Ali Mansour1, Andrea Loggini2, Faten El Ammar3, Ronald Alvarado-Dyer4, Sean Polster5, Agnieszka Stadnik6, Paramita Das7, Peter C Warnke8, Bakhtiar Yamini9, Christos Lazaridis10, Christopher Kramer11, W Andrew Mould12, Meghan Hildreth13, Matthew Sharrock14, Daniel F Hanley15, Fernando D Goldenberg16, Issam A Awad17. 1. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: Ali.Mansour@uchospitals.edu. 2. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: Andrea.Loggini@uchospitals.edu. 3. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: Faten.ElAmmar@uchospitals.edu. 4. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: Ronald.Alvaradodyer@uchospitals.edu. 5. Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. 6. Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: astadnik@surgery.bsd.uchicago.edu. 7. Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: pdas@surgery.bsd.uchicago.edu. 8. Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: pwarnke@surgery.bsd.uchicago.edu. 9. Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: byamini@surgery.bsd.uchicago.edu. 10. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: clazaridis@neurology.bsd.uchicago.edu. 11. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: ckramer1@neurology.bsd.uchicago.edu. 12. Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA. Electronic address: amould@jhmi.edu. 13. Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA. Electronic address: mhildre3@jhmi.edu. 14. Division of Neurocritical Care, Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: sharrock@unc.edu. 15. Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA. Electronic address: dhanley@jhmi.edu. 16. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: fgoldenb@neurology.bsd.uchicago.edu. 17. Neurosciences Intensive Care Unit, Department of Neurology, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA; Department of Neurological surgery, University of Chicago Medicine and Biological Sciences, Chicago, IL, USA. Electronic address: iawad@uchicago.edu.
Abstract
OBJECTIVE: We hypothesize that procedure deployment rates and technical performance with minimally invasive surgery and thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE) can be enhanced in post-trial clinical practice, per Phase III trial results and lessons learned. MATERIALS AND METHODS: We identified ICH patients and those who underwent MISTIE procedure between 2017-2021 at a single site, after completed enrollments in the Phase III trial. Deployment rates, complications and technical outcomes were compared to those observed in the trial. Initial and final hematoma volume were compared between site measurements using ABC/2, MISTIE trial reading center utilizing manual segmentation, and a novel Artificial Intelligence (AI) based volume assessment. RESULTS: Nineteen of 286 patients were eligible for MISTIE. All 19 received the procedure (6.6% enrollment to screening rate 6.6% compared to 1.6% at our center in the trial; p=0.0018). Sixteen patients (84%) achieved evaculation target < 15 mL residual ICH or > 70% removal, compared to 59.7% in the trial surgical cohort (p=0.034). No poor catheter placement occurred and no surgical protocol deviations. Limitations of ICH volume assessments using the ABC/2 method were shown, while AI based methodology of ICH volume assessments had excellent correlation with manual segmentation by experienced reading centers. CONCLUSIONS: Greater procedure deployment and higher technical success rates can be achieved in post-trial clinical practice than in the MISTIE III trial. AI based measurements can be deployed to enhance clinician estimated ICH volume. Clinical outcome implications of this enhanced technical performance cannot be surmised, and will need assessment in future trials.
OBJECTIVE: We hypothesize that procedure deployment rates and technical performance with minimally invasive surgery and thrombolysis for intracerebral hemorrhage (ICH) evacuation (MISTIE) can be enhanced in post-trial clinical practice, per Phase III trial results and lessons learned. MATERIALS AND METHODS: We identified ICH patients and those who underwent MISTIE procedure between 2017-2021 at a single site, after completed enrollments in the Phase III trial. Deployment rates, complications and technical outcomes were compared to those observed in the trial. Initial and final hematoma volume were compared between site measurements using ABC/2, MISTIE trial reading center utilizing manual segmentation, and a novel Artificial Intelligence (AI) based volume assessment. RESULTS: Nineteen of 286 patients were eligible for MISTIE. All 19 received the procedure (6.6% enrollment to screening rate 6.6% compared to 1.6% at our center in the trial; p=0.0018). Sixteen patients (84%) achieved evaculation target < 15 mL residual ICH or > 70% removal, compared to 59.7% in the trial surgical cohort (p=0.034). No poor catheter placement occurred and no surgical protocol deviations. Limitations of ICH volume assessments using the ABC/2 method were shown, while AI based methodology of ICH volume assessments had excellent correlation with manual segmentation by experienced reading centers. CONCLUSIONS: Greater procedure deployment and higher technical success rates can be achieved in post-trial clinical practice than in the MISTIE III trial. AI based measurements can be deployed to enhance clinician estimated ICH volume. Clinical outcome implications of this enhanced technical performance cannot be surmised, and will need assessment in future trials.
Authors: Issam A Awad; Sean P Polster; Julián Carrión-Penagos; Richard E Thompson; Ying Cao; Agnieszka Stadnik; Patricia Lynn Money; Maged D Fam; Janne Koskimäki; Romuald Girard; Karen Lane; Nichol McBee; Wendy Ziai; Yi Hao; Robert Dodd; Andrew P Carlson; Paul J Camarata; Jean-Louis Caron; Mark R Harrigan; Barbara A Gregson; A David Mendelow; Mario Zuccarello; Daniel F Hanley Journal: Neurosurgery Date: 2019-06-01 Impact factor: 4.654
Authors: Dominique A Cadilhac; Helen M Dewey; Theo Vos; Rob Carter; Amanda G Thrift Journal: Health Qual Life Outcomes Date: 2010-05-14 Impact factor: 3.186
Authors: Craig S Anderson; Emma Heeley; Yining Huang; Jiguang Wang; Christian Stapf; Candice Delcourt; Richard Lindley; Thompson Robinson; Pablo Lavados; Bruce Neal; Jun Hata; Hisatomi Arima; Mark Parsons; Yuechun Li; Jinchao Wang; Stephane Heritier; Qiang Li; Mark Woodward; R John Simes; Stephen M Davis; John Chalmers Journal: N Engl J Med Date: 2013-05-29 Impact factor: 91.245
Authors: Stephan A Mayer; Nikolai C Brun; Kamilla Begtrup; Joseph Broderick; Stephen Davis; Michael N Diringer; Brett E Skolnick; Thorsten Steiner Journal: N Engl J Med Date: 2008-05-15 Impact factor: 91.245
Authors: Darin B Zahuranec; Lynda D Lisabeth; Brisa N Sánchez; Melinda A Smith; Devin L Brown; Nelda M Garcia; Lesli E Skolarus; William J Meurer; James F Burke; Eric E Adelman; Lewis B Morgenstern Journal: Neurology Date: 2014-05-16 Impact factor: 9.910
Authors: A David Mendelow; Barbara A Gregson; Elise N Rowan; Gordon D Murray; Anil Gholkar; Patrick M Mitchell Journal: Lancet Date: 2013-05-29 Impact factor: 79.321