1. L. Nelson Hopkins, M.D. Mandy J. Binning, M.D.
"Thrombolysis with Aspiration vs Mechanical Intervention: Do we have an Answer?" 
L. Nelson Hopkins, M.D.
Mandy J. Binning, M.D.

3. L. Nelson Hopkins, MD DISCLOSURES Consulting Fees
Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corporation, Micrus Endovascular Cordis, a Johnson & Johnson company
Grants/Contracted Research
Cordis, a Johnson & Johnson company, Boston Scientific Corporation, Micrus Endovascular
Honoraria
AccessClosure, Inc., Bard Peripheral Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company, marketRx, Inc., Micrus Endovascular, Medsn
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
APW Holding, Inc., Boston Scientific Corporation, Magellan Spine Tech, Inc., MedFocus Accelerator Fund, Micrus Endovascular

4. "Thrombolysis with Aspiration vs Mechanical Intervention: Do we have an Answer?"
E Levy MD
Adnan Siddiqui, MD, PhD
L N Hopkins, MD
SUNY Buffalo
Dept of Neurosurgery

5. Public Health Impact of Stroke
Stroke is 3rd leading cause of death (~ 1 of every 15 deaths)
1/3 die
1/3 severely disabled
1/3 recover some form of independence
Stroke is leading cause of long-term care disability.
5 million Americans currently living with effects of stroke
$70 billion annually in the US

6. Ischemic Penumbra

7. Stroke Treatment
What about IV tPA ??????

8. NIHSS >10  75% decrease odds of recovery (STARS study)
Ischemic Stroke
Intravenous thrombolysis (rtPA)
Marginally effective.
Large branch occlusions do not respond.
May cause ICH.
Time window: “3 hours”.
Mild to moderate stroke.
NIHSS >10  75% decrease odds of recovery (STARS study)
NIH Trial NEJM ‘95; 333:1581
MAST Trial Lancet ‘95; 346:1509
ECASS Trial JAMA ‘95; 274:1017
ECASS II Trial Lancet ‘98; 352:1245

9. IV Alteplase in Acute Stroke FDA Approved
NINDS
ECASS II
Albers
3 mo death/functional dependency
57%
58%
57%

10. Current Strategies For the Endovascular Management of Acute Stroke
Pharmacologic
Intra-arterial tPA
Mechanical
Concentric - Merci Device
Penumbra
EKOS
Foreign body retrieval devices
Alligator, Neuronet, Snares
Best data demonstrate only 50-80% recanalization rate rate
Endovascular Bypass
Stent
Arranged in order of success

11. AJNR Am J Neuroradiol. 2004;25:322-328
Mechanical Therapy
Why is it our first choice?
Higher recanalization rates
Low SICH rates
17% re-occlusion rates after IAT
AJNR Am J Neuroradiol. 2004;25:

12. Mechanical Therapy Options
Proximal Device-Penumbra (FDA Approved)
Distal Device- Merci (FDA approved)
Thrombus disruption
Wire manipulation
Balloon angioplasty
Intracranial Stents

13. Concentric Multi-Merci
Multi-Merci Recanalization Rates
54.1% (60/111) Retriever alone
69.4% (77/111) Post Procedure
78 L5 +/- X5/X6
33 X5/X6
Included 27 patients who failed IV tPA
Multi-Merci Part II includes an additional 52 patients
mRS<2: 39%
Mortality: 30%
Symptomatic ICH: 7.9%
Asymptomatic ICH: 28.9%

14. Penumbra Thrombus Perturbation and Aspiration
041
032
026

15. Aspiration System Matched 041 Separator™ Reperfusion Catheter 041
1274B 17 17 17

16. Penumbra

17. Clot Retrieval Penumbra

18. Penumbra Data NIHSS>8 and less than 8h from onset
81.6% revascularization to TIMI 2 or 3
SAE 3.2%
28 % ICH (11.2 %of which were sx)
NIHSS improved by >/= %
mRS</= %
Mortality at 30d 26.4%

19. The Buffalo Experience. .

20. Methods
Endovascular AIS interventions from 2006 to 2008 were recorded prospectively
Admission: Patient demographics; comorbid conditions; smoking status; hx CVA/TIA; AP/AC status, and/or statin therapy at presentation; time of stroke onset; presentation NIHSS; location of occlusion; degree of occlusion (TIMI).

21. Methods
CT Perfusion Study (Aquilion One – 320 slice scanner or 64 slice scanner)
All analyzed and processed by Endovascular Fellow
Preserved Volume Map (>30%)

22. Demographics 193 patients Mean age 68.4 + 17.8 (Median 73)
Male- 82, Female- 111
Mean presenting NIHSS (Median 14)

23. Occlusions and Recanalization
TIMI 1- 32
TIMI
Recanalization (70%)
TIMI 3 67
TIMI 2 68

24. Recanalization rate (%)
Types of Therapy
No. patients
Recanalization rate (%)
Merci retriever
108
67.6
Penumbra 4
100
Intracranial stent 52
71.2
Intracranial angioplasty 55
63.6
Extracranial stent 36
72.2
Extracranial angioplasty 24 75
GPIIb-IIIa antagonist
Intravenous 38
76.3
Intra-arterial 54
66.7

25. Summary NINDS Proact II IMS II MULTI-MERCY Penumbra Buffalo Exp
< 8 hr
# pts
333
180 81
164
125
193
140
NIHSS 14 17 19
Recan
66%
58%
68%
82%
70%
sICH 6%
10%
11% 9%
mRS (0-2)
39%
40%
46%
36%
25%
44%
Mortality
16%
26%
32%
28%

26. Primary Stent for Stroke – a new paradigm

27. SARIS FDA approved pilot study 20 patients Multicenter
Note: Due to administrative issues 1 center recruited all patients
Using the Wingspan stent
Evaluate safety
Prospective!!

28. FDA approved prospective pilot study to evaluate safety
20 patients using the Wingspan stent as a bail out therapy
Multi-center: Due to administrative issues 1 center recruited all patients
Presentation NIHSS
Recanalization %
SICH %
mRS < 2 at 3 months %
Mortality at 3 months %
Limitation- Cherry picked few ideal patients
Stroke Nov;40(11):3552-6

29. Retrospective Study from 4 centers
20 patients with Enterprise stent for salvage after other modalities failed for revascularization of AIS
Presentation NIHSS 17
TIMI 2/3 recanalization 100%
Mean NIHSS improvement at discharge 8 points
J Neurosurg Sep 18.

30. SARIS outpaces the Buffalo Mechanical Revascularization Experience
Buffalo Exp ( )
< 8 hr
> 8 hr
SARIS
0-3 hr Endo
# pts
193
140 30 20 94
NIHSS 14 13 15
Recan
70%
66%
67%
100%
sICH 9% 6%
10% 5%
mRS (0-2)
39%
44%
20%
45%
37%
Mortality
28%
26%
33%
25%

31. SARIS CASE
60 yo M
Presented with R-sided weakness and dysphasia that improved to NIHSS 2
History of afib, off coumadin due to recent fall with small SDH
CTA showed L ICA T-occlusion
Started on ASA/Plavix/Heparin gtt
7 hours later exam declined acutely to NIHSS 10
CT no change in SDH
Angiogram, migration of thrombus to L M1

37. Devices used 8F sheath 6F Envoy Nautica/Goldtip BMW
Wingspan stent 2.5x20mm
Heparin 5000 U

38. Outcome Immediate improvement on table NIHSS 10 to 4
POD #2 NIHSS 1 (slight dysphasia)

39. Post-procedure CTP

40. Stent patent

41. Post-procedure Day #2

42. McKnight Brain Institute
SARIS II
University of Florida
McKnight Brain Institute

43. Conclusions
Mechanical Endovascular Treatment is Preferred in Acute Stroke
Technical Nuances of Mechanical Revascularization
Penumbra, Merci
Intracranial stent (SARIS)
Buffalo Experience-Recanalization with Penumbra and Merci not as successful as stenting
The word is still out—maybe stenting will be best

44. Thank you! 46