Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial

Hanley, Daniel F.; Thompson, Richard E.; Rosenblum, Michael; Yenokyan, Gayane; Lane, Karen; McBee, Nichol; Mayo, Steven; Bistran-Hall, Amanda J.; Gandhi, Dheeraj; Mould, W. Andrew; Ullman, Natalie; Ali, Hasan; Carhuapoma, J. Ricardo; Kase, Carlos S.; Lees, Kennedy R.; Dawson, Jesse; Wilson, Alastair; Betz, Joshua; Sugar, Elizabeth A.; Hao, Yi; Avadhani, Radhika; Caron, Jean-Louis; Harrigan, Mark R.; Carlson, Andrew P.; Bulters, Diederik; Ledoux, Didier; Huang, Judy; Cobb, Cully A.; Gupta, Gaurav; Kitagawa, Ryan S.; Chicoine, Michael R.; Patel, Hiren; Dodd, Robert; Camarata, Paul J.; Wolfe, Stacey Quintero; Stadnik, Agnieszka; Money, Patricia Lynn; Mitchell, Patrick; Sarabia, Rosario; Harnof, Sagi; Barzó, Pál; Unterberg, Andreas; Teitelbaum, Jeanne; Wang, Weimin; Anderson, Craig S.; Mendelow, A. D.; Gregson, Barbara; Janis, Scott; Vespa, Paul; Ziai, Wendy; Zuccarello, Mario; Awad, Issam A.; Abdul-Rahim, Azmil H; Abou-Hamden, Amal; Abraham, Michael; Ahmed, Azam; Alba, Carlos Alarcon; Aldrich, E. François; Altschul, David; Amin‐Hanjani, Sepideh; Anderson, Doug; Ansari, Safdar; Antezana, David; Ardelt, Agnieszka; Arikán, Fuat; Báguena, Marcelino; Baker, Alexandra; Barrer, Steven J.; Becker, Kyra J.; Bergman, Thomas; Boström, Azize; Braun, Jamie; Brindley, Peter G.; Broaddus, William C.; Brown, Robert H.; Büki, András; Cao, Bing; Cao, Ying; Carrión‐Penagos, Julián; Chalela, Julio A.; Chang, Tiffany R.; Chorro, Indalecio Moran; Chowdhry, Shakeel A.; Corral, Luisa; Csiba, László; Davies, Jason M.; Díaz, Alberto Torres; Derdeyn, Colin P.; Diringer, Michael N.; Dlugash, Rachel; Ecker, Robert D.; Economas, Tracey; Enríquez, Pedro; Ezer, Erzsébet; Fan, Yuhua; Feng, Hua; Franz, Douglas; Freeman, W. David; Fusco, Matthew R.; Galicich, Walter; Gelea, Mary Leigh; Goldstein, Joshua N.; Gonzalez, Alejandro Carrasco; Grabarits, Christina; Greenberg, Steven M.; Gress, Daryl R.; Gu, Eugene; Hall, Christiana E.; Hernández, Fernando Muñoz; Hoesch, Robert E.; Hoh, Brian L.; Houser, Jennifer; Hu, Rong; Huang, Yi; Hussain, Mohammed Akbar; Insinga, Salvatore; Jadhav, Ashutosh; Jaffe, Jennifer; Jahromi, Babak S.; Jallo, Jack; James, Michael L.; James, Robert F.; Jankowitz, Brian T.; Jeon, Esther; Jichici, Draga; Jonczak, Karin; Jonker, Ben; Karlen, Nicki; Keric, Naureen; Kerz, Thomas; Knopman, Jared; Koenig, Carolyn; Krishnamurthy, Satish; Kumar, Avinash B.; Kureshi, Inam; Laidlaw, John D.; Lakhanpal, Arun; Latorre, Julius Gene; Leifer, Dana; Leiphart, James W.; Lenington, Sarah; Li, Yunke; Lopez, George Α.; Lovick, Darren; Lumenta, C. B.; Luo, Jingqin; Maas, Matthew B.; MacDonald, Joel; MacKenzie, Larami; Madan, Vikram; Majkowski, Ryan; Major, Ottó; Malhorta, Rishi; Malkoff, Marc; Mangat, Halinder S.; Maswadeh, Ahmed; Matouk, Charles; McArthur, Kate; McCaul, Scott; Medow, Joshua E.; Mezey, G; Mighty, Janet; Miller, David; Mohan, Krishna; Muir, Keith W.; Munoz, Lorenzo F.; Nakaji, Peter; Nee, Alex; Nekoovaght-Tak, Saman; Nyquist, Paul; O’Kane, Roddy; Okasha, Mohamed; O’Kelly, Cian; Ostapkovich, Noeleen; Pandey, Aditya S.; Parry‐Jones, Adrian; Perla, Krissia Rivera; Pollack, Ania; Polster, Sean P; Pouratian, Nader; Quinn, Terry; Rajajee, Ventatakrishna; Reddy, Kesava; Rehman, Mohammed; Reimer, Ronald; Rincón, Fred; Rybinnik, Igor; Sánchez, Baltasar; Sansing, Lauren H; Schneck, Michael; Schuerer, Ludwig; Schul, David B.; Schweitzer, Jeffrey S.; Seder, David B.; Seyfried, Donald; Sheth, Kevin N; Spiotta, Alejandro M; Stechison, Michael T.; Szabó, Katalin; Tamayo, Gonzalo; Tánczos, Krisztián; Taussky, Philipp; Terry, John B.; Testai, Fernando D.; Thomas, Kathrine; Thompson, Carol B.; Thompson, Gregory; Torner, James C.; Tran, Huy; Tucker, Kristi; Ungar, Lior; Varelas, Panos; Vargas, Nataly Montano; Vatter, Hartmut; Venkatasubramanian, Chitra; Vermillion, Krista; Vollmer, Dennis G.; Wang, Yan; Wang, Ying; Wen, Jiajun; Whitworth, Louis Tony; Willis, Byron; Wrencher, Myriha; Wright, Shawn E.; Xu, Yong-ge; Yanase, Lisa R; Yi, Xuxia; Yu, Zhiyuan; Zomorodi, Ali R.

doi:10.1016/s0140-6736(19)30195-3

Cited by 605 publications

(519 citation statements)

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“…All patients were treated according to the guidelines of the German societies of Neurology and Neurosurgery. The indication for minimally invasive hematoma evacuation was based on previous findings [16,18,27,33] Further information on patient management and intraoperative imaging can be found in the online supplement. In addition to intraoperative imaging, a routine CT scan was performed on postoperative day (POD) 1.…”

Section: Patient Managementmentioning

confidence: 99%

Intraoperative CT and cone-beam CT imaging for minimally invasive evacuation of spontaneous intracerebral hemorrhage

et al. 2020

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Background Minimally invasive surgery (MIS) for evacuation of spontaneous intracerebral hemorrhage (ICH) has shown promise but there remains a need for intraoperative performance assessment considering the wide range of evacuation effectiveness. In this feasibility study, we analyzed the benefit of intraoperative 3-dimensional imaging during navigated endoscopyassisted ICH evacuation by mechanical clot fragmentation and aspiration. Methods 18 patients with superficial or deep supratentorial ICH underwent MIS for clot evacuation followed by intraoperative computerized tomography (iCT) or cone-beam CT (CBCT) imaging. Eligibility for MIS required (a) availability of intraoperative iCT or CBCT, (b) spontaneous lobar or deep ICH without vascular pathology, (c) a stable ICH volume (20-90 ml), (d) a reduced level of consciousness (GCS 5-14), and (e) a premorbid mRS ≤ 1. Demographic, clinical, and radiographic patient data were analyzed by two independent observers. Results Nine female and 9 male patients with a median age of 76 years (42-85) presented with an ICH score of 3 (1-4), GCS of 10 (5-14) and ICH volume of 54 ± 26 ml. Clot fragmentation and aspiration was feasible in all cases and intraoperative imaging determined an overall evacuation rate of 80 ± 19% (residual hematoma volume: 13 ± 17 ml; p < 0.0001 vs. Pre-OP). Based on the intraoperative imaging results, 1/3rd of all patients underwent an immediate re-aspiration attempt. No patient experienced hemorrhagic complications or required conversion to open craniotomy. However, routine postoperative CT imaging revealed early hematoma re-expansion with an adjusted evacuation rate of 59 ± 30% (residual hematoma volume: 26 ± 37 ml; p < 0.001 vs. Pre-OP). Conclusions Routine utilization of iCT or CBCT imaging in MIS for ICH permits direct surgical performance assessment and the chance for immediate re-aspiration, which may optimize targeting of an ideal residual hematoma volume and reduce secondary revision rates.

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Section: Patient Managementmentioning

confidence: 99%

Intraoperative CT and cone-beam CT imaging for minimally invasive evacuation of spontaneous intracerebral hemorrhage

et al. 2020

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“…Coagulopathy and a sustained high systolic blood pressure (SBP) create an increased risk of ongoing bleeding, and are both associated with neurological deterioration (33). The risk of poor outcome following ICH is increased for all different anticoagulants in current use (28), although NOAC-treated ICH patients have smaller ICH volume, are less prone to haematoma expansion and have lower mortality than Warfarin-treated ICH patients (34)(35)(36)(37)(38)(39)(40). Approximately 25% of ICH patients are on antiplatelet therapy and their prognosis is worse than that of patients not on antiplatelet therapy (41).…”

Section: Prognostic Factorsmentioning

confidence: 99%

“…MIS includes procedures such as stereotactic puncture and drainage, with or without administration of local clot fibrinolysis, endoscopy assisted surgery, and other techniques aiming to minimise surgical access trauma (156). The phase II trial (MISTIE II) of stereotactical application of a catheter within the ICH followed by local administration of rtPA showed positive effects on PHE formation and ICH residual volume and found the technique to be safe (157), however, the recently published phase III trial (MISTIE III) showed no positive effect on functional outcome (35).…”

Section: Minimally Invasive Surgerymentioning

confidence: 99%

Surgically Treated Intracerebral Haemorrhage : Pathophysiology and Clinical Aspects

Tobieson

2019

Linköping University Medical Dissertations

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To Ester!If it doesn't challenge you it doesn't change you! /the inside of my Ironman cap  Abstract i ABSTRACT Mortality and morbidity of intracerebral haemorrhage (ICH) is excessively high, and the case fatality rate has not improved in the last decades. Although surgery for ICH can be life-saving, no positive effect on functional outcome has been found in large cohorts of ICH patients. Increased understanding of the pathophysiology of ICH is needed to develop improved treatment strategies. Svensk sammanfattningiii KIRURGISK BEHANDLING AV HJÄRN-BLÖDNINGAR Spontan primär hjärnblödning (ICH), som inte beror på pulsåderbråck, utgör ca 12.5% av alla strokeinsjuknanden per år i Sverige, och står för en ansenlig del av den årliga stroke-relaterade dödligheten och förlusten av funktion. Endast en liten del av patienterna kan rehabiliteras åter till ett självständigt liv. I dagsläget saknas effektiv behandling utöver att förebygga att blödningen ökar i storlek genom snabb korrigering av koagulationsrubbningar och blodtryckssänkande behandling. Ca 5 % av alla ICH i Sverige opereras, men det saknas tydlig evidens för nyttan av kirurgi utöver som livräddande åtgärd.(ii-iii) Mikrodialys är en användbar metod för att studera hjärnskada efter ICH och kan kombineras med proteomik analys men det finns fallgropar och svårigheter med tekniken att ta hänsyn till, såsom att proteiner fastnar på mikrodialysmembranet.(iv) Den nationsövergripande genomgången av kirurgiskt behandlade ICH patienter påvisar likheter avseende patienternas ålder och medvetandegrad, men skillnader i volym och lokalisation av opererade blödningar, samt i den postoperativa vården. Dessa skillnader bör vara fokus för framtida forskningsstudier för att möjliggöra utformningen av bättre riktlinjer för klinisk praxis.

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“…12 This phenomenon of T2* non-hypointensity, related to early erythrolysis, demonstrated in the animal models, is being investigated in humans with MRI. 13 Currently, no definite intervention has been shown to be beneficial for ICH, be it hematoma evacuation 14,15 or iron chelation treatment such as deferoxamine. 16 However, there is significant enthusiasm as MISTIE III has shown that patients who have greater than 75% of their ICH evacuated are clinically significantly better than those managed conservatively.…”

mentioning

confidence: 99%

Hemorrhagic stroke—Pathomechanisms of injury and therapeutic options

et al. 2019

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Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial

Abstract: Enlighten-Research publications by members of the University of Glasgow http://eprints.gla.ac.uk Minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label phase 3 trial with blinded endpoint

Cited by 605 publications

References 46 publications

Intraoperative CT and cone-beam CT imaging for minimally invasive evacuation of spontaneous intracerebral hemorrhage

Intraoperative CT and cone-beam CT imaging for minimally invasive evacuation of spontaneous intracerebral hemorrhage

Surgically Treated Intracerebral Haemorrhage : Pathophysiology and Clinical Aspects

Hemorrhagic stroke—Pathomechanisms of injury and therapeutic options

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