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

Is Proximal Embolic Protection a Solution for High Risk CAS Is Proximal Embolic Protection a Solution for High Risk CAS? What Does the ARMOUR Trial Tell Us? E Levy MD Adnan Siddiqui, MD, PhD L N Hopkins, MD SUNY Buffalo Dept of Neurosurgery

Negative Results of CAS Trials Have Taught Us Much Mistakes: the “Portals of Discovery” Experience is important Sx pts (recent) are higher risk…even with filters Elderly pts can be dangerous Arch disease increases risk 2/3 of strokes occur post procedure 1/5 strokes occur contralateral to CAS Long procedures increase risk Minor strokes usually resolve completely

ICSS Ischemia on MRI DWI and FLAIR Images CAS CEA New DWI Ischemia 46% 14% 1 Mo FLAIR Ischemia 30% 8%

Key Point Carotid stenting prevents stroke Ie. After the first 30 days

Annual Stroke Rate > 30 days (All Symptomatic) CEA CAS

Annual Stroke Rate > 30 days (All Symptomatic) CEA CAS EVA – 3S 0.7 0.4

Annual Stroke Rate > 30 days (All Symptomatic) CEA CAS EVA – 3S 0.7 0.4 SPACE 1.3 1.4

Annual Stroke Rate > 30 days (All Symptomatic) CEA CAS EVA – 3S 0.7 0.4 SPACE 1.3 1.4 CREST Lead-In 1.1

New technology Better pt selection Learning who NOT to stent Identified Risk Factors: A Major Wake Up Call What We Needed What To Do ? Better pt selection Learning who NOT to stent Improved technique New technology

Recent Trials ARMOUR EMPIRE PROTECT EPIC All “high risk” Death and Stroke all around 3% All meet AHA guidelines for low risk Proximal EP

CAS Risk Factors Sx (hot) lesion… Elderly pts… Low GSM… Duration Filter… Pre dil without EP … Tortuousity- severe… Multiple stents… Concentric calcium… Aortic Arch disease… Renal Failure...

CAS Risk Factors CEA Sx (hot) lesion… Elderly pts… Low GSM… Duration Filter… Pre dil without EP … Tortuousity- severe… Multiple stents… Concentric calcium… Aortic Arch disease… Renal Failure... CEA

Preventing Emboli

CEA 1)Temporary (>30min) Occl CCA, ECA & ICA 2)Open Artery …Remove Plaque 3)Close Artery…Restore Flow

Proximal Protection Temporary Occlusion of ECA and CCA Stent…Aspirate Debris… Restore Flow Endovascular CEA CCA/ ECA CCA/ ECA/ Flow Reversal CCA/ECA + Filter

proximAl pRotection with the MO.ma device dUring caRotid stenting Principal Investigators: Gary Ansel - Columbus (OH) L. Nelson Hopkins – Buffalo (NY)

Overview Proximal Flow Blockage Cerebral Protection Device CCA clamping: blockage of antegrade blood flow ECA clamping: blockage of retrograde blood flow Debris removal: syringe blood aspiration 5 10 15 20

Overview 6F I.D. fully usable Working Channel 9F O.D. shaft Guiding Sheath integrating 2 compliant balloons 6F I.D. fully usable Working Channel 9F O.D. shaft

Key Facts high system stability and back-up support Guiding sheath with 2 anchoring balloons high system stability and back-up support guide wire of choice to cross the lesion Lesion crossing under protection No need for suitable landing zone in the distal diseased ICA All type and size debris aspiration

Results 2° Endpoint (ITT) MO.MA Device Success 98.2% Technical Success 94.6% Procedural Success 93.2% Restenosis at 30 days 1.6% TLR at 30 days 0% Access Site Complications 3.1%

Endovascular Clamping Intolerances CEC adjudicated: unresolved clamping intolerances, TIAs and Strokes 29 “Resolved” all without TIA (<5 minutes) 2 “Unresolved”: 1 TIA + 1 Minor Stroke on the day of the procedure ARMOUR Study definitions of Endovascular Clamping Intolerances: Resolved Intolerance: temporary symptoms lasting < 20 min. after declamping Unresolved Intolerance: temporary symptoms lasting > 20 min. after declamping

Serious Adverse Events Site reported SAE = 16.4% of subjects (ITT) No (0%) Unanticipated Adverse Device Effects (UADE)

Results 1° Endpoint 30d Results (ITT & Full Population) 30d Results by Symptoms and Age (ITT)

EMPiRE Major Adverse Event Rates * Includes TIA – not typically included in CAS MAE rate

EMPiRE Major Adverse Event Rates by Subgroup (Stroke, Death, MI)

Carotid Stent Trials* 30d Event Rates * Study parameters and “Event” definitions may vary per clinical trial

Proximal Embolic Protection Conclusions Contrary to popular opinion… EASY TO USE Intolerance is rare… and usually reversible Less emboli get to brain… MRI & TCD Procedure of choice for: Recent sx Low GSM, long ulcerative lesions Perilesional kinks String sign Acute carotid occlusion/ stroke Luminal thrombus

Ischemic Stroke We Are On To Something !

Endovascular Endarterectomy !!

Thank You!