Issam A Awad1, Sean P Polster1, Julián Carrión-Penagos1, Richard E Thompson2, Ying Cao1, Agnieszka Stadnik1, Patricia Lynn Money3, Maged D Fam1, Janne Koskimäki1, Romuald Girard1, Karen Lane2, Nichol McBee2, Wendy Ziai2, Yi Hao2, Robert Dodd4, Andrew P Carlson5, Paul J Camarata6, Jean-Louis Caron7, Mark R Harrigan8, Barbara A Gregson9, A David Mendelow9, Mario Zuccarello3, Daniel F Hanley2. 1. Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois. 2. Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland. 3. Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, Ohio. 4. Department of Neurosurgery, Stanford University School of Medicine, Stanford, California. 5. Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico. 6. Department of Neurosurgery, University of Kansas School of Medicine, Kansas City, Kansas. 7. Department of Neurosurgery, University of Texas, San Antonio, Texas. 8. Division of Neurosurgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama. 9. Neurosurgical Trials Group, Newcastle University, Newcastle upon Tyne, United Kingdom.
Abstract
BACKGROUND: Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). OBJECTIVE: To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. METHODS: Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. RESULTS: Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. CONCLUSION: This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.
RCT Entities:
BACKGROUND: Minimally invasive surgery procedures, including stereotactic catheter aspiration and clearance of intracerebral hemorrhage (ICH) with recombinant tissue plasminogen activator hold a promise to improve outcome of supratentorial brain hemorrhage, a morbid and disabling type of stroke. A recently completed Phase III randomized trial showed improved mortality but was neutral on the primary outcome (modified Rankin scale score 0 to 3 at 1 yr). OBJECTIVE: To assess surgical performance and its impact on the extent of ICH evacuation and functional outcomes. METHODS: Univariate and multivariate models were used to assess the extent of hematoma evacuation efficacy in relation to mRS 0 to 3 outcome and postulated factors related to patient, disease, and protocol adherence in the surgical arm (n = 242) of the MISTIE trial. RESULTS: Greater ICH reduction has a higher likelihood of achieving mRS of 0 to 3 with a minimum evacuation threshold of ≤15 mL end of treatment ICH volume or ≥70% volume reduction when controlling for disease severity factors. Mortality benefit was achieved at ≤30 mL end of treatment ICH volume, or >53% volume reduction. Initial hematoma volume, history of hypertension, irregular-shaped hematoma, number of alteplase doses given, surgical protocol deviations, and catheter manipulation problems were significant factors in failing to achieve ≤15 mL goal evacuation. Greater surgeon/site experiences were associated with avoiding poor hematoma evacuation. CONCLUSION: This is the first surgical trial reporting thresholds for reduction of ICH volume correlating with improved mortality and functional outcomes. To realize the benefit of surgery, protocol objectives, surgeon education, technical enhancements, and case selection should be focused on this goal.
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Authors: Sean P Polster; Julián Carrión-Penagos; Seán B Lyne; Barbara A Gregson; Ying Cao; Richard E Thompson; Agnieszka Stadnik; Romuald Girard; Patricia Lynn Money; Karen Lane; Nichol McBee; Wendy Ziai; W Andrew Mould; Ahmed Iqbal; Stephen Metcalfe; Yi Hao; Robert Dodd; Andrew P Carlson; Paul J Camarata; Jean-Louis Caron; Mark R Harrigan; Mario Zuccarello; A David Mendelow; Daniel F Hanley; Issam A Awad Journal: Neurosurgery Date: 2021-04-15 Impact factor: 4.654