Platform Presentation The Joint Annual Meeting of the Stroke Society of Australasia (SSA) and Smartstrokes 2023

Early, Minimally Invasive Intracerebral Haemorrhage Evacuation: a Phase 2a Feasibility, Safety and Promise of Surgical Efficacy Study. (#33)

Timothy J Kleinig 1 , Amal Abou-Hamden 2 , John Laidlaw 3 , Leonid Churilov 4 , Christopher P Kellner 5 , Teddy Wu 6 , J Mocco 5 , Hui Lau 3 , Alexios Adamides 3 , Bhadu Kavar 3 , James Dimou 3 , Jennifer Cranefield 1 , Amy McDonald 7 , Stephanie Plummer 7 , Stephen M Davis 7 , Bruce CV Campbell 7
  1. Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia
  2. Neurosurgery, Royal Adelaide Hospital, ADELAIDE, SA, Australia
  3. Neurosurgery, Royal Melbourne Hospital, Adelaide, SA, Australia
  4. Medical School, University of Melbourne, Melbourne, Vic, Australia
  5. Neurosurgery, Mt Sinai Hospital, New York, NY, USA
  6. Neurology, Christchurch Hospital, Christchurch, Canterbury, New Zealand
  7. Neurology, Royal Melbourne Hospital, Melbourne, Victoria, Australia

Background: Surgical treatment of intracerebral haemorrhage (ICH) is unproven, although meta-analyses suggest that both early conventional surgery with craniotomy, and minimally-invasive surgery (MIS) may be beneficial. We aimed to demonstrate the safety, feasibility and promise of efficacy of early MIS for ICH using the Aurora Surgiscope and Evacuator.

Methods: We performed a prospective, single-arm phase IIa Simon’s Two-Stage design study at two stroke centres (10 patients with supratentorial ICH volumes ≥20mL and NIHSS≥6, surgery commencing <12 hours post-onset). Positive outcome was defined as ≥50% 24-hour ICH volume reduction, with the safety outcome lack of significant ICH reaccumulation.

Results: From December 2019-July 2020 we enrolled 10 patients at two Australian Comprehensive Stroke Centres, median age 70 (interquartile range(IQR) 65-74), National Institute of Health Stroke Scale(NIHSS) score 19(IQR 19-29), ICH volume 59mL(IQR 25-77), at a median 227 minutes(IQR 175-377) post-onset. MIS was commenced at a median 531 minutes(IQR 437-628) post-onset, was of 98 minutes median duration(IQR 77-110) with median immediate post-operative haematoma evacuation of 70%(IQR 67-80%).

A positive outcome was achieved in 5/5 first-stage patients and in 4/5 second-stage patients. One patient developed significant 24-hour ICH reaccumulation; otherwise 24-hour stability was observed (median reduction 71%(IQR 61-80), 5/9 patients <15mL residual)).

Three patients died, unrelated to surgery. There were no surgical safety concerns. At six months the median modified Rankin score was 4(IQR 3-6) with 30% achieving mRS 0-3. 

Conclusion: Early ICH MIS using the Aurora Surgiscope and Evacuator appears feasible and safe, warranting further exploration.