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Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study
BACKGROUND: Previous randomised controlled trials could not demonstrate that surgical evacuation of intracerebral haemorrhage (ICH) improves functional outcome. Increasing evidence suggests that minimally invasive surgery may be beneficial, in particular when performed early after symptom onset. The...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Vienna
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10134719/ https://www.ncbi.nlm.nih.gov/pubmed/37103585 http://dx.doi.org/10.1007/s00701-023-05599-2 |
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author | Sondag, Lotte Schreuder, Floris H.B.M. Pegge, Sjoert A.H. Coutinho, Jonathan M. Dippel, Diederik W.J. Janssen, Paula M. Vandertop, W. Peter Boogaarts, Hieronymus D. Dammers, Ruben Klijn, Catharina J.M. |
author_facet | Sondag, Lotte Schreuder, Floris H.B.M. Pegge, Sjoert A.H. Coutinho, Jonathan M. Dippel, Diederik W.J. Janssen, Paula M. Vandertop, W. Peter Boogaarts, Hieronymus D. Dammers, Ruben Klijn, Catharina J.M. |
author_sort | Sondag, Lotte |
collection | PubMed |
description | BACKGROUND: Previous randomised controlled trials could not demonstrate that surgical evacuation of intracerebral haemorrhage (ICH) improves functional outcome. Increasing evidence suggests that minimally invasive surgery may be beneficial, in particular when performed early after symptom onset. The aim of this study was to investigate safety and technical efficacy of early minimally invasive endoscopy-guided surgery in patients with spontaneous supratentorial ICH. METHODS: The Dutch Intracerebral Haemorrhage Surgery Trial pilot study was a prospective intervention study with blinded outcome assessment in three neurosurgical centres in the Netherlands. We included adult patients with spontaneous supratentorial ICH ≥10mL and National Institute of Health Stroke Scale (NIHSS) score ≥2 for minimally invasive endoscopy-guided surgery within 8 h after symptom onset in addition to medical management. Primary safety outcome was death or increase in NIHSS ≥4 points at 24 h. Secondary safety outcomes were procedure-related serious adverse events (SAEs) within 7 days and death within 30 days. Primary technical efficacy outcome was ICH volume reduction (%) at 24 h. RESULTS: We included 40 patients (median age 61 years; IQR 51–67; 28 men). Median baseline NIHSS was 19.5 (IQR 13.3–22.0) and median ICH volume 47.7mL (IQR 29.4–72.0). Six patients had a primary safety outcome, of whom two already deteriorated before surgery and one died within 24 h. Sixteen other SAEs were reported within 7 days in 11 patients (of whom two patients that already had a primary safety outcome), none device related. In total, four (10%) patients died within 30 days. Median ICH volume reduction at 24 h was 78% (IQR 50–89) and median postoperative ICH volume 10.5mL (IQR 5.1–23.8). CONCLUSIONS: Minimally invasive endoscopy-guided surgery within 8 h after symptom onset for supratentorial ICH appears to be safe and can effectively reduce ICH volume. Randomised controlled trials are needed to determine whether this intervention also improves functional outcome. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03608423, August 1st, 2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00701-023-05599-2. |
format | Online Article Text |
id | pubmed-10134719 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Vienna |
record_format | MEDLINE/PubMed |
spelling | pubmed-101347192023-04-28 Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study Sondag, Lotte Schreuder, Floris H.B.M. Pegge, Sjoert A.H. Coutinho, Jonathan M. Dippel, Diederik W.J. Janssen, Paula M. Vandertop, W. Peter Boogaarts, Hieronymus D. Dammers, Ruben Klijn, Catharina J.M. Acta Neurochir (Wien) Original Article BACKGROUND: Previous randomised controlled trials could not demonstrate that surgical evacuation of intracerebral haemorrhage (ICH) improves functional outcome. Increasing evidence suggests that minimally invasive surgery may be beneficial, in particular when performed early after symptom onset. The aim of this study was to investigate safety and technical efficacy of early minimally invasive endoscopy-guided surgery in patients with spontaneous supratentorial ICH. METHODS: The Dutch Intracerebral Haemorrhage Surgery Trial pilot study was a prospective intervention study with blinded outcome assessment in three neurosurgical centres in the Netherlands. We included adult patients with spontaneous supratentorial ICH ≥10mL and National Institute of Health Stroke Scale (NIHSS) score ≥2 for minimally invasive endoscopy-guided surgery within 8 h after symptom onset in addition to medical management. Primary safety outcome was death or increase in NIHSS ≥4 points at 24 h. Secondary safety outcomes were procedure-related serious adverse events (SAEs) within 7 days and death within 30 days. Primary technical efficacy outcome was ICH volume reduction (%) at 24 h. RESULTS: We included 40 patients (median age 61 years; IQR 51–67; 28 men). Median baseline NIHSS was 19.5 (IQR 13.3–22.0) and median ICH volume 47.7mL (IQR 29.4–72.0). Six patients had a primary safety outcome, of whom two already deteriorated before surgery and one died within 24 h. Sixteen other SAEs were reported within 7 days in 11 patients (of whom two patients that already had a primary safety outcome), none device related. In total, four (10%) patients died within 30 days. Median ICH volume reduction at 24 h was 78% (IQR 50–89) and median postoperative ICH volume 10.5mL (IQR 5.1–23.8). CONCLUSIONS: Minimally invasive endoscopy-guided surgery within 8 h after symptom onset for supratentorial ICH appears to be safe and can effectively reduce ICH volume. Randomised controlled trials are needed to determine whether this intervention also improves functional outcome. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03608423, August 1st, 2018. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00701-023-05599-2. Springer Vienna 2023-04-27 2023 /pmc/articles/PMC10134719/ /pubmed/37103585 http://dx.doi.org/10.1007/s00701-023-05599-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Original Article Sondag, Lotte Schreuder, Floris H.B.M. Pegge, Sjoert A.H. Coutinho, Jonathan M. Dippel, Diederik W.J. Janssen, Paula M. Vandertop, W. Peter Boogaarts, Hieronymus D. Dammers, Ruben Klijn, Catharina J.M. Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title | Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title_full | Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title_fullStr | Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title_full_unstemmed | Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title_short | Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study |
title_sort | safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the dutch intracerebral haemorrhage surgery trial pilot study |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10134719/ https://www.ncbi.nlm.nih.gov/pubmed/37103585 http://dx.doi.org/10.1007/s00701-023-05599-2 |
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