Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN
Fiehler, Jens ; Ortega-Gutierrez, Santiago ; Anagnostakou, Vania ; Cortese, Jonathan ; Cekirge, H Saruhan ; Fiorella, David ; Hanel, Ricardo ; Kulcsar, Zsolt ; Lamin, Saleh ; Liu, Jianmin ... show 10 more
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Ortega-Gutierrez, Santiago
Anagnostakou, Vania
Cortese, Jonathan
Cekirge, H Saruhan
Fiorella, David
Hanel, Ricardo
Kulcsar, Zsolt
Lamin, Saleh
Liu, Jianmin
Lylyk, Pedro
Marden, Franklin A
Pereira, Vitor M
Psychogios, Marios-Nikos
Rice, Hal
Rouchaud, Aymeric
Saatci, Isil
Siddiqui, Adnan H
Spelle, Laurent
Yang, Pengfei
Grams, Astrid
Gounis, Matthew J
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UMass Chan Affiliations
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Abstract
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.
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Fiehler J, Ortega-Gutierrez S, Anagnostakou V, Cortese J, Cekirge HS, Fiorella D, Hanel R, Kulcsar Z, Lamin S, Liu J, Lylyk P, Marden FA, Pereira VM, Psychogios MN, Rice H, Rouchaud A, Saatci I, Siddiqui AH, Spelle L, Yang P, Grams A, Gounis MJ. Evaluation of flow diverters for cerebral aneurysm therapy: recommendations for imaging analyses in clinical studies, endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS, and WFITN. J Neurointerv Surg. 2024 Jun 2:jnis-2023-021404. doi: 10.1136/jnis-2023-021404. Epub ahead of print. PMID: 38830670.