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

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.

Informations de copyright

© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

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.