Publications by authors named "Anaïs Charles-Nelson"

33 Publications

Rivaroxaban versus Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial.

Chest 2021 Oct 7. Epub 2021 Oct 7.

F-CRIN INNOVTE network, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, CHU de St-Etienne, Saint-Etienne, France.

Background: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated venous thromboembolism (VTE).

Research Question: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?

Study Design And Methods: In a randomized open-label non-inferiority trial, patients with active cancer who had proximal deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) were randomly assigned to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months.

Results: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 6.4% vs 10.1%, subdistribution hazard ratio [SHR] 0.75, 95% confidence interval [CI] 0.21-2.66, in both the intention-to-treat and per-protocol populations). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 1.4% vs 3.7%, SHR 0.36, 95%CI 0.04-3.43). Major or clinically relevant non-major bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 12.2% vs 9.8%, SHR 1.27, 95%CI 0.49-3.26). Overall, 19 (25.7%) and 20 (23.8%) patients died in the rivaroxaban and dalteparin groups, respectively (HR 1.05, 95% CI, 0.56-1.97).

Interpretation: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for non-inferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.

Trial Registration: NCT02746185.
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http://dx.doi.org/10.1016/j.chest.2021.09.037DOI Listing
October 2021

Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial.

Thromb Haemost 2021 Sep 24. Epub 2021 Sep 24.

AP-HP, hôpital européen Georges-Pompidou, Service de Pneumologie et de Soins Intensifs, APHP.Centre - Université de Paris, Paris, France.

Intermediate-high-risk pulmonary embolism (PE) is characterized by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent hemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of hemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International THrOmbolysis (PEITHO)-3 study (ClinicalTrials.gov Identifier: NCT04430569) is a randomized, placebo-controlled, double-blind, multicenter, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate-high-risk PE will also fulfill at least one clinical criterion of severity: systolic blood pressure ≤110 mm Hg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, hemodynamic decompensation, or PE recurrence within 30 days of randomization. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, hemodynamic decompensation, or stroke within 30 days; dyspnea, functional limitation, or RV dysfunction at 6 months and 2 years; and utilization of health care resources within 30 days and 2 years. The study is planned to enroll 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.
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http://dx.doi.org/10.1055/a-1653-4699DOI Listing
September 2021

Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial.

Circ Cardiovasc Interv 2021 11 23;14(11):e011314. Epub 2021 Aug 23.

Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, France (P.D., N.D., E.P.).

Background: In patients with ST-segment-elevation myocardial infarction and multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions guided by fractional flow reserve (FFR) is superior to treatment of the culprit lesion alone. Whether deferring nonculprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at 1 year in ST-segment-elevation myocardial infarction patients with multivessel coronary artery disease and an FFR-guided strategy for nonculprit lesions, according to whether or not ≥1 PCI was performed.

Methods: Outcomes were analyzed in patients of the randomized FLOWER-MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, nonculprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, nonfatal myocardial infarction, and unplanned hospitalization with urgent revascularization at 1 year.

Results: Among 1171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI, and 198 (34%) had no PCI. Mean FFR before decision (ie, PCI or not) of nonculprit lesions was 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42 [95% CI, 0.20-0.88]; =0.02).

Conclusions: In patients with ST-segment-elevation myocardial infarction undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm these data. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02943954. Graphic Abstract: A graphic abstract is available for this article.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.011314DOI Listing
November 2021

Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A Multicenter Prospective Study.

J Vasc Interv Radiol 2021 Aug 5;32(8):1136-1143. Epub 2021 Jun 5.

Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, ImViA Laboratory-EA 7535, François-Mitterrand University Hospital, Dijon, France.

Purpose: To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization.

Materials And Methods: This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months).

Results: The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items.

Conclusions: EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.
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http://dx.doi.org/10.1016/j.jvir.2021.05.014DOI Listing
August 2021

Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction.

N Engl J Med 2021 07 16;385(4):297-308. Epub 2021 May 16.

From Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Université de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique, Sorbonne Université, INSERM Unité 698 (T.S.), Université de Paris, INSERM Unité 1148, and Hôpital Bichat, AP-HP (P.G.S.), Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (G.M., J.S.), Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP (I.D.-Z., A.B.), the Department of Cardiology, Hôpital Lariboisière, AP-HP, INSERM Unité 942, Université de Paris (J.-G.D.), the Department of Cardiology, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Laboratory for Vascular Translational Science, Université de Paris (G.D.), the Clinical Research Unit and Centre d'Investigation Clinique 1418 INSERM, George Pompidou European Hospital, AP-HP (A.C.N., G. Chatellier), and the French Alliance for Cardiovascular Trials (E.P., T.S., P.G.S., G.L., D.B., G.D., N.D.), Paris, Centre Hospitalier Universitaire (CHU) de Nîmes, Nîmes (G. Cayla), Service de Cardiologie, AP-HP, Université de Paris Est Créteil, Hôpitaux Universitaires Henri Mondor, Créteil, and Unité 955-Mondor Institute for Biomedical Research, Equipe 03, INSERM, Ecole Nationale Vétérinaire d'Alfort, Maisons-Alfort (R.G.), Hôpital du Bon Secours, Metz (K.K.), Clinique St. Martin (J.-F.M.) and the Cardiology Department, Caen University Hospital (V.R.), Caen, the Department of Cardiology, CHU Clermont-Ferrand, CNRS UMR 6602, Université Clermont Auvergne, Clermont-Ferrand, the Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille (P.M.), and the Heart and Lung Institute, University Hospital of Lille, Institut Pasteur of Lille, INSERM Unité 1011 (G.L.), Lille, and the Intensive Cardiac Care Unit, Department of Cardiology, Rangueil University Hospital, and the Medical School, Toulouse III Paul Sabatier University, Toulouse (T.L.), Groupement de Coopération Saintaire de Cardiologie de la Côte Basque, Centre Hospitalier de la Côte Basque, Bayonne (J.-N.L.), the Cardiology Department, Hôpitaux de Chartres, Chartres (G.R.), and Physiopathologie et Epidémiologie Cérébro-Cardiovasculaires, Equipe d'Accueil (EA 7460), University of Bourgogne Franche-Comté, and the Cardiology Department, University Hospital Center of Dijon Bourgogne, Dijon (Y.C.) - all in France; Cardiovascular Center Aalst, Aalst, Belgium (B.D.B.); and the Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.).

Background: In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear.

Methods: In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year.

Results: The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively.

Conclusions: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).
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http://dx.doi.org/10.1056/NEJMoa2104650DOI Listing
July 2021

Relevance of treatment-free remission recommendations in chronic phase chronic leukemia patients treated with frontline tyrosine kinase inhibitors.

Cancer Med 2021 06 14;10(11):3635-3645. Epub 2021 May 14.

Groupe France Intergroupe des Leucémies Myéloïdes Chroniques, Hôpital Haut-Lévêque, Pessac, France.

Background: Tyrosine kinase inhibitors (TKI) can be safely discontinued in chronic phase chronic myeloid leukemia (CP-CML) patients who had achieved a sustained deep molecular response. Based on the results of discontinuation trials, recommendations regarding patient selection for a treatment-free remission (TFR) attempt had been proposed. The aims of this study were to evaluate the rate of patients eligible for TKI discontinuation and molecular recurrence-free survival (MRFS) after stop according to recommendations.

Methods: Over a 10-year period, newly diagnosed CP-CML patients and treated with first-line TKI in the nine French participating centers were included. Eligibility to treatment discontinuation and MRFS were analyzed and compared according to selection criteria defined by recommendations and first-line treatments.

Results: From January 2006 to December 2015, 398 patients were considered. Among them, 73% and 27% of patients received imatinib or either second or third generation tyrosine kinase inhibitors as frontline treatment, respectively. Considering the selection criteria defined by recommendations, up to 55% of the patients were selected as optimal candidates for treatment discontinuation. Overall 95/398 (24%) discontinued treatment. MRFS was 51.8% [95% CI 41.41-62.19] at 2 years and 43.8% [31.45-56.15] at 5 years. Patients receiving frontline second-generation TKI and fulfilling the eligibility criteria suggested by recommendations had the lowest probability of molecular relapse after TKI stop when compare to others.

Conclusion: One third of CP-CML patients treated with TKI frontline fulfilled the selection criteria suggested by European LeukemiaNet TFR recommendations. Meeting selection criteria and second-generation TKI frontline were associated with the highest MRFS.
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http://dx.doi.org/10.1002/cam4.3921DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178499PMC
June 2021

Patent foramen ovale closure in stroke patients with migraine in the CLOSE trial. The CLOSE-MIG study.

Eur J Neurol 2021 08 16;28(8):2700-2707. Epub 2021 Jun 16.

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Centre d'Investigations Cliniques 1418 (CIC1418), Paris, France.

Background And Purpose: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial.

Methods: This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists.

Results: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up.

Conclusions: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.
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http://dx.doi.org/10.1111/ene.14892DOI Listing
August 2021

Risks of ventilator-associated pneumonia and invasive pulmonary aspergillosis in patients with viral acute respiratory distress syndrome related or not to Coronavirus 19 disease.

Crit Care 2020 12 18;24(1):699. Epub 2020 Dec 18.

AP-HP (Assistance Publique-Hôpitaux de Paris), Hôpitaux universitaires Henri Mondor, DMU Médecine, Service de Médecine Intensive Réanimation, 94010, Créteil, France.

Background: Data on incidence of ventilator-associated pneumonia (VAP) and invasive pulmonary aspergillosis in patients with severe SARS-CoV-2 infection are limited.

Methods: We conducted a monocenter retrospective study comparing the incidence of VAP and invasive aspergillosis between patients with COVID-19-related acute respiratory distress syndrome (C-ARDS) and those with non-SARS-CoV-2 viral ARDS (NC-ARDS).

Results: We assessed 90 C-ARDS and 82 NC-ARDS patients, who were mechanically ventilated for more than 48 h. At ICU admission, there were significantly fewer bacterial coinfections documented in C-ARDS than in NC-ARDS: 14 (16%) vs 38 (48%), p < 0.01. Conversely, significantly more patients developed at least one VAP episode in C-ARDS as compared with NC-ARDS: 58 (64%) vs. 36 (44%), p = 0.007. The probability of VAP was significantly higher in C-ARDS after adjusting on death and ventilator weaning [sub-hazard ratio = 1.72 (1.14-2.52), p < 0.01]. The incidence of multi-drug-resistant bacteria (MDR)-related VAP was significantly higher in C-ARDS than in NC-ARDS: 21 (23%) vs. 9 (11%), p = 0.03. Carbapenem was more used in C-ARDS than in NC-ARDS: 48 (53%), vs 21 (26%), p < 0.01. According to AspICU algorithm, there were fewer cases of putative aspergillosis in C-ARDS than in NC-ARDS [2 (2%) vs. 12 (15%), p = 0.003], but there was no difference in Aspergillus colonization.

Conclusions: In our experience, we evidenced a higher incidence of VAP and MDR-VAP in C-ARDS than in NC-ARDS and a lower risk for invasive aspergillosis in the former group.
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http://dx.doi.org/10.1186/s13054-020-03417-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747772PMC
December 2020

Analysis of Trajectories of Care After Bariatric Surgery Using Data Mining Method and Health Administrative Information Systems.

Obes Surg 2020 Jun;30(6):2206-2216

INSERM, UMRS 1138, Centre de Recherche des Cordeliers, Paris, France.

Context: The 30-day readmission rate after bariatric surgery is considered an important metric of the quality of hospital care. However, readmission rate beyond 30 days is rarely reported and does not provide any information about trajectories of care which would be of great interest for healthcare planning. The aim of this study was to analyze trajectories of care during the first year after bariatric surgery on a nationwide basis using data mining methods.

Method: This was a retrospective descriptive study on the trajectories of care within the first year after bariatric surgery. Data were extracted from a national administrative claims database (the PMSI database) and trajectories were defined as principal diagnosis of successive readmissions. Formal Concept Analysis was performed to find common concepts of trajectories of care.

Results: We included for analysis 198,389 bariatric procedures performed on 196,323 patients. Twelve main concepts were selected. About one third of patients (32.4%) were readmitted in the first year after surgery. Most common trajectories were as follows: regular follow-up (14.9%), cholelithiasis (2.2%), abdominal pain (1.9%), and abdominal sepsis (1.3%). Important differences were found in trajectories among different bariatric procedures: 1.8% of gastric banding patients had pregnancy-related events (delivery or medical abortion), while we observed a readmission rate for abdominal sepsis in 2.7% and 5.1% of patients operated of gastric bypass and sleeve gastrectomy respectively.

Conclusion: Administrative claim data can be analyzed through Formal Concept Analysis in order to classify trajectories of care. This approach permits to quantify expected postoperative complications and to identify unexpected events.
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http://dx.doi.org/10.1007/s11695-020-04430-6DOI Listing
June 2020

How to analyze and interpret recurrent events data in the presence of a terminal event: An application on readmission after colorectal cancer surgery.

Stat Med 2019 08 23;38(18):3476-3502. Epub 2019 Apr 23.

Sorbonne Universités, UPMC Univ Paris 06, UMRS 1138, Centre de Recherche des Cordeliers, Paris, France.

Recurrent events arise when an event occurs many times for a subject. Many models have been developed to analyze these kind of data: the Andersen-Gill's model is one of them as well as the Prentice-William and the Peterson's model, the Wei Lee and Weissfeld's model, or even frailty models, all assuming an independent and noninformative censoring. However, in practice, these assumptions may be violated by the existence of a terminal event that permanently stops the recurrent process (eg, death). Indeed, a patient who experiences an early terminal event is more likely to have a lower number of recurrent events than a patient who experiences a terminal event later. Thus, ignoring terminal events in the analysis may lead to biased results. Many methods have been developed to handle terminal events. In this paper, we describe the existing methods classifying into conditional or marginal methods and compare them in a simulation study to highlight bias in results if an inappropriate method is used, when recurrent events and terminal event are correlated. In addition, we apply the different models on a real dataset to show how results should be interpreted. Finally, we provide recommendations for choosing the appropriate method for analyzing recurrent events in the presence of a terminal event.
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http://dx.doi.org/10.1002/sim.8168DOI Listing
August 2019

Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial.

Eur Respir J 2018 10 4;52(4). Epub 2018 Oct 4.

Hôpital privé Arras les Bonettes, Arras, France.

The anti-tumour and anti-metastatic properties of heparins have not been tested in patients with early stage cancer. Whether adjuvant low molecular weight heparin (LMWH) tinzaparin impacts the survival of patients with resected non-small cell lung cancer (NSCLC) was investigated.Patients with completely resected stage I, II or IIIA NSCLC were randomly allocated to receive subcutaneous tinzaparin 100 IU·kg once a day for 12 weeks or no treatment in addition to standard of care. The trial was open-label with blinded central adjudication of study outcomes. The primary outcome was overall survival.In 549 patients randomised to tinzaparin (n=269) or control (n=280), mean±sd age was 61.6±8.9 years, 190 (34.6%) patients had stage II-III disease, and 220 (40.1%) patients received adjuvant chemotherapy. Median follow-up was 5.7 years. There was no significant difference in overall survival between groups (hazard ratio (HR) 1.24, 95% CI 0.92-1.68; p=0.17). There was no difference in the cumulative incidence of recurrence between groups (subdistribution HR 0.94, 95% CI 0.68-1.30; p=0.70).Adjuvant tinzaparin had no detectable impact on overall and recurrence-free survival of patients with completely resected stage I-IIIA NSCLC. These results do not support further clinical evaluation of LMWHs as anti-tumour agents.
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http://dx.doi.org/10.1183/13993003.01220-2018DOI Listing
October 2018

Is ventilatory therapy combined with exercise training effective in patients with heart failure and sleep-disordered breathing? Results of a randomized trial during a cardiac rehabilitation programme (SATELIT-HF).

Arch Cardiovasc Dis 2018 Oct 2;111(10):573-581. Epub 2018 May 2.

Pneumology Department, centre hospitalier Bligny, 91640 Briis-sous-Forge, France.

Background: Sleep-related disordered breathing is common in patients with chronic heart failure.

Aim: To assess the efficacy of short-term nocturnal ventilatory therapy combined with exercise training (V+ET) compared with exercise training alone (ET) in patients with chronic heart failure with sleep-disordered breathing.

Methods: Patients in New York Heart Association functional class II-IIIb, with an apnoea-hypopnoea index (AHI)>15/h, and enrolled in a cardiac rehabilitation programme, were centrally randomized to V+ET or ET. Subjects were classified as having obstructive sleep apnoea (OSA) (n=49) or central sleep apnoea (CSA)/mixed (n=69). The primary outcome was the change in the 10-second average oxygen consumption at maximum exercise (VO) at the end of the cardiac rehabilitation programme.

Results: Fifty-eight patients were randomized to V+ET and 60 patients to ET. The median increase in VO was 15% [interquartile range 6-36%] in the V+ET group and 16% [0-31%] in the ET group (P=0.34). AHI decreased in both groups, but significantly more in the V+ET group (P=0.006). The decrease in the ventilatory efficiency (VE/VCO) slope was not statistically different between the two-randomization groups (P=0.10). In subjects with CSA, the VE/VCO slope decreased significantly more in the V+ET group (P=0.03), while there was no difference between the two-randomization groups in subjects with OSA (P=0.75). Six cardiovascular events occurred in patients with OSA (all randomized to the ET group); in subjects with CSA, two events occurred in the V+ET group and three in the ET group.

Conclusions: Short-term nocturnal ventilation combined with exercise training does not increase the exercise capacity of patients with chronic heart failure.
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http://dx.doi.org/10.1016/j.acvd.2018.03.005DOI Listing
October 2018

Correction to: Differentiating focal nodular hyperplasia from hepatocellular adenoma: Is hepatobiliary phase MRI (HBP-MRI) using linear gadolinium chelates always useful?

Abdom Radiol (NY) 2018 08;43(8):2212

Groupe Henri Mondor Albert Chenevier, Imagerie Medicale, AP-HP, 94010, Creteil, France.

The original version of this article unfortunately contained a mistake. There was an error in the last sentence of the summary and the last sentence of the discussion. It should read as "On HBP, all FNH appeared hyper- or iso-intense compared to adjacent liver while close to 97% of HCA appeared hypointense".
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http://dx.doi.org/10.1007/s00261-017-1423-xDOI Listing
August 2018

Differentiating focal nodular hyperplasia from hepatocellular adenoma: Is hepatobiliary phase MRI (HBP-MRI) using linear gadolinium chelates always useful?

Abdom Radiol (NY) 2018 07;43(7):1670-1681

Groupe Henri Mondor Albert Chenevier, Imagerie Medicale, AP-HP, 94010, Creteil, France.

Purpose: To assess the value of Hepatobiliary phase MRI (HPB-MRI) to differentiate FNH and HCA, and evaluate its impact on diagnostic accuracy, diagnostic confidence, inter-observer variability, and patient clinical management.

Methods: Forty-nine patients referred for Gd-BOPTA-enhanced MRI were retrospectively included in this IRB-approved study, with a total of 119 lesions-90 FNH and 29 HCA. Two observers separately assessed in 2 distinct randomized reading sessions the performance of MRI with (HBP-MRI) or without (conventional MRI) the use of HBP images. Each lesion was ranked with a 5-point scale (from 1 Typical FNH to 5 Certainly not a FNH). Sensitivity, specificity, overall accuracy, and inter-observer agreement for the differentiation of FNH from HCA were calculated and compared between conventional and HBP-MRI.

Results: Both sensitivity (respective values of 38.9% and 97.8%), overall accuracy (respective values of 53.8% and 98.3%), and inter-observer agreement (respective values of Kappa 0.56 and 0.88) were significantly higher using HBP-MRI than with conventional MRI, with unchanged specificity (100%). The sensitivity of conventional MRI for the diagnosis of FNH was significantly lower in lesions ≤ 3 cm (20% vs. 88%). Overall, HBP could have changed lesion management in 59/119 cases (49.5%), including 53 FNH and 6 HCA with no impact in 60/119 lesions (50.5%) including all 35 lesions classified as scores 1 and 2 for the diagnosis of FNH.

Conclusions: The clinical impact of HBP-MRI is mostly important for smaller than 3-cm FNH, and more limited in larger FNH lesions as well as for HCA diagnosis for which conventional MRI is already accurate. The use of extracellular contrast agents upfront could limit the required use of linear HBP contrast agents for benign hepatocellular lesion characterization. On HBP, all FNH appeared hypointense compared to adjacent liver while close to 97% of HCA appeared hypointense.
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http://dx.doi.org/10.1007/s00261-017-1377-zDOI Listing
July 2018

Cognitive dysfunction associated with aluminum hydroxide-induced macrophagic myofasciitis: A reappraisal of neuropsychological profile.

J Inorg Biochem 2018 04 6;181:132-138. Epub 2017 Oct 6.

INSERM/UPEC U955 Team 10 'Biology of Neuromuscular System', Faculty of Médecine, 94000 Créteil, France; Expert Center for Neuromuscular Diseases, Department of Pathology, Henri Mondor University Hospital, 94000 Créteil, France. Electronic address:

Patients with macrophagic myofasciitis (MMF) present with diffuse arthromyalgias, chronic fatigue, and cognitive disorder. Representative features of MMF-associated cognitive dysfunction include attentional dysfunction, dysexecutive syndrome, visual memory deficit and left ear extinction. Our study aims to reevaluate the neuropsychological profile of MMF. 105 unselected consecutive MMF patients were subjected to a neuropsychological battery of screen short term and long-term memory, executive functions, attentional abilities, instrumental functions and dichotic listening. From these results, patients were classified in four different groups: Subsymptomatic patients (n=41) with performance above pathological threshold (-1.65 SD) in all tests; Fronto-subcortical patients (n=31) who showed pathological results at executive functions and selective attention tests; Papezian patients (n=24) who showed pathological results in storage, recognition and consolidation functions for episodic verbal memory, in addition to fronto-subcortical dysfunction; and Extinction patients (n=9) who had a left ear extinction at dichotic listening test in association to fronto-subcortical and papezian dysfunction. In addition, inter-test analysis showed that patients with apparently normal cognitive functions (Subsymptomatic group) performed significantly worse to attention tests compared to others. In conclusion, our study shows that (i) most patients have specific cognitive deficits; (ii) all patients with cognitive deficit have impairment of executive functions and selective attention; (iii) patients without measurable cognitive deficits display significant weakness in attention; (iv) episodic memory impairment affects verbal, but not visual, memory; (v) none of the patients show an instrumental dysfunction.
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http://dx.doi.org/10.1016/j.jinorgbio.2017.09.019DOI Listing
April 2018

Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke.

N Engl J Med 2017 09;377(11):1011-1021

From the Department of Neurology, Sainte-Anne Hospital, INSERM 894, Département Hospitalo-Universitaire (DHU) NeuroVasc Sorbonne Paris-Cité (J.-L.M., G.T.), and the Department of Neurology, Saint-Joseph Hospital (M.Z.), Paris Descartes University, the Department of Neurology and Stroke Unit (C.G.) and the Department of Cardiology (J.-M.J.), Bichat Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), INSERM 1148, DHU FIRE (Fibrosis Inflammation and Remodeling in Cardiovascular, Renal, and Respiratory Diseases) Sorbonne Paris-Cité, the Department of Neurology, Saint-Antoine Hospital, AP-HP, Pierre et Marie Curie University (P.F.), the Department of Neurology, Lariboisière Hospital, DHU NeuroVasc Sorbonne Paris-Cité, Paris Diderot University (P.R.), and the Epidemiology and Clinical Research Unit, Georges Pompidou European Hospital, AP-HP, INSERM Centre d'Investigation Clinique 1418 (A.C.-N., G.C.), Paris, the Departments of Physiology (G.D.), Neurology (H.H.), and Cardiology (J.-L.D.-R.), Henri Mondor Hospital, AP-HP, University Paris Est Creteil, Creteil, the Departments of Neurology (B.G.) and Cardiology (P. Guérin), Centre Hospitalier Universitaire (CHU) Nantes, Nantes, the Department of Neurology, University Hospital, Rouen (E.M.), the Stroke Department (L.M.) and the Departments of Interventional Cardiology (R.R.) and Cardiovascular Investigations (M.B.), Pierre Wertheimer and Louis Pradel Hospitals, Lyon University, Lyon, the Department of Neurology, Gui de Chauliac Hospital, INSERM 894 (C.A.), and the Department of Interventional Cardiology, Clinique du Millénaire, INSERM 1191 (C.P.), Montpellier University, Montpellier, the Department of Neurology, Dijon Stroke Registry, EA 7460 (Y.B.), and the Department of Cardiology (J.-C.E.), University Hospital, Burgundy University, Dijon, the Departments of Neurology (F.V., T.M.) and Cardiology (N.M.), Jean Minjoz University Hospital, Franche-Comté University, Besançon, the Departments of Neurology (O.D.) and Cardiology (B.B.), Michallon Hospital, Grenoble Alpes University, Grenoble, the Department of Neurology and Stroke Unit (S.C.) and the Department of Cardiology (L.L.), University Hospital, Jules Verne Picardie University, Amiens, the Department of Neurology, Yves le Foll Hospital, Saint Brieuc (C.V.), the Department of Neurology and Stroke Unit (N.D.-P.) and the Department of Cardiology and Congenital Heart Disease (F.G.), Centre Hospitalier Régional Universitaire (CHRU) Lille, Lille Nord de France University, Lille, the Department of Neurology and Stroke Unit (I.S.) and the Department of Congenital Cardiac Diseases (J.-B.T.), CHU Bordeaux, Bordeaux University, Bordeaux, the Department of Neurology, University Hospital, INSERM 1059, Lyon University, Saint-Etienne (P. Garnier), the Departments of Neurology (A.F.) and Cardiology (J.-R.L.), University Hospital, Clermont-Ferrand, the Department of Neurology and Stroke Unit, Cavale Blanche Hospital, INSERM 1078, University of Western Brittany, Brest (S.T.), the Department of Neurology, La Timone Hospital, Aix-Marseille University, Marseille (E.R.-B.), the Department of Neurology, Saint-Jean Hospital, Perpignan (D.S.), the Department of Neurology and Stroke Unit, Central Hospital, Nancy (J.-C.L.), the Departments of Neurology (J.-F.P.) and Cardiology and Vascular Diseases (J.-M.S.), Pontchaillou Hospital, Rennes University, Rennes, the Department of Neurology, Caen University Hospital, Caen (M.A.), the Department of Neurology, Docteur Schaffner Hospital, Lens (C.L.) - all in France; the Stroke Center, Department of Neurology, Vaudois University Hospital, Lausanne University, Lausanne, Switzerland (P.M.); the Department of Cardiology, CHU Sart Tilman, Liege University, Liege, Belgium (L.P.); and the Department of Neurology, University Hospital, Duisburg-Essen University, Duisberg-Essen, Germany (C.W.).

Background: Trials of patent foramen ovale (PFO) closure to prevent recurrent stroke have been inconclusive. We investigated whether patients with cryptogenic stroke and echocardiographic features representing risk of stroke would benefit from PFO closure or anticoagulation, as compared with antiplatelet therapy.

Methods: In a multicenter, randomized, open-label trial, we assigned, in a 1:1:1 ratio, patients 16 to 60 years of age who had had a recent stroke attributed to PFO, with an associated atrial septal aneurysm or large interatrial shunt, to transcatheter PFO closure plus long-term antiplatelet therapy (PFO closure group), antiplatelet therapy alone (antiplatelet-only group), or oral anticoagulation (anticoagulation group) (randomization group 1). Patients with contraindications to anticoagulants or to PFO closure were randomly assigned to the alternative noncontraindicated treatment or to antiplatelet therapy (randomization groups 2 and 3). The primary outcome was occurrence of stroke. The comparison of PFO closure plus antiplatelet therapy with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 2, and the comparison of oral anticoagulation with antiplatelet therapy alone was performed with combined data from randomization groups 1 and 3.

Results: A total of 663 patients underwent randomization and were followed for a mean (±SD) of 5.3±2.0 years. In the analysis of randomization groups 1 and 2, no stroke occurred among the 238 patients in the PFO closure group, whereas stroke occurred in 14 of the 235 patients in the antiplatelet-only group (hazard ratio, 0.03; 95% confidence interval, 0 to 0.26; P<0.001). Procedural complications from PFO closure occurred in 14 patients (5.9%). The rate of atrial fibrillation was higher in the PFO closure group than in the antiplatelet-only group (4.6% vs. 0.9%, P=0.02). The number of serious adverse events did not differ significantly between the treatment groups (P=0.56). In the analysis of randomization groups 1 and 3, stroke occurred in 3 of 187 patients assigned to oral anticoagulants and in 7 of 174 patients assigned to antiplatelet therapy alone.

Conclusions: Among patients who had had a recent cryptogenic stroke attributed to PFO with an associated atrial septal aneurysm or large interatrial shunt, the rate of stroke recurrence was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone. PFO closure was associated with an increased risk of atrial fibrillation. (Funded by the French Ministry of Health; CLOSE ClinicalTrials.gov number, NCT00562289 .).
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http://dx.doi.org/10.1056/NEJMoa1705915DOI Listing
September 2017

Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial.

JAMA 2017 08;318(6):548-556

Department of Biostatistics, Hôpital Européen Georges Pompidou, AP-HP, and University Paris Descartes-Sorbonne Paris Cité, Paris, France.

Importance: Low cardiac output syndrome after cardiac surgery is associated with high morbidity and mortality in patients with impaired left ventricular function.

Objective: To assess the ability of preoperative levosimendan to prevent postoperative low cardiac output syndrome.

Design, Setting, And Participants: Randomized, double-blind, placebo-controlled trial conducted in 13 French cardiac surgical centers. Patients with a left ventricular ejection fraction less than or equal to 40% and scheduled for isolated or combined coronary artery bypass grafting with cardiopulmonary bypass were enrolled from June 2013 until May 2015 and followed during 6 months (last follow-up, November 30, 2015).

Interventions: Patients were assigned to a 24-hour infusion of levosimendan 0.1 µg/kg/min (n = 167) or placebo (n = 168) initiated after anesthetic induction.

Main Outcomes And Measures: Composite end point reflecting low cardiac output syndrome with need for a catecholamine infusion 48 hours after study drug initiation, need for a left ventricular mechanical assist device or failure to wean from it at 96 hours after study drug initiation when the device was inserted preoperatively, or need for renal replacement therapy at any time postoperatively. It was hypothesized that levosimendan would reduce the incidence of this composite end point by 15% in comparison with placebo.

Results: Among 336 randomized patients (mean age, 68 years; 16% women), 333 completed the trial. The primary end point occurred in 87 patients (52%) in the levosimendan group and 101 patients (61%) in the placebo group (absolute risk difference taking into account center effect, -7% [95% CI, -17% to 3%]; P = .15). Predefined subgroup analyses found no interaction with ejection fraction less than 30%, type of surgery, and preoperative use of β-blockers, intra-aortic balloon pump, or catecholamines. The prevalence of hypotension (57% vs 48%), atrial fibrillation (50% vs 40%), and other adverse events did not significantly differ between levosimendan and placebo.

Conclusions And Relevance: Among patients with low ejection fraction who were undergoing coronary artery bypass grafting with cardiopulmonary bypass, levosimendan compared with placebo did not result in a significant difference in the composite end point of prolonged catecholamine infusion, use of left ventricular mechanical assist device, or renal replacement therapy. These findings do not support the use of levosimendan for this indication.

Trial Registration: EudraCT Number: 2012-000232-25; clinicaltrials.gov Identifier: NCT02184819.
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http://dx.doi.org/10.1001/jama.2017.9973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5817482PMC
August 2017

Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

Eur J Prev Cardiol 2017 08 1;24(12):1274-1282. Epub 2017 Jun 1.

8 Service de réadaptation cardiaque, Institut Cœur Effort Santé, France.

Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant additional improvement in exercise capacity in cardiac heart failure patients.
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http://dx.doi.org/10.1177/2047487317712601DOI Listing
August 2017

ICU Patients Requiring Renal Replacement Therapy Initiation: Fewer Survivors and More Dialysis Dependents From 80 Years Old.

Crit Care Med 2017 Aug;45(8):e772-e781

1Réanimation Médicale, Hôpital Henri Mondor-APHP, Créteil, France.2Réanimation Médicale, Hôpital Européen Georges Pompidou-APHP, Paris, France.3Unité de recherche clinique, Hôpital Européen Georges Pompidou-APHP, Paris, France.4INSERM, UMR_S 1138, Centre de Recherche des Cordeliers, Paris, France.

Objectives: To assess the role of advanced age on survival and dialysis dependency after initiation of renal replacement therapy for acute kidney injury.

Design: Retrospective pooled analysis of prospectively collected data.

Setting: ICUs of two teaching hospitals in Paris area, France.

Subjects: One thousand five hundred thirty adult patients who required renal replacement therapy initiation in the ICU.

Interventions: None.

Measurements And Main Results: Survival and post acute kidney injury chronic dialysis dependency were assessed at hospital discharge according to the quintile (Q) of age. The oldest quintile included 289 patients 80 years old and over. Seventy-three percent of included patients had respiratory and hemodynamic supports at renal replacement therapy initiation, similarly distributed across quintiles. Mortality increased with age strata from 63% in Q1 (≤ 52 yr) to 76% in Q5 (≥ 80 yr) (p < 0.001). After adjustment, age did not increase the risk of death up to 80 years. The oldest patients (≥ 80 yr) had a significant higher risk of dying (adjusted odds ratio, 2.59; 95% CI, 1.66-4.03). Dialysis dependency was more frequent among survivors 80 years old or older (30% vs 14%; p = 0.001). Age 80 years old or older was an independent risk for dialysis dependency only for patients with prior advanced chronic kidney disease (p = 0.04). Baseline estimated glomerular filtration rate was the only one predictor of dialysis dependency identified.

Conclusions: Patients with advanced age represent a substantial subgroup of patients requiring renal replacement therapy in the ICU. From 80 years, age should be considered as an additional risk of dying over the severity of organ failures. Patients 80 years old or older are likely to recover sufficient renal function allowing renal replacement therapy discontinuation when baseline estimated glomerular filtration rate is above 44 mL/min/1.73 m. At 3 months, only 6% were living at home, dialysis independent.
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http://dx.doi.org/10.1097/CCM.0000000000002407DOI Listing
August 2017

Outcomes in elderly patients admitted to the intensive care unit with solid tumors.

Ann Intensive Care 2017 Dec 6;7(1):26. Epub 2017 Mar 6.

Intensive Care Unit, European Georges Pompidou Hospital, Paris, France.

Background: As the population ages and cancer therapies improve, there is an increased call for elderly cancer patients to be admitted to the intensive care unit (ICU). This study aimed to assess short-term survival and prognostic factors in critically ill patients with solid tumors aged ≥65 years.

Methods: We conducted a retrospective study. The primary endpoint was ICU mortality. Resumption of anticancer therapy in patients who survived the ICU stay and 90-day mortality were secondary endpoints. All patients aged ≥65 years admitted to the ICU of Georges Pompidou Hospital (Paris, France) between 2009 and 2014 were eligible.

Results: Of 2327 eligible elderly patients (EP), 262 (75.0 ± 6.7 years) with solid tumors were analyzed. These patients were extremely critically ill (SAPS 2 61.9 ± 22.5), and 60.3% had metastatic disease. Gastrointestinal, lung and genitourinary cancers were the most common types of tumors. Mechanical ventilation was required in 51.5% of patients, inotropes in 48.1% and dialysis in 12.6%. Most patients (66.7%) were admitted for reasons unrelated to cancer, including sepsis (30.5%), acute respiratory failure (28.2%) and neurological problems (8.0%). ICU mortality in patients with cancer was 33.6 versus 32.6% among patients without cancer (p = 0.75). Among the cancer EP, the 90-day mortality was 51.9% (n = 136). In multivariate analysis, increased SAPS 2 score and primary tumor site were associated with 90-day death, whereas previous anticancer therapies and poor performance status were not. Among survivor patients from ICU with anti-tumoral treatment indication, 77 (52.7%) had resumption of anticancer treatment.

Conclusions: Elderly solid tumor patients admitted to the ICU had a mortality rate similar to EP without cancer. Prognostic factors for 90-day mortality were more related to severity of clinical status at admission than the presence or stage of cancer, suggesting that early admission of EP with cancer to the ICU is appropriate.
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http://dx.doi.org/10.1186/s13613-017-0250-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5339259PMC
December 2017

Predictive Factors of "Forgotten Knee" Acquisition After Total Knee Arthroplasty: Long-Term Follow-Up of a Large Prospective Cohort.

J Arthroplasty 2017 02 23;32(2):413-418.e1. Epub 2016 Jun 23.

Department of Orthopaedic Surgery, Clinique Arago, Paris, France.

Background: In a large prospective cohort, we recently showed that only 66.1% of total knee arthroplasty (TKA) with a perfect outcome according to Knee Society Knee Score was completely forgotten in all everyday activities. The main objective of this study was to identify clinical and orthopedic factors associated with the acquisition of "forgotten knee" (FK).

Methods: Patients undergoing TKA were enrolled between January 2001 and January 2008. Preoperative medical history, anthropometric data, and clinical data were recorded, and composite scores (Knee Society Score, Lequesne) were assessed. Radiography was performed before and after surgery. At each follow-up, FK acquisition was assessed by a closed question "Does the operated knee feel always normal in all everyday activities?"

Results: We included 510 TKAs performed in 423 patients followed up for a mean of 76.6 ± 28.5 months. On multivariate analysis, depression at baseline and presence of patellar subluxation after surgery were negatively associated with FK acquisition (odds ratio [OR] = 0.28 [95% confidence interval {CI}, 0.13-0.61], P = .001; and OR = 0.31 [0.12-0.79], P = .01, respectively), whereas increased active flexion at last follow-up was positively associated (OR = 1.07 [1.03-1.10], P < .0001). In patients with a perfect outcome (Knee Society Knee Score = 100), preoperative patellar pain, and postoperative patellar subluxation were negatively associated with FK acquisition (OR = 0.41 [0.18-0.93], P = .03 and OR = 0.21 [0.05-0.90], P = .04, respectively). Gender, age, body mass index, preoperative pain and functional limitation, and patellar resurfacing were not significantly related to FK.

Conclusion: Depression and patella maltracking may be associated with lack of FK acquisition after TKA, while postoperative increase in flexion may have a positive impact.
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http://dx.doi.org/10.1016/j.arth.2016.06.020DOI Listing
February 2017

Visceral fat area predicts survival in patients with advanced hepatocellular carcinoma treated with tyrosine kinase inhibitors.

Dig Liver Dis 2015 Oct 10;47(10):869-76. Epub 2015 Jul 10.

APHP, Groupe Henri Mondor Albert Chenevier, Liver Unit, Henri Mondor Hospital, Créteil, France; University Paris Est Créteil, Créteil, France; INSERM U955, Team 18, Créteil, France. Electronic address:

Background: Anthropometric measurements have been linked to resistance to anti-angiogenic treatment and survival.

Methods: Patients with advanced hepatocellular carcinoma treated with sorafenib or brivanib in 2008-2011 were included in this retrospective study. Anthropometric measurements were assessed using computed tomography and were correlated with drug toxicity, radiological response, and overall survival.

Results: 52 patients were included, Barcelona Clinic Liver Classification B (38%) and C (62%), with a mean value of α-fetoprotein of 29,554±85,654 ng/mL, with a median overall survival of 10.5 months. Sarcopenia was associated with a greater rate of hand-foot syndrome (P=0.049). Modified Response Evaluation Criteria In Solid Tumours (mRECIST) and Choi criteria were significantly associated with survival, but RECIST criteria were not. An absence of hand-foot syndrome and high-visceral fat area were associated with progressive disease as assessed by RECIST and mRECIST criteria. In multivariate analyses, high visceral fat area (HR=3.6; P=0.002), low lean body mass (HR=2.4; P=0.015), and presence of hand-foot syndrome (HR=1.8; P=0.004) were significantly associated with overall survival. In time-dependent multivariate analyses; only high visceral fat area was associated with survival.

Conclusion: Visceral fat area is associated with survival and seems to be a predictive marker for primary resistance to tyrosine kinase inhibitors in patients with advanced hepatocellular carcinoma.
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http://dx.doi.org/10.1016/j.dld.2015.07.001DOI Listing
October 2015

Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial.

Intensive Care Med 2015 Oct 23;41(10):1800-8. Epub 2015 Jul 23.

Unité de recherche clinique, Hôpital Européen Georges Pompidou-APHP, Paris, France.

Purpose: We previously showed that external cooling decreases day 14 mortality in febrile septic shock. Because cooling may participate in heart rate control, we studied the respective impact of heart rate and temperature lowering on mortality.

Methods: Post hoc analysis of the Sepsiscool randomized controlled trial database (NCT00527007). Cooling was applied to maintain normothermia (36.5-37 °C) during 48 h. We assessed the time spent below different thresholds of temperature and heart rate on day 14 mortality. The best threshold was selected by AUC-ROC and tested as a potential mediator of mortality reduction. Mediation analysis was adjusted for severity and treatments influencing temperature and heart rate evolution. Sensitivity analysis was done using only patients with appropriate antimicrobial therapy.

Results: A total of 197/200 patients with adequate heart rate and temperature monitoring were analyzed. The best threshold differentiating survivors and nonsurvivors was 38.4 °C for temperature and 95 b/min for heart rate. During the 48 h of intervention, cooling significantly increased the time spent with a temperature below 38.4 °C, p = 0.001, and with a heart rate below 95 b/min, p < 0.01. The longer was the time spent with a temperature below 38.4 °C, the lower was the mortality [adjOR 0.17 (0.06-0.49), p = 0.001]. The time spent with a heart rate below 95 b/min was similar in survivors and nonsurvivors [adjOR 0.68 (0.27-1.72), p = 0.42]. Mediation analysis showed that the time spent with a temperature below 38.4 °C was a significant mediator of mortality.

Conclusion: The time spent with a temperature below 38.4 °C was independently associated with patient's outcome and explained 73% of the effect of the randomization on the day 14 mortality. Heart rate lowering was not a mediator of mortality.
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http://dx.doi.org/10.1007/s00134-015-3987-7DOI Listing
October 2015

Delirium and Circadian Rhythm of Melatonin During Weaning From Mechanical Ventilation: An Ancillary Study of a Weaning Trial.

Chest 2015 Nov;148(5):1231-1241

Keenan Research Centre and Critical Care Department, St. Michael's Hospital, Toronto, ON, Canada; Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.

Background: Delirium is frequent in patients in the ICU, but its association with the outcome of weaning from mechanical ventilation has not been assessed. Circadian rhythm alteration may favor delirium. In the current study, we assessed the impact of delirium during weaning and associated alterations in the circadian rhythm of melatonin excretion.

Methods: This was a substudy of 70 participants of the B-type Natriuretic Peptide for the Fluid Management of Weaning trial, comparing two fluid management strategies during weaning. Patients with or without delirium (as assessed using the Confusion Assessment Method for the ICU) were compared in terms of baseline characteristics and outcomes and the circadian rhythm of melatonin excretion using the 24-h excretion of its urinary metabolite 6-sulfatoxymelatonin (aMT6s).

Results: Among the 70 patients included, 43 (61.4%) experienced delirium at the initiation of weaning. Delirium at the initiation of weaning was associated with more alcohol consumption, a greater severity of illness, and medication use before weaning (including neuromuscular blockade, antibiotics, sedatives, and narcotics). Delirium at the initiation of weaning was associated with more respiratory and neurologic complications and a reduced probability of successful extubation (Cox multivariate model hazard ratio of successful extubation = 0.54; 95% CI, 0.30-0.95; P = .03). Delirium was also associated with a significant reduction in peak, mean, amplitude, and total values of aMT6s urinary excretion during the first 24 h of weaning (general linear model F statistic = 5.81, P = .019).

Conclusions: Delirium is frequent at the initiation of ventilator weaning. It is associated with a prolongation of weaning and an alteration in the circadian rhythm of melatonin excretion.

Trial Registry: ClinicalTrials.gov; No.: NCT00473148; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1378/chest.15-0525DOI Listing
November 2015

"Forgotten knee" after total knee replacement: A pragmatic study from a single-centre cohort.

Joint Bone Spine 2015 May 23;82(3):177-81. Epub 2015 Jan 23.

Department of Orthopaedic Surgery, Espace Médical Vauban, 75007 Paris, France.

Objectives: After total knee replacement (TKR), some patients find their operated knee totally natural and can be said to have "forgotten" it, while others, although satisfied with their results, remain conscious of their prosthesis. This is not well assessed on conventional end-points. Since 2001, we have studied the prevalence of "forgotten knee" (FK) after TKR in a prospective pragmatic cohort, with comparison to conventional scores.

Methods: Patients undergoing TKR were enrolled between January 2001 and January 2008. Preoperative medical history and anthropometric and clinical data were recorded, and composite scores (Knee Society Score (KSS), Lequesne) were assessed. At each follow-up visit, FK acquisition was assessed by the closed question "Do you feel the operated knee to be always normal in all everyday activities?".

Results: Five hundred and eighty-four TKRs in 485 patients were included. Among the TKR, 91.6% were performed for severe osteoarthritis of the knee. FK frequency at a mean 75.8 months' follow-up was 42.9% while 86.1% of TKRs had excellent (KS Knee Score (KSKS)>80) or 34.9% perfect (KSKS=100) outcome. Only 66.1% of the 204 TKRs with perfect outcome on KSKS were reported as FK. Most patients achieved FK within 18 months.

Conclusion: In this prospective study, 42.9% of TKRs were considered always forgotten in all everyday activities.
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http://dx.doi.org/10.1016/j.jbspin.2014.11.006DOI Listing
May 2015

Environmental influences on daily emergency admissions in sickle-cell disease patients.

Medicine (Baltimore) 2014 Dec;93(29):e280

From the AP-HP, Hôpital H. Mondor - A. Chenevier, Service de Réanimation Médicale, CARMAS research group (AMD, DC, CB-B); Université Paris Est, Faculté de médecine (AMD, DC, FG, CB-B, BM); Inserm, U955, Equipe 8 (AMD, BM); AP-HP, Hôpital H. Mondor - A. Chenevier, Unité de Recherche Clinique (CD-R, AC-N, SK); AP-HP, Hôpital H. Mondor - A. Chenevier, Service d'Information Médicale (FH); AP-HP, Hôpital H. Mondor - A. Chenevier, Unité des Maladies du Globule Rouge (AH, FG); and AP-HP, Hôpital H. Mondor - A. Chenevier, Unité de Pneumologie, Créteil 94000, France (BM); AP-HP, Hôpital Européen Georges Pompidou (SK); Inserm UMRS1138, Centre de Recherche des Cordeliers, Equipe 22, Université Paris Descartes (SK).

Previous reports have suggested a role for weather conditions and air pollution on the variability of sickle cell disease (SCD) severity, but large-scale comprehensive epidemiological studies are lacking. In order to evaluate the influence of air pollution and climatic factors on emergency hospital admissions (EHA) in SCD patients, we conducted an 8-year observational retrospective study in 22 French university hospitals in Paris conurbation, using distributed lag non-linear models, a methodology able to flexibly describe simultaneously non-linear and delayed associations, with a multivariable approach. During the 2922 days of the study, there were 17,710 EHA, with a mean daily number of 6.1 ± 2.8. Most environmental factors were significantly correlated to each other. The risk of EHA was significantly associated with higher values of nitrogen dioxide, atmospheric particulate matters, and daily mean wind speed; and with lower values of carbon monoxide, ozone, sulfur dioxide, daily temperature (minimal, maximal, mean, and range), day-to-day mean temperature change, daily bright sunshine, and occurrence of storm. There was a lag effect for 12 of 15 environmental factors influencing hospitalization rate. Multivariate analysis identified carbon monoxide, day-to-day temperature change, and mean wind speed, along with calendar factors (weekend, summer season, and year) as independent factors associated with EHA. In conclusion, most weather conditions and air pollutants assessed were correlated to each other and influenced the rate of EHA in SCD patients. In multivariate analysis, lower carbon monoxide concentrations, day-to-day mean temperature drop and higher wind speed were associated with increased risk of EHA.
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http://dx.doi.org/10.1097/MD.0000000000000280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602624PMC
December 2014

Predictors of flexion using the rotating concave-convex total knee arthroplasty: preoperative range of motion is not the only determinant.

Knee Surg Sports Traumatol Arthrosc 2015 Jun 23;23(6):1734-40. Epub 2014 Dec 23.

Service de chirurgie orthopédique et traumatologique, Hôpital Cochin, APHP, Université René Descartes, 27 rue du Faubourg Saint-Jacques, 75679, Paris Cedex 14, France,

Purpose: The range of motion achieved after a total knee arthroplasty (TKA) affects many daily activities and overall patients' satisfaction. This study aims to define the determinants affecting post-operative midterm active flexion according to a specific cruciate-sacrificing prosthesis, the rotating concave-convex (ROCC(®)) TKA.

Method: Four hundred and eighty-four consecutive patients (584 TKAs) were prospectively followed. After baseline patient demographics and anatomical characteristics, clinical and radiological post-operative assessments were periodically recorded. The rotational alignment of the femoral component was additionally reported for 120 patients. Eligibility for final inclusion was a minimum of 5-year follow-up. Univariate analyses followed by a multivariate model were fitted to determine the independent predictors of midterm active knee flexion.

Results: Thirty-four TKA (5.8%) were excluded for a secondary surgery before their 50 years, 69 patients died (11.8%), and 21 (3.6%) were lost to follow-up. Overall, 460 TKAs were included. The post-operative mean knee flexion angle was measured at 127.7° ± 9.3°. Significant factors affecting final flexion under univariate analyses were the patient height and body mass index, the absence of previous surgery, a depressive state, the preoperative flexion angle, a preoperative flexion contracture, a patellar residual subluxation, the reconstructed patellar height, and the rotation of the femoral component. The multivariate model confirmed the patient's height, a depression, the preoperative flexion angle, a patellar residual subluxation, and the patellar height as statistically significant determinants.

Conclusion: Aside from the preoperative flexion angle, numerous predictors of flexion, both patient- and procedure-related were identified. Surgeons should take these into account both when adequately informing their patient before surgery and when performing the arthroplasty itself.

Level Of Evidence: Prognostic, Level II.
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http://dx.doi.org/10.1007/s00167-014-3479-2DOI Listing
June 2015

Bilateral thalamic stimulation induces insomnia in patients treated for intractable tremor.

Sleep 2015 Mar 1;38(3):473-8. Epub 2015 Mar 1.

AP-HP, Groupe Henri Mondor - Albert Chenevier, Service de Neurochirurgie, Unité de Neurochirurgie Fonctionnelle, Créteil, France.

Study Objectives: To explore the influence of acute bilateral ventral intermediate thalamic nucleus (VIM) stimulation on sleep.

Design: Three consecutive full-night polysomnography recordings were made in the laboratory. After the habituation night, a random order for night ON-stim and OFF-stim was applied for the second and third nights.

Setting: Sleep disorders unit of a university hospital.

Patients: Eleven patients with bilateral stimulation of the ventral intermediate nucleus of the thalamus (VIM) for drug-resistant tremor.

Measurements: Sleep measures on polysomnography.

Results: Total sleep time was reduced during night ON-stim compared to OFF- stim, as well as rapid eye movement sleep percentage while the percentage of N2 increased. Wakefulness after sleep onset time was increased.

Conclusion: Our results show that bilateral stimulation of the VIM nuclei reduces sleep and could be associated with insomnia.
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http://dx.doi.org/10.5665/sleep.4512DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4335528PMC
March 2015

Bariatric surgery and liver transplantation: a systematic review a new frontier for bariatric surgery.

Obes Surg 2015 Jan;25(1):134-42

Department of Digestive Surgery, Centre Hospitalier Intercommunal de Créteil, 40 avenue de Verdun, 94000, Créteil, France.

This study aims to conduct a systematic review on bariatric surgery (BS) for patients in the setting of liver transplantation (LT). A literature review was conducted on the PubMed, Embase, and Cochrane Library databases. Studies in the English language on adults reporting on BS prior to, during, or after LT were included. Eleven studies with 56 patients were retrieved. Two studies reported on BS before, two during, and seven after LT. Sleeve gastrectomy was the most common procedure, followed by Roux-en-Y gastric bypass, biliopancreatic diversion, and gastric banding. The overall mortality rate was nil in the early postoperative period and 5.3 % in the first postoperative year. The reoperation rate was 12.2 %. Obesity surgery seems feasible in this population, but mortality and morbidity are higher.
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http://dx.doi.org/10.1007/s11695-014-1430-8DOI Listing
January 2015
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