One-year efficacy and safety of the Trufill ...
Type de document :
Compte-rendu et recension critique d'ouvrage
DOI :
PMID :
Titre :
One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study.
Auteur(s) :
Gory, Benjamin [Auteur correspondant]
Institut des sciences cognitives Marc Jeannerod - Centre de neuroscience cognitive - UMR5229 [ISC-MJ]
Huot, Laure [Auteur]
Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 [CIIL]
Riva, Roberto [Auteur]
Labeyrie, Paul [Auteur]
Physiopathologie et imagerie des troubles neurologiques [PhIND]
Levrier, Olivier [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Lebedinsky, Ariel [Auteur]
Winogradsky Institute of Microbiology [Moscow]
Brunel, Hervé [Auteur]
Gauvrit, Jean-Yves [Auteur]
Vision, Action et Gestion d'informations en Santé [VisAGeS]
Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes]
Blanc, Raphael [Auteur]
Chabert, Emmanuel [Auteur]
Département Recherches Subatomiques [DRS-IPHC]
Derex, Laurent [Auteur]
Health Service and Performance Research [HESPER]
Emery, Evelyne [Auteur]
Service de Neurochirurgie [CHU Caen]
Nicolas, Arnaud [Auteur]
DePuy Synthes [Zuchwil]
Desal, Hubert [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Rodesch, Georges [Auteur]
Turjman, Francis [Auteur]
Institut des sciences cognitives Marc Jeannerod - Centre de neuroscience cognitive - UMR5229 [ISC-MJ]
Huot, Laure [Auteur]
Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 [CIIL]
Riva, Roberto [Auteur]
Labeyrie, Paul [Auteur]
Physiopathologie et imagerie des troubles neurologiques [PhIND]
Levrier, Olivier [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Lebedinsky, Ariel [Auteur]
Winogradsky Institute of Microbiology [Moscow]
Brunel, Hervé [Auteur]
Gauvrit, Jean-Yves [Auteur]
Vision, Action et Gestion d'informations en Santé [VisAGeS]
Service de radiologie et imagerie médicale [Rennes] = Radiology [Rennes]
Blanc, Raphael [Auteur]
Chabert, Emmanuel [Auteur]
Département Recherches Subatomiques [DRS-IPHC]
Derex, Laurent [Auteur]
Health Service and Performance Research [HESPER]
Emery, Evelyne [Auteur]
Service de Neurochirurgie [CHU Caen]
Nicolas, Arnaud [Auteur]
DePuy Synthes [Zuchwil]
Desal, Hubert [Auteur]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital [CHU Nantes]
Rodesch, Georges [Auteur]
Turjman, Francis [Auteur]
Titre de la revue :
Interventional Neuroradiology
Éditeur :
Edizioni del Centauro
Date de publication :
2017-04-17
ISSN :
1591-0199
Mot(s)-clé(s) en anglais :
Intracranial aneurysms
recanalization
coiling
endovascular treatment
recanalization
coiling
endovascular treatment
Discipline(s) HAL :
Sciences du Vivant [q-bio]/Neurosciences [q-bio.NC]
Résumé en anglais : [en]
Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life ...
Lire la suite >Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life routine clinical practice. Methods A total of 167 patients with 167 aneurysms (39.1% ruptured) were enrolled in the prospective TRULINE study. The primary endpoint was the safety, assessed by the combined morbidity-mortality rate observed since the time of the procedure and up to one-year follow-up. For safety, primary analyses were performed on intent-to-treat population (attempted coils procedure) and all adverse events have been reviewed by an independent Data Safety Monitoring Board. For efficacy, primary analyses were performed on the per-protocol population (patients treated with more than 70% of Trufill coils and not retreated during the follow-up period) and an independent core laboratory evaluated angiographic results. Results At one-year post-procedure, neurologic impairment was observed in 6.5% (95% confidence interval: 3.5-11.8) of the patients, and 2.6% (95% confidence interval: 1.0-6.8) had a permanent neurological deterioration. Three deaths were observed, unrelated to the procedure or coils. At one year, complete occlusion was seen in 52 aneurysms (54.2%), neck remnant in 28 aneurysms (29.2%), and aneurysm remnant in 16 aneurysms (16.7%). During the one-year follow-up, the overall incidence of recurrence was 30.2% with a mean interval of 13.8 ± 4.5 months and the retreatment for major recanalization was needed in nine patients (6.3%). Conclusions The TRULINE study confirms that endovascular coiling with Trufill DCS Orbit and Orbit Galaxy detachable coils is safe and effective.Lire moins >
Lire la suite >Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life routine clinical practice. Methods A total of 167 patients with 167 aneurysms (39.1% ruptured) were enrolled in the prospective TRULINE study. The primary endpoint was the safety, assessed by the combined morbidity-mortality rate observed since the time of the procedure and up to one-year follow-up. For safety, primary analyses were performed on intent-to-treat population (attempted coils procedure) and all adverse events have been reviewed by an independent Data Safety Monitoring Board. For efficacy, primary analyses were performed on the per-protocol population (patients treated with more than 70% of Trufill coils and not retreated during the follow-up period) and an independent core laboratory evaluated angiographic results. Results At one-year post-procedure, neurologic impairment was observed in 6.5% (95% confidence interval: 3.5-11.8) of the patients, and 2.6% (95% confidence interval: 1.0-6.8) had a permanent neurological deterioration. Three deaths were observed, unrelated to the procedure or coils. At one year, complete occlusion was seen in 52 aneurysms (54.2%), neck remnant in 28 aneurysms (29.2%), and aneurysm remnant in 16 aneurysms (16.7%). During the one-year follow-up, the overall incidence of recurrence was 30.2% with a mean interval of 13.8 ± 4.5 months and the retreatment for major recanalization was needed in nine patients (6.3%). Conclusions The TRULINE study confirms that endovascular coiling with Trufill DCS Orbit and Orbit Galaxy detachable coils is safe and effective.Lire moins >
Langue :
Anglais
Vulgarisation :
Non
Source :