Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study

Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombecto...

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Published inThe lancet child & adolescent health Vol. 8; no. 12; pp. 882 - 890
Main Authors Sporns, Peter B, Bhatia, Kartik, Abruzzo, Todd, Pabst, Lisa, Fraser, Stuart, Chung, Melissa G, Lo, Warren, Othman, Ahmed, Steinmetz, Sebastian, Jensen-Kondering, Ulf, Schob, Stefan, Kaiser, Daniel P O, Marik, Wolfgang, Wendl, Christina, Kleffner, Ilka, Henkes, Hans, Kraehling, Hermann, Nguyen-Kim, Thi Dan Linh, Chapot, René, Yilmaz, Umut, Wang, Furene, Hafeez, Muhammad Ubaid, Requejo, Flavio, Limbucci, Nicola, Kauffmann, Birgit, Möhlenbruch, Markus, Nikoubashman, Omid, Schellinger, Peter D, Musolino, Patricia, Alawieh, Ali, Wilson, Jenny, Grieb, Dominik, Gersing, Alexandra S, Liebig, Thomas, Olivieri, Martin, Schwabova, Jaroslava Paulasova, Tomek, Ales, Papanagiotou, Panagiotis, Boulouis, Grégoire, Naggara, Olivier, Fox, Christine K, Orlov, Kirill, Kuznetsova, Alexandra, Parra-Farinas, Carmen, Muthusami, Prakash, Regenhardt, Robert W, Dmytriw, Adam A, Burkard, Tanja, Martinez, Mesha, Brechbühl, Daniel, Steinlin, Maja, Sun, Lisa R, Hassan, Ameer E, Kemmling, André, Lee, Sarah, Fullerton, Heather J, Fiehler, Jens, Psychogios, Marios-Nikos, Wildgruber, Moritz
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.12.2024
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Abstract Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke. In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960. Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6–14]), and 91 patients received best medical treatment (6 years [3–12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10–19) in the endovascular thrombectomy group and 9 (5–13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0–0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0–2) in the endovascular thrombectomy group and 2 (1–3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0–2) in the endovascular thrombectomy group and 2 (1–3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1–3] vs 2 [1–4]; p=0·074). Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children. None.
AbstractList Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke.BACKGROUNDEmerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke.In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960.METHODSIn this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960.Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074).FINDINGSBetween Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074).Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children.INTERPRETATIONClinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children.None.FUNDINGNone.
Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke. In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960. Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074). Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children. None.
Author Fullerton, Heather J
Wang, Furene
Orlov, Kirill
Grieb, Dominik
Tomek, Ales
Wendl, Christina
Liebig, Thomas
Möhlenbruch, Markus
Abruzzo, Todd
Gersing, Alexandra S
Naggara, Olivier
Lee, Sarah
Psychogios, Marios-Nikos
Lo, Warren
Kleffner, Ilka
Schob, Stefan
Fox, Christine K
Brechbühl, Daniel
Limbucci, Nicola
Parra-Farinas, Carmen
Kraehling, Hermann
Alawieh, Ali
Jensen-Kondering, Ulf
Regenhardt, Robert W
Marik, Wolfgang
Kaiser, Daniel P O
Kauffmann, Birgit
Musolino, Patricia
Fraser, Stuart
Chung, Melissa G
Burkard, Tanja
Chapot, René
Pabst, Lisa
Hafeez, Muhammad Ubaid
Muthusami, Prakash
Wilson, Jenny
Schwabova, Jaroslava Paulasova
Yilmaz, Umut
Henkes, Hans
Nguyen-Kim, Thi Dan Linh
Martinez, Mesha
Bhatia, Kartik
Kuznetsova, Alexandra
Dmytriw, Adam A
Fiehler, Jens
Papanagiotou, Panagiotis
Requejo, Flavio
Othman, Ahmed
Steinmetz, Sebastian
Schellinger, Peter D
Hassan, Ameer E
Kemmling, André
Sporns, Peter B
Olivieri, Martin
Wildgruber, Moritz
Boulouis, Grégoire
Steinlin, Maja
Sun, Lisa R
Nikoubashman, Omid
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  givenname: Daniel P O
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  organization: Institute of Radiology, University Hospital Regensburg, Regensburg, Germany
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  organization: Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Germany
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  organization: Neuroradiological Clinic, Katharinenhospital, Klinikum Stuttgart, Stuttgart, Germany
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  givenname: Thi Dan Linh
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  givenname: Flavio
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  givenname: Peter D
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  organization: Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA
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  organization: Division of Pediatric Neurology, Oregon Health & Science University, Portland, OR, USA
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  organization: Department of Neuroradiology, LMU University Hospital, LMU Munich, Munich, Germany
– sequence: 35
  givenname: Martin
  surname: Olivieri
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  organization: Pediatric Thrombosis and Hemostasis Unit, Dr von Hauner Children's Hospital, LMU Munich, Munich, Germany
– sequence: 36
  givenname: Jaroslava Paulasova
  surname: Schwabova
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  givenname: Ales
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  givenname: Grégoire
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  givenname: Olivier
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  organization: French Center for Pediatric Stroke, Paris, France
– sequence: 41
  givenname: Christine K
  surname: Fox
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  organization: Department of Neurology and Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA
– sequence: 42
  givenname: Kirill
  surname: Orlov
  fullname: Orlov, Kirill
  organization: Research Center of Endovascular Neurosurgery, Federal Center of Brain Research and Neuro Technologies of FMBA, Moscow, Russia
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  givenname: Alexandra
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  givenname: Prakash
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  givenname: Robert W
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  organization: University Hospital, LMU Munich, Germany
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– sequence: 51
  givenname: Maja
  surname: Steinlin
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  organization: Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
– sequence: 52
  givenname: Lisa R
  surname: Sun
  fullname: Sun, Lisa R
  organization: Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA
– sequence: 53
  givenname: Ameer E
  surname: Hassan
  fullname: Hassan, Ameer E
  organization: Department of Neurology, University of Texas Rio Grande Valley, Harlingen, TX, USA
– sequence: 54
  givenname: André
  surname: Kemmling
  fullname: Kemmling, André
  organization: Department of Neuroradiology, University of Marburg, Marburg, Germany
– sequence: 55
  givenname: Sarah
  surname: Lee
  fullname: Lee, Sarah
  organization: Division of Child Neurology, Department of Neurology, Stanford University, Stanford, CA, USA
– sequence: 56
  givenname: Heather J
  surname: Fullerton
  fullname: Fullerton, Heather J
  organization: Department of Neurology and Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA
– sequence: 57
  givenname: Jens
  surname: Fiehler
  fullname: Fiehler, Jens
  organization: Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
– sequence: 58
  givenname: Marios-Nikos
  surname: Psychogios
  fullname: Psychogios, Marios-Nikos
  organization: Department of Neuroradiology, University Hospital Basel, Basel, Switzerland
– sequence: 59
  givenname: Moritz
  surname: Wildgruber
  fullname: Wildgruber, Moritz
  organization: Department of Radiology, LMU University Hospital, LMU Munich, Munich, Germany
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CitedBy_id crossref_primary_10_1016_j_pediatrneurol_2025_01_004
crossref_primary_10_1016_S2352_4642_24_00257_8
crossref_primary_10_1055_a_2503_3994
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39401506 - Lancet Child Adolesc Health. 2024 Dec;8(12):844-845. doi: 10.1016/S2352-4642(24)00257-8.
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Snippet Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular...
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SubjectTerms Adolescent
Child
Child, Preschool
Endovascular Procedures - methods
Female
Humans
Infant
Infant, Newborn
Ischemic Stroke - surgery
Ischemic Stroke - therapy
Male
Prospective Studies
Registries
Stroke - surgery
Stroke - therapy
Thrombectomy - methods
Treatment Outcome
Title Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study
URI https://dx.doi.org/10.1016/S2352-4642(24)00233-5
https://www.ncbi.nlm.nih.gov/pubmed/39401507
https://www.proquest.com/docview/3116675508
Volume 8
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