SOLITAIRE™ STENT USED AS A REVASCULARIZATION DEVICE IN ACUTE

ISCHEMIC CEREBRAL STROKEMONTPELLIER PRELIMINARY

EXPERIENCE

P. Machi, V. Costalat, C. Riquelme, I.L. Maldonado, A. Bonafé

CHU Montpellier (France)

Solitaire™FR (EV3)

Theoretical interestsTheoretical interests

• immediate flow restoration (temporary endovascular bypass)•clot retrievier

TREATMENT STRATEGY : IV FIBINOLYSIS ; MECHANICAL THROMBECTOMY( MTB)

0-3h 3h-4h30 4h30-6h00

> 6h00

ICA-MCA Tandem

Combined 0.9mg/kg rt-Pa

Combined0.9mg/kg rt-Pa

MTB ?

T-Carot Combined Combined MTB ?

M1 Rescue*0.9mg/kg rt-Pa

Rescue*0.9mg/kg rt-Pa

MTB ?

BA Combined Combined Combined Combined

*NIHSS > 7

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 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 CONSIDERATIONSTECHNICAL CONSIDERATIONSGeneral 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.

4:11 +5’

Rebar 18 positionned downstream from the trhombus

4:21+ {7’waiting}

Solitaire deploymentPartial flow restoration

4:47(+45’) {7’waiting}

4;29

Clot retrieval Solitaire repositioning

4:55 (56’)

ANGIOGRAPHICAL RESULTS 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 1 0 3 58 min 2

2 L M1 23 Combined 1 0 3 47 min 7

3 BA GCS 4 MTB 1 0 3 50 min Died

4 L M1 20 Rescue 4 0 3 106 min 20

5 L M1 18 Rescue 1 0 3 38 min 10

6 Left T 22 Combined 3 0 3 71 min 2

7 R M1 10 Rescue 1 0 3 18 min 0

8 BA GCS 3 MTB 1 0 3 35 min 18

9 R M1 TEmbolic complication

MTB 1 0 3 31 min 0

10 BA GCS 3 Combined 2 0 3 43 min 25

11 R M1 18 Combined 2 0 3 43 min 3

12 R M1 10 Combined 2 0 3 42 min 16

13 L M1 16 Combined 1 0 3 20 min 0

14 BA GCS 3 MTB 4 0 2 FAILED ?

15 Left T 14 Combined 5 0 3 99 min 19

16 BA 14 MTB 2 0 3 59 min 5

Site Initial NIHSS/GCS

Strategy Flow Restoration Attempt

Initial TIMI

Final TIMI

Time to Revasc (min)

3 months NIHSS

17 AB 20 Combiné 4 0 3 77 4

18 ACI T 23 Combiné 4 0 3 75 0

19 ACM1 GCS 4 RESCUE 1 0 3 26  -

20 AB 20 Combiné 2 0 3 36 0

21  ACM 18 RESCUE   0 3   0

22 ACI 22 Combiné 1 0 3 19 8

23 AB 10 EV 1 0 3 120  -

24 ACI T GCS 3 Combiné 1 0 3 53 21

25 AB GCS 3 Combiné 2 0 3 52  0

26 ACI T GCS 3 Combiné 4 0 0 X death 

27 M1 18 RESCUE 2 0 3 82 20

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

COMPLICATIONSCOMPLICATIONS PER –PROCEDURAL THROMBOEMBOLIC

EVENTS:1) PICA (x2) occlusion after a successfull basilar artery

revascularization during a combined procedure

2) ACA occlusion after a successfull T revascularization during a combined procedure

HEMORRHAGIC COMPLICATIONS:1) PH1: MCA te occlusion angio for dural CC fistula

2) PH2: L-MCA infarct with subsequent hemorrhagic transformation2) 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

PATIENT 8: GCS 3 ON ADMISSION, NIHSS 18 AT DICHARGE

BILATERAL PICA OCCLUSION after a basilar artery revascularization during a combined procedure

first passage

second passage

First passage

Second passage

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

efore efore AfterBefore

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

1. Rapid recanalization, often in one flow restoration recovery,

2. No vascular damages so far (mild spasm (2 cases), no subarachnoid hemorrhage, no vascular perforation)

3. 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}