Whether the large effect size of endovascular thrombectomy (EVT) for stroke due to large-vessel occlusion applies to stroke due to medium-vessel occlusion is unclear. In a multicenter, prospective, randomized, open-label trial with blinded outcome evaluation, we assigned patients with acute ischemic stroke due to medium-vessel occlusion who presented within 12 hours from the time that they were last known to be well and who had favorable baseline noninvasive brain imaging to receive EVT plus usual care or usual care alone. The primary outcome was the modified Rankin scale score (range, 0 [no symptoms] to 6 [death]) at 90 days, reported as the percentage of patients with a score of 0 or 1. A total of 530 patients from five countries were enrolled between April 2022 and June 2024, with 255 patients assigned to the EVT group and 275 to the usual-care group. Most patients (84.7%) had primary occlusions in a middle-cerebral-artery branch. A modified Rankin scale score of 0 or 1 at 90 days occurred in 106 of 255 patients (41.6%) in the EVT group and in 118 of 274 (43.1%) in the usual-care group (adjusted rate ratio, 0.95; 95% confidence interval [CI], 0.79 to 1.15; P = 0.61). Mortality at 90 days was 13.3% in the EVT group and 8.4% in the usual-care group (adjusted hazard ratio, 1.82; 95% CI, 1.06 to 3.12). Symptomatic intracranial hemorrhage occurred in 14 of 257 patients (5.4%) in the EVT group and in 6 of 272 (2.2%) in the usual-care group. Endovascular treatment for acute ischemic stroke due to medium-vessel occlusion within 12 hours did not lead to better outcomes at 90 days than usual care. (Funded by the Canadian Institutes for Health Research and Medtronic; ESCAPE-MeVO ClinicalTrials.gov number, NCT05151172.).
Background: Endovascular embolization is an effective treatment option for cerebral arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs). A variety of liquid embolic agents have been and are currently used for embolization of AVMs and DAVFs. Knowledge of the special properties of the agent which is used is crucial for an effective and safe embolization procedure. Material and Methods: This article describes the properties and indications of the liquid embolic agents which are currently available: cyanoacrylates (also called glues), and the copolymers Onyx, Squid and PHIL, as well as their respective subtypes. Results: Cyanoacrylates were the predominantly used agents in the 1980s and 1990s. They are currently still used in specific situations, for example for the occlusion of macro-shunts, for the pressure cooker technique or in cases in which microcatheters are used that are not compatible with dimethyl-sulfoxide. The first broadly used copolymer-based embolic agent Onyx benefits from a large amount of available experience and data, which demonstrated its safety and efficacy in the treatment of cerebral vascular malformations, while its drawbacks include temporary loss of visibility during longer injections and artifacts in cross-sectional imaging. The more recently introduced agents Squid and PHIL aim to overcome these shortcomings and to improve the success rate of endovascular embolization. Novelties of these newer agents with potential advantages include extra-low viscosity versions, more stable visibility, and a lower degree of imaging artifacts. Conclusion: All the available liquid embolic agents feature specific potential advantages and disadvantages over each other. The choice of the most appropriate embolic agent must be made based on the specific material characteristics of the agent, related to the specific anatomical characteristics of the target pathology.
BACKGROUND AND PURPOSE: Embolization plays a key role in the treatment of arteriovenous malformations. The aim of this study was to evaluate an established (Onyx) and a novel (precipitating hydrophobic injectable liquid [PHIL]) liquid embolic agent in an in vitro AVM model. MATERIALS AND METHODS: An AVM model was integrated into a circuit system. The artificial nidus (subdivided into 28 honeycomb-like sections) was embolized with Onyx 18 (group Onyx; n = 8) or PHIL 25 (group PHIL; n = 8) with different pause times between the injections (30 and 60 seconds, n = 4 per study group) by using a 1.3F microcatheter. Procedure times, number of injections, embolization success (defined as the number of filled sections of the artificial nidus), volume of embolic agent, and frequency and extent of reflux and draining vein embolization were assessed. RESULTS: Embolization success was comparable between Onyx and PHIL. Shorter pause times resulted in a significantly higher embolization success for PHIL (median embolization score, 28 versus 18; P = .011). Compared with Onyx, lower volumes of PHIL were required for the same extent of embolization (median volume per section of the artificial nidus, 15.5 versus 3.6 μL; P < .001). CONCLUSIONS: While the embolization success was comparable for Onyx and PHIL, pause time had a considerable effect on the embolization success in an in vitro AVM model. Compared with Onyx, lower volumes of PHIL were required for the same extent of embolization.
30 March 2023 in American Journal of Neuroradiology
BACKGROUND AND PURPOSE: Flow diverters with antithrombotic coatings are increasingly used to improve the safety of flow diverter treatments of intracranial aneurysms. This study aimed to investigate the safety and short-term efficacy of the new FRED X flow diverter. MATERIALS AND METHODS: Medical charts and procedural and imaging data of a consecutive series of patients with intracranial aneurysms who were treated with the FRED X at 9 international neurovascular centers were retrospectively analyzed. RESULTS: One hundred sixty-one patients (77.6% women; mean age, 55 years) with 184 aneurysms (11.2% acutely ruptured) were included in this study. Most aneurysms were located in the anterior circulation (77.0%), most frequently at the ICA (72.7%). The FRED X was successfully implanted in all procedures. Additional coiling was performed in 29.8%. In-stent balloon angioplasty was necessary in 2.5%. The rate of major adverse events was 3.1%. Thrombotic events occurred in 7 patients (4.3%) with 4 intra- and 4 postprocedural in-stent thromboses, respectively (1 patient had both peri- and postprocedural thrombosis). Of these thrombotic events, only 2 (1.2%) led to major adverse events (ischemic strokes). Postinterventional neurologic morbidity and mortality were observed in 1.9% and 1.2%, respectively. The rate of complete aneurysm occlusion after a mean follow-up of 7.0 months was 66.0%. CONCLUSIONS: The new FRED X is a safe and feasible device for aneurysm treatment. In this retrospective multicenter study, the rate of thrombotic complications was low, and the short-term occlusion rates are satisfactory.
A frequently reported drawback of ethylene vinyl alcohol copolymer-based liquid embolic agents is the production of artifacts in diagnostic imaging. New embolic agents, such as Precipitating hydrophobic injectable liquid (PHIL; MicroVention, Tustin, CA, USA), are supposed to induce significantly fewer artifacts. The purpose of this study is to assess the degree of artifacts induced by the liquid embolic agents Onyx (Medtronic Neurovascular, Irvine, CA, USA) and PHIL in conventional computed tomography (CT), cone-beam CT and magnetic resonance imaging (MRI) in an experimental in vivo model. In 10 pigs the rete mirabile was embolized with Onyx (n = 5) or PHIL (n = 5). After embolization, conventional CT, cone-beam CT and MRI were performed. The degree of artifacts was graded qualitatively (five-point scale; for CT and MRI) and quantitatively (HUs of well-defined regions of interest (ROIs); for CT only). Artifacts were significantly more severe for Onyx both in the qualitative (e.g. conventional CT: 2 versus 5 (medians); p = 0.008) and in the quantitative image analysis (e.g. cone-beam CT: standard deviation of a ROI near to the embolic agent cast, 94 HU versus 38 HU (medians); p = 0.008). Neither Onyx nor PHIL produced any apparent artifacts in MRI. PHIL produces fewer artifacts than Onyx in conventional CT and cone-beam CT in an experimental in vivo model.
16 June 2020 in Journal of NeuroInterventional Surgery
Background Balloon-assisted techniques can improve the endovascular treatment of cerebrospinal vascular malformations. The aim of this study was to report the first clinical multicenter experience with the new Scepter Mini dual-lumen microballoon catheter. Methods Patients with cerebral or spinal vascular malformations treated with the Scepter Mini at seven European neurovascular centers were retrospectively reviewed. Clinical data, angiographic features of the vascular malformations, procedural parameters including the type of application, navigability, technical failures, complications and embolization success were assessed. Results The usage of 34 Scepter Mini microballoon catheters in 20 patients was analyzed. Most treated malformations (80.0%) were cerebral arteriovenous malformations. Four different applications were reported: embolization via Scepter Mini (n=23, 67.6%), balloon-occlusion with simultaneous embolization via a second microcatheter (n=3, 8.8%), diagnostic angiography with simultaneous balloon-inflation for flow arrest (n=4, 11.8%), and navigation support (n=4, 11.8%). The mean diameter of the blood vessels in which the Scepter Mini was inflated was 1.9±0.5 mm. The navigability of the Scepter Mini was rated as ‘easy’ or ‘very easy’ in 88.2% of cases. Complete occlusion of the malformation was achieved in 60.9% of cases. Technical failures occurred in 4/23 embolization procedures, and all were related to insufficient stability of the balloon within the vessel. No complications related to the Scepter Mini were observed, while unrelated complications occurred in three patients (15.0%). Conclusions The Scepter Mini is a promising new device for balloon-assisted embolization of cerebrospinal vascular malformations via small feeders. Beyond embolization, the Scepter Mini can also be used for other applications, such as superselective flow arrest and navigation support.