Antenatal HIV screening: results from the National Perinatal Survey, France, 2016.

BackgroundUniversal antenatal HIV screening programmes are an effective method of preventing mother-to-child transmission.AimsTo assess the coverage and yield of the French programme on a nationally representative sample of pregnant women, and predictive factors for being unscreened or missing information on the performance/ result of a HIV test.MethodsData came from the medical records of women included in the cross-sectional 2016 French National Perinatal Survey. We calculated odds ratios (OR) to identify factors for being unscreened for HIV and for missing information by multivariable analyses.ResultsOf 13,210 women, 12,782 (96.8%) were screened for HIV and 134 (1.0%) were not; information was missing for 294 (2.2%). HIV infection was newly diagnosed in 19/12,769 (0.15%) women screened. The OR for being unscreened was significantly higher in women in legally registered partnerships (OR: 1.3; 95% CI: 1.1-1.6), with 1-2 years of post-secondary schooling (OR: 1.6; 95% CI: 1.2-2.1), part-time employment (OR: 1.4; 95% CI: 1.1-1.8), inadequate antenatal care (OR: 1.9; 95% CI: 1.5-2.4) and receiving care from > 1 provider (OR: 1.8; 95% CI: 1.1-2.8). The OR of missing information was higher in multiparous women (OR: 1.4; 95% CI: 1.2-1.5) and women cared for by general practitioners (OR: 1.4; 95% CI: 1.1-1.9).ConclusionsThe French antenatal HIV screening programme is effective in detecting HIV among pregnant women. However, a few women are still not screened and awareness of the factors that predict this could contribute to improved screening levels.

Are Meteorological Conditions within the First Trimester of Pregnancy Associated with the Risk of Severe Pre-Eclampsia?

BACKGROUND: Severe pre-eclampsia (SPE) is the second cause of maternal death in developed countries. The literature suggests different risk factors for early- and late-onset pre-eclampsia. SPE is usually related to the early-onset type. Pre-eclampsia rate exhibits seasonal variation. However, the weather-SPE association is still unknown. We examined the associations between maternal exposure to meteorological parameters after conception and SPE. METHODS: From 2008 to 2011, all deliveries of women living in the Yvelines area, France, have been prospectively registered. Meteorological measurements from weather stations scattered inside Yvelines were averaged on two exposure windows: early-pregnancy (30 days after conception) and first-trimester (90 days after conception). The relationship between SPE and season of conception was also examined. Hierarchical complementary log-log regression models were used to estimate the weather-SPE association. RESULTS: SPE was diagnosed in 526 (0.8%) out of 63,633 singleton pregnancies. Increasing temperature or sunshine across both windows was associated with increased SPE risk. Early-pregnancy minimum temperature showed the strongest effect with adjusted odds ratio (OR) per 1 degree Celsius: 1.03 [95% confidence interval (CI) 1.01, 1.04]. The risk of SPE was higher when conception was in summer as compared to winter (OR 1.53, 95% CI 1.27, 1.85). Effect estimates showed only small variations in sensitivity analyses. CONCLUSIONS: Our findings of a weather impact during early pregnancy on SPE may provide a new clue for understanding the causes of pre-eclampsia. Further investigation into the biologic mechanisms for this finding is required.

The use of DRG for identifying clinical trials centers with high recruitment potential: a feasability study.

Recruitment of large samples of patients is crucial for evidence level and efficacy of clinical trials (CT). Clinical Trial Recruitment Support Systems (CTRSS) used to estimate patient recruitment are generally specific to Hospital Information Systems and few were evaluated on a large number of trials. Our aim was to assess, on a large number of CT, the usefulness of commonly available data as Diagnosis Related Groups (DRG) databases in order to estimate potential recruitment. We used the DRG database of a large French multicenter medical institution (1.2 million inpatient stays and 400 new trials each year). Eligibility criteria of protocols were broken down into in atomic entities (diagnosis, procedures, treatments...) then translated into codes and operators recorded in a standardized form. A program parsed the forms and generated requests on the DRG database. A large majority of selection criteria could be coded and final estimations of number of eligible patients were close to observed ones (median difference = 25). Such a system could be part of the feasability evaluation and center selection process before the start of the clinical trial.

Influence of ICU case-volume on the management and hospital outcomes of acute exacerbations of chronic obstructive pulmonary disease*.

OBJECTIVES: To study the relationship between case-volume and the use of noninvasive ventilation during acute exacerbations of chronic obstructive pulmonary disease in ICUs. DESIGN: A 13-year multicenter retrospective cohort study of prospectively collected data. SETTING: Medical ICUs. PATIENTS: From 1998 to 2010, patients with acute exacerbations of chronic obstructive pulmonary disease were identified through a regional database. INTERVENTIONS: The characteristics of hospitalization (including the type of mechanical ventilation) and demographic data of the patients were analyzed. ICUs were categorized into tertiles of the running mean annual volume of admissions. A logistic model performed a conditional multivariate analysis of prognostic factors after matching on a propensity score of being admitted to a high-volume unit and on the year of admission. MEASUREMENTS AND MAIN RESULTS: Fourteen thousand four hundred forty acute exacerbations of chronic obstructive pulmonary disease were identified. The Simplified Acute Physiology Score II and ICU mortality increased during the study period (36 to 41 and 12% to 14%, respectively). The proportion of patients receiving any mechanical ventilation support also increased during the study period (from 64% to 86%), with a marked increase in the use of noninvasive ventilation (from 18% to 49%) and a decrease in the use of invasive ventilation (from 34% to 19%). Participating units were distributed into low-volume (< 25 patients per year), medium-volume (26-47 patients per year), and high-volume (> 47 patients per year) tertiles. There was a significant association between case-volume and 1) the proportion of patients receiving noninvasive ventilation (highest vs lowest case-volume tertiles: odds ratio, 1.43 [95% CI, 1.23-1.66]) and 2) lower mortality. CONCLUSIONS: Between 1998 and 2010, severity and mortality of acute exacerbations of chronic obstructive pulmonary disease admitted to Collège des Utilisateurs de Données en Réanimation ICUs increased. There was an increasing use of noninvasive ventilation and a decreasing use of invasive ventilation. Use of noninvasive ventilation was related to case-volume, suggesting that increasing experience favors the use of noninvasive ventilation and was associated with a strong trend toward decreased mortality.

Impact of case volume on survival of septic shock in patients with malignancies.

OBJECTIVE: Septic shock is a frequent and severe complication in the course of malignancies. In a large multicenter cohort of septic shock patients with hematologic malignancies and solid tumors, we assessed the temporal trend in survival and the prognostic factors, with particular emphasis on case volume. DESIGN: A 12-yr multicenter retrospective cohort study of prospectively collected data. PATIENTS AND METHODS: Cancer patients with septic shock were selected over a 12-yr period (1997-2008) from a French regional database (CUB-Réa). The following variables were extracted: demographic characteristics, type of malignancy, characteristics of infection, severity-of-illness score (Simplified Acute Physiology Score II), organ failure supports, and vital status. For each unit, a running mean annual volume of admissions was calculated for the purpose of categorization into volume tertiles. Prognostic factors were analyzed by a conditional multivariate logistic model after matching on a propensity score of being admitted to a high-volume unit and on the year of admission. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 3,437 patients were included in the study. The intensive care unit mortality rate dramatically dropped over time (from 70.4% in 1997 to 52.5% in 2008, relative decrease 25.4%, p < .001). Participating units were distributed into low-volume (< five patients per year), medium-volume (five to 12 patients per year), and high-volume (≥ 13 patients per year) tertiles. A medical cause for intensive care unit admission, Simplified Acute Physiology Score II, invasive mechanical ventilation, renal replacement therapy, fungal infections, and unknown microorganism were identified as poor prognostic factors. Case volume demonstrated a strong influence on survival, admission in a high-volume unit being associated with a marked decrease in mortality as compared to low-volume units (adjusted odds ratio 0.63; 95% confidence interval [0.46-0.87], p = .002). CONCLUSIONS: Survival of septic shock patients with malignancies markedly increased over the recent years. Furthermore, we identified case volume as a major prognostic factor in this setting.

Long-term changes in arterial structure and function and left ventricular geometry after enzyme replacement therapy in patients affected with Fabry disease.

AIMS: Fabry disease is a lysosomal storage disorder due to deficient alpha-galactosidase A activity, characterised by glycosphingolipids deposition in tissues. Patients have a common arterial involvement and contract progressive renal and cardiac disease. Although short-term effects of enzyme replacement therapy (ERT) on target organs have been established, no data are available on the long-term outcome. METHODS AND RESULTS: We studied the effects of ERT (agalsidase beta, 1 mg/kg/14 days) on arterial and cardiac structure and function during a longitudinal study beginning in 1999, with 4.5 ± 0.4 years follow-up (four visits) in 30 patients (age: 33 ± 12 years). In addition, we studied 16 untreated Fabry patients during 2.6 ± 1.6 years (two visits). Aortic stiffness was determined by carotid-femoral pulse wave velocity, central pulse pressure by aplanation tonometry, and carotid and radial intima-media thickness and diameter by high definition echotracking device. Left ventricular mass was determined by MRI. A significant decrease in aortic stiffness (-0.56 ± 0.13 m/s/yr, p = 0.0002) was observed after ERT whereas central pulse pressure did not change. Carotid intima-media thickness (IMT) increased (+18 ± 6 µm/yr; p < 0.005) whereas radial IMT remained stable. Radial artery diameter decreased (-50 ± 20 µm/years, p < 0.05) whereas carotid diameter did not change. Carotid circumferential wall stress was reduced (-1.7 ± 0.6 kPa/yrs, p < 0.01). Left ventricular mass index significantly decreased (-7.8 ± 2.3 g/m(2)/yr, p < 0.005). CONCLUSION: A sustained reduction in aortic stiffness and left ventricular hypertrophy, and a limited radial artery wall thickening were observed after long-term enzyme replacement therapy. There was no significant benefit of treatment on carotid hypertrophy.

Cardiovascular events in patients with fabry disease natural history data from the fabry registry.

OBJECTIVES: These analyses were designed to determine the incidence of major cardiovascular (CV) events and the natural history of CV complications in patients with Fabry disease. BACKGROUND: Fabry disease, a genetic disorder caused by deficiency of alpha-galactosidase A activity, is associated with CV dysfunction. METHODS: Major CV events (myocardial infarction, heart failure, or cardiac-related death) were analyzed in 2,869 Fabry Registry patients during the natural history period (i.e., before enzyme replacement therapy or among patients who never received therapy). Multivariate logistic regression analyses were performed to identify significant predictors of CV events. RESULTS: Eighty-three of 1,424 men (5.8%) and 54 of 1,445 women (3.7%) experienced CV events at mean ages of 45 and 54 years, respectively. Heart failure was the most common first CV event, reported by 50 men (3.5%) and 33 women (2.3%). Hypertension and left ventricular hypertrophy were the risk factors most strongly associated with CV events. When these parameters were used as covariates in logistic regression analyses, the odds ratio (OR) for hypertension in men was 7.8 (95% confidence interval [CI]: 2.1 to 28.6, p = 0.0019), and the OR for hypertension in women was 4.5 (95% CI: 1.6 to 12.3, p = 0.0037). The OR for left ventricular hypertrophy was 4.8 in men (95% CI: 1.03 to 22.2, p = 0.0463) and 8.2 in women (95% CI: 2.6 to 26.0, p = 0.0003). CONCLUSIONS: Major CV events occurred in approximately 5% of Fabry Registry patients during the natural history period. All patients with Fabry disease should be monitored for possible CV risk factors, particularly hypertension and left ventricular hypertrophy.

Screening patients with hypertrophic cardiomyopathy for Fabry disease using a filter-paper test: the FOCUS study.

BACKGROUND: Patients with Fabry disease (FD) show left ventricular hypertrophy (LVH) mimicking hypertrophic cardiomyopathy (HCM) of sarcomeric origin and might benefit, if detected early, from specific enzyme replacement therapy. The prevalence of FD in patients with LVH of 13 mm or greater, screened using the leucocyte alpha-galactosidase A (α-gal A) activity test, a technique that is difficult to apply routinely, ranged from 0% to 6%. OBJECTIVE: To screen systematically for FD in patients with a diagnosis of HCM (LVH ≥15 mm) in primary cardiology practice, a validated, physician-friendly α-gal A assay was used on dried blood spots using a filter paper test. DESIGN AND PATIENTS: A cohort of 392 adults (278 men) followed for HCM were screened for FD. A standard blood test was used for confirmation in nine men in whom the α-gal A result was 40% or less. RESULTS: Four men (1.5%; 1.8% of men ≥40 years vs 0% <40 years; all with α-gal A <30%), but no women, were diagnosed with FD. Index cases presented with diffuse but asymmetric LVH, with severe obstruction in one case and frequent high-grade atrioventricular conduction block necessitating a pacemaker in three cases. Family screening identified eight additional cases. Genotyping was performed successfully on DNA extracted from the filter papers. CONCLUSION: In male patients diagnosed as having HCM, pure FD cardiac variants are not exceptional and can be specifically identified using a simple filter-paper test. The sensitivity of this test is low in female patients.

Uneventful pregnancy outcome after enzyme replacement therapy with agalsidase beta in a heterozygous female with Fabry disease: A case report.

No reproductive studies have been performed with enzyme replacement therapy (ERT) for Fabry disease (FD, OMIM 301500), a lysosomal storage disorder. Therefore, use during pregnancy is theoretically contraindicated. We report the first case of agalsidase beta treatment throughout pregnancy. High-range proteinuria remained stable and the patient gave birth to a healthy boy after an uncomplicated pregnancy. The decision to administer ERT during pregnancy should be made on an individual basis, considering the FD status and possible risks.