Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN.

BACKGROUND

Multiple studies and meta-analyses have described the technical and clinical outcomes in large cohorts of aneurysm patients treated with flow diverters (FDs). Variations in evaluation methodology complicate making comparisons among studies, hinder understanding of the device behavior, and pose an obstacle in the assessment of further advances in FD therapy.

METHODS

A multidisciplinary panel of neurointerventionalists, imaging experts, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies.

RESULTS

A standardized methodology is proposed for evaluating and reporting radiological outcomes of FD treatment of intracranial aneurysms. The recommendations include general imaging considerations for clinical studies and evaluations of longitudinal changes, such as neointimal lining and stenosis. They cover standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage. These reporting standards further define four specific braid deformation patterns: foreshortening, fish-mouthing, braid bump deformation, and braid collapse, collectively termed 'F2B2'.

CONCLUSIONS

When widely applied, standardization of methods of measuring and reporting outcomes will help to harmonize the assessment of treatment outcomes in clinical studies, help facilitate communication of results among specialists, and help enable research and development to focus on specific aspects of FD techniques and technology.

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: JF: Research support: German Ministry of Science & Education (BMBF) and of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Cerenovus, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Med, Tonbridge. Stockholder: Tegus Medical, Vastrax, Eppdata. DF: Medtronic – Consulting, Proctoring, Cerenovous – Consulting, Microvention – Consulting, Proctoring, Research Support, Penumbra – Consulting, Research Support, Stryker – Consulting, Research Support, Balt USA – Consulting, Research Support, Siemens – Research Support, MENTICE-Vascular Simulations – Consultant, Neurogami – Stockholder, Consultant, RAPID. AI – Consultant, RAPID Medical – Consultant, Qapel Medical –Consultant, Arsenal Medical – Consultant, Phenox Medical – Consultant, Scientia Medical – SAB, Consultant, Stockholder, NVMed – SAB, Stockholder, Perfuze – SAB, Consultant, Stockholder, Vesalio - ConsultantIS: Consulting and proctoring agreement with Medtronic & Microvention. SH: Consulting and proctoring agreement with Medtronic & Microvention. Stocks: Neuravention Inc., Vesalio Inc., Synchron Inc., Bend It Technologies, Sim & Size Inc., Borvo Medical Inc., Prometheus Inc., Piraeus Inc., Neuros Medical Inc. MJG: (1) Consultant on a fee-per-hour basis for Alembic, Astrocyte Pharmaceuticals, BendIt Technologies, Cerenovus, Imperative Care, Jacob’s Institute, Medtronic Neurovascular, Mivi Neurosciences, Phenox GMbH, Q’Apel, Route 92 Medical, Scientia, Simcerre, Stryker Neurovascular, Stryker Sustainability Solutions, Wallaby Medical; holds stock in Imperative Care, InNeuroCo, Galaxy Therapeutics, Kapto, Neurogami and Synchron; (2) Research support from the National Institutes of Health (NIH), the United States–Israel Binational Science Foundation, Anaconda, ApicBio, Arsenal Medical, Axovant, Balt, Cerenovus, Ceretrieve, CereVasc, Cook Medical, Galaxy Therapeutics, Gentuity, Gilbert Foundation, Imperative Care, InNeuroCo, Insera, Jacob’s Institute, Magneto, MicroBot, Microvention, Medtronic Neurovascular, MIVI Neurosciences, Naglreiter MDDO, Neurogami, Q’Apel, Philips Healthcare, Progressive Medical, Pulse Medical, Rapid Medical, Route 92 Medical, Scientia, Stryker Neurovascular, Syntheon, ThrombX Medical, Wallaby Medical, the Wyss Institute, Xtract Medical; and (3) Associate Editor of Basic Science on the JNIS Editorial Board.