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

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

Low incidence of SARS-CoV-2, risk factors of mortality and the course of illness in the French national cohort of dialysis patients

International audienceThe aim of this study was to estimate the incidence of COVID-19 disease in the French national population of dialysis patients, their course of illness and to identify the risk factors associated with mortality. Our study included all patients on dialysis recorded in the French REIN Registry in April 2020. Clinical characteristics at last follow-up and the evolution of COVID-19 illness severity over time were recorded for diagnosed cases (either suspicious clinical symptoms, characteristic signs on the chest scan or a positive reverse transcription polymerase chain reaction) for SARS-CoV-2. A total of 1,621 infected patients were reported on the REIN registry from March 16th, 2020 to May 4th, 2020. Of these, 344 died. The prevalence of COVID-19 patients varied from less than 1% to 10% between regions. The probability of being a case was higher in males, patients with diabetes, those in need of assistance for transfer or treated at a self-care unit. Dialysis at home was associated with a lower probability of being infected as was being a smoker, a former smoker, having an active malignancy, or peripheral vascular disease. Mortality in diagnosed cases (21%) was associated with the same causes as in the general population. Higher age, hypoalbuminemia and the presence of an ischemic heart disease were statistically independently associated with a higher risk of death. Being treated at a selfcare unit was associated with a lower risk. Thus, our study showed a relatively low frequency of COVID-19 among dialysis patients contrary to what might have been assumed