1. Stroke After TAVR: Surgeon View
Michael Mack, M.D.
Baylor Healthcare System
Dallas, TX

2. Michael J. Mack, MD
I have no real or apparent conflicts of interest to report.
My presentation will include off label discussions:
Edwards Sapien Valve

3. Stroke VARC Definition

4. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

5. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

6. Observed Stroke

7. 2-2.5%

8. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

10. TAVR – Stroke Edwards (TF) Core Valve Study Stroke (%) REVIVAL (55) a
3.6
VANCOUVER (114) b
5.0
PARTNER EU (61) c
3.3
SOURCE (920) d
2.9
FRENCH (853) e
3.5
UK (172) f
4.0
BELGIAN (99) g
2.0
CANADIAN (168) h
3.0
Core Valve
Stroke (%)
Study
1.2
ITALIAN (663) 1 NR
GERMAN (588) 2
1.9
AUSTRAL.-NZ (118) 3
SPANISH (108) 4
4.5
FRENCH (66) 5
4.3
UK (460) 6
5.0
BELGIAN (141) 7
2.8
AVERAGE
aKodali et al AJC 2011;107:
bWebb TCT 2008
cLefevre et al EurHeartJ 2011;32:148-57
dThomas et al Euro PCR 2011
eGilard M EuroPCR 2011
fLudman EuroPCR 2010
gBosmans ICVTS 2011;12:762-7
hRodes-Cabau et al. JACC 2010;55:In Press
1Tamburino Circulation 2011;123;
2Zahn EuroPCR 2010
3Meredith TCT2010
4Avanzas Rev Esp Cardiol 2010;63(2):141-8
5Eltchaninoff Eur Heart J 2010; Sept 15, 2010 epub
6Moat EuroPCR 2010
7Bosmans EuroPCR 2010

12. N Engl J Med 2011;364:

13. Editorial Response N Engl J Med 2011;364:2256-58
This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
Choose View / Master / Slide Master from your menu.
Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle)
N Engl J Med 2011;364: 13

14. Neurological Events at 30 Days and 1 Year All Patients (N=699)
30 Days
1 Year
Outcome
TAVR (N = 348)
AVR (N = 351)
All Stroke or TIA – no. (%)
19 (5.5)
8 (2.4)
0.04
27 (8.3)
13 (4.3)
TIA – no. (%)
3 (0.9)
1 (0.3)
0.33
7 (2.3)
4 (1.5)
0.47
All Stroke – no. (%)
16 (4.6)
0.12
20 (6.0)
10 (3.2)
0.08
Major Stroke – no. (%)
13 (3.8)
7 (2.1)
0.20
17 (5.1)
0.07
Minor Stroke – no. (%)
0.34
2 (0.7)
0.84
Death/maj stroke – no. (%)
24 (6.9)
28 (8.2)
0.52
92 (26.5)
93 (28.0)
0.68
p-value
p-value

15. Neurologic Events in PARTNER-A
As treated (AT) analysis of types of neurological events (Sept 2010 datalock)
TIA 26%
TIA 25%
Major 58%
Major 69%
Minor 6%
Minor 16%
31/344
16/315
47 patients, 49 events
Ischemic- 72%, hemorrhagic- 0%, Isch → hem- 4%, unknown- 24%

16. Early hazard of neurologic event
TAVR
%/mo
AVR
Figure 1a
Months after Procedure

17. Neurological events at 30 days and 1 year (AT, n= 657) TF stratum (n= 461) TF TAVR vs. AVR

18. Neurological events at 30 days and 1 year (AT, n= 657) TA stratum (n= 196) TA TAVR vs. AVR

19. Neurologic events % Considering competing risk of death AVR-TA 11
TAVR-TA
9.1
6.9
TAVR-TF
5.8
AVR-TF
2.2
2.6 67 59
114 32
106 18
179 64
160 62
223 76
170
221 92
TAVR-TF
TAVR-TA AVR-TF
AVR-TA

20. 30 Day Neurological Events: PARTNER A (ITT)TA TF
per cent
Smith et al, NEJM, June 2011

21. TA- CAP Clinical Outcomes at 30 Days and 1 Year (AT) n=822
All percents are KM estimates.
30 Days
1 Year
Outcome
PMA-TA (n = 104)
AVR (n = 92)
NRCA-TA (n = 822)
NRCA-TA
(n = 822)
All-Cause Mortality – pts. (%)
9 (8.7%)
7 (7.6%)
66 (8.2%)
30 (29.1%)
23 (25.3%)
148 (23.6%)
Stroke – pts. (%)
7 (7.0%)
5 (5.5%)
16 (2.0%)
10 (10.8%)
6 (7.0%)
22 (3.7%)
Death or Stroke – pts. (%)
16 (15.4%)
11 (12.0%)
80 (9.9%)
36 (34.8%)
27 (29.7%)
163 (25.7%)
Note: p-values between NRCA-TA vs PMA-TA and NRCA-TA vs AVR are all not significant.

22. What Does A Patient REALLY Want To Know ?
What are my chances of being alive with out a stroke ?

23. Partner I-A-Death /Neurologic Events
32.5%
31.1%
8.9%
8.9%

24. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

25. PARTNER-A: Timing of Neurological Events
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
ICU stay (d)
0-2
3-5
6-10
11-30
31-364
>730

26. The Source

27. New Onset Atrial Fibrillation – 31.9%
Cerebrovascular event/Systemic Embolization 13.6% vs. 3.2% p=0.021

28. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

29. Stroke after TAVR Role of Embolic Protection

30. PARTNER-A: Timing of Neurological Events
51%
procedural
(<10 d) n
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
AVR
TAVR
ICU stay (d)
0-2
3-5
6-10
11-30
31-364
>730

31. Brain DWMRI after TAVR

32. Diffusion-Weighted MRI Study
Philipp Kahlert, MD
West German Heart Center Essen
Pre-TAVI
Post-TAVI
Example of an 82-year-old patient two days after successful TAVI
This is a representative example of a patient’s BRAIN MRI pre-TAVI and post TAVI where we appreciate the multiple insults to both the cerebrum cerebellum. This presentation tells us there is an embolic phenomenon occuring.

33. Silent Cerebral Embolism after TAVR
Diffusion Weighted MRI – TAVR vs Surgical AVR
New Lesions
Lesion Volume
mm3 %
Age (yrs)
Kahlert PK et al. Circulation 2010;121:

34. Brain DWMRI after TAVR Valve New MRI lesions Stroke Ghanem CoreValve
73%
10%
Knipp
SAPIEN
58% 4%
Kahlert
Both
84% 0%
Astarci
91%
Rodes, Webb
68%
3.3%

36. Stroke After TAVR Stroke After Surgical AVR Stroke After TAVR
Cause of Stroke with TAVR
Possible Solutions
Will Stroke Limit TAVR?

37. Stroke After TAVR Stroke is 2X higher with TAVR vs. surgical AVR
Stroke is related to age
Stroke is related to atherosclerotic disease burden
Stroke is caused by mainly by manipulation at the diseased aortic valve
Role of embolic protection intuitive but not proven

38. Stroke After TAVR
Cerebral emboli occur in most patients with only a small minority being clinically apparent
New onset post operative atrial fibrillation probably plays a role
There is probably not a significant late hazard risk of stroke with TAVR
Role of postoperative anticoagulation/antiplatelet therapy unknown