[en] [en] BACKGROUND: The concept of intra-aneurysmal flow disruption has emerged as a new paradigm for the treatment of primarily bifurcation aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of patients treated with the new ARTISSE intrasaccular device (ISD).
METHODS: Selected patients with bifurcation aneurysms that matched the indications of the ARTISSE ISD defined by the manufacturer were treated in a single center. Clinical and angiographic follow-up was conducted at 6 and 36 months. Aneurysm occlusion was assessed using the Raymond-Roy classification scale.
RESULTS: Nine subjects with nine unruptured bifurcation aneurysms were enrolled. Mean aneurysm size was 7.2±1.2 mm (range 5.5-9.7 mm). An adequate aneurysm occlusion (defined as a complete occlusion or a neck remnant) was achieved in 6/9 patients (66.7%) at 6 months and 4/7 patients (57.1%) at 36 months follow-up. Two of the nine subjects experienced a major stroke (22.2%), including one on postoperative day 1 due to a procedure-related parent vessel occlusion and subsequent ischemic stroke. The other major stroke occurred within the 36-month follow-up period during treatment of a separate aneurysm with coils, leading to perforation with hemorrhagic stroke causing a permanent neurological deficit.
CONCLUSION: The ARTISSE ISD was successfully deployed in all nine cases. There were, however, several procedure-related complications and results in terms of angiographic aneurysm occlusion were modest.
Disciplines :
Neurology
Author, co-author :
Piotin, Michel; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France mpiotin@for.paris ; Laboratory for Vascular Translational Science UMRS 1148, INSERM, Paris, France
Fahed, Robert ; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France ; Department of Medicine / Division of Neurology and Department of Medical Imaging / Division of Radiology, The Ottawa Hospital, Ottawa, Ontario, Canada
Redjem, Hocine; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Smajda, Stanislas; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Desilles, Jean Philippe; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France ; Laboratory for Vascular Translational Science UMRS 1148, INSERM, Paris, France
Escalard, Simon; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Maïer, Benjamin; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Hebert, Solène; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Delvoye, François ; Université de Liège - ULiège > Département des sciences cliniques ; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
Mazighi, Mikael; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France ; Laboratory for Vascular Translational Science UMRS 1148, INSERM, Paris, France
Blanc, Raphaël ; Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France ; Laboratory for Vascular Translational Science UMRS 1148, INSERM, Paris, France
Language :
English
Title :
The ARTISSE intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results.
Ding YH, Lewis DA, Kadirvel R, et al. The Woven EndoBridge: a new aneurysm occlusion device. AJNR Am J Neuroradiol 2011;32:607–11.
Kwon SC, Ding YH, Dai D, et al. Preliminary results of the Luna aneurysm embolization system in a rabbit model: a new intrasaccular aneurysm occlusion device. AJNR Am J Neuroradiol 2011;32:602–6.
Pierot L, Szikora I, Barreau X, et al. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg 2021;13:363–8.
Piotin M, Biondi A, Sourour N, et al. The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results. J Neurointerv Surg 2018;10:e34.
Arthur AS, Molyneux A, Coon AL, et al. The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) study. J Neurointerv Surg 2019;11:924–30.
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.
Pierot L, Moret J, Barreau X, et al. Aneurysm treatment with Woven EndoBridge in the cumulative population of 3 prospective, multicenter series: 2-year follow-up. Neurosurgery 2020;87:357–67.
Chapot R, Mosimann PJ, Darsaut TE, et al. Retreatments must be included in the evaluation of device performance. J Neurointerv Surg 2021;13:e5.
Gbur JL, Lewandowski JJ. Fatigue and fracture of wires and cables for biomedical applications. Int Mater Rev 2016;61:231–314.
Schaffer J, Gordon R. Engineering characteristics of drawn filled nitinil tube. In: Pelton AR, Duerig T, eds. SMST-2003: Proceedings of the International Conference on Shape Memory and Superelastic Technologies, 2004: 109–18.
Kabbasch C, Goertz L, Siebert E, et al. Factors that determine aneurysm occlusion after embolization with the Woven EndoBridge (WEB). J Neurointerv Surg 2019;11:503–10.
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.
Fahed R, Ben Maacha M, Ducroux C, et al. Agreement between core laboratory and study investigators for imaging scores in a thrombectomy trial. J Neurointerv Surg 2018;10:e30.
Goyal N, Hoit D, DiNitto J, et al. How to WEB: a practical review of methodology for the use of the Woven EndoBridge. J Neurointerv Surg 2020;12:512–20.
Peterson J, Goyal N, Arthur AS, et al. Technical aspects of web device in aneurysm treatment. J Neurointerv Surg 2020;12:924.
Raymond J, Fahed R, Darsaut TE. Randomize the first patient. J Neuroradiol 2017;44:291–4.
