Risultati per: Standard di cura nel diabete 2024

Circulation, Volume 150, Issue Suppl_1, Page A4147960-A4147960, November 12, 2024. Introduction:Blood pressure targets for the elderly are still controversial, there is a lack of certainty about the benefit and safety of targeting ≤ 130mmHg systolic blood pressure. Evaluate the benefit in important cardiovascular outcomes and safety in elderly patients of a blood pressure control ≤ 130mmHg compared to standard of care.Methods:The research was performed in PubMed, EMBASE, Scielo, LILACS, and Cochrane Central Register of Controlled Trials (CENTRAL) from January 1st, 2013 to May 1st, 2023. Randomized controlled trials that were published between January 1st, 2013 and May 1st, 2023 that included hypertensive patients over 60 years old which reported major adverse cardiovascular outcomes (MACE) or all-cause mortality, cardiovascular mortality and safety outcomes were selected. The data extraction was performed independently by two investigators following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). A meta-analysis was performed using a fixed-effect model. The results were reported as the pooled results using risk ratio (RR) and a confidence interval (CI) of 95%.Results:The 4 trials included a number of 16,834 patients, the mean age was over 65 years, there was a good balance between genders, 13.3% of patients had cardiovascular disease, 10.9% diabetes, and 15.5% chronic kidney disease. The mean achieved blood pressure was roughly under 130mmHg, only one study was over (135mmHg) and the mean follow-up time was over 32 months. The intensive therapy decreased the outcomes for mortality (RR = 0.75, 95% CI 0.64 – 0.87, p

Circulation, Volume 150, Issue Suppl_1, Page A4146606-A4146606, November 12, 2024. Background:Intracoronary measurement of fractional flow reserve (FFR) has demonstrated higher sensitivity and better negative predicative value in evaluation of coronary artery disease than visual/angiographic only evaluation. Nonetheless, there is profound lack of evidence in the available literature that discusses the rate of complications when utilizing FFR versus standard angiography.Research Question:Does FFR carry higher or lower risk of procedural complications when compared with standard angiography?Aim:Compare the risk of complications encountered in FFR guidance in comparison to angiography only.Methods:The following databases were searched; PubMed, SCOPUS, CENTRAL, Web of Science. The following keywords were used; ((Fractional flow reserve OR FFR) AND (Adverse effect OR Complication)). The studies were included if they compared Angiography-guided Percutaneous Coronary Intervention (PCI) and Fractional Flow Reserve (FFR)-guided PCI in terms of mortality or Major Adverse Cardiac Events (MACE). Case reports and series, animal studies, reviews and non-English articles were excluded from this study. The exposure of interest was FFR-guided PCI whereas the outcomes of interest were MACE and mortality.Results:A total of 1,822 articles were identified. After removing duplicates, initial screening, and secondary screening, 15 articles were included and the total number of included patients was 421,291. The percentage of patients who underwent FFR guidance was 3.5% whereas the rest underwent angiography only. Male predominance was noted in both, FFR and angiography. The mean age of the patients who underwent FFR and angiography was 64.9 ± 9.1 and 65.2 ± 9.3 years, respectively. The model that compared between angiography only and FFR in MACE (14 studies) showed that FFR was significantly associated with lower risk of MACE compared to angiography (RR=0.62, 95%CI:0.48-0.81); this model also showed significant heterogeneity (P-value

Circulation, Volume 150, Issue Suppl_1, Page A4138167-A4138167, November 12, 2024. Background:Intracerebral hemorrhage (ICH) has high morbidity and mortality. Traditional craniotomy causes significant trauma and lacks proven benefits. Minimally invasive techniques (MIT) like CT-guided thrombolysis, endoscopic, and neuronavigation surgeries show promise in reducing secondary neurotoxicity. Our meta-analysis compares MIT with standard treatments for supratentorial spontaneous intracerebral hematomas (SSICHs) to evaluate their effectiveness in improving clinical outcomes.Methods:We comprehensively searched PubMed, EMBASE, and Cochrane Library for studies published before June 1, 2024, comparing MIT versus standard treatment for ICH. Data were analyzed using R (v.4.3). Pooled proportions with 95% confidence intervals (CIs) were calculated using a random effects model. Odds ratios (ORs) and mean differences (MDs) with 95% CIs were used for dichotomous and continuous variables. Outcomes included overall survival, functional neurological outcome, hospitalization length, recurrent bleeding, volume reduction, and Glasgow Coma Scale (GCS) score at discharge.Results:We identified six studies, including 1,117 patients. There were 463 patients who underwent MIT and 654 patients who received standard treatment. The MIT group exhibited statistically significant increased odds of survival (OR: 1.98 [1.25, 3.15]; I2=26%; p=0.004) and functional neurological outcome (OR: 1.94 [1.27, 2.96]; I2=25%; p=0.002) compared to the standard treatment group. The MIT group demonstrated statistically significant lower length of hospitalization (MD: -2.89 [-4.49, -1.30]; I2=47%; p=0.0004) and better GCS score at discharge (MD: 1.50 [1.00, 2.00]; I2=0%; p

Circulation, Volume 150, Issue Suppl_1, Page A4125157-A4125157, November 12, 2024. Background:Recent evidence suggests that sodium-glucose cotransporter-2 inhibitors (SGLT2-i) may improve outcomes in patients with coronary artery disease (CAD) through various physiological pathways. However, their impact on patients who have undergone percutaneous coronary intervention (PCI) is not well established. This meta-analysis aims to evaluate the effectiveness of additive SGLT2 inhibitors versus standard therapy alone in patients with CAD after PCI.Methods:A systematic search was conducted across the Medline, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) and observational studies that compared the addition of SGLT2 inhibitors to standard therapy versus standard therapy alone in patients post-PCI. The outcomes analyzed were Major Adverse Cardiovascular Events (MACE), all-cause death, cardiovascular death, recurrent acute myocardial infarction (AMI), nonfatal stroke, revascularization, and hospitalization for heart failure (HF).Results:A total of 7 studies met the inclusion criteria, encompassing a total of 11,800 individuals (5,004 on SGLT2-i and 6,796 non-SGLT2-i; mean age of 62.7 years; 28% women; 95% diabetic patients). SGLT2 inhibitors significantly reduced the risk of all-cause mortality (RR 0.6, 95% CI: 0.5-0.72, p

Circulation, Volume 150, Issue Suppl_1, Page A4137708-A4137708, November 12, 2024. Introduction:Intravenous hydration and contrast media volume reduction are the most important preventive factors against CI-AKI after PCI. Multiple studies have demonstrated the effectiveness of intravenous hydration before PCI, however, varied hydration protocols have rather complicated standardization. Doctors’ preferences and local institutional factors further hinder protocol implementation, resulting in reduced compliance.Hypothesis:Standardizing hydration protocol increases the compliance rate of preprocedural hydration orders and administration, reducing the incidence of CI-AKI.Methods:A team at Memorial Hermann The Woodlands Medical Center, comprising a cardiovascular nurse coordinator, catheterization laboratory director, pharmacist, information technologist, and hospital administrators, was formed to improve PCI outcomes through a multi-faceted approach. This involved a standardized hydration protocol with direct education, continuous monitoring, and repeated internal feedback, reviewed monthly. The new protocol included normal saline pre- and post-procedure maintenance fluids, with a 250 ml normal saline bolus pre-operatively. Maintenance fluids were set at 75 ml/hr, and 20 ml/hr for patients with congestive heart failure and an ejection fraction ≤ 40%. The team reviewed 233 patients under the old protocol and 281 under the new protocol. Compliance rates of pre-procedural intravenous hydration were compared and CI-AKI incidence, defined as a >50% increase or a 0.3 mg/dL increase in creatinine levels within 5 days post-procedure, was assessed. Chi square tests and t-tests were used to compare cohorts on 12 parameters and CI-AKI incidence assessment, with a p-value of 0.05.Results:Compliance with pre-procedural hydration significantly increased under the new protocol (86.1% vs 55.4%, p

Circulation, Volume 150, Issue Suppl_1, Page ASa901-ASa901, November 12, 2024. Introduction:In the United States, the incidence of in-hospital cardiac arrest (IHCA) ranges from 0.1-0.5% and most larger studies report about 20% of patients survive to hospital discharge. IHCA after cardiac surgery is unique because patients are often monitored closely and arrest etiologies are frequently reversible. This may contribute to improved survival, however current data on cardiac arrest outcomes that reflect the rapidly evolving landscape of cardiac surgery and intensive care are lacking.Aims:To identify the incidence, prognostic features, and outcomes of cardiac arrest following cardiac surgery at a single high-volume academic center.Methods:We identified all adult (≥18 years) patients who underwent cardiac surgery and experienced in-hospital cardiac arrest at our institution from 2011-2024 in our local Society of Thoracic Surgery database. The primary outcome was the incidence of cardiac arrest after cardiac surgery. In an exploratory analysis, we fit a multivariable logistic regression for death before discharge, adjusting for variables noted in Tables 1 and 2. All analyses were performed in R (Version 2024.04.1+748). A p value < .05 was considered significant. No adjustment for the family-wise error rate was made – all analyses should be considered hypothesis-generating.Results:Of 10,152 surgeries, 263 cases (2.6%) of postoperative cardiac arrest were identified. Survival to discharge occurred in 123 (50%) of cases. Median age was 67 (IQR 57-75) and 103 (39%) patients were female (Table 1). In adjusted analyses, death before discharge was significantly associated with use of extracorporeal membrane oxygenation (OR 3.52, CI 1.51-8.23, p=0.003), postoperative dialysis (OR 3.27, CI 1.57-6.77, p=0.001), pre-operative stroke (OR 2.28, CI 1.17-4.46, p=0.016), post-operative stroke (OR 3.01, CI 1.04-8.73, p=0.042), and age (OR 1.03, CI 1.01-1.05, p=0.016) (Figure 1). Survival to discharge was associated with placement of permanent pacing device (OR 0.30, CI 0.11-0.81, p=0.017).Conclusions:Incidence of IHCA after cardiac surgery is much higher than in the general inpatient population. However, survival to discharge is also common, suggesting that cardiac surgical patients have distinctly different outcomes after IHCA compared to other inpatient populations. In an exploratory analysis, we identified several factors associated with survival to hospital discharge after cardiac arrest which can be examined in future studies.

Il numero 1 al mondo per l’iniziativa ‘Un ace per la ricerca’

Listen to the JAMA Editor’s Summary for an overview and discussion of the important articles appearing in JAMA.

Circulation, Volume 150, Issue 19, Page 1484-1486, November 5, 2024.

Introduction
In female patients diagnosed with gynaecological cancer, the main priority is treating cancer itself. However, a significant number of these patients develop lower limb lymphoedema (LLL), with its incidence strongly influenced by the diagnostic cut-off (a difference in leg circumference between both legs of 5% or 10%). LLL significantly impacts patients’ quality of life (QoL) due to functional impairment, the daily time investment required for treatment, financial costs and affected body image. Additionally, it increases the risk of cellulitis, often leading to hospitalisation for intravenous antibiotics. Timely recognition and acknowledgement of symptoms are crucial first steps in improving the QoL for these women. LLL is a common and irreversible complication following treatment for gynaecological cancer. Despite its clinical significance, there are limited prospective studies investigating LLL incidence, risk factors, early detection and clinical course in this patient population. Therefore, the objective of this observational cohort study is to investigate the incidence rate of stage 0–1 or stage 2–3 LLL based on the International Society of Lymphology criteria in the first 2 years after gynaecological cancer treatment. The embedded randomised control study (RCT) examines the added value of prophylactic compression garments (class II) to standard care in preventing irreversible lymphoedema after gynaeco-oncological therapy.

Methods and analysis
In June 2022, two university hospitals in Belgium initiated a multicentre observational cohort study, which also includes an embedded RCT. The study aims to enrol 400 patients before they begin cancer treatment or within 14 days of starting chemotherapy, radiotherapy or surgery. This cohort will be followed for up to 2 years. The embedded RCT will focus on patients who develop clinical lymphoedema stage 0–1 within the first 12 months following their initial cancer treatment. A total of 196 patients will be randomised into two groups: the intervention group (98 patients), receiving usual care plus prophylactic compression garments (compression class 2 (CCL2): 23–32 mm Hg), and the control group (98 patients), receiving only usual care. The RCT aims to assess the impact of adding prophylactic compression garments to standard care on further deterioration. Assessments will be conducted at baseline, and at 3, 12 and 24 months after initial cancer treatment. An additional assessment (T-visit) will be provided if there is a transition to LLL stage 0–1 or from stage 0–1 to stage 2–3 LLL, based on follow-up findings or patient initiative, using the predictive value of a validated self-report lower extremity questionnaire. This questionnaire is part of a lymph diary app provided to all patients. The primary outcome of the observational study is to determine the incidence rate of stage 0–1 or stage 2–3 LLL in the first 2 years after gynaecological cancer treatment. The primary outcome of the RCT is to evaluate the effect of wearing CCL2 preventive garments to avoid progression to higher-stage lymphoedema in patients who develop LLL within 1 year of treatment. Key secondary outcomes of the observational study include the timing of the development of LLL, risk factors for developing LLL and the impact of LLL on QoL and sexuality, as well as the evaluation of screening and diagnostic tools. The secondary outcomes of the RCT include tolerance and compliance with wearing the preventive compressive garments, the impact of the garments on limb volume and the patient’s time and financial investment.

Ethics and dissemination
The study was approved by the Ethics Committee of the two academic hospitals: the University Hospital of Ghent in September 2021 and the University Hospital of Leuven in December 2021. Approval has been granted for the study protocol, informed consent forms and other related documents by the main Ethics Committee of Ghent (BC-09915) and the local Ethics Committee of Leuven (S65724). All patients will provide written informed consent before participating in the trial. The results will be shared through peer-reviewed journals and presentations.

Trial registration number
NCT05469945.

New England Journal of Medicine, Volume 391, Issue 17, Page 1633-1641, October 31, 2024.

New England Journal of Medicine, Volume 391, Issue 17, Page 1663-1663, October 31, 2024.

Introduction
Linezolid is a broadly used antibiotic to treat complicated infections caused by gram-positive bacteria. Therapeutic drug monitoring of linezolid concentrations is recommended to maximise its efficacy and safety, mainly haematological toxicity. Different pharmacokinetic/pharmacodynamic targets have been proposed to improve linezolid exposure: the ratio of the area under the concentration–time curve during a 24-hour period to minimum inhibitory concentration (MIC) between 80 and 120; percentage of time that the drug concentration remains above the MIC during a dosing interval greater than 85% and the trough concentration between 2 and 7 mg/L. This clinical trial aims to evaluate the safety, efficacy and the clinical and economic utility of personalised dosing of linezolid using Bayesian forecasting methods to attain pharmacokinetic/pharmacodynamic targets, known as model-informed precision dosing.

Methods and analysis
This is a pragmatic, multicentre, randomised, parallel, controlled, phase IV and low intervention trial. Participants will be randomly assigned 1:1 to each group (n=346 per group). Control group will receive the standard dose of linezolid. Intervention group will receive personalised dosage of linezolid based on pharmacokinetic–pharmacodynamic adjustments. The primary outcome will be the incidence of thrombocytopenia in both groups.

Ethics and dissemination
This protocol was approved by the Ethical Committee of the Investigation with Medicines of Galicia (code 2022/140) and authorised by the Spanish Agency for Medicines and Medical Devices. The trial is implemented in accordance with the Declaration of Helsinki and the international ethical and scientific quality standard, the Good Clinical Practice. The results will be published in peer-reviewed journals.

Trial registration number
EudraCT registration code: 2022-000144-30.

The UK Congress of Obesity (UKCO) is an annual conference of the Association for the study of Obesity (ASO), a charitable organisation that aims to understand obesity and its prevention and treatment. The ninth UKCO took place on September 24–25, 2024, at Rhodes House in Oxford, UK, with the theme of “Breaking barriers: shaping the future of obesity prevention and management”. Through a range of posters, presentations, and discussions, the programme covered a variety of topics under this theme, including, new and emerging treatments for obesity, the role of the food environment and food policy, barriers to accessing treatment, childhood and adolescent obesity, obesity policy, and food insecurity and obesity.