European Multicenter Study for the Evaluation of a Dual-Layer Flow-Diverting Stent for Treatment of Wide-Neck Intracranial Aneurysms: The European Flow-Redirection Intraluminal Device Study

Article Figures & Data

Table 1:

Baseline characteristics

Characteristics
No. of aneurysms	579
No. of patients	531
No. of procedures	534
Patient demographics
Male (No.)	147 (27.7%)
Female (No.)	384 (72.3%)
Age at time of treatment (median) (range) (yr)	54 (13–86)
Presentation of patients (No.)
Incidental	249 (46.9%)
Headaches	98 (18.4%)
Cranial nerve palsy	37 (7%)
Recanalization of previously treated aneurysm	58 (10.9%)
Subarachnoid hemorrhage	65 (12.2%)
Acute (≤3 days)	41 (7.7%)
Stroke	20 (3.8%)
Other	4 (0.8%)
Patients with multiple aneurysms (No.)	141 (26.6%)
Aneurysms per patient (median) (range)	1 (1–5)
Patients with a single aneurysm	390 (73.5%)
Patients with 2 aneurysms	101 (19%)
Patients with 3 aneurysms	30 (5.7%)
Patients with 4 aneurysms	8 (1.5%)
Patients with 5 aneurysms	2 (0.3%)
Pretreatment mRS (per patient) (No.)
0–2	525 (98.8%)
3–5	6 (1.2%)
Aneurysm characteristics (No.)
Left	272 (47.0%)
Right	257 (44.4%)
Midline	50 (8.6%)
Anterior circulation (No.)
Internal carotid artery
Posterior communicating	50 (8.6%)
Paraophthalmic	270 (46.6%)
Cavernous	45 (7.8%)
Other	67 (11.5%)
Middle cerebral artery	37 (6.4%)
Anterior cerebral artery	16 (2.7%)
Anterior communicating artery	4 (0.9%)
Pericallosal artery	13 (2.2%)
Posterior circulation (No.)	36 (6.2%)
Basilar artery	30 (5.2%)
Posterior cerebral artery	9 (1.6%)
Superior cerebellar artery	2 (0.3%)
Aneurysm morphology (No.)
Saccular
Sidewall	459 (79.2%)
Bifurcation	63 (10.9%)
Fusiform/dissecting/blister
Fusiform	27 (4.7%)
Dissecting	20 (3.5%)
Blister	10 (1.7%)
Maximal diameter (median) (range) (mm)	7.6 (1–36.6)
Neck diameter (median) (range) (mm)	4.5 (1–30)

Table 2:

Complications and adverse events per procedure

	Periprocedural (In-Hospital Stay) (No.)	During Follow-Up (after Hospital Discharge) (No.)
Complications
Spontaneous rupture of the FRED-treated aneurysm	0	2
Spontaneous nonaneurysmal intracranial hemorrhage	3	1
Symptomatic ischemic stroke
Minor (≤1 mo)	8	5
Major (>1 mo)	2	1
Stent/parent artery stenosis	5	3
Stent/parent artery occlusion	4	8
Permanent cranial neuropathy	0	0
Other complications
Groin hematoma	1
Dissection	1
Aneurysm growth		2
Total	24 (4.5%)	22 (4.1%)
Adverse events
Detachment in the hub of the microcatheter	2
Poor opening on deployment	10
Torquing of stent on deployment	1
Multiple repositioning	2
Visible gap between inner and outer stent		1
Fish mouthing of the distal stent end		13
Total	15 (2.8%)	14 (2.6%)
Transient morbidity (≤90 days)	10 (1.9%)	7 (1.3%)
Permanent morbidity (>90 days)	3 (0.6%)	1 (0.2%)
Mortality	4 (0.75%)	4 (0.75%)