Woven EndoBridge device for ruptured aneurysms: perioperative results of a US multicenter experience.

BACKGROUND

The Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms.

METHODS

This retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond-Roy classification.

RESULTS

A total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed.

CONCLUSIONS

This study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted.

Informations de copyright

© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. PJ is a consultant for Medtronic, Microvention, Balt, and Cerus. MRG and SITs are consultants to Stryker. JEDA is a consultant to Medtronic, Penumbra, and Sequent. YK is a consultant for Penumbra and for Medtronic Neurovascular. ATR is a consultant to Stryker and Cerenovus. SB is a consultant to Stryker Neurovascular and MicroVention. DF is a consultant to Balt, Marblehead, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. JV is a proctor for Microvention for the WEB device. MC is a consultant to Cerenovus. AHS reports grants from Coinvestigator: NIH/NINDS 1R01NS091075 Virtual Intervention of Intracranial Aneurysms; personal fees from Adona Medical, Amnis Therapeutics, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Vastrax, VICIS, Viseon; additional personal fees from Amnis Therapeutics, Canon Medical Systems USA, Cerenovus, Corindus, Integra LifeSciences, Medtronic, MicroVention, Minnetronix Neuro, Northwest University, Penumbra, Rapid Medical, Stryker, VasSol, WL Gore & Associates; consultant fees for opinion on the design of clinical trials. RAH reports conflict of interest with Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, MiVI, and Codman and is a stockholder for Neurvana, Elum, Endostream, Three Rivers Medical, Synchron, RisT, Cerebrotech, Deinde, BendIT, and InNeurCo. All the other authors have no competing interests to report.