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.

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

"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

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

Ischemic Penumbra

Stroke Treatment What about IV tPA ??????

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

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

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

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;25:322-328

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

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%

Penumbra Thrombus Perturbation and Aspiration 041 032 026

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

Penumbra

Clot Retrieval Penumbra

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 >/=4 57.8% mRS</=2 25% Mortality at 30d 26.4%

The Buffalo Experience. .

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).

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

Demographics 193 patients Mean age 68.4 + 17.8 (Median 73) Male- 82, Female- 111 Mean presenting NIHSS 13.9 + 5.3 (Median 14)

Occlusions and Recanalization TIMI 1- 32 TIMI 0- 161 Recanalization (70%) TIMI 3 67 TIMI 2 68

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

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%

Primary Stent for Stroke – a new paradigm

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!!

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 14 Recanalization 100% SICH 5% mRS < 2 at 3 months 45% Mortality at 3 months 25% Limitation- Cherry picked few ideal patients Stroke. 2009 Nov;40(11):3552-6

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. 2009 Sep 18.

SARIS outpaces the Buffalo Mechanical Revascularization Experience Buffalo Exp (2006-2008) < 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%

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

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

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

Post-procedure CTP

Stent patent

Post-procedure Day #2

McKnight Brain Institute SARIS II University of Florida McKnight Brain Institute

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

Thank you! 46