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Observational Study
. 2020 Jan 1;77(1):25-34.
doi: 10.1001/jamaneurol.2019.3403.

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

Peter B Sporns  1 , Ronald Sträter  2 , Jens Minnerup  3 , Heinz Wiendl  3 , Uta Hanning  4 , René Chapot  5 , Hans Henkes  6 , Elina Henkes  6 , Astrid Grams  7 , Franziska Dorn  8 , Omid Nikoubashman  9 , Martin Wiesmann  9 , Georg Bier  1   10 , Anushe Weber  11 , Gabriel Broocks  4 , Jens Fiehler  4 , Alex Brehm  12 , Marios Psychogios  12 , Daniel Kaiser  13 , Umut Yilmaz  14 , Andrea Morotti  15 , Wolfgang Marik  16 , Richard Nolz  17 , Ulf Jensen-Kondering  18 , Bernd Schmitz  19 , Stefan Schob  20 , Oliver Beuing  21 , Friedrich Götz  22 , Johannes Trenkler  23 , Bernd Turowski  24 , Markus Möhlenbruch  25 , Christina Wendl  26 , Peter Schramm  27 , Patricia Musolino  28 , Sarah Lee  29 , Marc Schlamann  30 , Alexander Radbruch  31 , Nicole Rübsamen  32 , André Karch  32 , Walter Heindel  1 , Moritz Wildgruber  1 , André Kemmling  3
Affiliations
Observational Study

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

Peter B Sporns et al. JAMA Neurol. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Wiendl reported receiving personal fees from AbbVie, Actelion, Alexion, Biogen, Cognomed, Evgen, F. Hoffmann-La Roche Ltd, Gemeinnützige Hertie-Stiftung, Genzyme, IGES, Johnson & Johnson, MedDay Pharmaceuticals, Merck Serono, Novartis, Roche Pharma AG, Sanofi-Aventis, Teva, WebMD Global, and the Swiss Multiple Sclerosis Society; and grants from the German Ministry for Education and Research, Deutsche Forschungsgesellschaft, Else Kröner Fresenius Foundation, Fresenius Foundation, Gemeinnützige Hertie-Stiftung, NRW Ministry of Education and Research, Interdisciplinary Center for Clinical Studies Muenster, RE Children's Foundation, Biogen, GlaxoSmithKline, and Roche Pharma AG outside the submitted work. Dr Chapot reported receiving personal fees from Microvention, Stryker, Medtronic, Balt, Siemens, and Rapid Medical outside the submitted work. Dr H. Henkes reported receiving personal fees and nonfinancial support from phenox GmbH during the conduct of the study; in addition, Dr H. Henkes had patents issued to 10 2004 040 868.8, 200580033578.6, 11/678,285, 50 2006 012 111.5, PCT/EP 2005/009057, 05 777 177.6-2318, and 10 2005 059 670.3, and is coinventor of several other patents related to thrombectomy. Dr E. Henkes reported receiving personal fees from phenox GmbH during the conduct of the study; in addition, Dr E. Henkes had a patent to stent retriever with royalties paid and is a paid consultant for Acandis, Germany. Dr Wiesmann reported receiving grants, personal fees, and nonfinancial support from Stryker Neurovascular; personal fees and nonfinancial support from Medtronic, Penumbra Inc, and Siemens Healthcare; and nonfinancial support from ab medica, Acandis, Asahi Intecc, Cerenovus, Kaneka Pharmaceuticals, Mentice AB, Microvention, and phenox outside the submitted work. Dr Fiehler reported serving as a paid consultant for Acandis, Boehringer Ingelheim, Cerenovus, Covidien, Evasc Neurovascular, MD Clinicals, Medtronic, Medina, Microvention, Penumbra, Route92, Stryker, and Transverse Medical. Dr Trenkler reported receiving grants from Medtronic outside the submitted work. Dr Möhlenbruch reported receiving grants and nonfinancial support from Balt; personal fees from Medtronic; grants, personal fees, and nonfinancial support from MicroVention; and grants and personal fees from Stryker outside the submitted work. Dr Radbruch reported receiving grants and personal fees from Guerbet and Bayer outside the submitted work. Dr Kemmling reported receiving personal fees from Penumbra, Stryker, and phenox outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Course of Pediatric National Institutes of Health Stroke Scale (PedNIHSS) Scores in Patients of the Save ChildS Study (N = 73)
Possible score range for the PedNIHSS is 0 (no deficit) to 34 (maximum deficit).
Figure 2.
Figure 2.. Pediatric National Institutes of Health Stroke Scale (PedNIHSS) Scores (PedNIHSS) in Save ChildS at Different Times Compared With NIHSS Measured in the HERMES Meta-analysis Trials
Possible score range for the PedNIHSS is 0 (no deficit) to 34 (maximum deficit). Error bars represent interquartile range.
Figure 3.
Figure 3.. Modified Rankin Scale (mRS) Scores in Save ChildS Measured at Discharge and 180 Days Compared With mRS Scores in the HERMES Meta-analysis Trials Measured at 90 Days
Possible score range for the mRS is 0 (no deficit) to 6 (death). aIn SWIFT PRIME, mRS scores of 5 and 6 were combined into 1 category mRS score greater than or equal to 5.
Figure 4.
Figure 4.. Proportion of Symptomatic Intracerebral Hemorrhage (sICH) Events in Save ChildS Compared With the Results of the HERMES Meta-analysis Trials
A, Proportion of sICH in the 7 HERMES studies and combined estimate. B, Proportion of sICH in Save ChildS and combined estimate including 7 Hermes studies.
See this image and copyright information in PMC

Comment in

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