Showing papers by "Peter D. Schellinger published in 2021"
National and Kapodistrian University of Athens1, University Hospital of Basel2, Oslo University Hospital3, Aristotle University of Thessaloniki4, University of Lisbon5, University of Texas Health Science Center at Houston6, Democritus University of Thrace7, university of lille8, University of Tennessee Health Science Center9
TL;DR: In this article, the authors summarize recent randomized and real-world data on the safety and efficacy of off-label use of intravenous thrombolysis (IVT) for acute ischemic stroke.
Abstract: Intravenous thrombolysis (IVT) represents the only systemic reperfusion therapy able to reverse neurological deficit in patients with acute ischemic stroke (AIS). Despite its effectiveness in patients with or without large vessel occlusion, it can be offered only to a minority of them, because of the short therapeutic window and additional contraindications derived from stringent but arbitrary inclusion and exclusion criteria used in landmark randomized controlled clinical trials. Many absolute or relative contraindications lead to disparities between the official drug label and guidelines or expert recommendations. Based on recent advances in neuroimaging and evidence from cohort studies, off-label use of IVT is increasingly incorporated into the daily practice of many stroke centers. They relate to extension of therapeutic time windows, and expansion of indications in co-existing conditions originally listed in exclusion criteria, such as use of alternative thrombolytic agents, pre-treatment with antiplatelets, anticoagulants or low molecular weight heparins. In this narrative review, we summarize recent randomized and real-world data on the safety and efficacy of off-label use of IVT for AIS. We also make some practical recommendations to stroke physicians regarding the off-label use of thrombolytic agents in complex and uncommon presentations of AIS or other conditions mimicking acute cerebral ischemia. Finally, we provide guidance on the risks and benefits of IVT in numerous AIS subgroups, where equipoise exists and guidelines and treatment practices vary.
22 citations
National and Kapodistrian University of Athens1, University of Tennessee Health Science Center2, Population Health Research Institute3, Baylor College of Medicine4, Michael E. DeBakey Veterans Affairs Medical Center in Houston5, University of Duisburg-Essen6, University of Helsinki7, University of Texas Health Science Center at Houston8, National University of Singapore9, Masaryk University10, University of Glasgow11, Texas Medical Center12, John Hunter Hospital13, Autonomous University of Barcelona14, University of Alberta15, Hamad Medical Corporation16, University of Ioannina17, Charité18, Oslo University Hospital19, Texas A&M Health Science Center20, Houston Methodist Hospital21, Ruhr University Bochum22
TL;DR: 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.
Abstract: Objective 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.
11 citations
University of Tennessee1, National and Kapodistrian University of Athens2, Population Health Research Institute3, University of Toulouse4, University of Bergen5, Haukeland University Hospital6, Texas Medical Center7, University of Ioannina8, Ruhr University Bochum9, Paris Descartes University10, University of Calgary11, Allen Institute for Brain Science12, Hebron University13, St. Michael's GAA, Sligo14, Imperial College London15, University of Duisburg-Essen16, University of Helsinki17, University of Texas Health Science Center at Houston18, Hamad Medical Corporation19, University of Alberta20, University of Glasgow21, Charité22, Houston Methodist Hospital23, Texas A&M Health Science Center24, Michael E. DeBakey Veterans Affairs Medical Center in Houston25, Baylor College of Medicine26
TL;DR: Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thromboelsis alone in patients with AIS with large vessel occlusion.
Abstract: Background and Purpose: Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safet...
3 citations
George Ntaios1, Menno V. Huisman2, Hans-Christoph Diener3, Jonathan L. Halperin4 +898 more•Institutions (7)
TL;DR: The lack of clear association between the SAMe-TT2R2 score and anticoagulant selection may be attributed to the relative efficacy and safety profiles between NOACs and VKAs, as well as to the absence of trial evidence that a SAM e-TT 2R2-guided strategy for the selection of the type of anticoAGulation in NVAF patients has an impact on clinical outcomes of efficacy andSafety.
3 citations
DOI•
17 Nov 2021TL;DR: In this paper, a short prospective protocol using Bland-Altman analysis was developed to assess the level of agreement between operators with different expertise levels in nerve ultrasound of the left median and ulnar nerve arm.
Abstract: Currently, there is no standardized method to evaluate operator reliability in nerve ultrasound. A short prospective protocol using Bland–Altman analysis was developed to assess the level of agreement between operators with different expertise levels. A control rater without experience in nerve ultrasound, three novices after two months of training, an experienced rater with two years of experience, and a reference rater performed blinded ultrasound examinations of the left median and ulnar nerve in 42 nerve sites in healthy volunteers. The precision of Bland–Altman agreement analysis was tested using the Preiss–Fisher procedure. Intraclass correlation coefficients (ICC), coefficients of variation, and Bland–Altman limits of agreement were calculated. The sample size calculation and Preiss–Fisher procedure showed a sufficient precision of Bland–Altman agreement analysis. Limits of agreement of all trained novices ranged from 2.0 to 2.9 mm2 and were within the test’s maximum tolerated difference. Ninety-five percent confidence intervals of limits of agreement revealed a higher precision in the experienced rater’s measurements. Operator reliability in nerve ultrasound of the median and ulnar nerve arm nerves can be evaluated with a short prospective controlled protocol using Bland–Altman statistics, allowing a clear distinction between an untrained rater, trained novices after two months of training, and an experienced rater.