Dataset Information

Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke: The Save ChildS Study.

ABSTRACT: Importance:Randomized clinical trials have shown the efficacy of thrombectomy of large intracranial vessel occlusions in adults; however, any association of therapy with clinical outcomes in children is unknown. Objective:To evaluate the use of endovascular recanalization in pediatric patients with arterial ischemic stroke. Design, Setting, and Participants:This retrospective, multicenter cohort study, conducted from January 1, 2000, to December 31, 2018, analyzed the databases from 27 stroke centers in Europe and the United States. Included were all pediatric patients (<18 years) with ischemic stroke who underwent endovascular recanalization. Median follow-up time was 16 months. Exposures:Endovascular recanalization. Main Outcomes and Measures:The decrease of the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score from admission to day 7 was the primary outcome (score range: 0 [no deficit] to 34 [maximum deficit]). Secondary clinical outcomes included the modified Rankin scale (mRS) (score range: 0 [no deficit] to 6 [death]) at 6 and 24 months and rate of complications. Results:Seventy-three children from 27 participating stroke centers were included. Median age was 11.3 years (interquartile range [IQR], 7.0-15.0); 37 patients (51%) were boys, and 36 patients (49%) were girls. Sixty-three children (86%) received treatment for anterior circulation occlusion and 10 patients (14%) received treatment for posterior circulation occlusion; 16 patients (22%) received concomitant intravenous thrombolysis. Neurologic outcome improved from a median PedNIHSS score of 14.0 (IQR, 9.2-20.0) at admission to 4.0 (IQR, 2.0-7.3) at day 7. Median mRS score was 1.0 (IQR, 0-1.6) at 6 months and 1.0 (IQR, 0-1.0) at 24 months. One patient (1%) developed a postinterventional bleeding complication and 4 patients (5%) developed transient peri-interventional vasospasm. The proportion of symptomatic intracerebral hemorrhage events in the HERMES meta-analysis of trials with adults was 2.79 (95% CI, 0.42-6.66) and in Save ChildS was 1.37 (95% CI, 0.03-7.40). Conclusions and Relevance:The results of this study suggest that the safety profile of thrombectomy in childhood stroke does not differ from the safety profile in randomized clinical trials for adults; most of the treated children had favorable neurologic outcomes. This study may support clinicians' practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.

SUBMITTER: Sporns PB

PROVIDER: S-EPMC6802048 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke: The Save ChildS Study.

Sporns Peter B PB Sträter Ronald R Minnerup Jens J Wiendl Heinz H Hanning Uta U Chapot René R Henkes Hans H Henkes Elina E Grams Astrid A Dorn Franziska F Nikoubashman Omid O Wiesmann Martin M Bier Georg G Weber Anushe A Broocks Gabriel G Fiehler Jens J Brehm Alex A Psychogios Marios M Kaiser Daniel D Yilmaz Umut U Morotti Andrea A Marik Wolfgang W Nolz Richard R Jensen-Kondering Ulf U Schmitz Bernd B Schob Stefan S Beuing Oliver O Götz Friedrich F Trenkler Johannes J Turowski Bernd B Möhlenbruch Markus M Wendl Christina C Schramm Peter P Musolino Patricia P Lee Sarah S Schlamann Marc M Radbruch Alexander A Rübsamen Nicole N Karch André A Heindel Walter W Wildgruber Moritz M Kemmling André A

JAMA neurology 20200101 1

<h4>Importance</h4>Randomized clinical trials have shown the efficacy of thrombectomy of large intracranial vessel occlusions in adults; however, any association of therapy with clinical outcomes in children is unknown.<h4>Objective</h4>To evaluate the use of endovascular recanalization in pediatric patients with arterial ischemic stroke.<h4>Design, setting, and participants</h4>This retrospective, multicenter cohort study, conducted from January 1, 2000, to December 31, 2018, analyzed the datab ...[more]

PMID: 31609380

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Project description:Background and purposeIn acute middle cerebral artery (MCA) stroke, CT angiographic (CTA) source images (CTA-SI) identify tissue likely to infarct despite early recanalization. This pilot study evaluated the impact of recanalization status on clinical and radiologic predictors of patient outcomes.Materials and methodsOf 44 patients undergoing CT/CTA within 6 hours of developing symptoms of proximal MCA ischemia, 19 patients achieved complete proximal MCA (MCA M1) recanalization. Admission National Institutes of Health Stroke Scale (NIHSS) score, onset-to-imaging time, CTA-SI Alberta Stroke Program Early CT Score, MCA M1 occlusion, cerebrovascular collaterals score, and CTA-SI lesion volume were correlated with 3- to 6-month follow-up modified Rankin Scale (mRS). We developed 2 stepwise regression models: one for patients with complete MCA M1 recanalization and one for patients without complete recanalization.ResultsComplete and incomplete recanalization groups had similar median admission NIHSS scores (19 versus 19) and mean onset-to-imaging times (2.3 versus 1.9 hours) but different proportions of patients achieving mRS scores 0-2 (74% versus 40%; P = .04). The only independent predictors of clinical outcome in patients with complete recanalization were onset-to-imaging time and admission CTA-SI lesion volume (total model R(2) = 0.75; P = .01). The only independent predictors of outcome in patients with incomplete recanalization were admission CTA-SI lesion volume and NIHSS score (total model R(2) = 0.66; P = .007).ConclusionRegardless of recanalization status, admission CTA-SI lesion volume was associated with clinical outcome. Recanalization status did, however, affect which variables in addition to CTA-SI volume significantly impacted clinical outcome: time with complete recanalization and NIHSS with incomplete recanalization. This finding may support the development of a model predicting the potential clinical benefit expected with early successful recanalization.

Project description:Aim of this study was to establish a simple and highly reproducible physiological circulation model to investigate endovascular device performance. The developed circulation model included a pneumatically driven pulsatile pump to generate a flow rate of 2.7 L/min at 70 beats per minute. Sections from the superficial femoral arteries were used in order to simulate device/tissue interaction and a filter was integrated to analyze periinterventional thromboembolism of white, red and mixed thrombi. The working fluid (3 L) was a crystalloid solution constantly tempered at 36.5 °C. To evaluate the model, aspiration thrombectomy, stent-implantation and thrombectomy with the Fogarty catheter were performed. Usability of the model was measured by the System Usability Scale (SUS) - Score. Histological specimens were prepared and analyzed postinterventional to quantify tissue/device interaction. Moreover, micro- and macroembolism were evaluated for each thrombus entity and each device. Results were tested for normality using the D'Agostino-Pearson test. Statistical comparisons of two groups were performed using the Student's t-test. All devices were able to remove the occlusions after a maximum of 2 attempts. First-pass-recanalization was not fully achieved for aspiration thrombectomy of mixed thrombi (90.6%), aspiration thrombectomy of red thrombi (84.4%) and stent-implantation in occlusions of red thrombi (92.2%). Most micro- and macroembolism were observed using the Fogarty catheter and after stent-implantation in occlusions of white thrombi. Histological examinations revealed a significant reduction of the vascular layers suggesting vascular damage after use of the Fogarty catheter (327.3 ± 3.5 μm vs. 440.6 ± 3.9 μm; p = 0.026). Analysis of SUS rendered a mean SUS-Score of 80.4 which corresponds to an excellent user acceptability of the model. In conclusion, we describe a stable, easy to handle and reproducible physiological circulation model for the simulation of endovascular thrombectomy including device performance and thromboembolism.

Dataset Information

Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke: The Save ChildS Study.

Publications

Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke: The Save ChildS Study.

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