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}