The efficacy and safety of guideline-recommended treatments for heart failure (HF) are uncertain in patients with Chagas disease. To evaluate the efficacy and safety of the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan in patients with HF with reduced ejection fraction due to Chagas disease. From December 10, 2019, through September 13, 2023, patients with HF, confirmed diagnosis of Chagas disease, left ventricular ejection fraction of 40% or less, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) of 600 pg/mL or greater (or B-type natriuretic peptide [BNP] ≥150 pg/mL) or 400 pg/mL or greater (or BNP ≥100 pg/mL) if hospitalized for HF within the previous 12 months were screened at 83 sites in Argentina, Brazil, Colombia, and Mexico. Statistical analysis was conducted between May and July 2025. Patients were randomized to receive sacubitril/valsartan (target dose, 200 mg twice daily) or enalapril (target dose, 10 mg twice daily), in addition to standard therapy. The primary end point was a hierarchical composite outcome tested, in order, of death from cardiovascular causes, hospitalization for HF, or relative change in NT-proBNP from baseline to 12 weeks. The primary analysis was done using a win ratio approach. Overall, 462 participants were randomized to receive sacubitril/valsartan and 460 to receive enalapril (mean [SD] age, 64.2 [10.8] years; 387 [42.0%] were female). Over a median (IQR) follow-up of 25.2 (18.4-33.2) months, cardiovascular death occurred in 110 patients (23.8% [18.3% wins in the hierarchical comparison]) in the sacubitril/valsartan group and 117 patients (25.4% [17.5% wins]) in the enalapril group. A total of 102 patients (22.1% [7.7% wins]) in the sacubitril/valsartan group and 111 (24.1% [6.9% wins]) in the enalapril group experienced a first hospitalization for HF. Patients in the sacubitril/valsartan group had a median (IQR) decrease in NT-proBNP of 30.6% (−54.3% to −0.9%) at 12 weeks, leading to 22.5% wins, while those in the enalapril group had a 5.5% (−31.9% to 37.5%) decrease (7.2% wins). The resulting stratified win ratio was 1.52 (95% CI, 1.28-1.82; P < .001) for sacubitril/valsartan compared with enalapril. In patients with HF with reduced ejection fraction due to Chagas disease, there was no significant difference in clinical outcomes between sacubitril/valsartan and enalapril, but there was a greater reduction in NT-proBNP at 12 weeks in patients in the sacubitril/valsartan group. ClinicalTrials.gov Identifier: NCT04023227
Background:Evidence exists on the major disruptions in pediatric healthcare services occurred during the COVID-19 pandemic, but what happened when all restrictions were lifted is unclear. This study examined trends in pediatric hospital admission and Emergency Department visit rates during the first 12 months following the end of the state of emergency in Italy, compared to pre-pandemic levels. Methods:We conducted a multicenter, retrospective, quasi-experimental before after study including 11 North Italian hospitals. Using electronic health records from March 2017 to March 2023, we compared standardized rates recorded during 1 year following the end of the emergency with the situation before the pandemic, using interrupted time series. We examined trends overall and for individual diagnostic categories that had exhibited the largest impact in our previous studies concerning data up to March 2022. Results:A total of 104,083 hospitalizations and 858,762 Pediatric Emergency Department visits were analyzed. Compared to the 3 years before the outbreak, post-emergency hospitalization rates increased by 23% (Standardized Hospitalization Rate Ratio 1.23, 95% CI 1.20-1.25), whereas Pediatric Emergency Department visits after a sharp decrease returned to pre-pandemic rates (Standardized Incidence Rate Ratio 0.98, 95% CI 0.96-1.00). Mental health-related hospitalizations exhibited the largest increase, peaking in the first months of the post-pandemic year (level change, Hospitalization Rate Ratio (HRR)2.57, 95%CI 1.61-4.12), then decreasing slightly in the last months but still maintaining much higher than pre-pandemic values. Notably, hospitalization rates in adolescent girls (12-17 years) increased almost 4-fold (level change, HRR 3.72, 95%CI 2.02-6.85, p < 0.001), whereas the increase was not significant for boys in the same age group (level change, HRR 1.42, 95%CI 0.65-3.11, p = 0.378). Respiratory diseases, after drastically declining during the two pandemic years, experienced steadily increasing monthly trends, finally stabilizing in the post-pandemic year at pre-pandemic levels. Conclusion:The COVID-19 pandemic has had long-term consequences on pediatric healthcare utilization. Data from this and future studies can guide the development of proactive policies aiming to mitigate healthcare disruptions and ensure access to essential pediatric services in the event of future health crises, with special consideration to vulnerable populations. The persistent rise in hospital admissions for mental health disorders, particularly teenage girls, make this field a challenging, absolute priority for public health.
Obesity is a chronic disease associated with increased morbidity and mortality and reduced quality of life. Pharmacotherapy can be associated with life style interventions aiming at increasing and maintaining weight loss and ameliorating obesity-related medical conditions. In patients affected by obesity and uncontrolled obesity-associated complications or high degree of BMI (> 40 kg/m2), metabolic bariatric surgery (MBS) can be a feasible therapeutic option. Many different types of surgical procedures have been developed in last decades, mainly performed via laparoscopic approaches. However, clinical indications for MBS and the selection of the most appropriate type of procedure have not been clarified so far. The Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to design and develop the updated version of the Italian guidelines aimed at assisting healthcare professionals in the choice of the surgical option for the treatment of obesity and related medical conditions. Between June and October 2022, a panel of 24 experts and an evidence review team (ERT, 10 members), participated in the definition of clinical questions, outcomes, and recommendations and collected and analyzed all the available evidence on the basis of pre-specified search strategies. GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) methodology and PICO (Patient, Intervention, Comparison, Outcome) conceptual framework have been adopted for the development of the present guidelines. The aim of the present guideline is to verify indications to bariatric surgical endoscopy with respect to the presence of comorbid conditions, evaluate the different types of endoscopic bariatric procedure and revise indication to revisional bariatric endoscopy and postoperative procedures.
