Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure

MISTIE III Trial Investigators

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1157-1168
Number of pages12
JournalNeurosurgery
Volume84
Issue number6
DOIs
StatePublished - Jun 1 2019

Fingerprint

Minimally Invasive Surgical Procedures
Cerebral Hemorrhage
Tissue Plasminogen Activator
Hematoma
Mortality
Catheters
Intracranial Hemorrhages
Stroke
Hypertension
Education
Therapeutics

Keywords

  • Intracranial hemorrhage
  • Intraparenchymal hemorrhage
  • Minimally invasive surgery
  • MISTIE
  • Recombinant tissue plasminogen activator

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

@article{453a2f13c65a44419ff3f5c7fd956147,
title = "Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure",
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.",
keywords = "Intracranial hemorrhage, Intraparenchymal hemorrhage, Minimally invasive surgery, MISTIE, Recombinant tissue plasminogen activator",
author = "{MISTIE III Trial Investigators} and Awad, {Issam A.} and Polster, {Sean P.} and Juli{\'a}n Carri{\'o}n-Penagos and Richard Thompson and Ying Cao and Agnieszka Stadnik and Money, {Patricia Lynn} and Fam, {Maged D.} and Janne Koskim{\"a}ki and Romuald Girard and Karen Lane and Nichol McBee and Ziai, {Wendy C} and Yi Hao and Robert Dodd and Carlson, {Andrew P.} and Camarata, {Paul J.} and Caron, {Jean Louis} and Harrigan, {Mark R.} and Gregson, {Barbara A.} and Mendelow, {A. David} and Mario Zuccarello and Hanley, {Daniel F}",
year = "2019",
month = "6",
day = "1",
doi = "10.1093/neuros/nyz077",
language = "English (US)",
volume = "84",
pages = "1157--1168",
journal = "Neurosurgery",
issn = "0148-396X",
publisher = "Lippincott Williams and Wilkins",
number = "6",

}

TY - JOUR

T1 - Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure

AU - MISTIE III Trial Investigators

AU - Awad, Issam A.

AU - Polster, Sean P.

AU - Carrión-Penagos, Julián

AU - Thompson, Richard

AU - Cao, Ying

AU - Stadnik, Agnieszka

AU - Money, Patricia Lynn

AU - Fam, Maged D.

AU - Koskimäki, Janne

AU - Girard, Romuald

AU - Lane, Karen

AU - McBee, Nichol

AU - Ziai, Wendy C

AU - Hao, Yi

AU - Dodd, Robert

AU - Carlson, Andrew P.

AU - Camarata, Paul J.

AU - Caron, Jean Louis

AU - Harrigan, Mark R.

AU - Gregson, Barbara A.

AU - Mendelow, A. David

AU - Zuccarello, Mario

AU - Hanley, Daniel F

PY - 2019/6/1

Y1 - 2019/6/1

N2 - 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.

AB - 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.

KW - Intracranial hemorrhage

KW - Intraparenchymal hemorrhage

KW - Minimally invasive surgery

KW - MISTIE

KW - Recombinant tissue plasminogen activator

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U2 - 10.1093/neuros/nyz077

DO - 10.1093/neuros/nyz077

M3 - Article

C2 - 30891610

AN - SCOPUS:85066457671

VL - 84

SP - 1157

EP - 1168

JO - Neurosurgery

JF - Neurosurgery

SN - 0148-396X

IS - 6

ER -