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 Chen; Ryan Priest; Peter Kan; David Fiorella; Donald Frei; Beverly Aagaard-Kienitz; Orlando Diaz; Adel M Malek; C Michael Cawley; Ajit S Puri; David F Kallmes

doi:10.1136/neurintsurg-2021-018501

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

J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.

Authors

Ricardo A Hanel¹, Gustavo M Cortez², Demetrius Klee Lopes³, Peter Kim Nelson⁴, Adnan H Siddiqui⁵, Pascal Jabbour⁶, Vitor Mendes Pereira⁷, Istvan Szikora István⁸, Osama O Zaidat⁹, Chetan Bettegowda¹⁰, Geoffrey P Colby¹¹, Maxim Mokin¹², Clemens M Schirmer¹³, Frank R Hellinger¹⁴, Curtis Given¹⁵, Timo Krings¹⁶, Philipp Taussky¹⁷, Gabor Toth¹⁸, Justin F Fraser¹⁹, Michael Chen²⁰, Ryan Priest²¹, Peter Kan²², David Fiorella²³, Donald Frei²⁴, Beverly Aagaard-Kienitz²⁵, Orlando Diaz²⁶, Adel M Malek²⁷, C Michael Cawley²⁸, Ajit S Puri²⁹, David F Kallmes³⁰

Affiliations

¹ Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA [email protected].
² Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
³ Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.
⁴ Interventional Radiology, NYU Langone Medical Center, New York, New York, USA.
⁵ Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
⁶ Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
⁷ Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.
⁸ Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
⁹ Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
¹⁰ Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
¹¹ Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
¹² Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
¹³ Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
¹⁴ Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
¹⁵ Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
¹⁶ Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
¹⁷ Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
¹⁸ Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
¹⁹ Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
²⁰ Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.
²¹ Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
²² Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
²³ Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.
²⁴ Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.
²⁵ Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
²⁶ Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
²⁷ Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
²⁸ Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
²⁹ Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
³⁰ Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

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.

Keywords: aneurysm; flow diverter; intervention.

Publication types

Clinical Trial

MeSH terms

Cerebral Angiography / methods
Embolization, Therapeutic* / methods
Follow-Up Studies
Humans
Intracranial Aneurysm* / diagnostic imaging
Intracranial Aneurysm* / etiology
Intracranial Aneurysm* / therapy
Prospective Studies
Retrospective Studies
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT02186561