Piessen G.,Center Hospitalier University |
Muscari F.,Center Hospitalier University |
Rivkine E.,Center Hospitalier Intercommunal |
Lorimier G.,Anticancer Center Papin |
And 4 more authors.
Archives of Surgery | Year: 2011
Hypothesis: Independent risk factors for postoperative morbidity after colectomy are most likely linked to disease characteristics. Design: Retrospective analysis. Setting: Twenty-eight centers of the French Federation for Surgical Research. Patients: In total, 1721 patients (1230 with colon cancer [CC] and 491 with diverticular disease [DD]) from a databank of 7 prospective, multisite, randomized trials on colorectal resection. Intervention: Elective left colectomy via laparotomy. Main Outcome Measures: Preoperative and intraoperative risk factors for postoperative morbidity. Results: Overall postoperative morbidity was higher in CC than in DD (32.4% vs 30.3%) but the difference was not statistically significant (P=.40). Two independent risk factors for morbidity in CC were antecedent heart failure(odds ratio [OR], 3.00; 95% confidence interval [CI], 1.42-6.32) (P=.003) and bothersome intraluminal fecal matter (2.08; 1.42-3.06) (P=.001). Three independent risk factors for morbidity in DD were at least 10% weight loss (OR, 2.06; 95% CI, 1.25-3.40) (P=.004), body mass index (calculated as weight in kilograms divided by height in meters squared) exceeding 30 (2.05; 1.15-3.66) (P=.02), and left hemicolectomy (vs left segmental colectomy) (2.01; 1.19-3.40) (P=.009). Conclusions: Patients undergoing elective left colectomy for CC or for DD constitute 2 distinct populations with completely different risk factors for morbidity, which should be addressed differently. Improving colonic cleanliness (by antiseptic enema) may reduce morbidity in CC. In DD, morbidity may be reduced by appropriate preoperative nutritive support (by immunonutrition), even in patients with obesity, and by preference of left segmental colectomy over left hemicolectomy. By decreasing morbidity, mortality should be lowered as well, especially when reoperation becomes necessary. ©2011 American Medical Association. All rights reserved.
Roubaud-Baudron C.,University of Paris Descartes |
Pagnoux C.,University of Paris Descartes |
Grasland A.,Hopital Louis Mourier |
Le Guen J.,University of Paris Descartes |
And 8 more authors.
Journal of Rheumatology | Year: 2012
Objective. To evaluate the efficacy compared to the relapse risk and tolerance of systematic rituximab (RTX) infusions as maintenance therapy for patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), who entered remission taking conventional immunosuppressants or RTX. Methods. A retrospective study of the main clinical characteristics, outcomes, and RTX tolerance of patients who had received &γε; 2 RTX maintenance infusions in our center, regardless of induction regimen, between 2003 and 2010. Results. We identified 28 patients [4 MPA and 24 GPA; median age 55.5 yrs (range 18-78); 17 (60%) males] who received a median of 4 (range 2-10) RTX maintenance infusions, with median followup of 38 months (range 21-97) since diagnosis or last flare. None experienced a RTX infusion-related adverse event; 15 patients (among the 21 with available data) had hypogammaglobulinemia (predominantly IgM) prior to their last RTX maintenance infusion; 3 had infectious events (1 cutaneous abscess, 1 otitis, 1 fatal H1N1 flu). Two patients suffered pulmonary relapses shortly before a planned RTX maintenance infusion (both had increased antineutrophil cytoplasmic antibody levels and 1 had CD19+ lymphocyte reconstitution). Conclusion. Rituximab maintenance therapy was well tolerated but did not completely prevent relapses and persistent "grumbling" disease. These preliminary results remain to be confirmed by a randomized controlled trial currently in progress. The Journal of Rheumatology Copyright © 2012. All rights reserved.
Sibiude J.,Hopital Louis Mourier |
Sibiude J.,French Institute of Health and Medical Research |
Mandelbrot L.,Hopital Louis Mourier |
Mandelbrot L.,French Institute of Health and Medical Research |
And 16 more authors.
PLoS Medicine | Year: 2014
Background:Antiretroviral therapy (ART) has major benefits during pregnancy, both for maternal health and to prevent mother-to-child transmission of HIV. Safety issues, including teratogenic risk, need to be evaluated. We estimated the prevalence of birth defects in children born to HIV-infected women receiving ART during pregnancy, and assessed the independent association of birth defects with each antiretroviral (ARV) drug used.Methods and Findings:The French Perinatal Cohort prospectively enrolls HIV-infected women delivering in 90 centers throughout France. Children are followed by pediatricians until 2 y of age according to national guidelines.We included 13,124 live births between 1994 and 2010, among which, 42% (n = 5,388) were exposed to ART in the first trimester of pregnancy. Birth defects were studied using both European Surveillance of Congenital Anomalies (EUROCAT) and Metropolitan Atlanta Congenital Defects Program (MACDP) classifications; associations with ART were evaluated using univariate and multivariate logistic regressions. Correction for multiple comparisons was not performed because the analyses were based on hypotheses emanating from previous findings in the literature and the robustness of the findings of the current study. The prevalence of birth defects was 4.4% (95% CI 4.0%-4.7%), according to the EUROCAT classification. In multivariate analysis adjusting for other ARV drugs, maternal age, geographical origin, intravenous drug use, and type of maternity center, a significant association was found between exposure to zidovudine in the first trimester and congenital heart defects: 2.3% (74/3,267), adjusted odds ratio (AOR) = 2.2 (95% CI 1.3-3.7), p = 0.003, absolute risk difference attributed to zidovudine +1.2% (95% CI +0.5; +1.9%). Didanosine and indinavir were associated with head and neck defects, respectively: 0.5%, AOR = 3.4 (95% CI 1.1-10.4), p = 0.04; 0.9%, AOR = 3.8 (95% CI 1.1-13.8), p = 0.04. We found a significant association between efavirenz and neurological defects (n = 4) using the MACDP classification: AOR = 3.0 (95% CI 1.1-8.5), p = 0.04, absolute risk +0.7% (95% CI +0.07%; +1.3%). But the association was not significant using the less inclusive EUROCAT classification: AOR = 2.1 (95% CI 0.7-5.9), p = 0.16. No association was found between birth defects and lopinavir or ritonavir with a power >85% for an odds ratio of 1.5, nor for nevirapine, tenofovir, stavudine, or abacavir with a power >70%. Limitations of the present study were the absence of data on termination of pregnancy, stillbirths, tobacco and alcohol intake, and concomitant medication.Conclusions:We found a specific association between in utero exposure to zidovudine and heart defects; the mechanisms need to be elucidated. The association between efavirenz and neurological defects must be interpreted with caution. For the other drugs not associated with birth defects, the results were reassuring. Finally, whatever the impact that some ARV drugs may have on birth defects, it is surpassed by the major role of ART in the successful prevention of mother-to-child transmission of HIV.Please see later in the article for the Editors' Summary. © 2014 Sibiude et al.
Cosnes J.,University Pierre and Marie Curie |
Bourrier A.,University Pierre and Marie Curie |
Laharie D.,Hopital Haut Leveque |
Nahon S.,Groupe Hospitalier Intercommunal le Raincy Montfermeil |
And 11 more authors.
Gastroenterology | Year: 2013
Background & Aims Immunomodulator therapy is effective for patients with Crohn's disease (CD) but has not been shown to affect disease progression, presumably because it is given too late after diagnosis. We compared the efficacy of early treatment (within 6 months after diagnosis) with azathioprine versus conventional management of patients at high risk for disabling disease. Methods We performed an open-label trial of adults with a diagnosis of CD for less than 6 months who were at risk for disabling disease. From July 2005 to November 2010, patients at 24 French centers were randomly assigned to treatment with azathioprine (2.5 mg â̂™ kg-1 â̂™ day-1, n = 65) or conventional management (azathioprine only in cases of corticosteroid dependency, chronic active disease with frequent flares, poor response to corticosteroids, or development of severe perianal disease) (n = 67). The primary end point was the proportion of trimesters spent in corticosteroid-free and anti-tumor necrosis factor (TNF) - free remission during the first 3 years after inclusion. Results During the 3-year follow-up period, 16 patients in the azathioprine group were switched to mercaptopurine or methotrexate therapy because of intolerance or poor efficacy. Forty-one patients in the conventional management group required immunosuppressant therapy (61%; median time to first prescription, 11 months). In the azathioprine group, a median 67% of trimesters were spent in remission (interquartile range, 11%-85%) compared with 56% in the conventional management group (interquartile range, 29%-73%) (P =.69). Among secondary outcomes, a higher cumulative proportion of patients in the azathioprine group were free of perianal surgery than in the conventional management group (96% ± 3% and 82% ± 6% at month 36, respectively; P =.036). The cumulative proportion of patients free of intestinal surgery and anti-TNF therapy did not differ between groups. Conclusions Based on results from a clinical trial, administration of azathioprine within 6 months of diagnosis of CD was no more effective than conventional management in increasing time of clinical remission. Clinicaltrials.gov, Number NCT00546546. © 2013 by the AGA Institute.
Brousse V.,Reference Center for Sickle Cell Disease |
Elie C.,Hopital Necker |
Elie C.,University of Paris Descartes |
Benkerrou M.,Reference Center for Sickle Cell Disease |
And 9 more authors.
British Journal of Haematology | Year: 2012
Acute splenic sequestration crisis (ASSC) is an unpredictable life-threatening complication of sickle cell disease (SCD) in infants. Here, our objective was to update available clinical information on ASSC. We retrospectively studied the 190 patients who were diagnosed at birth with SS or Sbeta 0 in the Paris conurbation between 2000 and 2009 and who experienced ASSC. They had 437 ASSC episodes (0·06/patient-year). Median age at the first episode was 1·4years (0·1-7) and 67% of patients had more than one episode. Age was the only factor predicting recurrence: the risk was lower when the first episode occurred after 2years versus before 1year of age (hazard ratio, 0·60; 95% confidence interval, 0·41-0·88; P=0·025). A concomitant clinical event was found in 57% of episodes. The mortality rate was 0·53%. The treatment consisted in watchful waiting without prophylactic blood transfusions or splenectomy in 103 (54%) patients and in a blood transfusion programme in 55 (29%) patients. Overall, splenectomy was performed in 71 (37%) patients, at a median age of 4·5years (range, 1·9-9·4). In conclusion, aggressive treatment may be warranted in patients experiencing ASSC before 2years of age. Randomized controlled trials are needed to define the best treatment modalities. © 2012 Blackwell Publishing Ltd.
Sibiude J.,Hopital Louis Mourier |
Sibiude J.,University Paris - Sud |
Warszawski J.,University Paris - Sud |
Blanche S.,University of Paris Descartes
Expert Opinion on Drug Safety | Year: 2015
Introduction: The prevention of mother-to-child HIV-1 transmission by antiretroviral drug treatment is remarkably effective. The risk of transmission to the child is now almost zero for women optimally treated during pregnancy. The rapid expansion of this prophylactic treatment has led the World Health Organization to aspire to the virtual elimination of mother-to-child transmission and pediatric AIDS over the next few years. In 2014, more than 900,000 women worldwide were treated with antiretroviral drugs during pregnancy. The issue of fetal and neonatal antiretroviral drug tolerance is therefore extremely important.Areas covered: This review focuses on the possible impact of in utero exposure to antiretroviral drug on newborn health. To restrict analysis to this period is justified by the specificities of transplacental drug exposure and fetal vulnerability. Relevant data are available from trials and observational cohorts. The significance of various bio-markers detectable at birth is still unresolved, but merits a careful evaluation. Long-term assessment is associated with various logistical difficulties.Expert opinion: The health of 'exposed but not infected' children poses no major problem in the immense majority of cases, but a series of biological, clinical and imaging-based warning signs have emerged indicating the need for careful attention to be paid to this issue. Some effects that are straightforward to manage in industrialized countries may have more severe consequences in countries in which access to effective healthcare is limited. Nucleoside/nucleotide analogs are potentially genotoxic to mitochondrial and nuclear DNA, and the principal question to be addressed concerns their potential long-term effects. © 2015 Informa UK, Ltd.
PubMed | hopital Bichat, hopital Beaujon, Paris Observatory and hopital Louis Mourier
Type: Journal Article | Journal: Journal de gynecologie, obstetrique et biologie de la reproduction | Year: 2016
To study inter-observer variability of decision concerning the route of delivery using pelvimetry in case of one previous cesarean section and abnormal pelvic measures.Observational study conducted in 2014 in 4 university maternity units among 36 obstetricians. Two groups of obstetricians-as they practiced in a center where pelvimetry was routinely performed (n=12) or not (n=24)-had to choose a route of delivery for 10 clinical cases of women with a single uterine scar and a tight pelvis. The routine pelvimetry group had pelvimetry results. The group no pelvimetry became aware of pelvimetry results as a second step and had to indicate whether this information changed or not their management. The measurement of the inter-observer variability was estimated by estimating the proportion of agreement according to Grant method.The proportion of agreements of an attempted vaginal delivery between obstetricians in the group routine pelvimetry was 64.7% (95%CI [61-68.5]) and 97.3% (95%CI [96.4 to 98.3]) in the group no pelvimetry, prior knowledge of pelvimetry results. An attempted vaginal delivery was decided in 77.5% versus 98.7% (P<0.001). After knowledge of pelvimetry results in the group no pelvimetry had, the number of attempted vaginal deliver was not different (77.5% vs. 78%, P=0.920).In women with one previous cesarean section, in case of tight pelvis discovered after pelvimetry, inter-observer variability of decision concerning the route of delivery is increased. Centers that choose to continue using the routine pelvimetry should develop procedures to limit this variability.
Miguel-Montanes R.,Medico Surgical Intensive Care Unit |
Hajage D.,Hopital Louis Mourier |
Messika J.,Medico Surgical Intensive Care Unit |
Messika J.,French Institute of Health and Medical Research |
And 18 more authors.
Critical Care Medicine | Year: 2015
Objectives: Tracheal intubation of ICU patients is frequently associated with severe hypoxemia. Although noninvasive ventilation reduces desaturation during intubation of severely hypoxemic patients, it does not allow for per-procedure oxygenation and has not been evaluated in mild-to-moderate hypoxemic patients for whom high-flow nasal cannula oxygen may be an alternative. We sought to compare pre- and per-procedure oxygenation with either a nonrebreathing bag reservoir facemask or a high-flow nasal cannula oxygen during tracheal intubation of ICU patients. Design: Prospective quasi-experimental before-after study (ClinicalTrials. gov: NCT01699880). Setting: University hospital medico-surgical ICU. Patients: All adult patients requiring tracheal intubation in the ICU were eligible. Interventions: In the control (before) period, preoxygenation was performed with a nonrebreathing bag reservoir facemask and in the change of practice (after) period, with high-flow nasal cannula oxygen. Measurements and Main Results: Primary outcome was median lowest Spo2 during intubation, and secondary outcomes were Spo2 after preoxygenation and number of patients with saturation less than 80%. One hundred one patients were included. Median lowest Spo2 during intubation were 94% (83-98.5) with the non-rebreathing bag reservoir facemask versus 100% (95-100) with high-flow nasal cannula oxygen (p < 0.0001). Spo2 values at the end of preoxygenation were higher with high-flow nasal cannula oxygen than with nonrebreathing bag reservoir facemask and were correlated with the lowest Spo2 reached during the intubation procedure (r = 0.38, p < 0.0001). Patients in the nonrebreathing bag reservoir facemask group experienced more episodes of severe hypoxemia (2% vs 14%, p = 0.03). In the multivariate analysis, preoxygenation with high-flow nasal cannula oxygen was an independent protective factor of the occurrence of severe hypoxemia (odds ratio, 0.146; 95% CI, 0.01-0.90; p = 0.037). Conclusions: High-flow nasal cannula oxygen significantly improved preoxygenation and reduced prevalence of severe hypoxemia compared with nonrebreathing bag reservoir facemask. Its use could improve patient safety during intubation. Copyright © 2015 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Messika J.,Hopital Louis Mourier |
Messika J.,French Institute of Health and Medical Research |
Messika J.,University Paris Diderot |
Ahmed K.B.,Hopital Louis Mourier |
And 12 more authors.
Respiratory Care | Year: 2015
BACKGROUND: Beneficial effects of high-flow nasal cannula (HFNC) oxygen on oxygenation and respiratory parameters have been reported in a small number of subjects with acute respiratory failure (ARF). We aimed to evaluate its effect in subjects with ARDS. METHODS: This was an observational single-center study. Prospectively obtained data were retrospectively analyzed. All patients admitted over 1 y to a university hospital medicosurgical ICU were included. Classification was according to the highest ventilatory support required. HFNC indications were reviewed, and demographics, clinical characteristics, and course of subjects with ARDS according to intubation need were compared. RESULTS: Of 607 subjects admitted, 560 required ventilatory or oxygen support, among whom 180 received noninvasive ventilatory support. HFNC was used in 87 subjects and as first-line treatment in 51 subjects (29% of first-line noninvasively treated subjects), 45 of which had ARDS (PaO2/FIO2 of 137 mm Hg; 22 men, 57.9 y of age). Pneumonia accounted for 82% of ARDS causes. The intubation rate in these subjects was 40%. Higher Simplified Acute Physiology Score II (SAPS II; 46 vs 29, P = .001), occurrence of additional organ failure (76% vs 26%, P = .002), mainly hemodynamic (50% vs 7%, P = .001) or neurological (22% vs 0, P = .01), and trends toward lower PaO2/FIO2 and higher breathing frequency after HFNC initiation were evidenced in subjects who failed HFNC. Higher SAPS II scores were associated with HFNC failure in multivariate analysis. CONCLUSIONS: In daily care, over one fourth of subjects requiring noninvasive ventilatory support were treated via HFNC, with a high success rate in subjects with severe ARDS. We conclude that HFNC may be considered as first-line therapy in ARF, including patients with ARDS. © 2015 by Daedalus Enterprises.
PubMed | Service de Reanimation Medico Chirurgicale, Groupe Hospitalier Des Hopitaux Universitaires Of Lest Parisien and Hopital Louis Mourier
Type: Journal Article | Journal: Annals of intensive care | Year: 2016
To evaluate the diagnostic performances of two training programs for residents with no prior ultrasound experience to reach competences in extended basic critical care transthoracic echocardiography (CCE) including Doppler capabilities.This is a prospective observational study in two intensive care units of teaching hospitals. Group I (five residents) completed a short training program (4-h theory; 3-h practical); group II (six residents) completed a longer training program (6-h theory; 12-h practical). The residents and an expert examined all patients who required a transthoracic echocardiography. Their agreement studied by Cohens coefficient, concordance coefficient correlation (CCC) and Bland-Altman plots was used as an indicator of program effectiveness.Group I performed 136 CCEs (mean/resident 27; range 22-32; 65 in ventilated patients) in 115 patients (62 men; 6418years; Simplified Acute Physiologic Score [SAPS] II 3718). Group II performed 158 CCEs (mean/resident 26; range 21-31; 65 in ventilated patients) in 108 patients (64men; 5817 years; SAPS II 4222). Both groups adequately assessed left ventricular (LV) systolic function ( 0.75, 95% confidence interval [CI] 0.64-0.86; 0.77, 95% CI 0.66-0.88, respectively) and pericardial effusion ( 0.83, 95% CI 0.67-0.99; 0.76, 95% CI 0.60-0.93, respectively). Group II appraised severe right ventricular dilatation and significant left-sided valve disease with good to very good agreement ( 0.80, 95% CI 0.56-0.96; 0.79, 95% CI 0.66-0.93, respectively). Regarding left ventricular ejection fraction, E/A ratio, E/e ratio and aortic peak velocity assessed by group II, CCCs were all >0.70 and the bias (mean difference) SD on Bland-Altman analysis was 1.38.8%, 00.3, 0.42.2 and 0.10.4m/s, respectively. Detection of paradoxical septum ( 0.65, 95% CI 0.37-0.93), of heterogeneous LV contraction ( 0.49, 95% CI 0.33-0.65) and of respiratory variation of the inferior vena cava ( 0.27, 95% CI 0.09-0.45), as well as stroke volume measurement (CCC 0.65, 95% CI 0.54-0.74; biasSD -1.44.7cm), was appraised by group II with moderate agreement requiring probably more comprehensive training.Although a training program blending 6-h theory and 12-h practical may be adapted to achieve some essential competences, it seems to be insufficiently to perform a complete extended basic critical care transthoracic echocardiography including Doppler capabilities.