Publications by authors named "Nicolas Molinari"

215 Publications

Apnoea-hypopnoea indices determined via continuous positive airway pressure (AHI-CPAP) versus those determined by polysomnography (AHI-PSG): a protocol for a systematic review and meta-analysis.

BMJ Open 2021 May 10;11(5):e044499. Epub 2021 May 10.

Department of Respiratory Diseases, Univ Montpellier, CHU Montpellier, Montpellier, France.

Introduction: To date, continuous positive airway pressure (CPAP) remains the cornerstone of obstructive sleep apnoea treatment. CPAP data describing residual sleep-disordered breathing events (ie, the CPAP-measured apnoea-hypopnoea indices (AHI-CPAP)) is difficult to interpret because it is an entirely different metric than the polysomnography (PSG) measured AHI gold standard (AHI-PSG). Moreover, manufacturer definitions for apnoea and hypopnoea are not only different from those recommended for PSG scoring, but also different between manufacturers. In the context of CPAP initiation and widespread telemedicine at home to facilitate sleep apnoea care, there is a need for concrete evidence that AHI-CPAP can be used as a surrogate for AHI-PSG.

Methods And Analysis: No published systematic review and meta-analysis (SRMA) has compared the accuracy of AHI-CPAP against AHI-PSG and the primary objective of this study is therefore to do so using published data. The secondary objectives are to similarly evaluate other sleep disordered breathing indices and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, body mass index levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4% PSG desaturation criteria versus 3% PSG on accuracy. The Preferred Reporting Items for SRMA protocols statement guided study design. Randomised controlled trials and observational studies of adult patients (≥18 years old) treated by a CPAP device will be included. The CPAP intervention and PSG comparator must be performed synchronously. PSGs must be scored manually and follow the American Academy of Sleep Medicine guidelines (2007 AASM criteria or more recent). To assess the risk of bias in each study, the Quality Assessment of Diagnostic Accuracy Studies 2 tool will be used.

Ethics And Dissemination: This protocol received ethics committee approval on 16 July 2020 (IRB_MTP_2020_07_2020000404) and results will be disseminated via peer-reviewed publications.

Prospero/trial Registration Numbers: CRD42020159914/NCT04526366; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-044499DOI Listing
May 2021

Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study.

Ann Intensive Care 2021 May 4;11(1):69. Epub 2021 May 4.

Department of Anaesthesia & Critical Care Medicine, Montpellier University Hospital Center, Gui de Chauliac Hospital, Montpellier, France.

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.
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http://dx.doi.org/10.1186/s13613-021-00857-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096880PMC
May 2021

Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol Fumarate versus Other Triple Combinations in COPD: A Systematic Literature Review and Network Meta-analysis.

Adv Ther 2021 Apr 30. Epub 2021 Apr 30.

AstraZeneca, Cambridge, UK.

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 β-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.
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http://dx.doi.org/10.1007/s12325-021-01703-zDOI Listing
April 2021

Maternal HLA Ib Polymorphisms in Pregnancy Allo-Immunization.

Front Immunol 2021 30;12:657217. Epub 2021 Mar 30.

Aix Marseille Univ, CNRS, EFS, ADES, "Biologie des Groupes Sanguins", Marseille, France.

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 ( and ). Anti-HLA class I and II antibodies were identified in 24% of the women. The maternal allele was significantly associated with a higher fraction of anti-HLA I immunization (20.0% 4.8%, p = 0.048). The maternal HLA-G 3'-untranslated region haplotype and the allele were significantly associated with a low anti-HLA I C1q activation (16.7% . 57.1%, p = 0.028; 16.7% 50.0%, p = 0.046; respectively). Both and - showed significantly higher levels of IgG4 compared with the other haplotypes. The results support an association of certain alleles with allo-immunization during pregnancy. Further studies are needed to elucidate the roles of and in reducing the risk for allo-immunization.
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http://dx.doi.org/10.3389/fimmu.2021.657217DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8042285PMC
March 2021

Long-term outcome in patients with aneurysmal subarachnoid hemorrhage requiring mechanical ventilation.

PLoS One 2021 12;16(3):e0247942. Epub 2021 Mar 12.

Department of Critical Care Medicine and Anesthesiology (DAR C), Gui de Chauliac University Hospital of Montpellier, Montpellier, France.

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<3), and 156 (68%) had a poor outcome (mRS≥3). The estimated 1-year survival rate was 63%. One-hundred sixty-three patients patients (71%) suffered from early brain injuries (EBI), 33 (14%) from rebleeding, 80 (35%) from vasospasm and 63 (27%) from delayed cerebral ischemia (DCI). Multivariable logistic regression identified independent factors associated with poor outcome including delay between aSAH diagnosis and mRS assessment (OR, 0.96; 95% CI, 0.95-0.98; p<.0001), age (OR per 10 points, 1.57; 95% CI, 1.12-2.19; p = 0.008), WFNS V versus WFNS III (OR, 5.71; 95% CI 1.51-21.61; p = 0.004), subarachnoid rebleeding (OR, 6.47; 95% CI 1.16-36.06; p = 0.033), EBI (OR, 4.52; 95% CI 1.81-11.29; p = 0.001) and DCI (OR, 4.73; 95% CI, 1.66-13.49; p = 0.004).

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.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247942PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7954305PMC
March 2021

Efficacy of a long-term pulmonary rehabilitation maintenance program for COPD patients in a real-life setting: a 5-year cohort study.

Respir Res 2021 Mar 10;22(1):79. Epub 2021 Mar 10.

PhyMedExp, University of Montpellier, INSERM, CNRS, CHRU, Montpellier, France.

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.
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http://dx.doi.org/10.1186/s12931-021-01674-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7948332PMC
March 2021

Changing trends in hepatocellular carcinoma management: Results from a nationwide database in the last decade.

Eur J Cancer 2021 Mar 11;146:48-55. Epub 2021 Feb 11.

Department of Diagnostic and Interventional Radiology, Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ejca.2021.01.009DOI Listing
March 2021

Bilateral mandibular block improves pain relief and morphine consumption in mandibular osteotomies: a prospective, randomized, double-blind, placebo-controlled clinical trial.

Reg Anesth Pain Med 2021 Apr 9;46(4):322-327. Epub 2021 Feb 9.

Department of Anesthesiology and Critical Care Medicine, Gui de Chauliac Hospital, Montpellier University Hospital Center, Montpellier, France

Background: The 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.

Methods: 107 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.

Results: The 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=), as well as the incidence of severe pain during the 24 hours of follow-up (4.0% vs 22.8%, p<0.01). The mandibular block had no impact on the incidence of PONV.

Conclusion: Bilateral 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 Number: NCT02618993.
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http://dx.doi.org/10.1136/rapm-2020-102417DOI Listing
April 2021

Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study.

Respir Res 2021 Jan 15;22(1):17. Epub 2021 Jan 15.

Apard Groupe Adène, Montpellier, France.

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 < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term.

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 (IQ: 60-74), initial Apnea-Hypopnea-Index (AHI) of 39 (31-56)/h, residual AHI 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 < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043).

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).
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http://dx.doi.org/10.1186/s12931-021-01618-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7809735PMC
January 2021

Deportalization, Venous Congestion, Venous Deprivation: Serial Measurements of Volumes and Functions on Morphofunctional 99mTc-Mebrofenin SPECT-CT.

Diagnostics (Basel) 2020 Dec 23;11(1). Epub 2020 Dec 23.

Department of Radiology, St. Eloi Hospital, Montpellier University Hospital, 34090 Montpellier, France.

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) ( = 5) or extended liver venous deprivation (eLVD, i.e., portal and right and middle hepatic veins embolization) ( = 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 ( = 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 ( = 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 ( = 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.
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http://dx.doi.org/10.3390/diagnostics11010012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7823835PMC
December 2020

Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial.

Anesth Analg 2021 02;132(2):556-565

From the Department of Anesthesiology and Critical Care Medicine, Lapeyronie University Hospital, Montpellier Cedex 5, France.

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 (<81.3 mm Hg) and MIS (<1.5 mA) cutoffs.

Conclusions: Our exploratory study evaluated concepts to generate hypotheses. The combinations of IP and MIS might help the physician during a PNB procedure. A low IP and low MIS might confirm a subparaneural location, and a high IP and a low MIS might be an alert for the intraneural location of the needle tip.
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http://dx.doi.org/10.1213/ANE.0000000000005308DOI Listing
February 2021

Vancomycin Serum Concentration after 48 h of Administration: A 3-Years Survey in an Intensive Care Unit.

Antibiotics (Basel) 2020 Nov 10;9(11). Epub 2020 Nov 10.

Service des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, 30029 Nîmes, France.

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 24-48 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 20-25 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) = (12.5-20.8) mg/kg) was given in 151/179 patients (84%). The median daily doses of vancomycin infusion for D1 and D2 were 2000 [(IQR (1600-2000)) and 2000 (IQR (2000-2500)) mg/d], respectively. The median duration of treatment was 4 (2-7) days. At D2 or D3, the median value of first serum vancomycin concentration was 19.8 (IQR (16.0-25.1)) with serum vancomycin concentration between 20-25 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.
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http://dx.doi.org/10.3390/antibiotics9110793DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7698174PMC
November 2020

Imaging strategies for patients with suspicion of uncomplicated colic pain: diagnostic accuracy and management assessment.

Eur Radiol 2021 May 13;31(5):2983-2993. Epub 2020 Oct 13.

Department of Medical Imaging, Montpellier University Hospital, Lapeyronie Hospital, 191, Avenue du Doyen Gaston Giraud, 34295, Montpellier Cedex 5, France.

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.
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http://dx.doi.org/10.1007/s00330-020-07264-zDOI Listing
May 2021

Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol.

BMJ Open 2020 10 7;10(10):e036718. Epub 2020 Oct 7.

Department of Anaesthesiology and Critical Care Medicine B (DAR B), Saint-Eloi Hospital, University Teaching Hospital of Montpellier, 80 avenue Augustin Fliche, 34295 Montpellier, France, Universite de Montpellier, Montpellier, Languedoc-Roussillon, France.

Introduction: 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.

Methods And Analysis: The endotracheal tube plus stylet to increase first-attempt success during orotracheal intubation compared with endotracheal tube alone in ICU patients (STYLETO) trial is an investigator-initiated, multicentre, stratified, parallel-group unblinded trial with an electronic system-based randomisation. Patients will be randomly assigned to undergo the initial intubation attempt with endotracheal tube alone (ie,without stylet, control group) or endotracheal tube + stylet (experimental group). The primary outcome is the proportion of patients with successful first-attempt orotracheal intubation. The single, prespecified, secondary outcome is the incidence of complications related to intubation, in the hour following intubation. Other outcomes analysed will include safety, exploratory procedural and clinical outcomes.

Ethics And Dissemination: The study project has been approved by the appropriate ethics committee 'Comité-de-Protection-des-Personnes Nord-Ouest3-19.04.26.65808 Cat2 RECHMPL19_0216/STYLETO2019-A01180-57'". Informed consent is required. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. If combined use of endotracheal tube plus stylet facilitates tracheal intubation of ICU patients compared with endotracheal tube alone, its use will become standard practice, thereby decreasing first-attempt intubation failure rates and, potentially, the frequency of intubation-related complications.

Trial Registration Details: ClinicalTrials.gov Identifier: NCT04079387; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2019-036718DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542923PMC
October 2020

Management of sleep apnoea syndrome (SAS) in patients with vasovagal syncope (VVS): a protocol for the VVS-SAS cohort study.

BMJ Open 2020 09 30;10(9):e038791. Epub 2020 Sep 30.

Department of Medical Information, IMAG, CNRS, Univ Montpellier, Centre Hospitalier Universitaire de Montpellier, Montpellier, France.

Introduction: Recurrent 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 Analysis: This 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 Dissemination: The 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 Number: NCT04294524. Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-038791DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7528365PMC
September 2020

COPD is deleterious for pericytes: implications during training-induced angiogenesis in skeletal muscle.

Am J Physiol Heart Circ Physiol 2020 11 28;319(5):H1142-H1151. Epub 2020 Sep 28.

PhyMedExp, INSERM-CNRS-Montpellier University, CHU Montpellier, Montpellier, France.

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 (%V̇o: COPD-RI) or absolute (mL·min·kg: COPD-AI) intensity as SHS. Capillary-to-fiber ratio (C/F) and NG2 pericyte coverage were assessed from 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 (V̇o) than both patients with COPD-RI and patients with COPD-AI (Group × Time: = 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: = 0.011). Conversely to SHS serum, COPD serum altered pericyte morphology ( < 0.001) and drastically reduced MSC differentiation into pericytes ( < 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. 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.
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http://dx.doi.org/10.1152/ajpheart.00306.2020DOI Listing
November 2020

Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study.

Crit Care 2020 09 22;24(1):569. Epub 2020 Sep 22.

Department of Anesthesiology and Critical Care Medicine, Arnaud de Villeneuve Hospital, CHU Montpellier, Univ Montpellier, Montpellier, France.

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 (EtCO) are known to be related to cardiac output. We have designed a study to test whether PP and EtCO 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 < 20 mmHg. NCO was measured with pulmonary artery catheter or echocardiography and compared to PP and EtCO. The ability of PP and EtCO to predict NCO < 1 L/min was evaluated with receiver operating characteristics (ROC) curves.

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 EtCO relationships with NCO were nonlinear and showed strong correlations for NCO < 2 L/min (r = 0.69 and r = 0.78 respectively). A PP < 15 mmHg and EtCO < 14 mmHg had good predictive values for detecting NCO < 1 L/min (area under ROC curve 0.93 [95% CI 0.89-0.96] and 0.97 [95% CI 0.94-0.99] respectively, p = 0.058).

Conclusions: PP and EtCO 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.
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http://dx.doi.org/10.1186/s13054-020-03280-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507590PMC
September 2020

Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions.

Respir Res 2020 Sep 21;21(1):243. Epub 2020 Sep 21.

Department of Respiratory Diseases, Univ Montpellier, CHU Montpellier, 371, Avenue Doyen Giraud, 34295, Montpellier Cedex 5, France.

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 (IQ) 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 < 0.001). MV differences between ASV-F (p = 0.002) and ASV-V (p < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type.

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.
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http://dx.doi.org/10.1186/s12931-020-01509-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507637PMC
September 2020

Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?

BMC Med Ethics 2020 08 13;21(1):72. Epub 2020 Aug 13.

IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.

Background: Patient skepticism concerning medical innovations can have major consequences for current public health and may threaten future progress, which greatly relies on clinical research. The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in clinical research. Specifically, we sought to evaluate if distrust in pharmaceutical companies and associated psychosocial factors could represent a recruitment bias in clinical trials and thus threaten the applicability of their results.

Methods: This prospective, multicenter survey consisted in the administration of a self-questionnaire to patients during a pulmonology consultation. The 1025 questionnaires distributed collected demographics, socio-professional and basic health literacy characteristics. Patients were asked to rank their level of trust for pharmaceutical companies and indicate their willingness to participate in different categories of research (pre or post marketing, sponsored by an academic institution or pharmaceutical company). Logistic regression was used to determine factors contributing to "trust" versus "distrust" group membership and willingness to participate in each category of research.

Results: One thousand patients completed the survey, corresponding to a response rate of 97.5%. Data from 838 patients were analyzed in this study. 48.3% of respondents declared that they trusted pharmaceutical companies, while 35.5% declared distrust. Being female (p = 0.042), inactive in the employment market(p = 0.007), and not-knowing the name of one's disease(p = 0.010) are factors related to declared distrust. Distrust-group membership is associated with unwillingness to participate in certain categories of trials such as pre-marketing and industry-sponsored trials.

Conclusion: Distrust in pharmaceutical companies is associated with a specific patient profile and with refusal to participate in certain subcategories of trials. This potential recruitment bias may explain the under-representation of certain categories of patients such as women in pre-marketing drug trials.
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http://dx.doi.org/10.1186/s12910-020-00509-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7424561PMC
August 2020

Macintosh Videolaryngoscope for Intubation in the Operating Room: A Comparative Quality Improvement Project.

Anesth Analg 2021 02;132(2):524-535

From the PhyMedExp, University of Montpellier, Institut National de la Santé et de la Recherche Médicale (INSERM), Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire (CHU) Montpellier, Montpellier, France.

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.
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http://dx.doi.org/10.1213/ANE.0000000000005031DOI Listing
February 2021

The Plasmatic Aldosterone and C-Reactive Protein Levels, and the Severity of Covid-19: The Dyhor-19 Study.

J Clin Med 2020 Jul 21;9(7). Epub 2020 Jul 21.

Montpellier School of Medicine, University of Montpellier, 34000 Montpellier, France.

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' 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 ( < 0.01 and = 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.
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http://dx.doi.org/10.3390/jcm9072315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7408691PMC
July 2020

Global implementation of the world health organization's International Classification of Diseases (ICD)-11: The allergic and hypersensitivity conditions model.

Allergy 2020 09 14;75(9):2206-2218. Epub 2020 Jul 14.

University Hospital of Montpellier, Montpellier, France.

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 subsections 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.
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http://dx.doi.org/10.1111/all.14468DOI Listing
September 2020

Single Circulating Fetal Trophoblastic Cells Eligible for Non Invasive Prenatal Diagnosis: the Exception Rather than the Rule.

Sci Rep 2020 06 17;10(1):9861. Epub 2020 Jun 17.

Laboratoire de Génétique de Maladies Rares, Institut Universitaire de Recherche Clinique, EA7402 Université de Montpellier, CHU Montpellier, Montpellier, France.

Non-Invasive Prenatal Diagnosis (NIPD), based on the analysis of circulating cell-free fetal DNA (cff-DNA), is successfully implemented for an increasing number of monogenic diseases. However, technical issues related to cff-DNA characteristics remain, and not all mutations can be screened with this method, particularly triplet expansion mutations that frequently concern prenatal diagnosis requests. The objective of this study was to develop an approach to isolate and analyze Circulating Trophoblastic Fetal Cells (CFTCs) for NIPD of monogenic diseases caused by triplet repeat expansion or point mutations. We developed a method for CFTC isolation based on DEPArray sorting and used Huntington's disease as the clinical model for CFTC-based NIPD. Then, we investigated whether CFTC isolation and Whole Genome Amplification (WGA) could be used for NIPD in couples at risk of transmitting different monogenic diseases. Our data show that the allele drop-out rate was 3-fold higher in CFTCs than in maternal cells processed in the same way. Moreover, we give new insights into CFTCs by compiling data obtained by extensive molecular testing by microsatellite multiplex PCR genotyping and by WGA followed by mini-exome sequencing. CFTCs appear to be often characterized by a random state of genomic degradation.
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http://dx.doi.org/10.1038/s41598-020-66923-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7300110PMC
June 2020

Feasibility of Type 3 Polygraphy for Evaluating Leak Determinants in CPAP-Treated OSA Patients: A Step Toward Personalized Leak Management.

Chest 2020 11 13;158(5):2165-2171. Epub 2020 Jun 13.

University of Grenoble Alpes, Grenoble, France; AGIR à dom. Association, Meylan, France; Sleep Laboratory, Thorax and Vessels Division, Grenoble Alpes University Hospital, France.

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).
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http://dx.doi.org/10.1016/j.chest.2020.05.593DOI Listing
November 2020

Elective late open conversion after endovascular aneurysm repair is associated with comparable outcomes to primary open repair of abdominal aortic aneurysms.

J Vasc Surg 2021 Feb 27;73(2):502-509.e1. Epub 2020 May 27.

Department of Thoracic and Vascular Surgery, Arnaud de Villeneuve Hospital, Montpellier, France.

Objective: Three of four patients with infrarenal abdominal aortic aneurysm are now treated with endovascular aneurysm repair (EVAR). The incidence of secondary procedures and surgical conversions is increasing for a population theoretically unfit for open surgery. The indications and outcomes of late open surgical conversions after EVAR in a high-volume tertiary vascular unit are reported.

Methods: This retrospective single-center study includes all patients who underwent a late open conversion between January 1996 and July 2018. Data were collected from records on patient demographics, operative indications, surgical strategy, perioperative outcomes, and medium-term survival.

Results: Sixty-two consecutive patients (88.7% male) with a mean age of 77.5 years are included. The median duration since index EVAR was 38.5 months; 65% of stent grafts requiring late open conversion had suprarenal fixation. Indications included 22.6% type IA, 16.1% type IB, and 45.2% type II endoleaks; 12.9% graft thrombosis; and 14.5% endoprosthesis infection. Complete endograft explantation was performed in 37.1% of patients and a partial explantation in 54.8%, whereas 8.1% of stent grafts were wholly preserved in situ. Overall 30-day mortality was 12.9% (n = 8) in the cohort and 2.7% for elective patients. The all-cause morbidity rate was 40.1%, and the median length of hospital stay was 9 days. After follow-up of 28.4 months (range, 1.8-187.3 months), all-cause survival was 58.8%. Avoidance of aortic clamping (P = .006) and elective procedures (P = .019) were associated with a significant reduction in the length of hospital stay. Moreover, the 30-day mortality (P = .002), occurrence of postoperative renal dysfunction (P = .004), and intestinal ischemia (P = .017) were increased in the emergency setting. Excluding cases with rupture or infection, survival estimates were 97%, 97%, and 71% at 1 year, 2 years, and 5 years, respectively.

Conclusions: Technically more complex than primary open surgery, late open conversion is a procedure that generates an acceptable perioperative risk when it is performed in a high-volume aortic surgical center. Elective open conversion is associated with excellent early and late outcomes. Endograft preservation strategies decrease perioperative morbidity.
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http://dx.doi.org/10.1016/j.jvs.2020.05.033DOI Listing
February 2021

Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM' study, a multicentric randomised controlled trial.

Trials 2020 May 11;21(1):392. Epub 2020 May 11.

IMAG, CNRS, Univ Montpellier, CHU Montpellier, Montpellier, France.

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.

Trial Registration: ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.
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http://dx.doi.org/10.1186/s13063-020-04271-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212581PMC
May 2020

Agreement Between 2-Dimensional Shear Wave and Transient Elastography Values for Diagnosis of Advanced Chronic Liver Disease.

Clin Gastroenterol Hepatol 2020 12 26;18(13):2971-2979.e3. Epub 2020 Apr 26.

Centre d'investigation de la fibrose hépatique, Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, Pessac, France.

Background & Aims: 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).

Methods: 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.

Results: 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.

Conclusions: 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.
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http://dx.doi.org/10.1016/j.cgh.2020.04.034DOI Listing
December 2020

Quantification of liver fat content in liver and primary liver lesions using triple-echo-gradient-echo MRI.

Eur Radiol 2020 Sep 22;30(9):4752-4761. Epub 2020 Apr 22.

Department of Diagnostic and Interventional Radiology, St-Eloi University Hospital, Montpellier, France.

Objectives: To quantify and compare the fat fraction of background liver and primary liver lesions using a triple-echo-gradient-echo sequence. M&M: 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.

Results: 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 < 0.001 for FNH vs HCCs or HCA). A fat fraction threshold of 2.7% enabled distinction between HCA and FNH with a sensitivity of 80% and a specificity of 77%. The mean normal liver parenchyma fat fraction was lower than the intralesional fat fraction in the HCC group (p = 0.04) and higher in the FNH group (p = 0.001), but not significantly different in the HCA group (p = 0.51).

Conclusion: Triple-echo-gradient-echo is a feasible technique to quantify fat fraction of background liver and primary liver lesions. Intralesional fat fraction obtained from lesion whole volume is greater for HCCs and HCA compared to FNH. When trying to distinguish FNH and HCA, an intralesional fat fraction < 2.7% may orient toward the diagnosis of FNH.

Key Points: • Triple-echo technique is feasible to quantify intralesional fat fraction of primary liver lesions. • Whole volume intralesional fat fraction is greater for HCCs and HCA compared to FNH. • An intralesional fat fraction < 2.7% may orient toward the diagnosis of FNH.
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http://dx.doi.org/10.1007/s00330-020-06757-1DOI Listing
September 2020