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

Ricardo A. Hanel, Gustavo M. Cortez, Demetrius Klee Lopes, Peter Kim Nelson, Adnan H. Siddiqui, Pascal Jabbour, Vitor Mendes Pereira, Istvan Szikora István, Osama O. Zaidat, Chetan Bettegowda, Geoffrey P. Colby, Maxim Mokin, Clemens M. Schirmer, Frank R. Hellinger, Curtis Given, Timo Krings, Philipp Taussky, Gabor Toth, Justin F. Fraser, Michael ChenRyan Priest, Peter Kan, David Fiorella, Donald Frei, Beverly Aagaard-Kienitz, Orlando Diaz, Adel M. Malek, C. Michael Cawley, Ajit S. Puri, David F. Kallmes

Research output: Contribution to journalArticlepeer-review

31 Scopus citations

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.

Original languageEnglish
Article number018501
JournalJournal of NeuroInterventional Surgery
DOIs
StateAccepted/In press - 2022

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

  • aneurysm
  • flow diverter
  • intervention

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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