Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study
On behalf of the Dutch ICH Surgery Trial Study Group, part of the CONTRAST consortium
(2023) Acta Neurochirurgica, volume 165, issue 6, pp. 1585 - 1596
(Article)
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
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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.
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Keywords: Cerebrovascular disease, Intracerebral haemorrhage, Neurosurgery, Vascular surgery, Surgery, Clinical Neurology
ISSN: 0001-6268
Publisher: Springer Wien
Note: Funding Information: We acknowledge the support of the Netherlands Cardiovascular Research Initiative, which is supported by the Dutch Heart Foundation, CVON2015-01: CONTRAST, and the support of the Brain Foundation Netherlands (HA2015.01.06). The collaboration project is additionally financed by the Ministry of Economic Affairs by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships (LSHM17016). This work was funded in part through unrestricted funding by Stryker, Medtronic, and Cerenovus. The funding sources were not involved in study design, monitoring, data collection, statistical analyses, interpretation of results, or manuscript writing; Radboud UMC and Erasmus MC received additional unrestricted funding on behalf of CONTRAST, for the execution of the Dutch ICH Surgery Trial pilot study from Penumbra Inc. FHBM Schreuder is supported by a senior clinical scientist grant of the Dutch Heart Foundation (grant 2019T060). Funding Information: The Dutch Intracerebral Haemorrhage Surgery Trial pilot study—study group consists of the following: Lotte Sondag MD, Floris H.B.M. Schreuder MD PhD, Jelis Boiten MD PhD, Paul J.A.M. Brouwers MD PhD, Jonathan Coutinho MD PhD, Diederik W.J. Dippel MD PhD, M. Heleen den Hertog MD PhD, Paula M. Janssen MD, Wilmar M.T. Jolink MD PhD, L. Jaap Kappelle MD PhD, Kuan H. Kho MD PhD, Radboud W. Koot MD PhD, Paul L.M. de Kort MD PhD, Wouter A. Moojen MD PhD, Dharmin Nanda MD PhD, Onno P.M. Teernstra MD PhD, Bram van der Pol MD PhD, Inger R. de Ridder MD PhD, Marieke J.H. Wermer MD PhD, Albert van der Zwan MD PhD, W. Peter Vandertop MD PhD, Hieronymus D. Boogaarts MD PhD, Ruben Dammers MD PhD, Catharina J.M. Klijn MD PhD, Dana Holl, Anil Can. Study group authors’ affiliations can be found in Online resource Table 1. We would like to thank the Data Safety Monitoring Board, that consisted of the following: Craig Anderson (Chair), MD, PhD, FRACP, Director, The George Institute for Global Health and Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW, Sydney, Australia, Ale Algra, MD, PhD, Professor of Clinical Epidemiology of Cerebrovascular Diseases, Utrecht Stroke Center, Department of Neurology and Neurosurgery and Julius Center University Medical Center Utrecht, The Netherlands. Wilco C. Peul, MD, PhD, MBA, Professor and Chair of Neurosurgery, Leiden University Department of Neurosurgery, The Hague & Leiden, the Netherlands. Publisher Copyright: © 2023, The Author(s).
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