Paul Vespa1, Daniel Hanley2, Joshua Betz2, Alan Hoffer2, Johnathan Engh2, Robert Carter2, Peter Nakaji2, Chris Ogilvy2, Jack Jallo2, Warren Selman2, Amanda Bistran-Hall2, Karen Lane2, Nichol McBee2, Jeffery Saver2, Richard E Thompson2, Neil Martin2. 1. From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.). Pvespa@mednet.ucla.edu. 2. From the Departments of Neurosurgery and Neurology, David Geffen School of Medicine at University of California, Los Angeles (P.V., J.S., N. Martin); Department of Neurology, Johns Hopkins University, Baltimore, MD (D.H., J.B., A.B.-H., K.L., N. McBee, R.E.T.); Department of Neurosurgery, Case Western University (A.H., W.S.); Department of Neurosurgery, University of Pittsburgh, PA (J.E., P.N.); Department of Neurosurgery, University of California, San Diego (R.C.); Department of Neurosurgery, Harvard University, Massachusetts General Hospital, Boston (C.O.); and Department of Neurosurgery, Thomas Jefferson University, Philadelphia, PA (J.J.).
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.
RCT Entities:
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.
Authors: Paul Vespa; David McArthur; Chad Miller; Kristine O'Phelan; John Frazee; Chelsea Kidwell; Jeffery Saver; Sidney Starkman; Neil Martin Journal: Neurocrit Care Date: 2005 Impact factor: 3.210
Authors: Santosh B Murthy; Yogesh Moradiya; Jesse Dawson; Kennedy R Lees; Daniel F Hanley; Wendy C Ziai Journal: Stroke Date: 2015-09-22 Impact factor: 7.914
Authors: Lewis B Morgenstern; J Claude Hemphill; Craig Anderson; Kyra Becker; Joseph P Broderick; E Sander Connolly; Steven M Greenberg; James N Huang; R Loch MacDonald; Steven R Messé; Pamela H Mitchell; Magdy Selim; Rafael J Tamargo Journal: Stroke Date: 2010-07-22 Impact factor: 7.914
Authors: J Claude Hemphill; Steven M Greenberg; Craig S Anderson; Kyra Becker; Bernard R Bendok; Mary Cushman; Gordon L Fung; Joshua N Goldstein; R Loch Macdonald; Pamela H Mitchell; Phillip A Scott; Magdy H Selim; Daniel Woo Journal: Stroke Date: 2015-05-28 Impact factor: 7.914
Authors: S Y Matthew Goh; Andrei Irimia; Carinna M Torgerson; Meral A Tubi; Courtney R Real; Daniel F Hanley; Neil A Martin; Paul M Vespa; John D Van Horn Journal: Brain Inj Date: 2014-12-18 Impact factor: 2.311
Authors: W Andrew Mould; J Ricardo Carhuapoma; John Muschelli; Karen Lane; Timothy C Morgan; Nichol A McBee; Amanda J Bistran-Hall; Natalie L Ullman; Paul Vespa; Neil A Martin; Issam Awad; Mario Zuccarello; Daniel F Hanley Journal: Stroke Date: 2013-02-07 Impact factor: 7.914
Authors: Maged D Fam; Daniel Hanley; Agnieszka Stadnik; Hussein A Zeineddine; Romuald Girard; Michael Jesselson; Ying Cao; Lynn Money; Nichol McBee; Amanda J Bistran-Hall; W Andrew Mould; Karen Lane; Paul J Camarata; Mario Zuccarello; Issam A Awad Journal: Neurosurgery Date: 2017-11-01 Impact factor: 4.654
Authors: Ching-Jen Chen; Dale Ding; Natasha Ironside; Thomas J Buell; Andrew M Southerland; Daniel Woo; Bradford B Worrall Journal: World Neurosurg Date: 2019-02-08 Impact factor: 2.104
Authors: Wendy C Ziai; Nichol McBee; Karen Lane; Kennedy R Lees; Jesse Dawson; Paul Vespa; Richard E Thompson; A David Mendelow; Carlos S Kase; J Ricardo Carhuapoma; Carol B Thompson; Steven W Mayo; Pat Reilly; Scott Janis; Craig S Anderson; Mark R Harrigan; Paul J Camarata; Jean-Louis Caron; Mario Zuccarello; Issam A Awad; Daniel F Hanley Journal: Int J Stroke Date: 2019-04-03 Impact factor: 5.266
Authors: Issam A Awad; Sean P Polster; Julián Carrión-Penagos; Richard E Thompson; Ying Cao; Agnieszka Stadnik; Patricia Lynn Money; Maged D Fam; Janne Koskimäki; Romuald Girard; Karen Lane; Nichol McBee; Wendy Ziai; Yi Hao; Robert Dodd; Andrew P Carlson; Paul J Camarata; Jean-Louis Caron; Mark R Harrigan; Barbara A Gregson; A David Mendelow; Mario Zuccarello; Daniel F Hanley Journal: Neurosurgery Date: 2019-06-01 Impact factor: 4.654
Authors: Daniel F Hanley; Richard E Thompson; Michael Rosenblum; Gayane Yenokyan; Karen Lane; Nichol McBee; Steven W Mayo; Amanda J Bistran-Hall; Dheeraj Gandhi; W Andrew Mould; Natalie Ullman; Hasan Ali; J Ricardo Carhuapoma; Carlos S Kase; Kennedy R Lees; Jesse Dawson; Alastair Wilson; Joshua F Betz; Elizabeth A Sugar; Yi Hao; Radhika Avadhani; Jean-Louis Caron; Mark R Harrigan; Andrew P Carlson; Diederik Bulters; David LeDoux; Judy Huang; Cully Cobb; Gaurav Gupta; Ryan Kitagawa; Michael R Chicoine; Hiren Patel; Robert Dodd; Paul J Camarata; Stacey Wolfe; Agnieszka Stadnik; P Lynn Money; Patrick Mitchell; Rosario Sarabia; Sagi Harnof; Pal Barzo; Andreas Unterberg; Jeanne S Teitelbaum; Weimin Wang; Craig S Anderson; A David Mendelow; Barbara Gregson; Scott Janis; Paul Vespa; Wendy Ziai; Mario Zuccarello; Issam A Awad Journal: Lancet Date: 2019-02-07 Impact factor: 79.321
Authors: Harmanvir Ghuman; Madeline Gerwig; Francesca J Nicholls; Jessie R Liu; Julia Donnelly; Stephen F Badylak; Michel Modo Journal: Acta Biomater Date: 2017-09-13 Impact factor: 8.947
Authors: D Andrew Wilkinson; Aditya S Pandey; B Gregory Thompson; Richard F Keep; Ya Hua; Guohua Xi Journal: Neuropharmacology Date: 2017-09-22 Impact factor: 5.250