1. Surgical Performance Determines Functional Outcome Benefit in the Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) Procedure
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Andras Buki, Ludwig Schuerer, Barbara A. Gregson, Joshua N. Goldstein, Jared Knopman, Alexandra D Baker, Ashutosh P Jadhav, Laszlo Csiba, Terry Quinn, Kristi Tucker, Gayane Yenokyan, E. Francois Aldrich, Richard E. Thompson, John Laidlaw, Steven Mayo, Alastair Wilson, Michael L. James, Krista Vermillion, Andreas Unterberg, Fernando Muñoz Hernandez, Karin Jonczak, Jesse Dawson, Alejandro Carrasco Gonzalez, Jamie Braun, Rishi Malhorta, Lisa Yanase, Hua Feng, Craig S. Anderson, Ying Cao, Michael Rosenblum, Roddy O'Kane, Jeffrey S. Schweitzer, Krishna K. Mohan, Robert Hoesch, Robert D. Ecker, Rong Hu, Cian O'Kelly, Nader Pouratian, Igor Rybinnik, Yi Huang, Julius Gene Latorre, Peter Brindley, Scott Janis, Huy Tran, Weimin Wang, Mohammed Rehman, Nataly Montano Vargas, Zhiyuan Yu, Tiffany R. Chang, Christianto B. Lumenta, Rosario Sarabia, Paul M. Vespa, David Antezana, Keith W. Muir, Ying Wang, Kennedy R. Lees, Thomas Kerz, Steven J. Barrer, Safdar Ansari, Elizabeth A. Sugar, Louis Tony Whitworth, Romuald Girard, Thomas A. Bergman, Myriha Wrencher, Gaurav Gupta, Krissia Rivera Perla, Judy Huang, Doug Anderson, Joshua Betz, Ryan S. Kitagawa, Mohammed Hussain, Marcelino Báguena, Sepideh Amin-Hanjani, Krisztian Tanczos, Avinash B. Kumar, Brian L. Hoh, W. David Freeman, Tracey Economas, Dheeraj Gandhi, Mary Leigh Gelea, Hiren C. Patel, Esther Jeon, Byron Willis, Gonzalo Tamayo, Saman Nekoovaght-Tak, Lior Ungar, Ahmed Maswadeh, Adrian R Parry-Jones, Marc D. Malkoff, Michael Abraham, Carlos Alarcon Alba, Michael R. Chicoine, George A. Lopez, Jeanne Teitelbaum, Scott McCaul, Walter Galicich, David Schel, Ryan Majkowski, Douglas Franz, Agnieszka Ardelt, Issam A. Awad, Yunke Li, Hasan Ali, Satish Krishnamurthy, Yi Hao, Geza Mezey, Amal Abou-Hamden, James Leiphart, Xuxia Yi, Darren Lovick, Colin P. Dierdeyn, Jack Jallo, Jennifer Houser, Vikram Madan, Julián Carrión-Penagos, Jean-Louis Caron, Paul J. Camarata, Nichol McBee, Ania Pollack, Lorenzo F. Munoz, Sarah Lenington, Lauren H Sansing, Kathrine Thomas, Alberto Torres Díaz, Joel D. MacDonald, J. Ricardo Carhuapoma, Pedro Enriquez, Janet Mighty, Salvatore Insinga, Ottó Major, Steven M. Greenberg, Jinbiao Luo, Jennifer Jaffe, W. Andrew Mould, Cully Cobb, Sagi Harnof, Robert F James, Yan Wang, Ali R. Zomorodi, David B. Seder, Ventatakrishna Rajajee, Arun Lakhanpal, Robert H. Brown, Yongge Xu, Karen Lane, Naureen Keric, A. David Mendelow, David Ledoux, Azmil Abdul-Rahim, Babak S. Jahromi, Janne Koskimäki, Chitra Venkatasubramanian, Dennis G. Vollmer, Charles C. Matouk, William C. Broaddus, Julio A. Chalela, Fred Rincon, Sean P. Polster, Kevin N. Sheth, Patrick Mitchell, Daryl R. Gress, Daniel F Hanley, Bing Cao, Indalecio Moran Chorro, Mario Zuccarello, Maged D Fam, Carolyn Koenig, Aditya S. Pandey, Patricia Lynn Money, Christiana E. Hall, Baltasar Sanchez, Kesava Reddy, Hartmut Vatter, Robert L. Dodd, Panos Varelas, James C. Torner, Michael Schneck, Christina Grabarits, Azam Ahmed, Diederik Bulters, Paul A. Nyquist, Michael N. Diringer, Jason M Davies, Radhika Avadhani, Ben Jonker, Katalin Szabo, Agnieszka Stadnik, Donald Seyfried, Brian T. Jankowitz, Joshua E. Medow, Erzsebet Ezer, Pál Barzó, Luisa Corral, Inam Kureshi, Ronald Reimer, David Altschul, Fuat Arikan, Alex Nee, Stacey Q Wolfe, Mohamed Okasha, Matthew B. Maas, Mark R. Harrigan, John Terry, Natalie Ullman, Dana Leifer, Yuhua Fan, Jiajun Wen, Gregory Thompson, Alejandro M Spiotta, Amanda J. Bistran-Hall, Fernando D. Testai, Noeleen Ostapkovich, Eugene Gu, Kyra J. Becker, David Miller, Carlos S. Kase, Carol B. Thompson, Shawn E. Wright, Wendy C. Ziai, Philipp Taussky, Peter Nakaji, Nicki Karlen, Halinder S. Mangat, Andrew P. Carlson, Shakeel A. Chowdhry, Azize Boström, Rachel Dlugash, Michael T. Stechison, Kate McArthur, Larami MacKenzie, Matthew R. Fusco, and Draga Jichici
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Male ,medicine.medical_specialty ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Hematoma ,Fibrinolytic Agents ,Randomized controlled trial ,Modified Rankin Scale ,law ,medicine ,Humans ,Minimally Invasive Surgical Procedures ,cardiovascular diseases ,Research—Human—Clinical Trials ,Intraparenchymal hemorrhage ,Stroke ,Aged ,Intracerebral hemorrhage ,business.industry ,Recovery of Function ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Surgery ,Treatment Outcome ,Tissue Plasminogen Activator ,030220 oncology & carcinogenesis ,Emergency evacuation ,Female ,Neurology (clinical) ,business ,Intracranial Hemorrhages ,030217 neurology & neurosurgery ,Fibrinolytic agent - 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.
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- 2019