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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
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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
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First and most important Option…
Prevent Strokes !!
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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):
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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
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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
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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:
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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
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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
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Embolic Protection Filters Mounting evidence suggests they help
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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.
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Carotid vs TAVR Which is which?? CAS TAVR 12
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CAS and TAVR Without Embolic Protection
Would you do this? 13
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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
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CAS Incidence of new Cerebral Ischemic Lesions Newer EP Technology May Be Better ??
(27/31) (14/31) Filter Balloon
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Ipsi- and Contralateral Lesion Incidence
CAS Ipsi- and Contralateral Lesion Incidence The Importance of the Arch Ipsi- and contralateral Ipsilateral Contralateral
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Number of Ipsi- vs Contralateral Lesions
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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
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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%
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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):
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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):
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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);
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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
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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
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Thank you!
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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”
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