Eligibility For Intravenous Thrombolysis Research Articles

The Use of a Pre-Hospital Questionnaire Expedited the Acute Management of Patients with Ischemic Stroke in a Comprehensive Stroke Center

BackgroundDelays in intravenous thrombolysis (IVT) treatment for acute ischemic stroke decrease the benefit of treatment. Difficulties determining a patient's clinical eligibility for IVT is a frequent cause of treatment delays. ObjectiveWe aimed to assess the effectiveness of the "PROVIDENCE" datasheet, a pre- hospital assessment of contraindications for IVT use applied by emergency medical services personnel. MethodsWe performed a single-center cohort study comparing IVT decision and treatment times between patients with PROVIDENCE datasheets and those without. Patients were eligible if they were over 18 years old and presented to our comprehensive stroke center from the field with stroke-like symptoms with onset within 4.5hours. ResultsWe identified 465 records and included 166 records in our final analysis (54 in the study group and 112 in the control group). A subgroup of 85 patients received IVT (30 in the study group patients and 55 in the control group). The PROVIDENCE datasheet was associated with a faster median time by five minutes from the patient's initial presentation at the emergency department to the final decision regarding IVT eligibility (p = 0.032) and a faster time between the first encounter with a neurology provider and the decision regarding IVT administration by six minutes (p = 0.002) for the entire sample. In the subgroup that received IVT, the PROVIDENCE datasheet decreased the median decision time by seven minutes (p = 0.044) There was no significant difference in door-to-needle times between groups. ConclusionUsing the PROVIDENCE datasheet, first responders can quickly identify potential contraindications for IVT treatment in patients with stroke-like symptoms. This tool expedited decision-making and led to faster IVT administration process at a comprehensive stroke center.

Abstract TP102: Pre-Hospital Obtention of Vital Information for Decision Enforcement in Cerebrovascular Emergencies: The PROVIDENCE Study

Background: Difficulties determining an acute ischemic stroke patient's eligibility for intravenous thrombolysis (IVT) treatment is a frequent cause of delays. Objective: To assess the effectiveness of the "PROVIDENCE" datasheet, a pre-assessment of contraindications for IVT use applied by emergency medical services personnel in the field. Methods: This is a quasi-experimental study to evaluate the efficacy of the PROVIDENCE datasheet used by first responders. Participants were eligible if they were over 18 years old and presented to our center from the field with stroke-like symptoms with onset within 4.5 h. Results: We identified 465 records and included 166 records in our final analysis (54 in the study group and 112 in the control group). Eighty-five of the 166 patients received IVT (30 in the study group patients and 55 in the control group). The PROVIDENCE datasheet showed a noticeable median improvement in corrected time by five minutes from the patient's initial presentation at the emergency department to the final decision regarding IVT eligibility (p = 0.032). Additionally, the time between the first encounter with a neurology provider and the decision regarding IVT administration saw a median improvement of six minutes (p = 0.002) for the entire sample. In the subgroup that received IVT, the PROVIDENCE datasheet decreased by seven minutes (p = 0.044) the median time between the first encounter by the neurology provider and the decision regarding the administration of IVT. All other comparisons were not significant. However, the PROVIDENCE datasheet decreased the door-to-needle time by 6.5 minutes compared to the control group. Conclusion: Using the PROVIDENCE datasheet, first responders can quickly identify potential contraindications for IVT treatment in patients with stroke-like symptoms. This tool expedited decision-making and led to faster IVT administration process at a comprehensive stroke center.

Bridging Thrombolysis Achieved Better Outcomes Than Direct Thrombectomy After Large Vessel Occlusion: An Updated Meta-Analysis.

The utility and necessity of pretreatment with intravenous thrombolysis (IVT) before mechanical thrombectomy (MT) remains an issue of strong debate. This study aims to compare the outcomes of bridging thrombolysis (BT, IVT+MT) with direct MT (d-MT) after large vessel ischemic stroke based on the most up-to-date evidence. MEDLINE, EMBASE, Scopus, and the Cochrane Library from January 2017 to June 2020 were searched for studies that directly compared the outcomes of the 2 strategies. Methodological quality was assessed using the Quality in Prognostic Studies tool. Combined estimates of odds ratios (ORs) of BT versus d-MT were derived. Multiple subgroup analyses were performed, especially for IVT-eligible patients. Thirty studies involving 7191 patients in the BT group and 4891 patients in the d-MT group were included. Methodological quality was generally high. Compared with patients in the d-MT group, patients in the BT group showed significantly better functional independence (modified Rankin Scale score 0-2) at 90 days (OR=1.43 [95% CI, 1.28-1.61]), had lower mortality at 90 days (OR=0.67 [95% CI, 0.60-0.75]), and achieved higher successful recanalization (modified Thrombolysis in Cerebral Ischemia score 2b-3) rate (OR=1.23 [95% CI, 1.07-1.42]). No significant difference was detected in the occurrence of symptomatic intracranial hemorrhage between 2 groups (OR=1.01 [95% CI, 0.86-1.19]). Subgroup analysis showed that functional independence frequency remained significantly higher in BT group regardless of IVT eligibility or study design. Compared with d-MT, bridging with IVT led to better clinical outcomes, lower mortality at 90 days, and higher successful recanalization rates, without increasing the risk of near-term hemorrhagic complications. The benefits of BT based on this most recent literature evidence support the current guidelines of using BT.

Acute stroke awareness of family physicians: translation of policy to practice

BackgroundTranslating clinical guidelines into routine clinical practice is mandatory to achieve population level improvement of health. Emergence of specific therapy for acute stroke yielded the ‘time is brain’ concept introducing the need for emergency treatment, pointing to the need for increasing stroke awareness of the general population. General practitioners (GPs) manage chronic diseases and could hence catalyse stroke awareness. In our study, the knowledge of general practitioners toward accurate identification of acute stroke candidacy was investigated.MethodsGPs and residents in training for family medicine participated in a survey on a voluntary basis using supervised self-administration between the 1st of February 2018 and 31st July 2018. Two clinical cases of acute stroke that differed only regarding the patient’s eligibility for intravenous thrombolysis were presented. Participants answered two open-ended questions. Text analysis was performed using NVIVO software.ResultsOf the 127 respondents, 69 (54.3%) were female. The median age was 49 (34–62) years. The median time spent working after graduation was 14.5 (2–22.5) years. Board-certified GPs made up 77.2% of the sample. Qualitative analysis revealed stroke as the most frequent diagnosis for both cases. Territorial localization and possible aetiology were also established. Respondents properly identified eligibility for thrombolysis. Quantitative assessment showed that having the practice closer to the stroke centre increases the likelihood of adequate diagnosis for acute stroke.ConclusionsOur results show that GPs properly diagnose acute stroke and identify intravenous thrombolysis candidates. Moreover, we found that a vigorous acute stroke triage system facilitates the translation of theory into practice.

Bridging versus Direct Mechanical Thrombectomy in Acute Ischemic Stroke: A Subgroup Pooled Meta-Analysis for Time of Intervention, Eligibility, and Study Design

Background and Aim: The risk/benefit profile of intravenous thrombolysis (IVT) prior to endovascular thrombectomy (EVT) in acute ischemic stroke is still unclear. We provide a systematic review and meta-analysis including studies comparing direct EVT (dEVT) vs. bridging treatment (IVT + EVT), defining the impact of treatment timing and eligibility to IVT on functional status and mortality. Methods: Protocol was registered with PROSPERO (CRD42019135915) and followed PRISMA guidelines. PubMed, EMBASE, and Cochrane Central were searched for randomized controlled trials (RCTs), retrospective, and prospective studies comparing IVT + EVT vs. dEVT in adults (≥18) with acute ischemic stroke. Primary endpoint was functional independence at 90 days (modified Rankin Scale <3); secondary endpoints were (i) good recanalization (thrombolysis in cerebral infarction >2a), (ii) mortality, and (iii) symptomatic intracranial hemorrhage (sICH). Subgroup analysis was performed according to study type, eligibility to IVT, and onset-to-groin timing (OGT), stratifying studies for similar OGT. ORs for endpoints were pooled with meta-analysis and compared between reperfusion strategies. Results: Overall, 35 studies were included (n = 9,117). No significant differences emerged comparing patients undergoing dEVT and bridging treatment for gender, hypertension, diabetes, National Institute of Health Stroke Scale score at admission. Regarding primary endpoint, IVT + EVT was superior to dEVT (OR 1.44, 95% CI 1.22–1.69, p < 0.001, p_{heterogeneity}<0.001), with number needed to treat being 18 in favor of IVT + EVT. Results were confirmed in studies with similar OGT (OR 1.66; 95% CI 1.21–2.28), shorter OGT for IVT + EVT (OR 1.53, 95% CI 1.27–1.85), and independently from IVT eligibility (OR 1.53, 95% CI 1.29–1.82). Mortality at 90 days was higher in dEVT (OR 1.38; 95% CI 1.09–1.75), but no significant difference was noted for sICH. However, considering data from RCT only, reperfusion strategies had similar primary (OR 0.91, 95% CI 0.6–1.39) and secondary endpoints. Differences in age and clinical severity across groups were unrelated to the primary endpoint. Conclusions: Compared to dEVT, IVT + EVT associates with better functional outcome and lower mortality. Post hoc data from RCTs point to substantial equivalence of reperfusion strategies. Therefore, an adequately powered RCTs comparing dEVT versus IVT + EVT are warranted.

Eligibility for intravenous thrombolysis in acute ischemic stroke patients presenting in the 4.5-9h window.

Recent randomized-controlled clinical trials have provided preliminary evidence for expanding the time window of intravenous thrombolysis (IVT) in acute ischemic stroke (AIS) patients by applying certain neuroimaging criteria. We prospectively assessed the potential eligibility for IVT in the extended time window (4.5-9h) among consecutive AIS patients treated in a comprehensive stroke center during a nine-month period. Potential eligibility for IVT in the extended time window was evaluated by using inclusion criteria from the EXTEND trial. All patients were underwent baseline emergent neurovascular imaging using either computed tomography angiography/computed tomography perfusion (CTA/CTP) or magnetic resonance angiography/magnetic resonance perfusion (MRA/MRP). Images were post processed by the automated software RAPID. Our study population consisted of 317 AIS patients, and, among them, 31 (9.8%) patients were presented in the time window of 4.5-9h. Seven patients (2.2%) fulfilled the EXTEND neuroimaging criteria. Four patients (1.3%) were treated with IVT because they fulfilled both clinical and neuroimaging EXTEND criteria. Patients eligible for EXTEND neuroimaging criteria had no ischemic core lesion, whereas the mean volume of critical hypoperfusion was relatively small (17.0 ± 11.8ml). There was no hemorrhagic complication in any of the patients treated with IVT. The median mRS score at three months was 0 (range: 0-3) among patients who were eligible for EXTEND neuroimaging criteria. Our everyday clinical practice experience suggests 9.8% of consecutive AIS patients present in the 4.5-9h window and 2.2% adhere to EXTEND neuroimaging eligibility criteria for IVT. Only 1.3% of AIS is eligible for IVT according to EXTEND neuroimaging and clinical eligibility criteria.

Factors associated with delayed presentation at the emergency department in patients with acute ischemic stroke

ABSTRACTBackground and aims: Pre-hospital delay is a crucial factor that determines the eligibility for intravenous thrombolysis in patients with acute ischemic stroke. We aimed to evaluate the time to presentation at the emergency department (ED) and the factors that affect this time.Patients and methods: We prospectively studied 682 patients who were admitted with acute ischemic stroke (43.3% men, age 79.9 ± 6.6 years).Results: The median time to presentation at the ED was 2.1 h (range 0.15 to 168 h); 68.8% of the patients arrived within 4.5 h and 56.5% arrived within 3 h from the onset of symptoms. Independent predictors of presentation within 4.5 h were the use of emergency medical services (EMS) for transportation to the hospital (OR 2.61, 95% CI 1.38–4.94, p = .003), family history of cardiovascular disease (CVD)(OR 4.0 0,95%CI 1.61–12.23, p = .006) and the absence of history of smoking (OR 2.49, 95% CI 1.13–5.42, p = .021). Independent predictors of presentation within 3 h were the use of EMS for transportation to the hospital (OR 6.24, 95% CI 2.52–16.63, p = .0001), family history of CVD (OR 3.07, 95% CI 1.14–9.43, p = .03), and a moderately severe stroke at admission (OR vs. minor stroke 0.38, 95% CI 0.16–0.87, p = .02).Conclusions: A considerable proportion of patients with acute ischemic stroke arrives at the ED after the 4.5-h threshold for performing intravenous thrombolysis. Non-smokers, patients with a family history of CVD, with moderately severe stroke and those who use the EMS are more likely to arrive on time.

Mechanical Thrombectomy Outcomes With and Without Intravenous Thrombolysis in Stroke Patients: A Meta-Analysis.

Whether prior intravenous thrombolysis provides any additional benefits to the patients undergoing mechanical thrombectomy for large vessel, acute ischemic stroke remains unclear. We conducted a meta-analysis of 13 studies obtained through PubMed and EMBASE database searches to determine whether functional outcome (modified Rankin Scale) at 90 days, successful recanalization rate, and symptomatic intracerebral hemorrhage rate differed between patients who underwent mechanical thrombectomy with (MT+IVT) and without (MT-IVT) pre-treatment with intravenous thrombolysis. MT+IVT patients compared with MT-IVT patients had better functional outcomes (modified Rankin Scale score, 0-2; summary odds ratio [OR], 1.27 [95% confidence interval (CI), 1.05-1.55]; P=0.02; n=1769/1174), lower mortality (OR, 0.71 [95% CI, 0.55-0.91]; P=0.006; n=1774/1202), and higher rate of successful recanalization (OR, 1.46 [95% CI, 1.09-1.96]; P=0.01; n=1652/1216) without having increased odds of symptomatic intracerebral hemorrhage (OR, 1.11 [95% CI, 0.69-1.77]; P=0.67; n=1471/1143). A greater number of MT+IVT patients required ≤2 passes with a neurothrombectomy device to achieve successful recanalization (OR, 2.06 [95% CI, 1.37-3.10]; P=0.0005; n=316/231). Our results demonstrated that MT+IVT patients had better functional outcomes, lower mortality, higher rate of successful recanalization, requiring lower number of device passes, and equal odds of symptomatic intracerebral hemorrhage compared with MT-IVT patients. The results support the current guidelines of offering intravenous thrombolysis to eligible patients even if they are being considered for mechanical thrombectomy. Because the data are compiled from studies where the 2 groups differed based on eligibility for intravenous thrombolysis, randomized trials are necessary to accurately evaluate the added value of intravenous thrombolysis in patients treated with mechanical thrombectomy.

Eligibility and Predictors for Acute Revascularization Procedures in a Stroke Center

Endovascular treatment (EVT) is a new standard of care for selected, large vessel occlusive strokes. We aimed to determine frequency of potentially eligible patients for intravenous thrombolysis (IVT) and EVT in comprehensive stroke centers. In addition, predictors of EVT eligibility were derived. Patients from a stroke center-based registry (2003-2014), admitted within 24 hours of last proof of usual health, were selected if they had all data to determine IVT and EVT eligibility according to American Heart Association/American Stroke Association (AHA/ASA) guidelines (class I-IIa recommendations). Moreover, less restrictive criteria adapted from randomized controlled trials and clinical practice were tested. Maximum onset-to-door time windows for IVT eligibility were 3.5 hours (allowing door-to-needle delay of ≤60 minutes) and 4.5 hours for EVT eligibility (door-to-groin delay ≤90 minutes). Demographic and clinical information were used in logistic regression analysis to derive variables associated with EVT eligibility. A total of 2704 patients with acute ischemic stroke were included, of which 26.8% were transfers. Of all patients with stroke arriving at our comprehensive stroke center, a total proportion of 12.4% patients was eligible for IVT. Frequency of EVT eligibility differed between AHA/ASA guidelines and less restrictive approach: 2.9% versus 4.9%, respectively, of all patients with acute ischemic stroke and 10.5% versus 17.7%, respectively, of all patients arriving within <6 hours. Predictors for AHA-EVT eligibility were younger, shorter onset-to-admission delays, higher National Institutes of Health Stroke Scale (NIHSS), decreased vigilance, hemineglect, absent cerebellar signs, atrial fibrillation, smoking, and decreasing glucose levels (area under the curve=0.86). Of patients arriving within 6 hours at a comprehensive stroke center, 10.5% are EVT eligible according to AHA/ASA criteria, 17.7% according to criteria resembling randomized controlled trials, and twice as many patients are IVT eligible (36.2%).

Abstract 3243: A Comparison of Vascular Neurologist Interpretation versus Radiology Reports of Computed Tomographic Imaging for Determining Eligibility of Intravenous Thrombolysis in Patients with Acute Ischemic Stroke

Background: Computed tomographic (CT) scan is the gold standard imaging for determining acute ischemic stroke patient eligibility for intravenous thrombolysis (IV t-PA). In most institutions neurologists or clinicians interpret the intial CT images to determine eligibility, although some institutional protocols require the neuroradiologist interpretation. Objective: To evaluate the variability of determining eligibility for IV rt-PA by vascular neurologist interpretation of CT scan versus review of the radiology interpretation (presented in final report) in patients with acute ischemic stroke. Methods: We compiled a database of all IV rt-PA treated ischemic stroke patients at our academic institutions based on vascular neurologists’ CT scan interpretation . The patients’ CT scan reports were reviewed by an independent board certified vascular neurologist who was blinded to all clinical information except that all patients were being considered for IV rt-PA to determine eligibility for IV rt-PA. The reviewer’s responses were then compared with the treating team’s decision to identify discrepancy between decisions and assess impact on clinical outcome (including 24 hour NIHSS score and discharge modified Rankin scale), symptomatic hemorrhage (sICH), and asymptomatic hemorrhage (aICH). Results: A total of 171 acute ischemic stroke patients, were included in the study and had received IV rt-PA. The mean age (±SD) was 61±14 years, the mean (±SD) NIHSS score was 7±2. The independent reviewer decided to treat with IV t-PA in 123 (72%) of cases after review of radiology reports. The most common reasons for deciding against thrombolysis were findings of early ischemic changes, possible established infarct, or inability to exclude ICH in the radiology report. Assuming equal variances, the clinical improvement based on NIHSS and mRS at discharge, sICH, and aICH were not significantly different with IV rt-PA treatment between those who were treated but would be excluded and those who will be included based on a review of radiology reports. Conclusion: The study demonstrates that administering IV rt-PA to patients based on vascular neurologist interpretation of CT scan versus review of the radiology interpretation does not lead to significant differences in clinical outcome, aICH, or sICH and should not be a pre-requisite to avoid delays in IV rt-PA administration.

Eligibility for intravenous thrombolysis in acute stroke: A multicenter prospective study

P182 Objective: To elucidate the proportion of patients who would have been eligible for alteplase treatment following the ECASS II criteria in a prospective study conducted in 20 Spanish general or university hospitals. Methods: The first 100 consecutive patients with an acute stroke admitted between 9/98 and 4/99 in each participating hospital were evaluated. Data concerning exclusion criteria for tPA, demographic variables, distance to hospital (&lt;5km,5–20km,&gt;20km), time (0–6am,6–12,12–6pm,6–12pm) and place (home, work/street, hospital) of symptoms onset, subject detecting the event (victim, family member, bystander), dispatch system (own initiative, EMS, primary physician, community hospital), delay and type of transport (own transport, basic, or advanced life support ambulance), cardiovascular risk factors, stroke severity (Canadian scale) and type of stroke were recorded. Results: Out of 1599 screened patients, 166 (10.4%) fulfilled all criteria for tPA treatment. Multiple reasons for exclusion were time from onset &gt;6h in 23%, or unknown in 23%, delay in neurological attention &gt;6h in 39%, TC not available within 6h from onset in 34%, hemorrhage in 14%, early signs of infarction involving &gt;33% MCA in 8%, TIA or rapidly improving symptoms in 24%, coma or hemiplegia plus forced eye deviation in 5%, hypertension &gt;185/110 in 2%, coagulation abnormalities in 1%, and other reasons in 6%. Univariate analyses showed that high eligibility for tPA was associated with type of the first medical intervention (emergency medical system)(p=0.006), type of transport (basic or advanced life support ambulance)(p&lt;0.0001), stroke severity (p&lt;0.001), and type of stroke (cardioembolic) (p=0.0027). Age, distance to hospital, time and place of stroke onset, subject detecting the event, and risk factors were not significantly related to eligibility. Conclusions: Candidates for intravenous tPA treatment within 6 hours from stroke onset are 10% of patients admitted in general hospitals of an EU country. Delay in neurologic attention and CT examination were the main reasons for exclusion. Dispatch system, and type of transport were modifiable factors related to eligibility.

Eligibility for intravenous thrombolysis in acute stroke: A multicenter prospective study

P182 Objective: To elucidate the proportion of patients who would have been eligible for alteplase treatment following the ECASS II criteria in a prospective study conducted in 20 Spanish general or university hospitals. Methods: The first 100 consecutive patients with an acute stroke admitted between 9/98 and 4/99 in each participating hospital were evaluated. Data concerning exclusion criteria for tPA, demographic variables, distance to hospital ( 20km), time (0–6am,6–12,12–6pm,6–12pm) and place (home, work/street, hospital) of symptoms onset, subject detecting the event (victim, family member, bystander), dispatch system (own initiative, EMS, primary physician, community hospital), delay and type of transport (own transport, basic, or advanced life support ambulance), cardiovascular risk factors, stroke severity (Canadian scale) and type of stroke were recorded. Results: Out of 1599 screened patients, 166 (10.4%) fulfilled all criteria for tPA treatment. Multiple reasons for exclusion were time from onset >6h in 23%, or unknown in 23%, delay in neurological attention >6h in 39%, TC not available within 6h from onset in 34%, hemorrhage in 14%, early signs of infarction involving >33% MCA in 8%, TIA or rapidly improving symptoms in 24%, coma or hemiplegia plus forced eye deviation in 5%, hypertension >185/110 in 2%, coagulation abnormalities in 1%, and other reasons in 6%. Univariate analyses showed that high eligibility for tPA was associated with type of the first medical intervention (emergency medical system)(p=0.006), type of transport (basic or advanced life support ambulance)(p Conclusions: Candidates for intravenous tPA treatment within 6 hours from stroke onset are 10% of patients admitted in general hospitals of an EU country. Delay in neurologic attention and CT examination were the main reasons for exclusion. Dispatch system, and type of transport were modifiable factors related to eligibility.