LivaNova (United States)

There is a spelling mistake in one of the authors listed in the published version of the paper: "Martin Otler" should be read "Martin Ortler" The original article is corrected.

Abstract Background Up to 25 percent of patients suffering from an acute stroke are diagnosed with delirium during the hospital stay, with older age increasing the risk. Generalized slowing in the electroencephalogram (EEG) supports the diagnosis of delirium. We examined the potential of single-channel EEG (DeltaScan®) as an easy-to-use device on intensive care units for detecting delirium. Our aim was to compare clinically established delirium diagnoses with bihemispheric EEG recordings and single-channel EEG to analyze the diagnostic accuracy of EEG-based diagnoses. Methods Within the first five days after stroke onset, patients received single-channel EEG DeltaScan® and a routine 21-channel EEG. The DeltaScan® analyzes right sided fronto-parietal EEG using a proprietary algorithm focusing on polymorphic delta activity (PDA). In routine EEG the power spectral density (PSD) in predefined frequency bands was analyzed based on 2-minute eyes-closed resting state segments. EEG-analyses were conducted in MNE (v1.3.1) in Python (3.10) and RStudio (v4.2.1). Results In 9 of 53 patients (52–90 years) delirium was diagnosed according to DSM-V criteria. Sensitivity of DeltaScan® was 44% (95% CI = 15.3–77.3%), while specificity was 71% (95% CI = 57–83%). We found patients with right hemispheric stroke having a higher probability to be false positive in DeltaScan® (p = 0.01). The 21-channel EEG based power analysis revealed frontal delta (sensitivity 0.89, 95% CI = 0.67-1; specificity 0.68, 95% CI = 0.54–0.8) as the best predictor of diagnosed delirium. Conclusions When EEG is used in clinical practice to support a delirium diagnosis in stroke patients, bihemispheric recordings are likely preferable over unilateral recordings. Slowing in the delta- or theta-frequency spectrum over the site of stroke may lead to false-positive results in single channel EEG based delirium scoring.

Extracorporeal carbon dioxide removal (ECCO2R) devices are increasingly used in treating acute-on-chronic respiratory failure caused by chronic lung diseases. There are no large studies that investigated safety, efficacy, and the independent association of prognostic variables to survival that could define the role of ECCO2R devices in such patients. This multicenter, multinational, retrospective study investigated the efficacy, safety of a single ECCO2R device (Hemolung) in patients with acute on chronic respiratory failure and identified variables independently associated with intensive care unit (ICU) survival. The primary outcome was improvement in blood gasses with the use of Hemolung. Secondary outcomes included reduction in tidal volume, respiratory rate, minute ventilation, survival to ICU discharge, and complication profile. Multivariable regression analysis was used to identify variables that are independently associated with ICU survival. A total of 62 patients were included. There was a significant improvement in pH and partial pressure of carbon dioxide in arterial blood (PaCO2) along with a reduction in respiratory rate, tidal volume, and minute ventilation with Hemolung therapy. The complication profile did not differ between survivors and nonsurvivors. Multivariable analysis identified the duration of Hemolung therapy to be independently associated with survival to ICU discharge (adjusted odds ratio = 1.21; 95% confidence interval [CI] = 1.040-1.518; p = 0.01).

Kavakbasi, Erhan MD; Rosemann, Kevin MD; Yilmaz, Mert MD; Vasileiadou, Afroditi MD; Falcone, Vladislava Dipl-Psych; Baune, Bernhard T. PhD, MD, MPH, MBA, FRANZCP Author Information

Background: The auricular branch of the vagus nerve runs superficially, which makes it a favorable target for non-invasive stimulation techniques to modulate vagal activity. For this reason, there have been many early-stage clinical trials on a diverse range of conditions. These trials often report conflicting results for the same indication.Methods: Using the Cochrane Risk of Bias tool we conducted a systematic review of auricular vagus nerve stimulation (aVNS) randomized controlled trials (RCTs) to identify the factors that led to these conflicting results. The majority of aVNS studies were assessed as having “some” or “high” risk of bias, which makes it difficult to interpret their results in a broader context.Results: There is evidence of a modest decrease in heart rate during higher stimulation dosages, sometimes at above the level of sensory discomfort. Findings on heart rate variability conflict between studies and are hindered by trial design, including inappropriate washout periods, and multiple methods used to quantify heart rate variability. There is early-stage evidence to suggest aVNS may reduce circulating levels and endotoxin-induced levels of inflammatory markers. Studies on epilepsy reached primary endpoints similar to previous RCTs testing implantable vagus nerve stimulation therapy. Preliminary evidence shows that aVNS ameliorated pathological pain but not evoked pain.Discussion: Based on results of the Cochrane analysis we list common improvements for the reporting of results, which can be implemented immediately to improve the quality of evidence. In the long term, existing data from aVNS studies and salient lessons from drug development highlight the need for direct measures of local neural target engagement. Direct measures of neural activity around the electrode will provide data for the optimization of electrode design, placement, and stimulation waveform parameters to improve on-target engagement and minimize off-target activation. Furthermore, direct measures of target engagement, along with consistent evaluation of blinding success, must be used to improve the design of controls—a major source of concern identified in the Cochrane analysis. The need for direct measures of neural target engagement and consistent evaluation of blinding success is applicable to the development of other paresthesia-inducing neuromodulation therapies and their control designs.