Safety and effectiveness of SOFIA/SOFIA PLUS for direct aspiration as first line treatment in patients with acute anterior ischemic stroke: results from the prospective, multicentric SESAME study

  • Background: Mechanical thrombectomy is a cornerstone treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO), yet the optimal technique remains debated. The SOFIA/SOFIA PLUS catheter has emerged as a promising tool for direct aspiration thrombectomy. Purpose: This prospective multi-center study, adhering Good-Clinical-Practice guidelines, aimed to evaluate the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first-line treatment technique in patients with acute anterior circulation LVO. Materials and methods: Between 10/2017 and 12/2021, 246 consecutive patients presenting with AIS due to anterior circulation LVO were enrolled from 14 European centers. Primary treatment with SOFIA catheters was performed within 6 h of symptom onset. Clinical and radiological data were collected, and statistical analyses were conducted. Results: The mean age of the included patients was 71.6 ± 13.9 years, with 44.7% being male. PrimaryBackground: Mechanical thrombectomy is a cornerstone treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO), yet the optimal technique remains debated. The SOFIA/SOFIA PLUS catheter has emerged as a promising tool for direct aspiration thrombectomy. Purpose: This prospective multi-center study, adhering Good-Clinical-Practice guidelines, aimed to evaluate the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first-line treatment technique in patients with acute anterior circulation LVO. Materials and methods: Between 10/2017 and 12/2021, 246 consecutive patients presenting with AIS due to anterior circulation LVO were enrolled from 14 European centers. Primary treatment with SOFIA catheters was performed within 6 h of symptom onset. Clinical and radiological data were collected, and statistical analyses were conducted. Results: The mean age of the included patients was 71.6 ± 13.9 years, with 44.7% being male. Primary aspiration achieved complete recanalization in 72.8% of patients, with functional independence observed in 63.8% after 90 days. Secondary outcomes included a median NIHSS of 4 at 24 h post-procedure, median ASPECTS of 7 on follow-up imaging, and a mortality rate of 24.4% at 90 days. No device malfunctions were observed, and the rate of symptomatic intracranial hemorrhage was 4.4%. Conclusion: Primary aspiration with the SOFIA/SOFIA PLUS catheter demonstrates favorable safety and efficacy profiles in the treatment of anterior circulation LVO. These findings support the utilization of this technique as a first-line approach in mechanical thrombectomy for AIS, contributing to the growing body of evidence endorsing the effectiveness of direct aspiration thrombectomy in stroke management.show moreshow less

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Author:Ulf Neuberger, Gaultier Marnat, Xavier Barreau, Antonio Pitrone, Antonio A. Caragliano, Monika Killer-Oberpfalzer, Johannes A. R. Pfaff, Christoph J. MaurerORCiDGND, Ansgar BerlisORCiDGND, Reinoud Bokkers, Maarten Uyttenboogaart, Nader Sourour, Frédéric Clarençon, Fritz Wodarg, Christophe Cognard, Georg Bohner, Johannes Trenkler, Laurent Spelle, Werner Weber, Nasreddine Nouri, Susanne Bonekamp, Götz Thomalla, Jens Fiehler, Martin Bendszus, Markus A. Möhlenbruch
URN:urn:nbn:de:bvb:384-opus4-1162863
Frontdoor URLhttps://opus.bibliothek.uni-augsburg.de/opus4/116286
ISSN:1664-2295OPAC
Parent Title (English):Frontiers in Neurology
Publisher:Frontiers Media SA
Place of publication:Lausanne
Type:Article
Language:English
Year of first Publication:2024
Publishing Institution:Universität Augsburg
Release Date:2024/11/05
Volume:15
First Page:1441810
DOI:https://doi.org/10.3389/fneur.2024.1441810
Institutes:Medizinische Fakultät
Medizinische Fakultät / Universitätsklinikum
Medizinische Fakultät / Lehrstuhl für Diagnostische und Interventionelle Neuroradiologie
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):CC-BY 4.0: Creative Commons: Namensnennung (mit Print on Demand)