Background and purpose To report on the feasibility, safety, and outcome of acute intracranial stenting (ICS) with the Acclino (Flex) Stent and NeuroSpeed Balloon Catheter in cases of failed mechanical thrombectomy (MT) for acute ischemic stroke (AIS).
Methods We retrospectively reviewed the data of patients treated with acute bailout stenting after failed MT in three large neurointerventional centers using exclusively the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter. Functional outcome was assessed by the rate of major early neurological recovery (mENR) at 24 hours and at 90 days with the modified Rankin Scale (mRS). Safety evaluation included symptomatic intracranial hemorrhage (sICH), mortality, and intervention-related serious adverse events (SAEs).
Results 50 patients with a median age of 71 years met the inclusion criteria and 52% (26/50) of the occluded vessels were located within the anterior circulation. mENR was observed in 38.8% and 90-day favorable outcome (mRS ≤2) was 40.6% (13/32). Higher NIH Stroke Scale scores on admission were significantly associated with poor functional outcome (mRS ≥3) at 90 days (adjusted OR 1.28; 95% CI 1.07 to 1.53; p=0.007). sICH occurred in two cases of the study population. There were no intervention-related SAEs.
Conclusion Intracranial bailout stenting with the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter after failed MT is a feasible and effective recanalization method for atherosclerotic stenosis-based stroke that is associated especially with low rates of sICH.
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CPS and LM contributed equally.
Contributors LM, UH, and CPS made substantial contributions to the conception and design of the work. Data acquisition was performed by CPS, LM, HL, LUK, SL, and JR. UH and LM performed the data analysis. Interpretation of the data was done by JF, GT, CPS, UH, LM. LM, CPS, and UH drafted the manuscript and all of the other authors revised it critically for important intellectual content. All authors approved the final version to be published. They agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the manuscript are appropriately investigated and resolved.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests CPS: Consultant and/or proctor for Acandis, Balt, and Rapid Medical. JF: Consultant for Acandis, Boehringer Ingelheim, Codman, Microvention, Sequent, Stryker. Speaker for Bayer Healthcare, Bracco, Covidien/ev3, Penumbra, Philips, Siemens. Grants from Bundesministeriums für Wirtschaft und Energie (BMWi), Bundesministerium für Bildung und Forschung (BMBF), Deutsche Forschungsgemeinschaft (DFG), European Union (EU), Covidien, Stryker (THRILL study), Microvention (ERASER study), Philips. JHB: Received consultancy fees from Acandis, Cerenovus, MicroVention, Stryker. MB: Consultant for Acandis. RC: Consultant and/or proctor for BALT, Stryker, Microvention, Rapid Medical, Siemens Medical Systems. GT: Received personal fees as consultant/lecturer from Acandis, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daichi Sankyo, Stryker, and research grants from Bayer, Federal Ministry for Economic Affairs and Energy (BMWi), Corona-Foundation, German Research Foundation (DFG), Else Kröner-Fresenius Foundation, European Union (Horizon 2020), German Innovation Fund. JR: Consultant for Acandis and Phenox. LUK: Received speaker honoraria from Boehringer Ingelheim, Medtronic and Stryker.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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