Analytical assessment and performance of the 0/3h algorithm with novel high sensitivity cardiac troponin I.

BACKGROUND: Recently, Ortho Clinical Diagnostics have launched a high sensitivity cardiac troponin I assay adapted on Vitros3600 / 5600. We aimed at evaluating the analytical and clinical performances using the 0/3-hour algorithm, of the Ortho hs-cTnI assay on the Vitros 3600® (Ortho Clinical Diagnostics, Illkirch, France) analyzer with comparison to Roche hs-cTnT assay on the Cobas8000/e801® module (Roche diagnostics, Meylan, France) and the Abbott STAT hs-cTnI assay on the Alinity i® (Abbott, Rungis, France) analyzer. METHODS: Imprecision studies, linearity, limit of detection, and the interference to hemolysis were performed for Ortho hs-cTnI assay. The concordance study was based on results of troponin obtained from 160 patients with chest pain to the emergency department. Testing was performed simultaneously measuring the Roche hs-cTnT and the Ortho hs-cTnI, then on remaining sample the concentration of Abbott hs-cTnI (n = 150). We applied the 0/3h algorithm to rule out/rule in, in acute myocardial infarction. RESULTS: Analytical performances were acceptable and in accordance with manufacturer's data. For late presenters 100, 92.8 and 88.8% patients could be rule-out with Roche, Ortho and Abbott assay, respectively with one NSTEMI missed with both hs-TnI assays. Applying the hs-cTn cut-offs from 0/3-hour algorithm, 107 (66.8%) could be rule out with Roche hs-cTnT with no AMI missed (sensitivity 100% [95%CI: 90.5 to 100] and NPV 100%); 89 with Ortho hs-cTnI (sensitivity 97.3% [95%CI: 85.8-99.9] and NPV 98.8% [95%CI:92.7-99.8]); and 61 with Abbott hs-cTnI (sensitivity 97% [95%CI: 84.2-99.9] and NPV 98.4% [95%CI: 89.8-99.7]). For rule-in, 23.7% (n = 37) from the total population would be designated in this group, with a specificity of 86.9% (95%CI: 79.7-92.4) and PPV of 69.8% (95%CI: 59.4-78.5) vs specificity of 72.3% (95%CI:63.5-80.0) and PPV of 51.4% (95%CI: 44.1-58.2)with Roche hs-cTnT vs Ortho hs-cTnI respectively; and with Abbott, 33 patients had constitued this group with a specificity of 52.1% (95%CI:42.7-61.4) and PPV of 36.4% (95%CI: 32.0-41.0). CONCLUSION: In conclusion, according to ESC guidelines, our results indicate that the Ortho hs-cTnI assay for the Vitros 3600 instrument is a method that may be used in the clinical practice using 0/3-hour algorithm.

Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol.

INTRODUCTION: Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT. METHODS AND ANALYSIS: DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0-2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0-2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment. ETHICS AND DISSEMINATION: The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal. TRIAL REGISTRATION NUMBER: NCT03969511.

A Regional Network Organization for Thrombectomy for Acute Ischemic Stroke in the Anterior Circulation; Timing, Safety, and Effectiveness.

BACKGROUND: Mechanical thrombectomy (MT) in association with intravenous thrombolysis is recommended for treatment of acute ischemic stroke (AIS), with large vessel occlusion (LVO) in the anterior circulation. Because MT is only available in comprehensive stroke centers (CSC), the challenge of stroke organization is to ensure equitable access to the fastest endovascular suite. Our aim was to evaluate the feasibility, efficacy, and safety of MT in patients initially managed in 1 CSC (mothership), compared with patients first managed in primary stroke center (PSC), and then transferred to the CSC for MT (drip-and-ship). METHODS: We retrospectively analyzed 179 consecutive patients (93 in the mothership group and 86 in the drip-and-ship group), with AIS secondary to LVO in the anterior cerebral circulation and a clinical-radiological mismatch (NIHSS ≥ 8 and DWI-ASPECT score ≥5), up to 6 hours after symptoms onset. We evaluated 3-month functional modified Rankin scale (mRS), periprocedural time management, mortality, and symptomatic intracranial haemorrhage (sICH). RESULTS: Despite significant longer process time in the drip-and-ship group, mRS ≤ 2 at 3 months (39.8% versus 44.1%, P = .562), Thrombolysis in cerebral infarction 2b-3 (85% versus 78%, P = .256), and sICH (7.0% versus 9.7%, P = .515) were similar in both group regardless of baseline clinical or radiological characteristics. After multivariate logistic regression, the predictive factors for favorable outcome were age (odds ratio [OR] -5years= 1.32, P < .001), initial NIHSS (OR -5points = 1.59, P = .010), absence of diabetes (OR = 3.35, P = .075), and the delay magnetic resonance imagining-puncture (OR -30min = 1.16, P = .048). CONCLUSIONS: Our study showed encouraging results from a regional protocol of MT comparing patients transferred from PSC or brought directly in CSC.

Point-of-care creatinine testing in patients receiving contrast-enhanced computed tomography scan.

BACKGROUND: The aim of this study was to evaluate the creatinine assay on the ABL800 FLEX© blood gas analyzer for the screening of pre-existing renal impairment before radiographic contrast administration in the emergency department (ED), by comparing it with standard practice using central laboratory blood testing. METHODS: The evaluation comprised two elements. The first, conducted in the central laboratory, focused on the analytical performance of the ABL800 creatinine assay. This included assessment of imprecision and accuracy by comparison with central laboratory standard creatinine assay. We also compared ABL 800 estimated glomerular filtration rate (eGFR) and 99mTc-DTPA measured GFR (mGFR). The second part, conducted in ED sought to determine the impact that implementation of the creatinine at the point-of-care (POC) has on the timeframe in which ED patients are submitted for computed tomography scan (CT). RESULTS: The ABL800 enzymatic creatinine assay met the National Kidney Disease Education Program acceptance criteria for imprecision and showed good agreement with the isotope dilution mass spectrometry-traceable Roche enzymatic assay used in the central laboratory. Furthermore, ABL800 eGFR was in total agreement with mGFR by a reference method. The implementation of POC testing creatinine in the ED significantly reduced patient waiting times for contrast enhanced CT (1.73[0.75-3.01] vs 2.57 [1.53-3.48] hours, for period with and without ABL800 respectively, p=0.04). CONCLUSION: The ABL800 assay is comparable with central laboratory reference method in terms of analytical performance and superior in terms of turnaround time. Implementation of creatinine at POC reduces delay results, potentially allowing ED clinical staff to make more rapid clinical decisions and reduce patient waiting time.