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  • 1
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    Online Resource
    Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. 9 ( 2022-09), p. 2876-2886
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 9 ( 2022-09), p. 2876-2886
    Abstract: In patients with intracerebral hemorrhage (ICH), the presence of intraventricular hemorrhage constitutes a promising therapeutic target. Intraventricular fibrinolysis (IVF) reduces mortality, yet impact on functional disability remains unclear. Thus, we aimed to determine the influence of IVF on functional outcomes. Methods: This individual participant data meta-analysis pooled 1501 patients from 2 randomized trials and 7 observational studies enrolled during 2004 to 2015. We compared IVF versus standard of care (including placebo) in patients treated with external ventricular drainage due to acute hydrocephalus caused by ICH with intraventricular hemorrhage. The primary outcome was functional disability evaluated by the modified Rankin Scale (mRS; range: 0–6, lower scores indicating less disability) at 6 months, dichotomized into mRS score: 0 to 3 versus mRS: 4 to 6. Secondary outcomes included ordinal-shift analysis, all-cause mortality, and intracranial adverse events. Confounding and bias were adjusted by random effects and doubly robust models to calculate odds ratios and absolute treatment effects (ATE). Results: Comparing treatment of 596 with IVF to 905 with standard of care resulted in an ATE to achieve the primary outcome of 9.3% (95% CI, 4.4–14.1). IVF treatment showed a significant shift towards improved outcome across the entire range of mRS estimates, common odds ratio, 1.75 (95% CI, 1.39–2.17), reduced mortality, odds ratio, 0.47 (95% CI, 0.35–0.64), without increased adverse events, absolute difference, 1.0% (95% CI, −2.7 to 4.8). Exploratory analyses provided that early IVF treatment (≤48 hours) after symptom onset was associated with an ATE, 15.2% (95% CI, 8.6–21.8) to achieve the primary outcome. Conclusions: As compared to standard of care, the administration of IVF in patients with acute hydrocephalus caused by intracerebral and intraventricular hemorrhage was significantly associated with improved functional outcome at 6 months. The treatment effect was linked to an early time window 〈 48 hours, specifying a target population for future trials.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.121.038455
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 2
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    Neurological manifestations and implications of COVID-19 pandemic
    SAGE Publications ; 2020
    In:  Therapeutic Advances in Neurological Disorders Vol. 13 ( 2020-01), p. 175628642093203-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 13 ( 2020-01), p. 175628642093203-
    Abstract: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide, with a vast majority of confirmed cases presenting with respiratory symptoms. Potential neurological manifestations and their pathophysiological mechanisms have not been thoroughly established. In this narrative review, we sought to present the neurological manifestations associated with coronavirus disease 2019 (COVID-19). Case reports, case series, editorials, reviews, case-control and cohort studies were evaluated, and relevant information was abstracted. Various reports of neurological manifestations of previous coronavirus epidemics provide a roadmap regarding potential neurological complications of COVID-19, due to many shared characteristics between these viruses and SARS-CoV-2. Studies from the current pandemic are accumulating and report COVID-19 patients presenting with dizziness, headache, myalgias, hypogeusia and hyposmia, but also with more serious manifestations including polyneuropathy, myositis, cerebrovascular diseases, encephalitis and encephalopathy. However, discrimination between causal relationship and incidental comorbidity is often difficult. Severe COVID-19 shares common risk factors with cerebrovascular diseases, and it is currently unclear whether the infection per se represents an independent stroke risk factor. Regardless of any direct or indirect neurological manifestations, the COVID-19 pandemic has a huge impact on the management of neurological patients, whether infected or not. In particular, the majority of stroke services worldwide have been negatively influenced in terms of care delivery and fear to access healthcare services. The effect on healthcare quality in the field of other neurological diseases is additionally evaluated.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286420932036
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 3
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    Online Resource
    Sonothrombolysis in Patients With Acute Ischemic Stroke With Large Vessel Occlusion: An Individual Patient Data Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 12 ( 2021-12), p. 3786-3795
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 12 ( 2021-12), p. 3786-3795
    Abstract: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials. Methods: We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time. Results: We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34] ). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52] ). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented. Conclusions: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.030960
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 4
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    Abstract 60: Outcomes Following Sonothrombolysis in Severe Acute Ischemic Stroke
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. suppl_1 ( 2012-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background & Purpose: A recent meta-analysis showed that sonothrombolysis is safe and can double the rate of early recanalization in acute ischemic stroke (AIS). We sought to explore whether patients with severe strokes could clinically benefit from ultrasound amplification of tPA-induced recanalization. Subjects & Methods: We compared functional outcomes at 3 months among randomized AIS patients with pre-treatment NIHSS scores 〉 =10 in the Combined Lysis of Thrombus in Brain Ischemia (CLOTBUST), Transcranial Ultrasound in Clinical Sonothrombolysis (TUCSON) and pilot randomized clinical safety study of sonothrombolysis with microspheres (Definity study). Patients had proximal arterial occlusions identified by baseline TCD and received intravenous (IV) tPA or IV tPA plus continuous 2-hour TCD ultrasound monitoring (=sonothrombolysis). Favorable outcome was defined as modified Rankin Scale (mRS) 0-1 at 3 months. Sustained complete recanalization was defined as Thrombolysis in Brain Ischemia (TIBI) flow grades 4-5 assessed by TCD at 2 hours after tPA bolus. Symptomatic intracranial hemorrhage (sICH) was defined using ECASS-2 definition as imaging evidence of ICH with clinical worsening (NIHSS 〉 =4) within 72 hours from stroke onset. Results: A total of 139 AIS patients with severe stroke due to proximal arterial occlusions (mean age 69±13years, 56% men, median NIHSS 17, interquartile range 14-21, range 10-34) were randomized in CLOTBUST (n=105), TUCSON (n=21) and Definity (n=13). A total of 60 (43%) and 79 (57%) patients were randomized to IV tPA and sonothrombolysis, respectively. Patients treated with IV tPA and sonothrombolysis did not differ in terms of age, baseline stroke severity, baseline TIBI grades and onset-to-treatment time. Symptomatic ICH rates were similar in patients treated with IV tPA and sonothrombolysis (5.0% vs. 5.1%; p=0.987). More patients achieved sustained complete recanalization in the sonothrombolysis than in the IV tPA group (38.0% vs. 18.3%; p=0.012). Favorable outcome (mRS 0-1) tended to be more prevalent in the sonothrombolysis than in the IV tPA group (36.6% vs. 23.2%; p=0.104). Conclusions: Our data point to a signal-of-efficacy and provide basis to determine the sample size of a phase 3 randomized trial of sonothrombolysis in patients with severe strokes ( NCT01098981 ).
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.43.suppl_1.A60
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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  • 5
    Online Resource
    Online Resource
    Blood pressure excursions in acute ischemic stroke patients treated with intravenous thrombolysis
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of Hypertension Vol. 39, No. 2 ( 2021-02), p. 266-272
    Details
    In: Journal of Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 39, No. 2 ( 2021-02), p. 266-272
    Abstract: To investigate the association of blood pressure BP excursions, defined as greater than 185 SBP or greater than 105 DBP, with the probability of intracranial hemorrhage (ICH) and worse functional outcomes in patients with acute ischemic stroke (AIS) treated with tissue plasminogen activator (tPA). Methods: We performed a post hoc analysis of the CLOTBUST-ER trial. Serial BP measurements were conducted using automated cuff recording according to the recommended BP protocol guidelines for tPA administration. The outcomes were prespecified efficacy and safety endpoints of CLOTBUST-ER. Results: The mean number of serial BP recordings per patient was 37. Of the 674 patients, 227 (34%) had at least one BP excursion ( 〉 185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P  = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80–0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81–0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87–0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88–0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82–0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04–1.53). Conclusion: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.
    Type of Medium: Online Resource
    ISSN: 0263-6352 , 1473-5598
    URL: Article
    DOI: 10.1097/HJH.0000000000002628
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 2017684-3
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  • 6
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    Comparative efficacy of different acute reperfusion therapies for acute ischemic stroke: a comprehensive benefit–risk analysis of clinical trials
    Wiley ; 2014
    In:  Brain and Behavior Vol. 4, No. 6 ( 2014-11), p. 789-797
    Details
    In: Brain and Behavior, Wiley, Vol. 4, No. 6 ( 2014-11), p. 789-797
    Abstract: Numerous acute reperfusion therapies ( RPT ) are currently investigated as potential new therapeutic targets in acute ischemic stroke ( AIS ). We conducted a comprehensive benefit–risk analysis of available clinical studies assessing different acute RPT , and investigated the utility of each intervention in comparison to standard intravenous thrombolysis ( IVT ) and in relation to the onset‐to‐treatment time ( OTT ). Methods A comprehensive literature search was conducted to identify all available published, peer‐reviewed clinical studies that evaluated the efficacy of different RPT in AIS . Benefit‐to‐risk ratio ( BRR ), adjusted for baseline stroke severity, was estimated as the percentage of patients achieving favorable functional outcome ( BRR 1, mRS score: 0–1) or functional independence (BRR2, mRS score: 0–2) at 3 months divided by the percentage of patients who died during the same period. Results A total of 18 randomized ( n  = 13) and nonrandomized ( n  = 5) clinical studies fulfilled our inclusion criteria. IV therapy with tenecteplase ( TNK ) was found to have the highest BRR s ( BRR 1 = 5.76 and BRR 2 = 6.82 for low‐dose TNK ; BRR 1 = 5.80 and BRR 2 = 6.87 for high‐dose TNK ), followed by sonothrombolysis ( BRR 1 = 2.75 and BRR 2 = 3.38), while endovascular thrombectomy with MERCI retriever was found to have the lowest BRR s ( BRR 1 range, 0.31–0.65; BRR 2 range, 0.52–1.18). A second degree negative polynomial correlation was detected between favorable functional outcome and OTT ( R 2 value: 0.6419; P   〈  0.00001) indicating the time dependency of clinical efficacy of all reperfusion therapies. Conclusion Intravenous thrombolysis ( IVT ) with TNK and sonothrombolysis have the higher BRR among investigational reperfusion therapies. The combination of sonothrombolysis with IV administration of TNK appears a potentially promising therapeutic option deserving further investigation.
    Type of Medium: Online Resource
    ISSN: 2162-3279 , 2162-3279
    URL: Issue
    URL: Article
    DOI: 10.1002/brb3.2014.4.issue-6
    DOI: 10.1002/brb3.279
    Language: English
    Publisher: Wiley
    Publication Date: 2014
    detail.hit.zdb_id: 2623587-0
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  • 7
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    Outcomes following Sonothrombolysis in Severe Acute Ischemic Stroke: Subgroup Analysis of the CLOTBUST Trial
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Abstract: Sonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic stroke patients. Aims In preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial. Methods We analyzed the data from all randomized acute ischemic stroke patients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4–5) and functional independence (modified Rankin Scale 0–1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset. Results Of 126 patients, a total of 85 acute ischemic stroke patients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14–20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00). Conclusions Our results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12340
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
    detail.hit.zdb_id: 2211666-7
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  • 8
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    International beliefs and head positioning practices in patients with spontaneous hyperacute intracerebral hemorrhage
    SAGE Publications ; 2023
    In:  Therapeutic Advances in Neurological Disorders Vol. 16 ( 2023-01), p. 175628642311611-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 16 ( 2023-01), p. 175628642311611-
    Abstract: Prior to the conduct of the Head Position in Stroke Trial (HeadPoST), an international survey ( n = 128) revealed equipoise for selection of head position in acute ischemic stroke. Objectives: We aimed to determine whether equipoise exists for head position in spontaneous hyperacute intracerebral hemorrhage (ICH) patients following HeadPoST. Design: This is an international, web-distributed survey focused on head positioning in hyperacute ICH patients. Methods: A survey was constructed to examine clinicians’ beliefs and practices associated with head positioning of hyperacute ICH patients. Survey items were developed with content experts, piloted, and then refined before distributing through stroke listservs, social media, and purposive snowball sampling. Data were analyzed using descriptive statistics and χ 2 test. Results: We received 181 responses representing 13 countries on four continents: 38% advanced practice providers, 32% bedside nurses, and 30% physicians; overall, participants had median 7 [interquartile range (IQR) = 3–12] years stroke experience with a median of 100 (IQR = 37.5–200) ICH admissions managed annually. Participants disagreed that HeadPoST provided ‘definitive evidence’ for head position in ICH and agreed that their ‘written admission orders include 30-degree head positioning’, with 54% citing hospital policies for this head position in hyperacute ICH. Participants were unsure whether head positioning alone could influence ICH longitudinal outcomes. Use of serial proximal clinical and technology measures during the head positioning intervention were identified by 82% as the most appropriate endpoints for future ICH head positioning trials. Conclusion: Interdisciplinary providers remain unconvinced by HeadPoST results that head position does not matter in hyperacute ICH. Future trials examining the proximal effects of head positioning on clinical stability in hyperacute ICH are warranted.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/17562864231161162
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 9
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    Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Neurological Disorders Vol. 12 ( 2019-01), p. 175628641986065-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 12 ( 2019-01), p. 175628641986065-
    Abstract: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p  〈  0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286419860652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
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  • 10
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    Abstract 156: Intravenous Thrombolysis for Acute Ischemic Stroke in the Golden Hour: A Systematic Review and Meta-Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Stroke Vol. 49, No. Suppl_1 ( 2018-01-22)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 49, No. Suppl_1 ( 2018-01-22)
    Abstract: Introduction: Data are scarce regarding the outcomes of acute ischemic stroke (AIS) patients treated with intravenous thrombolysis (IVT) within 60 min from symptom onset, termed the “golden hour” (GH) window. We present systematic review and meta-analysis of outcomes between AIS patients treated within (+) and outside (-) the GH. Methods: We performed a systematic review in MEDLINE and SCOPUS databases for observational studies providing unadjusted rates or adjusted odds ratios (OR) for the following outcomes: symptomatic intracranial hemorrhage (sICH), mortality and favourable functional outcome (FFO), defined as mRS-scores of 0-1. Results: We identified 3 eligible studies (range of median NIHSS-scores: 10-11 points), including a total of 72,662 IVT-treated patients (1.5% treated within the GH. GH(+) patients had higher FFO rates (42%, 95%CI:35%-48%) compared to GH(-) patients (31%, 95%CI:30%-31%). In adjusted analyses, IVT within the GH was associated with a two-fold increase in the odds of FFO (OR=2.02, 95%CI: 1.55-2.63, p 〈 0.001) without heterogeneity across studies (I 2 =0, p for Cochran Q=0.93; Figure). No significant differences on the risk of both sICH (OR=0.77, 95%CI: 0.53-1.13, p=0.180; I 2 =0, p for Cochran Q=0.63) and mortality (OR=0.61, 95%CI: 0.29-1.28, p=0.190; I 2 =72, p for Cochran Q=0.03) were documented between the two groups in adjusted analyses. Conclusions: AIS treated within the GH have substantially higher odds of FFO compared to IVT administered later during conventional time window independent of potential confounders. Improvement of care systems to achieve the earliest onset to treatment times should remain the goal of the front line stroke treatment.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.49.suppl_1.156
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
    detail.hit.zdb_id: 1467823-8
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