ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial.

Authors

• Paul Vespa
• Daniel Hanley
• Joshua Betz
• Alan Hoffer
• Johnathan Engh
• Robert Carter
• Peter Nakaji
• Chris Ogilvy
• Jack Jallo
• Warren Selman
• Amanda Bistran-Hall
• Karen Lane
• Nichol McBee
• Jeffery Saver
• Richard E Thompson
• Neil Martin

Publication/Presentation Date

11-1-2016

Abstract

BACKGROUND AND PURPOSE: Intracerebral hemorrhage (ICH) is a devastating disease without a proven therapy to improve long-term outcome. Considerable controversy about the role of surgery remains. Minimally invasive endoscopic surgery for ICH offers the potential of improved neurological outcome.

METHODS: We tested the hypothesis that intraoperative computerized tomographic image-guided endoscopic surgery is safe and effectively removes the majority of the hematoma rapidly. A prospective randomized controlled study was performed on 20 subjects (14 surgical and 4 medical) with primary ICH of >20 mL volume within 48 hours of ICH onset. We prospectively used a contemporaneous medical control cohort (n=36) from the MISTIE trial (Minimally Invasive Surgery and r-tPA for ICH Evacuation). We evaluated surgical safety and neurological outcomes at 6 months and 1 year.

RESULTS: The intraoperative computerized tomographic image-guided endoscopic surgery procedure resulted in immediate reduction of hemorrhagic volume by 68±21.6% (interquartile range 59-84.5) within 29 hours of hemorrhage onset. Surgery was successfully completed in all cases, with a mean operative time of 1.9 hours (interquartile range 1.5-2.2 hours). One surgically related bleed occurred peri-operatively, but no patient met surgical safety stopping threshold end points for intraoperative hemorrhage, infection, or death. The surgical intervention group had a greater percentage of patients with good neurological outcome (modified Rankin scale score 0-3) at 180 and 365 days as compared with medical control subjects (42.9% versus 23.7%; P=0.19).

CONCLUSIONS: Early computerized tomographic image-guided endoscopic surgery is a safe and effective method to remove acute intracerebral hematomas, with a potential to enhance neurological recovery.

CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00224770.

Volume

47

Issue

11

First Page

2749

Last Page

2755

ISSN

1524-4628

Published In/Presented At

Vespa, P., Hanley, D., Betz, J., Hoffer, A., Engh, J., Carter, R., Nakaji, P., Ogilvy, C., Jallo, J., Selman, W., Bistran-Hall, A., Lane, K., McBee, N., Saver, J., Thompson, R. E., Martin, N., & ICES Investigators (2016). ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke, 47(11), 2749–2755. https://doi.org/10.1161/STROKEAHA.116.013837

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

27758940

Department(s)

Administration and Leadership

Document Type

Article