Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study

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Abstract

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.

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Most cited references 52

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User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability.

Paul Yushkevich, Joseph Piven, Heather Cody Hazlett … (2006)

Active contour segmentation and its robust implementation using level set methods are well-established theoretical approaches that have been studied thoroughly in the image analysis literature. Despite the existence of these powerful segmentation methods, the needs of clinical research continue to be fulfilled, to a large extent, using slice-by-slice manual tracing. To bridge the gap between methodological advances and clinical routine, we developed an open source application called ITK-SNAP, which is intended to make level set segmentation easily accessible to a wide range of users, including those with little or no mathematical expertise. This paper describes the methods and software engineering philosophy behind this new tool and provides the results of validation experiments performed in the context of an ongoing child autism neuroimaging study. The validation establishes SNAP intrarater and interrater reliability and overlap error statistics for the caudate nucleus and finds that SNAP is a highly reliable and efficient alternative to manual tracing. Analogous results for lateral ventricle segmentation are provided.

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Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

Fakher Rahim, Yasir Waheed (2022)

Summary Background Regularly updated data on stroke and its pathological types, including data on their incidence, prevalence, mortality, disability, risk factors, and epidemiological trends, are important for evidence-based stroke care planning and resource allocation. The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) aims to provide a standardised and comprehensive measurement of these metrics at global, regional, and national levels. Methods We applied GBD 2019 analytical tools to calculate stroke incidence, prevalence, mortality, disability-adjusted life-years (DALYs), and the population attributable fraction (PAF) of DALYs (with corresponding 95% uncertainty intervals [UIs]) associated with 19 risk factors, for 204 countries and territories from 1990 to 2019. These estimates were provided for ischaemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage, and all strokes combined, and stratified by sex, age group, and World Bank country income level. Findings In 2019, there were 12·2 million (95% UI 11·0–13·6) incident cases of stroke, 101 million (93·2–111) prevalent cases of stroke, 143 million (133–153) DALYs due to stroke, and 6·55 million (6·00–7·02) deaths from stroke. Globally, stroke remained the second-leading cause of death (11·6% [10·8–12·2] of total deaths) and the third-leading cause of death and disability combined (5·7% [5·1–6·2] of total DALYs) in 2019. From 1990 to 2019, the absolute number of incident strokes increased by 70·0% (67·0–73·0), prevalent strokes increased by 85·0% (83·0–88·0), deaths from stroke increased by 43·0% (31·0–55·0), and DALYs due to stroke increased by 32·0% (22·0–42·0). During the same period, age-standardised rates of stroke incidence decreased by 17·0% (15·0–18·0), mortality decreased by 36·0% (31·0–42·0), prevalence decreased by 6·0% (5·0–7·0), and DALYs decreased by 36·0% (31·0–42·0). However, among people younger than 70 years, prevalence rates increased by 22·0% (21·0–24·0) and incidence rates increased by 15·0% (12·0–18·0). In 2019, the age-standardised stroke-related mortality rate was 3·6 (3·5–3·8) times higher in the World Bank low-income group than in the World Bank high-income group, and the age-standardised stroke-related DALY rate was 3·7 (3·5–3·9) times higher in the low-income group than the high-income group. Ischaemic stroke constituted 62·4% of all incident strokes in 2019 (7·63 million [6·57–8·96]), while intracerebral haemorrhage constituted 27·9% (3·41 million [2·97–3·91]) and subarachnoid haemorrhage constituted 9·7% (1·18 million [1·01–1·39]). In 2019, the five leading risk factors for stroke were high systolic blood pressure (contributing to 79·6 million [67·7–90·8] DALYs or 55·5% [48·2–62·0] of total stroke DALYs), high body-mass index (34·9 million [22·3–48·6] DALYs or 24·3% [15·7–33·2]), high fasting plasma glucose (28·9 million [19·8–41·5] DALYs or 20·2% [13·8–29·1]), ambient particulate matter pollution (28·7 million [23·4–33·4] DALYs or 20·1% [16·6–23·0]), and smoking (25·3 million [22·6–28·2] DALYs or 17·6% [16·4–19·0]). Interpretation The annual number of strokes and deaths due to stroke increased substantially from 1990 to 2019, despite substantial reductions in age-standardised rates, particularly among people older than 70 years. The highest age-standardised stroke-related mortality and DALY rates were in the World Bank low-income group. The fastest-growing risk factor for stroke between 1990 and 2019 was high body-mass index. Without urgent implementation of effective primary prevention strategies, the stroke burden will probably continue to grow across the world, particularly in low-income countries. Funding Bill & Melinda Gates Foundation.

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Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis.

Charlotte JJ van Asch, Merel JA Luitse, Gabriel Rinkel … (2010)

Since the early 1980s, imaging techniques have enabled population-based studies of intracerebral haemorrhage. We aimed to assess the incidence, case fatality, and functional outcome of intracerebral haemorrhage in relation to age, sex, ethnic origin, and time period in studies published since 1980. From PubMed and Embase searches with predefined inclusion criteria, we identified population-based studies published between January, 1980, and November, 2008. We calculated incidence and case fatality. Incidences for multiple studies were pooled in a random-effects binomial meta-analysis. Time trends of case fatality were assessed with weighted linear-regression analysis. 36 eligible studies described 44 time periods (mid-year range 1983-2006). These studies included 8145 patients with intracerebral haemorrhage. Incidence did not decrease between 1980 and 2008. Overall incidence was 24.6 per 100 000 person-years (95% CI 19.7-30.7). Incidence was not significantly lower in women than in men (overall incidence ratio 0.85, 95% CI 0.61-1.18). Using the age group 45-54 years as reference, incidence ratios increased from 0.10 (95% CI 0.06-0.14) for people aged less than 45 years to 9.6 (6.6-13.9) for people older than 85 years. Median case fatality at 1 month was 40.4% (range 13.1-61.0) and did not decrease over time, and was lower in Japan (16.7%, 95% CI 15.0-18.5) than elsewhere (42.3%, 40.9-43.6). Six studies reported functional outcome, with independency rates of between 12% and 39%. Incidence of intracerebral haemorrhage per 100 000 person-years was 24.2 (95% CI 20.9-28.0) in white people, 22.9 (14.8-35.6) in black people, 19.6 (15.7-24.5) in Hispanic people, and 51.8 (38.8-69.3) in Asian people. Incidence of intracerebral haemorrhage increases with age and has not decreased between 1980 and 2006. Case fatality is lower in Japan than elsewhere, increases with age, and has not decreased over time. More data on functional outcome are needed. Netherlands Heart Foundation. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

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Author and article information

Contributors

Catharina J.M. Klijn: Karin.Klijn@radboudumc.nl

Journal

Journal ID (nlm-ta): Acta Neurochir (Wien)

Journal ID (iso-abbrev): Acta Neurochir (Wien)

Title: Acta Neurochirurgica

Publisher: Springer Vienna (Vienna )

ISSN (Print): 0001-6268

ISSN (Electronic): 0942-0940

Publication date (Electronic): 27 April 2023

Publication date PMC-release: 27 April 2023

Pages: 1-12

Affiliations

[1 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, , Radboud University Medical Center, ; Geert Grooteplein Zuid 10, PO-box 9101, 6500HB Nijmegen, The Netherlands

[2 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Medical Imaging, , Radboud University Medical Center, ; Nijmegen, The Netherlands

[3 ]GRID grid.5650.6, ISNI 0000000404654431, Department of Neurology, , Amsterdam University Medical Centers, Academic Medical Center, ; Amsterdam, The Netherlands

[4 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Neurology, , Erasmus MC University Medical Center Rotterdam, ; Rotterdam, The Netherlands

[5 ]GRID grid.7177.6, ISNI 0000000084992262, Amsterdam UMC, , University of Amsterdam, Department of Neurosurgery, Amsterdam Neurosciences, Neurovascular Disorders, ; Meibergdreef 9, Amsterdam, The Netherlands

[6 ]GRID grid.12380.38, ISNI 0000 0004 1754 9227, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Neurosurgery, Amsterdam Neurosciences, Neurovascular Disorders, ; De Boelelaan, 1117 Amsterdam, Netherlands

[7 ]GRID grid.10417.33, ISNI 0000 0004 0444 9382, Department of Neurosurgery, , Radboud University Medical Center, ; Nijmegen, The Netherlands

[8 ]GRID grid.5645.2, ISNI 000000040459992X, Department of Neurosurgery, , Erasmus MC University Medical Center, ; Rotterdam, The Netherlands

Author information

Lotte Sondag https://orcid.org/0000-0002-2037-7484

Floris H.B.M. Schreuder https://orcid.org/0000-0002-7815-0207

Sjoert A.H. Pegge https://orcid.org/0000-0001-9314-6137

Jonathan M. Coutinho https://orcid.org/0000-0002-8284-982X

Diederik W.J. Dippel https://orcid.org/0000-0002-9234-3515

Paula M. Janssen https://orcid.org/0000-0002-2673-8543

W. Peter Vandertop https://orcid.org/0000-0001-5417-0265

Hieronymus D. Boogaarts https://orcid.org/0000-0001-5855-2447

Ruben Dammers https://orcid.org/0000-0001-7033-0644

Article

Publisher ID: 5599

DOI: 10.1007/s00701-023-05599-2

PMC ID: 10134719

PubMed ID: 37103585

SO-VID: 7690df94-e595-4ddb-bd4f-782ed46638c6

License:

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/.

Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study

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Abstract

Background

Methods

Results

Conclusions

Trial registration

Supplementary Information

Related collections

SICOT-J (Orthopedic surgery and traumatology)

Most cited references 52

User-guided 3D active contour segmentation of anatomical structures: significantly improved efficiency and reliability.

Global, regional, and national burden of stroke and its risk factors, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019

Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis.

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