Safety and Efficacy of Endovascular Sonolysis Using the EkoSonic Endovascular System in Patients with Acute Stroke

Article Figures & Data

Table 1:

Thrombolysis in Cerebral Ischemia criteria²⁸

TICI Flow Grade	Characteristics
Grade 0	No perfusion
Grade I	Perfusion past the initial occlusion, but no distal branch filling
Grade IIa	Partial perfusion with incomplete distal filling of <50% of the expected territory
Grade IIb	Partial perfusion with incomplete distal filling of 50%–99% of the expected territory
Grade IIc	Near-complete perfusion, but with delay in contrast runoff
Grade III	Full perfusion with normal filling of distal branches in a normal hemodynamic fashion

Table 2:

Demographic data of the study group

	EKOS MCA	Control MCA	P	EKOS BA	Control BA	P
No. of subjects	7	44	–	7	12	–
Age (mean) (yr)	69.1 ± 11.4	68.7 ± 11.2	<.05	61.0 ± 9.4	68.9 ± 12.9	<.05
Males (No.) (%)	5 (71.4%)	22 (50.0%)	<.05	5 (71.4%)	9 (75.0%)	<.05
Arterial hypertension (No.) (%)	7 (100%)	33 (75.0%)	<.05	4 (57.1%)	9 (75.0%)	<.05
Diabetes mellitus (No.) (%)	2 (28.6%)	8 (18.2%)	<.05	1 (14.3%)	3 (25.0%)	<.05
Hyperlipidemia (No.) (%)	2 (28.6%)	9 (20.5%)	<.05	2 (28.6%)	5 (41.7%)	<.05
Atrial fibrillation (No.) (%)	2 (28.6%)	19 (43.2%)	<.05	2 (28.6%)	4 (33.3%)	<.05
Smoking (No.) (%)	2 (28.6%)	8 (18.2%)	<.05	1 (14.3%)	2 (25.0%)	<.05
Heavy alcohol consumption (No.) (%)	0 (0%)	1 (2.3%)	<.05	0 (0%)	0 (0%)	<.05
ICA/VA stenosis >50% (No.) (%)	1/0 (14.3/0%)	7/0 (15.9/0%)	<.05	0/3 (0/42.3%)	0/4 (0/33.3%)	<.05
Left hemisphere (No.) (%)	3 (42.9%)	25 (56.8%)	<.05	–	–	–
Use of acetylsalicylic acid (No.) (%)	2 (28.6%)	15 (34.1%)	<.05	2 (28.6%)	4 (33.3%)	<.05
Stroke in medical history (No.) (%)	1 (14.3%)	7 (15.9%)	<.05	1 (14.3%)	3 (25.0%)	<.05
Myocardial infarction in history (No.) (%)	1 (14.3%)	8 (18.2%)	<.05	1 (14.3%)	2 (16.7%)	<.05
IV thrombolysis (No.) (%)	3 (42.9%)	26 (59.1%)	<.05	2 (28.6%)	6 (50.0%)	<.05
IAT (No.) (%)	6 (85.7%)	0 (0%)	–	7 (100%)	0 (0%)	–
cPTAS (No.) (%)	3 (42.9%)	0 (0%)	–	5 (71.4%)	0 (0%)	–

Table 3:

Recanalization at the end of use of the EkoSonic Endovascular System in patients with MCA and BA occlusion and procedural data

	MCA	BA	All
Complete MCA recanalization (TICI IIc-III)	4 (57.1%)	6 (85.7%)	10 (71.4%)
Partial MCA recanalization (TICI IIa-IIb)	2 (28.6%)	1 (14.3%)	3 (21.4%)
No recanalization (TICI 0-I)	1 (14.3%)	0 (0%)	1 (7.1%)
Time from onset to admission (mean) (min)	139.3 ± 76.6	171.4 ± 76.4	155.4 ± 78.1
Time from onset to EKOS start (mean) (min)	163.6 ± 75.5	210.7 ± 78.6	187.1 ± 80.6
Length of procedure (mean) (min)	67.1 ± 11.4	57.9 ± 9.4	62.5 ± 28.0

Table 4:

Clinical results in the particular subgroups

	EKOS MCA	Control MCA	P	EKOS BA	Control BA	P
Baseline NIHSS (median) (IQR)	15 (10–18)	15.5 (12–20)	<.05	27 (14.5–33)	24 (12–32)	<.05
NIHSS 24 hr (median) (IQR)	4 (2–6)	16 (12–20)	.0001	10 (7–25)	24 (14–28)	<.05
NIHSS day 7 (median) (IQR)	2 (1.5–4)	15.5 (7–20)	.0001	6 (4.5–19)	33 (8–33)	.049
Presence of ENI after 24 hours (No.) (%)	7 (100%)	2 (4.6%)	.0001	4 (57.1%)	2 (16.7%)	<.05
90-day mRS (median) (IQR)	1 (1–3.5)	5 (3–5)	.037	3 (2–4.5)	6 (4.5–6)	.034
mRS 0–3 at day 90 (No.) (%)	5 (71.4%)	8 (18.2%)	.008	4 (57.1%)	2 (16.7%)	<.05
mRS 0–2 at day 90 (No.) (%)	5 (71.4%)	6 (13.6%)	.003	2 (28.6%)	2 (16.7%)	<.05
SICH (No.) (%)	0 (0%)	1 (2.3%)	<.05	0 (0%)	1 (8.3%)	<.05
Malignant infarction (No.) (%)	0 (0%)	3 (6.8%)	<.05	0 (0%)	0 (0%)	<.05
7-day mortality (No.) (%)	0 (%)	3 (6.8%)	<.05	0 (%)	6 (50.0%)	.044
3-month mortality (No.) (%)	2 (28.6%)	10 (22.7%)	<.05	0 (0%)	8 (66.7%)	.013

Note:—ENI indicates early neurologic improvement; EKOS, EkoSonic Endovascular System; SICH, symptomatic intracerebral hemorrhage; IQR, interquartile range.