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Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT)

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dc.contributor.authorBALTACIOĞLU, FEYYAZ
dc.contributor.authorsFiorella, David; Molyneux, Andrew; Coon, Alexander; Szikora, Istvan; Saatci, Isil; Baltacioglu, Feyyaz; Sultan, Ali; Arthur, Adam
dc.date.accessioned2022-03-14T08:23:23Z
dc.date.available2022-03-14T08:23:23Z
dc.date.issued2017-12
dc.description.abstractIntroduction The Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study. Methods WEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events. Results One hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29-79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6-11.4) with a mean neck size of 4.8 mm (range 2.0-8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean +/- SD fluoroscopy time was 30.2 +/- 15.7 min. One primary safety event (PSE) (0.7%)-a delayed parenchymal hemorrhage 22 days after treatment-occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs. Conclusions The WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success.
dc.identifier.doi10.1136/neurintsurg-2016-012841
dc.identifier.eissn1759-8486
dc.identifier.issn1759-8478
dc.identifier.pubmed28096478
dc.identifier.urihttps://hdl.handle.net/11424/241683
dc.identifier.wosWOS:000424011600010
dc.language.isoeng
dc.publisherBMJ PUBLISHING GROUP
dc.relation.ispartofJOURNAL OF NEUROINTERVENTIONAL SURGERY
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectUNRUPTURED INTRACRANIAL ANEURYSMS
dc.subjectPIPELINE EMBOLIZATION DEVICE
dc.subjectNEUROFORM STENT
dc.subjectCOIL EMBOLIZATION
dc.subjectENDOVASCULAR TREATMENT
dc.subjectCEREBRAL ANEURYSMS
dc.subjectFOLLOW-UP
dc.subjectRECONSTRUCTION
dc.subjectEXPERIENCE
dc.subjectEFFICACY
dc.titleDemographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT)
dc.typearticle
dspace.entity.typePublication
local.avesis.id6ee2c115-c8b9-4270-ab3a-7d4b67380289
local.import.packageSS16
local.indexed.atWOS
local.indexed.atSCOPUS
local.indexed.atPUBMED
local.journal.numberofpages6
local.journal.quartileQ1
oaire.citation.endPage1196
oaire.citation.issue12
oaire.citation.startPage1191
oaire.citation.titleJOURNAL OF NEUROINTERVENTIONAL SURGERY
oaire.citation.volume9
relation.isAuthorOfPublication14b6381a-4f6e-4ff9-92f6-842a481bc163
relation.isAuthorOfPublication.latestForDiscovery14b6381a-4f6e-4ff9-92f6-842a481bc163

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