Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study |
| |
Authors: | Florent Gariel Gaultier Marnat Xavier Barreau Patrice Menegon Romain Bourcier Laurent Pierot Lauren Spelle Alain Bonafé Francis Turjman Benjamin Gory Jérôme Berge |
| |
Institution: | 9. Department of Neuroradiology, Hôpital Gui-de-Chauliac, 34295 Montpellier, France;10. Department of Neuroradiology, CHU of Reims, 51092 Reims, France;11. Department of Interventional Neuroradiology, CHU of Bicêtre, 94270 Le Kremlin-Bicêtre, France;12. Interventional Neuroradiology Department, Rothschild Foundation Hospital, 75019 Paris, France;13. Department of Interventional Neuroradiology, Jean-Minjoz University Hospital, 25030 Besançon, France;14. Neuroradiology Department, Toulouse University Hospital, 31300 Toulouse, France;15. Department of Interventional Neuroradiology, CHU of Limoges, 87042 Limoges, France;p. Department of Neuroradiology, Pitié-Salpêtrière Hospital, 75013 Paris, France;q. Department of Neuroradiology, CHU of Caen, 14000 Caen, France;r. Department of Neuroradiology, CHU of Tours, 37032 Tours, France;s. Department of Diagnostic and Therapeutic Neuroradiology, 54000 Nancy, France;t. Department of Neuroradiology, CHU of Clermont-Ferrand, 63000 Clermont-Ferrand, France;u. Department of Neuroradiology, CHU of Marseille, 13005 Marseille, France;v. Department of Neuroradiology, CHU of Dijon, 21079 Dijon, France;w. Department of Neuroradiology, CHU of Nantes, 44093 Nantes, France;x. Department of Neuroradiology, University Hospital of Zurich, Zurich, Switzerland;y. Department of Neuroradiology, Medical Centre-University of Freiburg, Freiburg, Germany;1. Department of Neuroradiology, University Hospital of Bordeaux, Bordeaux, France;2. Department of Neuroradiology, University Hospital of Nantes, Nantes, France;3. Department of Neuroradiology, CHU of Reims, Reims, France;4. Department of Interventional Neuroradiology, CHU of Bicêtre, Le Kremlin-Bicêtre, France;5. Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier, France;6. Department of Interventional Neuroradiology, Hospices Civils de Lyon, Lyon, France;7. Department of Diagnostic and Therapeutic Neuroradiology, Université de Lorraine, CHRU of Nancy, 54000 Nancy, France;8. Université de Lorraine, IADI, INSERM U1254, 54000 Nancy, France |
| |
Abstract: | Background and purposeFlow 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.MethodsWe 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.ResultsA 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.ConclusionFlow diversion with the Silk device has a reasonable safety and effectiveness profile for the endovascular treatment of intracranial aneurysms. |
| |
Keywords: | Intracranial aneurysms Endovascular treatment Flow diversion Flow diverter Silk DSMB"} {"#name":"keyword" "$":{"id":"kw0035"} "$$":[{"#name":"text" "_":"Data Safety and Monitoring Board FD"} {"#name":"keyword" "$":{"id":"kw0045"} "$$":[{"#name":"text" "_":"Flow Diverter mRS"} {"#name":"keyword" "$":{"id":"kw0055"} "$$":[{"#name":"text" "_":"modified Rankin Scale |
本文献已被 ScienceDirect 等数据库收录! |
|