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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.
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.
Afiliación
  • Hanel RA; Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA rhanel@lyerlyneuro.com.
  • Cortez GM; Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
  • Lopes DK; Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA.
  • Nelson PK; Interventional Radiology, NYU Langone Medical Center, New York, New York, USA.
  • Siddiqui AH; Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
  • Jabbour P; Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
  • Mendes Pereira V; Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada.
  • István IS; Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary.
  • Zaidat OO; Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA.
  • Bettegowda C; Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
  • Colby GP; Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA.
  • Mokin M; Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA.
  • Schirmer CM; Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA.
  • Hellinger FR; Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA.
  • Given C; Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
  • Krings T; Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada.
  • Taussky P; Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
  • Toth G; Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
  • Fraser JF; Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA.
  • Chen M; Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA.
  • Priest R; Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA.
  • Kan P; Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.
  • Fiorella D; Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA.
  • Frei D; Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA.
  • Aagaard-Kienitz B; Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.
  • Diaz O; Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA.
  • Malek AM; Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA.
  • Cawley CM; Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA.
  • Puri AS; Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
  • Kallmes DF; Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
J Neurointerv Surg ; 15(3): 248-254, 2023 Mar.
Article en En | MEDLINE | ID: mdl-35292570
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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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Aneurisma Intracraneal / Embolización Terapéutica Tipo de estudio: Guideline / Observational_studies Idioma: En Revista: J Neurointerv Surg Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Aneurisma Intracraneal / Embolización Terapéutica Tipo de estudio: Guideline / Observational_studies Idioma: En Revista: J Neurointerv Surg Año: 2023 Tipo del documento: Article