Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.

BACKGROUND: Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA). METHODS: MR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220. FINDINGS: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned, and 502 (94%) patients provided deferred consent or died before consent was obtained (255 in the endovascular treatment group and 247 in the control group; 261 [52%] females). The median mRS score at 90 days was lower in the endovascular treatment group than in the control group (3 [IQR 2-5] vs 4 [2-6]), and we observed a shift towards better outcomes on the mRS for the endovascular treatment group (adjusted common OR 1·67 [95% CI 1·20-2·32]). All-cause mortality did not differ significantly between groups (62 [24%] of 255 patients vs 74 [30%] of 247 patients; adjusted OR 0·72 [95% CI 0·44-1·18]). Symptomatic intracranial haemorrhage occurred more often in the endovascular treatment group than in the control group (17 [7%] vs four [2%]; adjusted OR 4·59 [95% CI 1·49-14·10]). INTERPRETATION: In this study, endovascular treatment was efficacious and safe for patients with ischaemic stroke caused by an anterior circulation large-vessel occlusion who presented 6-24 h from onset or last seen well, and who were selected on the basis of the presence of collateral flow on CTA. Selection of patients for endovascular treatment in the late window could be primarily based on the presence of collateral flow. FUNDING: Collaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation.

A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke.

BACKGROUND: The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations. METHODS: We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points. RESULTS: The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81). CONCLUSIONS: In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).

Impact of the lockdown on acute stroke treatments during the first surge of the COVID-19 outbreak in the Netherlands.

INTRODUCTION: We investigated the impact of the Corona Virus Disease 2019 (COVID-19) pandemic and the resulting lockdown on reperfusion treatments and door-to-treatment times during the first surge in Dutch comprehensive stroke centers. Furthermore, we studied the association between COVID-19-status and treatment times. METHODS: We included all patients receiving reperfusion treatment in 17 Dutch stroke centers from May 11th, 2017, until May 11th, 2020. We collected baseline characteristics, National Institutes of Health Stroke Scale (NIHSS) at admission, onset-to-door time (ODT), door-to-needle time (DNT), door-to-groin time (DGT) and COVID-19-status at admission. Parameters during the lockdown (March 15th, 2020 until May 11th, 2020) were compared with those in the same period in 2019, and between groups stratified by COVID-19-status. We used nationwide data and extrapolated our findings to the increasing trend of EVT numbers since May 2017. RESULTS: A decline of 14% was seen in reperfusion treatments during lockdown, with a decline in both IVT and EVT delivery. DGT increased by 12 min (50 to 62 min, p-value of < 0.001). Furthermore, median NIHSS-scores were higher in COVID-19 - suspected or positive patients (7 to 11, p-value of 0.004), door-to-treatment times did not differ significantly when stratified for COVID-19-status. CONCLUSIONS: During the first surge of the COVID-19 pandemic, a decline in acute reperfusion treatments and a delay in DGT was seen, which indicates a target for attention. It also appeared that COVID-19-positive or -suspected patients had more severe neurologic symptoms, whereas their EVT-workflow was not affected.

Chronic mesenteric ischemia: when and how to intervene on patients with celiac/SMA stenosis.

BACKGROUND: Studies that compared open surgical mesenteric artery repair (OSMAR) with percutaneous mesenteric artery stenting (PMAS) in patients with chronic mesenteric ischemia (CMI) are based on merely older studies in which only a minority of patients received PMAS. This does not reflect the current PMAS-first choice treatment paradigm. This article focused on the present opinions and changes in outcomes of OSMAR for CMI in the era of preferred use of PMAS. METHODS: Patients who received OSMAR for CMI from 1997 until 2014 in a tertiary referral centre for chronic mesenteric ischemia were included in this report. Patients were divided into two groups, the historical OSMAR preferred group and present PMAS preferred group. RESULTS: Patient characteristics, SVS comorbidity severity score, clinical presentation and number of diseased mesenteric arteries were not significantly changed after the widespread introduction of PMAS. In the present PMAS first era there were trends of less open surgical mesenteric artery multivessel repair, less antegrade situated bypasses, decreased clinical success but improved survival after OSMAR. CONCLUSIONS: Elective OSMAR should only be used in patients with substantial physiologic reserve and who have unfavourable mesenteric lesions, failed PMAS or multiple recurrences of in-stent stenosis/occlusion. PMAS in CMI patients is evolved from "bridge to surgery" to nowadays first choice treatment and "bridge to repeated PMAS" in almost all patients with CMI.

Mesenteric vascular treatment 2016: from open surgical repair to endovascular revascularization.

The rise of endovascular techniques has improved the outcome of mesenteric ischemia. Key principle in reduction of morbidity and mortality is "revascularization first, resection later". We believe that mesenteric ischemia is a clinical challenge demanding 24/7 multidisciplinary team availability. This article describes the current insights into treatment of mesenteric ischemia.

Mediastinoscopy as a therapeutic tool.

Mediastinoscopy is a safe and effective diagnostic modality to obtain tissue specimens from the anterior mediastinum in most patient lymph node tissue. The technique can also be applied to remove other material from the mediastinum. We describe a case in which a bullet was retrieved from the mediastinum, lying very close to the innominate artery. Important differences in using the device for this purpose are highlighted.

The incidence and microbial spectrum of ventilator-associated pneumonia after tracheotomy in a selective decontamination of the digestive tract-setting.

OBJECTIVES: Tracheotomy is considered to be an independent risk factor for ventilator-associated pneumonia (VAP). Antimicrobial prophylaxis, in particular with coverage of Pseudomonas aeruginosa, is presently advocated. Selective decontamination of the digestive tract (SDD) aims to prevent VAP in critically ill patients, including those after tracheotomy. We determined the incidence and microbial spectrum of VAP after tracheotomy in a SDD-setting. METHODS: Retrospective analysis of 231 tracheotomized patients during a 2-year period. RESULTS: Thirteen patients (5.6%) developed VAP. The median [IQR] day of onset was 8.0 [3.0-10.5] days after tracheotomy. The most predominant causative pathogen was Methicillin-sensitive Staphylococcus aureus (MSSA). Timing of tracheotomy was not different between patients developing VAP and those who did not. The type of tracheotomy (percutaneous or surgical, 84.6% versus 15.4%) had no significant influence on the incidence of VAP. CONCLUSIONS: The incidence of VAP after tracheotomy in a SDD-setting is low, with MSSA as the predominant causative pathogen. Accordingly, if antimicrobial prophylaxis is considered, it may be advisable to cover MSSA in an SDD-setting.