Background and purpose: This study evaluates the early clinical performance of the new Artisse Intrasaccular Device (Artisse ISD), a self-expandable intrasaccular flow diverter, for treating wide-necked aneurysms (WNAs). We report initial safety and efficacy outcomes in the first cohort of patients treated with this novel device.
Methods: Prospective clinical and radiological data were collected for all patients treated with the Artisse ISD at three Austrian neurovascular centers from July 2023 to August 2024. Aneurysm occlusion was assessed using the Raymond-Roy Classification (RR), the O-Kelly-Marotta (OKM) scale, and the Bicêtre Occlusion Scale Score (BOSS).
Results: In our study 23 patients (60.9% female, median age 62 years) with 23 saccular aneurysms were treated with the Artisse ISD. Nineteen aneurysms (82.6%) were unruptured and located in the anterior circulation. Initial post-procedure angiography revealed incomplete occlusion in all aneurysms, with significant contrast stasis observed (OKM A2/A3). In 16 patients with a minimum of 3 month follow-up, 81.3% of aneurysms demonstrated complete occlusion (RR1), while 6.3% showed neck remnants (RR2), adding up to an adequate occlusion rate of 87.6%. Two asymptomatic thromboembolic events (8.7%) occurred (small diffusion-weighted restrictions on routine postoperative magnetic resonance imaging (MRI)), with no hemorrhagic complications. No device migration or shape modification was observed during follow-up.
Conclusion: Early clinical experience with the Artisse ISD demonstrates promising safety and efficacy in the treatment of WNAs, with high rates of complete occlusion at 3 month follow-up.
Keywords: Aneurysm; Device; Intervention; Technique.
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