Abstract 24: Primary Results Of The Preset For Occlusive Stroke Treatment (prost) Randomized Clinical Trial

Stroke, Volume 54, Issue Suppl_1, Page A24-A24, February 1, 2023. Importance:Clinical trials focusing on new mechanical thrombectomy (MT) technologies have been typically single-arm studies using historical comparison data to determine the safety and efficacy of the novel device. To date, there has not been a contemporaneous prospective, randomized, controlled study comparing standard to newer designed stent-retrievers.Objective:To evaluate the safety and efficacy of the pRESET (phenox Ltd) compared to the Solitaire (Medtronic Corp) thrombectomy devices in the treatment of large vessel occlusion strokes (LVOS).Methods:Multicenter, prospective, randomized, open-label, blinded endpoint, core lab adjudicated, non-inferiority trial that enrolled 340 patients from October 2019 to February 2022 across 19 US & 5 German sites. Patients aged ≥ 18 years with either anterior or posterior circulation LVOS were included up to 8 hours after symptom onset. Patients were randomly assigned in a 1:1 ratio to either pRESET or Solitaire for the first three device passes.The Primary Endpoint was the proportion of patients achieving a modified Rankin Scale score of 0-2, analyzed by intent to treat with a non-inferiority margin of 0.125 based on the lower bound 95% Confidence Interval. The Primary Safety Endpoint was the proportion of subjects with device- or procedure-related symptomatic intracerebral hemorrhage at 24 (-8/+12) hours as per the SITS-MOST criteria. Secondary Outcome Measures included the rates of (1) Successful Revascularization (defined as expanded Thrombolysis in Cerebrovascular Infarction [eTICI] ≥2b50 ≤3 passes of the assigned device; (2) eTICI ≥2c following the first pass of the assigned device; (3) 90-day mortality and (4) Distribution of 90-day mRS across the entire spectrum of disability (ordinal shift).Results:The study database was locked in August 2022. The analysis is ongoing and the final results will be presented at the 2023 International Stroke Conference.Conclusions and Relevance:PROST is the first randomized clinical trial aiming to compare a novel versus an established stent-retriever technology, establishing a new scientific benchmark for stroke device trials. (ClinicalTrials.gov: NCT03994822).

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Febbraio 2023

Abstract TP122: Systolic Blood Pressure Variability Increases During The Initial 24 Hours After Intravenous Nicardipine Administration Among Patients With Primary Intracerebral Hemorrhage

Stroke, Volume 54, Issue Suppl_1, Page ATP122-ATP122, February 1, 2023. Background:Systolic blood pressure variability (SBPV) has been associated with poor outcomes among patients with intracerebral hemorrhage (ICH). Intravenous nicardipine (IVN) is frequently used for blood pressure management among hospitalized ICH patients, however SBPV in response to IVN has not been characterized.Methods:Data for primary ICH patients who received IVN were retrieved from a stroke-specific bioinformatics pipeline. SBPV was quantified as the coefficient of variation (CV) of cuff-measured systolic blood pressure, and CV was calculated over the time periods 0-24 hrs prior to (Pre24), 0-24 hrs after (Post24), and 24-48 hrs after (Post48) initial IVN administration. Group differences were assessed using Friedman’s Test and Bonferroni-corrected Wilcoxon Signed-rank tests. Contributions of SBPV at each timepoint to poor in-hospital mortality or discharge to hospice (poor outcome) were assessed in separate multivariable logistic regression models adjusted for patient characteristics. Adjusted Odds ratios (aOR) and 95% confidence intervals (CI) are reported.Results:Data included 370 ICH patients with a median [interquartile range] age of 65 [54 – 76]. Patients included were 46.0% female, 41.1% Non-Hispanic White, 25.1% Non-Hispanic Black, 23.8% Hispanic, 8.1% Asian, and 1.9% other. Patients had a median CV of 9.2 [6.1-13.6] in the Pre24 period, 11.6 [9.46 – 13.9] in Post24, and 9.5 [7.6 – 12.1] in Post48. SPBV showed significant differences across timepoints (p=0.000), with Post24 showing elevated SBPV (vs. Pre24 (p=0.000) or Post48 (p=0.000), Figure 1A, B). In multivariable modelling, patients in the highest quartile of SPBV during the Post24 period showed increased risk of poor outcome: aOR (CI) 2.91 (1.06-8.01), Figure 1C.Conclusions:SBPV increases over the first 24 hours of IVN administration and patients with higher SPBV during this time are at higher risk for in-hospital mortality. SPBV management protocols need to be evaluated.

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Febbraio 2023

Abstract TP145: Mechanical Thrombectomy Beyond 24 Hours

Stroke, Volume 54, Issue Suppl_1, Page ATP145-ATP145, February 1, 2023. Background:Multiple randomized controlled trials have shown that mechanical thrombectomy (MT) is superior to medical therapy. However, no robust evidence is available to assess the effectiveness of MT beyond the 24-hour window. In this study, we aimed to determine the safety and efficacy of MT in patients undergoing MT for stroke beyond 24 hours from last known normal (LKN).Methods:Retrospective review of a prospectively collected database for subjects who met extended window trial criteria, but underwent MT beyond 24 hours. Recorded variables included age, sex, NIHSS at baseline and at discharge, risk factors, level of occlusion, access site, thrombectomy method. Safety and efficacy outcomes included symptomatic intracerebral hemorrhage (sICH), procedural complications, number of passes, successful recanalization (TICI 2b-3), Δ NIHSS (baseline-discharge), favorable outcomes (mRS 0-2) at 90 days.Results:A total of 39 patients were included with a median age of 69 (IQR 61.5, 73.5); 54% were females. Hypertension was the most frequent risk factor in 76% of patients; 23 % of patients were smokers. Half of the patients had M1 occlusion (48.7%). Median preprocedural NIHSS was 11 (IQR 7.0, 19.5). Successful revascularization was achieved in 87%; median number of passes was 2 (IQR 1.0,3.0). Median ΔNIHSS was 3.0 (IQR -1.5, 8.0). Favorable outcome was achieved in 49% (95% CI: 34%-64%), and 95% were free of complications. A total of 3 patients (7.7%) had sICH. In an exploratory analysis, posterior circulation occlusion was associated with higher risk of poor mRS at 90 days (OR: 14.7, p = 0.016). Additionally, favorable discharge facility (home, home health, or rehab) was associated with a much lower risk of poor mRS at 90 days (OR: 0.11, p = 0.004).Conclusions:Our single center study of MT beyond 24 hours showed comparable clinical outcomes and safety profile to large MT trials within 24 hours, especially in anterior circulation occlusions. Posterior circulation occlusions were associated with worse outcomes, which warrants further investigation.

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Febbraio 2023

Early urine output monitoring in very preterm infants to predict in-hospital neonatal outcomes: a bicentric retrospective cohort study

Objective
To evaluate whether urine output (UO), rarely assessed in the literature, is associated with relevant neonatal outcomes in very preterm infants, and which UO threshold may be the most clinically relevant.

Design
Retrospective cohort study.

Setting
Two Level IV neonatal intensive care units.

Patients
Very preterm infants born between 240/7 and 296/7 weeks of gestation documented with eight UO measurements per day between postnatal day 1 and day 7.

Main outcome measures
Composite outcome defined as death before discharge, or moderate to severe bronchopulmonary dysplasia, or severe brain lesions. The association between this outcome and UO was studied using several UO thresholds.

Results
Among 532 infants studied, UO

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Gennaio 2023

Prevalence of, and factors associated with, alcohol use disorder among young adults (aged 15-24 years) living with HIV/AIDS in low-income and middle-income countries: protocol for a systematic review

Introduction
Alcohol use is a global driver of HIV infection and disease progression, mediated through risky behaviour and poor antiretroviral adherence. Most studies about the burden of alcohol use among people living with HIV (PLWH)/AIDS have been done in adult populations, but less is known about young people with HIV, especially in low-income and middle-income countries (LMICs), despite the high level of alcohol use in these settings. The aim of this review is to collate evidence on the prevalence of, and factors associated with, alcohol use disorder (AUD) among young adults (aged 15–24 years) living with HIV/AIDS in LMICs.

Methods and analysis
Two experienced librarians will conduct an independent article search in PubMed, PsycINFO, Embase and Web of Science databases, using relevant Medical Subject Headings terms and Boolean operators (‘AND’, ‘OR’). We will include English-language articles that were published in peer-reviewed journals from 1 January 2000, to 25 July 2022, that documented the prevalence of AUD among young people (15–24 years) living with HIV in LMICs. We shall exclude systematic review articles and qualitative studies. Two independent reviewers will screen the articles for eligibility and data will be extracted onto a preset Excel spreadsheet. Data analysis will be done using Stata V.14.0. Heterogeneity will be assessed by use of the I2 statistic and data will be pooled in meta-analyses where appropriate. Publication bias will be assessed using the funnel plot.

Ethics and dissemination
Ethical approval is not needed as this systematic review will be based on published studies. Findings from this study will be disseminated via submission for publication in a peer-reviewed journal, at conference presentations, and made available to health professionals, scientists and policy makers. Our data set can be made available on request.

Registration details
PROSPERO, CRD42022308955

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Gennaio 2023

24-Hour Carotid Stent Patency and Outcomes After Endovascular Therapy: A Multicenter Study

Stroke, Volume 54, Issue 1, Page 124-131, January 1, 2023. Background:Management of extracranial internal carotid artery steno-occlusive lesion during endovascular therapy remains debated. Stent occlusion within 24 hours of endovascular therapy is a frequent event after acute carotid artery stenting, and we currently lack large population results. We investigated the incidence, predictors, and clinical impact of stent occlusion after acute carotid artery stenting in current clinical practice.Methods:Patients treated by endovascular therapy with acute carotid artery stenting between 2015 and 2019 in 5 large-volume endovascular-capable centers were retrospectively analyzed. Patients were separated in 2 groups according to the stent patency at 24 hours after carotid artery stenting. We compared baseline characteristics, treatment modalities, and clinical outcome depending on 24-hour stent patency. Primary end point was favorable outcome, defined as a modified Rankin Scale score 0–2 at 3 months.Results:A stent occlusion was observed in 47/225 patients (20.9%). Patients with stent patency had a lower baseline National Institutes of Health Stroke Scale (median [interquartile range]: 13 [7–17] versus 18 [12–21]) and had more often stroke of atherothrombotic origin (77.0% versus 53.2%). A higher stent patency rate was found for patients treated with P2Y12antagonists at the acute phase (odds ratio [OR]‚ 2.95 [95% CI‚ 1.10–7.91];P=0.026) and treated with angioplasty (OR‚ 2.42 [95% CI‚ 1.24–4.67];P=0.008). A better intracranial angiographic reperfusion was observed in patients with 24-hour stent patency compared with patients without stent patency (OR‚ 8.38 [95% CI‚ 3.07–22.78];P

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Dicembre 2022

Effect of implementing the NEWS2 escalation protocol in a large acute NHS trust: a retrospective cohort analysis of mortality, workload and ability of early warning score to predict death within 24 hours

Objectives
To describe the inpatient population, establish patterns in admission and mortality over a 4-year period in different cohorts and assess the prognostic ability and workload implications of introducing the National Early Warning Score 2 (NEWS2) and associated escalation protocol.

Design
Retrospective cohort analyses of medical and surgical inpatient admissions.

Setting
Large teaching hospital with tertiary inpatient care and a major trauma centre employing an electronic observations platform, initially with a local early warning score, followed by NEWS2 introduction in June 2019.

Participants
332 682 adult patients were admitted between 1 January 2016 and 31 December 2019.

Outcome measures
Mortality, workload and ability of early warning score to predict death within 24 hours.

Results
Admissions rose by 19% from 76 055 in 2016 to 90 587 in 2019. Total bed days rose by 10% from 433 382 to 477 485. Mortality fell from 3.7% to 3.1% and was significantly lower in patients discharged from a surgical specialty, 1.0%–1.2% (p

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Novembre 2022

Abstract 10370: Effects of Tirzepatide on 24-Hour Ambulatory Blood Pressure and Heart Rate in Adults With Obesity – Results From the SURMOUNT-1 Ambulatory Blood Pressure Monitoring Sub-Study

Circulation, Volume 146, Issue Suppl_1, Page A10370-A10370, November 8, 2022. Background:Tirzepatide has demonstrated substantial reductions in body weight and in-office blood pressure (BP) in people with obesity with and without type 2 diabetes (T2D). The effects of tirzepatide on ambulatory BP and heart rate (HR) have not been evaluated. We sought to assess the effect of tirzepatide on 24-hour (24h) mean systolic BP (SBP), diastolic BP (DBP) and HR, as measured during 24h ambulatory BP monitoring (ABPM) in people living with obesity without T2D.Methods:In the SURMOUNT-1 ABPM sub-study, participants with a body mass index ≥30, or ≥27 kg/m2and at least one weight-related complication (excluding diabetes), with SBP/DBP

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Ottobre 2022

Abstract 10191: Associations of Urine Biomarkers of Kidney Tubule Health With Incident Hypertension and Blood Pressure Trajectories in Middle-Aged Adults

Circulation, Volume 146, Issue Suppl_1, Page A10191-A10191, November 8, 2022. Introduction:Kidney tubules play a key role in regulating blood pressure (BP). Urine biomarkers of kidney tubule injury associate with incident hypertension (HTN) in older adults with multiple comorbidities. Less is known about these associations in younger adults.Hypothesis:Urine biomarkers of kidney tubular injury and dysfunction associate with incident HTN and greater 10-year rise in BP in middle-aged adults.Methods:In 1,170 participants of the Coronary Artery Risk Development in Young Adults (CARDIA) study (mean age 45±4, 40% black, 56% women) without HTN, cardiovascular disease or kidney disease at the year 20 exam (baseline for this analysis), we measured urine monocyte chemoattractant protein-1, alpha-1-microglobulin, kidney injury molecule-1, epidermal growth factor [EGF], interleukin-18, chitinase-3-like protein 1, and uromodulin. We examined associations of biomarkers with incident HTN (onset of systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg or initiation of BP meds) after baseline in interval-censored Cox models and BP trajectories in linear mixed models adjusted for established risk factors.Results:During a median 9.9 years of follow up (IQR 5.9-10.2), 376 incident HTN events occurred. Compared to the lowest tertile of EGF, the risk of incident HTN was lower in the two higher tertiles in the model adjusted for age, sex, race, and urine creatinine, and in the fully adjusted model (Figure). The mean increase in SBP over 10 years was 3.4 mmHg lower in Tertile 3 vs. Tertile 1 of EGF (95%CI -6.1, -0.7). There were no statistically significant associations of urine EGF with incident HTN or BP trajectories when EGF was modeled as a continuous predictor. There were no statistically significant associations of other biomarkers with incident HTN or BP trajectory.Conclusions:In middle aged adults without HTN, cardiovascular or kidney disease, higher urine EGF levels associated with lower risk of incident HTN and lower 10-year mean rise in BP.

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Ottobre 2022

Abstract 13972: Intermittent Occlusion of the Superior Vena Cava Improves Urine Sodium Excretion in Patients With Acutely Decompensated Heart Failure

Circulation, Volume 146, Issue Suppl_1, Page A13972-A13972, November 8, 2022. BACKGROUND:Urine sodium excretion identifies risk for short and long-term adverse events in acutely decompensated heart failure (ADHF). The VENUS HF Early Feasibility Study is testing whether intermittent occlusion of the superior vena cava (SVC) with the preCARDIA system, a catheter mounted balloon and pump console, improves decongestion in ADHF. We hypothesized that preCARDIA therapy increases natriuresis in ADHF.Methods:In a multicenter, prospective, single-arm exploratory safety and feasibility trial, 32 patients with ADHF were assigned to preCARDIA therapy for 24 hours. Urine output and urine electrolytes were measured from a spot urine sample before, immediately after, and for 24 hours after preCARDIA treatment in 13 patients.Results:32 patients were enrolled and received the preCARDIA system. Thirteen patients had complete urine electrolytes available for analysis. Compared to pre-treatment values, total daily urine output increased (1.9±0.8 vs. 4.2±1.5 L/day, p

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Ottobre 2022