Background and purpose Stroke recurrence is high in patients with symptomatic intracranial stenosis despite best medical treatment. Based on evidence from past studies using previous stent generations, elective intracranial stenting (eICS) is considered in a minority of patients. This study aims to report on experience performing eICS with a novel device combination.
Methods We retrospectively reviewed data from three high volume stroke centers and analyzed patients that were treated with eICS for symptomatic intracranial stenosis using the Acclino (flex) stent and the NeuroSpeed balloon catheter (Acandis GmbH, Pforzheim, Germany). Study endpoints were periprocedural rates of stroke regardless of territory or death at discharge and at the time of follow-up after eICS. Safety evaluation included asymptomatic and symptomatic intracranial hemorrhage, serious adverse events related to the intervention, and evaluation of stent patency at the time of follow-up.
Results The median age of patients that met the inclusion criteria (n=76) was 69 years. Target vessels were located in the anterior circulation in 55.3% (42/76) of patients. The periprocedural stroke rate was 6.5% (fatal stroke 2.6%; non-fatal stroke 3.9%) at discharge after eICS. Asymptomatic intracranial hemorrhage was observed in 5.2% (4/76) of patients. Follow-up DSA revealed in-stent restenosis of 25% (15/60), and percutaneous transluminal angioplasty was performed again in 11.6% (7/60) of patients.
Conclusion Stenting for symptomatic intracranial stenosis with the Acclino (flex)/NeuroSpeed balloon catheter seemed to be safe and reinforces eICS as an endovascular therapy option for secondary stroke prevention. Future studies are warranted to confirm these findings and investigate antithrombotic strategies and in-stent restenosis to minimize periprocedural complications and guarantee long term stent patency.
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Correction notice This article has been corrected since it was published Online First. The registered trademark ® symbols were removed as per journal style.
Contributors LM, MB, 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. MB and LM performed the data analysis. Interpretation of the data was done by JF, MB, LM, GT, CPS, LM, and RC. LM 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, and Stryker; speaker for Bayer Healthcare, Bracco, Covidien/ev3, Penumbra, Philips, and 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), and Philips. JHB: consultancy fees from Acandis, Cerenovus, MicroVention, and Stryker. MB: consultant for Acandis. RC: consultant and/or proctor for BALT, Stryker, Microvention, Rapid Medical, and Siemens Medical Systems. GT: personal fees as consultant/lecturer from Acandis, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daichi Sankyo, and Stryker; 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), and German Innovation Fund. JR: consultant for Acandis and Phenox. LUK: speaker honoraria from Boehringer Ingelheim, Medtronic, and Stryker.
Patient consent for publication Not required.
Ethics approval All anonymized data were recorded with the approval of the local ethics committees.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.