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J Neurointerv Surg. 2018 Jun;10(6):553-559. doi: 10.1136/neurintsurg-2017-013448. Epub 2017 Sep 30.

Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

Author information

1
Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France.
2
Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France.
3
CHU Bordeaux, Bordeaux, BORDEAUX, France.
4
National Institute of Clinical Neurosciences, Budapest, Hungary.
5
CHU Tours, Tours, France.
6
CHU Lyon, Lyon, France.
7
Rigshospitalet, Copenhagen, Denmark.
8
CHU Toulouse, Toulouse, France.
9
CHU Montpellier, Montpellier, France.
10
Departrment of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
11
Helios General Hospital, Erfurt, Germany.
12
CHU Rennes, Rennes, France.
13
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Bochum, Germany.
14
CHU Nantes, Nantes, France.
15
CHU Poitiers, Poitiers, France.
16
Universitätsklinikum Köln, Cologne, Germany.
17
ZOL(Ziekenhuis Oost-Limburg) Genk, Genk, Belgium.
18
Institutfür Neuroradiologie, Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt, Germany.
19
Nuffield Department of Surgical Sciences, Oxford University, Oxford, UK.

Abstract

BACKGROUND:

Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.

PURPOSE:

To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.

METHODS:

WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

RESULTS:

The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.

CONCLUSIONS:

This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.

CLINICAL TRIAL REGISTRATION:

French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

KEYWORDS:

aneurysm

PMID:
28965106
PMCID:
PMC5969386
DOI:
10.1136/neurintsurg-2017-013448
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: LP: consultant for Balt, Microvention, Neuravi, and Penumbra. JM: consultant for Medtronic, Microvention, Stryker, and Balt. XB: consultant for Microvention and Stryker. ISI: consultant for Codman, Medtronic, Sequent, and Stryker. VC: consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker. JF: has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, EU. JK: consultant for Microvention/Sequent. WW: consultant for Microvention, Phenox, and Medtronic. TL: consultant for Medtronic, Mentice, Microvention, and Route92. AM: consultant for Microvention/Sequent and Cerus Endovascular. JB: consultant and shareholder for Oxford Endovascular Ltd; his institution received funding from MicroVention. LS: consultant for Stryker, MicroVention, Medtronic, Balt. J-YG, HD, and SV have no disclosures.

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