Strategies for embolization of direct arteriovenous shunts in brain arteriovenous malformations

Intranidal direct arteriovenous (AV) shunts are rarely observed in brain arteriovenous malformations (bAVMs).1 The endovascular treatment of such direct AV shunts may be challenging. Indeed, there is a significant risk of venous migration of the embolic agent used to occlude the AV shunt, leading to a subsequent risk of nidus bleeding due to impairment (slowdown or even occlusion) of the bAVM’s venous drainage.2 Various endovascular techniques have been developed to avoid the risk of such inopportune impairment of the venous drainage during attempts to occlude a direct intranidal AV shunt.3–5 We present in this Technical Video (video 1) different endovascular strategies to occlude such direct AV shunts using dual-lumen balloons with various liquid embolic agents, or using occlusion plugs.Video 1</jats:p

Results of watchful waiting of unruptured intracranial aneurysms in a Western patient population: a single-center cohort

BackgroundThe natural history of unruptured intracranial aneurysms (UIAs) in Western populations is still debated, especially for those &lt;7 mm. Reporting data of a large single-center cohort managed with watchful waiting is therefore interesting.MethodsFrom January 2011 to June 2019, 662 UIAs were followed up by yearly MR angiography. Morphologically stable UIAs were managed conservatively while unstable UIAs were offered treatment. The patients’ clinical and radiological data were analyzed retrospectively.ResultsUIAs were ≤4 mm in 60%, 4.1–7.0 mm in 33%, and &gt;7 mm in 7%. They were located on the anterior circulation in 90% of cases. The mean follow-up duration was 51.32 months for a total of 2831 aneurysm-years. During follow-up, 37 UIAs (5.5%) were treated because of an increase in size, and 8 UIAs were treated because of patient decision. Three aneurysms ruptured during follow-up for an annual risk of rupture of 0.1% (95% CI 0% to 0.24%). No risk factors for rupture were identified. The three ruptured cases made an excellent recovery. During follow-up, annual mortality from unrelated causes was 0.8% (95% CI 0.51% to 1.18%).ConclusionsThis single-center cohort evaluated our watchful waiting policy applied in two-thirds of all incidental UIAs. Morphological change of UIAs during follow-up led to treatment in 5.5% of cases. With such a management paradigm, we found a low rupture rate in these selected UIAs and the mortality was unrelated to aneurysms.</jats:sec

Impact of Number of Passes Before Rescue Therapy in Thrombectomy for Basilar Artery Strokes

Background When standard endovascular thrombectomy techniques fail to achieve a successful recanalization, it is often necessary to use rescue therapies (RTs). RTs are more commonly used in basilar artery occlusions and conventionally thought to represent “a last resort option.” We sought to study the outcomes of basilar artery occlusion patients who received RT, and further hypothesize that the number of instrumental passes before initiation of RT may be associated with increased risk for poor clinical outcomes. Methods We performed a retrospective analysis of the ETIS (“Endovascular Treatment in Ischemic Stroke”) registry. Our primary analysis included 277 patients who underwent thrombectomy for basilar artery occlusion, of whom 74 patients (26.7%) who received RT, defined as the use of intra‐arterial drugs, angioplasty, or stenting. Primary outcome measures included successful or complete reperfusion (final modified thrombolysis in cerebral infarction ≥2b or 3), functional independence (modified Rankin scale of 0–2), and mortality at 3 months. Results RT patients were more likely to have an atherosclerotic cause than non‐RT patients (46/74 [62.2%] versus 38/203 [18.7%]), were more likely to die (42/74 [56.8%] versus 73/203 [36.0%]), and were less likely to achieve functional independence (12/74 [16.2%] versus 84/203 [41.4%]). In the RT cohort, 17 of 74 patients (23.0%) had 1 pass before RT initiation, and 8 of 17 (47.1%) achieved a modified Rankin scale score of 0 to 2 at 3 months, with a mortality rate of 23.5% (4/17). The chance of achieving good clinical outcome decreased with each additional pass, whereas mortality increased. The odds of mortality at 3 months were highest in the >3 passes group, with an odds ratio of 10.29 (95% CI, 2.42–43.81) compared with 1 pass. None of the 25 patients with >3 passes before RT achieved 3‐month functional independence. Conclusions There is a significant correlation between the number of passes before initiation of RT and 3‐month clinical outcomes in basilar artery occlusion patients

Impact of Number of Passes Before Rescue Therapy in Thrombectomy for Basilar Artery Strokes

Background When standard endovascular thrombectomy techniques fail to achieve a successful recanalization, it is often necessary to use rescue therapies (RTs). RTs are more commonly used in basilar artery occlusions and conventionally thought to represent “a last resort option.” We sought to study the outcomes of basilar artery occlusion patients who received RT, and further hypothesize that the number of instrumental passes before initiation of RT may be associated with increased risk for poor clinical outcomes. Methods We performed a retrospective analysis of the ETIS (“Endovascular Treatment in Ischemic Stroke”) registry. Our primary analysis included 277 patients who underwent thrombectomy for basilar artery occlusion, of whom 74 patients (26.7%) who received RT, defined as the use of intra‐arterial drugs, angioplasty, or stenting. Primary outcome measures included successful or complete reperfusion (final modified thrombolysis in cerebral infarction ≥2b or 3), functional independence (modified Rankin scale of 0–2), and mortality at 3 months. Results RT patients were more likely to have an atherosclerotic cause than non‐RT patients (46/74 [62.2%] versus 38/203 [18.7%]), were more likely to die (42/74 [56.8%] versus 73/203 [36.0%]), and were less likely to achieve functional independence (12/74 [16.2%] versus 84/203 [41.4%]). In the RT cohort, 17 of 74 patients (23.0%) had 1 pass before RT initiation, and 8 of 17 (47.1%) achieved a modified Rankin scale score of 0 to 2 at 3 months, with a mortality rate of 23.5% (4/17). The chance of achieving good clinical outcome decreased with each additional pass, whereas mortality increased. The odds of mortality at 3 months were highest in the &gt;3 passes group, with an odds ratio of 10.29 (95% CI, 2.42–43.81) compared with 1 pass. None of the 25 patients with &gt;3 passes before RT achieved 3‐month functional independence. Conclusions There is a significant correlation between the number of passes before initiation of RT and 3‐month clinical outcomes in basilar artery occlusion patients. </jats:sec

Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study

International audienceBackground: The way that pain is assessed in the PACU could impact on postoperative pain and analgesic consumption. However, there is currently no evidence to support this speculation. The authors hypothesised that using a comfort scale reduces postoperative opioid consumption when compared with a standard numerical rating scale (NRS) to evaluate pain in the PACU.Methods: In this cluster-randomised trial, patients were assessed using either a comfort scale (comfort group) or a pain NRS (NRS group). The primary outcome was the opioid consumption in the PACU. The main secondary outcomes were postoperative pain, nausea and vomiting, length of stay in the PACU, and satisfaction.Results: Of 885 randomised patients, 860 were included in the analysis. Opioid consumption in the PACU was comparable in the comfort and NRS groups (median [interquartile range [IQR] 0 (0-5) vs 0 (0-6); P=0.2436), irrespective of the type of surgical procedure. The majority of patients did not need any postoperative opioid (59% in the comfort group and 56% in the NRS group, P=0.2260). There was no difference in postoperative pain, nausea and vomiting, time to reach an Aldrete score ≥9 after extubation, and global satisfaction.Conclusions: Using a comfort scale to assess pain in the PACU did not spare any opioid compared with use of a standard NRS. Further studies focusing on patients at risk of increased postoperative opioid consumption are necessary.Clinical trial registration: NCT05234216

Abstract P533: Incidence and Outcomes of Thrombectomy Rescue Therapies in Acute Basilar Artery Occlusions

Background: Hematoma expansion (HE) is an important therapeutic target in intracerebral hemorrhage. Recently proposed HE definitions have not been validated, and no previous definition has accounted for withdrawal of care (WOC). Objective: To compare conventional and revised definitions of hematoma expansion (HE), while accounting for WOC. Methods: We analyzed data from the ATACH-2 trial, comparing revised definitions of HE incorporating intraventricular hemorrhage (IVH) expansion to the conventional definition of “≥6 mL or ≥33%”. The primary outcome was modified Rankin Scale of 4-6 at 90-days. We calculated the incidence, sensitivity, specificity, positive and negative predictive values, and c- statistic for all definitions of HE. Definitions were compared using non-parametric methods. Secondary analyses were performed after removing patients who experienced WOC. Results: Primary analysis included 948 patients. Using the conventional definition, the sensitivity was 37.1% and specificity was 83.2% for the primary outcome. Sensitivity improved with all three revised definitions (53.3%, 48.7%, and 45.3%, respectively), with minimal change to specificity (78.4%, 80.5%, and 81.0%, respectively). The greatest improvement was seen with the definition “≥6 mL or ≥33% or any IVH”, with increased c -statistic from 60.2% to 65.9% (p &lt; 0.001). Secondary analysis excluded 46 participants who experienced WOC. The revised definitions outperformed the conventional definition in this population as well, with the greatest improvement in c -statistic using “≥6 mL or ≥33% or any IVH” (58.1% vs 64.1%, p &lt; 0.001). Conclusions: HE definitions incorporating intraventricular expansion outperformed conventional definitions for predicting poor outcome, even after accounting for care limitations. </jats:p

Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study

International audienceBackground: The way that pain is assessed in the PACU could impact on postoperative pain and analgesic consumption. However, there is currently no evidence to support this speculation. The authors hypothesised that using a comfort scale reduces postoperative opioid consumption when compared with a standard numerical rating scale (NRS) to evaluate pain in the PACU.Methods: In this cluster-randomised trial, patients were assessed using either a comfort scale (comfort group) or a pain NRS (NRS group). The primary outcome was the opioid consumption in the PACU. The main secondary outcomes were postoperative pain, nausea and vomiting, length of stay in the PACU, and satisfaction.Results: Of 885 randomised patients, 860 were included in the analysis. Opioid consumption in the PACU was comparable in the comfort and NRS groups (median [interquartile range [IQR] 0 (0-5) vs 0 (0-6); P=0.2436), irrespective of the type of surgical procedure. The majority of patients did not need any postoperative opioid (59% in the comfort group and 56% in the NRS group, P=0.2260). There was no difference in postoperative pain, nausea and vomiting, time to reach an Aldrete score ≥9 after extubation, and global satisfaction.Conclusions: Using a comfort scale to assess pain in the PACU did not spare any opioid compared with use of a standard NRS. Further studies focusing on patients at risk of increased postoperative opioid consumption are necessary.Clinical trial registration: NCT05234216

Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study

International audienceBackground: The way that pain is assessed in the PACU could impact on postoperative pain and analgesic consumption. However, there is currently no evidence to support this speculation. The authors hypothesised that using a comfort scale reduces postoperative opioid consumption when compared with a standard numerical rating scale (NRS) to evaluate pain in the PACU.Methods: In this cluster-randomised trial, patients were assessed using either a comfort scale (comfort group) or a pain NRS (NRS group). The primary outcome was the opioid consumption in the PACU. The main secondary outcomes were postoperative pain, nausea and vomiting, length of stay in the PACU, and satisfaction.Results: Of 885 randomised patients, 860 were included in the analysis. Opioid consumption in the PACU was comparable in the comfort and NRS groups (median [interquartile range [IQR] 0 (0-5) vs 0 (0-6); P=0.2436), irrespective of the type of surgical procedure. The majority of patients did not need any postoperative opioid (59% in the comfort group and 56% in the NRS group, P=0.2260). There was no difference in postoperative pain, nausea and vomiting, time to reach an Aldrete score ≥9 after extubation, and global satisfaction.Conclusions: Using a comfort scale to assess pain in the PACU did not spare any opioid compared with use of a standard NRS. Further studies focusing on patients at risk of increased postoperative opioid consumption are necessary.Clinical trial registration: NCT05234216

Development of extracellular vesicle-based medicinal products: A position paper of the group “Extracellular Vesicle translatiOn to clinicaL perspectiVEs – EVOLVE France”

International audienceExtracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes Committee from the ISCT are expected to contribute in an active way to the development of EV-based medicinal products by providing update on the scientific progress in EVs field, information to patients and expert resource network for regulatory bodies. The contribution of our work group "Extracellular Vesicle translatiOn to clinicaL perspectiVEs - EVOLVE France", created in 2020, can be positioned in complement to all these important initiatives. Based on complementary scientific, technical, and medical expertise, we provide EV-specific recommendations for manufacturing, quality control, analytics, non-clinical development, and clinical trials, according to current European legislation. We especially focus on early phase clinical trials concerning immediate needs in the field. The main contents of the investigational medicinal product dossier, marketing authorization applications, and critical guideline information are outlined for the transition from research to clinical development and ultimate market authorization