دورية أكاديمية
أعرض في EDS

Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study.

التفاصيل البيبلوغرافية
العنوان: Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study.
المؤلفون: Trivelato FP; Division of Interventional Neuroradiology, Felício Rocho Hospital, Belo Horizonte, Brazil., Wajnberg E; Division of Interventional Neuroradiology, Americas Medical Services, Rio de Janeiro, Brazil., Rezende MTS; Division of Interventional Neuroradiology, Felício Rocho Hospital, Belo Horizonte, Brazil., Ulhôa AC; Division of Interventional Neuroradiology, Felício Rocho Hospital, Belo Horizonte, Brazil., Piske RL; Division of Interventional Neuroradiology, Hospital Beneficiência Portuguesa, São Paulo, Brazil., Abud TG; Division of Interventional Neuroradiology, Hospital Israelita Albert Einstein, São Paulo, Brazil., de Castro-Afonso LH; Division of Interventional Neuroradiology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil., Abath CGC; Division of Interventional Neuroradiology, AngioRad, Recife, Brazil., Nakiri GS; Division of Interventional Neuroradiology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil., Araújo JFS; Division of Interventional Neuroradiology, Americas Medical Services, Rio de Janeiro, Brazil., Silva JLJ; Division of Interventional Neuroradiology, AngioRad, Recife, Brazil., Tosello RT; Division of Interventional Neuroradiology, Hospital Beneficiência Portuguesa, São Paulo, Brazil., Vanzin JR; Division of Interventional Neuroradiology, Hospital de Clínicas, Passo Fundo, Brazil., Manzato LB; Division of Interventional Neuroradiology, Hospital de Clínicas, Passo Fundo, Brazil., Baccin CE; Division of Interventional Neuroradiology, Hospital Israelita Albert Einstein, São Paulo, Brazil., da Mota BAA; Division of Interventional Neuroradiology, AngioRad, Recife, Brazil., Abud DG; Division of Interventional Neuroradiology, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
المصدر: Neurosurgery [Neurosurgery] 2020 Jul 01; Vol. 87 (1), pp. 104-111.
نوع المنشور: Journal Article; Multicenter Study; Observational Study
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins, Inc Country of Publication: United States NLM ID: 7802914 Publication Model: Print Cited Medium: Internet ISSN: 1524-4040 (Electronic) Linking ISSN: 0148396X NLM ISO Abbreviation: Neurosurgery Subsets: MEDLINE
أسماء مطبوعة: Publication: 2022- : [Philadelphia] : Lippincott Williams & Wilkins, Inc.
Original Publication: Baltimore, Williams & Wilkins.
مواضيع طبية MeSH: Blood Vessel Prosthesis*/adverse effects , Patient Safety*, Embolization, Therapeutic/*methods , Intracranial Aneurysm/*diagnostic imaging , Intracranial Aneurysm/*therapy, Adult ; Aged ; Cerebral Angiography/methods ; Embolization, Therapeutic/adverse effects ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome
مستخلص: Background: The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications.
Objective: To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield.
Methods: This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported.
Results: Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo.
Conclusion: The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.
(Copyright © 2019 by the Congress of Neurological Surgeons.)
فهرسة مساهمة: Keywords: Aneurysm; Embolization; Endovascular; Flow diverter
تواريخ الأحداث: Date Created: 20190911 Date Completed: 20201214 Latest Revision: 20201214
رمز التحديث: 20240628
DOI: 10.1093/neuros/nyz356
PMID: 31504821
قاعدة البيانات: MEDLINE
الوصف
تدمد:1524-4040
DOI:10.1093/neuros/nyz356