Mechanical Thrombectomy in Acute Stroke: Prospective Pilot Trial of the Solitaire FR Device while Under Conscious Sedation

Article Figures & Data

Table 1:

Patient characteristics

Age in years (median) (IQR)	69.5 (56–75)
Female (No.) (%)	18 (50%)
Baseline NIHSS score (median) (IQR)	17.5 (12.5–21)
Site of occlusion (No.) (%)
MCA	21 (58.4%)
Terminal ICA	2 (5.5%)
Tandem occlusion	9 (25.0%)
Basilar artery	4 (11.1%)
Combined therapy with rtPA (No.) (%)	23 (63.9%)
ASPECT score on DWI (median) (IQR)	7 (5–8)
Anterior circulation (n = 32)	7 (5–8)
Posterior circulation (n = 4)	8 (8–8.5)
Baseline TICI 0/1 (No.) (%)	31 (86.1%) /5 (13.9%)

Table 2:

Safety: mortality and procedural complications

	n (%)
Mortality at 3 months	8 (22.2%)
Symptomatic ICH	5 (13.9%)
Cerebral edema	3 (8.3%)
Failure rate	5 (13.9%)
Device-related complications (dissection)	1 (2.8%)
Symptomatic ICH at 24 hours	3 (8.3%)
Symptomatic ICH at 3 months	6 (16.7%)
Fatal outcomes	5 (13.9%)
Poor outcome (mRS 5)	1 (2.8%)

Table 3:

Efficacy: angiographic and clinical outcome

Time from stroke symptom onset to recanalization (min) (median) (IQR)	320 (256–348)
Anterior circulation (n = 32)	320 (256–344)
Posterior circulation (n = 4)	331 (267–371)
Endovascular procedure time^{^a} (min) (median) (IQR)	27.5 (20–46)
Recanalization rate^{^b} (No.) (%)	28 (77.8%)
TICI
3	14 (38.9%)
2b	6 (16.7%)
2a	8 (22.2%)
1	2 (5.5%)
0	6 (16.7%)
Number of device passes (median) (IQR)	1.5 (1–2)
NIHSS score at discharge^{^c} (min) (median) (IQR)	8.5 (1–14)
mRS <2 at 3 months (No.) (%)	22 (61.1%)

Table 4:

Comparison with other Solitaire patient series

	Present Study	Machi et al¹¹	Roth et al¹⁰	Castaño et al^9a	Stampfl et al¹²
Number of patients	36	56	22	20	18
CS or GA	CS	GA	Both	GA	GA
Baseline NIHSS score	17.1	15.8	19.4	19	21
ASPECT score	6.6	–	–	–	–
Symptom onset to recanalization (min)	302	353	277	352	289
Successful recanalization	77.8%^{^c}	89%^{^d}	90.9%^{^c}	90%^{^d}	88%^{^c}
NIHSS score at discharge	9	7	–	9.4	–
Symptomatic ICH^{^b}	8.3%	1.7%	13.6%	10%^{^e}	16.6%
mRS ≤2 at 3 months	61.1%	46%	50%	45%	33.30%^{^e}
Mortality at 3 months	22.2%	7.1%^{^e}	18.1%	20%	33%^{^e}

Note:—We show our results with mean in order to favor comparison with other series. Only the Castaño et al⁹ results are presented with median. CS indicates conscious sedation; GA, general anesthesia; ICH, intracranial hemorrhage; min, minutes.
a In this series, the Solitaire device was not always used alone (3 times after the Merci device and twice after intra-arterial tissue plasminogen activator).
↵b Depicted on CT (at 24 hours).
↵c Defined by TICI ≥2a.
↵d Defined by TICI ≥2b.
↵e Evaluation was done at discharge.