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Background The course of chronic obstructive pulmonary disease (COPD) is punctuated by exacerbations, most often of infectious origin, responsible for many intensive care unit (ICU) and intermediate care unit (IMCU) admissions. Our objective was to study in-hospital mortality during severe COPD exacerbations in ICU and IMCU based on the performance of bronchoscopy. Methods A retrospective analysis was carried out on stays in ICUs for COPD exacerbation from the French Programme for the Medicalisation of Information Systems databases for the years 2014 and 2015. Propensity score matching of stays made it possible to constitute two comparable groups on the factors of excess mortality described in the literature (age, sex, SAPS 2, type of admission and bronchial tumour). Results We identified 14,491 stays for COPD exacerbation in ICUs, 2586 of which received a bronchoscopy. Mortality was significantly higher in the fibroscopy group (31.32% versus 19.8%). After propensity score matching, we found an excess of mortality in the intervention group (OR = 1.749 [1.516–2.017]) associated with a significantly longer length of stay. The main diagnoses associated with an increased risk of death were pulmonary embolism (OR = 3.251 [1.126–9.384]), bacterial pneumonia (OR = 1.906 [1.173–3.098]) and acute respiratory failure (OR = 1.840 [1.486–2.278]). Conclusions Performing bronchoscopy during ICU hospitalisations for severe COPD exacerbations was associated with increased mortality. This increased mortality appears to be related to a bias in patient selection with a procedure reserved for patients with the adverse course.

BACKGROUND Nerve damage can occur after peripheral nerve block (PNB). Ultrasound guidance does not eliminate the risk of intraneural injection or nerve injury. Combining nerve stimulation and injection pressure (IP) monitoring with ultrasound guidance has been suggested to optimize needle tip location in PNB. In this prospective observational study, we hypothesized that measured pairs of IP and minimum intensity of stimulation (MIS) might differentiate successive needle tip locations established by high-resolution ultrasound during PNB. METHODS For this exploratory study, 240 observations for 40 ultrasound-guided PNBs were studied in 28 patients scheduled for orthopedic surgery. During the progression of the needle to the nerve observed by ultrasonography, the IP was measured continuously using a computerized pressure-sensing device with a low flow rate of solution. Stimulation thresholds and electrical impedance were obtained by an impedance analyzer coupled to the nerve stimulator at 6 successive needle positions. The median (quartile) or mean (95% confidence interval [CI]) was reported. A mixed model analysis was used, and the sample was also explored using a classification and regression tree (CART) algorithm. RESULTS Specific combinations of IP and MIS were measured for subcutaneous, epimysium contact, intramuscular, nerve contact (231 mm Hg [203-259 mm Hg] and 1.70 mA [1.38-2.02 mA]), intraneural location (188 mm Hg [152-224 mm Hg] and 0.58 mA [0.46-0.70 mA]), and subparaneural location (47 mm Hg [41-53 mm Hg] and 1.35 mA [1.09-1.61 mA]). The CART algorithm shows that the optimal subparaneural needle tip position might be defined by the lowest pressure (

International audience; Improvements in skeletal muscle endurance and oxygen uptake are blunted in patients with chronic obstructive pulmonary disease (COPD), possibly because of a limitation in the muscle capillary oxygen supply. Pericytes are critical for capillary blood flow adaptation during angiogenesis but may be impaired by COPD systemic effects, which are mediated by circulating factors. This study compared the pericyte coverage of muscle capillaries in response to 10 wk of exercise training in patients with COPD and sedentary healthy subjects (SHS). Fourteen patients with COPD were compared with seven matched SHS. SHS trained at moderate intensity corresponding to an individualized moderate-intensity patient with COPD trained at the same relative (%V̇o2: COPD-RI) or absolute (mL·min-1·kg-1: COPD-AI) intensity as SHS. Capillary-to-fiber ratio (C/F) and NG2+ pericyte coverage were assessed from vastus lateralis muscle biopsies, before and after 5 and 10 wk of training. We also tested in vitro the effect of COPD and SHS serum on pericyte morphology and mesenchymal stem cell (MSC) differentiation into pericytes. SHS showed greater improvement in aerobic capacity (V̇o2VT) than both patients with COPD-RI and patients with COPD-AI (Group × Time: P = 0.004). Despite a preserved increase in the C/F ratio, NG2+ pericyte coverage did not increase in patients with COPD in response to training, contrary to SHS (Group × Time: P = 0.011). Conversely to SHS serum, COPD serum altered pericyte morphology (P < 0.001) and drastically reduced MSC differentiation into pericytes (P < 0.001). Both functional capacities and pericyte coverage responses to exercise training are blunted in patients with COPD. We also provide direct evidence of the deleterious effect of COPD circulating factors on pericyte morphology and differentiation.NEW & NOTEWORTHY This work confirms the previously reported impairment in the functional response to exercise training of patients with COPD compared with SHS. Moreover, it shows for the first time that pericyte coverage of the skeletal capillaries is drastically reduced in patients with COPD compared with SHS during training-induced angiogenesis. Finally, it provides experimental evidence that circulating factors are involved in the impaired pericyte coverage of patients with COPD.

Background Unintentional leaks (ULs) are frequent adverse effects in CPAP-treated patients. We previously published a novel methodology for analyzing the determinants of UL using polysomnography. We now propose a simplified recording system using a type 3 polygraphic device (Somnolter; Nomics S.A.). Research Question (1) To describe individual UL determinants provided by the Somnolter software in automatic-CPAP-treated OSA patients; (2) To subsequently describe the clinical consensus of four physicians on how to manage each individual UL situation. Study Design and Methods Somnoler recordings performed under nasal automatic-CPAP were automatically analyzed with APIOS software. For each polygraphic recording, APIOS provided the OR and the CIs for potential determinants of UL: mouth opening, CPAP pressure, body position, and mandibular oscillation. Based on these results, each of four physicians was asked to choose one of four strategies: (1) increase or decrease therapeutic pressure; (2) change nasal mask for oro-nasal mask/chinstrap; (3) favor a nonsupine or supine position; (4) no action for individual leak management. Subsequently, a meeting was held to determine a consensus choice for each individual case. Results Seventy-eight consecutive patients underwent home-polygraphy with Somnolter. Fifty recordings were analyzed (16 females; 65 [57-75] years of age; BMI = 31.1 [27.4-35.3]). Individual diagnosis of UL was routinely feasible. The determinants of UL were heterogeneous in the population, and diagnosis of UL was not feasible in 10 patients. Based on the results from this analysis, we established consensus leak management strategies at the individual level. The average Cohen κ coefficient for the four raters was 0.58. Pressure modification was proposed in 36% of patients, no action in 24%, installation of a facial mask/chinstrap in 22%, and positional treatment in 18%. Interpretation The use of type 3 polygraphy for characterizing leak determinants in patients treated with nasal automatic-CPAP is feasible in routine practice. Leak determinants are patient specific. Interrater concordance for determining individual leak management strategies demonstrated a “fair” level of agreement. Trial Registry ClinicalTrials.gov ; No.: NCT03381508; URL: www.clinicaltrials.gov ).

BACKGROUND: “Macintosh”-videolaryngoscopes (VLs) are VLs that allow both direct and indirect laryngoscopy for intubation. We describe the decision-making and implementation-processes that our hospital used regarding the choice of device. We compared the performances of 4 Macintosh-VLs both in direct and indirect laryngoscopy. METHODS: A quality-improvement-project for airway management aiming at implementing Macintosh-VL for all intubation procedures performed in the operating room, involving 4 Macintosh-VLs (McGrath-Mac, C-MAC-S, C-MAC-S-Pocket-Monitor [PM], and APA). Three consecutive steps were described: (1) direct laryngoscopy with Macintosh-VL, (2) indirect laryngoscopy with Macintosh-VL (intubation attempt with Macintosh-style blade in case of Cormack I or II), (3) intubation attempt with hyperangulated blade in case of Cormack III/IV or failure of Macintosh-style blade. The main end point was the need to move to step III and use a hyperangulated blade. A mixed-effects multivariable logistic regression analysis was performed to compare devices on the main end point while considering site as a random effect. Comparison of means was performed using analysis of variance and Tukey’s test for multiple comparisons (number of laryngoscopy attempts, numeric rate scale [NRS] difficulty of intubation and NRS user-friendliness). Comparison of percentages was performed using a χ2 test for the need to move to step III and a Kruskal-Wallis test for the quality of image (bad, passable, good, very good, excellent). A P value ≤.008 was considered statistically significant. RESULTS: From May to September 2017, 589 patients were included. Using the McGrath-Mac (22/180 [12%]) was associated with less use of hyperangulated blade than using the C-MAC-S (39/132 [30%], odds ratio [OR] [99.2% confidence interval {CI}] 0.34 [0.16–0.77], P = .0005), the APA (35/138 [25%], OR [99.2% CI] 0.42 [0.19–0.93]; P = .004), but not the C-MAC-S-PM (29/139 [21%], OR [99.2% CI] 0.53 [0.23–1.2]; P = .04). Overall, the number of intubation attempts was significantly lower using the McGrath Mac than the C-MAC-S or the C-MAC-S-PMVLs. Subjective appreciation of intubation difficulty and user-friendliness of the devices showed respectively lower and higher NRS scores for the McGrath-Mac compared to the other devices, whereas subjective assessment of image quality showed higher quality for the C-MAC-S and C-MAC-S-PM compared to the APA or McGrath-Mac. CONCLUSIONS: Among 4 single-use Macintosh-VLs, glottic visualization in direct and indirect laryngoscopy with the Macintosh-style blade was significantly improved with the McGrath-Mac compared to other Macintosh-VLs, leading to a less frequent need to resort to the hyperangulated blade and reduced overall number of intubation attempts.

The International Classification of Diseases (ICD) provides a common language for use worldwide as a diagnostic and classification tool for epidemiology, clinical purposes and health management. Since its first edition, the ICD has maintained a framework distributing conditions according to topography, with the result that some complex conditions, such as allergies and hypersensitivity disorders (A/H) including anaphylaxis, have been poorly represented. The change in hierarchy in ICD-11 permitted the construction of the pioneer section addressed to A/H, which may result in more accurate mortality and morbidity statistics, including more accurate accounting for mortality due to anaphylaxis, strengthen classification, terminology and definitions. The ICD-11 was presented and adopted by the 72nd World Health Assembly in May 2019 and the implementation is ongoing worldwide. We here present the outcomes from an online survey undertaken to reach out the allergy community worldwide in order to peer review the terminology, classification and definitions of A/H introduced into ICD-11 and to support their global implementation. Data are presented here for 406 respondents from 74 countries. All of the sub-sections of the new A/H section of the ICD-11 had been considered with good accuracy by the majority of respondents. We believe that, in addition to help during the implementation phase, all the comments provided will help to improve the A/H classification and to increase awareness by different disciplines of what actions are needed to ensure more accurate epidemiological data and better clinical management of A/H patients.

To quantify and compare the fat fraction of background liver and primary liver lesions using a triple-echo-gradient-echo sequence. This IRB-approved study included 128 consecutive patients who underwent a liver MRI for lesion characterization. Fat fraction from the whole lesion volume and the normal liver parenchyma were computed from triple-echo (consecutive in-phase, opposed-phase, in-phase echo times) sequence. Forty-seven hepatocellular carcinoma (HCCs), 25 hepatocellular adenomas (HCAs), and 56 focal nodular hyperplasia (FNH) were included. The mean intralesional fat fraction for various lesions was 7.1% (range, 0.5–23.6; SD, 5.6) for HCAs, 5.7% (range, 0.8–14; SD, 2.9) for HCCs, and 2.3% (range, 0.8–10.3; SD, 1.9) for FNHs (p = 0.6 for HCCs vs HCA, p

International audience; Background: Oral corticosteroid (OCS) treatment for severe asthma is associated with substantial disease burden. Thus, OCS dosage reduction is desirable. Relative efficacy of biologics in reducing OCS treatment for severe, uncontrolled asthma is not fully characterized.Objective: We performed a matching‐adjusted indirect comparison (MAIC) to assess the relative effects on OCS treatment reduction of three biologic asthma treatments.Methods: In MAIC of benralizumab vs. mepolizumab and vs. dupilumab, patient‐level data from the Phase III benralizumab OCS‐sparing trial, ZONDA, were weighted to match treatment effect–modifying patient characteristics in comparator trials.Results: After matching adjustment, mean difference between benralizumab and mepolizumab for OCS reduction was 6.08% (95% CI −22.22‐34.38; P = .67) by week 24, and odds ratio of OCS elimination was 2.32 (95% CI 0.48‐11.15; P = .29). A trend in annual asthma exacerbation rate reduction favouring benralizumab over mepolizumab was observed, although it was not statistically significant (rate ratio [RR] = 0.56 [95% CI 0.28‐1.13; P = .11]). Mean difference between benralizumab and dupilumab for OCS reduction was −0.71% (95% CI −20.56‐19.15; P = .94), and odds ratio of OCS elimination was 2.26 (95% CI 0.52‐9.84; P = .28). A non‐significant trend in annual asthma exacerbation rate reduction favouring benralizumab over dupilumab was observed (RR = 0.50 [95% CI 0.20‐1.28; P = .15]). Effective sample size was 49% (72 vs. 148) and 25% (36 vs. 142) of original sample size for MAIC of benralizumab vs. mepolizumab and benralizumab vs. dupilumab, respectively.Conclusions and Clinical Relevance: Following patient baseline characteristics matching across clinical trials, benralizumab demonstrated efficacy comparable to mepolizumab and dupilumab for OCS dosage reduction, OCS elimination, and annual exacerbation rate reduction. Comparatively low effective sample sizes indicated substantial differences for patient populations between ZONDA and mepolizumab and dupilumab trials.

Background Pulmonary rehabilitation (PR) improves exercise capacity, health-related quality of life (HRQoL) and dyspnea in chronic obstructive pulmonary disease (COPD) patients. Maintenance programs can sustain the benefits for 12 to 24 months. Yet, the long-term effects (> 12 months) of pragmatic maintenance programs in real-life settings remain unknown. This prospective cohort study assessed the yearly evolution in the outcomes [6-min walking distance (6MWD), HRQoL, dyspnea] of a supervised self-help PR maintenance program for COPD patients followed for 5 years. The aim was to assess the change in the outcomes and survival probability for 1 to 5 years after PR program discharge in COPD patients following a PR maintenance program supported by supervised self-help associations. Methods Data were prospectively collected from 144 COPD patients who followed a pragmatic multidisciplinary PR maintenance program for 1 to 5 years. They were assessed yearly for 6MWD, HRQol (VQ11) and dyspnea (MRC). The 5-year survival probability was compared to that of a control PR group without a maintenance program. A trajectory-based cluster analysis identified the determinants of long-term response. Results Maintenance program patients showed significant PR benefits at 4 years for 6MWD and VQ11 and 5 years for MRC. The 5-year survival probability was higher than for PR patients without PR maintenance. Two clusters of response to long-term PR were identified, with responders being the less severe COPD patients. Conclusions This study provides evidence of the efficacy of a pragmatic PR maintenance program in a real-life setting for more than 3 years. In contrast to short-term PR, long-term PR maintenance appeared more beneficial in less severe COPD patients.

International audience; The relationship between cancer and primary Sjögren's syndrome (pSS) is uncertain. While the increased risk of hematological malignancies is well-known, data on the comparative incidence of solid neoplasms is conflicting. This study aimed to explore the associations between cancer and pSS. This nationwide population-based retrospective study from the French health insurance database (PMSI) evaluated patients hospitalized with new-onset pSS from 2011 to 2018 against age- and sex-matched hospitalized controls (1:10). The incidence of hematological malignancies and solid neoplasms was compared between the two groups. Mortality and multiple cancer incidence were also evaluated. Adjusted Hazard Ratios (aHR) calculations included confounding factors, such as low socioeconomic status. Among 25,661 hospitalized patients with pSS versus 252,543 matched patients (median follow-up of 3.96 years), we observed a higher incidence rate of lymphomas (aHR, 1.97 [95% CI, 1.59-2.43]), Waldenström macroglobulinemia (aHR, 10.8 [6.5-18.0]), and leukemia (aHR, 1.61 [1.1-2.4]). Thyroid cancer incidence was higher (aHR, 1.7 [1.1-2.8]), whereas bladder and breast cancer incidences were lower (aHR, 0.58 [0.37-0.89] and 0.60 [0.49-0.74], respectively). pSS patients with breast cancer exhibited a lower mortality rate. A limitation was that the database only encompasses hospitalized patients, and immunological and histological details are not listed. We confirmed the increased risk of hematological malignancies and thyroid cancers among patients with pSS. The lower risk of breast cancer suggests a role of hormonal factors and raises questions of the concept of immune surveillance within breast tissue. Epidemiological and translational studies are required to elucidate the relationships between pSS and cancer.

Background Critical care randomized controlled trials (RCTs) are often published in high-impact journals, whether general journals [the New England Journal of Medicine (NEJM), The Lancet, the Journal of the American Medical Association (JAMA)] or critical care journals [Intensive Care Medicine (ICM), the American Journal of Respiratory and Critical Care Medicine (AJRCCM), Critical Care Medicine (CCM)]. As rejection occurs in up to 97% of cases, it might be appropriate to assess pre-submission probability of being published. The objective of this study was to develop and internally validate a simplified score predicting whether an ongoing trial stands a chance of being published in high-impact general journals. Methods A cohort of critical care RCTs published between 1999 and 2018 in the three highest impact medical journals (NEJM, The Lancet, JAMA) or the three highest impact critical care journals (ICM, AJRCCM, CCM) was split into two samples (derivation cohort, validation cohort) to develop and internally validate the simplified score. Primary outcome was journal of publication assessed as high-impact general journal (NEJM, The Lancet, JAMA) or critical care journal (ICM, AJRCCM, CCM). Results A total of 968 critical care RCTs were included in the predictive cohort and split into a derivation cohort (n = 510) and a validation cohort (n = 458). In the derivation cohort, the sample size (P value P value = 0.01), mortality as primary outcome (P value = 0.002) or a composite item including mortality as primary outcome (P value = 0.004), and topic [ventilation (P value P value Conclusions The SCOTI score, developed and validated by split sample, accurately predicts the chances of a critical care RCT being published in high-impact general journals, compared to high-impact critical care journals.

Objectives The role of health-related quality of life (HRQoL) and psychological variables in pulmonary arterial hypertension (PAH) progression remains poorly quantified. We aimed to investigate the relationship between disease progression in PAH patients and HRQoL and psychological characteristics. Methods A 3-year longitudinal cohort was initiated. Patients with stable PAH (groups I–IV ineligible for angioplasty/endarterectomy) were included (n=55). Standard clinical variables, including invasive haemodynamic parameters, were prospectively recorded. A battery of questionnaires was used to characterise the psychological status of patients upon study initiation, and HRQoL was quantified using the SF-36 Questionnaire every 3 months for 24 months, and then again at 36 months. Guideline-defined disease progression and progression-free survival were recorded for 36 months. Measurements and main results Psychological distress was highly prevalent at baseline. The Physical Component Summary (PCS) and the Mental Component Summary (MCS) of the HRQoL were poor (PCS=37.13±8.18; MCS=42.42±10.88) but stable over 3 years of follow-up. Among PCS subscales, Physical Functioning (PF) (p=0.012) was identified as being independently associated with disease progression (Cox survival model), along with mean pulmonary arterial pressure (p=0.003) and cardiac output (p=0.005). Depression was the unique independent psychological characteristic associated with PF (p=0.0001). Conclusions PAH patients have poor HRQoL. In addition to already known criteria related to disease severity, the HRQoL PF subscale is independently associated with disease progression in PAH. This may be explained by depression., Baseline subscale SF-36 Physical Functioning questionnaire for PAH patients is independently associated with disease progression at 3 years. HRQoL should be considered as a complement to risk assessment criteria. https://bit.ly/3mrZhHT

Rationale: Prolonged mechanical ventilation is often associated with either a decrease (known atrophy) or an increase (supposed injury) in diaphragmatic thickness. Shear wave elastography is a noni...

Background Pectoral nerve blocks have been proposed for analgesia during and after breast cancer surgery, but data are conflicted in aesthetic breast surgery. This trial tested the primary hypothesis that adding a preincisional pectoral nerve block is superior to systemic multimodal analgesic regimen alone for pain control after breast augmentation surgery. A second hypothesis is that rescue opioid consumption would be decreased with a long-lasting effect for both outcomes during the following days. Methods Seventy-three adult female patients undergoing aesthetic breast augmentation surgery under general anesthesia were randomly allocated to receive a pectoral nerve block versus no block. Both groups received standard care with protocolized multimodal analgesia alone including systematic acetaminophen and nonsteroidal anti-inflammatory drugs. The primary outcome measure was the maximal numerical rating scale in the first 6 h after extubation. Secondary outcomes included intraoperative remifentanil consumption and from extubation to day 5: maximal numerical rating scale, postoperative cumulative opioid consumption and postoperative opioid side effects, and patient satisfaction recorded at day 5. Results The maximal numerical rating scale score in the first 6 h was lower in the pectoral nerve block group compared with the control group (3.9 ± 2.5 vs. 5.2 ± 2.2; difference: –1.2 [95% CI, –2.3 to –0.1]; P = 0.036). The pectoral nerve block group had a lower maximal numerical rating scale between days 1 and 5 (2.2 ± 1.9 vs. 3.2 ± 1.7; P = 0.032). The cumulative amount of overall opioids consumption (oral morphine equivalent) was lower for the pectoral nerve block group from hour 6 to day 1 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 31.5] mg, P = 0.006) and from days 1 to 5 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 51] mg, P = 0.002). Conclusions Pectoral nerve block in conjunction with multimodal analgesia provides effective perioperative pain relief after aesthetic breast surgery and is associated with reduced opioid consumption over the first 5 postoperative days. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

BACKGROUND: Accurate identification of insufficient future liver remnant (FLR) is required to select patients for liver preparation and limit the risk of post-hepatectomy liver failure (PHLF). The objective of this study was to investigate the correlations and discrepancies between the most-commonly used FLR volume metrics and (99m)Tc-mebrofenin hepatobiliary scintigraphy (HBS). METHODS: In 101 non-cirrhotic patients who underwent HBS before major hepatectomy, we retrospectively analyzed the correlations and discrepancies between FLR function and FLR volume metrics: actual percentage (FLRV%), standardized to body surface area (FLRV%(BSA)) and weight (FLRV%(weight)), and FLR to body weight ratio (FLRV-BWR). RESULTS: Among 67 patients with FLR function ≥2.69%/min/m(2), PHLF was observed in none and 13 patients according to respectively 50-50 and ISGLS criteria. FLRV%, FLRV%(BSA), FLRV%(weight) and FLRV-BWR significantly correlated with FLR function (P

Background and purpose Carotid webs (CaW) may be an under-recognized cause of anterior circulation cryptogenic ischemic stroke (ACIS). Prevalence is still unknown in European patients with ACIS. Objective To evaluate the prevalence of CaW in ACIS and describe patients with CaW phenotype in a cohort of patients from a French stroke center. Methods We conducted a retrospective monocentric cohort study from 01/01/2015 to 31/12/2019 (Montpellier University Hospital, France), in consecutive anterior ischemic stroke (AIS) patients ≤65 years old from a prospective stroke database. Using ASCOD phenotyping, ACIS patients were selected and cervical CTA were reviewed to find CaW. Results Among 1053 consecutive AIS patients, 266 ACIS patients with CTA were included. Among patients included (mean age 50, women 58%), CaW was in the ipsilateral carotid (iCaW) in 21 patients: 7.9% (95%CI [4.6–11.1]), (mean age 51, 11 women, 16 Caucasian). iCaW were uncovered during study review of CTA in 6/21 (29%) patients. Comparison between patients with iCaW and those without iCaW showed no differences except that of a higher rate of intracranial large vessel occlusion (LVO) (62.4 vs 37.6%; p = 0.03). Patients with iCaW under conservative medical therapy had an annualized stroke recurrence rate (SRR) of 11.4% (95%CI [8.4–15.1]. Conclusions iCaW was identified as a source of stroke in about 8% of a French population ≤65 years with ACIS. iCaW was associated with a higher rate of LVO and a high SRR under conservative medical therapy.

Background Patients affected with aneurysmal subarachnoid hemorrhage (aSAH) often require intensive care, and then present distinctive outcome from less severe patients. We aimed to specify their long-term outcome and to identify factors associated with poor outcome. Methods We conducted a retrospective study in a French university hospital intensive care unit. Patients with aSAH requiring mechanical ventilation hospitalized between 2010 and 2015 were included. At least one year after initial bleeding, survival and degree of disability were assessed using the modified Rankin Scale (mRS) via telephone interviews. A multivariable logistic regression analysis was performed to determine independent factors associated with poor outcome defined as mRS≥3. Results Two-hundred thirty-six patients were included. Among them, 7 were lost to follow-up, and 229 were analyzed: 73 patients (32%) had a good outcome (mRS Conclusion Among aSAH patients requiring assisted ventilation, two-third of them survived at one year, and one-third showed good long-term outcome. As it appears as an independant factor associated with poor outcome, DCI shoud retain particular attention in future studies beyond angiographic vasospasm.

BACKGROUND: Recent advancements in computed tomography (CT) scanning and post processing have provided new means of assessing factors affecting respiratory function. For lung cancer patients requiring resection, and especially those with respiratory comorbidities such as chronic obstructive pulmonary disease (COPD), the ability to predict post-operative lung function is a crucial step in the lung cancer operability assessment. The primary objective of the CLIPPCAIR study is to use novel CT data to develop and validate an algorithm for the prediction of lung function remaining after pneumectomy/lobectomy. METHODS: Two sequential cohorts of non-small cell lung cancer patients requiring a pre-resection CT scan will be recruited at the Montpellier University Hospital, France: a test population (N=60) on which predictive models will be developed, and a further model validation population (N=100). Enrolment will occur during routine pre-surgical consults and follow-up visits will occur 1 and 6 months after pneumectomy/lobectomy. The primary outcome to be predicted is forced expiratory volume in 1 second (FEV1) six months after lung resection. The baseline CT variables that will be used to develop the primary multivariable regression model are: expiratory to inspiratory ratios of mean lung density (MLD(e/i) for the total lung and resected volume), the percentage of voxels attenuating at less than ‒950 HU (PVOX(‒950) for the total lung and resected volume) and the ratio of iodine concentrations for the resected volume over that of the total lung. The correlation between predicted and real values will be compared to (and is expected to improve upon) that of previously published methods. Secondary analyses will include the prediction of transfer factor for carbon monoxide (TLCO) and complications in a similar fashion. The option to explore further variables as predictors of post-resection lung function or complications is kept open. DISCUSSION: Current methods for estimating post-resection lung function are imperfect and can add assessments (such as scintigraphy) to the pre-surgical workup. By using CT imaging data in a novel fashion, the results of the CLIPPCAIR study may not only improve such estimates, it may also simplify patient pathways. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03885765).

BackgroundThe sensory innervation of the lower jaw mainly depends on the third root of the trigeminal nerve, the mandibular nerve (V3). The aim of this single-center, prospective, randomized, double-blind, placebo-controlled study was to evaluate the effectiveness of bilateral V3 block for postoperative analgesia management in mandibular osteotomies.Methods107 patients undergoing mandibular surgery (75 scheduled osteotomies and 32 mandible fractures) were randomized in two groups. A bilateral V3 block was performed in each group, either with ropivacaine 0.75% (block group, n=50) or with a placebo (placebo group, n=57). A postoperative multimodal analgesia was equally provided to both groups. The primary outcome was the cumulative morphine consumption at 24 hours. Secondary outcomes were the occurrence of severe pain and the incidence of postoperative nausea and vomiting (PONV) in the first 24 hours. Data were analyzed on an intention-to-treat basis.ResultsThe cumulative morphine consumption at 24 hours was significantly lower in the block group (median 8.0 mg (IQR 2.0–21.3) vs 12.0 mg (IQR 8.0–22.0), p=0.03), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, pConclusionBilateral V3 block for mandibular osteotomies is an effective opioid-sparing procedure. It provided better postoperative analgesia in the first 24 hours, and it did not affect PONV incidence.Trial registration numberNCT02618993.

Background Transcranial sonography is a point-of-care tool recommended in intensive care units (ICU) to monitor brain injured patients. Objectives of the study was to assess feasibility and reliability of the third ventricle (V3) diameter measurement using transcranial sonography (TCS) compared to brain computed-tomography (CT), the gold standard measurement, and to measure the TCS learning curve. Design: prospective study, in a 16-bed neurological ICU in an academic hospital. Every consecutive brain injured adult patient, who required a brain CT and TCS monitoring were included. The V3 diameter was blindly measured by TCS and CT. Intraclass correlation coefficient (ICC) and Bland–Altman plot were used to assess the reliability and agreement between TCS and CT V3 measurements. Diagnosis performance of the V3 diameter using TCS to detect hydrocephalus was measured. Absolute difference between V3 measurement by residents and experts was measured consecutively to assess the learning curve. Results Among the 100 patients included in the study, V3 diameter could be assessed in 87 patients (87%) from at least one side of the skull. Both temporal windows were available in 70 patients (70%). The ICC between V3 diameter measured by TCS and CT was 0.90 [95% CI 0.84–0.93] on the right side, and 0.92 [0.88–0.95] on the left side. In Bland–Altman analysis, mean difference, standard deviation, 95% limits of agreement were 0.36, 1.52, − 2.7 to 3.3 mm, respectively, on the right side; 0.25, 1.47, − 2.7 to 3.1 mm, respectively, on the left side. Among the 35 patients with hydrocephalus, V3 diameters could be measured by TCS in 31 patients (89%) from at least one side. Hydrocephalus was, respectively, excluded, confirmed, or inconclusive using TCS in 35 (40%), 25 (29%) and 27 (31%) of the 87 assessable patients. After 5 measurements, every resident reached a satisfactory measurement compared to the expert operator. Conclusion TCS allows rapid, simple and reliable V3 diameter measurement compared with the gold standard in neuro-ICU patients. Aside from sparing irradiating procedures and transfers to the radiology department, it may especially increase close patient monitoring to detect clinically occult hydrocephalus earlier. Further studies are needed to measure the potential clinical benefit of this method. Trial registration: ClinicalTrials.gov ID: NCT02830269.

International audience; Aims Optimizing medical cardiac treatment for sleep apnoea (SA) in patients with chronic heart failure and reduced ejection fraction (HFrEF) is an expert Grade C recommendation based on six studies encompassing a total of 67 patients only. Whether sacubitril-valsartan (SV), a cornerstone of HFrEF medical treatment, impacts SA is unknown and requires evaluation.Methods and results The ENTRESTO-SAS trial is a six-centre, prospective, open-label real-life cohort study (NCT02916160). Ambulatory patients eligible for SV (i.e. HFrEF adults who remain symptomatic despite optimal treatment) were evaluated before and after 3 months of SV (including nocturnal ventilatory polygraphy); 118 patients were final analysed [median age was 66 (IQ 25-75 : 56-73) years, 81.4% male, 36.5% New York Heart Association III-IV, N-terminal pro-B-type natriuretic peptide level of 1564 (701-3376) ng/L, left ventricular ejection fraction of 30 (25-34)%, 60.7% ischaemic HFrEF, 97.5% initially treated with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, 83.9% with beta-blockers, 64.4% with mineralocorticoid receptor antagonists, and 74.6% with diuretics]. Three groups were defined according to initial central/obstructive apnoea-hypopnoea indices (AHIs): G1 (n = 49, AHI central ≥ 5/h and AHI obstructive < 15/h); G2 (n = 27, AHI obstructive ≥ 15/h); and G3 (n = 42, AHI central < 5/h and AHI obstructive < 15/h). At 3 months, the AHI (main predefined outcome) decreased significantly by À7.10/h (IQ 25-75 : À16.10 to 0.40; P < 0.001) in G1 + G2 without positive airway pressure treatment (45 patients, median initial AHI of 24.20 (IQ 25-75 : 16.40-43.50)/h). Of these, 24.4% presented an AHI decrease ≥50% and 37.78% had a final AHI < 15/h (tendency for improvement from an initial value of 20%: P = 0.0574). For G1 patients (n = 37), AHI significantly decreased from a median of 22.90 (16.00-43.50)/h to 19.20 (12.70-31.10)/h (P = 0.002). For G2 patients (n = 8), AHI decreased from a median of 30.10 (26.40-47.60)/h to 22.75 (14.60-36.90)/h (statistically non-significant, P = 0.059).Conclusions In this real-life population, SV treatment for 3 months in SA patients is associated with a significant decrease in AHI. These results support the current guidelines that recommend first an optimization of the HFrEF treatment in patients with HFrEF and central SA. A potential positive airway pressure sparing effect merits further investigation.

In patients with chronic obstructive pulmonary disease (COPD) who experience further exacerbations or symptoms, despite being prescribed dual long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) or inhaled corticosteroid (ICS)/LABA therapies, triple ICS/LAMA/LABA therapy is recommended. A previous network meta-analysis showed comparable efficacy of the ICS/LAMA/LABA, budesonide/glycopyrronium bromide/formoterol fumarate (BUD/GLY/FOR) 320/18/9.6 µg, to other fixed-dose and open combination triple therapies at 24 weeks in COPD. Subsequently, the ETHOS study was published, including data for 8509 patients, assessing the efficacy and safety of BUD/GLY/FOR over 52 weeks. This network meta-analysis (NMA) was conducted to compare the relative efficacy, safety, and tolerability of BUD/GLY/FOR 320/18/9.6 µg with other fixed-dose and open combination triple therapies in COPD over 52 weeks, including data from ETHOS. A systematic literature review was conducted to identify ≥ 10-week randomized controlled trials, including ≥ 1 fixed-dose or open combination triple-therapy arm, in patients with moderate-to-very severe COPD. The methodologic quality and risk of bias of included studies were assessed. Study results were combined using a three-level hierarchical Bayesian NMA model to assess efficacy and safety outcomes at or over 24 and 52 weeks. Meta-regression and sensitivity analyses were used to assess heterogeneity across studies. Nineteen studies (n = 37,741 patients) met the inclusion criteria of the review; 15 contributed to the base case network. LAMA/LABA dual combinations were combined as a single treatment group to create a connected network. Across all outcomes for exacerbations, lung function, symptoms, health-related quality of life, safety, and tolerability, the efficacy and safety of BUD/GLY/FOR were comparable to those of other triple ICS/LAMA/LABA fixed-dose (fluticasone furoate/umeclidinium/vilanterol and beclomethasone dipropionate/glycopyrronium bromide/formoterol fumarate) and open combinations at or over 24 and 52 weeks. Sensitivity analyses and meta-regression results for exacerbation outcomes were broadly in line with the base case NMA. In this NMA, BUD/GLY/FOR 320/18/9.6 μg showed comparable efficacy versus other ICS/LAMA/LABA fixed-dose or open combination therapies in terms of reducing exacerbation rates and improving lung function, symptoms and health-related quality of life in patients with moderate-to-very-severe COPD, in line with previously published meta-analysis results of triple combinations in COPD. The safety and tolerability profile of BUD/GLY/FOR was also found to be comparable to other triple combination therapies. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01703-z.

During pregnancy the formation of alloreactive anti-human leukocyte antigen (HLA) antibodies are a major cause of acute rejection in organ transplantation and of adverse effects in blood transfusion. The purpose of the study was to identify maternal HLA class Ib genetic factors associated with anti-HLA allo-immunization in pregnancy and the degree of tolerance estimated by IgG4 expression. In total, 86 primiparous women with singleton pregnancies were included in the study. Maternal blood samples and umbilical cord samples were collected at delivery. Clinical data were obtained. Maternal blood serum was screened for HLA class I and II antibodies, identification of Donor Specific Antibody (DSA), activation of complement measured by C1q and IgG4 concentrations. Mothers were genotyped for HLA class Ib (HLA-E, -F and -G). Anti-HLA class I and II antibodies were identified in 24% of the women. The maternal HLA-E*01:06 allele was significantly associated with a higher fraction of anti-HLA I immunization (20.0% vs. 4.8%, p = 0.048). The maternal HLA-G 3’-untranslated region UTR4-HLA-G*01:01:01:05 haplotype and the HLA-F*01:03:01 allele were significantly associated with a low anti-HLA I C1q activation (16.7% vs. 57.1%, p = 0.028; 16.7% vs. 50.0%, p = 0.046; respectively). Both HLA‑G and HLA-F*01:03:01 showed significantly higher levels of IgG4 compared with the other haplotypes. The results support an association of certain HLA class Ib alleles with allo-immunization during pregnancy. Further studies are needed to elucidate the roles of HLA-E*01:06, HLA-F*01:03 and HLA‑G UTR4 in reducing the risk for allo-immunization.

The objective was to assess the changes in regional volumes and functions under venous-impaired vascular conditions following liver preparation. Twelve patients underwent right portal vein embolization (PVE) (n = 5) or extended liver venous deprivation (eLVD, i.e., portal and right and middle hepatic veins embolization) (n = 7). Volume and function measurements of deportalized liver, venous-deprived liver and congestive liver were performed before and after PVE/eLVD at days 7, 14 and 21 using 99mTc-mebrofenin hepatobiliary scintigraphy with single-photon emission computed tomography and computed tomography (99mTc-mebrofenin SPECT-CT). Volume and function progressed independently in the deportalized liver (p = 0.47) with an early decrease in function (median −18.2% (IQR, −19.4–−14.5) at day 7) followed by a decrease in volume (−19.3% (−22.6–−14.4) at day 21). Volume and function progressed independently in the venous deprived liver (p = 0.80) with a marked and early decrease in function (−41.1% (−52.0–−12.9) at day 7) but minimal changes in volume (−4.7% (−10.4–+3.9) at day 21). Volume and function progressed independently in the congestive liver (p = 0.21) with a gradual increase in volume (+43.2% (+38.3–+51.2) at day 21) that preceded a late and moderate increase in function at day 21 (+34.8% (−8.3–+46.6)), concomitantly to the disappearance of hypoattenuated congestive areas in segment IV (S4) on CT, initially observed in 6/7 patients after eLVD and represented 35.3% (22.2–46.4) of whole S4 volume. Liver volume and function progress independently whatever the vascular condition. Hepatic congestion from outflow obstruction drives volume increase but results in early impaired function.

International audience; Purpose: The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear. We hypothesised that the first-attempt intubation success rate would be higher with tracheal tube + stylet than with tracheal tube alone.Methods: In this multicentre randomised controlled trial, conducted in 32 intensive care units, we randomly assigned patients to tracheal tube + stylet or tracheal tube alone (i.e. without stylet). The primary outcome was the proportion of patients with first-attempt intubation success. The secondary outcome was the proportion of patients with complications related to tracheal intubation. Serious adverse events, i.e., traumatic injuries related to tracheal intubation, were evaluated.Results: A total of 999 patients were included in the modified intention-to-treat analysis: 501 (50%) to tracheal tube + stylet and 498 (50%) to tracheal tube alone. First-attempt intubation success occurred in 392 patients (78.2%) in the tracheal tube + stylet group and in 356 (71.5%) in the tracheal tube alone group (absolute risk difference, 6.7; 95%CI 1.4-12.1; relative risk, 1.10; 95%CI 1.02-1.18; P = 0.01). A total of 194 patients (38.7%) in the tracheal tube + stylet group had complications related to tracheal intubation, as compared with 200 patients (40.2%) in the tracheal tube alone group (absolute risk difference, - 1.5; 95%CI - 7.5 to 4.6; relative risk, 0.96; 95%CI 0.83-1.12; P = 0.64). The incidence of serious adverse events was 4.0% and 3.6%, respectively (absolute risk difference, 0.4; 95%CI, - 2.0 to 2.8; relative risk, 1.10; 95%CI 0.59-2.06. P = 0.76).Conclusions: Among critically ill adults undergoing tracheal intubation, using a stylet improves first-attempt intubation success.

BACKGROUND In critically ill patients, warnings about a risk of death and acute kidney injury (AKI) with hydroxyethyl starch (HES) solutions have been raised. However, HES solutions may yet have a role to play in major abdominal surgery. This meta-analysis and trial sequential analysis (TSA) aimed to investigate the effect of HES intravascular volume replacement on the risk of AKI, intraoperative blood transfusion, and postoperative intra-abdominal complications compared to crystalloid intravascular volume replacement. METHODS In this meta-analysis and TSA, we searched for randomized controlled trials (RCTs) comparing intraoperative HES intravascular volume replacement to crystalloid intravascular volume replacement in adult patients undergoing major abdominal surgery. Primary outcome was 30-day AKI, defined as a binary outcome according to Kidney Disease Improving Global Outcomes (KDIGO) criteria, combining stages 1, 2, and 3 into an AKI category versus no AKI category (stage 0). Secondary outcomes included rates of intraoperative blood transfusion and postoperative intra-abdominal complications. We used random effects models to calculate summary estimates. We used relative risk (RR) as summary measure for dichotomous outcomes, with corresponding 95% confidence intervals (CIs) for the primary outcome (P value

Background For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as Methods The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS. Results 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ25–75: 60–74), initial Apnea–Hypopnea-Index (AHI) of 39 (31–56)/h, residual AHIflow was 1.9 (0.9–4) events/h), CPAP-treatment lasted 4.4 (2.0–9.7) years, CPAP-usage was 6.8 (5.5–7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p Conclusion In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).

International audience; Objective: The therapeutic strategies for hepatocellular carcinoma (HCC) have greatly expanded in recent years. However, the actual usage of each of these treatments in clinical routine remains unknown. Here, we analysed the distribution and changes of the main surgical and radiological therapeutic procedures nationwide during the last decade.Methods: Retrospectively, analysis of the data on all >18-year-old patients with a diagnosis of HCC identified in the French Program for the Medicalization of Information Systems database that contains all discharge summaries from all French hospitals. The number and percentage of the therapeutic procedures performed from January 2010 to December 2019 were extracted.Results: A total of 68,416 therapeutic procedures were performed in 34,000 HCC patients. Whereas HCC incidence remained stable, the annual number of procedures frankly increased over the decade (from 4267 to 8042). Trans-arterial chemoembolization was the most frequently performed technical procedure, with a double-digit annual growth from 2010 (n = 1932) to 2015 (n = 4085), before stabilization from 2016. Selective internal radiation therapy displayed the highest increase in the decade (+475%). Among curative treatments, the annual number of percutaneous tumour ablations more than doubled in 10 years, till representing 64% of curative treatments in cirrhotic patients in 2019. Surgical tumour resections showed a 1.5-fold increase in 10 years, due to the great increase in minimally invasive approaches, whereas the proportion of open resection progressively decreased.Conclusion: Minimally invasive procedures have gained major importance in HCC management during the last decade. Percutaneous thermal ablation has emerged as the first curative treatment performed for patients with HCC.Trial registration: ClinicalTrials.gov NCT04163627.

Background Muscle weakness following critical illness is the consequence of loss of muscle mass and alteration of muscle quality. It is associated with long-term disability. Ultrasonography is a reliable tool to quantify muscle mass, but studies that evaluate muscle quality at the critically ill bedside are lacking. Shear wave ultrasound elastography (SWE) provides spatial representation of soft tissue stiffness and measures of muscle quality. The reliability and reproducibility of SWE in critically ill patients has never been evaluated. Methods Two operators tested in healthy controls and in critically ill patients the intra- and inter-operator reliability of the SWE using transversal and longitudinal views of the diaphragm and limb muscles. Reliability was calculated using the intra-class correlation coefficient and a bootstrap sampling method assessed their consistency. Results We collected 560 images. Longitudinal views of the diaphragm (ICC 0.83 [0.50–0.94]), the biceps brachii (ICC 0.88 [0.67–0.96]) and the rectus femoris (ICC 0.76 [0.34–0.91]) were the most reliable views in a training set of healthy controls. Intra-class correlation coefficient for inter-operator reproducibility and intra-operator reliability was above 0.9 for all muscles in a validation set of healthy controls. In critically ill patients, inter-operator reproducibility and intra-operator 1 and 2 reliability ICCs were respectively 0.92 [0.71–0.98], 0.93 [0.82–0.98] and 0.92 [0.81–0.98] for the diaphragm; 0.96 [0.86–0.99], 0.98 [0.94–0.99] and 0.99 [0.96–1] for the biceps brachii and 0.91 [0.51–0.98], 0.97 [0.93–0.99] and 0.99 [0.97–1] for the rectus femoris. The probability to reach intra-class correlation coefficient greater than 0.8 in a 10,000 bootstrap sampling for inter-operator reproducibility was respectively 81%, 84% and 78% for the diaphragm, the biceps brachii and the rectus femoris respectively. Conclusions SWE is a reliable technique to evaluate limb muscles and the diaphragm in both healthy controls and in critically ill patients. Trial registration The study was registered (ClinicalTrial NCT03550222).

The present study assessed the proportion of intensive care unit (ICU) patients who had a vancomycin serum concentration between 20 and 25 mg/L after 24&ndash, 48 h of intravenous vancomycin administration. From 2016 to 2018, adult ICU patients with vancomycin continuous infusion (CI) for any indication were included. The primary outcome was the proportion of patients with a first-available vancomycin serum concentration between 20&ndash, 25 mg/L at 24 h (D2) or 48 h (D3). Of 3894 admitted ICU patients, 179 were included. A median loading dose of 15.6 (interquartile range (IQR) = (12.5&ndash, 20.8) mg/kg) was given in 151/179 patients (84%). The median daily doses of vancomycin infusion for D1 and D2 were 2000 [(IQR (1600&ndash, 2000)) and 2000 (IQR (2000&ndash, 2500)) mg/d], respectively. The median duration of treatment was 4 (2&ndash, 7) days. At D2 or D3, the median value of first serum vancomycin concentration was 19.8 (IQR (16.0&ndash, 25.1)) with serum vancomycin concentration between 20&ndash, 25 mg/L reported in 43 patients (24%). Time spent in the ICU before vancomycin initiation was the only risk factor of non-therapeutic concentration at D2 or D3. Acute kidney injury occurred significantly more when vancomycin concentration was supra therapeutic at D2 or D3. At D28, 44 (26%) patients had died. These results emphasize the need of appropriate loading dose and regular monitoring to improve vancomycin efficacy and avoid renal toxicity.

Tracheal intubation is one of the most daily practiced procedures performed in intensive care unit (ICU). It is associated with severe life-threatening complications, which can lead to intubation-related cardiac arrest. Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; to facilitate passage of the tube through the laryngeal inlet. However, some complications from stylets have been reported including mucosal bleeding, perforation of the trachea or oesophagus and sore throat. The use of a stylet for first-attempt intubation has never been assessed in ICU and benefit remains to be established., ClinicalTrials.gov Identifier: NCT04079387; Pre-results.

International audience

IntroductionRecurrent vasovagal syncope (VVS) is associated with decreased quality-of-life and frequent use of emergency services. The evidence base for causality, diagnostic procedures and potential VVS treatments is poor. Scattered observations in the literature suggest a link between respiratory disturbances during sleep and VVS. Empirical observations lead us to further hypothesise that the appropriate management of sleep apnoea syndrome (SAS) may help resolve comorbid recurrent VVS in certain patients. We therefore designed this pilot study to provide a framework for the observation of changes in outcomes accompanying the deployment of SAS treatments in patients with VVS.Methods and analysisThis is a multicentre, registry-based study whose primary objective is to evaluate the effect of SAS management on the number of syncope/presyncope episodes in a population suffering from both VVS and SAS. To this effect, syncope rates prior to the treatment of SAS will be compared with those occurring after the initiation of the latter. In addition, yearly assessments will collect data for echocardiography, polysomnography, Holter monitoring, table tilt tests, multiple sleep latency tests, SAS management parameters and questionnaires describing fatigue, depression and quality-of-life. Sixty patients will be included with a minimum follow-up period of 12 months. The primary analysis will use comparisons of centrality for paired data to describe the changes in syncope rates before versus after the initiation of SAS management. Longitudinal data will be analysed using mixed models with patients set as a random effect. Subgroup analyses will be performed for SAS-treatment adherence and efficacy.Ethics and disseminationThe VVS-SAS registry was approved by an ethics committee (Comité pour la Protection des Personnes Ile-de-France VI, Reference number CPP/2-18) in accordance with French law. The princeps publication will present before–after SAS management results and longitudinal analyses.Trial registration numberNCT04294524. Pre-results.

Backgrounds To explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices). Methods The OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups (k-means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer’s software for 6 months. Results One hundred seventy-seven patients (87.57% male) were analysed with a median (IQ25–75) initial Apnea-Hypopnea-Index of 50 (38–62)/h, an ASV-treatment duration of 2.88 (1.76–4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k-means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 (p = 0.029) and C4 (p = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 (p = 0.006) and C2 (p p = 0.002) and ASV-V (p Conclusions Real-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety. Trial registration The OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986). 1 April 2015.

Background. The new coronavirus SARS-CoV-2, responsible for the Covid-19 pandemic, uses the angiotensin converting enzyme type 2 (ACE2), a physiological inhibitor of the renin angiotensin aldosterone system (RAAS), as a cellular receptor to infect cells. Since the RAAS can induce and modulate pro-inflammatory responses, it could play a key role in the pathophysiology of Covid-19. Thus, we aimed to determine the levels of plasma renin and aldosterone as indicators of RAAS activation in a series of consecutively admitted patients for Covid-19 in our clinic. Methods. Plasma renin and aldosterone levels were measured, among the miscellaneous investigations needed for Covid-19 management, early after admission in our clinic. Disease severity was assessed using a seven-category ordinal scale. Primary outcome of interest was the severity of patients&rsquo, clinical courses. Results. Forty-four patients were included. At inclusion, 12 patients had mild clinical status, 25 moderate clinical status and 7 severe clinical status. In univariate analyses, aldosterone and C-reactive protein (CRP) levels at inclusion were significantly higher in patients with severe clinical course as compared to those with mild or moderate course (p &lt, 0.01 and p = 0.03, respectively). In multivariate analyses, only aldosterone and CRP levels remained positively associated with severity. We also observed a positive significant correlation between aldosterone and CRP levels among patients with an aldosterone level greater than 102.5 pmol/L. Conclusions. Both plasmatic aldosterone and CRP levels at inclusion are associated with the clinical course of Covid-19. Our findings may open new perspectives in the understanding of the possible role of RAAS for Covid-19 outcome.

Background Veno-arterial extracorporeal life support (VA-ECLS) results in cardiopulmonary shunting with reduced native cardiac output (NCO). Low NCO occurrence is common and associated with risk of thromboembolic and pulmonary complications. Practical tools for monitoring NCO during VA-ECLS would therefore be valuable. Pulse pressure (PP) and end-tidal carbon dioxide (EtCO2) are known to be related to cardiac output. We have designed a study to test whether PP and EtCO2 were efficient for the monitoring of NCO during VA-ECLS. Methods In this prospective single-center observational study, patients who underwent a VA-ECLS for cardiogenic shock from January 2016 to October 2017 were included, provided low NCO was suspected by a PP 2. The ability of PP and EtCO2 to predict NCO Results Among the 106 patients treated with VA-ECLS for cardiogenic shock during the study period, 26 were studied, allowing the collection of 196 study points. PP and EtCO2 relationships with NCO were nonlinear and showed strong correlations for NCO r = 0.69 and r = 0.78 respectively). A PP 2 p = 0.058). Conclusions PP and EtCO2 may offer an accurate real-time monitoring of low NCO events during VA-ECLS support. Further studies are needed to show if their utilization may help to implement therapeutic strategies in order to prevent thromboembolic and respiratory complications associated with VA-ECLS, and to improve patients’ prognosis. Trial registration NCT03323268, July 12, 2016

Background: Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.Methods: Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.Discussion: Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible., ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.

Anti-transcriptional intermediary factor-1γ (TIF-1γ) autoantibody may be associated with cancer in adult patients with dermatomyositis. The aim of this study was to evaluate the risk of cancer in the presence of anti-TIF-1γ autoantibody in adult dermatomyositis. A comprehensive database search of EMBASE, MEDLINE and the Cochrane Library up to May 2018 was performed using the main key words “dermatomyositis”, “”myositis”, “inflammatory myopathies” and “anti-TIF-1”. Eighteen studies, with a total of 1,962 dermatomyositis, were included in the meta-analysis. The pooled prevalence of cancer-associated dermatomyositis in patients with anti-TIF-1γ autoantibody was 0.41 (95% confidence interval (CI) 0.36–0.45). In the presence of anti-TIF-1γ autoantibody, the overall diagnostic odds ratio of cancer was 9.37 (95% CI 5.37–16.34) with low heterogeneity (Cochran’s Q: 14.88 (df = 17, p = 0.604); I2 = 0%). The results of this systematic review confirm that detection of anti-TIF-1γ autoantibody is a valuable tool to identify a subset of adult dermatomyositis patients with higher risk of cancer.

International audience; Objective: Compare different imaging scenarios in the diagnosis of uncomplicated renal colic due to urolithiasis (URCU).Materials and methods: A total of 206 prospectively included patients had been admitted with suspected URCU and had undergone abdominal plain film (APF), US and unenhanced CT after clinical STONE score evaluation. CT was the reference standard. We assessed sensitivity (Se), specificity (Spe) and Youden index for colic pain diagnosis, percentage of patients managed by urologic treatment with stone identified, percentage of alternative diagnoses (AD) and exposure to radiation, according to single imaging approaches, strategies driven by patient characteristics and conditional imaging strategies after APF and US.Results: One hundred (48.5%) patients had a final diagnosis of URCU and 19 underwent urologic treatment. The conditional strategy, i.e. CT in patients who had no stone identified at US, had a perfect sensitivity and specificity. This enabled diagnosis of all stones requiring urology management while decreasing the number of CT exams by 22%. The strategy whereby CT was used when there was neither direct or indirect APF + US finding of colic pain nor alternative diagnoses in patients with a STONE score ≥ 10 had a sensitivity of 0.95 and a specificity of 0.99, identified 84% of stones managed by urologic treatment and decreased the number of CT examinations by 76%.Conclusion: In patients with clinical findings consistent with URCU, the use of ultrasound as first-line imaging modality, with CT restricted to patients with negative US and a STONE score ≥ 10, led to a sensitivity and specificity of above 95%, identified 84% of stones requiring urological management and reduced the number of CT scans needed by fourfold.Key points: • For diagnosis, the use of APF + US as first-line imaging, with CT restricted to patients with both a normal APF + US and a STONE score ≥ 10, provides both a sensitivity and specificity superior or equal to 95% and reduces the number of CT scans necessary by fourfold. • For management, the use of APF + US as first-line imaging, with CT restricted to patients with both a normal APF + US and a STONE score ≥ 10, maintains a 84% stone identification rate in urology-treated patients.

International audience; Purpose. – Focal F-18-fluoro-deoxy-glucose uptake in the myocardium can be a sign of resting myocardial ischemia. The purpose of our study was to assess the relevance of performing myocardial perfusion scintigraphy to screen for myocardial ischemia in patients with an incidental finding of focal myocardial F-18-fluoro-deoxy-glucose uptake on a routine F-18-fluoro-deoxy-glucose positron- emission-tomography-computed-tomography.Methods. – In our retrospective multicentric study, patients were included if they had had an incidental finding of myocardial focal F-18-fluoro-deoxy-glucose uptake on a routine F-18-fluoro-deoxy-glucose positron-emission-tomography-computed-tomography and had also undergone myocardial perfusion scintigraphy within 3 months before or after the F-18-fluoro-deoxy-glucose positron-emission- tomography-computed-tomography. Patients with a pattern of ischemia or scar on the myocardial perfusion scintigraphy in the same territory as the focal F-18-fluoro-deoxy-glucose uptake were considered positive.Results. – Seven of the 34 included patients were positive, with an abnormality on the MPS data in the same territory as the focal myocardial F-18-fluoro-deoxy-glucose uptake. 2 of the 6 patients with focal F- 18-fluoro-deoxy-glucose uptake in the left anterior descending vascular supply territory and 2 of the 4 patients with focal F-18-fluoro-deoxy-glucose uptake in the standard right coronary artery territory had an abnormal myocardial perfusion scintigraphy. All 12 patients with focal F-18-fluoro-deoxy- glucose uptake restricted to the basal anterolateral and basal inferolateral segments were negative. Conclusion. – PatientswithanincidentalfindingoffocalF-18-fluoro-deoxy-glucoseuptakeonaroutine F-18-fluoro-deoxy-glucose positron-emission-tomography-computed-tomography may be considered as being at risk for coronary artery disease, when this uptake is multisegmentary in the same typical coronary territory and not restricted to the basal anterolateral and basal inferolateral segments.

Inter-platform variation in liver stiffness evaluation (LSE) could hinder dissemination and clinical implementation of new ultrasound methods. We aimed to determine whether measurements of liver stiffness by bi-dimensional shear wave elastography (2D-SWE) with a Supersonic Imagine apparatus are comparable to those made by vibration-controlled transient elastography (VCTE).We collected data from 1219 consecutive patients with chronic liver disease who underwent LSE by VCTE and 2D-SWE (performed by blinded operators), on the same day, at a single center in France from September 2011 through June 2019. We assessed the ability of liver stiffness value distributions and 2D-SWE performances to identify patients with compensated advanced chronic liver disease (cACLD) according to the Baveno VI criteria, based on VCTE cut-off values.VCTE and 2D-SWE values correlated (Pearson's correlation coefficient, 0.882; P.0001; Lin concordance coefficient, 0.846; P.0001). The median stiffness values were 6.7 kPa with VCTE (interquartile range, 4.8-11.6 kPa) and 7.1 kPa with 2D-SWE (interquartile range, 5.4-11.1 kPa) (P = .736). 2D-SWE values were slightly higher in the low percentiles and lower in the high percentiles; the best match with VCTE values were at approximately 7-9 kPa. The area under the curve of 2D-SWE for identifying of VCTE values below 10 was 0.964 (95% CI, 0.952-0.976) and for VCTE values above 15 kPa was 0.976 (95% CI, 0.963-0.988), with Youden index-associated cut-off values of 9.5 and 13kPa and best accuracy cut-off values of 10 kPa and 14 kPa, respectively. A 2D-SWE cut-off value of 10 kPa detected VCTE values below 10k Pa with 92% sensitivity, 87% specificity, and 91% accuracy.Measurement of liver stiffness by VCTE or 2D-SWE produces comparable results. 2D-SWE accurately identifies patients with cACLD according to the Baveno VI criteria based on VCTE cut-off values. A 10 kPa 2D-SWE cut-off value can be used to rule out cACLD.

To assess the learning curve for performing reliable liver stiffness measurements using a new hybrid machine composed of transient elastography (TE) interfaced with an ultrasound device for radiographers and radiologists with different levels of expertise in ultrasound imaging. Ten novice operators who had never performed TE measurements were prospectively evaluated from April to October 2018: senior radiologists, young radiologists, fellows, radiographers, and residents, with different levels of experience in abdominal ultrasound imaging. All operators had a short theoretical training followed by a training session under supervision in three patients. Then, each operator had to perform TE in 50 consecutive patients with chronic liver disease, using beforehand ultrasound examination to select measurement area in the right liver lobe, and if needed, the XL probe. Percentages of failures and reliable measurements were compared. The rates of failures of measurements, poorly reliable, reliable, and very reliable results, were of 4.2% (21/500), 2.4% (12/500), 47.6% (238/500), and 45.8% (229/500), respectively. The rates of reliable plus very reliable results were excellent, ranging from 91 to 96% among all the subgroups. The rates of very reliable, reliable, and unreliable results did not differ between operator subgroups and especially between junior radiologists, senior radiologists, and radiographers. No breaking point was observed in the interquartile range/median values over time. TE interfaced with ultrasound in this hybrid machine presents no learning curve effect. After a short initial training session, a novice observer is able to perform high rates of reliable and very reliable TE measurements. • When performing liver stiffness measurements using a new hybrid machine composed of transient elastography interfaced with ultrasound, the rate of failures of measurements is very low, below 5%. • After a short training session and using ultrasound planning, a novice operator, whatever its expertise in ultrasound imaging, is capable of performing high rates of reliable and very reliable measurements. • No learning curve is needed for performing reliable liver stiffness measurements using this new hybrid machine.

The relation between driving pressure (plateau pressure-positive end-expiratory pressure) and mortality has never been studied in obese ARDS patients. The main objective of this study was to evaluate the relationship between 90-day mortality and driving pressure in an ARDS population ventilated in the intensive care unit (ICU) according to obesity status. We conducted a retrospective single-center study of prospectively collected data of all ARDS patients admitted consecutively to a mixed medical-surgical adult ICU from January 2009 to May 2017. Plateau pressure, compliance of the respiratory system (Crs) and driving pressure of the respiratory system within 24 h of ARDS diagnosis were compared between survivors and non-survivors at day 90 and between obese (body mass index ≥ 30 kg/m2) and non-obese patients. Cox proportional hazard modeling was used for mortality at day 90. Three hundred sixty-two ARDS patients were included, 262 (72%) non-obese and 100 (28%) obese patients. Mortality rate at day 90 was respectively 47% (95% CI, 40–53) in the non-obese and 46% (95% CI, 36–56) in the obese patients. Driving pressure at day 1 in the non-obese patients was significantly lower in survivors at day 90 (11.9 ± 4.2 cmH2O) than in non-survivors (15.2 ± 5.2 cmH2O, p

To determine the prevalence of and risk factors for cardiac arrest during intubation in ICU, as well as the association of ICU intubation-related cardiac arrest with 28-day mortality.Retrospective analysis of prospectively collected data.Sixty-four French ICUs.Critically ill patients requiring intubation in the ICU.None.During the 1,847 intubation procedures included, 49 cardiac arrests (2.7%) occurred, including 14 without return of spontaneous circulation (28.6%) and 35 with return of spontaneous circulation (71.4%). In multivariate analysis, the main predictors of intubation-related cardiac arrest were arterial hypotension (systolic blood pressure90 mm Hg) prior to intubation (odds ratio = 3.406 [1.797-6.454]; p = 0.0002), hypoxemia prior to intubation (odds ratio = 3.991 [2.101-7.583]; p0.0001), absence of preoxygenation (odds ratio = 3.584 [1.287-9.985]; p = 0.0146), overweight/obesity (body mass index25 kg/m; odds ratio = 2.005 [1.017-3.951]; p = 0.0445), and age more than 75 years old (odds ratio = 2.251 [1.080-4.678]; p = 0.0297). Overall 28-day mortality rate was 31.2% (577/1,847) and was significantly higher in patients who experienced intubation-related cardiac arrest than in noncardiac arrest patients (73.5% vs 30.1%; p0.001). After multivariate analysis, intubation-related cardiac arrest was an independent risk factor for 28-day mortality (hazard ratio = 3.9 [2.4-6.3]; p0.0001).ICU intubation-related cardiac arrest occurs in one of 40 procedures with high immediate and 28-day mortality. We identified five independent risk factors for cardiac arrest, three of which are modifiable, possibly to decrease intubation-related cardiac arrest prevalence and 28-day ICU mortality.

The aim of this study was to quantitatively evaluate the ability of the body-surface-area (BSA) model to predict tumor-absorbed dose and treatment outcome through retrospective voxel-based dosimetry. Methods: Data from 35 hepatocellular carcinoma patients with a total of 42 90Y-resin microsphere radioembolization treatments were included. Injected activity was planned with the BSA model. Voxel dosimetry based on 99mTc-labeled macroaggregated albumin SPECT and 90Y-microsphere PET was retrospectively performed using a dedicated treatment planning system. Average dose and dose–volume histograms (DVHs) of the anatomically defined tumors were analyzed. The selected dose metrics extracted from DVHs were minimum dose to 50% and 70% of the tumor volume and percentage of the volume receiving at least 120 Gy. Treatment response was evaluated 6 mo after therapy according to the criteria of the European Association for the Study of the Liver. Results: Six-month response was evaluated in 26 treatments: 14 were considered to produce an objective response and 12 a nonresponse. Retrospective evaluation of 90Y-microsphere PET–based dosimetry showed a large interpatient variability with a median average absorbed dose of 60 Gy to the tumor. In 62% (26/42) of the cases, tumor, nontumoral liver, and lung doses would have complied with the recommended thresholds if the injected activity calculated by the BSA method had been increased. Average doses, minimum dose to 50% and 70% of the tumor volume, and percentage of the volume receiving at least 120 Gy were significantly higher in cases of objective response than in nonresponse. Conclusion: In our population, average tumor-absorbed dose and DVH metrics were associated with tumor response. However, the activity calculated by the BSA method could have been increased to reach the recommended tumor dose threshold. Tumor uptake, target and nontarget volumes, and dose distribution heterogeneity should be considered for activity planning.

Aims Sleep-disordered breathing (SDB) is a highly prevalent co-morbidity in patients with chronic heart failure (CHF) and can play a detrimental role in the pathophysiology course of CHF. However, the best way to manage SDB in CHF remains a matter of debate. Sacubitril-valsartan has been included in the 2016 European Society of Cardiology guidelines as an alternative to angiotensin-converting enzyme inhibitors to further reduce the risk of progression of CHF, CHF hospitalization, and death in ambulatory patients. Sacubitril and valsartan are good candidates for correcting SDB of CHF patients because their known mechanisms of action are likely to counteract the pathophysiology of SDB in CHF. Methods and results The ENTRESTO-SAS trial is a 3-month, multicentric, prospective, open-label real-life cohort study. Patients eligible for sacubitril-valsartan treatment (i.e. adults with left ventricular ejection fraction ≤35%, who remain symptomatic despite optimal treatment with an angiotensin-converting enzyme inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist) will be evaluated before and after 3 months of treatment (nocturnal ventilatory polygraphy, echocardiography, laboratory testing, and quality-of-life and SDB questionnaires). The primary outcome is the change in the Apnoea-Hypopnoea Index, before and after 3 months of treatment. One hundred twenty patients are required to detect a significant 20% improvement of the Apnoea-Hypopnoea Index with a power of 90% at an alpha risk of 5%. Conclusions In the context of the SERVE-HF study, physicians are waiting for new trials and alternative therapies. We sought to assess in the ENTRESTO-SAS trial whether sacubitril-valsartan could improve the outcome of SDB in CHF patients.

International audience

Background Obesity is a major public health issue. Combining exercise training, nutrition, and therapeutic education in metabolic rehabilitation (MR) is recommended for obesity management. However, evidence from randomized controlled studies is lacking. In addition, MR is associated with poor patient adherence. Mobile health devices improve access to MR components. Objective The aim of this study is to compare the changes in body composition, anthropometric parameters, exercise capacity, and quality of life (QOL) within 12 weeks of patients in the telerehabilitation (TR) program to those of usual care patients with obesity. Methods This was a parallel-design randomized controlled study. In total, 50 patients with obesity (BMI>30 kg/m²) were included in a TR group (TRG) or a usual care group (UCG) for 12 weeks. Patients underwent biometric impedance analyses, metabolic exercise tests, actimetry, and QOL and satisfaction questionnaires. The primary outcome was the change in fat mass at 12 weeks from baseline. Secondary outcomes were changes in body weight, metabolic parameters, exercise capacity, QOL, patients’ adhesion, and satisfaction. Results A total of 49 patients completed the study. No significant group × time interaction was found for fat mass (TRG: mean 1.7 kg, SD 2.6 kg; UCG: mean 1.2 kg, SD 2.4 kg; P=.48). Compared with the UCG, TRG patients tended to significantly improve their waist to hip ratios (TRG: −0.01 kg, SD 0.04; UCG: +0.01 kg, SD 0.06; P=.07) and improved QOL physical impact (TRG: +21.8, SD 43.6; UCG: −1.2, SD 15.4; P=.005). Significant time effects were observed for body composition, 6-minute walk test distance, exercise metabolism, sedentary time, and QOL. Adherence (95%) and satisfaction in the TRG were good. Conclusions In adults with obesity, the TR program was not superior to usual care for improving body composition. However, TR was able to deliver full multidisciplinary rehabilitation to patients with obesity and improve some health outcomes. Given the patients’ adherence and satisfaction, pragmatic programs should consider mobile health devices to improve access to MR. Further studies are warranted to further establish the benefits that TR has over usual care. Trial Registration ClinicalTrials.gov NCT03396666; http://clinicaltrials.gov/ct2/show/NCT03396666