By Yasha Kadkhodayan, MD. Overview of interventional neuroradiology approaches to brain aneurysm and stroke care, discussion of processes in place at Abbott Northwestern to enhance the delivery of stroke care.

1. 2014 UPDATE
Neurointerventional therapy for
brain aneurysms and acute stroke
at Abbott Northwestern Hospital
Yasha Kadkhodayan, MD
Interventional Neuroradiology
Abbott Northwestern Hospital
Consulting Radiologists Ltd
Minneapolis, MN

2. Disclosures
• Consultant for Covidien
• Site investigator for
– Penumbra 3D Separator Trial for Acute Ischemic Stroke
– Study of the Penumbra Coil 400 System to Treat Aneurysms (ACE),
Sponsor: Penumbra Inc.
– Pivotal Study of the FRED Stent System in the Treatment of Intracranial
Aneurysms, Sponsor: Microvention-Terumo Inc.

3. Interventional Neuroradiology at ANW

5. International Subarachnoid Aneurysm Trial (ISAT) of
neurosurgical clipping versus endovascular coiling
in 2,143 patients with ruptured intracranial aneurysms:
a randomised trial
Dr. Andrew Molyneux, International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group
The Lancet, Volume 360,
Issue 9342, Pages 1267 -
1274, 26 October 2002

7. ISAT Death at 7 years

8. ISAT Rebleeding at 7 years

10. Clipping vs coiling for
4,899 unruptured brain aneurysms in USA

11. Management of a ruptured brain aneurysm
• Securing the aneurysm to prevent re-bleeding
• EVD for hydrocephalus
• ICU care for blood pressure control, vasospasm, salt wasting…
• Endovascular treatment of vasospasm

12. 49 y/o man with confusion, blurry vision,
crawling around in North Dakota oil fields

13. NCCT at St. Joseph’s Hospital
Dickinson, ND
523 miles
OneCall Transfer Center arranges
conference call between referring
ED physician, neurointerventionalist
& neurointensivist at Abbott
Patient air-lifted to Abbott
(612) 863-1000

14. Upon arrival, stuporous, withdrawing to painful stimuli
EVD placed emergently by neurosurgeon on call

15. Basilar tip aneurysm

16. Balloon-assisted coiling

17. Balloon-assisted coiling

18. POD #10
New right arm drift
Marked increased in left MCA velocity
123  256 cm/s

19. CTA

20. Balloon angioplasty

21. Before and after

22. Transferred from ICU on POD #11
Home to Illinois on POD #17

23. MRA at 6 months

24. Endovascular treatment of aneurysms at
Abbott Northwestern

25. 6
(1%)
30
(5%)
86
(14%)
86
(14%)
89
(15%)
76
(12%)
49
(8%)
52
(9%)
33
(5%)
27
(4%)
21
(3%)
21
(3%)
13
(2%)
24
(4%)
0
10
20
30
40
50
60
70
80
90
<2 2 3 4 5 6 7 8 9 10 11 12 13 >13
NumberofAneurysms
Maximum Aneurysm Dimension (mm)
Rounded to the closest whole number
Ruptured Cerebral Aneurysms Treated Endovascularly (n=613)
373
Aneurysms
<7mm
(61%)
134
Aneurysms
7-9mm
(22%)
106
Aneurysms
≥10mm
(17%)

26. Ruptured brain aneurysms at Abbott
• 149 patients treated endovascularly from 1/1/09 to 6/30/13
– 97% of ruptured aneurysms treated at Abbott
• 70% women, 30% men
• Mean age: 56 years (20 – 91 years)
• Mean aneurysm size: 7 mm (1.4 – 27 mm)
• Mean distance traveled from presenting ED to Abbott for
transfers: 136 miles (7 – 525 miles)

27. Other interventions performed
• Emergent external ventricular drainage: 54%
• Endovascular vasospasm treatment: 21%
• Decompressive craniectomy: 5%
• Ventriculoperitoneal shunt: 20%

28. • Mean ICU LOS: 13.8 days (1 – 39 days)
• Mean hospital LOS: 18.6 days (1 – 39 days)
• Discharge disposition
– Home: 50%
– Rehabilitation facility: 29%
– Skilled nursing facility: 12%
– Expired: 9%
• 3 patients lost to follow-up (2%)
• Mean time to last follow-up among survivors: 19.5
months (0.8 – 55.1 months)
Disposition

29. All Patients Hunt-Hess 1-2 Hunt-Hess 3 Hunt-Hess 4 Hunt-Hess 5
146
(100%)
61
(42%)
43
(29%)
29
(20%)
13
(9%)
mRS 0-2:
103
(71%)
56
(92%)
28
(65%)
14
(48%)
5
(38%)
mRS 3:
15
(10%)
2
(3%)
6
(14%)
3
(10%)
4
(31%)
mRS 4-5:
7
(5%)
0 2
(5%)
4
(14%)
1
(8%)
mRS 6:
21
(14%)
3
(5%)
7
(16%)
8
(28%)
3
(23%)
Clinical outcomes

30. Acute stroke intervention in 2014
In light of NEJM trials published last year

31. 46 y/o woman with atrial fibrillation on Pradaxa,
remarkable recovery from previous left MCA stroke in 2011,
now with sudden onset right-sided weakness and aphasia
NIHSS 14

32. LKW at midnight
OSH 0400 at ANW

33. CTA, ASPECTS 6-7

34. Puncture at 0620

35. Solitaire in place

36. TICI 2b, 7 hours from LKW

37. Next day

38. Clinical follow-up
• NIHSS 2 at 48 hours
• mRS 2 at 30 days
• Minimal right pronator drift, slurs some words
• Going back to work next month

39. IMS 3
Endovascular Therapy after Intravenous t-PA
versus t-PA Alone for Stroke
Joseph P. Broderick, M.D., Yuko Y. Palesch, Ph.D., Andrew M. Demchuk, M.D., Sharon D. Yeatts, Ph.D., Pooja Khatri, M.D., Michael D.
Hill, M.D., Edward C. Jauch, M.D., Tudor G. Jovin, M.D., Bernard Yan, M.D., Frank L. Silver, M.D., Rüdiger von Kummer, M.D., Carlos A.
Molina, M.D., Bart M. Demaerschalk, M.D., Ronald Budzik, M.D., Wayne M. Clark, M.D., Osama O. Zaidat, M.D., Tim W. Malisch, M.D.,
Mayank Goyal, M.D., Wouter J. Schonewille, M.D., Mikael Mazighi, M.D., Ph.D., Stefan T. Engelter, M.D., Craig Anderson, M.D., Ph.D.,
Judith Spilker, R.N., B.S.N., Janice Carrozzella, R.N., B.A., R.T.(R.), Karla J. Ryckborst, R.N., B.N., L. Scott Janis, Ph.D., Renée H. Martin,
Ph.D., Lydia D. Foster, M.S., Thomas A. Tomsick, M.D., for the Interventional Management of Stroke (IMS) III Investigators
N Engl J Med
Volume 368(10):893-903
March 7, 2013

40. Acute stroke, ages 18 to 82
NIHSS ≥10, IV-tPA eligible
Randomized 2 to 1 in favor of intervention
1/3 received only
standard dose IV-tPA
2/3 received
IV-tPA
Standard dose
Plus angiography and endovascular treatment
Low dose
IMS 3: Trial design

41. mRS distribution
mRS 0-2: 42.7% in endovascular arm
mRS 0-2: 40.2% in IV-tPA alone arm

42. Safety endpoints

43. Limitations
• Only 10% of patients were treated with current technology
• Only 1/3 of all patients had confirmed LVO
• Nearly 1/5 of patients in the interventional arm had no
treatable occlusion
• Intervention occurred 1 hour after IV-tPA
• TICI 2b or 3 achieved in only 44% of patients with an M1
occlusion, similar or lower rate for other sites
IMS 3 reflects obsolete technology and
does not reflect current clinical practice

44. Demchuk A, IMS III: Comparison of outcomes between IV and IV/IA treatment in baseline CTA confirmed ICA, M1, M2 and
basilar occlusions. Presented at ISC 2013. Honolulu, HI
Outcomes with confirmed occlusion
0-2: 47.2%
0-2: 38.5%

45. Time is brain
Each 30 minutes = 10% loss!

46. Optimizing delivery of stroke care
• Comprehensive care requires a complete neurovascular team
available 24/7/365
– Vascular Neurologist
– Neurointerventionalist
– Neurointensivist
– Neurosurgeon

47. ANW stroke network
• 33 regional sites
• 15 sites with tele-health
• 15 sites with imaging link
• Mean distance to Abbott
– 76 miles (13 to 150 miles)

48. Initial focus
• Prompt IV-tPA (≤ 60 min) to ALL eligible patients
– 4.5 hrs from LKW
– No intracranial hemorrhage
– Blood glucose ≥ 60 mg/dL
– INR < 1.7 (only required if on anticoagulation)
– No recent surgery or stroke (relative)

49. ANW door to needle
(as of March 2014)
0
10
20
30
40
50
60
70
80
90
100
2010 2011 2012 2013 2014
98
67
58
55
47
76
69
53
47
37
Minutes
Door to IV tPA
Mean
Median
N= 31 N= 22 N=37 N=10N=59
American Stroke Association
Benchmark: < 60 minutes
ANW 2014 Goal: < 40 minutes

50. Small subset go to angiography suite

51. Optimizing stroke care
6 hours
mRS 0-2: 46%
mRS 6: 23%
4.5 hours
mRS 0-2: 67%
mRS 6: 17%
Standardized
algorithm
implemented

52. – July 1st 2011 to March 31st, 2014
85 mechanical thrombectomies
– 51% women, 49% men
– Mean age: 67 years (33 - 90 years)
– Mean admission NIHSS: 15.4 (3 - 27)
– History of atrial fibrillation: 38%
– Mean distance from presenting ED to Abbott for transfers:
56 miles (13 - 314 miles)
– Successful recanalization (TICI 2b/3): 85%
– Mean time from onset to reperfusion: 5 hours 40 minutes
ANW thrombectomy experience

53. ANW Mechanical Thrombectomy
Anterior Circulation Strokes
Administer IV-tPA when appropriate
NIHSS ≥8 or global aphasia
Contact ANW Stroke Neurologist via OneCall
NIR calculates NCCT ASPECTS
ASPECTS ≥5
Not optimal
candidate for
thrombectomy, may
consider on an
individual basis
Age < 70
LKW ≤ 6 hrs
No
Yes
Age < 70
LKW > 6 hours
or unknown
Age ≥ 70
Transfer for
emergent
thrombectomy
Obtain emergent CTA head / neck
(on-site if possible)
NIR calculates CTA ASPECTS
CTA ASPECTS
≥5
CTA ASPECTS
<5

54. • Discharge disposition
– Home: 26%
– Rehabilitation facility: 40%
– Skilled nursing facility: 13%
– Expired/hospice: 21%
Disposition

55. All patients
TICI 0-2a
(15%)
TICI 2b/3
(85%)
p-value
mRS 0-2 46% 8% 53% 0.003
mRS 3 11% 15% 10% 0.6
mRS 4-6 43% 77% 37% 0.008
7x
2x
Clinical outcomes

56. Conclusions
• Requires coordinated team effort
• New devices have led to
– Decreased procedure times
– Higher rates of recanalization
– Fewer complications
• Recanalization a requisite but not guarantee of good outcome
• Integrating systems of care and standardizing patient selection
to decrease time from onset to recanalization imperative to
maximize good outcomes

57. • Randomized trials
– THERAPY: IA tx + IV-tPA vs IV-tPA alone
for acute ischemic stroke
– Penumbra 3D Separator device for
acute ischemic stroke
– HEAT: Hydrogel vs bare platinum coils
• MHI-partnered trials
– RECOVER-STROKE: IA stem cell
infusion for acute ischemic stroke
• Registries
– ACE: Penumbra coil registry
– GEL-THE-NEC: Hydrogel coil registry
– ASPIRE: Pipeline device registry
– INTREPED: Pipeline device registry
– NAISR: Intracranial stent registry
• Humanitarian use devices
– Neuroform intracranial stent
– Onyx HD-500 liquid embolic
– NeuroFlo perfusion augmentation for
cerebral vasospasm
– Wingspan intracranial stent
• Investigational devices
– FRED: Flow-diversion device PMA
– LVIS & LVIS Jr: Intracranial stent PMA
• Investigator-initiated research
– SPASM: Advanced MRI for patients
with ruptured brain aneurysms
• funded by the ANW Foundation
NeuroIR clinical trials at ANW

58. Continuous improvement
• A model that
– Values centers of excellence
– Concentrates high volume of tertiary care
– Practices evidence-based medicine
– Monitors outcomes in robust and rigorous manner
– Advances the field through clinical research

59. Neurointervention
Benjamin Crandall, DO
Josser Delgado, MD
Jill Scholz, CNP
Anna Blem, CNP
Jennifer Fease, BS
Kira Tran, BS
Sandee Verootis
Neurosurgery
Gregg Dyste, MD
Kyle Uittenbogaard, MD
Robert Roach, MD
Hart Garner, MD
Mahmood Nagib, MD
Michael McCue, MD
Vascular Neurology
Mark Young, MD
Ronald Tarrel, DO
Richard Shronts, MD
David Dorn, MD
Adam Todd, MD
Ruth Anderson, CNP
Karen Gozel, CNP
Timothy Hehr, MSN
Holly Carroll, MSN
Neuro Critical Care
Kelley Lockhart, MD
Lisa Kirkland, MD
Roman Melamed, MD
Ramiro Saavedra, MD
Clara Zamorano, MD
Omer Sultan, MD
Alyssa Maizan, CNP
Ken Johnson, CNP
Acknowledgements
Abbott One Call Transfer Center
612-863-1000
Interventional Neuroradiology
612-863-4808