Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results,...

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Detalles Bibliográficos
Autores principales: Hanel, Ricardo A, Cortez, Gustavo M, Lopes, Demetrius Klee, Nelson, Peter Kim, Siddiqui, Adnan H, Jabbour, Pascal, Mendes Pereira, Vitor, István, Istvan Szikora, Zaidat, Osama O, Bettegowda, Chetan, Colby, Geoffrey P, Mokin, Maxim, Schirmer, Clemens M, Hellinger, Frank R, Given, Curtis, Krings, Timo, Taussky, Philipp, Toth, Gabor, Fraser, Justin F, Chen, Michael, Priest, Ryan, Kan, Peter, Fiorella, David, Frei, Donald, Aagaard-Kienitz, Beverly, Diaz, Orlando, Malek, Adel M, Cawley, C Michael, Puri, Ajit S, Kallmes, David F
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Hemorrhagic Stroke
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985759/
https://www.ncbi.nlm.nih.gov/pubmed/35292570
http://dx.doi.org/10.1136/neurintsurg-2021-018501
Descripción
Sumario:BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.

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