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J Neurointerv Surg. 2018 Aug;10(8):765-770. doi: 10.1136/neurintsurg-2017-013559. Epub 2018 Jan 19.

Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study.

Author information

1
Department of Neuroradiology, Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France.
2
Department of Neuroradiology, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicetre, France.
3
Department of Neuroradiology, CHU Pellegrin, Bordeaux, France.
4
Department of Neuroradiology, CHU Toulouse, Toulouse, France.
5
Department of Neuroradiology, Hôpital Bretonneau, Université François Rabelais, Tours, France.
6
Department of Neuroradiology, CHU Saint-Etienne, Saint-Etienne, France.
7
Department of Neuroradiology, Fondation Ophtalmologique A. de Rothschild, Paris, France.
8
Department of Neuroradiology, Hôpital Jean-Minjoz, CHRU de Besançon, Besançon, France.
9
Department of Neuroradiology, CHU Dupuytren, Limoges, France.
10
Department of Neuroradiology, Hôpital Charles Nicolle, Université de Rouen, Rouen, France.
11
Department of Neurosurgery, CHU Lille, Lille, France.
12
Department of Neuroradiology, CHU Rennes, Rennes, France.
13
Department of Neuroradiology, Hôpital Gui de Chauliac, Université de Montpellier, Montpellier, France.

Abstract

BACKGROUND AND PURPOSE:

Flow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices.

METHODS:

Unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment.

RESULTS:

A total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (<10 mm) in 71 patients (68.9%). Treatment was successfully performed in 98/103 patients (95.1%). Thromboembolic (TE) complications occurred in 5/103 patients (4.9%), intraoperative rupture in 2/103 patients (1.9%), delayed aneurysm rupture in 1/103 patient (1.0%), and delayed hematoma occurred in 1/103 patient (1.0%). Six-months' mortality and morbidity rates were 1/102 (1.0%) and 2/102 (2.0%), respectively.

CONCLUSIONS:

Aneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%).

CLINICAL TRIAL REGISTRATION:

NCT02921698.

KEYWORDS:

aneurysm

PMID:
29352057
PMCID:
PMC6204937
DOI:
10.1136/neurintsurg-2017-013559
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: LP is a consultant for Balt, Microvention, Neuravi, and Penumbra. LS is a consultant for Balt, Medtronic, Microvention, and Stryker. DH is consultant for Codman, Medtronic, Sequent ,and Stryker. MP is consultant for Balt, Medtronic, Microvention, and Stryker. AB is consultant for Balt, Medtronic, Microvention, Stryker, and Phenox. XB is consultant for Microvention, Sequent, and Stryker. VC is consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker.

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