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

• Type of Material: Article
• Authors: Ricardo A Hanel, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida; Gustavo M Cortez, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida; Demetrius Klee Lopes, Advocate Aurora Health; Peter Kim Nelson, NYU Langone Medical Center; Adnan H Siddiqui, University at Buffalo; Pascal Jabbour, Thomas Jefferson University Hospital; Vitor Mendes Pereira, Toronto Western Hospital; Istvan Szikora István, National Institute of Neurosciences, Budapest, Hungary; Osama O Zaidat, Mercy Health Saint Vincent Medical Center, Toledo, Ohio; Chetan Bettegowda, Johns Hopkins University; Geoffrey P Colby, University of California Los Angeles; Maxim Mokin, University of South Florida; Clemens M Schirmer, Geisinger Health System; Frank R Hellinger, Florida Hospital Neuroscience Institute; Curtis Given, Baptist Health Lexington; Tiimo Krings, Toronto Western Hospital; Philipp Taussky, University of Utah Health; Gabor Toth, Cleveland Clinic; Justin F Fraser, University of Kentucky; Michael Chen, Rush University; Ryan Priest, Oregon Health and Science University; Peter Kan, Baylor College of Medicine; David Fiorella, Stony Brook University; Donald Frei, Swedish Medical Center; Beverly Aagaard-Kienitz, University of Wisconsin-Madison; Orlando Diaz, Houston Methodist Research Institute; Adel M Malek, Tufts Medical Center; Charles Cawley, Emory University; Ajit S Puri, University of Massachusetts Worcester; David F Kallmes, Mayo Clinic, Rochester
• Language: English
• Date: 2022-03-14
• Publisher: BMJ PUBLISHING GROUP
• Publication Version: Final Published Version
• Copyright Statement: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/neurintsurg-2021-018501
• Title of Journal or Parent Work: JOURNAL OF NEUROINTERVENTIONAL SURGERY
• Volume: 15
• Issue: 3
• Start Page: 248
• End Page: 254
• Keywords: NATURAL-HISTORY; Neurosciences & Neurology; Neuroimaging; Life Sciences & Biomedicine; Science & Technology; ARTERY ANEURYSMS; DIVERSION; Surgery; ENDOVASCULAR TREATMENT; COILING
• Research Categories: Health Sciences, Radiology; Health Sciences, Medicine and Surgery

Abstract

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.