1. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study
- Author
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Laurent Pierot, Mohamed Aggour, Michel Piotin, Xavier Barreau, Charbel Mounayer, Laurent Spelle, Denis Herbreteau, Jean-Yves Gauvrit, Chrisanthi Papagiannaki, Jean-Paul Lejeune, Vincent Costalat, Jérôme Berge, Alessandra Biondi, Anne-Christine Januel, Université de Reims Champagne-Ardenne (URCA), Service de Neuroradiologie Interventionnelle et Fonctionnelle, Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département de Neuro-Radiologie [Bordeaux] (DNR - Bordeaux), CHU Bordeaux [Bordeaux], CHU Toulouse [Toulouse], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Saint-Etienne, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Neuroradiologie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Department of Neuroradiology (X.B.), CHU Bordeaux, Service de Neurologie [CHU Limoges], CHU Limoges, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes], CHU Pontchaillou [Rennes], CHU Montpellier, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Gauvrit, Jean-Yves, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Service de radiologie et imagerie médicale [Rennes], Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-CHU Pontchaillou [Rennes]
- Subjects
Male ,Time Factors ,Aneurysm, Ruptured ,030218 nuclear medicine & medical imaging ,0302 clinical medicine ,Prospective Studies ,Interventional neuroradiology ,MESH: Treatment Outcome ,MESH: Aged ,MESH: Middle Aged ,Endovascular Procedures ,General Medicine ,Middle Aged ,3. Good health ,Anterior communicating artery ,Hemorrhagic Stroke ,Treatment Outcome ,Middle cerebral artery ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Female ,Neurosurgery ,Internal carotid artery ,Adult ,medicine.medical_specialty ,MESH: Endovascular Procedures ,MESH: Intracranial Aneurysm ,Self Expandable Metallic Stents ,03 medical and health sciences ,Aneurysm ,medicine.artery ,medicine ,Anterior cerebral artery ,Humans ,[SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Mortality ,Aged ,MESH: Humans ,MESH: Mortality ,business.industry ,MESH: Time Factors ,MESH: Adult ,Intracranial Aneurysm ,medicine.disease ,MESH: Prospective Studies ,MESH: Male ,Surgery ,MESH: Self Expandable Metallic Stents ,Clinical trial ,MESH: Morbidity ,aneurysm ,Feasibility Studies ,Neurology (clinical) ,Morbidity ,business ,MESH: Feasibility Studies ,MESH: Aneurysm, Ruptured ,MESH: Female ,030217 neurology & neurosurgery - Abstract
Background and purposeFlow diverters are increasingly used for the treatment of intracranial aneurysms. Evaluation of the first devices available for clinical use showed high efficacy of this treatment although safety results were worse compared with coiling or balloon-assisted coiling. The Safety and Efficacy Analysis of FRED Embolic Device in Aneurysm Treatment (SAFE) trial is a single-arm, multicenter, prospective study conducted to precisely analyze the safety and efficacy of the FRED and FRED Jr devices.MethodsUnruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. Adverse events were independently evaluated by a Clinical Event Committee with a vascular neurosurgeon and an interventional neuroradiologist. Primary safety outcome measures were morbidity and mortality rates at 6 months after treatment.ResultsA total of 103 patients/aneurysms were included in 13 interventional neuroradiology (INR) centers. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral artery or anterior communicating artery in nine (8.7%), and middle cerebral artery in eight (7.8%). Aneurysms were small (ConclusionsAneurysm treatment with the FRED device is safe with low mortality (1.0%) and morbidity (2.0%).Clinical trial registrationNCT02921698.
- Published
- 2018