. Lansky, et al., London Valves 2015
11. van Mieghem N, et al. EuroIntervention 2016;12:
12. Kapadia, et al., JACC. doi: /j.jacc
13. Sacco et al., Stroke 2013
14. Vermeer et al., Stroke 2003
15. Vermeer et al., New Engl J Med 2009

10. Embolic Protection Filters Mounting evidence suggests they help

11. Common Sense Debris captured in CAS filters 30-60% Debris captured in TAVR filters 80-99%
Debris Captured in 99% of TAVR patients in SENTINEL (n=105 patients), including:2
Arterial wall
Valve tissue
Calcification
Foreign material
Myocardium
Organizing and acute thrombus
Carotid filters captured debris in 57% of carotid stenting patients in ARCHeR (n=581 patients), including:1
Foam cells, smooth muscle cells, cholesterol, collagen/elastin, platelet/fibrin
EP Mandatory in CAS
Guidant Accunet
EP Not Mandatory in TAVR!!????
Claret Sentinel
Gray W, et al. ARCHeR J Vasc Surg 2006;44:258-69
2. Kapadia S, et al. SENTINEL JACC 2017;69:367–77
CAUTION: Investigational device. Limited to investigational use by United States law.

12. Carotid vs TAVR
Which is which??
CAS TAVR 12

13. CAS and TAVR Without Embolic Protection
Would you do this? 13

14. PROFI: A Prospective, Randomized Trial of Proximal Balloon Occlusion vs. Filter Embolic Protection in Patients Undergoing Carotid Stenting Hints for TAVR
Klaudija Bijuklic Fadija Hazizi, Andreas Wandler, Joachim Schofer
Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg University Cardiovascular Center
Germany 14

15. CAS Incidence of new Cerebral Ischemic Lesions Newer EP Technology May Be Better ??
(27/31)
(14/31)
Filter
Balloon

16. Ipsi- and Contralateral Lesion Incidence
CAS
Ipsi- and Contralateral Lesion Incidence
The Importance of the Arch
Ipsi- and contralateral
Ipsilateral
Contralateral

17. Number of Ipsi- vs Contralateral Lesions

18. Stroke What to do if you have one????
Recognize it…Intermittent Neuro exams
Emergency Stroke Study (CT, CTA, CTP)
Call Stroke Team
Have Neuro devices available
Catheters(Penumbra, Terumo, Stryker, Medtronic)
Clot Retrievers(Medtronic, Stryker, Penumbra)
CDC.Gov stroke facts page
Remove Clot; Reperfuse Brain ASAP
-Anyone qualified

19. Time is Brain Each minute… stroke destroys: 1.9 million neurons,
Meaning What??
Each minute… stroke destroys:
1.9 million neurons,
14 billion synapses,
12 km (7.5 miles) of myelinated fibers
If we can reopen the occluded artery within 2 hours…
-Recovery rate is 90%
If it takes 6 hours to open the occluded artery…
-Recovery rate is 20%

20. In-Hospital Stroke
2.2-17% of all stroke symptoms start during a hospitalization2
Against expectation, these strokes often have a longer delay to diagnosis, delayed treatment, and decreased adherence to the measures of care
Largest study found 49% of patients were on antiplatelet therapy, and 17% were on anticoagulation3
2Cumbler, E. In-Hospital Ischemic Stroke. Neurohospitalist. 2015; 5(3);
3Cumbler E, Wald H, Bhatt DL, et al. Quality of care and outcomes for in-hospital ischemic stroke: findings from the national Get With The Guidelines-stroke. Stroke. 2014;45(1):

21. In-Hospital Stroke
Most common services are cardiology and cardiovascular surgery4
Admitting diagnosis for patients with in-hospital strokes
Cardiovascular 24%
Neurology/neurosurgery 15%
Hematology/oncology 8%
Ortho/trauma 7%
GI 7%
Respiratory 5%
Two thirds have the initial symptom onset witnessed, usually by a nurse5,6
4Park JH, Cho HJ, Kim DW, et al. Comparison of the characteristics for in-hospital and out-of-hospital ischaemic strokes. Eur J Neur. 2009; 16(5):
5Vera R, Lago A, Fuentes B, et al. In-hospital stroke: a multi-centre prospective registry. Eur J Neurol. 2011;18(1):
6Albers MJ, Brass LM, Perry A, Webb D, Dawson DV. Evaluation times for patients with in-hospital strokes. Stroke. 1993;24(12):

22. Prognosis of In-Hospital Stroke Prior to 2015
Longer length of stay
Greater disability … worse mRS
Half as likely to return directly home
Moderate to severe disability of 45-61% (community stroke rate is 25-36%)
MORTALITY RATE 2-3 X community stroke rates2
14-19% MORTALITY
Why So Bad??
-Speed of revascularization determines prognosis
-Patients are already in house
-Huge opportunity here !!
2Cumbler, E. In-Hospital Ischemic Stroke. Neurohospitalist. 2015; 5(3);

23. TAVR and Stroke
Subclinical stroke is a serious and under recognized problem
What are the long-term neurocognitive sequelae to radiographic infarcts on MRI?
Pharma mgmt…can it help?
Immediate recognition and restoring flow

24. Future Stroke Prevention in TAVR
Understand & modify risk factors
EP keeps some debris out of the Brain
Be prepared for rare event…big stroke
Stroke Tools… have them available
CT perfusion (CT, CTA, CT Perfusion)
Develop a stroke team… speed is key

25. Thank you!

26. SENTINEL…ACC Summary
“The results of this trial indicate that routine use of the Sentinel TCEP does not result in a significant reduction in new lesion volume on MRI and nondisabling strokes within 30 days. It adds to the total procedure and fluoroscopic times with a slight increase in vascular complication rates”