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Development and validation of a rapidly deployable CT-guided stereotactic system for external ventricular drainage: preclinical study.

ABSTRACT: External ventricular drainage (EVD) is an emergency neurosurgical procedure to decrease intracranial pressure through a catheter mediated drainage of cerebrospinal fluid. Most EVD catheters are placed using free hands without direct visualization of the target and catheter trajectory, leading to a high rate of complications- hemorrhage, brain injury and suboptimal catheter placement. Use of stereotactic systems can prevent these complications. However, they have found limited application for this procedure due to their long set-up time and expensive hardware. Therefore, we have developed and pre-clinically validated a novel 3D printed stereotactic system for rapid and accurate implantation of EVD catheters. Its mechanical and imaging accuracies were found to be at par with clinical stereotactic systems. Preclinical trial in human cadaver specimens revealed improved targeting accuracy achieved within an acceptable time frame compared to the free hand technique. CT angiography emulated using cadaver specimen with radio-opaque vascular contrast showed vessel free catheter trajectory. This could potentially translate to reduced hemorrhage rate. Thus, our 3D printed stereotactic system offers the potential to improve the accuracy and safety of EVD catheter placement for patients without significantly increasing the procedure time.

SUBMITTER: Barath AS

PROVIDER: S-EPMC8410845 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Development and validation of a rapidly deployable CT-guided stereotactic system for external ventricular drainage: preclinical study.

Barath Abhijeet S AS Rusheen Aaron E AE Cabrera Juan M Rojas JMR Shin Hojin H Blaha Charles D CD Bennet Kevin E KE Goerss Stephan J SJ Lee Kendall H KH Oh Yoonbae Y

Scientific reports 20210901 1

External ventricular drainage (EVD) is an emergency neurosurgical procedure to decrease intracranial pressure through a catheter mediated drainage of cerebrospinal fluid. Most EVD catheters are placed using free hands without direct visualization of the target and catheter trajectory, leading to a high rate of complications- hemorrhage, brain injury and suboptimal catheter placement. Use of stereotactic systems can prevent these complications. However, they have found limited application for thi ...[more]

PMID: 34471205

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Project description:ImportanceIntraventricular lavage has been proposed as a minimally invasive method to evacuate intraventricular hemorrhage. There is little evidence to support its use.ObjectiveTo evaluate the safety and potential efficacy of intraventricular lavage treatment of intraventricular hemorrhage.Design, setting, and participantsThis 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.InterventionsParticipants were randomized to receive either intraventricular lavage or standard drainage.Main outcomes and measuresThe 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.ResultsA 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 relevanceThis 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 registrationClinicalTrials.gov Identifier: NCT05204849.

Project description:Objective. The objective of this study is to develop and validate a method for automatically identifying segments of intracranial pressure (ICP) waveform data from external ventricular drainage (EVD) recordings during intermittent drainage and closure.Methods. The proposed method uses time-frequency analysis through wavelets to distinguish periods of ICP waveform in EVD data. By comparing the frequency compositions of the ICP signals (when the EVD system is clamped) and the artifacts (when the system is open), the algorithm can detect short, uninterrupted segments of ICP waveform from the longer periods of non-measurement data. The method involves applying a wavelet transform, calculating the absolute power in a specific range, using Otsu thresholding to automatically identify a threshold, and performing a morphological operation to remove small segments. Two investigators manually graded the same randomly selected one-hour segments of the resulting processed data. Performance metrics were calculated as a percentage.Results. The study analyzed data from 229 patients who had EVD placed following subarachnoid hemorrhage between June 2006 and December 2012. Of these, 155 (67.7%) were female and 62 (27%) developed delayed cerebral ischemia. A total of 45 150 h of data were segmented. 2044 one-hour segments were randomly selected and evaluated by two investigators (MM and DN). Of those, the evaluators agreed on the classification of 1556 one-hour segments. The algorithm was able to correctly identify 86% (1338 h) of ICP waveform data. 8.2% (128 h) of the time the algorithm either partially or fully failed to segment the ICP waveform. 5.4% (84 h) of data, artifacts were mistakenly identified as ICP waveforms (false positives).Conclusion. The proposed algorithm automates the identification of valid ICP waveform segments of waveform in EVD data and thus enables the inclusion in real-time data analysis for decision support. It also standardizes and makes research data management more efficient.

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Development and validation of a rapidly deployable CT-guided stereotactic system for external ventricular drainage: preclinical study.

Publications

Development and validation of a rapidly deployable CT-guided stereotactic system for external ventricular drainage: preclinical study.

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