Post-TAVI Cerebral Embolisms and Potential Protection Means
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1 Post-TAVI Cerebral Embolisms and Potential Protection Means Josep Rodés-Cabau, MD Quebec Heart & Lung Institute, Laval University Quebec City, Quebec, Canada EBR Marseille, May 2012
2 Conflict of Interest Disclosure Consultant for Edwards Lifesciences, St-Jude Medical Research grants from Edwards Lifesciences
3 A B C Right cerebellum Left frontal D Right occipital Right parietal Left and right frontal Rodés-Cabau et al. JACC 2011
4 Cerebral MRI Studies Study n Valve type Approach Ischemic defects Median number of lesions Kahlert et al. 32 Edwards SAPIEN (n=22) TF Edwards: 86% Edwards: 4 ( ) Circulation 2010 CoreValve (n=10) CoreValve: 80% CoreValve: 2.6 ( ) Ghanem et al. 22 CoreValve TF 73% 2.5 ( ) JACC 2010 Rodés-Cabau et al. 60 Edwards SAPIEN TF (n=29) TF: 66% TF: 3 (1-7) JACC 2011 TA (n=31) TA: 71% TA: 4 (2-9) Fairbairn et al. 31 CoreValve TF 77% 2 (1-5) Heart 2011 Arnold et al. 25 Edwards SAPIEN TA 68% NA JACC Intv 2010
5 MRI Findings - Cognitive/Neurological Status Study Cognitive/Neurological status Results Stroke Kahlert et al. Circulation 2010 NIHSS, MMSE, mrs No change 0% Ghanem et al. JACC 2010 NIHSS, NSE Neurological impairment: 3 (10%) 3.6% Rodés-Cabau et al. JACC 2011 NIHSS, MMSE No change 3.3% Fairbairn et al. Heart 2011 NIHSS No change 6.0% Arnold et al. JACC: Cardio Interv 2010 Standardized clinical assessment Neurological impairment: 5 (20%) 4.0% NIHSS: National Institutes of Health Stroke Scale MMSE: Mini Mental State Examination mrs: modified Rankin Scale NSE: Neuron-specific enolase
6 % patients 8 Clinically Apparent Stroke Large Multicenter Registries/Series TF Edwards TA Edwards Edwards TF/TA CoreValve Overall Canadian1 SOURCE 2 France3 TRAVERCE4 European5 Italian6 German7 Belgian8 UK 9 TF Edwards n=168 TA Edwards n=177 TF Edwards n=463 TA Edwards n=575 1-Rodes-Cabau et al, JACC Thomas et al, Circulation Eltchaninoff et al, Eur Heart J, Walther et al, Eur J Cardiothorac Surg, 2010 TF Edwards n=95 TA Edwards n=71 TF Corevalve n=66 SC CoreValve n=12 TA Edwards n=168 TF Corevalve n=646 TF Corevalve n=599 SC CoreValve n=64 5-Piazza et al, EuroInterv Tamburino et al, Circulation, Zahn et al, Eur Heart J, Bosmans et al, Interactive Cardiovasc and Thoracic Surgery, 2011 Corevalve n=588 Edwards n=109 TF n=644 SC n=22 TA n=26 Transaortic n=5 TF/TA Edwards n=187 Corevalve n= Ludman P, JACC 2010 Edwards n=410 Corevalve n=452
7 Stroke Interventional Cardiology Procedures Stroke (%) TAVI PCI Without With Embolic protection CAS LAA closure TAVI: Transcatheter Aortic Valve Implantation PCI: Percutaneous Coronary Intervention CAS: Carotid Artery Stenting LAA: Left Atrial Appendage
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9 Leon M. ICI symposium 2010
10 Transcranial Doppler findings HITS Medtronic CoreValve Edwards SAPIEN-TF Edwards SAPIEN-TA Valve Passage Stiff Wire BAV Balloon BAV Delivery System Positioning Implant Total Adapted from Kahlert, AHA 2010
11 Miller C. AATS 2011
12 Messika-Zeitoun et al. Circulation 2004
13 TAVI (n=209) / 30-Day Cerebrovascular Events Cerebrovascular events (%) p=0.006 Aortic Valve Calcium volume (mm 3 ) 5000 p= (IQR: ) ( ) 0 yes no 0 yes no Balloon Postdilation 30-day Cerebrovascular events Nombela-Franco et al. JACC Intv, in press
14 Number of patients <1 Procedure Timing of Stroke post-tavi (30 days) Canadian Experience and PARTNER cohort B (22 patients) * Days of follow-up *1 patient with hemorrhagic stroke Hynes B, Rodés-Cabau J. Annals NYAS 2012
15 30-Day Cardioembolic Events Following TAVI, According to the Occurrence of New-Onset Atrial Fibrillation (NOAF) % P= day <24h >24h 30-day NOAF (n=44) No-NOAF (n=94) Amat-Santos et al. JACC 2012
16 TAVI and New-Onset Atrial Fibrillation Amat-Santos, et al. JACC 2012
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18 CLINICAL EXPERIENCE PUBLISHED REGISTRIES Patient characteristics Variables Mean (min-max) Age (years) 82 (50-98) Male sex (%) 44 (24-57) Diabetes (%) 28 (23-35) Hypertension 60 (36-85) Prior Mean coronary disease CHADS2 (%) score 54 (41-69) ~ 3 Prior CABG (%) 25 (14-45) Chronic renal failure (%) 35 (20-62) COPD (%) 26 (21-30) Prior stroke (%) 9 (7-11) Peripheral vascular disease (%) 19 (7-35) TA 30 (11-50) TF 11 (4-19) Porcelain aorta (%) 12 (7-18) Frailty (%) 21 (17-25)
19 C TAVI procedure Filter wire EZ (Boston Scientific) Courtesy of Chen YH, Taipei Veterans hospital
20 EMBOLIC PROTECTION DEVICES
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24 TAVR / Antithrombotic Treatment Pre-procedure Aspirin ( mg) +/- clopidogrel (loading dose?) Procedure Heparin (100 U/Kg, ACT >250 sec) Post-procedure Aspirin ( mg/d, indefenitely) + clopidogrel (75 mg/d, 3-6 months) Chronic AF, new-onset AF Warfarin + aspirin + clopidogrel Warfarin + aspirin or warfarin + clopidogrel Warfarin
25 Antithrombotic therapy: Aspirin vs. Aspirin+Clopidogrel Outcomes at 30 days Antithrombotic therapy (Aspirin+Clopidogrel) n=40 Aspirin n=39 Outcomes at 6 months Antithrombotic therapy (Aspirin+Clopidogrel) n=40 Aspirin n=39 Adapted from Paolo et al, Am J Cardiol 2011
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27 Miller C. AATS 2011
28 CONCLUSIONS TAVI is associated with a high rate (~70%) of new cerebral ischemic defects as evaluated by MRI Stroke rate at 30 days is ~ 3.5% (0.6 to 6.7%) Cerebral embolism during the TAVI procedure is probably multifactorial but seems to be mainly related to valve prosthesis positioning and implantation Only about 50% of neurologic events occur during the TAVI procedure Preliminary data suggest that most cerebrovascular events after the first 24 hrs are mainly related to atrial arrythmias The potential role of embolic protection devices should be evaluated in future studies The most appropriate antithrombotic treatment following TAVI needs to be established
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