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Immunologic reactions to protamine sulfate during cardiac surgery are very rare. The frequency and outcome of such adverse reactions is unclear. We report a case of lethal anaphylactic reaction to protamine that occurred in a non-diabetic patient following the uneventful replacement of the ascending aorta. We also briefly review the mechanisms of this adverse reaction and emit some considerations on the management of this situation. [Copyright &y& Elsevier]

Background: The results of most school-based health promotion initiatives are inconclusive., Objectives: This trial assessed the effect of time-varying exposures to a multicomponent school-based health promotion intervention (SI! Program) on adiposity markers., Methods: A total of 48 schools in Madrid (Spain) were cluster randomized to receive the SI! Program through elementary education grades 1 to 6 (E1-6, 12 schools, 459 children), 1 to 3 (E1-3, 12 schools, 513 children), or 4 to 6 (E4-6, 12 schools, 419 children) or to receive the standard curriculum (control, 12 schools, 379 children). The primary endpoint was the between-group difference at 3- and 6-year follow-up in the change from baseline in adiposity markers and the overall knowledge-attitudes-habits (KAH) score., Results: At 3-year follow-up, children who had the intervention showed significantly lower increases than the control group in z-scores for body mass index (BMI), waist-to-height ratio (WHtR), and waist circumference (WC) (zBMI: -0.09; 95% CI: -0.16 to -0.03; P = 0.003; zWC and zWHtR: -0.19; 95% CI: -0.28 to -0.10; P < 0.001). At 6-year follow-up, the beneficial trend in zWC and zWHtR was maintained in the E1-6 and E1-3 groups: difference zWC control vs E1-6 (-0.19; 95% CI: -0.36 to -0.03; P = 0.020), control vs E1-3 (-0.22; 95% CI: -0.38 to -0.06; P = 0.009); difference zWHtR control vs E1-6 (-0.24; 95% CI: -0.41 to -0.06; P = 0.009), and control vs E1-3 (-0.29; 95% CI: -0.47 to -0.11; P = 0.001). No significant between-group differences were found in the change of overall KAH score., Conclusions: Early elementary school interventions may be more effective than later interventions on abdominal adiposity. Further research should assess the sustainability effects of school-based health promotion programs., Competing Interests: Funding Support and Author Disclosures The study was supported by the SHE Foundation-la Caixa Foundation under agreement LCF/PR/CE16/10700001. Mr Martínez-Gómez is the recipient of grant FPU21/04891 (Ayudas para la formación de profesorado universitario, FPU-2021) from the Ministry of Education, Cluture, and Sport. Dr Fernández-Jiménez is the recipient of grant PI22/01560 from the Carlos III Institute of Health (Instituto de Salud Carlos III [ISCIII]) with cofunding from the European Union. The National Center for Cardiovascular Research (Centro Nacional de Investigaciones Cardiovasculares [CNIC]) is supported by the ISCIII, the Ministry of Science, Innovation, and Universities (MCIUN), and the Pro CNIC Foundation and is a Severo Ochoa Center of Excellence (grant CEX2020-001041-S funded by MICIN/AEI/10.13039/501100011033). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To determine cardiovascular health (CVH) trajectories and their association with sociodemographic and cardiometabolic outcomes in adolescence., Methods: One thousand eighty adolescents attending 24 secondary schools enrolled in the SI! Program for Secondary Schools trial in Spain were assessed at approximately 12, 14, and 16 years of age. CVH was assessed according to American Heart Association criteria based on seven metrics (smoking status, body mass index, physical activity, diet, blood pressure, total cholesterol, and blood glucose), and CVH trajectories were identified by latent class trajectory modeling. Associations between CVH trajectories, sociodemographic characteristics, and cardiometabolic outcomes were analyzed using generalized linear and Poisson models., Results: Five CVH trajectory groups were identified: poor-stable (27 adolescents [2.5%]), intermediate-substantial rise (79 [7.3%]), intermediate-substantial decline (63 [5.8%]), intermediate-mild decline (403 [37.3%]), and intermediate-mild rise (508 [47.1%]). Boys and adolescents from families with low-average income, low-intermediate educational attainment, and a migrant background more frequently belonged to groups with lower baseline CVH and poor or declining trajectories. The intermediate-substantial decline group had the highest prevalence ratio for overweight/obesity (3.84; 95% confidence interval: 2.86-5.16) and metabolic syndrome (4.93; 95% confidence interval: 1.21-20.04) at age 16, whereas prevalence was lowest in the intermediate-mild rise group., Discussion: Adolescent CVH trajectories differ according to socioeconomic characteristics and are associated with cardiometabolic outcomes. Primordial prevention interventions should be implemented early in life, taking into account CVH trajectories and with a particular focus on vulnerable populations., (Copyright © 2023 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Importance: School-based interventions offer an opportunity for health promotion in adolescence., Objective: To assess the effect of 2 multicomponent educational health promotion strategies of differing duration and intensity on adolescents' cardiovascular health (CVH)., Design, Setting, and Participants: The SI! Program for Secondary Schools is a 4-year cluster randomized clinical intervention trial conducted in 24 secondary schools from Barcelona and Madrid, Spain, from September 7, 2017, to July 31, 2021. Eligible participants were adolescents enrolled in the first grade of secondary school., Interventions: Schools and their participants were randomized to receive a health promotion intervention (SI! Program) over 4 school years (long-term intervention [LTI], 8 schools, 412 adolescents) or 2 school years (short-term intervention [STI], 8 schools, 504 adolescents) or to receive the standard curriculum (control, 8 schools, 441 adolescents)., Main Outcome and Measures: The primary end point was the between-group difference at 2 and 4 years in the change from baseline of the overall CVH score, as defined by the American Heart Association (range, 0-14 points, with a higher score indicating a healthier CVH profile). Intervention effects were tested with multilevel mixed-effects models. A complete-case intention-to-treat analysis was performed as the primary analysis., Results: Of the randomized students, the study enrolled 1326 adolescents (684 [51.6%] boys, mean [SD] age, 12.5 [0.4] years at recruitment) with a study completion rate of 86.0%. Baseline overall CVH scores were 10.3 points in the LTI group, 10.6 points in the STI group, and 10.5 points in the control group. After 2 years, at halfway through the LTI and at the end of the STI, the difference in the CVH score change was 0.44 points (95% CI, 0.01-0.87; P = .04) between the LTI group and the control group and 0.18 points (95% CI, -0.25 to 0.61; P = .39) between the STI group and the control group. At 4 years, differences for the LTI and STI groups vs control were 0.12 points (LTI: 95% CI, -0.19 to 0.43; P = .42) and 0.13 points (STI: 95% CI, -0.17 to 0.44; P = .38). No adverse events were reported., Conclusions and Relevance: Overall, the tested school-based health promotion strategies in this randomized clinical trial had a neutral effect on the CVH of the adolescents. Although there was evidence of a marginal beneficial effect at a point halfway through implementation in the LTI group, such a benefit was not noted at 4 years. Further research is warranted into the efficacy of school-based health promotion programs., Trial Registration: ClinicalTrials.gov Identifier: NCT03504059.

Background: Several unhealthy lifestyle behaviors in adolescence are often linked to overweight/obesity. Some of them may be present simultaneously, leading to combined effects on health. Therefore, the clustering of several unhealthy behaviors in adolescents might be associated with adiposity excess., Purpose: To identify lifestyle patterns and analyze their association with adiposity in early adolescents., Methods: A cross-sectional cluster analysis was performed in 1183 adolescents (50.5% girls) with a mean age of 12.5 (0.4) years included in the SI! Program for Secondary Schools in Spain to identify lifestyle patterns based on healthy diet, step counts, sleep time, and leisure screen time. Generalized mixed models were applied to estimate the association between lifestyle patterns and adiposity indices., Results: Four lifestyle patterns were derived: Cluster 1-higher screen time and poorer diet (n = 213), Cluster 2-lower activity and longer sleepers (n = 388), Cluster 3-active and shorter sleepers (n = 280), and Cluster 4-healthiest (n = 302). Except for the number of steps (12,008 (2357) day), the lifestyle behaviors in our sample presented levels far below the recommendations, especially for sleep duration. Cluster 4 included the largest proportion of adolescents from high socioeconomic status families (47.7%) and the lowest prevalence of overweight/obesity (23.1%). Compared to Cluster 4-healthiest, adolescents in the remaining clusters presented a higher prevalence of overweight/obesity and central obesity, showing Cluster 3 the highest prevalences (PR:1.31 [95%CI: 1.31, 1.31] and PR:1.40 [95%CI: 1.33, 1.47])., Conclusions: Clustering of lifestyle patterns in early adolescence allows the identification of individuals with excess adiposity, in whom health promotion strategies should be stressed, especially in socioeconomically disadvantaged groups., Trial Registration: Clinical Trial Registry, NCT03504059. Registered 20/04/2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03504059 ., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Implementing a health promotion program for children is a complex endeavor. In this review, we outline the key lessons learned over 10 years of experience in implementing the SI! Program (Salud Integral-Comprehensive Health) for cardiovascular health promotion in preschool settings in 3 countries: Colombia (Bogotá), Spain (Madrid), and the United States (Harlem, New York). By matching rigorous efficacy studies with implementation science, we can help bridge the divide between science and educational practice. Achieving sustained lifestyle changes in preschool children through health promotion programs is likely to require the integration of several factors: 1) multidisciplinary teams; 2) multidimensional educational programs; 3) multilevel interventions; 4) local program coordination and community engagement; and 5) scientific evaluation through randomized controlled trials. Implementation of effective health promotion interventions early in life may induce long-lasting healthy behaviors that could help to curb the cardiovascular disease epidemic., Competing Interests: Funding Support and Author Disclosures This work is supported by the SHE Foundation and “la Caixa” Foundation (LCF/CE16/10700001). The project in Colombia was funded by Santo Domingo Foundation; the study in the United States (FAMILIA) was funded by the American Heart Association (grant no. 14SFRN20490315); and the study in Spain (SI! Program) was funded by the SHE Foundation, the research grant FIS-PI11/01885 (Fondo de Investigación Sanitaria del Instituto de Salud Carlos III), and Fundació la Marató de TV3 (369/C/2016). Dr Santos-Beneit is the recipient of grant LCF/PR/MS19/12220001 funded by “la Caixa” Foundation (ID 100010434). Dr Fernández-Jiménez is the recipient of grant PI19/01704 funded by the Fondo de Investigación Sanitaria–Instituto de Salud Carlos III and co-funded by the European Regional Development Fund/European Social Fund “A way to make Europe”/“Investing in your future.” The Centro Nacional de Investigaciones Cardiovasculares is supported by the Instituto de Salud Carlos III, the Ministerio de Ciencia e Innovación, and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (CEX2020-001041-S). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Fifty-Fifty trial demonstrated that a peer-group-based intervention was able to improve healthy behaviors in individuals with cardiovascular (CV) risk factors immediately post-intervention., Objectives: To determine the long-term sustainability of a one-year peer-group-based intervention focused on CV health and behavior., Methods: A total of 543 adults aged 25 to 50 years with at least 1 CV risk factor were screened and recruited, received initial training through workshops, and were then randomized 1:1 to a peer-group-based intervention group (IG) or a self-management control group (CG) for 12 months. At a median of 52 months from baseline, 321 participants were re-assessed (~60% retention). The primary outcome was the mean change in a composite health score related to blood pressure, exercise, weight, alimentation, and tobacco use (Fuster-BEWAT score [FBS], range 0-15). Intervention effects were assessed using linear-mixed effects models., Results: The mean age of retained participants was 48.0 years (SD: 5.4), and 73% were female. Consistent with previous results, the change of overall FBS was significantly greater in the IG than in the CG at 12-month follow-up (between-group difference, 0.60 points; 95% CI, 0.08-1.12; P = .025). Assessment of long-term sustainability (52-month follow-up) showed that there were no between-group differences in the mean overall FBS (IG mean score, 8.52; 95% CI, 7.97-9.07 vs CG mean score, 8.51; 95% CI, 7.93-9.10; P = .972) or in the change of overall FBS from screening (IG mean change, 0.64; 95% CI, 0.00-1.28; CG mean change, 0.46; 95% CI, -0.20-1.12; P = .497)., Conclusions: A one-year peer-group-based intervention showed favorable results at immediate post-intervention but did not demonstrate significant differences between the IG and CG at 52 months. Combination of an initial training period (workshops) with the maintenance of peer-support groups or other re-intervention strategies may be required to achieve sustained effects on healthy behaviors., Trial Registration: ClinicalTrials.gov identifier NCT02367963. Registered (https://clinicaltrials.gov/show/NCT02367963)., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Previous studies on the association between dietary habits and cardiovascular risk factors (CVRF) in adolescents have generated conflicting results. The aim of this study was to describe dietary patterns (DP) in a large sample of Spanish adolescents and to assess their cross-sectional relationship with CVRF. In total, 1324 adolescents aged 12.5 ± 0.4 years (51.6% boys) from 24 secondary schools completed a self-reported food frequency questionnaire. DPs were derived by cluster analysis and principal component analysis (PCA). Anthropometric measurements, blood pressure, lipid profile, and glucose levels were assessed. Linear mixed models were applied to estimate the association between DPs and CVRF. Three DP-related clusters were obtained: Processed (29.2%); Traditional (39.1%); and Healthy (31.7%). Analogous patterns were obtained in the PCA. No overall differences in CVRF were observed between clusters except for z-BMI and z-FMI values, total cholesterol, and non-HDL cholesterol, with the Processed cluster showing the lowest mean values. However, differences were small. In conclusion, the overall association between DPs, as assessed by two different methods, and most analyzed CVRF was weak and not clinically relevant in a large sample of adolescents. Prospective analysis may help to disentangle the direction of these associations.

Unhealthy habits in adolescents are increasing at an alarming rate. The school offers a promising environment in which to implement effective preventive strategies to improve adolescents' lifestyle behaviors. The SI! Program is a multilevel multicomponent school-based health-promotion intervention aimed at all stages of compulsory education in Spain. We present the study design of the SI! Program for Secondary Schools, targeting adolescents aged 12 to 16 years., Aim: The main goal of this study is to evaluate the impact of the SI! Program educational intervention on adolescent lifestyle behaviors and health parameters., Methods: The study was designed as a cluster-randomized controlled intervention trial and enrolled 1326 adolescents from 24 public secondary schools in Spain, together with their parents/caregivers. Schools and their students were randomly assigned to the intervention group (the SI! curriculum-based educational program over 2 or 4 academic years) or to the control group (usual curriculum). The primary endpoint will be the change from baseline at 2-year and 4-year follow-up in the composite Ideal Cardiovascular Health (ICH) score, consisting of four health behaviors (body mass index, dietary habits, physical activity, and smoking) and three health factors (blood pressure, total cholesterol, and glucose). Secondary endpoints will include 2-year and 4-year changes from baseline in ICH score subcomponents, the Fuster-BEWAT health scale, adiposity markers (waist circumference and body composition), polyphenol and carotenoid intake, and emotion management., Discussion: The overarching goal of the SI! Program is to instill healthy behaviors in children and adolescents that can be sustained into adulthood. The SI! Program for Secondary School is a comprehensive health-promotion intervention targeting 12-16-year-old adolescents and their immediate environment. The present study addresses the optimal timing and impact of the educational intervention on health in adolescence., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Unhealthy habits in children are increasing at an alarming rate. The school provides a promising setting for effective preventive strategies to improve children's lifestyle behaviors. The SI! Program is a multilevel multicomponent school-based educational intervention aimed at all stages of compulsory education in Spain. Here, we present the design of the SI! Program for Elementary School cluster-randomized controlled trial, targeting children aged 6 to 11 years. This trial aims to study the impact of different timings and intensities of exposure to SI! Program activities on elementary school children and their immediate environment (parents/caregivers, teachers, and school). The trial includes 1770 children from 48 public elementary schools in Madrid (Spain), together with their parents and teachers. Schools and their children were randomly assigned to the intervention group (the SI! curriculum-based educational program over 3 or 6 academic years) or to the control group (standard curriculum). The primary outcomes are the change from baseline at 3-year and 6-year follow-up in children's scores for knowledge, attitudes, and habits (KAH) and health factors (blood pressure, height, weight, waist circumference, and skinfold thickness). Secondary outcomes include 3-year and 6-year changes from baseline in lifestyle questionnaire scores for parents/caregivers and teachers, and in the school environment questionnaire. The overarching goal of the SI! Program is to provide an effective and sustainable health promotion program for the adoption of healthy behaviors in children. The present trial will address the impact and the optimal timing and duration of this educational intervention in the elementary school setting., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The preschool years offer a unique window of opportunity to instill healthy life-style behaviors and promote cardiovascular health., Objectives: This study sought to evaluate the effect of a 3-year multidimensional school-based intervention to improve life-style-related behaviors., Methods: We performed a cluster-randomized controlled intervention trial involving 24 public schools in Madrid, Spain, that were assigned to either the SI! Program intervention or the usual curriculum and followed for 3 years. The SI! Program aimed to instill and develop healthy behaviors in relation to diet, physical activity, and understanding how the human body and heart work. The primary outcome was change in the overall knowledge, attitudes, and habits (KAH) score (range 0 to 80). The intervention's effect on adiposity markers was also evaluated., Results: A total of 2,062 children from 3 to 5 years of age were randomized. After 3 years of follow-up, the overall KAH score was 4.9% higher in children in the intervention group compared with the control group (21.7 vs. 16.4; p < 0.001). A peak effect was observed at the second year (improvement 7.1% higher than in the control group; p < 0.001). Physical activity was the main driver of the change in KAH at all evaluation times. Children in the intervention group for 2 years and 1 year showed greater improvement than control subjects (5.9%; p < 0.001 and 2.9%; p = 0.002, respectively). After 3 years, the intervention group showed a higher probability than the control group of reducing the triceps skinfold z-score by at least 0.1 (hazard ratio: 1.40, 95% confidence interval: 1.04 to 1.89; p = 0.027)., Conclusions: The SI! Program is an effective strategy for instilling healthy habits among preschoolers, translating into a beneficial effect on adiposity, with maximal effect when started at the earliest age and maintained over 3 years. Wider adoption may have a meaningful effect on cardiovascular health promotion. (Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial [Preschool&#95;PSI!]; NCT01579708)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: The biodegradable ring was recently developed for mitral and tricuspid annuloplasty. The study aim was to assess the histological biocompatibility of the biodegradable ring and orifice area growth in a porcine model., Methods: The smallest (size 16) biodegradable ring was implanted into the tricuspid annulus of 16 juvenile pigs. All animals were followed up by transthoracic echocardiography to evaluate tricuspid valve function. Animals were sacrificed at one, three, six, nine and 12 months after implantation. Macroscopic and histological analyses were performed on three sections per ring implantation site. Parameters from the study group were compared to those obtained from control animals that underwent cardiopulmonary bypass without ring implantation., Results: Histological examination showed that the biodegradable ring was gradually replaced by fibrous tissue, with complete hydrolytic degradation within six months. The thickness of the dense fibrous tissue reached that of the initial ring at 12 months. No fibrous tissue development was observed in control animals. Echocardiography showed no signs of tricuspid valve dysfunction, a preserved ventricular contractility, and physiological growth of the tricuspid valve orifice. Macroscopic measurement of the valve orifice area confirmed that the generated fibrous tissue allows for physiological growth of the native annulus., Conclusion: The concept of annulus remodeling using a biodegradable ring which preserves the growth potential of the native annulus opens new perspectives for valve repair procedures in the pediatric population. An undoubted contribution is also made to evolving annuloplasty technology.