1. Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study
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Florent Gariel, Gaultier Marnat, Xavier Barreau, Patrice Menegon, Romain Bourcier, Laurent Pierot, Lauren Spelle, Alain Bonafé, Francis Turjman, Benjamin Gory, Jérôme Berge, Vincent Costalat, Gregory Gascou, Cyril Dargazanli, Sébastien Soize, Georges Metaxas, Jacques Moret, Léon Ikka, Jildaz Caroff, Aymeric Rouchaud, Christian Mihaela, Nidal Benachour, Michel Piotin, Raphaël Blanc, Hocine Redjem, Elisa Pomero, Alessandra Biondi, Christophe Cognard, Anne-Christine Januel, Jean Darcourt, Adrien Guenego, Philippe Tall, Fabrice Bonneville, Charbel Mounayer, Suzana Saleme, Nader Sourour, Frédéric Clarençon, Charlotte Barbier, Denis Herbreteau, Ana-Paula Narata, Richard Bibi, Serge Bracard, René Anxionnat, Anne-Laure Derelle, Romain Tonnelet, Liang Liao, Emmanuel Chabert, Hervé Brunel, Frederic Ricolfi, Hubert Desal, Zsolt Kulcsar, Christian Taschner, Département de Neuro-Radiologie [Bordeaux] (DNR - Bordeaux), CHU Bordeaux [Bordeaux], Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire de Reims (CHU Reims), Service de Neuroradiologie [CHU de Bicêtre], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Neuroradiologie [Hôpital Gui de Chauliac], Hôpital Gui de Chauliac [Montpellier], Service de neuroradiologie [Lyon], Hôpital neurologique et neurochirurgical Pierre Wertheimer [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Département de neuroradiologie diagnostique et thérapeutique [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Neuroradiologie Diagnostique et Thérapeutique [Toulouse], Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Service de Neuroradiologie interventionnelle [CHU Limoges], CHU Limoges, Service de Neuroradiologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Départment de Neuroradiologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de neuroradiologie [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Clermont-Ferrand, Service de neuroradiologie diagnostique et interventionnelle, Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Service de neuroradiologie, imagerie des urgences [CHU de Dijon], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), University hospital of Zurich [Zurich], University Hospital Freiburg, Université de Lorraine (UL)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), and DIVERSION investigators: Vincent Costalat , Gregory Gascou , Cyril Dargazanli, Sébastien Soize, Georges Metaxas, Jacques Moret , Léon Ikka, Jildaz Caroff, Aymeric Rouchaud, Christian Mihaela, Nidal Benachour, Michel Piotin, Raphaël Blanc, Hocine Redjem, Elisa Pomero , Alessandra Biondi, Christophe Cognard, Anne-Christine Januel, Jean Darcourt, Adrien Guenego, Philippe Tall, Fabrice Bonneville , Charbel Mounayer , Suzana Saleme, Nader Sourour, Frédéric Clarençon, Charlotte Barbier, Denis Herbreteau, Ana-Paula Narata, Richard Bibi , Serge Bracard , René Anxionnat , Anne-Laure Derelle, Romain Tonnelet, Liang Liao , Emmanuel Chabert , Hervé Brunel, Frederic Ricolfi, Hubert Desal, Zsolt Kulcsar, Christian Taschner
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Adult ,medicine.medical_specialty ,medicine.medical_treatment ,Silk ,Subgroup analysis ,[SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Aneurysm ,Occlusion ,[INFO.INFO-IM]Computer Science [cs]/Medical Imaging ,medicine ,Humans ,Endovascular treatment ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Prospective cohort study ,Survival rate ,ComputingMilieux_MISCELLANEOUS ,Aged ,Retrospective Studies ,Flow diverter ,Radiological and Ultrasound Technology ,business.industry ,Endovascular Procedures ,Flow diversion ,Stent ,Intracranial Aneurysm ,Middle Aged ,medicine.disease ,Confidence interval ,3. Good health ,Surgery ,Treatment Outcome ,Stents ,Neurology (clinical) ,Intracranial aneurysms ,business ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,030217 neurology & neurosurgery - Abstract
Background and purpose Flow diverters are considered as an essential tool in the stent-based treatment of complex intracranial aneurysms. We report here a subgroup analysis of the nationwide prospective DIVERSION study to investigate the safety and efficacy of the Silk flow diverter at 12 months follow-up. Methods We performed a subgroup analysis of patients included in the DIVERSION, a national prospective cohort study including all flow diverters placement between 2012 and 2014 in France, and treated with the Silk. The primary outcome was the morbi-mortality at 12 months, including death, morbidity event and aneurysm retreatment within 12 months post-treatment. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran's scale by an independent imaging core laboratory during follow-up. Results A total of 102 procedures involving 101 patients (mean age ± standard deviation, 54.3 ± 13.5 years) harbouring 118 aneurysms (113/118 located in the anterior circulation; mean size 8.2 ± 7.1 mm) were included. During the 12-month follow-up, 34 (33.3%) procedures experienced at least one morbi-mortality event: 3 deaths, 27 morbidity events and 4 retreatments. Overall, 1/3 deaths and 10/27 morbidity events were related to the device and/or the procedure, leading to a specific survival rate and a specific free-morbidity survival rate at 12 months of 98.98% [95% confidence interval, 92.98%–99.86%] and 89.73% [95%CI, 81.71%–94.36%], respectively. The rate of permanent-related neurological deficit was 5.9% within 12 months. One year follow-up imaging showed satisfactory occlusion in 82.2% of cases. Conclusion Flow diversion with the Silk device has a reasonable safety and effectiveness profile for the endovascular treatment of intracranial aneurysms.
- Published
- 2021
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