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Background: ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC., Materials and Methods: Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site., Results: A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2., Conclusion: The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: To assess the psychometric properties of the Coronavirus Information Overload scale (CovIO) and explore relationships between CovIO, its predictors and several health behaviours related to the COVID-19 pandemic, using Cancer Information Overload (CIO) scale results as a reference for comparison., Methods: 2003 participants representative of the French adult population answered a self-administered questionnaire over two waves of polling (N 1(June 2020) = 1003, N 2(January 2021) = 1000). Respondents were randomized to fill CovIO or CIO scale. Psychometric properties of scales were evaluated with Confirmatory Factor Analysis (CFA). Predictors were assessed using multivariate linear regression., Results: CovIO scale showed satisfactory psychometric properties (α=0.86, ω=0.86, RMSEA=0.050) without any measurement invariance issue. CovIO increased between waves of sampling and was significantly linked to education, health literacy and trust in institutions among other variables. A negative relationship between information overload and preventive behaviours was also observed., Conclusion: The CovIO scale is a valid tool for assessing COVID-19 information overload. The dynamical formation of information overload and links with theorised predictors, especially, health literacy are confirmed., Practice Implications: Longitudinal designs could help better understand the potential detrimental effect of information overload and improving public health campaigns. Interventions to reduce the degree of overload are needed., Competing Interests: Conflict of interest statement The authors have no conflicts to declare., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Non-Alcoholic Fatty Liver Disease (NAFLD) is a common condition affecting around 10-25% of the general adult population, 15% of children, and even > 50% of individuals who have type 2 diabetes mellitus. It is a major cause of liver-related morbidity, and cardiovascular (CV) mortality is a common cause of death. In addition to being the initial step of irreversible alterations of the liver parenchyma causing cirrhosis, about 1/6 of those who develop NASH are at risk also developing CV disease (CVD). More recently the acronym MAFLD (Metabolic Associated Fatty Liver Disease) has been preferred by many European and US specialists, providing a clearer message on the metabolic etiology of the disease. The suggestions for the management of NAFLD are like those recommended by guidelines for CVD prevention. In this context, the general approach is to prescribe physical activity and dietary changes the effect weight loss. Lifestyle change in the NAFLD patient has been supplemented in some by the use of nutraceuticals, but the evidence based for these remains uncertain. The aim of this Position Paper was to summarize the clinical evidence relating to the effect of nutraceuticals on NAFLD-related parameters. Our reading of the data is that whilst many nutraceuticals have been studied in relation to NAFLD, none have sufficient evidence to recommend their routine use; robust trials are required to appropriately address efficacy and safety., Competing Interests: Declaration of Competing Interest Manfredi Rizzo: speakers bureau: Amgen, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Meda, Mylan, Merck Sharp & Dohme, Novo Nordisk, Roche Diagnostics, Sanofi, and Servier; consultant to Amgen, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Meda, Mylan, Merck Sharp & Dohme, Novo Nordisk, Roche Diagnostics, Sanofi, and Servier; Medical and Scientific Advisor, Europe East and South at Novo Nordisk; Peter E. Penson has received honoraria and/or travel reimbursement for events sponsored by AKCEA, Amgen, AMRYT, Link Medical, Mylan, Napp, Sanofi; Niki Katsiki; Dimitri P. Mikhailidis has given talks, acted as a consultant or attended conferences sponsored by Amgen and Novo Nordisk; Peter P. Toth: speakers bureau: Amgen, Esperion, Kowa, Merck, Novo-Nordisk; consultant to Amarin, bio89, Kowa, Merck, Resverlogix, Theravance; Maciej Banach: speakers bureau: Amgen, Herbapol, Kogen, KRKA, Polpharma, Mylan/Viatris, Novartis, Novo-Nordisk, Sanofi-Aventis, Teva, Zentiva; consultant to Amgen, Daichii Sankyo, Esperion, Freia Pharmaceuticals, Novartis, Novo-Nordisk, Polfarmex, Sanofi-Aventis; Grants from Amgen, Mylan/Viatris, Sanofi and Valeant; CMO at Nomi Biotech Corporation Ltd.; all other authors have no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Labelled Background: Haemoptysis is a life-threatening complication of cystic fibrosis (CF). One treatment is bronchial artery embolisation (BAE) using embolic-microspheres (EMs). During BAE, pulmonary arteries can be seen on digital subtracted angiography while iodine containing contrast material injection is performed in the bronchial artery. This suggests that EMs could go from bronchial to nontarget pulmonary arteries. The aim was to evaluate if EMs could be found inside pulmonary arteries on lung explants after BAE in transplanted CF patients., Methods: Retrospective observational study including patients with CF who underwent lung transplantation and had previously needed BAE. Clinical, chest CT angiography, and angiographic data were reviewed from medical records. Pathology examination of lung explants was performed to analyze the EMs anatomical localisation., Results: Eight patients were included between 2013 and 2015, four males with a mean age of 29 (19-45) years. All patients had bronchial artery hypertrophy on CT and bronchial-to-pulmonary artery shunting during BAE. On pathology examination, EM ≤800 µm were found in the pulmonary arteries in all patients and were responsible for distal branch occlusions. Two pulmonary infarcts were observed on CT angiography after BAE and confirmed histopathologically., Conclusions: EM migration from the bronchial to pulmonary arteries is a common occurrence after BAE in patients with advanced stage CF. Although BAE is a highly effective means of controlling haemoptysis in CF, studies on the optimal particle size are needed to preserve pulmonary artery circulation, because these results suggest that low size EMs could lead to nontarget embolisation., Competing Interests: Declaration of Competing Interest None., (Copyright © 2022. Published by Elsevier B.V.)

Introduction: One option for therapeutic de-escalation in older women with early breast cancer (EBC) is partial breast irradiation (PBI) instead of whole-breast irradiation (WBI) when the latter has no clear advantages. We aimed to explore the decision-making processes and the lived experiences of WBI and PBI from the perspectives of older women with EBC., Materials and Methods: Thematic content analysis was performed on qualitative data collected using narrative interviews., Results: Twenty-two women aged 65 and over participated (ten patients who underwent WBI and twelve who underwent PBI). We identified three themes from their narratives: 1) Acceptance of a paternalistic relationship with physicians, 2) Strong need for an informed choice, and 3) PBI can help people conceal cancer-related physical marks. Narratives underlined participants' preferences for each of the two treatments and their perceptions about therapeutic de-escalation. Misconceptions about therapeutic de-escalation were observed., Discussion: When providing information about EBC treatment options, patients' perceived burden of side effects should be considered. Moreover, eliciting the value older patients place on available breast cancer treatments, as well as their related goals and preferences, could foster their participation in the therapeutic de-escalation decision-making process., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Objectives: Our study aimed to provide an updated overview of the use of the French contact tracing application, TousAntiCovid, and identify evolutions since the beginning of the pandemic., Study Design: We conducted a survey study on a representative sample of the French adult population., Methods: Our data were collected by the Obervatoire Régional de la Santé (ORS) using a self-administered online questionnaire. This was completed by a sample of 2,022 people stratified to match French official census statistics for gender, age, occupation, and area of housing. We conducted statistical analysis using Python (Pandas - Scipy - Statsmodels) with chi-squared and Wilcoxon rank-sum tests to control for statistical significance., Results: A small majority of respondents used TousAntiCovid (55.5%), while 41.0% had never downloaded it. Only one-quarter of the respondents (23.3%) used it for contact tracing with Bluetooth, while a third (32.2%) used it only for storing their health pass. The app's use increased with education level, income, and younger age. A large majority (85%) of non-vaccinated respondents had never downloaded TousAntiCovid., Conclusion: Our results suggest that the role and use of France's official COVID-19 app TousAntiCovid has evolved in line with the government's strategy; while initially focusing on contact tracing, its development has led to the possibility to store test and vaccination documentation. The survey also confirmed previous results pointing to the lasting differences in socio-economic status in terms of adoption of the app. This is problematic because the long-term nature of the pandemic could require the government to keep a range of strategies open, including contact tracing. Public discussion of the current and future roles of the French contact tracing app is therefore needed., (Copyright © 2022 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.)

Objective: To simultaneously investigate the psychometric properties of three recently developed health literacy measurement scales throughout adolescence in the general population., Methods: French versions of the Health Literacy for School-Aged Children (HLSAC, unidimensional) scale, the Health Literacy Assessment Scale for Adolescents (HAS-A, multidimensional) and the 16-item European Health Literacy Survey questionnaire (HLS-EU-Q16, unidimensional) were completed by 1 444 adolescents in 8th, 9th, 11th grade in general school and 11-12th grade in vocational school. Psychometric properties were studied using confirmatory factor analysis, McDonald's omega coefficient and hypothesis testing., Results: Structural validity was acceptable (HLS-EU-Q16) to good (HAS-A and HLSAC), no measurement invariance issue was found and internal consistency was acceptable for the three scales (0.68-0.84). Convergent validity was low (Pearson correlation coefficients<0.5) and the only scale for which results were in agreement with a priori hypotheses was the HLSAC., Conclusions: Our results were supportive of the use of HLSAC to assess health literacy during adolescence but the HAS-A, with a slightly better structural validity, can also be promoted due to its three measured dimensions., Practice Implications: The use of these scales in practice will help to focus on health literacy, a critical factor for prevention and health promotion in adolescence., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Regular physical activity (PA) and healthy body weight have proven benefits on survival in breast cancer (BC) survivors. We aimed to define predictors of long-term PA and weight gain in a representative sample of BC survivors., Methods: Data were analysed from 723 women with BC who participated in both the 2012 and 2015 French National VICAN surveys., Results: Five years after diagnosis, 26.0, 60.6, and 13.4 % of BC survivors reported regular, occasional and no PA, respectively. Moreover, 27.4 % had a weight gain ≥5 kg. In multinomial logistic regressions, regular and occasional PA were both associated with not having depressive disorders, with higher post-traumatic growth, and with a healthy and stable Body Mass Index. Occasional PA was associated with the use of non-conventional medicine, and regular PA with better mental quality of life and normal arm mobility. Weight gain ≥5 kg was associated with younger age, heavier body weight at diagnosis, and lymphedema 5 years after diagnosis., Conclusions: Mental well-being is associated with successful long-term patient investment in PA. Psychological support and early management of disease sequelae are needed to help ensure BC survivors engage in and maintain healthy lifestyles., Competing Interests: Declaration of competing interest None., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: This longitudinal study aimed to measure the time course of intellectual changes after pediatric focal resective epilepsy surgery and to identify their predictors., Methods: We analyzed a cohort of 81 school-aged children with focal epilepsy and intractable seizures who underwent neurosurgery (focal resection) from 2000 to 2018 in La Timone Hospital (Marseille). Neuropsychological assessments were carried out before and then 1, 2, 3, and 5 years after epilepsy surgery., Results: Eighty-one patients with a median age at surgery of 13.74 years [4.25] were enrolled. Overall, 45 of the 81 (55%) recruited patients were improved after the surgery on at least one of the five domains of the Wechsler Intelligence Scale. Temporal lobe localization and postoperative seizure freedom were the main prognostic factors impacting intellectual outcome (improvement and decline) after epilepsy surgery. Younger patients at surgery were less likely to have a postoperative IQ decline. Intellectual improvement after epilepsy surgery could be delayed for up to 5 years after surgery and concerned all intellectual domains except the Verbal Comprehension Index (VCI). Intellectual decline after epilepsy surgery occurred mainly during the first two years after the surgery and was reflected in full-scale intelligence quotient (FSIQ) and Working Memory Index (WMI)., Conclusions: Our study points out that children and adolescents with TLE who achieved freedom from seizure after epilepsy surgery are the leading candidates for achieving postoperative intellectual improvement. This enhancement in intellectual function shows a long time course, whereas intellectual decline is evidenced earlier., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Elevated plasma concentrations of hepatic- and intestinally-derived triglyceride-rich lipoproteins (TRL) are implicated in the pathogenesis of atherosclerotic cardiovascular disease and all-cause mortality. Excess of TRL is the driving cause of atherogenic dyslipidemia commonly occurring in insulin-resistant individuals such as patients with obesity, type 2 diabetes and metabolic syndrome. Interestingly, growth hormone (GH)-deficient individuals display similar atherogenic dyslipidemia, suggesting an important role of GH and GH deficiency in the regulation of TRL metabolism., Objective: We aimed to examine the direct and/or indirect role of GH on TRL metabolism., Methods: We investigated the effect on fasting and postprandial hepatic-TRL and intestinal-TRL metabolism of short-term (one month) withdrawal of GH in 10 GH-deficient adults., Results: After GH withdrawal, we found a reduction in fasting plasma TRL concentration (significant decrease in TRL-TG, TRL-cholesterol, TRL-apoB-100, TRL-apoC-III and TRL-apoC-II) but not in postprandial TRL response. This reduction was due to fewer fasting TRL particles without a change in TG per particle and was not accompanied by a change in postprandial TRL-apoB-48 response. Individual reductions in TRL correlated strongly with increases in insulin sensitivity and decreases in TRL-apoC-III., Conclusion: In this relatively short term 'loss of function' human experimental model, we have shown an unanticipated reduction of hepatic-TRL particles despite increase in total body fat mass and reduction in lean mass. These findings contrast with the atherogenic dyslipidemia previously described in chronic GH deficient states, providing a new perspective for the role of GH in lipoprotein metabolism., (Copyright © 2021. Published by Elsevier Inc.)

Background: Adjuvant endocrine therapy (AET) improves long-term survival of breast cancer patients, yet many women are nonadherent or discontinue this treatment. In this study we aimed to describe AET adherence trajectories over 5 years after treatment initiation and to identify factors associated with these trajectories, in a nationwide French cohort of breast cancer survivors., Patients and Methods: Every woman diagnosed with a first nonmetastatic breast cancer in 2011 in France who initiated AET in the 12 months after surgery was included from the French cancer cohort. We identified all reimbursements for AET from national health administrative data sets and modeled AET adherence trajectories over 5 years, using group-based trajectory modeling on the basis of the monthly proportion of days covered by AET. Associated factors were identified using multinomial logistic regressions., Results: We included 33,260 women. A 6-trajectory model was selected: 1, immediate discontinuation (6.6%); 2, continuous suboptimal adherence (4.3%); 3, progressive nonadherence then discontinuation (6.3%); 4, early nonadherence then discontinuation (5.7%); 5, continuous optimal adherence (68.8%); and 6, late nonadherence then discontinuation (8.3%). The main factors associated with nonadherence trajectories were extreme age (younger than 50 and older than 70 years) and switching AET., Conclusion: Approximately 70% of women had optimal adherence over all 5 years. The original nationwide approach enabled us to identify the "continuous suboptimal adherence trajectory" never previously described., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To evaluate the performances of systematic posttreatment pelvic magnetic resonance imaging (PPMRI) in predicting prognosis of patients treated with chemoradiation therapy (CRT) for locally advanced cervical cancer (LACC)., Materials and Methods: Multi-institutional data from 216 patients presenting FIGO IB2-IIB cervical cancer for which PPMRI was performed following CRT were retrospectively reviewed. Incomplete response was defined as the identification of persistent lesion on PPMRI. Primary endpoints were patients' 5-year recurrence free (RFS) and overall (OS) survivals. Secondary endpoint was the identification of residual histologic disease on hysterectomy specimens when completion surgery was performed., Results: PPMRI identified an incomplete response in 102 (47.2%) cases. A 70% or more reduction in tumor size on PPMRI was identified as the best predictive cut-off for recurrence (37.7% sensitivity and 78.7% specificity) and death (50% sensitivity and 77.9% specificity) with significant impact on those risks (HRa: 0.42; 95%CI: 0.23-0.77 and HRa: 0.18; 95%CI: 0.06-0.50, respectively). Completion hysterectomy was performed in 117 (54.4%) cases, with histologic residual disease in 55 (47.4%). PPMRI demonstrated 74.5% sensitivity and 50.8% specificity in predicting residual disease. Although survival of patients with complete response at PPMRI was not impacted by completion hysterectomy, it significantly increased 5-year RFS and OS of those with incomplete response: 38.7% vs. 65.3% (p < 0.001) and 63% vs. 82.9% (p = 0.038), respectively., Conclusion: A 70% or more reduction of in tumor size on PPMRI following CRT in patients with LACC is predictive of RFS and OS. PPMRI could help triaging patients who could benefit from completion hysterectomy., Competing Interests: Declaration of competing interest All authors have no conflict of interest to declare., (Copyright © 2020. Published by Elsevier Ltd.)

Objectives: To demonstrate the best psychometric properties of the revised 5-item Cancer Information Overload (CIO) scale over the 10- and 8-item versions, for both English and French native speakers, and to explore the relationships between CIO and several cancer risk management behaviours in a large sample of caregivers, cancer survivors and healthy subjects., Methods: 2809 participants (2568 from France, 241 from Australia) from two cancer survivor networks answered a self-administered questionnaire. After assessing the psychometric properties we studied the impact of CIO on health behaviours using multivariate logistic regression., Results: Internal consistency assessment and Confirmatory Factor Analysis (CFA) showed satisfactory results (α = 0.87 and 0.83, ω = 0.87 and 0.83, RMSEA = 0.078 and 0.081 for the 8-item and 5-item versions respectively), as well as multi-group CFA where measurement invariance was partial for one item only in each version. CIO was independently associated with smoking, sunburns, and rare skin checks, but not with alcohol misuse., Conclusion: The 5-item version of the CIO scale showed adequate psychometric properties and discriminant association with multiple prevention behaviours., Practice Implications: The 5-item CIO scale is valid and can help push research forward in the domain of disease prevention and message acceptance. Its role in clinical practice remains to be determined., Competing Interests: Declaration of Competing Interest The authors have no conflicts to declare., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Research Question: What is the evolution of adenomyosis on magnetic resonance imaging (MRI) after a 3-month treatment course of daily 5 mg doses of ulipristal acetate (UPA) for symptomatic fibroids?, Design: A monocentric prospective pilot study on patients who underwent a 3-month treatment course of UPA for symptomatic fibroids between January 2014 and December 2017. Patients underwent pelvic MRI shortly before (pre-MRI) and after treatment (post-MRI). The diagnosis of adenomyosis on MRI was defined by the observation of intramyometrial cysts and/or haemorrhagic foci within these cystic cavities and/or a thickening of the junctional zone >12 mm. The progression of adenomyosis was defined by the presence of at least one of the aforementioned criteria of adenomyosis on the pre-MRI and by at least one of the following on the post-MRI: (i) increased thickness of the junctional zone ≥20% and/or (ii) increased number of intramyometrial cysts. The appearance of adenomyosis was defined by the absence of the aforementioned criteria of adenomyosis on the pre-MRI and the presence of at least one of these criteria on the post-MRI., Results: Seventy-two patients were included. The MRI features of adenomyosis progressed for 12 of 15 patients (80.0%) for whom adenomyosis was identified on the pre-MRI. An appearance of adenomyosis was identified after treatment for 15 of 57 patients (26.3%) for whom adenomyosis was not identified on the pre-MRI., Conclusions: A 3-month treatment course of daily 5 mg doses of UPA could provoke a short-term progression or an emergence of typical adenomyosis intramyometrial cysts on MRI examinations., (Copyright © 2020 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

Objectives: The primary objective was to assess the value of the European Society of Cardiology (ESC) criteria, including 18 F-fluorodeoxyglucose positron emission tomography/computed tomography ( 18 F-FDG-PET/CT) in prosthetic valve infective endocarditis (PVE). Secondary objectives were: 1) to assess the reproducibility of 18 F-FDG-PET/CT; 2) to compare its diagnostic value with that of echocardiography; and 3) to assess the diagnostic value of the presence of a diffuse splenic uptake BACKGROUND: 18 F-FDG PET/CT has been added as a major criterion in the ESC 2015 infective endocarditis (IE) guidelines, but the benefit of the ESC criteria has not been prospectively compared with the conventional Duke criteria., Methods: Between 2014 and 2017, 175 patients with suspected PVE were prospectively included in 3 French centers. After exclusion of patients with uninterpretable 18 F-FDG PET/CT, 115 patients were evaluated, including 91 definite and 24 rejected IE, as defined by an expert consensus., Results: Cardiac uptake by 18 F-FDG PET/CT was observed in 67 of 91 patients with definite PVE and 6 with rejected IE (sensitivity 73.6% [95% confidence interval (CI): 63.3% to 82.3%], specificity 75% [95% CI: 53.3% to 90.2%]). The ESC 2015 classification increased the sensitivity of Duke criteria from 57.1% (95% CI: 46.3% to 67.5%) to 83.5% (95% CI: 74.3% to 90.5%) (p < 0.001), but decreased its specificity from 95.8% (95% CI: 78.9% to 99.9%) to 70.8% (95% CI: 48.9% to 87.4%). Intraobserver reproducibility of 18 F-FDG PET/CT was good (kappa = 0.84) but interobserver reproducibility was less satisfactory (kappa = 0.63). A diffuse splenic uptake was observed in 24 (20.3%) patients, including 23 (25.3%) of definite PVE, and only 1 (4.2%) rejected PVE (p = 0.024)., Conclusions: 18 F-FDG PET/CT is a useful diagnostic tool in suspected PVE, and explains the greater sensitivity of ESC criteria than Duke criteria. However, 18 F-FDG PET/CT also presents with important limitations concerning its feasibility, specificity, and reproducibility. Our study describes for the first time a new endocarditis criterion, that is, the presence of a diffuse splenic uptake on 18 F-FDG PET/CT., Competing Interests: Author Disclosures This study was supported by grants from the PHRC (projet hospitalier de recherche clinique) PHRC 2012 n° 2013-01 et -la Fondation Coeur et Recherche. The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The natural history of type B intramural hematomas is little-known. Aneurysmal progression or an aortic dissection occurs in 15 to 20% of the cases. The study of the natural anatomical evolution could help identify the patients at risk of unfavorable evolution., Methods: All the patients monitored for a type B intramural hematoma between 2009 and 2018 were included in this monocentric retrospective study. Computed tomography angiography centerline measurement of diameters was obtained in various points of aortic segmentation on day (D) 0 and at one month (M1). Aortic volumes (lumen, intramural hematoma, and total volume) were calculated. The circulating volume was calculated using the volume rendering method. The volume of the intramural hematoma was measured using a manual section-by-section segmentation tool, and the total volume was obtained by summing up the two preceding volumes. Two groups of patients were compared: group 1 (favorable anatomical evolution) and group 2 (unfavorable anatomical evolution)., Results: Between January 2008 and August 2018, 25 patients were managed for a type B intramural hematoma in our center. After an average follow-up of 15.5 months (1-52), 13 patients (52%) presented a favorable evolution and 12 (48%) an unfavorable evolution. At M1, a significant increase of the luminal diameters (37 mm vs. 32 mm; P < 0.01) and a significant reduction in the longitudinal extension (19 mm vs. 26 mm; P < 0.01) were observed. The maximum aortic diameter evolved significantly between D0 and M1 in the unfavorable evolution group (49 mm vs. 44 mm, respectively; P = 0.038). Such a difference was not found in the favorable evolution group (37.4 vs. 37.1, respectively; P = 0.552). An overall significant reduction in the total aortic volume (166 cm 3 vs. 219 cm 3 ; P < 0.01), the circulating volume (124 cm 3 vs. 145 cm 3 ; P = 0,026), and the volume of the hematoma (42 cm 3 vs. 39 cm 3 ; P < 0.01) was observed. The circulating volume decreased significantly between D0 and M1 in the favorable evolution group (110 cm 3 vs. 135 cm 3 ; P = 0.05), whereas no difference was noted in the unfavorable group (142 cm 3 vs, 157 cm 3 ; P = 0.24)., Conclusions: The progression of the maximum aortic diameter and of the circulating volume after one month of follow-up could be predictive factors of the poor long-term evolution of type B intramural hematomas., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Ticagrelor induces more potent platelet reactivity (PR) inhibition with reduced interindividual variability compared to clopidogrel. Although on-clopidogrel PR was shown to correlate with ischemia and bleeding events, no study has investigated the relationship between on-ticagrelor PR and outcome., Objectives: We aimed to evaluate the relationship between on-ticagrelor PR, assessed by the vasodilator-stimulated phosphoprotein index (VASP), and thrombotic and bleeding events in patients with acute coronary syndrome (ACS) treated by percutaneous coronary intervention (PCI)., Methods: We performed a prospective, multicenter observational study on patients treated with PCI for ACS. The VASP index was used to assess PR after ticagrelor loading dose (LD). The primary endpoint was the link between major adverse cardiovascular events (MACE) and PR., Results: Among the 530 patients with ACS included, 183 (34.5%) were admitted for ST elevation myocardial infarction. We observed high potency and limited interindividual variability after the ticagrelor LD (VASP 19.1% ± 16.6%). At 1 month, 21 (3.8%) MACE and 29 (5.5%) bleedings ≥ 2 according to the Bleedings Academic Research Consortium (BARC) scale were recorded. Neither MACE nor bleeding was associated with PR (P = .34 and P = .78, respectively). However, there was a strong association between PR and the occurrence of definite acute stent thrombosis (P = .03). Platelet reactivity was the only factor associated with acute definite stent thrombosis., Conclusion: In patients receiving a ticagrelor LD while undergoing PCI for ACS, PR using the VASP did not predict MACE or bleeding, but it was significantly associated with the occurrence of definite acute stent thrombosis., (© 2019 Aix-Marseille University. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc.)

Objectives: Shared decision-making (SDM) in health care is widely encouraged. However, for SDM to occur patients need to be able to obtain, understand and apply medical information. Our aim was to assess the relationship between health literacy (HL), numeracy and SDM (using French translations of validated measures)., Methods: A cross-sectional survey using a self-administered online questionnaire was proposed to all members of the Seintinelles association. Several scales were used to measure HL (FCCHL and 3HLQ/SILS), numeracy (SNS-3), the SDM process (CollaboRATE) and explore their inter-relationships., Results: Data from 2 299 respondents (96.7% women, 46.1% with a history of cancer) were analysed. All measurement scales showed adequate psychometric properties. Functional HL, communicative HL and numeracy were positively associated with SDM while no significant relation was observed between critical HL and SDM. Furthermore, perceived difficulties in asking physicians' questions and deprivation were negatively associated with SDM., Conclusion: Patient support to reach SDM requires high levels of HL, particularly in the functional and communicative domains. Efforts must be made to improve access and understanding of health information., Practice Implications: Brief self-reported measures could be used to screen for low levels of health literacy, tailor information accordingly and improve patient involvement in healthcare decision-making., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Type II endoleaks are the most common complications after endovascular repair of abdominal aortic aneurysms (EVARs). Some studies have shown the benefit of preventive inferior mesenteric artery (IMA) embolization, but its efficacy and cost-effectiveness continue to be controversial. The aim of this study was to evaluate the efficacy of this procedure on the increase in aneurysmal sac diameter during follow-up., Materials and Methods: All consecutive patients who underwent the embolization of the IMA before EVAR in our center, between January 2014 and July 2016, were included. We retrospectively compared the diameter of the aortic aneurysm sac, the rate of endoleak and reinterventions, and the theoretical cost of management between these patients (group 2) and a historical cohort of patients treated for EVAR before January 2014 who did not undergo prior IMA embolization (group 1)., Results: Two hundred twenty-four patients were retrospectively analyzed. After exclusion, we compared a group of 37 embolized patients with a control group of 46 patients. The rate of enlargement in the aneurysmal sac diameter was significantly higher in the control group at 2 years (27.9% vs. 4.3%, P = 0.025). The type II endoleak rate at 2 years was significantly higher in the control group (53.1% vs. 18.2%, P = 0.012), as was the aneurysm-related reintervention rate (31.1% vs. 8.1%, P = 0.013). Multivariate analysis confirmed these results. At 2 years of follow-up, there was no difference in the overall cost of patient management between the 2 groups., Conclusions: Preventive IMA embolization is an effective, reliable, and cost-effective technique that seems to reduce the rate of the aneurysmal sac diameter enlargement, type II endoleak, and reinterventions after EVAR., (Copyright © 2019. Published by Elsevier Inc.)

Objective: The objective of this study was to compare surgical risk and early and late mortality of patients treated for anatomically classified juxtarenal aortic aneurysms (JRAs) by fenestrated endovascular aneurysm repair (F-EVAR) or open surgical repair (OSR) during a period when the two treatments were available and to validate an institutional algorithm for JRA repair., Methods: We retrospectively included all patients treated electively in our center between January 2005 and December 2015 for JRAs classified into three anatomic categories, excluding suprarenal aneurysms. Lee score and American Society of Anesthesiologists (ASA) class evaluated preoperative surgical risk. We compared clinical and radiologic parameters between the patients treated by F-EVAR and those treated by OSR. The primary study end point was 30-day mortality. We also compared 5-year survival., Results: From 2005 to 2015, there were 191 patients separated into two groups, one treated by OSR (n = 134; mean age, 69 years) and the other treated by F-EVAR (n = 57; mean age, 74 years). Patients of the F-EVAR group were significantly older (P = .001). Intensive care unit length of stay was significantly higher in the OSR group (3.4 days vs 1.5 days; P = .01). Surgical risk was significantly higher in the F-EVAR group as measured by Lee score ≥2 (OSR, 8.9 %; F-EVAR, 21%; P = .02) and ASA class 3 and class 4 (OSR, 32.8%; F-EVAR, 73.6%; P = .001), whereas 30-day postoperative mortality was not significantly different (OSR, 1.5%; F-EVAR, 0%; P = .394). The 5-year survival was not significantly different in the two groups (OSR, 82.1%; F-EVAR, 69.2%)., Conclusions: In this study, despite a higher surgical risk by Lee score and higher ASA class in the group of patients treated by F-EVAR, postoperative mortality was not significantly different between these groups. In our opinion, F-EVAR and OSR of JRA are complementary., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with other nutraceutical compounds), monacolin K administered daily dose (≤3, 3.1-5 or >5 mg/day), follow-up (>12 or ≤12 weeks), with statin therapy or statin-intolerance and type of control treatment (placebo or statin treatment). Data were pooled from 53 RCTs comprising 112 treatment arms, which included 8535 subjects, with 4437 in the RYR arm and 4303 in the control one. Monacolin K administration was not associated with increased risk of MuD (odds ratio (OR) = 0.94, 95% confidence interval (CI) 0.53,1.65). Moreover, we showed reduced risk of Non-MuD (OR = 0.59, 95%CI 0.50, 0.69) and SAE (OR = 0.54, 95%CI 0.46, 0.64) vs. control. Subgroups analyses confirmed the high tolerability profile of RYR. Furthermore, increasing daily doses of monacolin K were negatively associated with increasing risk of Non-MuD (slope: -0.10; 95%CI: -0.17, -0.03; two-tailed p < 0.01). Based on our data, RYR use as lipid-lowering dietary supplement seems to be overall tolerable and safe in a large kind of moderately hypercolesterolaemic subjects., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Involvement of patients in decision-making about their health has been promoted nationally and internationally since several years. Despite this, patient (and their relatives) participation remains insufficient and one of the objectives of the current French national cancer policy (Plan cancer 2014-2019) is to give everyone the possibility to play an active role in the management of their care. This overview focuses on decision-making autonomy of cancer patients through two main questions: why and how to promote it? After a brief review of the decision-making models described in the literature in the past decades insisting on the major role of the decisional context and the dynamic character of this context, this article presents a selection of published works which aimed to respond to those 2 questions., (Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Background: Elevated apolipoprotein C-III (apoC-III) has been postulated to contribute to the atherogenic dyslipidemia seen in obesity and insulin-resistant states, mainly by impairing plasma triglyceride-rich lipoprotein (TRL) metabolism. Bariatric surgery is associated with improvements of several obesity-associated metabolic abnormalities, including a reduction in plasma triglycerides (TGs) and an increase in plasma high-density lipoprotein cholesterol (HDL-C)., Objectives: We investigated the specific effect of bariatric surgery on apoC-III concentrations in plasma, non-HDL, and HDL fractions in relation to lipid profile parameters evolution., Methods: A total of 132 obese subjects undergoing bariatric surgery, gastric bypass (n = 61) or sleeve gastrectomy (n = 71), were studied 1 month before surgery and 6 and 12 months after surgery., Results: Plasma apoC-III, non-HDL-apoC-III, and HDL-apoC-III concentrations were markedly reduced after surgery and strongly associated with reduction in plasma TG. This decrease was accompanied by a redistribution of apoC-III from TRL to HDL fractions. In multivariate analysis, plasma apoC-III was the strongest predictor of TG reduction after surgery, and the increase of HDL-C was positively associated with plasma adiponectin and negatively with body mass index., Conclusion: Marked reduction of apoC-III and changes in its distribution between TRL and HDL consistent with a better lipid profile are achieved in obese patients after bariatric surgery. These apoC-III beneficial modifications may have implications in dyslipidemia improvement and contribute to cardiovascular risk reduction after surgery., (Copyright © 2017 National Lipid Association. Published by Elsevier Inc. All rights reserved.)

Objective: A management protocol for infants hospitalized for acute bronchiolitis, established after the study conducted in our unit in 2012, recommends a chest X-ray when the clinical course is unusual or if a differential diagnosis is suspected. The goal of this study was to evaluate professional practices after the introduction of this new management protocol., Study Design: Retrospective descriptive study in two pediatric units from October 2013 to March 2015, including infants (0-23 months) hospitalized for their first episode of acute bronchiolitis without any underlying chronic condition., Result: Overall, 599 infants were included (median age, 3.7 months, 54 % boys). Nearly six out of ten (n=355, 59.3 %) had at least one chest radiograph (38.5 % fewer than in 2012). It was abnormal in 96.3 % of cases, revealing distension and/or bronchial wall thickening (56.7 %), focal opacity (23.5 %), or atelectasis (19.5 %). An X-ray was performed out of the recommendations in 42.5 % of cases. The chest X-ray result led to management changes in 52 infants with prescription of antibiotics for pneumonia (86.5 %) and allowed the diagnosis of heart disease in one case (0.2 %). Management of acute bronchiolitis (X-ray and antibiotics) was statistically different between the two pediatric units., Discussion: This protocol led to a significant decrease in the number of chest X-rays. However, many are still performed out of the recommendations, resulting in an increase of antibiotic use for pneumonia., Conclusion: The decrease in use of chest X-rays in acute bronchiolitis for hospitalized infants was significant but remains insufficient., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Background: No predictive marker has been yet identified for bevacizumab which is widely used in metastatic colorectal cancer., Aims: Evaluate impact of single nucleotide polymorphisms involved in Vascular Endothelial Growth Factor pathway on efficacy and tolerance of bevacizumab., Methods: We retrospectively included patients who were treated with bevacizumab-based chemotherapy for metastatic colorectal cancer, and for whom a deoxyribonucleic acid sample was available. Ten polymorphisms in Vascular Endothelial Growth Factor-A, his receptors and hypoxia inducible factor-1α were genotyped on germ line DNA using real-time polymerase chain reaction TaqMan(®)., Results: 89 patients were included. The CC genotype for rs3025039 (Vascular Endothelial Growth Factor-A c.*237C>T) was associated with a significantly better time to treatment failure (14.2 months) as compared to the CT and TT genotypes (6.0 months) in univariate (p = 0.004) and multivariate (p = 0.022; HR = 0.57; 95% CI [0.35-0.92]) analysis. Patients with at least one T allele showed worse overall survival and progression-free survival as compared to homozygous CC patients in univariate analysis (respectively p = 0.016 and p = 0.044). There was significantly more severe hypertension for the CC genotype (29.5%) compared to CT and TT genotypes (7.1%) (p = 0.022) in multivariate analysis., Conclusions: In this retrospective study, the rs3025039 polymorphism was significantly associated with time to treatment failure and hypertension in patients treated with bevacizumab-based chemotherapy., (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Objectives: To evaluate tissue characteristics of the placenta by transabdominal ShearWave Elastography in pregnant baboon., Materials and Method: For 9 months (03/2013-12/2013) two operators (EQ, GG) performed ultrasound of the placenta during pregnancy pregnant baboons station partner primatology project. The identification of the placenta was performed previously in 2D ultrasound. The elastography method was then activated. Three measurements were carried out by operator for each placenta. The intraclass correlation coefficients within and between observers were calculated for the objective assessment (elastography) of placental maturity., Results: During the study period, 21 pregnant baboons were included and ultrasounds were performed between 1 and 3 times each. The measurements have been carried out by two operators in 100% of cases. The intra- and inter-observer ICC for single values are respectively 0.657 - 95% CI (0.548 to 0.752) and 0.458 - 95% CI (0.167 to 0.675). The intra- and inter-observer ICC for average values are respectively 0.852 - 95% CI (0.784 to 0.901) and 0.628 - 95% CI (0.286 to 0.806)., Conclusion: The study by transabdominal ShearWave Elastography of placenta's pregnant baboons is possible. The intra- and inter-operator reproducibility of this method is good using the average of three measurements. The objective study via elastography ShearWave of the degree of placental maturity seems not yet be used in clinical practice. Studies of larger cohorts are needed., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Background: The clinical benefit of ticagrelor compared to clopidogrel in ACS patients suggested off-target property. Such pleiotropic effect could be mediated by circulating endothelial progenitor cells (EPC) which are critical for vascular healing. We aimed to investigate the impact of ticagrelor on EPC in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI)., Methods: We prospectively randomized 106 ACS patients to ticagrelor or clopidogrel. Sub-populations of CD34+ circulating progenitor cells (PC) were analyzed by flow cytometry allowing one to determine the levels of CD34+ PC, CD34+CD45+ Hematopoietic PC, CD34+133+ immature PC and CD34+KDR+ EPC on admission and at 1 month. Changes in PC level were calculated as the difference between 1 month and baseline value., Results: The 2 groups were similar regarding baseline characteristics including PC numbers on admission. The 2 groups had similar change in overall CD34+ PC and hematopoietic CD34+45+ PC level (p=0.2). On the contrary, when considering CD34+133+ PC and CD34+KDR+ EPC, we observed that patients treated by ticagrelor had a significantly higher increase in levels of these PC subtypes compared to those treated by clopidogrel (0.23 (-0.33; 0.79) vs 0.00 (-0.5; 0.34); p=0.04 and 0.01 (-0.04; 0.05) vs -0.01 (-0.06; 0.03); p=0.02). Changes in the level of CD34+CD133+ PC correlated with platelet activity measured by the VASP index (r=-0.30; p=0.008). By contrast the increase in the level of CD34+KDR+ EPC in the ticagrelor group was independent of platelet activity., Conclusions: Ticagrelor increases the number of EPC in ACS patients suggesting a benefit on endothelial regeneration that may participate in the pleiotropic property of the drug., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Metastatic breast cancer (MBC) is an incurable disease and represents a complex therapeutic challenge for oncologists. Despite the possibility of prescribing new agents such as tailored therapy, cytotoxic chemotherapy and hormone therapy remain the major treatments for MBC. Several lines of chemotherapy can be proposed for these patients, but beyond the second-line, evidence of effectiveness is lacking and such treatment has important associated toxicity affecting quality of life (QoL). Prospective data on third-line chemotherapy is very poor. There is no recent retrospective data and it mainly includes single-centre experiences. Moreover, prognostic parameters considered in these retrospective studies are limited to clinico-pathological factors. Previous reports don't evaluate prognostic impact of circulating tumour cells (CTC) and baseline QoL. METAL3 METAstatic Line 3 is a prospective, multicentric trial designed to prospectively construct a prognostic score (including selected clinico-pathological factors, CTC and baseline QoL) to identify patients who benefit from third-line chemotherapy for MBC in terms of overall survival (training cohort). Score will then be validated with another cohort (validation cohort). The aim of this paper is to review literature data on third-line chemotherapy for MBC and to describe in detail our prospective study. We hope that this prognostic score could be used by physicians to develop new therapeutic strategies when there will be limited benefit of third-line chemotherapy; this score will also help to improve patient information on their outcome., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: The aim of this study was to determine the predictive factors of reduction in diameter ≥10 mm of the aneurysm sac after endovascular treatment and analyze evolution in these patients., Methods: Between December 1997 and December 2008, all patients electively treated at our center for an infrarenal abdominal aortic aneurysm (AAA) were included in a prospective registry. We did a retrospective study between patients whose aneurysm was reduced by at least 10 mm in diameter on computed tomography scan during follow-up (Group 1) and the other patients who did not (Group 2). A univariate and multivariate statistical analysis was performed., Results: The files of 197 patients (mean age 74.8 years) with a mean follow-up of 54.8 months were reviewed. One hundred two patients (51.8%) had a reduction of ≥10 mm of AAA diameter (Group 1); this reduction was achieved after an average follow-up of 23.6 months. The delay to obtain at least a 10-mm diameter reduction was not influenced by any preoperative characteristics of patients or characteristics of the AAA. Patients in Group 1 were younger (74 vs. 76 years, P = 0.039), with a longer (31 vs. 27.7 mm, P = 0.038) and narrower upper neck (23.1 vs. 24.0 mm, P = 0.02) compared with Group 2. After multivariate analysis, these 3 variables were independently predictive of reduction in AAA diameter. In Group 1, secondary procedures were performed in 13 patients after a diameter reduction of ≥10 mm, including 3 type 1 endoleaks treated after 36 months (1 case) and after 123 months (2 cases) and 1 type 3 endoleak treated after 78 months. In Group 2, secondary procedures were performed in 28 patients, including 9 type 1 endoleaks treated after a median time of 26 months and no type 3 endoleak. Secondary procedures were significantly more frequent in Group 2 than in Group 1 (29.4% vs. 12.7%, respectively; P = 0.005). Freedom from secondary procedure at 5 years was 87.9% in Group 1 and 65.4% in Group 2 (P = 0.003). Freedom from AAA rupture at 8 years was significantly superior in Group 1 than in Group 2 (100% vs. 83.5%, P = 0.008)., Conclusions: Sac shrinkage after endovascular aortic aneurysm repair is more likely observed in younger patients with long and small proximal neck anatomy and is associated with better long-term outcomes. However, late failures do occur even in those with significant sac shrinkage; therefore, follow-up should continue lifelong., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Familial hypercholesterolemia (FH) is the most common genetic disorder causing premature cardiovascular disease and death. Heterozygous FH conservatively affects approximately 1:500 Canadians, and the more serious homozygous form affects approximately 1:1,000,000 Canadians, although these numbers might be underestimated. Of approximately 83,500 Canadians estimated to have FH, most are undiagnosed, which represents a simultaneous public health deficit and opportunity, because early treatment of heterozygous FH can normalize life expectancy. Diagnostic algorithms for FH incorporate increased plasma low-density lipoprotein cholesterol, pathognomonic clinical features, and family history of early cardiovascular disease and hyperlipidemia. DNA-based detection of causative mutations in FH-related genes can help with diagnosis. Maximizing diagnosis and treatment of FH in Canada will involve a multipronged approach, including: (1) increasing awareness of FH among health care providers and patients; (2) creating a national registry for FH individuals; (3) setting standards for screening, including cascade screening in affected families; (4) ensuring availability of standard-of-care therapies, in particular optimization of plasma low-density lipoprotein cholesterol levels and timely access to future validated therapies; (5) promoting patient-based support and advocacy groups; and (6) forming alliances with international colleagues, resources, and initiatives that focus on FH. This document aims to raise awareness of FH nationally, and to mobilize knowledge translation, patient support, and availability of treatment and health care resources for this underrecognized, but important medical condition., (Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Duodenal GISTs represent 3-5% of all GISTs with limited understanding of patient outcomes. We conducted a retrospective analysis of primary localized duodenal GISTs., Methods: Patients were identified via a survey from 16 FSG centers (n = 105), and a group of 9 patients enrolled in the BFR14 trial. Data were collected from the original database and patient files, in agreement with French legislation., Results: 114 patients were included, with a median age of 57. Tumors originated mainly in D2 (33%), or D3 (24%), with a median size of 5 cm. 109 patients had resection of the primary tumor; with a Local Resection (LR, n = 82), a pancreaticoduodenectomy (PD, n = 23), and data were missing for 4 patients. Resections were R0 (n = 87, 79%), R1 (n = 8, 7%), R2 (n = 6). Tumor characteristics were: KIT+ (n = 104), CD34+ (n = 58). Miettinen risk was low (n = 43), and high (n = 52). Imatinib was administered preoperatively (n = 11) and post-operatively (n = 20). With a median follow-up of 36 months (2-250), 98 patients are alive, and 33 relapsed. The 5-year OS and EFS rates are 86.5% and 54.5%. EFS was similar for patients in the LR and the PD groups (P > 0.05). In multivariate analysis, ECOG PS, and CD34 expression are independent prognostic factors on OS. Miettinen risk and spindle cell type are independent predictive factors for relapse., Conclusions: Patients with resected duodenal GIST have a reasonably favorable prognosis. This study favors a preservation of pancreas when there are no anatomical constraints. LR exhibit similar survival and smaller morbidity then PD., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objective: To describe the chest radiographs of infants hospitalized for acute bronchiolitis and to assess whether patient management changed after radiography., Study Design: All infants hospitalized in our pediatric unit with a first episode of acute bronchiolitis from October 2010 to March 2012 were included in the study. Infants with chronic disease or transferred from a pediatric intensive care unit were excluded. The following data were collected: sex, age, neonatal history, atopy, tobacco exposure, admission criteria, treatment, laboratory parameters, ultrasonography and its outcome, results of chest radiography on admittance, the reason for a second chest radiograph, change in management as a result of the radiograph., Results: The study comprised 232 infants (median age 2.2 months, boys 56%, positive respiratory syncytial virus 73.4%). Among them, 227 children had a routine chest radiograph revealing distension and/or bronchial wall thickening (n=141, 62.4%), focal opacity (19.9%), or atelectasis (17.7%). This radiograph led to the prescription of antibiotics in six patients (2.6%) and allowed the diagnosis of vascular abnormality to be made in one case (0.4%). Thirty-five patients (15.4%) had a second chest radiograph during their hospitalization owing to oxygen dependency (n=21), respiratory distress (n=11), persistent fever (n=2), or no reason specified (n=1). Pneumonia (n=7) and/or atelectasis (n=15) were then found in 62.9%. Patient management (antibiotics, postural maneuvers) was modified in six patients (17.1%)., Conclusions: Routine chest radiographs contribute only partially to the treatment of infants hospitalized for acute bronchiolitis. However, radiography is useful when the hospitalized child does not improve at the expected rate or if the disease is severe. The indication of chest radiography in infants hospitalized for acute bronchiolitis should be discussed on a case by a case basis., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Objective: To develop a scale for assessing Respondents' Perceptions of Health Research Questionnaires (the REP-HQ Scale) and test this scale psychometrically., Study Design and Setting: A scale was drawn, based on detailed content analysis of patients' free comments, which were collected prospectively in a 2-year cohort study (n=228). The questionnaire corresponding to this scale was subsequently completed by a cohort of female BRCA1/2 carriers/noncarriers not affected by cancer, who had been followed up for 5 years since test result disclosure (n=246). Principal component analysis, Cronbach's alpha coefficient, and Pearson's correlations were used in the statistical analyses., Results: The perceived effects that emerged from the respondents' responses were analyzed and classified under the headings: "Useful medical information," "Usefulness of research," and "Labeling intrusion." Cronbach's alpha coefficients on the three dimensions were 0.75, 0.64, and 0.56, respectively. Carriers obtained lower scores than noncarriers on the first dimension (P=0.005) and on the overall score (P=0.002)., Conclusions: The REP-HQ scale is the first generic tool to be developed for assessing participants' perceptions about the effects of health research questionnaires. Further testing is now required to confirm the validity of the findings obtained here by applying this tool in other settings., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Post-treatment platelet reactivity (PR) is associated with ischemic and bleeding events in patients receiving P2Y12 receptor antagonists., Objectives: We aimed to study the relationship between post-treatment PR after a 60-mg loading dose (LD) of prasugrel and 1-year thrombotic and bleeding events., Method: Patients were prospectively included in this multicenter study if they had a successful percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and received prasugrel. The platelet reactivity index (PRI) was measured using the Vasodilator-Stimulated Phosphoprotein index (VASP) after a prasugrel LD. Endpoints included the rate of thrombotic events and bleeding events at 1 year., Results: Among the 301 patients enrolled, 9 (3%) were lost to follow-up at 1 year. The rates of thrombotic and bleeding events at 1 year were of 7.5% and 6.8%, respectively. Receiver-operating curve (ROC) analysis demonstrated an optimal cut-off value of 53.5% of PRI to predict thrombotic events at 1 year. Using this cut-off value we observed that patients exhibiting high on-treatment platelet reactivity (HTPR) had a higher rate of thrombotic events (22.4% vs. 2.9%; P < 0.001). In parallel the optimal cut-off value of PRI to predict bleeding was 16%. Patients with a PRI ≤ 16% had a higher rate of bleeding events compared with those with a PRI > 16% (15.6% vs. 3.3%; P < 0.001). In multivariate analysis, the PRI predicted both thrombotic and bleeding events (OR: 1.44, 95% confidence interval [CI]: 1.2-1.72; P < 0.001 and OR: 0.75, 95% CI: 0.59-0.96; P = 0.024 [respectively, per 10% increase])., Conclusion: Platelet reactivity measurement after a prasugrel LD predicts both ischemic and bleeding events at 1 year follow-up for ACS patients undergoing PCI., (© 2012 International Society on Thrombosis and Haemostasis.)

Aim: Mitochondrial disease is a heterogeneous disorder entity induced by defects in the mitochondrial respiratory chain complex. Neurological symptoms, including epilepsy, are common in children. The aim of this study was to research the clinical signs indicating mitochondrial disease., Methods: We retrospectively studied epileptic children who underwent a muscle and/or hepatic biopsy between 1995 and 2010 searching for a mitochondrial disease. Patients were separated into 2 groups depending on the biopsy result: group 1 (presence of mitochondrial disease) and group 2 (absence of mitochondrial disease). Epileptic phenotypes were compared between these 2 groups. In group 1, we specified the clinical phenotype and characterized mitochondrial disease., Results: Fifty-three children were included: 29 in group 1 and 24 in group 2. The average age at onset of epilepsy was 39.6 months in group 1 versus 11.8 months in group 2. In the 1st group, epilepsy was less refractory and associated with other clinical symptoms., Conclusions: In this study, epilepsy did not appear to be a unique sign of mitochondrial disease. It most often appeared during the 2nd year of life and is correlated with multiorgan involvement, notably ophthalmologic, such as oculomotor apraxia, optic atrophy, and retinitis pigmentosa, as well as auditory (deafness) and hepatic (hepatic failure, hepatomegaly). On the other hand, in children who did not have mitochondrial disease, epilepsy often began earlier (before 3 months of age), it was refractory, isolated without multiorgan involvement, and seems to be due to genetic anomalies in developmental genes, a finding that requires further research., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Devic neuromyelitis optica (NMO) is an inflammatory demyelinating disease of the central nervous system associating acute transverse myelitis and optic neuritis. This is a different disease from multiple sclerosis for which the presence of the NMO antibody directed against aquaporin 4 is a specific marker. Brain damage on MRI does not exclude the diagnosis; the location is superposable in the brain zones rich in aquaporin 4 channels. We report 2 cases of NMO with anti-aquaporin 4. One patient was not symptomatic of brain damage. In this patient, the affinity of anti-NMO for aquaporin 4, studied by flow cytometry, was particularly high. Both patients were treated with immunosuppressive agents (rituximab) due to the failure of or dependence on high-dose corticosteroids., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Objective: To identify the factors associated with long-term regrets expressed a posteriori by randomized controlled trial (RCT) participants questioned about their decision to participate in an RCT., Study Design and Setting: Participants were questioned 6 years on average after their inclusion in a breast cancer adjuvant therapy RCT. Among 115 women from 21 centers, 93 (81%) answered a self-administered questionnaire based on the Decision Regret Scale (DRS)., Results: Mean DRS score was 16.8 (standard deviation=15.9); 43.0% of participants expressed mild regret, and 25.8% expressed moderate to strong regret. A quarter of the women (25.6%) said that the decision was taken by the doctor alone, and 13.5% said it was not consistent with their own wishes. In the multivariate ordinal regression analysis, an involuntarily passive role in decision making was found to be associated with greater regret (cumulative proportional odds ratio=7.3, 95% confidence interval=2.0-27.6), regardless of age and being allotted or not to the standard treatment in the RCT., Conclusion: Whether patients' regret depended on their level of participation in the decision making or vice versa could not be determined in this cross-sectional survey, but efforts should be made to ensure that patients' participation in trials is always based on an active personal decision., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Unlabelled: The association of type 1 diabetes mellitus (DM) and epilepsy has been previously reported. However, the physiopathology of this association remains misunderstood., Objective: To describe epilepsy combined with type 1 DM in children., Methods: Retrospective monocentric study of all the epileptic and type 1 diabetic children consulting at the Timone University Hospital, Marseille, France. For each patient, the type of epilepsy and its electroclinical and radiographic characteristics were studied as well as the type of diabetes (biological characteristics, glycemic control), and the onset of these 2 diseases., Results: Ten patients are reported. Five suffered from generalized epilepsy (4 idiopathic, 1 nonidiopathic) and 5 from focal epilepsy (4 non-idiopathic, 1 idiopathic). For most of these cases, presence of GAD (glutamic acid decarboxylase) autoantibodies were confirmed and epilepsy followed diabetes., Conclusions: The 2 most common types of epilepsy in this association are idiopathic generalized epilepsy and non-idiopathic temporal epilepsy. Several mechanisms could be involved (immune, glycemia, and genetic disorders)., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Objective: Evaluate changes in obstetrical and neonatal outcome of women who delivered in maternity hospital since the 19(th) century., Materials and Methods: Data from a historic cohort of 1022 women who delivered between 1871 and 1874 in the hôtel Dieu hospital of Marseille were compared to those from 1159 women who delivered from 2005 to 2006 in the level 3 maternity of Nord hospital of Marseille (contemporary cohort). Deliveries that had occured before 22 weeks and/or with a foetal birth weight of less than 500 g were excluded., Results: A total of 2131 pregnancies were included: 1011 and 1120 in historic and contemporary cohort, respectively. Despite comparable mean term of delivery, mean birth weight of neonates from historic cohort were significantly lower: 2971 g (550-4900 g) vs 3250 g (500-5375 g), respectively (p<0.001). Stillbirths were reported in 72 (7.1%) cases in historic cohort compared to nine (0.8%) in contemporary cohort (p<0.001). Neonatal mortality was 3.7% in historic cohort and 1.9% in contemporary cohort (p=0.012). A total of 99 (9.8%) maternal deaths were reported in historic cohort, while none in contemporary cohort (p<0.001). A wide majority of maternal deaths were caused by maternal infection (72.9%); 5.2% were caused by postpartum haemorrhage., Conclusion: Our results illustrate the tremendous impact on maternal and neonatal outcome of advances in obstetrical management. The significant increase in the median foetal birth weight is likely to be related to wide changes in environmental conditions and behaviour., (Copyright © 2011. Published by Elsevier Masson SAS.)

We report a case of a child that suffered from a severe new onset status epilepticus a few days after a common viral infection. Despite extensive screening, no bacterial, viral or fungal infection could be found. Using immunohistochemical analysis, we found neuronal auto-antibodies directed against the neuropil, in blood and CSF, associated with CSF oligoclonal banding. Status epilepticus was highly refractory to antiepileptic drugs, but improved few days after Intra-Venous Immunoglobulin Injection (IVIG). The patient developed ongoing temporal lobe epilepsy that was still associated with neuropil auto-antibodies. Therefore, screening for antineuronal antibodies should be helpful to characterize and maybe to handle new onset status epilepticus without any obvious aetiology. Further studies should establish the link between epilepsy and such auto-antibodies., (Copyright © 2010 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.)

Background: Although risks and life-threatening complications associated with lead extraction are well characterized, practice patterns vary regarding whether procedures are performed in an operating room (OR) or electrophysiology (EP) laboratory with cardiothoracic surgical backup., Objective: Our objective was to compare procedural outcomes and complications associated with lead extraction in the OR vs. EP laboratory., Methods: Prospectively acquired data were pooled from 2 referral centers. Lead extraction procedures were performed between 2000 and 2010, encompassing a transition phase from the OR to EP laboratory. Analyses were conducted using generalized estimating equations., Results: A total of 1,364 leads (533 OR; 831 EP laboratory) were targeted in 684 consecutive procedures, 41.2% of which were in the OR. Laser sheaths and snares were used for 699 (51.2%) and 101 (7.4%) leads, respectively. Overall, 775 (93.1%) vs. 487 (91.4%) leads were completely extracted in the EP laboratory vs. OR [odds ratio 1.3, 95% confidence interval 0.9 to 2.1]. Complications occurred in 2.24% vs. 2.84%, respectively (P = .431). Two patients died because of superior vena caval lacerations (0.29%), 1 in each group. Rapid surgical intervention was helpful in 6 (0.9%) patients [4 OR (2 subclavian vein lacerations, 1 tricuspid valve laceration, 1 tamponade); 2 EP laboratory (tamponades)], with subsequently favorable outcomes. The only independent predictor of complications was older lead age [odds ratio 1.11 per year, 95% confidence interval 1.02 to 1.20]., Conclusion: Lead extraction in the EP laboratory with surgical backup is associated with a similarly low rate of complications and mortality as procedures performed in the OR., (Copyright © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

The failure of blood vessels to revascularize ischemic neural tissue represents a significant challenge for vascular biology. Examples include proliferative retinopathies (PRs) such as retinopathy of prematurity and proliferative diabetic retinopathy, which are the leading causes of blindness in children and working-age adults. PRs are characterized by initial microvascular degeneration, followed by a compensatory albeit pathologic hypervascularization mounted by the hypoxic retina attempting to reinstate metabolic equilibrium. Paradoxically, this secondary revascularization fails to grow into the most ischemic regions of the retina. Instead, the new vessels are misdirected toward the vitreous, suggesting that vasorepulsive forces operate in the avascular hypoxic retina. In the present study, we demonstrate that the neuronal guidance cue semaphorin 3A (Sema3A) is secreted by hypoxic neurons in the avascular retina in response to the proinflammatory cytokine IL-1β. Sema3A contributes to vascular decay and later forms a chemical barrier that repels neo-vessels toward the vitreous. Conversely, silencing Sema3A expression enhances normal vascular regeneration within the ischemic retina, thereby diminishing aberrant neovascularization and preserving neuroretinal function. Overcoming the chemical barrier (Sema3A) released by ischemic neurons accelerates the vascular regeneration of neural tissues, which restores metabolic supply and improves retinal function. Our findings may be applicable to other neurovascular ischemic conditions such as stroke.

Objectives: To evaluate the perineal morbidity of operative vaginal delivery using spatulas and vacuum., Methods: From December 2008 to May 2010, 419 single pregnancies after 37 weeks of gestation in cephalic position were prospectively included: 226 spontaneous vaginal deliveries and 193 operative vaginal deliveries (126 spatulas and 67 vacuum). Each patient had rigorous clinical examination of the perineum. Perineal tears were classified in four different degrees depending on their severity: injury to skin only or episiotomy, injury to the perineum involving perineal muscles, anal sphincter rupture without and with anal epithelium tear, respectively., Results: The rate of second degree or more perineal tear among patients who had spontaneous vaginal delivery, operative vaginal delivery using spatulas and vacuum was: 5.9%, 27% and 28.6%, respectively (p<0.001). If no significant difference was observed between the rate of perineal damages after spatulas and vacuum, compared to spontaneous vaginal delivery, only spatulas were significantly associated to the risk of third degree or more perineal damage: 2 (0.9%) vs. 6 (5.2%), respectively (p=0.022). Only operative vaginal delivery was identified as an independent risk factor for second degree or more perineal tear (AOR: 4.589; 95%CI: 2.012-10.467; p<0.001). Episiotomy had no independent significant impact on that risk (AOR: 0.690; 95%CI: 0.350-1.359; p=0.283)., Conclusion: Operative vaginal delivery using spatulas and vacuum does significantly increase perineal morbidity. This risk appears to be independent of the practice of episiotomy., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

Purpose: Morphologic abnormalities of the hippocampal formations (MAHF) are more frequently observed in magnetic resonance imaging (MRI). We wished to specify the types of disorders associated with these malformations based on a retrospective case series by studying the language of the children presenting these abnormalities., Patients and Methods: From the data of all the MRIs taken in the neuroradiology ward of our center over 16 months in patients under 18 years of age, we retrospectively selected the children with an MAHF, isolated or associated with other malformations. The MAHFs were defined and described according to criteria of shape or orientation defects of the hippocampal formations. We studied the files of the patients with isolated MAHF again. Those whose clinical presentation was compatible with language assessment were tested in a prospective approach., Results: Out of 2208 MRIs from 1 January 2007 to 30 April 2008, 96 (4.3%) showed an MAHF, including 61 (64%) boys and 35 (36%) girls, aged from 2 months to 17 years. Eighty-two (85%) had associated abnormalities, mainly including cerebral atrophy, corpus callosum agenesis or defect, and abnormal ventricular frontal horns. Fourteen (15%) had an isolated MAHF: 2 on the left hemisphere, 2 on the right hemisphere, and 10 on both. Of these 14, 9 were compatible with language assessment. From the test results, we divided these children into 2 groups, depending on the type and severity of the impairment. Four had very serious language disorders as part of mental retardation or autistic disorders; 4 others had language disorders predominantly in expression and phonology, with weak to pathological visual memory. This study showed no potential relation between the lateralization of MAHF and language disorders, nor between the existence of epilepsy and the severity of the language disorders. Of these 14 children, 9 had behavior and autism spectrum disorders and 7 were epileptic., Conclusion: Even though language disorders are often part of a larger deficiency presentation, the results we obtained suggest that isolated MAHFs are not only causes of amnestic disorders, but they could also directly underlie language disorders, particularly in expression., (Copyright (c) 2010 Elsevier Masson SAS. All rights reserved.)