Indocyanine green clearance test in liver transplantation: defining cut-off levels for graft viability assessment during organ retrieval and for the prediction of post-transplant graft function recovery – the Liver Indocyanine Green (LivInG) Trial Study Protocol

Introduction
Viability assessment of the graft is essential to lower the risk of liver transplantation (LT) failure and need for emergency retransplantation, however, this still relies mainly on surgeon’s experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision making.
This study aims to trial the use of indocyanine green clearance test (IGT) in the donor as an objective tool to assess graft viability and in the recipient to assess graft function recovery after LT.

Methods and analysis
This is an observational prospective single-centre study on consecutive liver transplant donors and recipients.

Primary objective
To determine the capability of IGT of predicting graft viability at the time of organ retrieval. Indocyanine green will be administered to the donor and the plasma disappearance rate (PDR) measured using the pulsidensitometric method. Some 162 IGT donor procedures will be required (α, 5%; β, 20%) using an IGT-PDR cut-off value of 13% to achieve a significant discrimination between viable and non-viable grafts.

Secondary objective
IGT-PDR will be measured at different time-points in the LT recipient: during the anhepatic phase, after graft reperfusion, at 24 hours, on day 3 and day 7 after LT. The slope of IGT values from the donor to the recipient will be evaluated for correlation with the development of early allograft dysfunction.

Ethics and dissemination
This research protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (reference number: 0048466/20, study ID: 3656) and by the Italian National Transplant Center (CNT) (reference number: Prot.11/CNT2021). Liver recipients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals and presented in congresses.

Trial registration number
NCT05228587.

Leggi
Agosto 2022

Diagnostic Performance of a Noninvasive Breath Test for Colorectal Cancer: COBRA1 Study

Colorectal cancer (CRC) is the third most common cancer globally.1 When diagnosed early, the 5-year survival rate is 92%,2 yet 23% of CRCs are diagnosed at an advanced stage3 in the United Kingdom with a 5-year survival rate of 10%.2 Early CRC has symptoms that are shared with common benign conditions.4 Colonoscopy capacity is limited, and referring all symptomatic patients for colonoscopy would overwhelm available resources. An intermediate triage test to identify patients at risk of CRC could streamline referral pathways.

Leggi
Luglio 2022

Features and predictive value of 6-min walk test outcomes in interstitial lung disease: an observation study using wearable monitors

Objectives
To describe 6-min walk test (6MWT) outcomes, and to investigate their correlations with cardiopulmonary and lung function among patients with interstitial lung disease (ILD) which was not limited to idiopathic pulmonary fibrosis.

Methods
We collected patients’ demographic data and obtained minute-by-minute 6MWT outcomes. Modified Borg scale was employed to assess patients’ dyspnoea, whereas New York Heart Association (NYHA) classification and pulmonary function test were used to evaluate patients’ cardiopulmonary functions.

Results
Heart rate (HR) exhibited a continuous upward trend, while SpO2 exhibited an overall downward with a slight increase at the fifth minute. The SpO2 nadir for 70 patients (9.3%) was lower than 80%. Further, the SpO2 nadir for 78.27% of the participants appeared at the end of the fourth minute. The 6-min walk distance (6MWD) had the strongest correlation with NYHA classification (r=0.82, p

Leggi
Giugno 2022

Evaluation of change in emergency care knowledge and skills among front-line healthcare providers in Ukraine with the Basic Emergency Care course: a pretest/post-test study

Objective
Evaluate the change in participant emergency care knowledge and skill confidence after implementation of the WHO-International Committee of the Red Cross (ICRC) Basic Emergency Care (BEC) course.

Design
Pretest/post-test quasi-experimental study.

Setting
Mechnikov Hospital in Dnipro, Ukraine.

Participants
Seventy-nine participants engaged in the course, of whom 50 (63.3%) completed all assessment tools. The course was open to healthcare providers of any level who assess and treat emergency conditions as part of their practice. The most common participant profession was resident physician (24%), followed by health educator (18%) and prehospital provider (14%).

Interventions
The 5-day WHO-ICRC BEC course.

Primary and secondary outcome measures
Change in pre-course and post-course knowledge and skill confidence assessments. Open-ended written feedback was collected upon course completion and analysed for common themes.

Results
Participant knowledge assessment scores improved from 19 (IQR 15–20) to 22 (IQR 19–23) on a 25-point scale (p

Leggi
Giugno 2022

COVID-19 among staff and their family members of a healthcare research institution in Bangladesh between March 2020 and April 2021: a test-negative case-control study

Objective
To identify factors associated with COVID-19 positivity among staff and their family members of icddr,b, a health research institute located in Bangladesh.

Setting
Dhaka, Bangladesh.

Participants
A total of 4295 symptomatic people were tested for SARS-CoV-2 by reverse-transcription PCR between 19 March 2020 and 15 April 2021. Multivariable logistic regression was done to identify the factors associated with COVID-19 positivity by contrasting test positives with test negatives.

Result
Forty-three per cent of the participants were tested positive for SARS-CoV-2. The median age was high in positive cases (37 years vs 34 years). Among the positive cases, 97% were recovered, 2.1% had reinfections, 24 died and 41 were active cases as of 15 April 2021. Multivariable regression analysis showed that age more than 60 years (adjusted OR (aOR)=2.1, 95% CI 1.3 to 3.3; p

Leggi
Giugno 2022

Combined Oral Triglyceride and Glucose Tolerance Test After Acute Ischemic Stroke to Predict Recurrent Vascular Events: The Berlin “Cream&Sugar” Study

Stroke, Ahead of Print. Background:Elevated triglyceride and glucose levels are associated with an increased cardiovascular disease risk including ischemic stroke. It is not known whether the response to a combined oral triglyceride and glucose challenge after ischemic stroke improves identification of patients with increased risk for recurrent vascular events.Methods:The prospective, observational Berlin “Cream&Sugar” study was conducted at 3 different university hospital sites of the Charité–Universitätsmedizin Berlin, Germany, between January 24, 2009 and July 31, 2017. Patients with first-ever ischemic stroke were recruited 3 to 7 days after stroke. An oral triglyceride tolerance test (OTTT) and consecutive blood tests before (t0) as well as 3 (t1), 4 (t2), and 5 hours (t3) after OTTT were performed in fasting patients. An oral glucose tolerance test was performed in all nondiabetic patients 3 hours after the start of OTTT. Outcomes of the study were recurrent fatal or nonfatal stroke as well as a composite vascular end point including stroke, transient ischemic attack, myocardial infarction, coronary revascularization, and cardiovascular death assessed 1 year after stroke. Cox regression models were used to estimate hazard ratios and corresponding 95% CIs between patients with high versus low levels of triglyceride and glucose levels.Results:Overall 755 patients were included; 523 patients completed OTTT and 1-year follow-up. Patients were largely minor strokes patients with a median National Institutes of Health Stroke Scale score of 1 (0–3). Comparing highest versus lowest quartiles of triglyceride levels, neither fasting (adjusted hazard ratiot0, 1.24 [95% CI, 0.45–3.42]) nor postprandial triglyceride levels (adjusted hazard ratiot3, 0.44 [95% CI, 0.16–1.25]) were associated with recurrent stroke. With regard to recurrent vascular events, results were similar for fasting triglycerides (adjusted hazard ratiot0, 1.09 [95% CI, 0.49–2.43]), however, higher postprandial triglyceride levels were significantly associated with a lower risk for recurrent vascular events (adjusted hazard ratiot3, 0.42 [95% CI, 0.18–0.95]). No associations were observed between fasting and post–oral glucose tolerance test blood glucose levels and recurrent vascular risk. All findings were irrespective of the diabetic status of patients.CONCLUSIONS:In this cohort of patients with first-ever‚ minor ischemic stroke, fasting triglyceride or glucose levels were not associated with recurrent stroke at one year after stroke. However, higher postprandial triglyceride levels were associated with a lower risk of recurrent vascular events which requires further validation in future studies. Overall, our results do not support the routine use of a combined OTTT/oral glucose tolerance test to improve risk prediction for recurrent stroke.

Leggi
Maggio 2022

Abstract WMP91: Angiographic Predictors Of Balloon Test Occlusion Outcomes

Stroke, Volume 53, Issue Suppl_1, Page AWMP91-AWMP91, February 1, 2022. Introduction:Balloon test occlusion (BTO) with adjunctive single-photon emission computed tomography (SPECT) has been utilized to predict clinical tolerance after permanent internal carotid artery (ICA) occlusion. Cerebrovascular anatomical characteristics might predict BTO outcomes and identify patients susceptible to test failure.Methods:We performed a single center retrospective study of patients who underwent catheter based cerebral angiogram and ICA BTO from July 2013 to June 2020. SPECT imaging was completed in all the patients who passed the clinical BTO; technetium 99m-ethyl cysteinate dimer was injected intravenously after 15-30 min of occlusion and induced hypotension. The diameter of each of the vessels of the Circle of Willis was measured angiographically. The severity of hypoperfusion on SPECT imaging was classified as none, mild, low intermediate, high intermediate, and severe.Results:A total of 57 patients underwent BTO; neoplasia was the most common indication (n=43, 75%). Twelve patients (21.1%) developed neurologic symptoms and clinically failed the BTO; 45 patients (78.9%) passed and proceeded to SPECT. Contralateral dominant vertebral artery (p=0.02), smaller ACom (p=0.002) and ipsilateral PCom (p=0.03) diameters were correlated with clinical BTO failure. Smaller ACom was most predictive with an AUC of 0.907. The Youden index identified an ACom diameter threshold of 1.1 mm, which demonstrated a sensitivity of 91.7% and specificity of 77.8% (OR 0.026, 95% CI 0.003 – 0.226, ROC=0.847) for the prediction of BTO failure. Patients with severe SPECT asymmetry had significantly smaller caliber ACom arteries (ACom median diameter 0.95 mm vs. rest of cohort median 1.4; p=0.0073).Conclusions:BTO outcomes may be predicted using angiographic findings. A small (

Leggi
Febbraio 2022

Abstract TP258: Assessing Post-stroke Motor Impairments Using Staircase Reaching Test

Stroke, Volume 53, Issue Suppl_1, Page ATP258-ATP258, February 1, 2022. Background:Behavior tests that assess side-specific motor impairments after unilateral lesion such as focal ischemic stroke have translational applications, as 8 out of 10 stroke survivors suffer from hemiparesis. Accurate measurements of neurological functions are therefore important for assessing the effectiveness of various treatment strategies. Here, we demonstrate the feasibility of the staircase test to objectively evaluate lateralized deficits in coordinated paw reaching in adult mice after experimental stroke.Methods:A cohort of adult male C57BL/6J mice (12-14 weeks of age) were subjected to a 14-day training period, where they were kept on a 21-hour food deprivation regime and at 85-90% of their original body weight. They were then subjected to permanent distal middle cerebral artery occlusion (dMCAO, n=10). The number of steps reached and pellets grasped/eaten were evaluated at pre-stroke baseline and post-stroke days (PD) 7-8 and 14-15; behavior data from PD7-8 and PD14-15 were averaged between the two days. Brains were collected at PD16 and sections immunostained with antibodies targeting neurons (MAP2) and/or activated microglia/macrophage (CD68).Results:Mice attained a stable baseline for reaching steps and consuming pellets after a 14-day training period. At PD7-8, stroked mice showed a significant decrease in their ability to grasp/consume pellets on the affected side (right limb) compared to pre-stroke baseline (p=0.001). At PD14-15, stroked mice exhibited a significant decline in their ability to reach longer distances on the affected side (right limb), attaining only 65% of their baseline performance (p=0.006). No significant deficit was shown on the non-affected side (left limb).Conclusions:Our results show that the staircase test can detect side-specific motor deficits up to PD15 in a dMCAO model. Ongoing studies with a larger cohort are evaluating longer-term deficits up to one-month post-stroke and assessing the effects of optogenetic cortico-thalamic circuit stimulations on grasping behavior using the staircase test.

Leggi
Febbraio 2022

Abstract WP2: Videooculography-assisted Head Impulse Test And Caloric Testing Improve Clinical Algorithms For Detecting Stroke In Acute Vertigo Patients

Stroke, Volume 53, Issue Suppl_1, Page AWP2-AWP2, February 1, 2022. Introduction:Stroke accounts for 4% of patients with acute vertigo, which is missed in up to one third of cases.Hypothesis:We hypothesized that detection of stroke underlying acute vertigo using HINTS plus (head-impulse test, nystagmus type, test of skew, hearing loss) can be improved by videooculography for automated analysis of head-impulse test (V-HIT).Materials and Methods:We evaluated patients with acute vestibular syndrome (AVS) presenting to the emergency room using HINTS plus and V-HIT-assisted HINTS plus in a randomized sequence. In addition, patients underwent cranial MRI and caloric testing. Image-confirmed posterior circulation stroke or vertebrobasilar TIA were defined as reference standard to calculate accuracy of applied vertigo assessment protocols. After study completion, we repeated statistical analysis for a third protocol that was composed post hoc by replacing the results of head-impulse test with those derived from caloric testing in the HINTS plus protocol.Results:We included 30 AVS patients (ages 55.4 ± 17.2 years, 14 females). Of these, 11 (36.7%) had MRI-confirmed posterior circulation ischemic stroke (n=4) or vertebrobasilar TIA (n=7). Conducting V-HIT-assisted HINTS plus as part of the emergency work up was feasible and displayed a tendency toward higher accuracy than conventional HINTS plus (sensitivity: 81.8%, 95%CI 48.2-97.7%; specificity 31.6%, 95%CI 12.6-56.6% vs. sensitivity 72.7%, 95%CI 39.0-94.0%; specificity 36.8%, 95%CI 16.3-61.6%). (Figure) The new caloric-supported algorithm displayed high accuracy (sensitivity 100%, 95%CI 66.4%-100%; specificity 66.7%, 95%CI 41%-86.7%).Conclusions:Our study provides pilot data on the capacity of videooculography to improve accuracy of acute vertigo assessment using HINTS plus and indicates potential value of acute caloric testing as integrative part of standardized AVS emergency work up.

Leggi
Febbraio 2022

Abstract WMP34: Early Oral Feeding Following Removal Of Feeding Tube In Stroke Patients Based On The Modified Volume-viscosity Swallow Test

Stroke, Volume 53, Issue Suppl_1, Page AWMP34-AWMP34, February 1, 2022. Objective:Dysphagia is common in patients with acute ischemic stroke patients (AIS). Feeding tubes are often placed to prevent aspiration pneumonia and supply nutrition when swallow function impaired are detected. However, little is known about when and how to start oral feeding in AIS. The purpose of this study is to establish a feasibility and effective intervention for early oral feeding following removal of feeding tube in patients with AIS.Methods:A total of 37 patients with AIS who were removed feeding tubes and start oral feeding in our hospital from 2017 to 2021 were retrospectively analyzed. An intervention program for early oral feeding, which consisted of the modified volume-viscosity swallow test (V-VST) and mechanical soft diet, was fully operationalized from October 2020 to July 2021. Outcomes were compared between an early oral feeding intervention group of 17 patients and a historical control group of 20 patients from July 2017 to September 2020. We compared the baseline characteristics between the groups. To analyze aspiration pneumonia probability, the Kaplan-Meier method were used.Results:The length of stay in hospital was significantly longer in the control group compared with the early oral feeding group (16.70±5.24 vs 12.88±4.46; P=0.024). Patients in the control group tolerated tube feeding longer days ( 9.45±2.93 vs 6.59±3.57; P=0.011 ). A log-rank test found no significant difference in aspiration pneumonia between the two groups ( P =0.111).Conclusions:Our data suggest that the intervention for early oral feeding can be used safely and possibly.

Leggi
Febbraio 2022