Risultati per: Sindromi coronariche acute

Introduction
Endovascular treatment is the standard of care for acute large vessel occlusion (LVO) in the anterior circulation. However, successful complete recanalisation is considerably difficult when the vessels are severely tortuous. At the bend, the stent retriever can distort, collapse and lose its ability to capture the clot due to structural change. The aim of the present study is to evaluate the safety and efficacy of the new thrombectomy device multisegment Mechanical Thrombectomy (MT) System for endovascular treatment of acute ischaemic stroke (AIS).

Methods and analysis
The present study is a prospective, multicentre, randomised controlled trial conducted in 11 stroke centres in China. The safety and efficacy of vascular recanalisation in patients with AIS who will be treated with a new thrombectomy device-multi-segment MT System or with Solitare FR within 8 hours of symptom onset will be compared. A total of 238 subjects who met the inclusion and exclusion criteria will be randomised into either a treatment group or a control group by an internet-based Central Random System in a 1:1 manner, and 30 subjects will be recruited into the small sample study. SAS V.9.4 statistical software will be used for statistical analysis of the primary endpoint indicators and other indicators.

Ethics and dissemination
The study involving human participants was reviewed and approved by the Ethics Committee of Drugs (devices) Clinical Experiment in Henan Provincial People’s Hospital (reference number: AF/SC-07/04.0) and other research centres participating in the clinical trial. The results yielded from this study will be presented at international conferences and sent to a peer-review journal to be considered for publication. The Standard Protocol Items: Recommendations for Interventional Trials checklist was utilised when drafting the study protocol.

Trial registration number
Registry on 10 September 2021 with Chinese clinical trial registry: ChiCTR2100051048.

New England Journal of Medicine, Volume 387, Issue 20, Page 1906-1909, November 2022.

Daoust R, Paquet J, Williamson D, et al. Accuracy of a self-report prescription opioid use diary for patients discharge from the emergency department with acute pain: a multicentre prospective cohort study. BMJ Open 2022;12:e062984. doi:10.1136/ bmjopen-2022-062984
This article has been corrected since it was published online. A collaborator group “On behalf of the OPUM research group” has been added to the author byline.

Objective
The effectiveness of MRI-guided intravenous recombinant tissue-type plasminogen activator (r-tPA) for acute ischaemic stroke (AIS) with an unknown time of onset has been demonstrated by the WAKE-UP Trial. We aim to evaluate its long-term cost-effectiveness from the perspective of Chinese and US healthcare payers.

Methods
A combination of decision tree and Markov model was built to project lifetime costs and quality-adjusted life-years (QALYs) associated with intravenous r-tPA or placebo treatment. Model inputs including the transition probabilities, costs and utilities were derived from the WAKE-UP Trial, similar cost-effectiveness studies and other published sources. To compare intravenous r-tPA to placebo, we calculated incremental costs, incremental QALYs and incremental cost-effectiveness ratio (ICER). One-way sensitivity, probabilistic sensitivity and subgroup analyses were performed to evaluate uncertainty in the results.

Results
In China, intravenous r-tPA gained an additional lifetime QALY of 0.293 with an additional cost of the Chinese Yuan (¥) of 7871 when compared with placebo, resulting in an ICER of ¥26 870 (US$3894)/QALY. In the USA, intravenous r-tPA yielded a higher QALY (difference: 0.430) and lower cost (difference: ¥–4563) when compared with placebo. In probabilistic sensitivity analyses, intravenous r-tPA had a 97.8% and 99.8% probability of being cost-effective or cost-saving in China and the USA, respectively. These findings remained robust under one-way sensitivity and subgroup analysis except for patients with a National Institute of Health Stroke Scale Score of less than 4, between 11 and 16, and over 16.

Conclusions
MRI-guided intravenous r-tPA for patients with AIS with an unknown time of onset is cost-effective in China and cost-saving in the USA.

Objective
To evaluate changes in admission rates for and quality of healthcare of ST-segment-elevation myocardial infarction (STEMI) during the period of the COVID-19 outbreak and postoutbreak.

Methods
We conducted a retrospective study among patients with STEMI in the outbreak time and the postoutbreak time.

Design
To examine the changes in the admission rates and in quality of healthcare, by comparison between periods of the postoutbreak and the outbreak, and between the postoutbreak and the corresponding periods.

Setting
Data for this analysis were included from patients discharge diagnosed with STEMI from all the hospitals of Suzhou in each month of the year until the end of July 2020.

Participants
1965 STEMI admissions.

Primary and secondary outcome measures
The primary outcome was the number of moecondary outcomnthly STEMI admissions, and the secondary outcomes were the quality metrics of STEMI healthcare.

Results
There were a 53% and 38% fall in daily admissions at the phase of outbreak and postoutbreak, compared with the 2019 corresponding. There remained a gap in actual number of postoutbreak admissions at 306 and the predicted number at 497, an estimated 26 deaths due to STEMI would have been caused by not seeking healthcare. Postoutbreak period of 2020 compared with corresponding period of 2019, the percentage of cases transferred by ambulance decreased from 9.3% to 4.2% (p=0.013), the door-to-balloon median time increased from 17.5 to 34.0 min (p=0.001) and the rate of percutaneous coronary intervention (PCI) therapy declined from 71.3% to 60.1% (p=0.002).

Conclusions
The impact of public health restrictions may lead to unexpected out-of-hospital deaths and compromised quality of healthcare for acute cardiac events. Delay or absence in patients should be continuously considered avoiding the secondary disaster of the pandemic. System delay should be modifiable for reversing the worst clinical outcomes from the COVID-19 outbreak, by coordination measures with focus on the balance between timely PCI procedure and minimising contamination of cardiac catheterisation rooms.

Objective
With one in five children in England living with obesity, we mapped the geographical distribution and format of child weight management services provided by acute National Health Service (NHS) trusts across England, to identify breadth of service provision.

Design
A cross-sectional survey.

Setting
The survey was sent to acute NHS trusts (n=148) in England in 2020, via a freedom of information request.

Participants
Responses were received from 139 of 148 (94%) acute NHS trusts, between March 2020 to March 2021.

Outcome measures
The survey asked each acute NHS trust whether they provide a weight management service for children living with obesity. For those trusts providing a service, data were collected on eligibility criteria, funding source, personnel involved, number of new patients seen per year, intervention duration, follow-up length and outcome measures. Service characteristics were reported using descriptive statistics. Service provision was analysed in the context of ethnicity and Index of Multiple Deprivation score of the trust catchment area.

Results
From the 139 survey respondents, 23% stated that they provided a weight management service for children living with obesity. There were inequalities in the proportion of acute NHS trusts providing a service across the different regions of England, ranging from 4% (Midlands) to 36% (London). For trusts providing a service, there was variability in the number of new cases seen per year, eligibility criteria, funding source, intervention format and outcome measures collected. A multidisciplinary approach was not routinely provided, with only 41% of services reporting ≥3 different staff disciplines.

Conclusion
In 2020/2021, there were geographical inequalities in weight management service provision by acute NHS trusts for children living with obesity. Services provided lacked standardisation, did not routinely offer children multidisciplinary care and were insufficient in size to meet need.

New England Journal of Medicine, Volume 387, Issue 19, Page 1809-1812, November 2022.

We recently published the COVIDPAN study1 and follow-up data2 in Gut, which explored the association between concomitant SARS-CoV-2 infection and acute pancreatitis (AP).1 2 We would like to further report the impact of SARS-CoV-2 pandemic on aetiology and management of patients presenting with AP, particularly those with gallstone pancreatitis (GSP) in a cohort of patients who did not have SARS-CoV-2 infection. Between 1 March 2020 and 23 July 2020, 1628 patients presenting with AP were included in the analysis with median age of 54 years (IQR 40–69). Gallstones were the predominant aetiology of AP (43.6%), followed by alcohol-related AP (25.8%) and idiopathic AP (21.5%). The idiopathic group was further followed for 12 months, and after completion of appropriate investigations, 14.4% of the cohort remain to have an idiopathic aetiology. Most patients had mild AP (1244, 77.8%), 256 (16%) had moderate to…

Circulation, Volume 146, Issue 19, Page e279-e279, November 8, 2022.

Circulation, Ahead of Print. Background: Acetazolamide inhibits proximal tubular sodium reabsorption and improved decongestion in the Acetazolamide in Decompensated heart failure with Volume OveRload (ADVOR) trial. It remains unclear whether the decongestive effects of acetazolamide differ across the spectrum of left ventricular ejection fraction (LVEF).Methods: This is a pre-specified analysis of the randomized, double blind, placebo-controlled ADVOR trial that enrolled 519 patients with acute heart failure, clinical signs of volume overload (edema, pleural effusion or ascites), NTproBNP >1,000 ng/L or BNP >250 ng/ml, to receive intravenous acetazolamide (500 mg once daily) or placebo on top of standardized intravenous loop diuretics (twice oral home maintenance dose). Randomization was stratified according to LVEF (≤40% or >40%). The primary endpoint was successful decongestion, defined as the absence of signs of volume overload within three days from randomization without the need for mandatory escalation of decongestive therapy because of poor urine output.Results: Median LVEF was 45% (25-75thpercentile: 30-55%) and 43% had a LVEF ≤40%. Patients with lower LVEF were younger, more likely to be male, with a higher prevalence of ischemic heart disease, a higher NTproBNP, less atrial fibrillation, and lower estimated glomerular filtration rate. No interaction on the overall beneficial treatment effect of acetazolamide on the primary endpoint of Successful decongestion (OR=1.77, 95% CI=[1.18-2.63], p=0.005, all p-values for interaction >0.401) was found when LVEF was assessed per randomization stratum (≤/ >40%), or as HFrEF, HFmrEF and HFpEF, or on a continuous scale. Acetazolamide resulted in improved diuretic response measured by higher cumulative diuresis and natriuresis and shortened length of stay without treatment effect modification by baseline LVEF (all p-values for interaction >0.160).Conclusions: Acetazolamide when added to treatment with loop diuretics in patients with AHF improves the incidence of successful decongestion, improves diuretic response and shortens length of stay, without treatment effect modification by baseline LVEF.

New England Journal of Medicine, Ahead of Print.

Introduction
The diagnosis, progression or recurrence of cancer is often highly traumatic for family caregivers (FCs), but systematic assessments of distress and approaches for its prevention and treatment are lacking. Acute leukaemia (AL) is a life-threatening cancer of the blood, which most often presents acutely, requires intensive treatment and is associated with severe physical symptoms. Consequently, traumatic stress may be common in the FCs of patients with AL. We aim to determine the prevalence, severity, longitudinal course and predictors of traumatic stress symptoms in FCs of patients with AL in the first year after diagnosis, and to understand their lived experience of traumatic stress and perceived support needs.

Methods and analysis
This two-site longitudinal, observational, mixed methods study will recruit 223 adult FCs of paediatric or adult patients newly diagnosed with AL from two tertiary care centres. Quantitative data will be collected from self-report questionnaires at enrolment, and 1, 3, 6, 9 and 12 months after admission to hospital for initial treatment. Quantitative data will be analysed using descriptive and machine learning approaches and a multilevel modelling (MLM) approach will be used to confirm machine learning findings. Semi-structured qualitative interviews will be conducted at 3, 6 and 12 months and analysed using a grounded theory approach.

Ethics and dissemination
This study is funded by the Canadian Institutes of Health Research (CIHR number PJT 173255) and has received ethical approval from the Ontario Cancer Research Ethics Board (CTO Project ID: 2104). The data generated have the potential to inform the development of targeted psychosocial interventions for traumatic stress, which is a public health priority for high-risk populations such as FCs of patients with haematological malignancies. An integrated and end-of-study knowledge translation strategy that involves FCs and other stakeholders will be used to interpret and disseminate study results.

New England Journal of Medicine, Volume 387, Issue 18, Page 1688-1698, November 2022.

Circulation, Ahead of Print. BACKGROUND:In patients who survive an acute myocardial infarction (AMI), angiotensin-converting enzyme inhibitors decrease the risk of subsequent major cardiovascular events. Whether angiotensin-receptor blockade and neprilysin inhibition with sacubitril/valsartan reduce major coronary events more effectively than angiotensin-converting enzyme inhibitors in high-risk patients with recent AMI remains unknown. We aimed to compare the effects of sacubitril/valsartan on coronary outcomes in patients with AMI.METHODS:We conducted a prespecified analysis of the PARADISE-MI trial (Prospective ARNI vs ACE Inhibitors Trial to Determine Superiority in Reducing Heart Failure Events After MI), which compared sacubitril/valsartan (97/103 mg twice daily) with ramipril (5 mg twice daily) for reducing heart failure events after myocardial infarction in 5661 patients with AMI complicated by left ventricular systolic dysfunction, pulmonary congestion, or both. In the present analysis, the prespecified composite coronary outcome was the first occurrence of death from coronary heart disease, nonfatal myocardial infarction, hospitalization for angina, or postrandomization coronary revascularization.RESULTS:Patients were randomly assigned at a median of 4.4 [3.0–5.8] days after index AMI (ST-segment–elevation myocardial infarction 76%, non–ST-segment–elevation myocardial infarction 24%), by which time 89% of patients had undergone coronary reperfusion. Compared with ramipril, sacubitril/valsartan decreased the risk of coronary outcomes (hazard ratio, 0.86 [95% CI, 0.74–0.99],P=0.04) over a median follow-up of 22 months. Rates of the components of the composite outcomes were lower in patients on sacubitril/valsartan but were not individually significantly different.CONCLUSIONS:In survivors of an AMI with left ventricular systolic dysfunction and pulmonary congestion, sacubitril/valsartan—compared with ramipril—reduced the risk of a prespecified major coronary composite outcome. Dedicated studies are necessary to confirm this finding and elucidate its mechanism.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT02924727.