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. 2024 Sep 25:15:1441810.
doi: 10.3389/fneur.2024.1441810. eCollection 2024.

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

Ulf Neuberger  1 , Gaultier Marnat  2 , Xavier Barreau  2 , Antonio Pitrone  3 , Antonio A Caragliano  3 , Monika Killer-Oberpfalzer  4 , Johannes A R Pfaff  5 , Christoph J Maurer  6 , Ansgar Berlis  6 , Reinoud Bokkers  7 , Maarten Uyttenboogaart  7 , Nader Sourour  8 , Frédéric Clarençon  8 , Fritz Wodarg  9 , Christophe Cognard  10 , Georg Bohner  11 , Johannes Trenkler  12 , Laurent Spelle  13 , Werner Weber  14 , Nasreddine Nouri  15 , Susanne Bonekamp  1 , Götz Thomalla  16 , Jens Fiehler  17 , Martin Bendszus  1 , Markus A Möhlenbruch  1
Affiliations

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

Ulf Neuberger et al. Front Neurol. .

Abstract

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. 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.

Keywords: aspiration (MeSH); good clinical practice (GCP); prospective observational study; stroke; thrombectomy.

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Conflict of interest statement

GT has received compensation by the University Heidelberg for activities as member of the CEC within the study, and fees as consultant or lecturer from Acandis, Alexion, Amarin, Astra Zeneca, Bayer, Boehringer Ingelheim, BristolMyersSquibb, Daiichi Sankyo, Portoly, Stryker outside this study. GM reports consulting fees from Microvention Europe, Stryker Neurovascular, Balt SAS, Sim and Cure and paid lectures from Medtronic, Phenox, Cerenovus, Bracco. All of these were outside this study. AP is the principal investigator of the SEALANT study sponsored by Microvention. MM received research grants from Acandis, Balt, Medtronic, Microvention, Phenox, Stryker* (*industry payments are made to the research fund of the institution), receives payment or honoraria for lectures from Balt, Medtronic, Stryker* (*industry payments are made to the research fund of the institution). SESAME was an investigator-initiated study (IIT). A grant for conducting the study was provided by Microvention. However, Microvention did not exert any influence on the study’ design. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flowchart of patients in the SESAME trial. mRS, modified Rankin Scale; ASPECTS, Alberta Stroke Program Early CT Score. Choice to use either SOFIA or SOFIA PLUS was at left at the discretion of the operator.
Figure 2
Figure 2
Distribution of mRS scores at 3 months of available data (n = 212) and the dataset after imputation (n = 246). A score of 0 on the mRS indicates no symptoms, a score of 1 indicates no clinically significant disability, a score of 2 indicates slight disability (patients are able to look after their own affairs without assistance but are unable to carry out all previous activities), a score of 3 indicates moderate disability (patients require some help but are able to walk unassisted), a score of 4 indicates moderately severe disability (patients are unable to attend to bodily needs without assistance and are unable to walk unassisted), a score of 5 indicates severe disability (patients require constant nursing care and attention), and a score of 6 indicates death. Percentages might not total 100 because of rounding. mRS, modified Rankin Scale.
See this image and copyright information in PMC

References

    1. Wafa HA, Wolfe CDA, Emmett E, Roth GA, Johnson CO, Wang Y. Burden of stroke in Europe: thirty-year projections of incidence, prevalence, deaths, and disability-adjusted life years. Stroke. (2020) 51:2418–27. doi: 10.1161/STROKEAHA.120.029606, PMID: - DOI - PMC - PubMed
    1. Lakomkin N, Dhamoon M, Carroll K, Singh IP, Tuhrim S, Lee J, et al. . Prevalence of large vessel occlusion in patients presenting with acute ischemic stroke: a 10-year systematic review of the literature. J Neurointerv Surg. (2019) 11:241–5. doi: 10.1136/neurintsurg-2018-014239, PMID: - DOI - PubMed
    1. Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, et al. . Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. (2016) 387:1723–31. doi: 10.1016/S0140-6736(16)00163-X, PMID: - DOI - PubMed
    1. Goyal M, Jadhav AP, Bonafe A, Diener H, Mendes Pereira V, Levy E, et al. . Analysis of workflow and time to treatment and the effects on outcome in endovascular treatment of acute ischemic stroke: results from the SWIFT PRIME randomized controlled trial. Radiology. (2016) 279:888–97. doi: 10.1148/radiol.2016160204, PMID: - DOI - PubMed
    1. Liebeskind DS, Jahan R, Nogueira RG, Jovin TG, Lutsep HL, Saver JL, et al. . Early arrival at the emergency department is associated with better collaterals, smaller established infarcts and better clinical outcomes with endovascular stroke therapy: SWIFT study. J Neurointerv Surg. (2016) 8:553–8. doi: 10.1136/neurintsurg-2015-011758, PMID: - DOI - PubMed

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