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Background: COVID-19 has been associated with increased risk of venous and arterial thromboembolism including ischemic stroke. We report on patients with acute ischemic stroke and concomitant COVID-19 in a diverse patient population.Methods: This is a retrospective analysis of patients hospitalized with acute ischemic stroke (AIS) and COVID-19 to our comprehensive stroke center in Chicago, IL, between March 1, 2020, and April 30, 2020. We reviewed stroke characteristics, etiologies, and composite outcomes. We then compared our cohort with historic patients with AIS without COVID-19 admitted in the same time frame in 2019 and 2020.Results: Out of 13 patients with AIS and COVID-19, Latinos and African-Americans compromised the majority of our cohort (76.8%), with age ranging from 31–80 years. Most strokes were cortical (84.6%) and more than 50% of patients had no identifiable source, and were categorized as embolic stroke of unknown source (ESUS). A trend toward less alteplase administration was noted in the COVID-19 stroke patients compared to the non-COVID group from 2020 and 2019 (7.1 vs. 20.7% p 0.435 and 7.1 vs. 27.2% p 0.178). Endovascular thrombectomy was performed in 3 (23%) patients. Systemic thrombotic complications occurred in 3 (23%) COVID-19 AIS patients. Median National Institutes of Health Stroke Scale and modified Rankin Scale at discharge were 11 (IQR 4–23) and 4 (IQR 3–4), respectively. In the logistic regression model corrected for age and sex, COVID-19 was associated with discharge to mRS > 2 (p 0.046, OR 3.82, CI 1.02–14.3). Eight patients (63.8%) were discharged home or to acute rehabilitation, and two deceased from COVID-19 complications.Conclusion: AIS in the setting of COVID-19 is associated with worse outcomes, especially among African-American and Latino populations. Large vessel disease with ESUS was common suggesting an increased risk of coagulopathy and endothelial dysfunction as a potential etiology.

PurposeThe primary correlate to survival and preservation of neurologic function in patients suffering from an acute ischemic stroke is time from symptom onset to initiation of therapy and reperfusion. Communication and coordination among members of the stroke team are essential to maximizing efficiency and subsequently early reperfusion. In this work, we aim to describe our preliminary experience using the Join mobile application as a means to improve interdisciplinary team communication and efficiency.Materials and MethodsWe describe our pilot experience with the initiation of the Join mobile application between July 2015 and July 2016. With this application, a mobile beacon is transported with the patient on the ambulance. Transportation milestone timestamps and geographic coordinates are transmitted to the treating facility and instantly communicated to all treatment team members. The transport team / patient can be tracked en route to the treating facility.ResultsDuring our pilot study, 62 patients were triaged and managed using the Join application. Automated time-stamping of critical events, geographic tracking of patient transport and summary documents were obtained for all patients. Treatment team members had an overall favorable impression of the Join application and recommended its continued use.ConclusionThe Join application is one of several components of a multi-institutional, interdisciplinary effort to improve the treatment of patients with acute ischemic stroke. The ability of the treatment team to track patient transport and communicate with the transporting team may improve reperfusion time and, therefore, improve neurologic outcomes.

Biocompatibility considerations have historically been important for orally inhaled and nasal drug products (OINDPs) and other drug-device combination products, because finished device components and packaging in these products are often in direct contact with formulation and the patient. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) discusses, in this article, the current regulatory landscape associated with biocompatibility and how biocompatibility is typically assessed for OINDPs, including risk management considerations and navigation of regulatory requirements. The article also describes current challenges related to alignment of regulatory expectations, particularly for drug-device combination products, and proposes some questions and topics for further discussion with regulatory agencies and other stakeholders to help advance alignment. To further illustrate current challenges and industry approaches to meeting biocompatibility requirements, we also present results of an IPAC-RS benchmarking survey and case studies., (© PDA, Inc. 2024.)

Introduction: A multidisciplinary panel of physicians was convened to gain understanding of the relationship between thromboembolic events (TEs) and immune-mediated diseases (IMDs). The primary objective of the panel was to assess areas of consensus on the IMD most prone to TE as well as modifiable and unmodifiable factors that might exacerbate or mitigate the risk of TEs., Methods: Thirteen nationally recognized physicians were selected based on their contributions to guidelines, publications and patient care. The modified Delphi panel consisted of four rounds of engagement: (1) a semi-structured interview, (2) an expert panel questionnaire, (3) an in-person panel discussion, and (4) a consensus statement survey., Results: Ulcerative colitis and Crohn's disease were identified as two of four IMDs with the highest TE risk. Consensus was reached on several non-modifiable and modifiable characteristics of high-risk. Approaches to reduce TE incidence were identified such as altering treatment, requiring the monitoring of patients for TEs and modifying patient behaviors. Janus kinase inhibitors and corticosteroids were identified as therapies that required further evaluation given their potential TE risk., Discussion: The panel reached a consensus that several IMDs are at an elevated risk of TEs. Physicians are unable to control most patient level risk factors but can control the therapies being used. Consequently, physicians should consider the specific IMD, be aware of TE risk factors, and take into account risk factors in selecting the therapies to optimally manage their conditions and to reduce the risk of TEs in this population.

Background/objective: Diffusion weighted imaging (DWI) lesions have been well described in patients with acute spontaneous intracerebral hemorrhage (sICH). However, there are limited data on the influence of these lesions on sICH functional outcomes. We conducted a prospective observational cohort study with blinded imaging and outcomes assessment to determine the influence of DWI lesions on long-term outcomes in patients with acute sICH. We hypothesized that DWI lesions are associated with worse modified Rankin Scale (mRS) at 3 months after hospital discharge., Methods: Consecutive sICH patients meeting study criteria were consented for an magnetic resonance imaging (MRI) scan of the brain and evaluated for remote DWI lesions by neuroradiologists blinded to the patients' hospital course. Blinded mRS outcomes were obtained at 3 months. Logistic regression was used to determine significant factors (p < 0.05) associated with worse functional outcomes defined as an mRS of 4-6. The generalized estimating equation (GEE) approach was used to investigate the effect of DWI lesions on dichotomized mRS (0-3 vs 4-6) longitudinally., Results: DWI lesions were found in 60 of 121 patients (49.6%). The presence of a DWI lesion was associated with increased odds for an mRS of 4-6 at 3 months (OR 5.987, 95% CI 1.409-25.435, p = 0.015) in logistic regression. Using the GEE model, patients with a DWI lesion were less likely to recover over time between 14 days/discharge and 3 months (p = 0.005)., Conclusions: DWI lesions are common in primary sICH, occurring in almost half of our cohort. Our data suggest that DWI lesions are associated with worse mRS at 3 months in good grade sICH and are predictive of impaired recovery after hospital discharge. Further research into the pathophysiologic mechanisms underlying DWI lesions may lead to novel treatment options that may improve outcomes associated with this devastating disease.

Background: Most patients with large vessel occlusion (LVO) stroke need to be transferred to receive thrombectomy. To save time, the decision to transfer often relies on clinical scales as a surrogate for LVO rather than imaging. However, clinical scales have been associated with high levels of diagnostic error. The aim of this study is to define the susceptibility to overdiagnosis of our current transfer decision process by measuring the rate of non-treatment transfers, the most common reasons for no treatment and potential predictors., Methods: Clinical and transfer data on consecutive patients transferred to a single endovascular capable centre for possible thrombectomy via stroke code activation were retrospectively reviewed. Whether patients underwent the procedure, why they did not undergo the procedure, and other clinical and logistical predictors were recorded. χ 2 tests and multivariate logistic regression analysis were performed., Results: From 2015 to 2016, 105/192 transferred patients (54%) did not undergo thrombectomy and the most common reason was absence of a LVO found on CTA after transfer (71/104 (68%)). 14/16 (88%) with a National Institutes of Health Stroke Scale (NIHSS) score <10 did not undergo thrombectomy while 41/78 (52%) with a NIHSS>20 underwent thrombectomy (p<0.001). Helicopter use was associated with no treatment (p=0.004) while arrival within 5 hours was associated with treatment (p<0.001)., Conclusions: Clinical scales appear to overdiagnose LVO and may be responsible for the majority of our stroke code transfers not undergoing thrombectomy. Primary stroke centres therefore have reason to develop the capability to rapidly acquire and interpret a CTA in patients with suspected LVO prior to transfer. Such efforts may reduce the costs associated with unnecessary thrombectomy transfers., Competing Interests: Competing interests: MC is a consultant for Genentech, Penumbra, Stryker and Medtronic., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: To describe the most common clinical factors and stroke etiologies in a case series of patients with end-stage renal disease on hemodialysis (ESRD/HD) with transient ischemic attack (TIA) or ischemic stroke (IS)., Background: Prior studies have shown that patients on HD are at an elevated risk of stroke, but these studies have focused on the overall stroke risk. This case series sought to determine the percentage of acute ischemic events that occur during or immediately after HD., Methods: ICD-9 codes were used to identify IS and TIA patients with ESRD/HD admitted to the stroke service from August 22, 2011, to June 21, 2014. Charts were reviewed to determine the age, sex, and race/ethnicity of the cohort. TIA/IS diagnosis was confirmed by a vascular neurologist. Clinical factors were assessed, including: onset during or shortly after HD, defined as occurring within 12 h of HD; the presence of a lesion on diffusion-weighted MRI; hypotension, hyponatremia, or hypoglycemia at symptom onset; the stroke etiology; the presence of focal neurologic deficits; whether the patient was in the window period for intravenous tissue plasminogen activator (IVtPA) upon presentation, and whether the patient received IVtPA., Results: We identified 34 ESRD/HD patients with a diagnosis of TIA/stroke in the specified time period. A majority of patients (70.6%) were African American. Patient age ranged from 32 to 84 years, with a median age of 67 years. Twenty-seven patients (79.4%) had confirmed ischemic infarcts on diffusion-weighted MRI. Seven patients (20.6%) were diagnosed with TIA. In 13 patients (38.2%), symptom onset occurred during or shortly after HD. Of these 13 patients, 8 (61.5%) had symptom onset during HD. Three patients (8.8%) had documented hypotension near the time of symptom onset, and 2 (5.9%) were hyponatremic on presentation to the emergency department. The distribution of stroke etiologies was as follows: 4 (11.8%) watershed distribution, 1 (2.9%) large artery atherosclerosis, 2 (20.6%) small vessel disease, 10 (29.4%) cardioembolic, and 9 (26.5%) cryptogenic. In 28 patients (82.4%), focal neurologic deficits were observed on presentation. Nine patients (26.5%) arrived within the window period for IVtPA, and 4 (11.8%) were eligible and received IVtPA., Conclusions: Of all patients with ESRD on HD admitted to the stroke service over the study period, over one third (38.3%) had the onset of their ischemic event during or shortly after HD, and nearly one quarter (23.5%) had the onset during HD. While clinicians may be tempted to attribute neurologic changes after HD to metabolic etiologies, they should also be aware that HD represents a period of elevated risk for acute ischemia.