Yasha Kayan, MD; Josser Delgado, MD

1. Neurointerventional Treatment of
Acute Stroke in 2015 at ANW
Yasha Kayan, MD
Josser E. Delgado, MD
Abbott Northwestern Hospital
Innovation Summit 2015

2. 2
Acute Ischemic Stroke Treatment
Ischemic Stroke
IV-tPA
IA
~21%
~6%
• IV-tPA
– large & small vessel
occlusions
– Within 4.5 hours from
onset
• Intra-arterial
– Mechanical
Thrombectomy & IA-
tPA
– IV-tPA candidates &
non-candidates
– large vessel
occlusions

3. 3
Hyper-dense Clot Sign
3
Hyperdense MCA Clot

4. 44
>8mm = 0%
recanalization
Riedel et al. Stroke 2011,42:1775-1777
Large Clot Size Decreases
Probability of Recanalization
from IV-tPA
Why is IV-tPA not enough?
Clot Length (mm)
ProbabilityofRecanalization

5. 5
Acute Ischemic Stroke: ELVOs
• Acute ischemic stroke from an
emergent large vessel occlusion
(ELVO) is a major medical emergency
that could lead to death or significant
disability among survivors if
untreated

6. 6
Large Vessels of the Brain
• Main Vessels
Treated with
Thrombectomy
– MCA – M1
& M2
– ACA (A1)
– ICA
– Basilar
– PCA
6
M1
M2
ICA
Basilar
A1
PCA

7. 7
Thrombectomy Locations
M1
ICA Terminus
Basilar
M2
PCA
M3
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
MCA
ICA
Posterior
ANW thrombectomy locations 2012-July2015 N=126

8. 8
Symptoms of Large Vessel Occlusions
8
Peter Vanacker, Mohamed Faouzi, Ashraf Eskandari, et al. EJMINT Original Article, 2014: 1444000227 (30th October 2014)

9. 9
Cortical Signs
RIGHT BRAIN: LEFT BRAIN:
- Right gaze preference - Left gaze preference
- Neglect - Aphasia
• If present, think LARGE VESSEL stroke

10. 10
Neuro IR Angio Suite
10

11. 11
Thrombectomy Arterial Access
11

12. 12
Mechanical Thrombectomy
Procedural Overview
Device Selection and Preparation:
Wire and catheter passed from femoral artery, over the aortic arch, through the
internal carotid artery, to the middle cerebral artery (MCA) and through the clot.
(Clot in MCA in illustration)

13. 13
Mechanical Thrombectomy
Procedural Overview
Positioning and Deployment of stent in the clot:
Guide catheter removed and stent catheter
advanced over the wire through the clot.

14. 14
Mechanical Thrombectomy
Procedural Overview
Positioning and Deployment of stent in the clot:
Catheter pulled back, stent deployed into clot.

15. 15
Mechanical Thrombectomy
Procedural Overview
Deployment of stent in the clot:
Stent embedded in clot –
traps the clot within device mesh.

16. 16
Mechanical Thrombectomy
Procedural Overview
Stent and clot removal:
Stent with embedded clot pulled back into guide catheter.
Entire system removed from femoral artery.
View of clot after retrieval:

17. 17
Penumbra Device (ADAPT Technique)
17
 Direct Aspiration by large
catheter at the site of
thrombus
 Rapid and Painless Clot
Extraction
 Intact Clot Extraction may
reduce distal emboli
Spiotta, et al. JNIS, 1/14

18. 18
“Solumbra” Aspiration + Stent-Retriever
Technique for Thrombectomy
18

19. 19
Evidence for Mechanical
Thrombectomy in 2013
• 3 randomized trials comparing IV-tPA to
intra-arterial therapy published in
NEJM in 2013 found no difference in
clinical outcomes:
 IMS III
 SYNTHESIS EXPANSION
 MR RESCUE

20. 20
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI
LVO (ICA, M1): 33% 34% 81%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27%
Good clinical
outcome (mRS 0-2): 43% 42% 13%
Symptomatic ICH: 6% 6% 5%
Death (90 days): 19% 8% 19%
Evidence for Mechanical
Thrombectomy in 2013

21. 21
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI
LVO (ICA, M1): 33% 34% 81%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27%
Good clinical
outcome (mRS 0-2): 43% 42% 13%
Symptomatic ICH: 6% 6% 5%
Death (90 days): 19% 8% 19%
Evidence for Mechanical
Thrombectomy in 2013
Outdated
technology

22. 22
Thrombectomy Devices
2004 2007 2010
MERCI
Penumbra
(original)
Solitaire
Trevo
2013
Penumbra
5MAX ACE
2012 – “stent-retrievers”
2013 – large
bore
aspiration

23. 23
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI
LVO (ICA, M1): 33% 34% 81%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27%
Good clinical
outcome (mRS 0-2): 43% 42% 13%
Symptomatic ICH: 6% 6% 5%
Death (90 days): 19% 8% 19%
Evidence for Mechanical
Thrombectomy in 2013
Most pts
DID NOT HAVE
large vessel
occlusions

24. 24
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI
LVO (ICA, M1): 33% 34% 81%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27%
Good clinical
outcome (mRS 0-2): 43% 42% 13%
Symptomatic ICH: 6% 6% 5%
Death (90 days): 19% 8% 19%
Evidence for Mechanical
Thrombectomy in 2013
Successful
recanalization
rates
WERE LOW

25. 25
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI
LVO (ICA, M1): 33% 34% 81%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27%
Good clinical
outcome (mRS 0-2): 43% 42% 13%
Symptomatic ICH: 6% 6% 5%
Death (90 days): 19% 8% 19%
Evidence for Mechanical
Thrombectomy in 2013
But also…
no difference
in risk profile
compared to iv-tPA

26. 26
• Recent advances in endovascular
thrombectomy devices have led to
– higher rates of successful recanalization
– marked reduction in thrombectomy procedures
times
 Translates into improved
clinical outcomes
Recent Advances in Treatment

27. 27
MR CLEAN Trial - 2015

28. 28
MR CLEAN: What Was Different?
• Confirmation of large vessel occlusion (ELVO)
was required
– ELVOs confirmed by CTA
– Imaging confirmation was not required in IMS3
• Specific measures taken to minimize selection
bias
– 100% of interventional stroke centers in Netherlands
participated
• Majority of procedures with modern technology

29. 29
MR CLEAN Trial Design
• Prospective RCT comparing Best Medical Management vs Best
Medical Management + IA therapy
• Key inclusion criteria
– Anterior circulation ELVO confirmed by CTA
– IA treatment initiated within 6 hours from
onset
• Primary Outcome: mRS score at 90 days (blinded assessment)

30. 30
Intervention Improves Outcomes
MR CLEAN Results

31. 31
acOR 2.16 (95% CI: 1.39 to 3.38)
acOR > 1 indicates higher odds of acheiving functional independence in favor of intervention
32.6%
19.1%
0%
10%
20%
30%
40%
Intervention Control
mRS ≤ 2 at 90 Days
Intervention Improves Outcomes
MR CLEAN Results

32. 32
Intervention Control
Mortality within 7 days 11.6% 12.4%
Mortality within 30 days 18.9% 18.4%
Symptomatic ICH 7.8% 6.4%
“There was no difference in the occurrence of serious
adverse events between the groups during the 90 day
follow-up. (p=0.31)”
MR CLEAN Investigators, A Randomized Trial of Intra-Arterial Treatment for Acute Ischemic Stroke, NEJM 2014
Intervention Is Safe
MR CLEAN Results

33. 33
Intervention
Benefits a
Broad
Population

34. 34
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation...
MERCI Stent-Trievers
LVO (ICA, M1): 33% 34% 81% 86%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59%
Good clinical
outcome (mRS
0-2):
43% 42% 13% 33%
Symptomatic
ICH: 6% 6% 5% 8%
Death (90 days): 19% 8% 19% 21%
Evidence for Mechanical
Thrombectomy in 2015

35. 35
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation...
MERCI Stent-Trievers
LVO (ICA, M1): 33% 34% 81% 86%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59%
Good clinical
outcome (mRS
0-2):
43% 42% 13% 33%
Symptomatic
ICH: 6% 6% 5% 8%
Death (90 days): 19% 8% 19% 21%
Evidence for Mechanical
Thrombectomy in 2015
Modern
technology

36. 36
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation...
MERCI Stent-Trievers
LVO (ICA, M1): 33% 34% 81% 86%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59%
Good clinical
outcome (mRS
0-2):
43% 42% 13% 33%
Symptomatic
ICH: 6% 6% 5% 8%
Death (90 days): 19% 8% 19% 21%
Evidence for Mechanical
Thrombectomy in 2015
When
applied
to ELVOs

37. 37
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation...
MERCI Stent-Trievers
LVO (ICA, M1): 33% 34% 81% 86%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59%
Good clinical
outcome (mRS
0-2):
43% 42% 13% 33%
Symptomatic
ICH: 6% 6% 5% 8%
Death (90 days): 19% 8% 19% 21%
Evidence for Mechanical
Thrombectomy in 2015
Leads to
higher
successful
recanalization
rates

38. 38
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation...
MERCI Stent-Trievers
LVO (ICA, M1): 33% 34% 81% 86%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59%
Good clinical
outcome (mRS
0-2):
43% 42% 13% 33%
Symptomatic
ICH: 6% 6% 5% 8%
Death (90 days): 19% 8% 19% 21%
Evidence for Mechanical
Thrombectomy in 2015
With a low
risk profile

39. 39
Evidence for Mechanical
Thrombectomy in 2015
TICI 2b/3
rate
mRS 0-2 at 90
days
Death rate
MR CLEAN 59% 32.6% v. 19.1% 21% v 22%
ESCAPE 72% 53% v. 29% 10% v. 19%
EXTEND-IA 86% 71% v. 40% 9% v. 20%
SWIFT PRIME 88% 60% v. 36% 9% v. 12%
REVASCAT 66% 44% v 28% 18% v 16%
5 Total Major Thrombectomy
Trials Published in NEJM in 2015

40. 40
IV-tPA + Endovascular Treatment
In 2015:
Now standard of care for
acute ischemic stroke due to
large vessel occlusions

41. 41
Thrombectomy Patient Algorithm
ANW Thrombectomy Standardized Algorithm
- Minimize risks
• Thrombectomy is a high risk procedure
- Maximize speed
• Time is brain

42. 42
Thrombectomy Risk Considerations
Intra-Procedural Complications

43. 43
Thrombectomy Risk Considerations
Futile Recanalization

44. 44
Thrombectomy Risk Considerations
Post-Procedural Symptomatic Intracranial Hemorrhage

45. 45
Thrombectomy Patient Algorithm
5 Guiding Principles
1. Always administer IV-tPA to ALL eligible patients
2. Define stroke severity required to intervene
3. Target proximal intracranial large-vessel
occlusions only: ICA terminus, M1, proximal M2,
basilar
4. Simplify imaging used to assess infarct core
5. Patient age and baseline condition matter

46. 46
ANW Mechanical Thrombectomy
Anterior Circulation Strokes
Administer IV-tPA when appropriate
NIHSS ≥6 or global aphasia
Contact ANW Stroke Neurologist via OneCall
NIR calculates NCCT ASPECTS*
ASPECTS ≥6 & Age ≤85
Not optimal
candidate for
thrombectomy, may
consider on an
individual basis
LKW ≤6 hrs
No
Yes
LKW >6
hours or
unknown
Transfer for
emergent
thrombectomy
Obtain emergent CTA head / neck
(on-site if possible)
NIR calculates CTA ASPECTS*
CTA ASPECTS
≥6
CTA ASPECTS
<6
*Imaging expires after 90 minutes

47. Case Examples

48. 48
60 y/o man, driving
• Driving alone in car, wife following in another
vehicle
• Suddenly unable to control right leg and right arm
• Markedly accelerates, wife unable to keep up
• Finally able to stop car, daughter and EMS note
unable to move right side or talk
• Transferred via EMS to OSH
• NIHSS = 23 at OSH prior to tPA

49. 49

50. 5050
The patient was taken to OSH and iv-tPA was administered. NCCT
a favorable ASPECTS (10) with a hyperdense left MCA sign.

51. 51
Successful mechanical thrombectomy of an embolus to
the M1 segment of the left middle cerebral artery with
the 5 Max ACE aspiration catheter

52. 52

53. 53
• Regains ability to speak within an hour
• First word was his wife’s name (she was thrilled!)
• MRI shows area of ischemia in left corona radiata
• Discharged to CKRI with minor coordination and
speech issues
• CEA one week later and discharged to home with
minor deficits
Results

54. 54
Acute ischemia within the left corona radiata extending into
the left basal ganglia.

55. 55

56. 56
47 y/o man, coughing

57. 57

58. 58

59. 59

60. 60

61. 61

62. 62
Abbott’s Thrombectomy Experience
– July 1st 2011 to December 31st, 2014
107 mechanical thrombectomies (2-3 per month)
– 49% women, 51% men
– Mean age: 67.5 years (33 – 93 years)
– Mean admission NIHSS: 16.5 (3 - 28)
– History of atrial fibrillation: 43%
– Mean distance from presenting ED to Abbott for
transfers: 51 miles (13 - 314 miles)

63. 63
Abbott’s Thrombectomy Experience
Successful recanalization (TICI 2b/3):
86%
Mean time from symptom onset to reperfusion:
321 minutes
(5 hours 21 minutes)

64. 64
Abbott’s Thrombectomy Experience
• Intra-procedural complications: 6.5%
– Embolus to previously-uninvolved vascular territory:
3.7% (ACA territory)
– Vessel perforation: 1.9%
– Catheter rupture/retention: 0.9%

65. 65
Abbott’s Thrombectomy Experience
– Symptomatic intracranial hemorrhage: 6.5%
• SAH: 3.7%
– 75% received either IA-tPA or glycoprotein IIb/IIIa inhibitor intra-
procedurally
• ICH: 2.8%
– Futile recanalization: 4.7%
• Requiring hemicraniectomy: 2.8%
• Resulting in death: 1.9%
• 60% ICA terminus occlusions
• 60% reperfused >5 hours from symptom onset

66. 66
Abbott’s Thrombectomy Experience
• Mean Neuro-ICU LOS: 3.5 days (0 – 19 days)
• Mean hospital LOS: 6.9 days (1 – 22 days)
• In-hospital mortality: 21.5%

67. 67
Abbott’s Thrombectomy Experience
• Discharge disposition:
– Home: 23%
– Rehabilitation facility: 38%
– Skilled nursing facility: 16%
– Expired/hospice: 23%

68. 68
Abbott’s Thrombectomy Experience
• Clinical outcome at 90-days available in 104
patients
– 97%, 3 pts pending 90-day follow-up

69. 69
Abbott’s Thrombectomy Experience
All
Patients:
TICI 0-2a
(15%):
TICI 2b/3
(85%):
p-
value:
mRS 0-2: 41% 6% 48% 0.002
mRS 3: 12% 12% 12% 1
mRS 4-6: 47% 81% 41% 0.05
8x
2x

70. 70
IMS III
(N=629)
SYNTHESIS
(N=362)
MR RESCUE
(N=118)
MR CLEAN
(N=500)
Abbott
(N=119)
Primary
Intervention:
MERCI
IA-tPA and clot
fragmentation
MERCI Stent-Trievers
ADAPT/
Solumbra
LVO (ICA, M1): 33% 34% 81% 86% 87%
Successful
recanalization
(TICI 2b/3):
44% Not reported 27% 59% 86%
Good clinical
outcome
(mRS 0-2):
43% 42% 13% 33% 44%
Symptomatic ICH: 6% 6% 5% 8% 8%
Death (90 days): 19% 8% 19% 21% 23%
Abbott’s Thrombectomy Experience

71. 71
180
154
151
176
28
74
106
122
43
52
56
64
0 50 100 150 200 250 300 350 400
2015
2014
2013
2012
Onset to ED Arrival ED Arrival to Arterial Puncture Arterial Puncture to Reperfusion
Standardized
algorithm
implemented
Optimizing Delivery of
Neurointerventional Stroke Care

72. 72
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
2014 2015
MRS 0-2 Death
Optimizing Delivery of
Neurointerventional Stroke Care
0
50
100
150
200
250
Door to Puncture Good
Outcome
Mortality
Door to Puncture
Time

73. 73
Conclusions
• Endovascular thrombectomy is a safe, highly
effective procedure that saves lives and reduces
disability when:
– Early treatment with IV-tPA for patients that qualify
– Patients are carefully selected to identify proximal occlusions
– Treatment is extremely fast
• For every four patients treated, one more patient
is independent at long term follow up

74. 74
Conclusions
• Coordinated neurovascular team effort
• Advent of new devices has led to
– decreased procedure times
– high rates of successful recanalization
– lower rates of intra-procedural complications
• Achieving TICI 2b/3 recanalization is requisite but
does not guarantee a good clinical outcome
• Integrating systems of care & standardizing patient
selection to decrease time to recanalization is
imperative to maximize good clinical outcomes

75. 75
Conclusions
• Each 5 minutes of delay eliminated benefit for
one person out of every 100 treated with
thrombectomy
• TIME IS BRAIN