Post-Trial Enhanced Deployment and Technical Performance with the MISTIE Procedure per Lessons Learned.
Adult
Aged
Aged, 80 and over
Artificial Intelligence
Cerebral Hemorrhage
/ diagnostic imaging
Clinical Trials, Phase III as Topic
Databases, Factual
Female
Humans
Male
Middle Aged
Neurosurgical Procedures
/ adverse effects
Predictive Value of Tests
Radiographic Image Interpretation, Computer-Assisted
Retrospective Studies
Thrombolytic Therapy
/ adverse effects
Time Factors
Tomography, X-Ray Computed
Treatment Outcome
Intracerebral hemorrhage
Intracranial hemorrhage
MISTIE, Artificial intelligence
Journal
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
ISSN: 1532-8511
Titre abrégé: J Stroke Cerebrovasc Dis
Pays: United States
ID NLM: 9111633
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
15
05
2021
accepted:
04
07
2021
pubmed:
25
7
2021
medline:
8
9
2021
entrez:
24
7
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 34303090
pii: S1052-3057(21)00401-8
doi: 10.1016/j.jstrokecerebrovasdis.2021.105996
pmc: PMC8384714
mid: NIHMS1723382
pii:
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
105996Subventions
Organisme : NINDS NIH HHS
ID : U01 NS080824
Pays : United States
Organisme : NINDS NIH HHS
ID : U24 NS107233
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Conflict of Interest statements for all authors were completed and are available upon request.
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