scholarly journals Thrombolysis for Evacuation of Intracerebral and Intraventricular Hemorrhage: A Guide to Surgical Protocols With Practical Lessons Learned From the MISTIE and CLEAR Trials

2020 ◽  
Vol 20 (1) ◽  
pp. 98-108 ◽  
Author(s):  
Sean P Polster ◽  
Julián Carrión-Penagos ◽  
Seán B Lyne ◽  
Fernando D Goldenberg ◽  
Ali Mansour ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Intraventricular Hemorrhage ◽  
Recombinant Tissue Plasminogen Activator ◽  
Lessons Learned ◽  
Catheter Placement ◽  
Phase Iii ◽  
Surgical Performance ◽  
Hematoma Evacuation ◽  
Functional Benefit ◽  
Modifiable Factors

Abstract BACKGROUND Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation (MISTIE) procedure was recently tested in a large phase III randomized trial showing a significant probability of functional benefit in those cases that reached the goal hematoma evacuation of ≤15 mL residual (or ≥70% removal). Benefit of thrombolysis was also identified in cases with large intraventricular hemorrhage, and achieving at least 85% volume reduction in the Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) III trial. OBJECTIVE To protocolize steps in the MISTIE and CLEAR procedures in order to maximize hematoma evacuation and minimize complications. METHODS We articulate data-driven lessons and expert opinions surrounding the factors of patient selection, catheter placement, and dosing, which impacted safety and surgical performance in the MISTIE and CLEAR trials. RESULTS Modifiable factors to maximize evacuation efficiency include optimizing catheter placement and pursuing aggressive dosing to achieve treatment goals, while strictly adhering to the safety steps as articulated in the respective trials. Prognostic factors that are viewed as nonmodifiable include greater initial intracerebral hemorrhage volume with irregular shape, smaller intraventricular bleeds, and the uncommon but consequential development of new bleeding during the dosing period despite strict protocol adherence. CONCLUSIONS Surgeon education in this tutorial is aimed at maximizing the benefit of the MISTIE and CLEAR procedures by reviewing case selection, safety steps, treatment objectives, and technical nuances. Key lessons include stability imaging, etiology screening, and technical adherence to the protocol in order to achieve defined thresholds of evacuation.

Abstract WMP103: Comparative Impact of Extent of Lobar Intracerebral Hemorrhage Removal on Outcome in the MISTIE III and STICH II Trials

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Sean P Polster ◽  
Julian Carrion-Penagos ◽  
Barbara A Gregson ◽  
Ying Cao ◽  
Richard E Thompson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcome ◽  
Minimally Invasive ◽  
Intracerebral Hemorrhage ◽  
Functional Outcome ◽  
Phase Iii ◽  
Surgical Interventions ◽  
Hematoma Evacuation ◽  
Functional Benefit ◽  
End Of Treatment

Introduction: The Minimally Invasive Surgery Plus Recombinant Tissue Plasminogen Activator for Intracerebral Hemorrhage Evacuation Phase III trial (MISTIE III) concluded that the extent of hematoma reduction confers a mortality and functional benefit. It is unclear if a minimum extent of evacuation is needed for mortality and functional outcome benefit in lobar cases with MISTIE and with open surgical interventions. Objective: We analyzed the effect of extent of lobar ICH evacuation on clinical outcome at 180 days after undergoing the MISTIE procedure and open craniotomy, in the context of the MISTIE III and STICH II clinical trials, respectively. Methods: Patients randomized to the surgical arm with lobar ICH, who underwent the procedure in the MISTIE III trial (n=84) and the STICH II trial (n=266) were analyzed, excluding cases crossing over to surgery. We assessed end of treatment ICH volume on post procedure CT scans and % hematoma evacuation, in relation to survival and likelihood of mRS 0-3. Cubic spline modeling with dichotomized outcome was used to compare the extent of hematoma evacuation on clinical outcome. Results: End of treatment volume of < 28 mL in lobar ICH MISTIE III patients and < 30 mL in STICH II trial patients showed a significantly increased probability of achieving an mRS of 0-3 at 180 days (p<0.03, p<0.006, respectively). This threshold was achieved in 83.1% of lobar cases undergoing MISTIE and in 92.1% of surgical cases in STICH II. Achieving survival benefit at 180 days trended towards improved probability with further hematoma volume reduction without a threshold value in MISTIE III, and was significant per mL reduction in STICH II (p<0.001). Analysis by percent of hematoma evacuation trended toward better probabilities of survival and improved functional outcome but were not significant. Conclusion: This analysis confirms that extent of hematoma evacuation is important in attaining the benefits of both minimally invasive and open surgical interventions in non-herniating lobar ICH patients randomized in clinical trials. Extent of ICH evacuation must be considered in the analysis of comparative effectiveness of various techniques and in the design of future trials.

The Story of Intracerebral Hemorrhage

Stroke ◽  
2021 ◽  
Author(s):  
Joseph P. Broderick ◽  
James C. Grotta ◽  
Andrew M. Naidech ◽  
Thorsten Steiner ◽  
Nikola Sprigg ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Factor Viia ◽  
Phase Iii ◽  
Hemostatic Agents ◽  
The Past ◽  
End Point ◽  
Clot Removal ◽  
Modifiable Factors ◽  
Large Phase

This invited special report is based on an award presentation at the World Stroke Organization/European Stroke Organization Conference in November of 2020 outlining progress in the acute management of intracerebral hemorrhage (ICH) over the past 35 years. ICH is the second most common and the deadliest type of stroke for which there is no scientifically proven medical or surgical treatment. Prospective studies from the 1990s onward have demonstrated that most growth of spontaneous ICH occurs within the first 2 to 3 hours and that growth of ICH and resulting volumes of ICH and intraventricular hemorrhage are modifiable factors that can improve outcome. Trials focusing on early treatment of elevated blood pressure have suggested a target systolic blood pressure of 140 mm Hg, but none of the trials were positive by their primary end point. Hemostatic agents to decrease bleeding in spontaneous ICH have included desmopressin, tranexamic acid, and rFVIIa (recombinant factor VIIa) without clear benefit, and platelet infusions which were associated with harm. Hemostatic agents delivered within the first several hours have the greatest impact on growth of ICH and potentially on outcome. No large Phase III surgical ICH trial has been positive by primary end point, but pooled analyses suggest that earlier ICH removal is more likely to be beneficial. Recent trials emphasize maximization of clot removal and minimizing brain injury from the surgical approach. The future of ICH therapy must focus on delivery of medical and surgical therapies as soon as possible if we are to improve outcomes.

scholarly journals Not “Doing the Same Thing Over and Over Again”

US Neurology ◽  
2018 ◽  
Vol 14 (1) ◽  
pp. 29 ◽  
Author(s):  
Daniel F Hanley ◽  
Wendy C Ziai ◽  
Issam A Awad
Keyword(s):  
Intracerebral Hemorrhage ◽  
Disease Severity ◽  
Intraventricular Hemorrhage ◽  
Lessons Learned ◽  
Stroke Severity ◽  
Therapeutic Trial ◽  
Mortality Reduction ◽  
High Likelihood ◽  
Full Spectrum ◽  
Neurologic Outcomes

Intracerebral hemorrhage (ICH) with intraventricular extension is a devastating disease occurring in 40% of patients with spontaneous ICH. Although the CLEAR III trial (NCT00784134) demonstrated mortality reduction with intraventricular alteplase (versus saline), lessons learned warrant a therapeutic trial focusing on disease severity and treatment endpoints that support a high likelihood of improvement. We must answer questions of maximizing therapy intensity in large intraventricular hemorrhage (IVH) to promote good neurologic outcomes if we are committed to treating ICH and the full spectrum of stroke severity.

scholarly journals Endoscopic Hematoma Evacuation for Intracerebral Hemorrhage(Neuroendoscopy)

2007 ◽  
Vol 16 (7) ◽  
pp. 533-540 ◽  
Author(s):  
Takuji Yamamoto ◽  
Yasuaki Nakao ◽  
Hideo Osada ◽  
Kentaro Mori ◽  
Minoru Maeda
Keyword(s):  
Intracerebral Hemorrhage ◽  
Hematoma Evacuation
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