Strokes After TAVR. Ioannis Iakovou, MD, PhD. Interventional Cardiology Onassis Cardiac Surgery Center

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1 Strokes After TAVR Ioannis Iakovou, MD, PhD Interventional Cardiology Onassis Cardiac Surgery Center

2 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (procedural versus non procedural) Predictors of stroke after TAVR Prevention methods

3 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (procedural versus non procedural) Predictors of stroke after TAVR Prevention methods

4 Strokes After TAVR

5 Strokes After TAVR 30 Days -All Stroke from PARTNER Trials nonrandomized continued access (NRCA) registry cohort

6 Stroke : Feasibility Trials 25 multicenter registries and 33 single-center studies Athappan et al, JACC 2014

7 In hospital or 30 day stroke TA versus TF (Major Registries) Athappan et al, JACC 2014

8 In Hospital or 30 Day Stroke ES versus MC Major Registires Athappan et al, JACC 2014

9 Single Center (TF versus TA) Athappan et al, JACC 2014

10 30 day or in hospital stroke MC versus ES single center Athappan et al, JACC 2014

11 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (Procedural versus non procedural) Predictors of stroke after TAVR Prevention Methods

12 All Stroke : PARTNER A

13 CoreValveTrial : All Stroke 795 patients underwent randomization at 45 centers in the United States Adams, NEJM, 2014

14 High Risk Surgical AVR and Stroke A retrospective review was performed on 159 patients Thourani et al, Ann ThoracSurg2011;91:49 56

15 prospective cohort study of subjects 65 years of age who were undergoing AVR for calcific aortic stenosis. Subjects were evaluated by neurologists preoperatively and postoperatively and underwent postoperative magnetic resonance imaging. Messe, Circulation, 2014

16 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (Procedural versus non procedural) Predictors of stroke after TAVR Prevention Methods

17 Stroke Timing within 1 year

18 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (Procedural versus non procedural) Predictors of stroke after TAVR Prevention Methods

19 Risk factors for Neurologic Events Samir Kapadia TCT 2014

20 TAVR and Stroke : Registry Data Samir Kapadia TCT 2014

21 Predictors of Stroke, Neuro events or MRI findings Samir Kapadia TCT 2014

22 Impact of Post-Dilatation Nombela-Franco et al, J Am Coll Cardiol Intv 2012;5:

23 Canadian Experience 1061 Patients 5 centers 679 (65%) Balloon expandable 361 (34%) Self expandable Analysis of events depending on timing of stroke Nombela-Franco et al, J Am Coll Cardiol Intv 2012;5:

24 Predictors of Early (30-Day) CVEs Nombela-Franco et al, J Am Coll Cardiol Intv 2012;5:

25 Predictors of Late CVEs (>30-day) Nombela-Franco et al, J Am Coll Cardiol Intv 2012;5:

26 Timing of NOAF after TAVR 138 consecutive patients with no prior history of atrial fibrillation (AF) underwent TAVI with a balloon-expandable valve NOAF occurred in 44 patients (31.9%) at a median time of 48 h Amat-Santoset al, JACC2012;59:178 88

27 New Onset AF after TAVR and Stroke NOAF was associated with a higher rate of stroke/systemic embolism, but not a higher mortality, at 30 days and at 1-year follow-up. Amat-Santoset al, JACC2012;59:178 88

28 Strokes After TAVR How common is stroke after TAVR Is it increasing? Is it more with TF vs TA? Is it different in SE or BE valves? How does this compare to surgery? Timing of stroke (Procedural versus non procedural) Predictors of stroke after TAVR Prevention Methods

29 Stroke Prevention Measures

30 Emboli Protection Devices

31 Histopathology Claret Debris Capture Van Mieghem et al, Circulation 2013;127:

32 US IDE Sentinel Study Summary Cerebral Protection in Transcatheter Aortic Valve Replacement The SENTINEL Study Study Objective Assess the safety and efficacy of the Claret Medical SentinelCerebral Protection System for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection) Study Population Subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or XT (if approved) Number of Centers Up to 15 clinical study centers

33 Implication Stroke prevention will help to move to lower risk patients It may be an advantage rather than disadvantage for TAVR compared to SAVR (similar to PCI compared to CABG)

34 Thank you!

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