Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up

Laurent Pierot, Istvan Szikora, Xavier Barreau, Markus Holtmannspoetter, Laurent Spelle, Denis Herbreteau, Jens Fiehler, Vincent Costalat, Joachim Klisch, Anne-Christine Januel, Werner Weber, Thomas Liebig, Luc Stockx, Joachim Berkefeld, Jacques Moret, Andy Molyneux, James Byrne, Laurent Pierot, Istvan Szikora, Xavier Barreau, Markus Holtmannspoetter, Laurent Spelle, Denis Herbreteau, Jens Fiehler, Vincent Costalat, Joachim Klisch, Anne-Christine Januel, Werner Weber, Thomas Liebig, Luc Stockx, Joachim Berkefeld, Jacques Moret, Andy Molyneux, James Byrne

Abstract

Background: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).

Methods: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

Results: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%.

Conclusions: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms.

Clinical trial registration: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Keywords: aneurysm.

Conflict of interest statement

Competing interests: LP consults for Balt, MicroVention, Neuravi, and Penumbra. ISI consults for Codman, Medtronic, Sequent, and Stryker. XB consults for MicroVention and Stryker. LS consults for Stryker, MicroVention, Medtronic, and Balt. 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, and the EU. VC consults for MicroVention and Balt, and receives educational grants from Medtronic and Stryker. JK consults for MicroVention/Sequent. WW consults for MicroVention, Phenox, and Medtronic. TL consults for Medtronic, Mentice, Microvention, and Route 92. JM consults for Medtronic, MicroVention, Stryker, and Balt. AM consults for MicroVention/Sequent and Cerus Endovascular. JB consults for, and is shareholder of, Oxford Endovascular Ltd; his institution received funding from MicroVention.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Population flow chart for two studies for safety and efficacy at 3 years. * This patient had no vascular follow-up imaging at 1 year, but had it at 3 years. "lost to follow-up" means that the centers were unable to contact the patients using different techniques (phone call, email, letter, etc) so the patient exited the study. "missed visits" means that the patient did not attend the 3-year follow-up, but attended a later visit.
Figure 2
Figure 2
Unruptured basilar tip aneurysm. a: DSA (frontal view) before web treatment shows the aneurysm. b: post-operative DSA (frontal view) shows residual flow in the aneurysm and the device. c: 1-year DSA shows complete aneurysm occlusion. d: 3-year MRA shows stable complete aneurysm occlusion.
Figure 3
Figure 3
Unruptured middle cerebral artery aneurysm. a: DSA (frontal view) shows the aneurysm. b: 1-year DSA (unsubstracted, non injected) shows web retraction. c:1-year DSA shows an aneurysm remnant. d: retreatment by stent-assisted coiling. e: final control DSA after retreatment shows complete aneurysm occlusion.

References

    1. Johnston SC, Dowd CF, Higashida RT, et al. . Predictors of rehemorrhage after treatment of ruptured intracranial aneurysms: the cerebral aneurysm rerupture after treatment (CARAT) study. Stroke 2008;39:120–5. 10.1161/STROKEAHA.107.495747
    1. Pierot L, Barbe C, Nguyen HA, et al. . Intraoperative complications of endovascular treatment of intracranial aneurysms with coiling or balloon-assisted coiling in a prospective multicenter cohort of 1088 participants: analysis of recanalization after endovascular treatment of intracranial aneurysm (ARETA) study. Radiology 2020;295:381–9. 10.1148/radiol.2020191842
    1. Shapiro M, Becske T, Sahlein D, et al. . Stent-supported aneurysm coiling: a literature survey of treatment and follow-up. AJNR Am J Neuroradiol 2012;33:159–63. 10.3174/ajnr.A2719
    1. Ferns SP, Sprengers MES, van Rooij WJ, et al. . Coiling of intracranial aneurysms: a systematic review on initial occlusion and reopening and retreatment rates. Stroke 2009;40:e523–9. 10.1161/STROKEAHA.109.553099
    1. Molyneux A, Kerr R, Stratton I, et al. . International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet 2002;360:1267–74. 10.1016/S0140-6736(02)11314-6
    1. Pierot L, Wakhloo AK. Endovascular treatment of intracranial aneurysms: current status. Stroke 2013;44:2046–54. 10.1161/STROKEAHA.113.000733
    1. Pierot L, Biondi A. Endovascular techniques for the management of wide-neck intracranial bifurcation aneurysms: a critical review of the literature. J Neuroradiol 2016;43:167–75. 10.1016/j.neurad.2016.02.001
    1. Pierot L, Liebig T, Sychra V, et al. . Intrasaccular flow disruption: a new endovascular approach for the treatment of intracranial aneurysms: results of a preliminary clinical evaluation in a multicenter series. AJNR Am J Neuroradiol 2012;33:1232–8.
    1. Pierot L, Klisch J, Cognard C, et al. . Endovascular web flow disruption in middle cerebral artery aneurysms: preliminary feasibility, clinical, and anatomical results in a multicenter study. Neurosurgery 2013;73:27–35. 10.1227/01.neu.0000429860.04276.c1
    1. Papagiannaki C, Spelle L, Januel AC, et al. . Flow disruption with web device: report of a prospective, multicenter series of 83 patients with 85 aneurysms. AJNR Am J Neuroradiol 2014;35:2006–11.
    1. Lubicz B, Klisch J, Gauvrit JY, et al. . Short-term and mid-term follow-ups in patients with wide-neck bifurcation aneurysms treated with the web device: a retrospective European study. AJNR Am J Neuroradiol 2014;35:432–8.
    1. Pierot L, Moret J, Turjman F, et al. . Web treatment of intracranial aneurysms: feasibility, complications, and 1-month safety results with the WEB DL and WEB SL/SLS in the French Observatory. AJNR Am J Neuroradiol 2015;36:922–7. 10.3174/ajnr.A4230
    1. Pierot L, Costalat V, Moret J, et al. . Safety and efficacy of aneurysm treatment with web: results of the WEBCAST study. J Neurosurg 2016;124:1250–6. 10.3171/2015.2.JNS142634
    1. Pierot L, Moret J, Turjman F, et al. . Web treatment of intracranial aneurysms: clinical and anatomic results in the French Observatory. AJNR Am J Neuroradiol 2016;37:655–9. 10.3174/ajnr.A4578
    1. Pierot L, Gubucz I, Buhk JH, et al. . Safety and efficacy of aneurysm treatment with the web: results of the WEBCAST 2 study. AJNR Am J Neuroradiol 2017;38:1151–5. 10.3174/ajnr.A5178
    1. Fiorella D, Molyneux A, Coon A, et al. . Demographic, procedural and 30-day safety results from the web Intra-saccular therapy study (WEB-IT). J Neurointerv Surg 2017;9:1191–6. 10.1136/neurintsurg-2016-012841
    1. Pierot L, Moret J, Barreau X, et al. . Safety and efficacy of aneurysm treatment with web in the cumulative population of three prospective, multicenter series. J Neurointerv Surg 2018;10:553–9. 10.1136/neurintsurg-2017-013448
    1. Pierot L, Moret J, Barreau X, et al. . Aneurysm treatment with Woven EndoBridge in the cumulative population of three prospective, multicenter series: 2-year follow-up. Neurosurgery 2020. 10.1093/neuros/nyz557. [Epub ahead of print: 20 Jan 2020].
    1. Kotowski M, Naggara O, Darsaut TE, et al. . Safety and occlusion rates of surgical treatment of unruptured intracranial aneurysms: a systematic review and meta-analysis of the literature from 1990 to 2011. J Neurol Neurosurg Psychiatry 2013;84:42–8. 10.1136/jnnp-2011-302068
    1. Nussbaum ES, Madison MT, Goddard JK, et al. . Microsurgical treatment of unruptured middle cerebral artery aneurysms: a large, contemporary experience. J Neurosurg 2019;130:1498–504. 10.3171/2018.1.JNS172466
    1. Benaissa A, Barbe C, Pierot L. Analysis of recanalization after endovascular treatment of intracranial aneurysm (ARETA trial): presentation of a prospective multicenter study. J Neuroradiol 2015;42:80–5. 10.1016/j.neurad.2014.04.003
    1. Kallmes DF, Brinjikji W, Cekirge S, et al. . Safety and efficacy of the pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies. J Neurosurg 2017;127:775–80. 10.3171/2016.8.JNS16467
    1. Becske T, Potts MB, Shapiro M, et al. . Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg 2017;127:81–8. 10.3171/2015.6.JNS15311
    1. Hetts SW, Turk A, English JD, et al. . Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol 2014;35:698–705. 10.3174/ajnr.A3755
    1. De Leacy RA, Fargen KM, Mascitelli JR, et al. . Wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques: a multicentre, core lab adjudicated study evaluating safety and durability of occlusion (branch). J Neurointerv Surg 2019;11:31–6. 10.1136/neurintsurg-2018-013771
    1. Pierot L, Bannery C, Batchinsky-Parrou V, et al. . Clipping of recanalized intracerebral aneurysms initially treated by the Woven EndoBridge device. J Neurointerv Surg 2019;11:807–11. 10.1136/neurintsurg-2019-014903
    1. Timsit C, Soize S, Benaissa A, et al. . Contrast-enhanced and time-of-flight MRA at 3T compared with DSA for the follow-up of intracranial aneurysms treated with the web device. AJNR Am J Neuroradiol 2016;37:1684–9. 10.3174/ajnr.A4791
    1. Raoult H, Eugène F, Le Bras A, et al. . CT angiography for one-year follow-up of intracranial aneurysms treated with the web device: utility in evaluating aneurysm occlusion and web compression at one year. J Neuroradiol 2018;45:343–8. 10.1016/j.neurad.2018.02.010

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