EditorialSafety and efficacy of flow-diverter stents in endovascular treatment of intracranial aneurysm: Interest of the prospective DIVERSION observational study
Section snippets
The DIVERSION study
In this context, the French Society of Neuroradiology in collaboration with the French National regulatory Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé – ANSM) have set up in 2012 the DIVERSION study, a prospective, consecutive, observational study conducted in 34 French centers (Table 1). The aim of this study was to evaluate the feasibility, safety and efficacy of FDS for the endovascular treatment of IA at 12
Objectives and collected data
The primary outcome is defined as the morbi-mortality rate at 12 months of treatment by FDS. Permanent morbidity is defined as a mRS ≥ 2.
The secondary outcomes are feasibility, procedural complications, and short- (1 month), mid- (3–6 months) and long-term (12 months) anatomical and clinical results.
All reported serious adverse events will be analyzed by an independant data safety and monitoring board (DSMB) composed of one neurologist, one neurosurgeon, one methodologist and one
Description of procedures included during the first year of DIVERSION
During the first 12 months of the study, 283 procedures with FDS were reported by 19 (56%) centers. To date, the data have been completed for 235 of these procedures, corresponding to 272 aneurysms (222 with intradural location and 50 extradural) treated with 321 FDS.
One hundred and seventy-two aneurysms (63%) were treated with the Pipeline Embolization Device ([PED], EV3, Irvine, CA), 77 (28%) with the Silk device (Balt, Montmorency, France), 16 (6%) with the FRED device (Microvention, Tustin,
Conclusion
Although safety and efficacy of FDS were reported in small single center-series, there is a current need for more precise information. The absence of randomized controlled trial assessing FDS did not diminish the interest of clinicians, and these devices are increasingly used based on a high efficacy and the possibility to treat large aneurysms with satisfactory results.
In 2010, the occurrence of serious adverse events has led the French and other National Regulatory Agencies to closely
Disclosure of interest
Benjamin Gory, François Chapuis, Saadia Embarek and Laure Huot declare they have no conflicts of interests concerning this article.
Francis Turjman is consultant for Balt, Covidien, and Codman.
Alain Bonafé is consultant for Covidien, Stryker Neurovascular and Codman.
Laurent Pierot is consultant for Balt, Stryker Neurovascular, Covidien and Microvention.
Laurent Spelle is consultant for Stryker Neurovascular, Covidien and Sequent Medical.
Jérome Berge is consultant for Penumbra.
Zsolt Kulcsar acts
References (24)
- et al.
Risk of recurrent subarachnoid haemorrhage, death, or dependence and standardised mortality ratios after clipping or coiling of an intracranial aneurysm in the international subarachnoid aneurysm trial (ISAT): long-term follow-up
Lancet Neurol
(2009) Flow diverter stents in the treatment of intracranial aneurysms: where are we?
J Neuroradiol
(2011)- et al.
Postmarket evaluation of breakthrough technologies
Am Heart J
(2008) - et al.
International subarachnoid aneurysm trial (ISAT) collaborative group: international subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial
Lancet
(2002) - et al.
Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils
Stroke
(2003) - et al.
Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT)
Stroke
(2007) - et al.
Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the Budapest experience with the Pipeline Embolization Device
AJNR Am J Neuroradiol
(2010) - et al.
Flow-diverter stent for the endovascular treatment of intracranial aneurysms. A prospective study in 29 patients with 34 aneurysms
Stroke
(2010) - et al.
Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis
Stroke
(2013) - et al.
Curative endovascular reconstruction of cerebral aneurysms with the pipeline embolization device: the Buenos Aires experience
Neurosurgery
(2009)
Flow-diverter silk stent for the treatment of intracranial aneurysms: 1-year follow-up in a multicenter study
AJNR Am J Neuroradiol
Early experience in the treatment of intracranial aneurysms by endovascular flow diversion: a multicentre prospective study
PLoS One
Cited by (16)
Safety and efficacy of the Silk flow diverter: Insight from the DIVERSION prospective cohort study
2021, Journal of NeuroradiologyCitation Excerpt :Our study is an ancillary analysis of the DIVERSION study. DIVERSION was a national prospective observational cohort study including all patients, aged 18 years or older, treated with a flow diverter in routine practice in a French neuroradiology centre from October 9, 2012 to February 7, 2014 [3,4] The study protocol and the consent form were approved by the French National Data Protection Commission (Commission Nationale de l’Informatique et des Libertés; CNIL). According to French laws, written informed consent was obtained from all patients.
Relationships and redundancies of selected hemodynamic and structural parameters for characterizing virtual treatment of cerebral aneurysms with flow diverter devices
2016, Journal of BiomechanicsCitation Excerpt :Endovascular treatment utilizing flow diverting devices (FDD) has recently been introduced for cerebral aneurysms (Arrese et al., 2013; Berge et al., 2012; De Vries et al., 2013; Gory et al., 2014; Murthy et al., 2014; Puffer et al., 2014; Takemoto et al., 2014; Zhou et al., 2014).
A new endovascular technique for small anterior choroidal artery aneurysms. A consecutive series using the 3-catheter-protective technique
2016, Journal of NeuroradiologyCitation Excerpt :An alternative endovascular solution for unruptured AChA aneurysms might be to place a so-called flow diverter stent in the ICA which may be technically less challenging. Covering the AChA with such stents is well described, but this has occasionally been associated with AChA occlusion [10] and delayed aneurysm rupture [11]. In the event that the aneurysm might not thrombose and shrink, it might be difficult or impossible to re-access the aneurysm due to the high mesh density of these stents.
Understanding flow patterns and inflammatory status in intracranial aneurysms: Towards a personalized medicine
2016, Journal of NeuroradiologyCitation Excerpt :Hemorrhagic ruptures most often occur on these organized atherosclerotic plaques covering the aortic wall. Comparison must be made carefully with thrombosis occurring spontaneously in the aneurysmal sac in the brain, especially in giant aneurysms and frequently after endovascular treatment by coils or implantation of a flow-diverter stent [29]. There are three stages of severity of this inflammation within the aneurysmal wall: an initial asymptomatic stage that is characterized by a simple circumferential parietal contrast enhancement, which has recently been proven to increase the potential risk of rupture [30]; a potentially symptomatic stage associated with clinical signs of compression and a high T2 Flair MRI signal, indicating a reversible vasogenic edema [18]; and the ultimate degradation of the support structure with cell lysis and potential rupture of the wall leading to SAH.
Differences in tissue proliferation and maturation between Matrix2 and bare platinum coil embolization in experimental swine aneurysms
2016, Journal of NeuroradiologyCitation Excerpt :We have developed a new swine terminal-type aneurysm model that maintains its patency for 3 months [9], which we intend to use for mid- and long-term studies. Moreover, several endovascular approaches are now available for the treatment of intracranial aneurysms, including standard coiling, balloon-assisted coiling, stent-assisted coiling, and flow diversion [20–22]. We are also mindful that consideration should be given to establishing the influence of these device choices on endothelialization of wide neck-type and low packing attenuation aneurysms.
Highly specialized neuroradiology
2015, Journal of Neuroradiology