Rationale, design and methodology of APPROACH-IS II: International study of patient-reported outcomes and frailty phenotyping in adults with congenital heart disease.

In recent years, patient-reported outcomes (PROs) have received increasing prominence in cardiovascular research and clinical care. An understanding of the variability and global experience of PROs in adults with congenital heart disease (CHD), however, is still lacking. Moreover, information on epidemiological characteristics and the frailty phenotype of older adults with CHD is minimal. The APPROACH-IS II study was established to address these knowledge gaps. This paper presents the design and methodology of APPROACH-IS II. APPROACH-IS II is a cross-sectional global multicentric study that includes Part 1 (assessing PROs) and Part 2 (investigating the frailty phenotype of older adults). With 53 participating centers, located in 32 countries across six continents, the aim is to enroll 8000 patients with CHD. In Part 1, self-report surveys are used to collect data on PROs (e.g., quality of life, perceived health, depressive symptoms, autonomy support), and explanatory variables (e.g., social support, stigma, illness identity, empowerment). In Part 2, the cognitive functioning and frailty phenotype of older adults are measured using validated assessments. APPROACH-IS II will generate a rich dataset representing the international experience of individuals in adult CHD care. The results of this project will provide a global view of PROs and the frailty phenotype of adults with CHD and will thereby address important knowledge gaps. Undoubtedly, the project will contribute to the overarching aim of improving optimal living and care provision for adults with CHD

Rivaroxaban Compared with Standard Anticoagulants for the Treatment of Acute Venous Thromboembolism in Children: a Randomised, Controlled, Phase 3 Trial

Background: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. Methods: In a multicentre, parallel-group, open-label, randomised study, children (aged 0–17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. Findings: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87–95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29–35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11–1·41). Repeat imaging showed an improved effect of rivaroxaban on thrombotic burden as compared with standard anticoagulants (p=0·012). Major or clinically relevant non-major bleeding in participants who received ≥1 dose occurred in ten (3%) of 329 children (all non-major) receiving rivaroxaban and in three (2%) of 162 children (two major and one non-major) receiving standard anticoagulants (HR 1·58, 95% CI 0·51–6·27). Absolute and relative efficacy and safety estimates of rivaroxaban versus standard anticoagulation estimates were similar to those in rivaroxaban studies in adults. There were no treatment-related deaths. Interpretation: In children with acute venous thromboembolism, treatment with rivaroxaban resulted in a similarly low recurrence risk and reduced thrombotic burden without increased bleeding, as compared with standard anticoagulants. Funding: Bayer AG and Janssen Research & Development. © 2020 Elsevier Ltd

The late late Albian (Mortoniceras fallax zone) Cephalopod Fauna from the Bracquegnies Formation at Strepy-Thieu (Hainaut, southern Belgium)

Excavations in 1989-1990 for the construction of a boat lift near the villages of Strépy and Thieu, east of Mons (province of Hainaut, southern Belgium), exposed a 40-metre section of the Bracquegnies Formation (Haine Green Sandstone Group; the 'Meule de Bracquegnies' of previous authors). Several hundred well-preserved, silicified cephalopods were collected from between 15 and 35 metres above the base of the sequence temporarily exposed there. The fauna is: Eutrephoceras clementianum (d'Orbigny, 1840), Puzosia (Puzosia) mayoriana (d'Orbigny, 1841), Callihoplites tetragonus (Seeley, 1865), Discohoplites valbonnensis valbonnensis (Hébert and Munier-Chalmas, 1875), Cantabrigites cantabrigense Spath, 1933, Mortoniceras (Mortoniceras) fallax (Breistroffer, 1940), M. (M.) nanum Spath, 1933, Neophlycticeras (Neophlyeticeras) blancheti (Pictet and Campiche, 1859), Stoliczkaia (Stoliczkaia) notha (Seeley, 1865), Anisoceras armatum (J. Sowerby, 1817), Hamites subvirgulatus Spath, 1941, Lechites (Lechites) gaudini (Pictet and Campiche, 1861) and Scaphites (Scaphites) sp. juv. This assemblage is the first extensive fauna from the Mortoniceras (Mortoniceras) fallax Zone of the upper Upper Albian to be described from an expanded section. The assemblage is dominated by specimens referred to a highly variable, dimorphic Callihoplites tetragonus (&gt; 250 specimens studied), of which many of the forms of Callihoplites described by Spath (1928) from the remanié Late Albian fauna at the base of the Lower Cenomanian Cambridge Greensand in eastern England are shown to be no more than intraspecific variants

Les falaises crayeuses du Boulonnais: lithologie et repères biostratigraphiques de l'Aptien au Sénonien

info:eu-repo/semantics/publishe

Chikungunya disease among infants in French West Indies during the 2014 outbreak

International audienceWe aimed to describe the clinical and laboratory features of Chikungunya disease in infants aged from 1 month to 2years

Efficient data management for putting forward data centric sciences

International audienceThe novel and multidisciplinary data centric and scientific movement promises new and not yet imagined applications that rely on massive amounts of evolving data that need to be cleaned, integrated, and analysed for modelling, prediction, and critical decision making purposes. This paper explores the key challenges and opportunities for data management in this new scientific context, and discusses how data management can best contribute to data centric sciences applications through clever data science strategies

Expérience monocentrique de la fermeture par cathétérisme interventionnel des communications interventriculaires

Studies on ventricular septal defects closure by catheterization confirm its feasibility without reporting clearly the indications and difficulties encountered. From 2001 to end-2006, 22 patients benefited from 26 ventricular septal defects closure (15 muscular and 7 membranous) at a median age and weight of 2.1 years and 12.5 kg, respectively. A perventricular catheterization was performed in 2 cases. Eighteen patients (82%) benefited from 21 prostheses with success. The closure was associated to surgery in 9 cases (41%) whereas it substituted surgery in the other 13 cases (59%). The median duration of the procedure was significantly longer in case of muscular ventricular septal defects (215 min (175-510) vs. 170 min (120-225), p=0.04). Major complications are reported in 5 cases out of 26 catheterization (19%), including one death related to conduction block, occurring after the implantation of two prostheses in a patient with aortopulmonary transposition. All other associated cardiac diseases have been corrected. A prosthetic emboli occurred in one case, 1.5 months after implantation. It had been retrieved by catheterization. Two patients died afterwards from non-procedure-related causes. After a median follow-up of 1.1 years, the 17 other patients remained asymptomatic. One child with a perimembranous prosthesis presents a paroxystic atrio-ventricular block. Even though indispensable for the curative treatment of several congenital cardiac diseases including non-operable ventricular septal defects, this procedure is related to a substantial rate of mortality and morbidity. The risk of atrio-ventricular block must be adequately considered in case of membranous ventricular septal defects