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
Authors
Ricardo A. Hanel, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
Gustavo M. Cortez, Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.Follow
Demetrius Klee Lopes, Advocate Aurora HealthFollow
Peter Kim Nelson, Interventional Radiology, NYU Langone Medical Center, New York, New York, USA.
Adnan H. Siddiqui, Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
Pascal Jabbour, Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
Vitor Mendes Pereira, Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.
Istvan Szikora István, Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
Osama O. Zaidat, Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
Chetan Bettegowda, Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.Follow
Geoffrey P. Colby, Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.Follow
Maxim Mokin, Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
Clemens M. Schirmer, Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
Frank R. Hellinger, Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
Curtis Given, Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
Timo Krings, Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
Philipp Taussky, Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
Gabor Toth, Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
Justin F. Fraser, Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
Michael Chen, Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.Follow
Ryan Priest, Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
Peter Kan, Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
David Fiorella, Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.
Donald Frei, Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.
Beverly Aagaard-Kienitz, Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.Follow
Orlando Diaz, Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
Adel M. Malek, Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
C Michael Cawley, Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.Follow
Ajit S. Puri, Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
David F. Kallmes, Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Recommended Citation
Hanel RA, Cortez GM, Lopes DK, et al. 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;15(3):248-254. doi:10.1136/neurintsurg-2021-018501
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.
Affiliations
Brain and Spine Institute, Advocate Aurora Health