Safety and efficacy of aneurysm treatment with WEB: Results of the WEBCAST study

Laurent Pierot, Vincent Costalat, Jacques Moret, I. Szikora, Joachim Klisch, Denis Herbreteau, Markus Holtmannspötter, Werner Weber, Anne Christine Januel, Thomas Liebig, Vojtech Sychra, Christoph Strasilla, Christophe Cognard, Alain Bonafé, Andrew Molyneux, James V. Byrne, Laurent Spelle

Research output: Contribution to journalArticle

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Abstract

Objective WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. Methods Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicenter good clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. Results Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [MRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (MRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. Conclusions The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

Original languageEnglish
Pages (from-to)1250-1256
Number of pages7
JournalJournal of Neurosurgery
Volume124
Issue number5
DOIs
Publication statusPublished - May 1 2016

Fingerprint

Aneurysm
Safety
Neck
Therapeutics
Rupture
Digital Subtraction Angiography
Retreatment
Intracranial Aneurysm
Stents
Morbidity
Mortality

Keywords

  • Endovascular treatment
  • Flow-diverter device
  • Intracranial aneurysms
  • Vascular disorders
  • WEB

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

Pierot, L., Costalat, V., Moret, J., Szikora, I., Klisch, J., Herbreteau, D., ... Spelle, L. (2016). Safety and efficacy of aneurysm treatment with WEB: Results of the WEBCAST study. Journal of Neurosurgery, 124(5), 1250-1256. https://doi.org/10.3171/2015.2.JNS142634

Safety and efficacy of aneurysm treatment with WEB : Results of the WEBCAST study. / Pierot, Laurent; Costalat, Vincent; Moret, Jacques; Szikora, I.; Klisch, Joachim; Herbreteau, Denis; Holtmannspötter, Markus; Weber, Werner; Januel, Anne Christine; Liebig, Thomas; Sychra, Vojtech; Strasilla, Christoph; Cognard, Christophe; Bonafé, Alain; Molyneux, Andrew; Byrne, James V.; Spelle, Laurent.

In: Journal of Neurosurgery, Vol. 124, No. 5, 01.05.2016, p. 1250-1256.

Research output: Contribution to journalArticle

Pierot, L, Costalat, V, Moret, J, Szikora, I, Klisch, J, Herbreteau, D, Holtmannspötter, M, Weber, W, Januel, AC, Liebig, T, Sychra, V, Strasilla, C, Cognard, C, Bonafé, A, Molyneux, A, Byrne, JV & Spelle, L 2016, 'Safety and efficacy of aneurysm treatment with WEB: Results of the WEBCAST study', Journal of Neurosurgery, vol. 124, no. 5, pp. 1250-1256. https://doi.org/10.3171/2015.2.JNS142634
Pierot, Laurent ; Costalat, Vincent ; Moret, Jacques ; Szikora, I. ; Klisch, Joachim ; Herbreteau, Denis ; Holtmannspötter, Markus ; Weber, Werner ; Januel, Anne Christine ; Liebig, Thomas ; Sychra, Vojtech ; Strasilla, Christoph ; Cognard, Christophe ; Bonafé, Alain ; Molyneux, Andrew ; Byrne, James V. ; Spelle, Laurent. / Safety and efficacy of aneurysm treatment with WEB : Results of the WEBCAST study. In: Journal of Neurosurgery. 2016 ; Vol. 124, No. 5. pp. 1250-1256.
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abstract = "Objective WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. Methods Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicenter good clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. Results Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1{\%}). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3{\%}). Thromboembolic events were observed in 9 of 51 patients (17.6{\%}), resulting in a permanent deficit (modified Rankin Scale [MRS] Score 1) in 1 patient (2.0{\%}). Intraoperative rupture was not observed. Morbidity (MRS score > 2) and mortality were 2.0{\%} (1 of 51 patients, related to rupture status on entry to study) and 0.0{\%} at 1 month, respectively. Success was achieved at 6 months in 85.4{\%} of patients treated with WEB: 23 of 41 patients (56.1{\%}) had complete occlusion, 12 of 41 (29.3{\%}) had a neck remnant, and 6 of 41 (14.6{\%}) had an aneurysm remnant. Conclusions The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.",
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T2 - Results of the WEBCAST study

AU - Pierot, Laurent

AU - Costalat, Vincent

AU - Moret, Jacques

AU - Szikora, I.

AU - Klisch, Joachim

AU - Herbreteau, Denis

AU - Holtmannspötter, Markus

AU - Weber, Werner

AU - Januel, Anne Christine

AU - Liebig, Thomas

AU - Sychra, Vojtech

AU - Strasilla, Christoph

AU - Cognard, Christophe

AU - Bonafé, Alain

AU - Molyneux, Andrew

AU - Byrne, James V.

AU - Spelle, Laurent

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N2 - Objective WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. Methods Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicenter good clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. Results Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [MRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (MRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. Conclusions The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

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KW - Intracranial aneurysms

KW - Vascular disorders

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