J Caroff1, C Mihalea2, J Klisch3, C Strasilla3, A Berlis4, T Patankar5, W Weber6, D Behme7, E A Jacobsen8, T Liebig9, S Prothmann10, C Cognard11, T Finkenzeller12, J Moret13, L Spelle13. 1. From the Interventional Neuroradiology NEURI Center (J.C., C.M., J.M., L.S.), Beaujon Hospital, Clichy, France Jildaz.caroff@bjn.aphp.fr. 2. From the Interventional Neuroradiology NEURI Center (J.C., C.M., J.M., L.S.), Beaujon Hospital, Clichy, France Department of Neurosurgery (C.M.), University of Medicine and Pharmacy "Victor Babes," Timisoara, Romania. 3. Department of Neuroradiology (J.K., C.S.), Helios General Hospital, Erfurt, Germany. 4. Department of Diagnostic and Interventional Neuroradiology (A.B.), Klinikum Augsburg, Augsburg, Germany. 5. MRI Department (T.P.), Leeds Teaching Hospitals National Health Service Trust, Leeds, UK. 6. Interventional Neuroradiology (W.W.), Ruhr University Medical Center, Bochum, Germany. 7. Departments of Radiology and Neuroradiology (D.B.), Klinikum Vest, Recklinghausen, Germany. 8. Interventional Neuroradiology (E.A.J.), Oslo University Hospital, Oslo, Norway. 9. Interventional Neuroradiology (T.L.), Universitatsklinik Koeln, Köln, Germany. 10. Abteilung für Diagnostische und Interventionelle Neuroradiologie (S.P.), Klinikum rechts der Isar, Technische Universität München, München, Germany. 11. Interventional Neuroradiology (C.C.), Centre Hospitalier Universitaire Hôpital Purpan, Toulouse, France. 12. Interventional Neuroradiology (T.F.), Klinikum Nürnberg Süd, Nürnberg, Germany. 13. From the Interventional Neuroradiology NEURI Center (J.C., C.M., J.M., L.S.), Beaujon Hospital, Clichy, France.
Abstract
BACKGROUND AND PURPOSE: The safety and efficiency of the dual-layer Woven EndoBridge (WEB) device has already been published. However, this international multicenter study sought to evaluate the safety of single-layer devices, which are the newest generation of the WEB intrasaccular flow-disrupter family. They have been designed to offer smaller-sized devices with a lower profile to optimize navigability and delivery, which may, in turn, broaden their range of use. MATERIALS AND METHODS: Data from all consecutive patients treated with a single-layer WEB device, in 10 European centers from June 2013 to May 2014 were included. Clinical presentations, technical details, intra- and perioperative complications, and outcomes at discharge were recorded. Clinical and angiographic data at last follow-up were also analyzed when available. RESULTS: Ninety patients with 98 WEB-treated aneurysms were included in this study. In 93 cases (95%), WEB placement was possible. Complete occlusion at the end of the procedure was obtained in 26 instances (26%). Additional treatment during the procedure (coiling and/or stent placement) was necessary in 12 cases (12.7%). Procedure-related complications occurred in 13 cases, leading to permanent neurologic deficits in 4 patients (4.4%). Early vascular imaging follow-up data were available for 44 patients (57%), with an average time interval of 3.3 months. Treatment-related morbidity and mortality rates at last follow-up were 2.2% and 1.1%, respectively. CONCLUSIONS: In this study, the feasibility and safety of the single-layer WEB device was comparable with that of the double-layer. However, further studies are needed to evaluate long-term efficacies.
BACKGROUND AND PURPOSE: The safety and efficiency of the dual-layer Woven EndoBridge (WEB) device has already been published. However, this international multicenter study sought to evaluate the safety of single-layer devices, which are the newest generation of the WEB intrasaccular flow-disrupter family. They have been designed to offer smaller-sized devices with a lower profile to optimize navigability and delivery, which may, in turn, broaden their range of use. MATERIALS AND METHODS: Data from all consecutive patients treated with a single-layer WEB device, in 10 European centers from June 2013 to May 2014 were included. Clinical presentations, technical details, intra- and perioperative complications, and outcomes at discharge were recorded. Clinical and angiographic data at last follow-up were also analyzed when available. RESULTS: Ninety patients with 98 WEB-treated aneurysms were included in this study. In 93 cases (95%), WEB placement was possible. Complete occlusion at the end of the procedure was obtained in 26 instances (26%). Additional treatment during the procedure (coiling and/or stent placement) was necessary in 12 cases (12.7%). Procedure-related complications occurred in 13 cases, leading to permanent neurologic deficits in 4 patients (4.4%). Early vascular imaging follow-up data were available for 44 patients (57%), with an average time interval of 3.3 months. Treatment-related morbidity and mortality rates at last follow-up were 2.2% and 1.1%, respectively. CONCLUSIONS: In this study, the feasibility and safety of the single-layer WEB device was comparable with that of the double-layer. However, further studies are needed to evaluate long-term efficacies.
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