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    Scopus© Citations 22  3
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    Emergency Department Workflow Times of Intravenous Thrombolysis with Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Prospective Cohort Study before and during the COVID-19 Pandemic
    (S. Karger AG, 2025-02-03)
    Matias Guzman
    ;
    LAVADOS GERMAIN, PABLO MANUEL  
    ;
    Gabriel Cavada
    ;
    Alejandro M. Brunser
    ;
    Veronica V. Olavarria
    Introduction: Tenecteplase (TNK) has demonstrated to be non-inferior to alteplase (ALT) for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS). There are potential workflow benefits associated with TNK use, aiming to reduce patient length of stay in the emergency department. Our aim was to investigate whether the routine use of TNK during the COVID-19 pandemic influenced workflow times compared to historical use of ALT, while maintaining non-inferior clinical outcomes in a non-drip and ship scenario of a comprehensive stroke center. Methods: We included patients with AIS admitted from September 2019 to September 2022 and compared those treated with TNK during the COVID-19 pandemic to those treated with ALT in the period immediately before. We compared emergency department length of stay (EDLOS), door-to-needle time (DTN), door-to-groin puncture time (DTG), clinical and safety outcomes with adjusted general linear regression models. Results: 110 patients treated with TNK and 111 with ALT were included in this study. Mean EDLOS was 251 (SD = 164) min for TNK users versus 240 (SD = 148) min for ALT (p = 0.62). Mean DTN was 43 (SD = 25) min for TNK versus 46 (SD = 27) min for ALT users (p = 0.39). Mean DTN under 60 min was achieved in 86 (78.2%) patients and in 85 (76.5%) patients of the TNK and ALT groups, respectively (p = 1.0). DTN under 45 min was achieved in 65.4% and 58.6% (p = 0.65) of the TNK and ALT groups, respectively. DTG time was 114 (SD = 43) min for TNK versus 111 (58 = SD) min in the ALT group (p = 0.88). DTG under 90 min was achieved in 32% of the TNK group and 35% of the ALT group (p = 0.69). There were no differences in any of the clinical or safety outcomes between groups at 90 days. Conclusions: The adoption of TNK during COVID-19 pandemic did not result in a change in EDLOS, DTN, or DTG times when compared to ALT in this cohort. Safety and clinical outcomes were similar between groups. Probably a greater benefit could have been seen in a drip and ship thrombolysis setting. Further research is needed to assess the potential advantages of TNK in drip and ship scenarios of IVT.
    Scopus© Citations 2  2
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    Effects of Intensive Blood Pressure Lowering on Brain Swelling in Thrombolyzed Acute Ischemic Stroke: The ENCHANTED Results
    (Ovid Technologies (Wolters Kluwer Health), 2025-06)
    Guobin Zhang
    ;
    Chen Chen
    ;
    Xinwen Ren
    ;
    Yang Zhao
    ;
    Menglu Ouyang
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    Clinical and Radiological Differences between Patients Diagnosed with Acute Ischemic Stroke and Chameleons at the Emergency Room: Insights from a Single-Center Observational Study
    (S. Karger AG, 2024-07-18)
    BRUNSER RABOVICH, ALEJANDRO MICHEL  
    ;
    LAVADOS GERMAIN, PABLO MANUEL  
    ;
    MUÑOZ VENTURELLI, PAULA ANDREA  
    ;
    OLAVARRIA IANISZEWSKY, VERONICA VIVIANA  
    ;
    Gabriel Cavada
    <jats:p>&lt;b&gt;&lt;i&gt;Introduction:&lt;/i&gt;&lt;/b&gt; Scarce data exist about clinical/radiological differences between acute ischemic strokes diagnosed in the emergency room (AISER) and stroke chameleons (SCs). We aimed at describing the differences observed in a comprehensive stroke center in Chile. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Prospective observational study of patients with ischemic stroke syndromes admitted to the emergency room (ER) of Clínica Alemana between December 2014 and October 2023. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; 1,197 patients were included; of these 63 (5.2%, 95% CI: 4.1–6.6) were SC; these were younger (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001), less frequently hypertensive (&lt;i&gt;p&lt;/i&gt; = 0.03), and they also had lower systolic (SBP) (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001), diastolic blood pressures (DBP) (&lt;i&gt;p&lt;/i&gt; = 0.011), and NIHSS (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001). Clinically, they presented less frequently gaze (&lt;i&gt;p&lt;/i&gt; = 0.008) and campimetry alterations (&lt;i&gt;p&lt;/i&gt; = 0.03), facial (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001) and limb weakness (left arm [&lt;i&gt;p&lt;/i&gt; = 0.004], right arm (&lt;i&gt;p&lt;/i&gt; = 0.041), left leg (&lt;i&gt;p&lt;/i&gt; = 0.001), right leg &lt;i&gt;p&lt;/i&gt; = 0.0029), sensory abnormalities (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001), and dysarthria (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001). Neuroradiological evaluations included less frequently large vessel occlusions (&lt;i&gt;p&lt;/i&gt; = 0.01) and other stroke locations (&lt;i&gt;p&lt;/i&gt; = 0.005); they also differed in their etiologies (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001). Brainstem strokes (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001) and extinction/inattention symptoms (&lt;i&gt;p&lt;/i&gt; &amp;lt; 0.001) were only seen in AISER. In multivariate analysis, younger age (OR: 0.945; 95% CI: 0.93–0.96), DBP (OR: 0.97; 95% CI, 0.95–0.99), facial weakness (OR: 0.39; 95% CI: 0.19–0.78), sensory abnormities (OR: 0.16.18; 95% CI, 0.05–0.4), infratentorial location (OR: 0.36; 95% CI, 0.15–0.78), posterior circulation involvement (OR: 3.02; 95% CI, 1.45–6.3), cardioembolic (OR: 3.5; 95% CI, 1.56–7.99), and undetermined (OR: 2.42; 95% CI, 1.22–4.7; 95%) etiologies, remained statistically significant. A stepwise analysis including only clinical elements present on the patient’s arrival to the ER, demonstrates that age (OR: 0.95; 95% CI: 0.94–0.97), DBP (OR: 0.97; 95% CI, 0.95–0.99), the presence of atrial fibrillation (OR: 2.22; 95% CI, 1.04–4.75, NIHSS (OR: 0.88; 95% CI, 0.71–0.89) and the presence in NIHSS of 1a level of consciousness (OR: 5.66; CI: 95% 1.8–16.9), 1b level of consciousness questions (OR: 3.023; 95% CI, 1.35–6.8), facial weakness (OR: 0.3; CI: 95% 0.17–0.8), and sensory abnormalities (OR: 0.27; 95% CI, 0.1–0.72) remained statistically significant. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; SC had clinical and radiological differences compared to AISER. An additional relevant finding is that neurological symptoms in a patient with atrial fibrillation, even with a negative diffusion-weighted imaging, should be carefully evaluated as a potential stroke until other causes are satisfactorily ruled out. </jats:p>
    Scopus© Citations 1  6
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    Scopus© Citations 7  4
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    Clinical Profile of Stroke Chameleons Receiving Intravenous Thrombolysis: Insights from a Single-Center Experience
    (S. Karger AG, 2024-11-13)
    BRUNSER RABOVICH, ALEJANDRO MICHEL  
    ;
    LAVADOS GERMAIN, PABLO MANUEL  
    ;
    MUÑOZ VENTURELLI, PAULA ANDREA  
    ;
    OLAVARRIA IANISZEWSKY, VERONICA VIVIANA  
    ;
    Eloy Mansilla
    <jats:p>Introduction: In emergency rooms (ERs), 5% of patients experiencing an acute ischemic stroke (AIS) receive an alternative diagnosis; these cases are known as stroke chameleons (SC). The percentage of SC treated with intravenous thrombolysis (IVT) and the characteristics have not been well described. We aimed at investigating the variables associated with the probability receiving IVT. Methods: In this prospective study, we included consecutive patients with SC admitted at the ER of Clínica Alemana between September 2014 and October 2023. Results: Among 1,193 stroke patients; sixty-three (5.2%) corresponded to SC. Ten of these cases (15.8%, 95% CI: 8.8–26.8) were treated with IVT, mean door-to-needle (DTN) time of 85.7 (SD 35) min, median of 73.5 (IQR 62–113) min. SCs who underwent IVT were younger (p = 0.01), with higher NIHSS (p = 0.05). They presented more frequently with altered level of consciousness in the NIHSS (p = 0.01), language abnormities (p = 0.001), and dysarthria (p = 0.01). In multivariate analysis, none of the variables were significantly associated with IVT. A secondary analysis showed that only time to brain imaging was significantly associated with IVT (OR: 0.99; 95% CI: 0.98–0.99; p = 0.01). Conclusions: Almost 1 out of every 7 SC could be treated with IVT but with a prolonged DTN time; the chance of being treated is associated with time to brain imaging. &lt;p&gt;Introduction: In emergency rooms (ERs), 5% of patients experiencing an acute ischemic stroke (AIS) receive an alternative diagnosis; these cases are known as stroke chameleons (SC). The percentage of SC treated with intravenous thrombolysis (IVT) and the characteristics have not been well described. We aimed at investigating the variables associated with the probability receiving IVT. Methods: In this prospective study, we included consecutive patients with SC admitted at the ER of Clínica Alemana between September 2014 and October 2023. Results: Among 1,193 stroke patients; sixty-three (5.2%) corresponded to SC. Ten of these cases (15.8%, 95% CI: 8.8–26.8) were treated with IVT, mean door-to-needle (DTN) time of 85.7 (SD 35) min, median of 73.5 (IQR 62–113) min. SCs who underwent IVT were younger (p = 0.01), with higher NIHSS (p = 0.05). They presented more frequently with altered level of consciousness in the NIHSS (p = 0.01), language abnormities (p = 0.001), and dysarthria (p = 0.01). In multivariate analysis, none of the variables were significantly associated with IVT. A secondary analysis showed that only time to brain imaging was significantly associated with IVT (OR: 0.99; 95% CI: 0.98–0.99; p = 0.01). Conclusions: Almost 1 out of every 7 SC could be treated with IVT but with a prolonged DTN time; the chance of being treated is associated with time to brain imaging. &lt;/p&gt;</jats:p>
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    Implementation of Low-Intensity Thrombolysis Monitoring Care in Routine Practice: Process Evaluation of the Optimal Post rtPA-IV Monitoring in Acute Ischemic Stroke Study in the USA
    (2024)
    Menglu Ouyang
    ;
    Francisca González  
    ;
    Michelle Montalbano
    ;
    April Pruski
    ;
    Stephen Jan
    <jats:p>&lt;b&gt;&lt;i&gt;Introduction:&lt;/i&gt;&lt;/b&gt; The ongoing OPTIMISTmain study, an international, multicenter, stepped-wedge cluster randomized trial, aims to determine effectiveness and safety of low-intensity versus standard monitoring in thrombolysis-treated patients with mild-to-moderate acute ischemic stroke (AIS). An embedded process evaluation explored integration and impact of the intervention on care processes at participating US sites. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; A mixed-methods approach with quantitative and qualitative data was collected between September 2021 and November 2022. Implementer surveys were undertaken at pre- and post-intervention phases to understand the perceptions of low-intensity monitoring strategy. A sample of stroke care nurses were invited to participate in semi-structured interviews at an early stage of post-intervention. Qualitative data were analyzed deductively using the normalization process theory; quantitative data were tabulated. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Interviews with 21 nurses at 8 hospitals have shown low-intensity monitoring was well accepted as there were less time constraints and reduced workload for each patient. There were initial safety concerns over missing deteriorating patients and difficulties in changing established routines. Proper training, education, and communication, and changing the habits and culture of care, were key elements to successfully adopting the new monitoring care into routine practice. Similar results were found in the post-intervention survey (42 nurses from 13 hospitals). Nurses reported time being freed up to provide patient education (56%), daily living care (50%), early mobilization (26%), mood/cognition assessment (44%), and other aspects (i.e., communication, family support). &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Low-intensity monitoring for patients with mild-to-moderate AIS, facilitated by appropriate education and organizational support, appears feasible and acceptable at US hospitals. </jats:p>
      4Scopus© Citations 3
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    The main Optimal Post rTpa-Iv Monitoring in Ischemic Stroke Trial (OPTIMISTmain): Protocol for a Pragmatic, Stepped Wedge, Cluster Randomized Controlled Trial
    (2023)
    Menglu Ouyang
    ;
    Roland Faigle
    ;
    Xia Wang
    ;
    Brenda Johnson
    ;
    Debbie Summers
    <jats:p>Introduction: Careful monitoring of patients who receive intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is resource-intensive, and potentially less relevant in those with mild degrees of neurological impairment who are at low risk of symptomatic intracerebral hemorrhage (sICH) and other complications. Methods: OPTIMISTmain is an international, multicenter, prospective, stepped wedge, cluster randomized, blinded outcome assessed trial aims to determine whether a less-intensity monitoring protocol is at least as effective, safe, and efficient as standard post-IVT monitoring in patients with mild deficits post-AIS. Clinically stable adult patients with mild AIS (defined by a NIHSS &amp;lt;10) who do not require intensive care within 2 h post-IVT are recruited at hospitals in Australia, Chile, China, Malaysia, Mexico, UK, USA, and Vietnam. An average of 15 patients recruited per period (overall 60 patient participants) at 120 sites for a total of 7,200 IVT-treated AIS patients will provide 90% power (one-sided α 0.025). The initiation of eligible hospitals is based on a rolling process whenever ready, stratified by country. Hospitals are randomly allocated using permuted blocks into 3 sequences of implementation, stratified by country and the projected number of patients to be recruited over 12 months. These sequences have four periods that dictate the order in which they are to switch from control (usual care) to intervention (implementation of low intensity monitoring protocol) to different clusters of patients in a stepped manner. Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs. every 30 min) for 8 h, and 4 hourly (vs. every 1 h) until 24 h, post-IVT. The primary outcome measure is functional recovery, defined by the modified Rankin scale (mRS) at 90 days, a seven-point ordinal scale (0 [no residual symptom] to 6 [death]). Secondary outcomes include death or dependency, length of hospital stay, and health-related quality of life, sICH, and serious adverse events. Conclusion: OPTIMISTmain will provide level I evidence for the safety and effectiveness of a low-intensity post-IVT monitoring protocol in patients with mild severity of AIS. </jats:p>
      3Scopus© Citations 4
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    Disparities in Stroke Incidence Over Time by Sex and Age in Latin America and the Caribbean Region 1997 to 2021: A Systematic Review and Meta‐Analysis
    (2023)
    Marilaura Nuñez
    ;
    Carlos Delfino
    ;
    Claudia Asenjo‐Lobos  
    ;
    SCHILLING REDLICH, ANDREA INGRID  
    ;
    LAVADOS GERMAIN, PABLO MANUEL  
    <jats:sec sec-type="background" xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en">High‐income country studies show unfavorable trends in stroke incidence (SI) in younger populations. We aimed to estimate temporal change in SI disaggregated by age and sex in Latin America and the Caribbean region.</jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> A search strategy was used in MEDLINE, WOS, and LILACS databases from 1997 to 2021, including prospective population‐based observational studies with first‐ever stroke incidence in Latin America. Reports without data broken down by age and sex were excluded. Risk of bias was assessed with The Joanna Briggs Institute's guide. The main outcomes were incidence rate ratio and relative temporal trend ratio of SI, comparing time periods before 2010 with after 2010. Pooled relative temporal trend ratios considering only studies with 2 periods in the same population were calculated by random‐effects meta‐analysis. Meta‐regression analysis was used to evaluate incidence rate determinants. From 9242 records identified, 6 studies were selected including 4483 first‐ever stroke in 4 101 084 individuals. Crude incidence rate ratio in younger subjects (&lt;55 years) comparing before 2010:after 2010 periods showed an increase in SI in the past decade (incidence rate ratio, 1.37 [95% CI, 1.23–1.50]), in contrast to a decrease in older people during the same period (incidence rate ratio, 0.83 [95% CI, 0.76–0.89]). Overall relative temporal trend ratio (&lt;55:≥55 years) was 1.65 (95 CI%, 1.50–1.80), with higher increase in young women (pooled relative temporal trend ratio, 3.08 [95% CI, 1.18–4.97]; <jats:italic>P</jats:italic> for heterogeneity &lt;0.001). </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en">An unfavorable change in SI in young people, especially in women, was detected in population‐based studies in the past decade in Latin America and the Caribbean. Further investigation of the explanatory variables is required to ameliorate stroke prevention and inform local decision‐makers.</jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Registration</jats:title> <jats:p xml:lang="en"> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.crd.york.ac.uk/prospero/">https://www.crd.york.ac.uk/prospero/</jats:ext-link> Identifier: CRD42022332563. </jats:p> </jats:sec>
      7Scopus© Citations 5