SOLITAIRE™ STENT USED AS A REVASCULARIZATION DEVICE IN ACUTE ISCHEMIC CEREBRAL STROKE MONTPELLIER PRELIMINARY EXPERIENCE P. Machi, V. Costalat, C. Riquelme, I.L. Maldonado, A. Bonafé CHU Montpellier (France) I would like to share with you the results we recently had using the solitaire flow restoration system in acute stroke

Theoretical interests Solitaire™FR (EV3) Theoretical interests immediate flow restoration (temporary endovascular bypass) clot retrievier May act as a temporary bypass allowing imedite ans sutained flow restoration after deployment on one hand and as aclot retriever on the other hand.The system was maintained open for 5 to10 ‘ and therafter pulled back into the guiding catheter

TREATMENT STRATEGY : IV FIBINOLYSIS ; MECHANICAL THROMBECTOMY( MTB) 3h-4h30 4h30-6h00 > 6h00 ICA-MCA Tandem Combined 0.9mg/kg rt-Pa MTB ? T-Carot M1 Rescue* BA Our institutional guidelines alows MTB to be associated with thrombolytics in a 4:30 hours time window in czses of terminal occlusion of ICA and at any time in cases of bailarartrey occlusion. cases of MCA oclusion that failed to improve after an IV fibrinolysis are treated with MTB provided that their NIHSS is superior to7. *NIHSS > 7

EXCLUSION CRITERIA Imaging Exclusion Criteria General Exclusion Criteria pregnancy, NIHSS>30 or coma (except in case of basilar artery occlusion), Pl<50 000, ACT>200 seconds, allergy to contrast media, uncontrolled arterial hypertension , life expectancy<3 months, rapid clinical improvement, stent downstream the guiding catheter Imaging Exclusion Criteria no MRA or DSA arterial occlusion, cerebral tumor, cerebral hemorrhage, mass effect, diffusion lesion (DWI)> 50% of MCA territory e.g ASPECTS<5

PATIENTS Age: 62 years (35 -89) Arterial occlusion: 26 patients: 14 men, 12 women Age: 62 years (35 -89) Arterial occlusion: 9 Middle Cerebral Artery (M1-M2) 8 Terminal Carotid 9 Basilar Artery

TECHNICAL CONSIDERATIONS General Anesthesia Femoral Approach Guiding catheter 6F for VA; 8F or 9F balloon guiding catheter for ICA (aspiration during system pull-back) Microcatheter at least .021 in of ID Microguidewire .014-.016 in Bolus of heparine IV (1000 IU after femoral puncture plus 1000 IU at the end of first hour) After procedure: no anticoagulation therapy at least for 24 hours, CT after the procedure and CT or MRI the day after.

Rebar 18 positionned downstream from the trhombus +5’ 4:11

Solitaire deployment Partial flow restoration 4:21+ {7’waiting}

Clot retrieval Solitaire repositioning 4:47(+45’) {7’waiting} 4;29

4:55 (56’)

ANGIOGRAPHICAL RESULTS TIMI classification TIMI 0 = NO modification TIMI 1 = contrast filling over the thrombus without reperfusion TIMI 2 = partial reperfusion TIMI 3 = total reperfusion Angiographic target TIMI > 2 In 22/26 (84.7%) cases a TIMI score of 3 was obtained In 1/26 (3.8%) cases a TIMI score of 2 was obtained Mean revascularization time 57.1 min (19-260) Number of pass on average 1.9 (1-5) In 2/26 (7.6%) case Solitaire was not able to retrieve the entire thrombus

PATIENT 14 - 4 PASS - SOLITAIRE FR FAILURE

Site Initial NIHSS/GCS Strategy Flow Restoration Attempt Initial TIMI Final TIMI Time to Revasc 3 months NIHSS 1 L M1 20 Rescue 3 58 min 2 L M1 23 Combined 47 min 7 BA GCS 4 MTB 50 min Died 4 106 min 5 18 38 min 10 6 Left T 22 71 min R M1 18 min 8 GCS 3 35 min 9 TEmbolic complication 31 min 43 min 25 11 R M1 12 42 min 16 13 20 min 14 FAILED ? 15 99 min 19 59 min

Site Initial NIHSS/GCS Strategy Flow Restoration Attempt Initial TIMI Final TIMI Time to Revasc (min) 3 months NIHSS 17 AB 20 Combiné 4 3 77 18 ACI T 23 75 19 ACM1 GCS 4 RESCUE 1 26  - 2 36 21  ACM   22 ACI 8 10 EV 120 24 GCS 3 53 25 52  0 X death  27 M1 82

PATIENT 6 - 3 SOLITAIRE FR PASSES – 71 MIN. TO RECANALIZE

PATIENT 12 – 2 SOLITAIRE FR PASSES – 42 MIN. TO RECANALIZE

PATIENT 1 - 1 SOLITAIRE FR PASSES – 58 MIN. TO RECANALIZE

PATIENT 4 - 4 SOLITAIRE FR PASSES – 106 MIN. TO RECANALIZE

COMPLICATIONS PER –PROCEDURAL THROMBOEMBOLIC EVENTS: PICA (x2) occlusion after a successfull basilar artery revascularization during a combined procedure ACA occlusion after a successfull T revascularization during a combined procedure HEMORRHAGIC COMPLICATIONS: PH1: MCA te occlusion angio for dural CC fistula PH2: L-MCA infarct with subsequent hemorrhagic transformation 2) PH asymptomatic ECASS(1and2) DEFINITIONS HI: petechial infarction without space-occupying effect HI1: small petechiae HI2: more confluent petechiae PH: hemorrhage (coagulum) with mass effect PH1: <30% of the infarcted area with mild space-occupying effect PH2: >30% of the infarcted area with significant space-occupying

First passage Second passage PATIENT 8: GCS 3 ON ADMISSION, NIHSS 18 AT DICHARGE BILATERAL PICA OCCLUSION after a basilar artery revascularization during a combined procedure second passage first passage First passage Second passage

After Before efore efore After 2)PATIENT 12:NHISS WORSENING FROM 10 IN ADMISSION TO 16 AT DISCHARGE ACA OCCLUSION AFTER T REVASCULARIZATION DURING A COMBINED PROCEDURE After Before efore efore After

PROCEDURE RELATED COMPLICATIONS Patient 4 :PH 2 ; NIHSS of 20 at discharge unchanged from admission

PATIENT 9 - 1 PASS - 31 MIN. TO RECANALIZE PH 1 ASYMPTOMATIC

CONCLUSIONS Short learning curve: friendly device Relatively Safe and effective for M1, T, and BA occlusion Rapid recanalization, often in one flow restoration recovery, No vascular damages so far (mild spasm (2 cases), no subarachnoid hemorrhage, no vascular perforation) Low incidence of technical failure Acceptable (?) level of Thromboembolic complications due to clot fragmentation even with combined procedure associating Solitaire®+ IV rt-Pa {0.9mg/kg}