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  • Early minimally invasive intracerebral hemorrhage evacuation: a phase 2a feasibility, safety, and promise of surgical efficacy study

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Hemorrhagic stroke
Case series
Early minimally invasive intracerebral hemorrhage evacuation: a phase 2a feasibility, safety, and promise of surgical efficacy study
  1. Timothy J Kleinig1,2,
  2. Amal Abou-Hamden3,4,
  3. John Laidlaw5,6,
  4. Leonid Churilov7,
  5. Christopher Paul Kellner8,
  6. Teddy Wu9,
  7. J Mocco10,
  8. Hui Lau5,
  9. Alexios Adamides5,
  10. Bhadrakant Kavar5,
  11. James Dimou5,
  12. Jennifer Cranefield1,
  13. Amy McDonald11,
  14. Stephanie Plummer3,
  15. Stephen Davis7,11,
  16. Bruce C V Campbell7,11
  1. 1 Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  2. 2 Medicine, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
  3. 3 Neurosurgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  4. 4 Surgery, The University of Adelaide Faculty of Health and Medical Sciences, Adelaide, South Australia, Australia
  5. 5 Department of Neurosurgery, The Royal Melbourne Hospital, Parkville, Victoria, Australia
  6. 6 Surgery, The University of Melbourne, Melbourne, Victoria, Australia
  7. 7 Medicine, The University of Melbourne, Melbourne, Victoria, Australia
  8. 8 Mount Sinai Medical Center, New York, New York, USA
  9. 9 Neurology, Christchurch Hospital, Christchurch, Canterbury, New Zealand
  10. 10 Neurosurgery, Mount Sinai Health System, New York, New York, USA
  11. 11 Neurology, Royal Melbourne Hospital, Parkville, Victoria, Adelaide, Australia
  1. Correspondence to Dr Timothy J Kleinig, Department of Neurology, Royal Adelaide Hospital, Adelaide, SA 5000, Australia; timothy.kleinig{at}sa.gov.au

Abstract

Background Surgical treatment of intracerebral hemorrhage (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 centers (10 patients with supratentorial ICH volumes ≥20 mL and National Institutes of Health Stroke Scale (NIHSS) score of ≥6, and surgery commencing <12 hours after 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 to July 2020, we enrolled 10 patients at two Australian Comprehensive Stroke Centers, median age 70 years (IQR 65–74), NIHSS score 19 (IQR 19–29), ICH volume 59 mL (IQR 25–77), at a median of 227 min (IQR 175–377) post-onset. MIS was commenced at a median time of 531 min (IQR 437–628) post-onset, had a median duration of 98 min (IQR 77–110), with a median immediate postoperative hematoma 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 <15 mL residual). Three patients died, unrelated to surgery. There were no surgical safety concerns. At 6 months, the median modified Rankin Scale score was 4 (IQR 3–6) with 30% achieving a score of 0–3.

Conclusion In this study, early ICH MIS using the Aurora Surgiscope and Evacuator appeared to be feasible and safe, warranting further exploration.

Trial registration number ACTRN12619001748101.

  • hemorrhage
  • brain
  • intervention
  • technique

https://doi.org/10.1136/jnis-2023-020446

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    Footnotes

    • X @TimothyKleinig, @chriskellnerMD

    • Contributors TJK, AA-H, JL, and BCVB designed and oversaw the study, and contributed to data acquisition and analysis. LC, JM, CPK, and SD assisted in study design and LC assisted in data analysis. JC, AM, JD, AA, HL, TW, BK, and SP played significant roles in data acquisition. All authors reviewed the manuscript for critical intellectual content. TJK drafted the manuscript and accepts full responsibility for the finished work, the full data set, and the decision to publish.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.

    • Competing interests SD reports grant funding from the Australian National Health and Medical Research Council, honoraria from Amgen and Boehringer Ingelheim, and DSMB participation for Medtronic, Abbott and CSL Behring. CPK reports research grant funding from Siemens, Penumbra, Medtronic, Integra, Viz.AI, Irras, ICE Neurosystems, CVAID, Longeviti and Endostream, founding ownership of Metis Innovative, Precision Recovery, Borealisa and investment in E8, Borvo, Synchron, Proprio, Fluid Biomed and Von Medical. JM reports Grants/Awards from PCORI, Stryker, Penumbra and Microvention, consulting fees from Viseon, Endostream, RIST, Synchron, Perflow, Viz.ai, CVAid, Imperative Care, Mendaera, is on the Endostream, Cerebrotech, Synchron and Siemans Board of Directors, and is an investor in Imperative Care, Endostream, Echovate, Viseon, BlinkTBI, Serenity, NTI Managers, RIST, Viz.ai, Synchron, Songbird, Tulavi, Vastrax, Neurolutions, Sim&Cure, Neurolutions, Bend-it, Myra Medical, Q’Apel, Instylla, Viseon, Adona, Tulavi, Radical, E8, Borvo, Spinaker and Mendaera.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.