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Minimally Invasive Endoscopic Intracerebral Hemorrhage Evacuation
Published on: October 15, 2021
Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage: A Randomized Clinical Trial
Mette Haldrup1,2,3, Mads Rasmussen2,4, Niwar Mohamad1,2,4,5
1Department of Neurosurgery, Aarhus University Hospital, Aarhus, Denmark.
Insights
Intraventricular lavage for intraventricular hemorrhage increased severe adverse events and catheter occlusions compared to standard drainage. Caution is advised when using this minimally invasive technique.
Area of Science:
- Neurosurgery
- Neurology
- Critical Care Medicine
Background:
- Intraventricular hemorrhage (IVH) poses significant risks, necessitating effective evacuation methods.
- Intraventricular lavage (IVL) has been proposed as a minimally invasive approach for IVH management.
- Limited evidence currently supports the safety and efficacy of IVL.
Purpose of the Study:
- To evaluate the safety and potential efficacy of intraventricular lavage in treating intraventricular hemorrhage.
- To compare IVL with standard drainage in terms of outcomes and adverse events.
Main Methods:
- A single-blinded, controlled, randomized clinical trial involving 21 participants with IVH.
- Participants were randomized (1:1) to receive either intraventricular lavage or standard drainage.
- The study included an interim analysis, which led to early termination due to safety concerns.
Main Results:
- The trial was terminated early due to a significantly increased risk of severe adverse events in the intraventricular lavage group (P=.04).
- Catheter occlusion rates were higher in the IVL group (38%) compared to standard drainage (7%).
- Procedure time for catheter placement was substantially longer for IVL (53.5 minutes) versus standard drainage (12 minutes).
Conclusions:
- Intraventricular lavage was associated with a significantly higher incidence of severe adverse events compared to standard drainage.
- The findings suggest caution is necessary when considering intraventricular lavage for IVH management.
- Further research is needed to determine the safety and efficacy of IVL in neurocritical care.
Importance:
Intraventricular lavage has been proposed as a minimally invasive method to evacuate intraventricular hemorrhage. There is little evidence to support its use.
Objective:
To evaluate the safety and potential efficacy of intraventricular lavage treatment of intraventricular hemorrhage.
Design, Setting, And Participants:
This single-blinded, controlled, investigator-initiated 1:1 randomized clinical trial was conducted at Aarhus University Hospital and Odense University Hospital in Denmark from January 13, 2022, to November 24, 2022. Follow-up duration was 90 days. The trial was set to include 58 patients with intraventricular hemorrhage. Prespecified interim analysis was performed for the first 20 participants. Data were analyzed from February to April 2023.
Interventions:
Participants were randomized to receive either intraventricular lavage or standard drainage.
Main Outcomes And Measures:
The main outcome was risk of catheter occlusions. Additional safety outcomes were catheter-related infections and procedure time, length of stay at the intensive care unit, duration of treatment, and 30-day mortality. The main outcome of the prespecified interim analysis was risk of severe adverse events. Efficacy outcomes were hematoma clearance, functional outcome, overall survival, and shunt dependency.
Results:
A total of 21 participants (median [IQR] age, 67 [59-82] years; 14 [66%] male) were enrolled, with 11 participants randomized to intraventricular lavage and 10 participants randomized to standard drainage; 20 participants (95%) had secondary intraventricular hemorrhage. The median (IQR) Graeb score was 9 (5-11), and the median (IQR) Glasgow Coma Scale score was 6.5 (4-8). The study was terminated early due to a significantly increased risk of severe adverse events associated with intraventricular lavage at interim analysis (risk difference for control vs intervention, 0.43; 95% CI, 0.06-0.81; P = .04; incidence rate ratio for control vs intervention, 6.0; 95% CI, 1.38-26.1; P = .01). The rate of catheter occlusion was higher for intraventricular lavage compared with drainage (6 of 16 patients [38%] vs 2 of 13 patients [7%]; hazard ratio, 4.4 [95% CI, 0.6-31.2]; P = .14), which met the prespecified α = .20 level. Median (IQR) procedure time for catheter placement was 53.5 (33-75) minutes for intraventricular lavage vs 12 (4-20) minutes for control (P < .001).
Conclusions And Relevance:
This randomized clinical trial of intraventricular lavage vs standard drainage found that intraventricular lavage was encumbered with a significantly increased number of severe adverse events. Caution is recommended when using the device to ensure patient safety.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05204849.
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