Dysphagia after stroke is common, especially in severely affected patients who have had a tracheotomy. In a pilot trial, pharyngeal electrical stimulation (PES) improved swallowing function in this ...group of patients. We aimed to replicate and extend this single-centre experience.
We did a prospective, single-blind, randomised controlled trial across nine sites (seven acute care hospitals, two rehabilitation facilities) in Germany, Austria, and Italy. Patients with recent stroke who required tracheotomy were randomly assigned to receive 3 days of either PES or sham treatment (1:1). All patients had the stimulation catheter inserted; sham treatment was applied by connecting the PES base station to a simulator box instead of the catheter. Randomisation was done via a computerised interactive system (stratified by site) in blocks of four patients per site. Patients and investigators applying PES were not masked. The primary endpoint was assessed by a separate investigator at each site who was masked to treatment assignment. The primary outcome was readiness for decannulation 24–72 h after treatment, assessed using fibreoptic endoscopic evaluation of swallowing and based on a standardised protocol, including absence of massive pooling of saliva, presence of one or more spontaneous swallows, and presence of at least minimum laryngeal sensation. We planned a sequential statistical analysis of superiority for the primary endpoint. Interim analyses were to be done after primary outcome data were available for 50 patients (futility), 70 patients, and every additional ten patients thereafter, up to 140 patients. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN18137204.
From May 29, 2015, to July 5, 2017, of 81 patients assessed, 69 patients from nine sites were randomly assigned to receive PES (n=35) or sham (n=34) treatment. Median onset to randomisation time was 28 days (IQR 19–41; PES 28 20–49; sham 28 18–40). The Independent Data and Safety Monitoring Board recommended that the trial was stopped early for efficacy after 70 patients had been recruited and primary endpoint data for 69 patients were available. This decision was approved by the steering committee. More patients were ready for decannulation in the PES group (17 49% of 35 patients) than in the sham group (three 9% of 34 patients; odds ratio OR 7·00 95% CI 2·41–19·88; p=0·0008). Adverse events were reported in 24 (69%) patients in the PES group and 24 (71%) patients in the sham group. The number of patients with at least one serious adverse event did not differ between the groups (ten 29% patients in the PES group vs eight 23% patients in the sham group; OR 1·30 0·44–3·83; p=0·7851). Seven (20%) patients in the PES group and three (9%) patients in the sham group died during the study period (OR 2·58 0·61–10·97; p=0·3059). None of the deaths or serious adverse events were judged to be related to PES.
In patients with stroke and subsequent tracheotomy, PES increased the proportion of patients who were ready for decannulation in this study population, many of whom received PES within a month of their stroke. Future trials should confirm whether PES is beneficial in tracheotomised patients who receive stimulation similarly early after stroke and explore its effects in other cohorts.
Phagenesis Ltd.
•Largest cohort of patients with COVID-19 and neurological symptoms who underwent LP.•In all 30 cases, RT-PCR for SARS-CoV-2 from CSF was negative.•CSF analysis findings, including WBC, were normal ...in most patients with COVID-19.•Neurological symptoms in COVID-19 seem to be caused mainly by indirect mechanism.
The Harlequin syndrome may occur in patients treated with venoarterial extracorporal membrane oxygenation (VA-ECMO), in whom blood from the left ventricle and the ECMO system supply different parts ...of the body with different paCO2-levels. The purpose of this study was to compare two variants of paCO2-analysis to account for the Harlequin syndrome during apnea testing (AT) in brain death (BD) determination.
Twenty-seven patients (median age 48 years, 26–76 years; male n = 19) with VA-ECMO treatment were included who underwent BD determination. In variant 1, simultaneous arterial blood gas (ABG) samples were drawn from the right and the left radial artery. In variant 2, simultaneous ABG samples were drawn from the right radial artery and the postoxygenator ECMO circuit. Differences in paCO2-levels were analysed for both variants.
At the start of AT, median paCO2-difference between right and left radial artery (variant 1) was 0.90 mmHg (95%-confidence intervall CI: 0.7–1.3 mmHg). Median paCO2-difference between right radial artery and postoxygenator ECMO circuit (variant 2) was 3.3 mmHg (95%-CI: 1.5–6.0 mmHg) and thereby significantly higher compared to variant 1 (p = 0.001). At the end of AT, paCO2-difference according to variant 1 remained unchanged with 1.1 mmHg (95%-CI: 0.9–1.8 mmHg). In contrast, paCO2-difference according to variant 2 increased to 9.9 mmHg (95%-CI: 3.5–19.2 mmHg; p = 0.002).
Simultaneous paCO2-analysis from right and left distal arterial lines is the method of choice to reduce the risk of adverse effects (e.g. severe respiratory acidosis) while performing AT in VA-ECMO patients during BD determination.
Osmotic demyelination syndrome (ODS), which embraces central pontine myelinolysis (CPM) and extrapontine myelinosis (EPM), is often underdiagnosed in clinical practice, but can be fatal. In this ...article, we review the etiology, patho- physiology, clinical features, diagnosis, treatment, and prognosis of ODS.
Pertinent publications from the years 1959 to 2018 were retrieved by a selective search in PubMed.
The most common cause of ODS is hyponatremia; particular groups of patients, e.g., liver transplant recipients, are also at risk of developing ODS. The pathophysiology of ODS consists of cerebral apoptosis and loss of myelin due to osmotic stress. Accordingly, brain areas that are rich in oligodendrocytes and myelin tend to be the most frequently affected. Patients with ODS often have a biphasic course, the first phase reflecting the underlying predisposing illness and the second phase reflecting ODS itself, with pontine dysfunction, impaired vigilance, and movement disorders, among other neurological abnormalities. The diagnostic modality of choice is magnetic resonance imaging (MRI) of the brain, which can also be used to detect oligosymptomatic ODS. The current mainstay of management is prevention; treatment strategies for manifest ODS are still experimental. The prognosis has improved as a result of MRI-based diagnosis, but ODS can still be fatal (33% to 55% of patients either die or remain permanently dependent on nursing care).
ODS is a secondary neurological illness resulting from a foregoing primary disease. Though rare overall, it occurs with greater frequency in certain groups of patients. Clinicians of all specialties should therefore be familiar with the risk constellations, clinical presentation, and prevention of ODS. The treatment of ODS is still experimental at present, as no evidence-based treatment is yet available.
IMPORTANCE: Many patients with severe stroke have impaired airway protective reflexes, resulting in prolonged invasive mechanical ventilation. OBJECTIVE: To test whether early vs standard ...tracheostomy improved functional outcome among patients with stroke receiving mechanical ventilation. DESIGN, SETTING, AND PARTICIPANTS: In this randomized clinical trial, 382 patients with severe acute ischemic or hemorrhagic stroke receiving invasive ventilation were randomly assigned (1:1) to early tracheostomy (≤5 days of intubation) or ongoing ventilator weaning with standard tracheostomy if needed from day 10. Patients were randomized between July 28, 2015, and January 24, 2020, at 26 US and German neurocritical care centers. The final date of follow-up was August 9, 2020. INTERVENTIONS: Patients were assigned to an early tracheostomy strategy (n = 188) or to a standard tracheostomy (control group) strategy (n = 194). MAIN OUTCOMES AND MEASURES: The primary outcome was functional outcome at 6 months, based on the modified Rankin Scale score (range, 0 best to 6 worst) dichotomized to a score of 0 (no disability) to 4 (moderately severe disability) vs 5 (severe disability) or 6 (death). RESULTS: Among 382 patients randomized (median age, 59 years; 49.8% women), 366 (95.8%) completed the trial with available follow-up data on the primary outcome (177 patients 94.1% in the early group; 189 patients 97.4% in the standard group). A tracheostomy (predominantly percutaneously) was performed in 95.2% of the early tracheostomy group in a median of 4 days after intubation (IQR, 3-4 days) and in 67% of the control group in a median of 11 days after intubation (IQR, 10-12 days). The proportion without severe disability (modified Rankin Scale score, 0-4) at 6 months was not significantly different in the early tracheostomy vs the control group (43.5% vs 47.1%; difference, −3.6% 95% CI, −14.3% to 7.2%; adjusted odds ratio, 0.93 95% CI, 0.60-1.42; P = .73). Of the serious adverse events, 5.0% (6 of 121 reported events) in the early tracheostomy group vs 3.4% (4 of 118 reported events) were related to tracheostomy. CONCLUSIONS AND RELEVANCE: Among patients with severe stroke receiving mechanical ventilation, a strategy of early tracheostomy, compared with a standard approach to tracheostomy, did not significantly improve the rate of survival without severe disability at 6 months. However, the wide confidence intervals around the effect estimate may include a clinically important difference, so a clinically relevant benefit or harm from a strategy of early tracheostomy cannot be excluded. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02377167
Background and purpose
Mechanical thrombectomy (MT) improves early clinical outcome in patients with acute ischemic stroke but insights on determinants of long-term outcome after MT treatment are ...scarce.
Methods
Data from stroke patients with anterior circulation large vessel occlusion of a prospective MT registry (01/2014–06/2017) of a large comprehensive stroke center were analyzed regarding clinical outcome between short- (3 months) and long-term (12 months) assessment reflected by a change of modified Rankin scores (∆mRS). Secondary endpoints included favorable long-term outcome (mRS 0–2). Multi-variable regression analysis was performed to identify determinants of outcome changes and favorable outcome at long term.
Results
Of 264 patients included, 42.0% showed a favorable long-term outcome. Longitudinal analysis found that some individuals still improved, but no overall mRS difference between short and long-term follow-up was detected ∆mRS − 0.004 (95% CI − 0.020; 0.013);
p
= 0.672. Right hemispheric stroke ∆mRS 0.286 (0.011; 0.561);
p
= 0.043 and high NIHSS at discharge ∆mRS, 0.039 (0.004; 0.074);
p
= 0.029 were associated with a longitudinal mRS decline. Favorable long-term outcome was associated with successful recanalization (
p
< 0.0001).
Conclusions
A significant number of patients with MT experience a favorable long-term outcome. Outcomes remained stable between short- and long-term follow-up, but some individuals may still show improvement beyond short-term rehabilitation. Right hemispheric stroke and clinical stroke severity at hospital discharge may be frail predictors for delayed decline of functional status, whereas successful recanalization remains a positive outcome predictor. Death rarely occurs beyond 3 months after MT treatment.
BACKGROUND:Along with subarachnoid hemorrhage (SAH), a ruptured aneurysm may also cause an intracerebral hematoma (ICH), which negatively impacts the functional outcome of SAH.
OBJECTIVE:To identify ...independent risk factors of aneurysmal ICH.
METHODS:Six hundred thirty-two consecutive patients with aneurysmal SAH treated at our institution from January 2005 to December 2012 were eligible for this study. Demographic parameters and preexisting comorbidities of patients, as well as various clinical and radiographic characteristics of SAH were correlated with the incidence and volume of aneurysmal ICH.
RESULTS:One hundred fifty-five patients (25%) had ICH on initial computed tomography with a mean volume of 26.7 mL (±26.8 mL). Occurrence and volume of ICH were associated with the location (distal anterior or middle cerebral artery >proximal anterior cerebral or internal carotid artery >posterior circulation, P < .001/P < .001) and size (>12 mm, P = .026/P < .001) of the ruptured aneurysm. Vascular risk factors independently increased the risk of ICH as well (arterial hypertensionodds ratio OR = 1.62, P = .032; diabetes mellitusOR = 3.06, P = .009), while the use of aspirin (P = .037) correlated with the volume of ICH. The predictors of ICH were included into a risk score (0-9 points) that strongly predicted the occurrence of ICH (P = .01). Poor functional outcome after SAH was independently associated with the occurrence of ICH (P = .003, OR = 2.77) and its volume (P = .001, OR = 1.07 per-mL-increase).
CONCLUSION:Aneurysmal ICH is strongly associated with poorer functional outcome and seems to be predictable even before the bleeding event. The proposed risk factors for aneurysmal ICH require further validation and may be considered for treatment decisions regarding unruptured intracranial aneurysms.
ABBREVIATIONS:ACA, anterior cerebral arteryDHC, decompressive hemicraniectomyEVD, external ventricular drainageICA, internal carotid arteryICH, intracerebral hematomaMCA, middle cerebral arterymRS, modified Rankin scalePC, posterior circulationSAH, subarachnoid hemorrhageSIRS, systemic inflammatory response syndromeTCD, transcranial Doppler sonography
The optimal treatment for patients with asymptomatic carotid artery stenosis is under debate. Since best medical treatment (BMT) has improved over time, the benefit of carotid endarterectomy (CEA) or ...carotid artery stenting (CAS) is unclear. Randomised data comparing the effect of CEA and CAS versus BMT alone are absent. We aimed to directly compare CEA plus BMT with CAS plus BMT and both with BMT only.
SPACE-2 was a multicentre, randomised, controlled trial at 36 study centres in Austria, Germany, and Switzerland. We enrolled participants aged 50-85 years with asymptomatic carotid artery stenosis at the distal common carotid artery or the extracranial internal carotid artery of at least 70%, according to European Carotid Surgery Trial criteria. Initially designed as a three-arm trial including one group for BMT alone (with a randomised allocation ratio of 2·9:2·9:1), the SPACE-2 study design was amended (due to slow recruitment) to become two substudies with two arms each comparing CEA plus BMT with BMT alone (SPACE-2a) and CAS plus BMT with BMT alone (SPACE-2b); in each case in a 1:1 randomisation. Participants and clinicians were not masked to allocation. The primary efficacy endpoint was the cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years. The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary analysis was by intention-to treat, which included all randomly assigned patients in SPACE-2, SPACE-2a, and SPACE-2b, analysed using meta-analysis of individual patient data. We did two-step hierarchical testing to first show superiority of CEA and CAS to BMT alone then to assess non-inferiority of CAS to CEA. Originally, we planned to recruit 3640 patients; however, the study had to be stopped prematurely due to insufficient recruitment. This report presents the primary analysis at 5-year follow-up. This trial is registered with ISRCTN, number ISRCTN78592017.
513 patients across SPACE-2, SPACE-2a, and SPACE-2b were recruited and surveyed between July 9, 2009, and Dec 12, 2019, of whom 203 (40%) were allocated to CEA plus BMT, 197 (38%) to CAS plus BMT, and 113 (22%) to BMT alone. Median follow-up was 59·9 months (IQR 46·6-60·0). The cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years (primary efficacy endpoint) was 2·5% (95% CI 1·0-5·8) with CEA plus BMT, 4·4% (2·2-8·6) with CAS plus BMT, and 3·1% (1·0-9·4) with BMT alone. Cox proportional-hazard testing showed no difference in risk for the primary efficacy endpoint for CEA plus BMT versus BMT alone (hazard ratio HR 0·93, 95% CI 0·22-3·91; p=0·93) or for CAS plus BMT versus BMT alone (1·55, 0·41-5·85; p=0·52). Superiority of CEA or CAS to BMT was not shown, therefore non-inferiority testing was not done. In both the CEA group and the CAS group, five strokes and no deaths occurred in the 30-day period after the procedure. During the 5-year follow-up period, three ipsilateral strokes occurred in both the CAS plus BMT and BMT alone group, with none in the CEA plus BMT group.
CEA plus BMT or CAS plus BMT were not found to be superior to BMT alone regarding risk of any stroke or death within 30 days or ipsilateral stroke during the 5-year observation period. Because of the small sample size, results should be interpreted with caution.
German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG).
•First study that evaluated free hand bedside catheter aspiration in CAA patients.•For up to 4 days urokinase was administered via the catheter.•Hematoma reduction was observed in all patients upon ...initial aspiration.•Significant hematoma reduction was observed after local clot lysis with urokinase.•Rebleeding upon administration of urokinase occurred in 1 patient (5 %).
Cerebral amyloid angiopathy (CAA) is an important cause of intracerebral hemorrhage (ICH). However, data on surgical intervention in CAA-related ICH is very limited. In this retrospective study we assessed safety and efficacy of free-hand catheter aspiration followed by local thrombolysis in CAA-related large ICH.
Patients with CAA-related lobar ICH>30 ml that were treated with this catheter technique were identified from our prospective database. The catheter was inserted at the bedside in the core of the hematoma and urokinase (5000IE) was administered every 6 h for a maximum of 4 days. Evolution of hematoma volume, perihemorrhagic edema (PHE) and midline-shift (MLS) as well as adverse events and functional outcome were analyzed.
Twenty-one patients (median age 79 years) were treated between 2013-2018. Hematoma volume decreased from 70 ml at admission (IQR 49–98 ml) to 52 ml (IQR 35−76 ml, p < 0.001) immediately after catheter aspiration, and to 23.5 ml (IQR 17–47 ml, p < 0.001) at the end of urokinase treatment. At day 4, PHE volume (from 45 ml IQR 33–71 ml to 36 ml IQR 22–50 ml; p = 0.001) and MLS (from 5 mm IQR 3.5–7 mm to 1 mm IQR 0.5–3 mm; p < 0.001) were reduced significantly. No infection was observed, rebleeding after administration of 4 × 5000IE urokinase occurred in one patient (5 %). At discharge, modified Rankin Scale was 3 in 33 %, 4 in 24 %, and 5 in 43 % of patients, and had further improved after rehabilitation to an mRS of 2 in 10 %, 3 in 38 %, 4 in 19 %, and 5 in 33 % (median 9 weeks after ictus). There were no patient deaths during this time.
Bedside catheter hematoma evacuation in large CAA-related ICH seemed feasible and safe and could immediately decrease mass effect. Further studies assessing functional outcome are warranted.
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