Cervical ripening balloon compared with vaginal dinoprostone for cervical ripening in obese women at term: A prospective cohort study.

OBJECTIVE: To evaluate vaginal delivery in obese women who underwent cervical ripening at term using a dinoprostone vaginal insert or a cervical ripening balloon (CRB), and to assess maternal and neonatal morbidity according to the method. METHODS: A prospective cohort study including obese women with a live singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using a dinoprostone vaginal insert or a CRB. The primary outcome was vaginal delivery. Secondary outcomes were a favorable cervix (Bishop score >6) after 24 h, the time from device insertion to delivery, and composite maternal and neonatal morbidity. RESULTS: In total, 135 consecutive women were analyzed (107 CRB, 79.3%; 28 dinoprostone vaginal insert, 20.7%). Vaginal delivery (86 [80.4%] after CRB vs 19 [67.9%] after dinoprostone vaginal insert; P = 0.248), favorable cervix within 24 h after device placement (52 [48.6%] vs 17 [60.7%]; P = 0.264), and maternal morbidity (12 [11.2%] vs 4 [14.3%]; P = 0.646) were similar between the groups. The time from device insertion to delivery also did not differ between the groups. Neonatal morbidity was significantly higher after the dinoprostone vaginal insert (11 [39.3%] vs 20 [18.7%]; P = 0.030). Cervical ripening using the dinoprostone vaginal insert, compared with the CRB, was significantly associated with neonatal morbidity (adjusted odds ratio 4.00, 95% confidence interval 1.34-12.5), but not with maternal morbidity (adjusted odds ratio 1.23, 95% confidence interval 0.30-4.38). CONCLUSIONS: Vaginal delivery, a favorable cervix after 24 h, the time from device insertion to delivery, and maternal morbidity did not significantly differ between the CRB and the dinoprostone vaginal insert for cervical ripening in obese women at term. Nevertheless, neonatal morbidity was significantly associated with the dinoprostone vaginal insert, compared with the CRB, among obese women who required cervical ripening at term.

Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial.

BACKGROUND: Endotracheal tube fixation in ventilated patients must be appropriate to ensure security during mechanical ventilation and prevent skin lesions. The incidence of endotracheal tube-caused pressure ulcers ranges from 7% to 45%. Various endotracheal tube fixations are used in intensive care units (ICUs) worldwide. By pressure exercised on the skin, these systems could lead to mucosal and skin peri-oral lesions. The main objective of this study is to evaluate the impact of the two fixation systems most commonly used in French ICUs (adhesive elastic band versus fixation cord with PolyVinyl Chloride (PVC) sheath) on the incidence of these peri-oral skin lesions. METHODS: This studyis a multicenter, open-label, controlled, superiority, cluster cross-over randomized trial. 768 patients will be recruited in the 16 ICUs involved. The inclusion of patients will be carried out over two 12-month periods. Each site begins with one of the evaluated fixation systems: elastic adhesive tape or cord associated with a protective sheath. After a 4-month break, each site switches to the other fixation system. The primary outcome is the development of at least one peri-oral lesion during the first ten days of maintaining an orally inserted endotracheal tube. The presence of lesions is assessed by a blinded adjudication committee using photographs taken daily. DISCUSSION: This study is the first multicenter, randomized trial designed to evaluate the impact of elastic adhesive tape versus fixation cord with PVC sheath on the incidence of peri-oral lesions. The results will provide data which could change and standardize care practices. TRIAL REGISTRATION: https://www.clinicaltrials.gov. Reference number: NCT04819425.

Daratumumab, carfilzomib, lenalidomide, and dexamethasone with tandem transplant for high-risk newly diagnosed myeloma.

ABSTRACT: High-risk (HR) cytogenetics are associated with poor outcomes in newly diagnosed multiple myeloma (NDMM), and dedicated studies should address this difficult-to-treat population. The phase 2 study 2018-04 from the Intergroupe Francophone du Myelome evaluated feasibility of an intensive strategy with quadruplet induction and consolidation plus tandem transplant in HR transplant-eligible (TE) NDMM. HR cytogenetics were defined by presence of del(17p), t(4;14), and/or t(14;16). Treatment consisted of daratumumab-carfilzomib-lenalidomide-dexamethasone (D-KRd) induction, autologous stem cell transplantation (ASCT), D-KRd consolidation, second ASCT, and daratumumab-lenalidomide maintenance. The primary end point was feasibility. Fifty patients with previously untreated NDMM were included. Median age was 57. Del(17p), t(4;14), and t(14;16) were found in 40%, 52%, and 20% of patients, respectively. At data cutoff, the study met the primary end point with 36 patients completing second transplant. Twenty patients discontinued the study due to stem cell collection failure (n = 8), disease progression (n = 7), adverse event (n = 4), or consent withdrawal (n = 1). Grade 3 to 4 D-KRd induction/consolidation-related adverse events (>5% of patients) were neutropenia (39%), anemia (12%), thrombocytopenia (7%), and infection (6%). The overall response rate was 100% for patients completing second transplant, including 81% complete response. Premaintenance minimal residual disease (MRD) negativity rate (10-6) was 94%. After a median follow-up of 33 months, the 30-month progression-free survival (PFS) and overall survival were 80% and 91%, respectively. In conclusion, D-KRd with tandem transplant is feasible in patients with HR TE-NDMM and resulted in high response rates and PFS. This trial was registered at www.clinicaltrials.gov as #NCT03606577.

Impact of the practice of touch-massage® by a nurse on the anxiety of patients with hematological disorders hospitalized in a sterile environment, a randomized, controlled study.

CONTEXT: In addition to curative care, supportive care is beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. We hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited. The main objective of this study was to show that anxiety could be reduced after a touch-massage® performed by a nurse trained in this therapy. METHODS: A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks, patients were randomized into either a group receiving 15-minute touch-massage® sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks. In the treated group, anxiety was assessed before and after each touch-massage® session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session. RESULTS: Sixty-two patients were randomized. Touch-massage® significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant. CONCLUSION: This study provides convincing evidence for integrating touch-massage® in the treatment of patients in sterile hematology unit. TRIAL REGISTRATION: NCT02343965.

Tocilizumab in combination with a standard induction chemotherapy in acute myeloid leukaemia patients (TOCILAM study): a single-centre, single-arm, phase 1 trial.

Background: In acute myeloid leukaemia (AML), interleukin-6 (IL-6) promotes chemo-resistance and its levels correlate with poor prognosis. IL-6 blockade may represent a promising therapeutic strategy. We aimed to test, tocilizumab, an anti-IL-6 receptor (R) monoclonal antibody in combination with standard intensive AML induction chemotherapy. Methods: This investigator-initiated single-centre phase 1 trial was conducted at Nantes University Hospital in France. According to a continual reassessment method, three escalating doses were tested of intravenous (IV) tocilizumab (4, 6, and 8 mg/kg) administered at day (d) 8 of a standard AML induction chemotherapy (IV idarubicine 8 mg/m2 d1 to d5 + IV cytarabine 100 mg/m2 d1 to d7). All adults (aged ≥ 18 years) with an Eastern Cooperative Oncology Group performance status of 0-2 and with a newly diagnosed (excluding patients with a favourable risk according to ELN-2017 classification if <60 year-old) or a relapsed/refractory AML were eligible. The primary objective was to determine the maximum tolerated dose of tocilizumab to administrate with a standard intensive AML induction. Safety outcomes were continuously monitored for at each participant contact. This trial is registered with ClinicalTrials.gov, NCT04547062. Findings: Between Dec 29, 2020 and Dec 1, 2022, 12 patients were enrolled, of whom 75% had an ELN-2017 high-risk profile, and were treated with tocilizumab- two patients at 4 mg/kg, two at 6 mg/kg and eight at 8 mg/kg of tocilizumab. No dose-limiting toxicity related to tocilizumab was documented. There were nine serious adverse events, none of which were related to tocilizumab, and there was no treatment-related deaths. MTD was thus not reached. Two deaths occurred during induction. In the remaining ten evaluable patients, nine responded to treatment. Interpretation: The combination of tocilizumab with standard AML intensive induction appears to be safe and resulting responses are encouraging. A dose of 8 mg/kg of tocilizumab given at day 8 of induction could be used for further phase 2/3 studies. Funding: The Leucémie Espoir Atlantique Famille (LEAF)-"Tous avec Fabien" association.

[Hypnotic pain management during ultrasound-guided infiltration of the hand]. / Gestion de la douleur par hypnose lors d'une infiltration écho-guidée de la main.

Ultrasound-guided infiltration, performed to relieve pain, is a common and sometimes painful procedure, particularly on the hand. This potential pain, induced by the treatment, can cause apprehension in patients prior to such a procedure. The rheumatology team at the departmental hospital center (CHD) in Vendée hypothesized that a hypnosis session, by creating an imaginary glove on the patient's painful hand prior to the procedure, could help reduce the pain felt, as well as anxiety.

Evaluation of the impact of non-slip socks on the motor recovery of elderly people in acute care hospitals: Protocol for a randomized, controlled trial study.

BACKGROUND: Older patients often arrive in acute care wards with inappropriate footwear. Hospitals may provide non-slip socks to improve the patients' safety. However, few studies have been conducted on the benefits of non-slip socks. A recent literature review found only two randomized controlled studies that evaluated non-slip socks, but the socks were not the primary focus of the studies. The aim of this study is therefore to specifically evaluate the benefits of non-slip socks on gait in hospitalized older people. METHODS: This open, randomized, controlled trial will include patients aged 75 years and over, hospitalized in an acute medical unit. Patients will be randomized to either remain barefoot or wear non-slip socks throughout their stay. The primary outcome is gait speed, assessed on Day 1 and Day 8. DISCUSSION: This randomized controlled trial should provide clinicians with a scientific rational for the recommendation, or not, of the use of non-slip socks for older patients in acute care hospitals. TRIAL REGISTRATION: https://clinicaltrials.gov/ on May 12, 2021 under the reference: NCT04882696 https://clinicaltrials.gov/ct2/show/NCT04882696.

Hematopoietic stem cell transplantation for acute lymphoblastic leukemia: why do adolescents and young adults outcomes differ from those of children? A retrospective study on behalf of the Francophone Society of Stem Cell Transplantation and Cellular Therapy (SFGM-TC).

PURPOSE: In the acute lymphoblastic leukemia (ALL) landscape, adolescents and young adults (AYA) often present high-risk diseases and increased chemotherapy-related toxicity. Studies analyzing the outcomes of AYA after hematopoietic stem cell transplantation (HSCT) are scarce. Our study aimed to compare the outcomes of children and AYA with ALL after HSCT and to determine the factors influencing potential differences. METHOD: 891 patients, from the SFGM-TC registry, aged between 1 and 25 years who received HSCT between 2005 and 2012 were included. The outcomes of AYA were compared to the ones of their younger counterparts. RESULTS: Five-year OS and GRFS were lower in AYA: 53.1% versus 64% and 36% versus 47% (p = 0.0012 and p = 0.007, respectively). WhileCIR was similar in both groups, 5 year-treatment related mortality was higher in AYA: 19% versus 13% (p = 0.04). The lower GRFS in AYA was mainly explained by a higher chronic graft versus host disease (cGvHD) incidence: 32% versus 19% (p < 0.001). Use of peripheral blood stem cells and use of anti-thymoglobulin appeared to be the main factors impacting cGvHD occurrence in AYA. CONCLUSION: AYA have worse outcomes than children after HSCT for ALL because of a greater risk of TRM due to cGvHD. HSCT practices should be questioned in this population.

Predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term.

OBJECTIVE: To determine predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term. METHOD: Prospective observational study of nulliparous women with singleton term fetuses in vertex presentation, intact membranes, and an unfavorable cervix (Bishop score < 6) who underwent cervical ripening with a cervical-ripening balloon (CRB; n = 47) or dinoprostone vaginal insert (PG; n = 28). The authors analyzed Bishop score criteria (dilatation, effacement, fetal station, consistency, position) before and after device removal. Primary outcome was favorable cervix (Bishop score ≥ 6) after device removal. Secondary outcomes were vaginal delivery, modification of Bishop score criteria, and perinatal morbidity. RESULTS: Rates of favorable cervix after cervical ripening were similar between groups (66.7% with CRB vs. 59.3% with PG; P = 0.526). Vaginal delivery (76.6% vs. 78.6%; P = 0.843) and perinatal morbidity did not differ between groups. CRB appeared to be more effective than PG in increasing consistency (+0.7 ± 0.2 vs. +0.3 ± 0.2; P = 0.001) and dilatation of the cervix (+1.3 ± 0.3 vs. +0.9 ± 0.3; P = 0.005). No Bishop score criterion was found as a significant predictor for vaginal delivery. CONCLUSION: CRB seems to be more effective than PG in increasing the consistency and dilatation of the cervix. Efficacy of CRB and PG for vaginal delivery was similar.

Predictive Factors for Successful Cervical Ripening among Women with Gestational Diabetes Mellitus at Term: A Prospective Study.

The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening. After cervical ripening, vaginal delivery occurred in 84.2% (n = 123) and was similar among groups (90.0% after PG, 83.1% after CRB, 83.3% after M, and 83.7% after R; p = 0.89). After a multivariable logistic regression analysis adjusted for potential confounders, the internal cervical os being open before cervical ripening was a predictor of vaginal delivery (adjusted odds ratio (OR) of 4.38, 95% confidence index (CI) of 1.62-13.3, p = 0.03), and previous cesarean delivery was a predictor of cesarean delivery (aOR of 7.67, 95% CI of 2.49-24.00, p < 0.01). Birthweight was also significantly associated with cesarean delivery (aOR of 1.15, 95% CI of 1.03-1.31, p = 0.02). The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.

Neonatal Morbidity after Cervical Ripening with a Singleton Fetus in a Breech Presentation at Term.

Vaginal delivery in women with a breech presentation is part of common practice in France despite much debate, and the induction of labor (IOL) with a fetus in a breech presentation at term remains uncommon. Little is known about the effectiveness of cervical ripening and its neonatal and maternal safety in these women. We present a retrospective study of 362 women who gave birth to a live singleton fetus in a breech presentation at term. The objective was to compare severe maternal and neonatal morbidity according to the planned mode of labor (spontaneous labor or the induction of labor (IOL) with a favorable cervix, cervical ripening, or elective cesarean delivery) and, specifically, to compare cervical ripening to the other modes of labor. The rate of severe neonatal morbidity was 3.0% and was significantly higher after the IOL compared to elective cesarean delivery (p = 0.02), and the severe maternal morbidity rates were similar. Multivariable logistic regression analysis found no significant association between cervical ripening and either composite severe neonatal (adjusted odds ratio [aOR] 2.80, 95% confidence interval [CI] 0.10-43.6) or maternal morbidity (aOR 1.29, 95% CI 0.05-11.5). Our results support a policy of offering cervical ripening to the appropriately selected candidates with a singleton fetus in a breech presentation at term without increasing the incidence of severe maternal and neonatal morbidity.

Ropivacaine perineal infiltration for postpartum pain management in episiotomy repair: a double-blind, randomised, placebo-controlled trial.

OBJECTIVE: To investigate whether perineal infiltration of ropivacaine after episiotomy would decrease the incidence of postpartum pain compared with placebo. DESIGN: Two-centre, double-blind, randomised, controlled trial. SETTING: Two French maternity units, October 2017 to April 2020. POPULATION: 272 women undergoing epidural analgesia with vaginal singleton delivery and mediolateral episiotomy at term (≥37 weeks) were randomly allocated perineal infiltration of ropivacaine (n = 135) or placebo (n = 137) in a 1:1 ratio before episiotomy repair. METHODS: Patients were followed at short term (12, 24, 48 h), mid-term (day 7) and long-term (3 and 6 months). MAIN OUTCOME MEASURES: The primary outcome was the rate of perineal pain, defined by a Numerical Pain Rating Scale (NPRS) exceeding 3/10, in the mid-term (day 7) postpartum period. Secondary outcomes were perineal pain (NPRS) and analgesic intake, quality of life (SF-36), postpartum depression (EPDS), pain neuropathic component (DN4) and sexual health (FSFI). RESULTS: Perineal pain occurred to an equal extent in the ropivacaine and placebo groups at day 7 (34.2% versus 30.4%, odds ratio 1.1, 95% confidence interval 0.7-1.8, p = 0.63). Similar results were recorded in the short and long term. High rates of dyspareunia and postpartum depression were documented in both groups. No differences were highlighted between the groups in terms of analgesic intake, adverse events, pain neuropathic component and postpartum quality of life. CONCLUSIONS: This study did not demonstrate any benefit of ropivacaine infiltration over placebo.

Femoral nerve inguinal approach versus proximal femoral triangle ap proach for continuous regional analgesia in active rehabilitation after total knee arthroplasty: A prospective, randomised study.

BACKGROUND: A catheter in femoral nerve block (F-Cath) is an effective regional analgesia technique in total knee arthroplasty (TKA) but results in significant quadriceps weakness. The femoral triangle catheter (FTB-Cath) seems to be an interesting alternative. In this study, we aim to demonstrate that the nerve block administration for analgesic purposes via an FTB-Cath results in less quadriceps weakness than via an F-Cath. METHODS: This study included patients scheduled for TKA performed under general anaesthesia. The patients were randomised to receive either an F-Cath or an FTB-Cath. A unique regimen of 0.2% ropivacaine was administrated for 72 h. The primary endpoint was quadriceps strength assessed clinically on postoperative day (POD) 2 by the Manual Muscle Test (MMT) using a motor grading scores (0-5). The secondary endpoints were quadriceps strength measured by a dynamometer, the Timed Up and Go (TUG) test, the 30-m walk test (30MWT) and pain scores. RESULTS: Forty-four patients were analysed (22 in each group). On POD 2, 77.3% of the patients in the FTB-Cath group had MMT scores ≥ 4 and 13.6% in the F-Cath group (p < 0.001). During the first four POD assessments, quadriceps strength evaluated with a dynamometer was less diminished in the FTB-Cath group (p < 0,001). There was no difference between groups regarding pain scores, TUG test results and 30MWT assessment. CONCLUSION: The FTB-Cath provided a better preservation of quadriceps strength than the F-Cath in TKA, with a similar pain relief.

Prospective observational study investigating the effectiveness, safety, women's experiences and quality of life at 3 months regarding cervical ripening methods for induction of labor at term-The MATUCOL study protocol.

BACKGROUND: The purposes of successful induction of labor (IOL) are to shorten the time for IOL to delivery, increase the vaginal delivery rate, and reduce the rate of maternal and neonatal morbidity. In cases of unfavorable cervix (Bishop score <6), cervical ripening is advised to improve vaginal delivery rate. It may be initiated by mechanical (double balloon catheter (DBC), synthetic osmotic dilator) or pharmacologic (prostaglandins) methods, and the problem is complex due to the multitude of cervical ripening methods. We are constantly looking for the optimal protocol of cervical ripening for each woman. The present study aims to elucidate whether cervical ripening method is associated with increase rate of vaginal delivery, good women's experience and unaltered long-term quality of life after cervical ripening at term regarding maternal and obstetric characteristics. METHODS AND DESIGN: The MATUCOL study is a monocentric, prospective, observational study of all consecutive women who required cervical ripening (Bishop score <6) using different methods (DBC, vaginal dinoprostone, oral misoprostol) with a live fetus at term (≥37 weeks) between January 2020 and August 2021. The outcomes will be mode of delivery, maternal and neonatal morbidity, discomfort/pain assessments during cervical ripening, women's experience and satisfaction, and the impact of cervical ripening on the health-related quality of life at 3 months. If it reports a significant efficacy/safety/perinatal morbidity/women's satisfaction/quality of life at 3 months post-delivery associated with a method of cervical ripening in a specific situation (gestational and/or fetal disease) using a multivariate analysis, its use should be reconsidered in clinical practice. DISCUSSION: This study will reveal that some cervical ripening methods will be more effectiveness, safe, with good women's experiences and QOL at 3 months compared to others regarding maternal and obstetric characteristics. TRIAL REGISTRATION: This study is being performed at La Roche sur Yon Hospital following registration as GNEDS on January 8, 2020.

Risk Factors for Carbetocin Failure after a Cesarean Section: Is Obesity One of Them?

Obese pregnant women have increased rates of fetal macrosomia, long labor, and cesarean sections, which lead to an increased risk of postpartum hemorrhage (PPH). Carbetocin is useful for the prevention of PPH after a cesarean section. Our study aimed to investigate predictors of carbetocin failure after a cesarean section, and specifically whether obesity is associated with carbetocin failure. We retrospectively analyzed all women who received carbetocin after a cesarean section. Carbetocin failure was defined as changes in hematocrit and hemoglobin, blood loss ≥ 1000 mL, and the need for an additional uterotonic agent or second-line therapies for persistent PPH. Univariate and multivariate analyses were performed to investigate predictors of carbetocin failure. The study included 600 women, with 131 (21.8%) obese women. Overall, 44 (7.3%) carbetocin failures were reported, and rates of obese women were similar between groups (carbetocin failure, 11.4% vs. 22.9%; p = 0.08). Previous PPH (p < 0.001), a cesarean section during labor (p = 0.01), cervical ripening (p = 0.02), and birthweight (p = 0.01) were significantly different between groups. In the multivariable logistic regression analysis adjusted for potential confounders, cervical ripening (adjusted odds ratio (OR) 2.23, 95% confidence interval (CI) 1.01-4.80), compared with spontaneous labor, was significantly associated with carbetocin failure. Obesity was not associated with carbetocin failure after cesarean sections.

Effect of an intensive cervical traction protocol on mid-term disability and pain in patients with cervical radiculopathy: An exploratory, prospective, observational pilot study.

BACKGROUND: Cervical radiculopathy is a relatively common and disabling condition involving local pain in the neck region and pain that radiates into the upper limb. Recent data suggest that cervical traction may effectively reduce disability and pain, with a dose-response relationship. The main aim of this study was therefore to evaluate the mid-term effect of an intensive cervical traction protocol for patients with cervical radiculopathy on disability, and to compare the effects with those reported by non-intensive protocols in the literature. METHODS: We conducted a prospective open observational study of 36 patients referred by their general practitioner for symptoms suggestive of cervical radiculopathy. All patients underwent the same treatment: a 30-minute cervical traction protocol, twice a day, for five consecutive days. The main objective was the evaluation of disability at 3 months. We evaluated at baseline (D1), the end of the protocol (D5) and at mid-term (M3) disability, cervical pain, radiating pain, pain on motor imagery, presence of neuropathic pain and medication consumption. The primary outcome was the proportion of patients for whom the Neck Disability Index improved by more than the minimum clinically important difference of 7 points by M3. RESULTS: Thirty-six patients were included in this study. The Neck Disability Index improved by more than the minimum clinically important difference in 48.3% at M3. Mean Neck Disability Index (p < .001), mean cervical VAS (p < .001), mean radiating VAS (p < .001), and mean VAS for imagined lateral flexion and rotation (p < .002) improved significantly from D1 to D5 and from D1 to M3. Consumption of medication reduced at each time point. The proportion of patients with neuropathic pain reduced from 61.1% at D1 to 33.3% at D5 and 48.3% at M3. CONCLUSION: Disability reduced by more than the minimum clinically important difference in almost half of the participants following the intensive traction protocol. These results are encouraging and suggest that this complex condition can be treated with relatively simple methods.

Prophylactic or Preemptive Low-Dose Azacitidine and Donor Lymphocyte Infusion to Prevent Disease Relapse following Allogeneic Transplantation in Patients with High-Risk Acute Myelogenous Leukemia or Myelodysplastic Syndrome.

Because of the persistently high rates of relapse of patients with high-risk acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), post-transplantation maintenance therapy has been proposed. We previously initiated a Phase II trial in which epigenetic therapy was combined with immunotherapy in an attempt to reduce disease relapse. In that study, low-dose azacitidine (AZA) and escalating doses of donor lymphocyte infusion (DLI) were given as post-allo-HSCT maintenance treatment. In the present study, we retrospectively analyze a larger cohort of patients receiving post-transplantation maintenance therapy and provide updates on some patients of the earlier study. The objectives of the present study were to analyze the cumulative incidence of relapse (CIR), overall survival (OS), and progression-free survival (PFS) and the incidence of acute and chronic graft-versus-host disease (GVHD) of patients with high-risk AML or MDS receiving post-transplantation maintenance treatment with AZA with or without DLI. We retrospectively analyzed 77 patients (54 with AML, 23 with MDS) considered at high risk based on either their genomic or clinical status at transplantation. Following allogeneic transplantation, they received at least 1 cycle of prophylactic or preemptive low-dose AZA with or without escalating doses of DLI to prevent disease relapse. Almost one-half of the patients (47%) were able to receive the full 12 cycles of scheduled AZA, and a majority (79%) received at least 1 DLI. With a median follow-up of 24 months, 19 patients (25%; 16 with AML, 3 with MDS) relapsed, at a median of 9.8 months (range, 4 to 58.6 months), giving a 22% CIR at 24 months. OS and PFS at 24 months were 70.8% and 68.3%, respectively. The cumulative incidences of grade II-IV acute GVHD and chronic GVHD were 27.4% and 45%, respectively. Only a minority of patients (11%) required delayed administration of AZA. These findings confirm that AZA-DLI maintenance is both tolerable and effective in reducing the risk of post-transplantation relapse.

Epidemiology and microbiology of ventilator-associated pneumonia in COVID-19 patients: a multicenter retrospective study in 188 patients in an un-inundated French region.

BACKGROUND: The COVID-19 pandemic is responsible for many hospitalizations in intensive care units (ICU), with widespread use of invasive mechanical ventilation (IMV) which exposes patients to the risk of ventilator-associated pneumonia (VAP). The characteristics of VAP in COVID-19 patients remain unclear. METHODS: We retrospectively collected data on all patients hospitalized for COVID-19 during the first phase of the epidemic in one of the seven ICUs of the Pays-de-Loire region (North-West France) and who were on invasive mechanical ventilation for more than 48 h. We studied the characteristics of VAP in these patients. VAP was diagnosed based on official recommendations, and we included only cases of VAP that were confirmed by a quantitative microbiological culture. FINDINGS: We analyzed data from 188 patients. Of these patients, 48.9% had VAP and 19.7% experienced multiple episodes. Our study showed an incidence of 39.0 VAP per 1000 days of IMV (until the first VAP episode) and an incidence of 33.7 VAP per 1000 days of IMV (including all 141 episodes of VAP). Multi-microbial VAP accounted for 39.0% of all VAP, and 205 pathogens were identified. Enterobacteria accounted for 49.8% of all the isolated pathogens. Bacteremia was associated in 15 (10.6%) cases of VAP. Pneumonia was complicated by thoracic empyema in five cases (3.5%) and by pulmonary abscess in two cases (1.4%). Males were associated with a higher risk of VAP (sHR 2.24 CI95% [1.18; 4.26] p = 0.013). INTERPRETATION: Our study showed an unusually high incidence of VAP in patients admitted to the ICU for severe COVID-19, even though our services were not inundated during the first wave of the epidemic. We also noted a significant proportion of enterobacteria. VAP-associated complications (abscess, empyema) were not exceptional. REGISTRATION: As an observational study, this study has not been registered.

A Prospective Study of Association of Micronutrients Deficiencies during Pregnancy and Neonatal Outcome among Women after Bariatric Surgery.

Little is known about the association of micronutrients deficiencies during pregnancy and neonatal outcome among women after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). We present a prospective study of 87 consecutive women with a history of RYGB (n = 37) or SG (n = 50) who underwent complete and regular clinical and biological nutritional assessments during pregnancy. Data on maternal characteristics, biological nutritional parameters, antenatal management, and perinatal outcome were collected. The objective was to evaluate serum levels of micronutrients at the second trimester, and to assess the association between micronutrients deficiencies and neonatal outcome. After RYGB, maternal age (34.3 ± 4.9 vs. 31.1 ± 4.6 years; p = 0.003) and pregnancy timing after surgery (64.5 ± 47.0 vs. 38.1 ± 28.1 months; p = 0.002) were significantly higher, and pre-pregnancy BMI was significantly lower (29.8 ± 5.6 vs. 32.9 ± 7.1 kg/m2; p = 0.03). Maternal and neonatal outcomes were similar. Additional supplementations after blood tests were similar in groups. Zinc, selenium, vitamins A1, B1, B6, C, and E levels were not different depending on the type of surgery. Zinc deficiency (7/87) was significantly more frequent after RYGP (18.9% vs. 0%; p = 0.02) and selenium deficiency (15/87) was similar in groups (21.6% after RYGB and 14.0% after SG; p = 0.36). The mean birth weight was significantly lower in selenium deficiency cases (3137 ± 550 vs. 3535 ± 737 g; p = 0.04). Selenium deficiency was negatively correlated with birth weight (r = -0.23; p = 0.03) and with birth weight z-score (r = -0.26; p = 0.01), but not correlated after adjustment for the procedure. The levels of micronutrients surveillance along pregnancy in women with a history of bariatric surgery is necessary to decrease the risk of inadequate fetal growth in the patients.