title: Surgical Performance in Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation Phase III Clinical Trial.
abstract: BACKGROUND
  Minimally invasive thrombolytic evacuation of intracerebral hematoma is being investigated in the ongoing phase III clinical trial of Minimally Invasive Surgery plus recombinant Tissue plasminogen activator for Intracerebral hemorrhage Evacuation (MISTIE III).
  
  
  OBJECTIVE
  To assess the accuracy of catheter placement and efficacy of hematoma evacuation in relation to surgical approach and surgeon experience.
  
  
  METHODS
  We performed a trial midpoint interim assessment of 123 cases that underwent the surgical procedure. Accuracy of catheter placement was prospectively assessed by the trial Surgical Center based on prearticulated criteria. Hematoma evacuation efficacy was evaluated based on absolute volume reduction, percentage hematoma evacuation, and reaching the target end-of-treatment volume of <15 mL. One of 3 surgical trajectories was used: anterior (A), posterior (B), and lobar (C). Surgeons were classified based on experience with the MISTIE procedure as prequalified, qualified with probation, and fully qualified.
  
  
  RESULTS
  The average hematoma volume was 49.7 mL (range 20.0-124), and the mean evacuation rate was 71% (range 18.4%-99.8%). First placed catheters were 58% in good position, 28% suboptimal (but suitable to dose), and 14% poor (requiring repositioning). Posterior trajectory (B) was associated with significantly higher rates of poor placement (35%, P = .01). There was no significant difference in catheter placement accuracy among surgeons of varying experience. Hematoma evacuation efficacy was not significantly different among the 3 surgical approaches or different surgeons' experience.
  
  
  CONCLUSIONS
  Ongoing surgical education and quality monitoring in MISTIE III have resulted in consistent rates of hematoma evacuation despite technical challenges with the surgical approaches and among surgeons of varying experience.
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Maged D
authors.initials: MD
authors.lastname: Fam
authors.affiliation: Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins Medical Institutions.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hanley
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Stadnik
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Hussein A
authors.initials: HA
authors.lastname: Zeineddine
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Romuald
authors.initials: R
authors.lastname: Girard
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Michael
authors.initials: M
authors.lastname: Jesselson
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Ying
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Department of Neurosurgery, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Lynn
authors.initials: L
authors.lastname: Money
authors.affiliation: Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins Medical Institutions.
authors.forename: Nichol
authors.initials: N
authors.lastname: McBee
authors.affiliation: Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins Medical Institutions.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Bistran-Hall
authors.affiliation: Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins Medical Institutions.
authors.forename: W Andrew
authors.initials: WA
authors.lastname: Mould
authors.affiliation: Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins Medical Institutions.
authors.forename: Karen
authors.initials: K
authors.lastname: Lane
authors.affiliation: Department of Neurosurgery, University of Kansas School of Medicine, Kansas City, Kansas; Investigators of the MISTIE III Trial.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Camarata
authors.affiliation: Department of Neurosurgery, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Mario
authors.initials: M
authors.lastname: Zuccarello
authors.affiliation: Clinical Trials Unit, Neurovascular Surgery Program, Section of Neurosurgery, University of Chicago Medicine, Chicago, Illinois.
authors.forename: Issam A
authors.initials: IA
authors.lastname: Awad
mesh_terms: D000328:Adult; D057785:Catheters / Q000009:adverse effects; D002543:Cerebral Hemorrhage / Q000188:drug therapy / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006406:Hematoma / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011446:Prospective Studies; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: Alteplase; Intracerebral hemorrhage; MISTIE; Minimally invasive; Tissue plasminogen activator