Intracranial bailout stenting with the Acclino (Flex) Stent/NeuroSpeed Balloon Catheter after failed thrombectomy in acute ischemic stroke: a multicenter experience.

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.
Competing Interests: 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.
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