Pilot Study: Safety and Performance Validation of an Ingestible Medical Device for Collecting Small Intestinal Liquid in Healthy Volunteers.

The connection between imbalances in the human gut microbiota, known as dysbiosis, and various diseases has been well established. Current techniques for sampling the small intestine are both invasive for patients and costly for healthcare facilities. Most studies on human gut microbiome are conducted using faecal samples, which do not accurately represent the microbiome in the upper intestinal tract. A pilot clinical investigation, registered as NCT05477069 and sponsored by the Grenoble Alpes University Hospital, is currently underway to evaluate a novel ingestible medical device (MD) designed for collecting small intestinal liquids by Pelican Health. This study is interventional and monocentric, involving 15 healthy volunteers. The primary objective of the study is to establish the safety and the performance of the MD when used on healthy volunteers. Secondary objectives include assessing the device's performance and demonstrating the difference between the retrieved sample from the MD and the corresponding faecal sample. Multi-omics analysis will be performed, including metagenomics, metabolomics, and culturomics. We anticipate that the MD will prove to be safe without any reported adverse effects, and we collected samples suitable for the proposed omics analyses in order to demonstrate the functionality of the MD and the clinical potential of the intestinal content.

Coronary microvascular dysfunction as assessed by multimodal diagnostic imaging in patients with hypertrophic cardiomyopathy is related to the severity of cardiac dysfunction.

INTRODUCTION: Coronary microvascular dysfunction (CMD) plays a major role in hypertrophic cardiomyopathy (HCM) physiopathology but its assessment in clinical practice remains a challenge. Nowadays, innovations in invasive and noninvasive coronary evaluation using multimodal imaging provide options for the diagnosis of CMD. The objective of the present study was to investigate if new multimodal imaging diagnosis of CMD could detect HCM patients with more impaired cardiac function by left atrioventricular coupling index (LACI). METHODS AND RESULTS: A total of 32 consecutive patients with a confirmed diagnosis of HCM (62 ± 13 years, 62% men) were prospectively screened for CMD using a multimodal imaging method. LACI was assessed by cardiovascular magnetic resonance imaging. Fifteen (47%) patients had CMD by multimodal imaging method. Patients with CMD presented a significantly higher LACI (48.5 ± 25.4 vs. 32.5 ± 10.6, p = .03). A multivariate logistic regression analysis demonstrated that CMD was independently associated with LACI (OR = 1.069, 95% CI 1.00-1.135, p = .03). CONCLUSION: Multimodal imaging diagnosis of CMD is applicable to HCM patients and is associated with more impaired cardiac function.

A comparative study of two automated solutions for cross-sectional skeletal muscle measurement from abdominal computed tomography images.

BACKGROUND: Measurement of cross-sectional muscle area (CSMA) at the mid third lumbar vertebra (L3) level from computed tomography (CT) images is becoming one of the reference methods for sarcopenia diagnosis. However, manual skeletal muscle segmentation is tedious and is thus restricted to research. Automated solutions are required for use in clinical practice. PURPOSE: The aim of this study was to compare the reliability of two automated solutions for the measurement of CSMA. METHODS: We conducted a retrospective analysis of CT images in our hospital database. We included consecutive individuals hospitalized at the Grenoble University Hospital in France between January and May 2018 with abdominal CT images and sagittal reconstruction. We used two types of software to automatically segment skeletal muscle: ABACS, a module of the SliceOmatic software solution "ABACS-SliceOmatic," and a deep learning-based solution called "AutoMATiCA." Manual segmentation was performed by a medical expert to generate reference data using "SliceOmatic." The Dice similarity coefficient (DSC) was used to measure overlap between the results of the manual and the automated segmentations. The DSC value for each method was compared with the Mann-Whitney U test. RESULTS: A total of 676 hospitalized individuals was retrospectively included (365 males [53.8%] and 312 females [46.2%]). The median DSC for SliceOmatic vs AutoMATiCA (0.969 [5th percentile: 0.909]) was greater than the median DSC for SliceOmatic vs. ABACS-SliceOmatic (0.949 [5th percentile: 0.836]) (p < 0.001). CONCLUSIONS: AutoMATiCA, which used artificial intelligence, was more reliable than ABACS-SliceOmatic for skeletal muscle segmentation at the L3 level in a cohort of hospitalized individuals. The next step is to develop and validate a neural network that can identify L3 slices, which is currently a fastidious process.

Individualized Net Benefit estimation and meta-analysis using generalized pairwise comparisons in N-of-1 trials.

BACKGROUND: The Net Benefit (Δ) is a measure of the benefit-risk balance in clinical trials, based on generalized pairwise comparisons (GPC) using several prioritized outcomes and thresholds of clinical relevance. We extended Δ to N-of-1 trials, with a focus on patient-level and population-level Δ. METHODS: We developed a Δ estimator at the individual level as an extension of the stratum-specific Δ, and at the population-level as an extension of the stratified Δ. We performed a simulation study mimicking PROFIL, a series of 38 N-of-1 trials testing sildenafil in Raynaud's phenomenon, to assess the power for such an analysis with realistic data. We then reanalyzed PROFIL using GPC. This reanalysis was finally interpreted in the context of the main analysis of PROFIL which used Bayesian individual probabilities of efficacy. RESULTS: Simulations under the null showed good size of the test for both individual and population levels. The test lacked power when being simulated from the true PROFIL data, even when increasing the number of repetitions up to 140 days per patient. PROFIL individual-level estimated Δ were well correlated with the probabilities of efficacy from the Bayesian analysis while showing similarly wide confidence intervals. Population-level estimated Δ was not significantly different from zero, consistently with the previous Bayesian analysis. CONCLUSION: GPC can be used to estimate individual Δ which can then be aggregated in a meta-analytic way in N-of-1 trials. GPC ability to easily incorporate patient preferences allow for more personalized treatment evaluation, while needing much less computing time than Bayesian modeling.

Comparison of Elecsys and Liaison immunoassays to determine Epstein-Barr virus serological status using further diagnostic approaches to clarify discrepant results.

Serological markers for Epstein-Barr virus (EBV) infection are commonly used to diagnose infectious mononucleosis and establish a serological status in pretransplant patients. This study prospectively assessed 1043 serum specimens sent to the laboratory for physician-ordered EBV testing. The three markers-antiviral capsid antigen (VCA) immunoglobulin M (IgM), anti-VCA immunoglobulin G (IgG), and anti-Epstein-Barr nuclear antigen (EBNA) antibodies-were tested using the Elecsys and the Liaison immunoassays. Specimens with discrepant results between the two assays were assessed using further EBV diagnostic approaches to conclude on the EBV serological status. In spite of substantial agreement between the two assays (88%) and with the presumed EBV status (>92%), the results showed differences in the performance of the assays. Liaison VCA IgM appeared to be the most sensitive test for the detection of the 38 sera classified as early primary infection in comparison with the Elecsys assay (91.4% vs. 68.6%, p = 0.008). Excluding the cases of early primary infection, the sensitivity values of the VCA IgM marker were comparable between the Liaison and Elecsys assays (95.2% and 92.9%, respectively, p = 1). Concerning the sera classified as past infection (n = 763), the Elecsys assay showed higher sensitivity values for the detection of the VCA and EBNA IgG markers in comparison with the Liaison assay (99.9% and 99.7% vs. 97.4% and 91.2%, respectively, p < 0.001). Overall, the Elecsys and Liaison assays showed similar performance. The interpretation of EBV serological profiles based on the clinical context may require serology follow up or further diagnostic approaches in challenging cases.

Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial.

BACKGROUND: Hypotension during surgery is frequent in the elderly population and is associated with acute kidney and myocardial injury, which are, themselves, associated with increased 30-day mortality. The present study compared the hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) to general anesthesia (GA) in patients ≥70 years of age undergoing hip fracture surgery. METHODS: We conducted a single-center, prospective, randomized study. In the HUSA group, patients were positioned with the operated hip above, and the hypobaric anesthetic solution was composed of 9 mg ropivacaine, 5 µg sufentanil, and 1 mL of sterile water. Anesthesia was adjusted for the GA group. Mean arterial pressure (MAP) was measured with a noninvasive blood pressure upper arm cuff every 3 minutes. Hypotension was treated with a bolus of ephedrine and then a continuous intravenous of norepinephrine to obtain a MAP ≥65 mm Hg. Primary outcome was the occurrence of severe hypotension, defined as a MAP <65 mm Hg for >12 consecutive minutes. RESULTS: A total of 154 patients were included. Severe hypotension was more frequent in the GA group compared to the HUSA group (odds ratio, 5.6; 95% confidence interval, 2.7-11.7; P < .001). There was no significant difference regarding the short-term outcomes between the HUSA and GA groups: acute kidney injury (respectively, 5.1% vs 11.3%; P = .22), myocardial injury (18.0% vs 14.0%; P = .63), and 30-day mortality (2.4% vs 4.7%; P = .65). CONCLUSIONS: HUSA leads to fewer episodes of severe intraoperative hypotension compared to GA in an elderly population undergoing hip fracture surgery.

ODIASP: Clinically Contextualized Image Analysis Using the PREDIMED Clinical Data Warehouse, Towards a Better Diagnosis of Sarcopenia.

Big Data and Deep Learning approaches offer new opportunities for medical data analysis. With these technologies, PREDIMED, the clinical data warehouse of Grenoble Alps University Hospital, sets up first clinical studies on retrospective data. In particular, ODIASP study, aims to develop and evaluate deep learning-based tools for automatic sarcopenia diagnosis, while using data collected via PREDIMED, in particular, medical images. Here we describe a methodology of data preparation for a clinical study via PREDIMED.

Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk?

BACKGROUND: Superselective clamping of tumor-targeted arteries aims to eliminate ischemia of the remnant kidney while keeping tumor bed bloodless during excision. OBJECTIVE: To evaluate the impact of superselective clamping on long-term renal function, compared with renal artery early unclamping. DESIGN, SETTING, AND PARTICIPANTS: A randomized monocentric single-blind trial (1:1) was conducted from February 2018 to August 2019. Patients with a single renal tumor were candidates for a robot-assisted partial nephrectomy (RAPN) in a referral center. EMERALD (NCT03679572) was powered to include 50 patients with an interim analysis after 30 cases. INTERVENTION: Superselective RAPN (SS-RAPN) with near-infrared fluorescence (NIRF) or conventional RAPN with renal artery early unclamping. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was the percent change of estimated glomerular filtration rate (eGFR) in the operated kidney after 6 mo (combination of eGFR and relative function on 99mTc-DMSA scintigraphy). Secondary endpoints assessed feasibility and safety of the technique. RESULTS AND LIMITATIONS: Relative eGFR reduction in the operated kidney at 6 mo did not differ significantly (-21.4% vs -23.4%, p=0.66). This absence of difference remained after adjusting on percentage of kidney volume preserved, which was an independent predictor of functional preservation. There were no significant differences in terms of blood loss, change in hemoglobin, postoperative complications, transfusion, and conversion to radical nephrectomy (two vs zero) or to open surgery (one vs zero). Despite a good accrual, the steering committee interrupted the trial after the interim analysis for futility given the absence of trend in favor of SS-RAPN. CONCLUSIONS: SS-RAPN using NIRF does not provide better renal function preservation than renal artery clamping, questioning the interest of this technique at a higher risk of bleeding. PATIENT SUMMARY: In this randomized controlled trial, superselective clamping of tumor feeding arteries did not show any advantage in terms of long-term renal function compared with conventional artery clamping.

Health Profile of Precarious Migrants Attending the Médecins Du Monde's Health and Social Care Centres in France: a Cross-Sectional Study.

Objective: The present study aimed to compare the precarious migrants' health problems managed in Médecins du Monde's health and social care centres (CASO) with those of patients attending general practice in France. Methods: We compared the most frequent health problems managed in the 19 CASO in metropolitan France with those of a national sample of usual general practice consultations, after standardisation for age and sex. Results: Precarious migrants had fewer health problems managed per consultation than other patients (mean: 1.31 vs. 2.16), and these corresponded less frequently to chronic conditions (21.3% vs. 46.8%). The overrepresented health problems among CASO consultations were mainly headache (1.11% vs. 0.45%), viral hepatitis (1.05% vs. 0.20%), type 1 diabetes (1.01% vs. 0.50%) and teeth/gum disease (1.01% vs. 0.23%). Their underrepresented health problems were mainly lipid disorder (0.39% vs. 8.20%), depressive disorder (1.36% vs. 5.28%) and hypothyroidism (0.50% vs. 3.08%). Prevention issues were nominal in precarious migrants (0.16%). Conclusion: Both chronic somatic and mental conditions of precarious migrants are presumably underdiagnosed. Their screening should be improved in primary care.

Muscle elasticity in patients with neonatal brachial plexus palsy using shear-wave ultrasound elastography. Preliminary results.

Ultrasound shear wave elastography (SWE) is a noninvasive, reliable and reproducible method, used for the qualitative and quantitative evaluation of tissues. The aim of this study was to compare muscle elasticity between the healthy and the involved sides in children with neonatal brachial plexus palsy (NBPP) using the elastography tool and to assess whether the difference was correlated with the Mallet grading system. We repeatedly measured the shear modulus coefficient of several muscles around the shoulder in stretched or passively relaxed positions on 14 patients. We evaluated the abductor muscles (supraspinatus and deltoid), the infraspinatus, the pectoralis major and the latissimus dorsi. We found a mean shear modulus significantly higher in most studied muscles in the pathologic side (P < 0.001), especially in the stretched position (P < 0.001). Moreover, the shear modulus increases with the degradation of the Mallet score for the abduction and external rotation tasks. SWE seems to be a reliable and reproducible tool to assess muscle elasticity in NBPP.

Correcting the bias of the net benefit estimator due to right-censored observations.

Generalized pairwise comparisons (GPCs) are a statistical method used in randomized clinical trials to simultaneously analyze several prioritized outcomes. This procedure estimates the net benefit (Δ). Δ may be interpreted as the probability for a random patient in the treatment group to have a better overall outcome than a random patient in the control group, minus the probability of the opposite situation. However, the presence of right censoring introduces uninformative pairs that will typically bias the estimate of Δ toward 0. We propose a correction to GPCs that estimates the contribution of each uninformative pair based on the average contribution of the informative pairs. The correction can be applied to the analysis of several prioritized outcomes. We perform a simulation study to evaluate the bias associated with this correction. When only one time-to-event outcome was generated, the corrected estimates were unbiased except in the presence of very heavy censoring. The correction had no effect on the power or type-1 error of the tests based on the Δ. Finally, we illustrate the impact of the correction using data from two randomized trials. The illustrative datasets showed that the correction had limited impact when the proportion of censored observations was around 20% and was most useful when this proportion was close to 70%. Overall, we propose an estimator for the net benefit that is minimally affected by censoring under the assumption that uninformative pairs are exchangeable with informative pairs.

Managing Missing Data in the Hospital Survey on Patient Safety Culture: A Simulation Study.

BACKGROUND: Case-wise analysis is advocated for the Hospital Survey on Patient Safety culture (HSOPS). OBJECTIVES: Through a computer-intensive simulation study, we aimed to evaluate the accuracy of various imputation methods in managing missing data in the HSOPS. METHODS: Using the original data from a cross-sectional survey of 5064 employees at a single university hospital in France, we produced simulation data on two levels. First, we resampled 1000 completed data based on the original 3045 complete responses using a bootstrap procedure. Second, missing values were simulated in these 1000 completed case data for comparison purposes, using eight different missing data scenarios. Third, missing values were imputed using five different imputation methods (1, random imputation; 2, item mean; 3, individual mean; 4, multiple imputation, and 5, sparse nonnegative matrix factorization. The performance for each imputation method was assessed using the root mean square error and dimension score bias. RESULTS: The five imputation methods yielded close root mean square errors, with an advantage for the multiple imputation. The bias differences were greater regarding the dimension scores, with a clear advantage for multiple imputation. The worst performance was achieved by the mean imputation methods. DISCUSSION AND CONCLUSIONS: We recommend the use of multiple imputation to handle missing data in HSOPS-based surveys, whereas mean imputation methods should be avoided. Overall, these results suggest the possibility of optimizing the HSOPS instrument, which should be reduced without loss of overall information.

Inconsistencies Between Two Cross-Cultural Adaptations of the Hospital Survey on Patient Safety Culture Into French.

OBJECTIVES: Two cross-cultural adaptations of the 12-dimension Hospital Survey on Patient Safety Culture (HSOPSC) into French coexist: the Occelli and Vlayen versions. The objective of this study was to assess the psychometric properties of the Occelli version in comparison with those reported for the Vlayen and the original US versions of this instrument. METHODS: Using the original data from a cross-sectional study of 5,064 employees at a single university hospital in France, we examined the acceptability, internal consistency, factorial structure, and construct validity of the Occelli version of the HSOPSC. RESULTS: The response rate was 76.8% (n = 3888). Our study yielded lower missing value rates (median, 0.4% [range, 0.0%-2.4%] versus 0.8% [range, 0.2%-11.4%]) and lower dimension scores (median, 3.19 [range, 2.67-3.54] versus 3.42 [range, 2.92-3.96]) than those reported for the Vlayen version. Cronbach alphas (median, 0.64; range, 0.56-0.84) compared unfavorably with those reported for the Vlayen (median, 0.73; range, 0.57-0.86) and original US (median, 0.78; range, 0.63-0.84) versions. The results of the confirmatory factor analysis were consistent between the Vlayen and Occelli versions, making it possible to conduct surveys from the 12-dimensional structure with both versions. CONCLUSIONS: The inconsistencies observed between the Occelli and Vlayen versions of the HSOPSC may reflect either differences between the translations or heterogeneity in the study population and context. Current evidence does not clearly support the use of one version over the other. The two cross-cultural adaptations of the HSOPSC can be used interchangeably in French-speaking countries.

Involvement in Root Cause Analysis and Patient Safety Culture Among Hospital Care Providers.

BACKGROUND: The experience feedback committee (EFC) is a tool designed to involve medical teams in patient safety management, through root cause analysis within the team. OBJECTIVE: The aim of the study was to determine whether patient safety culture, as measured by the Hospital Survey on Patient Safety Culture (HSOPS), differed regarding care provider involvement in EFC activities. METHODS: Using the original data from a cross-sectional survey of 5064 employees at a single university hospital in France, we analyzed the differences in HSOPS dimension scores according involvement in EFC activities. RESULTS: Of 5064 eligible employees, 3888 (76.8%) participated in the study. Among the respondents, 440 (11.3%) participated in EFC activities. Experience feedback committee participants had a more developed patient safety culture, with 9 of the 12 HSOPS dimension scores significantly higher than EFC nonparticipants (overall effect size = 0.31, 95% confidence interval = 0.21 to 0.41, P < 0.001). A multivariate analysis of variance indicated that all 12 dimension scores, taken together, were significantly different between EFC participants and nonparticipants (P < 0.0001), independently of sex, hospital department, and healthcare profession category. The largest differences in scores related to the "feedback and communication about error," "organizational learning," and "Nonpunitive response to error" dimensions. The analysis of the subgroup of professionals who worked in a department with a productive EFC, defined as an EFC implementing at least five actions per year, showed a higher patient safety culture level for seven of the 12 HSOPS dimensions (overall effect size = 0.19, 95% confidence interval = 0.10 to 0.27, P < 0.001). DISCUSSION AND CONCLUSIONS: Participation in EFC activities was associated with higher patient safety culture scores. The findings suggest that root cause analysis in the team's routine may improve patient safety culture.

Cytological features and nuclear scores: Diagnostic tools in preoperative fine needle aspiration of indeterminate thyroid nodules with RAS or BRAF K601E mutations?

INTRODUCTION: The cytological diagnosis of follicular-patterned thyroid lesions is challenging, especially since the World Health Organisation classification has recognised non-invasive follicular thyroid neoplasm with papillary-like features. These entities are often classified as indeterminate on cytology. Molecular testing has been proposed to help classify indeterminate nodules. RAS and K601E BRAF mutations are mostly encountered in follicular-patterned lesions, but their diagnostic value is not well established. Nuclear scores have also been proposed to help classify indeterminate lesions. OBJECTIVE: To investigate the correlation between cytological features and histology and to assess nuclear scores in a series of indeterminate RAS or BRAF K601E positive thyroid nodules. METHODS: The cytological parameters of 69 indeterminate RAS or BRAF K601E-positive thyroid nodules were evaluated. The Strickland and Maletta scores and a new nuclear score were assessed. Diagnosis of malignant, benign or indolent neoplasms was confirmed in each case by histology. Malignant and indolent nodules were considered surgical nodules, and adenomas non-surgical nodule. RESULTS: Surgical nodules were associated with the presence of ground glass nuclei (P = .001), grooves (P < .001) or irregular nuclear membranes (P = .01) on cytology. Nuclear scores were more often ≥2 in surgical nodules compared to benign ones (P < .001), with high sensitivity, but a low negative predictive value. CONCLUSIONS: Analysis of nuclear features is useful to distinguish non-surgical from surgical nodules in indeterminate FNAs. Although nuclear scores are not ideal rule-out tests for indeterminate RAS or BRAF K601E positive nodules, they seem useful to screen non-molecular tested or non-mutated indeterminate FNAs. This work shows that meticulous analysis of nuclear features on cytological specimens can be useful to distinguish non-surgical nodules (adenoma) from surgical nodules in indeterminate FNAs. Although nuclear scores are not rule-out tests for indeterminate RAS or BRAF K601E positive nodules, they are useful in screening non-molecular tested or non-mutated indeterminate FNAs for surgery.

Analysis of Preoperative CT Scan Can Help Predict Technical Failure of Endovascular Treatment of TASC C-D Aortoiliac Chronic Total Occlusions.

BACKGROUND AND AIMS: To evaluate if features of occlusion analyzable on preoperative computed tomography scan could predict risks of technical failure or iliac rupture of endovascular treatment of TransAtlantic InterSociety Consensus C-D aortoiliac chronic total occlusion. METHODS AND RESULTS: All patients treated by endovascular techniques for a TransAtlantic InterSociety Consensus C-D aortoiliac chronic total occlusion between 2009 and 2016 were included (107 patients, 148 iliac arteries). We evaluated the location of the occlusion and the importance of the arterial calcifications. For this factor, patients were divided into 3 groups: the Black occlusion group with mild or no calcifications, the white occlusion group with moderate no protrusive calcifications, and the white protrusive occlusion group with heavy endoluminal calcifications. Technical failure occurred in 11 iliac arteries and peroperative iliac rupture in 6. The location in the external iliac artery is the most significate risk factor of technical failure in univariate (OR = 9.93; P = 0.0012) and multivariate analysis (OR = 15.26; P = 0.0006). The presence of heavy endoluminal calcifications is a further significate risk factor (OR = 13.88; P = 0.0365). Rupture rate was comparable between the 3 groups. CONCLUSIONS: Preoperative computed tomography scan can predict risk of technical failure but not of iliac rupture.

Net benefit in the presence of correlated prioritized outcomes using generalized pairwise comparisons: A simulation study.

BACKGROUND: The prioritized net benefit (Δ) is a measure of the benefit-risk balance in clinical trials, based on generalized pairwise comparisons (GPC) using several prioritized outcomes. Its estimation requires the classification as Wins or Losses of all possible pairs of patients, one from the experimental treatment (E) group and one from the control treatment (C) group. In this simulation study, we assessed the impact of the correlation between prioritized outcomes on Δ, its estimate, bias, size, and power. METHODS: The theoretical Δ value was derived for the specific case of two correlated binary outcomes when a normal copula is used. Focusing on one efficacy and one toxicity outcome, two situations frequently met in practice were simulated: binary efficacy outcome with binary toxicity outcome, or time to event efficacy outcome with categorical toxicity outcome. Several scenarios of efficacy and toxicity were generated, with various levels of correlation. RESULTS: When E was more effective than C, positive correlations were mainly associated with a decrease in the proportion of Losses, while negative correlations were associated with a decrease in the proportion of Wins on the toxicity outcome. This resulted in an increase of Δ^ with the intensity of the positive correlation without adding any bias. Results were similar whatever the type of outcomes generated but led to power alteration. CONCLUSION: Correlations between outcomes analyzed with GPC led to substantial but predictable modifications of Δ and its estimate. Correlations should be taken into consideration when performing sample size estimations in clinical trials.

Severity and long-term complications of surgical site infections after orthognathic surgery: a retrospective study.

Surgical site infections (SSI) occur in 1.4% to 33.4% of cases after orthognathic surgery. This type of complication is a major concern to surgical teams, but there is no consensus for the prevention and treatment of SSI in orthognathic surgery. The purpose of this descriptive study was to evaluate the severity and the consequences of postoperative infections. The charts of all the patients operated on by the orthognathic surgery team between January 2015 and July 2017 were collected. All types of orthognathic procedures (Le Fort I maxillary osteotomy, bilateral sagittal split mandibular osteotomy, and genioplasty) were screened, and patients diagnosed with SSI were included. Demographic data, timing and severity of the infection, as well as long-term complications were recorded. Five hundred and twelve patients were screened. Forty-one patients (8%) presenting with SSI were included. There were 18 men and 23 women. The site of the infection was mandibular for 38 patients (92.7%) and maxillary for 3 patients (7.3%). The average time between surgery and infection was 31.5 days. Twenty-four patients received isolated oral antibiotics for inflammatory cellulitic reaction (58.8%), 15 patients had a localized collection treated by incision and drainage under local anesthesia (36.6%), and 2 patients had an extensive collection requiring surgical drainage under general anesthesia (4.9%). Five patients (12.2%) needed hardware removal for plate loosening, and 2 patients (4.9%) developed chronic osteomyelitis. Infection following orthognathic surgery is easily treated most of the time with no long-term complications. In cases of patients with potential risk factors for severe infection, antibiotics may be given with curative intents.

Esophageal Motility Disorders Associated With Death or Allograft Dysfunction After Lung Transplantation? Results of a Retrospective Monocentric Study.

OBJECTIVES: Pathological gastroesophageal reflux (GER) is a known risk factor for bronchiolitis obliterans syndrome (BOS) after lung transplantation. This study aimed at determining whether functional esophageal evaluation might predict BOS occurrence and survival in this setting. METHODS: Ninety-three patients who underwent esophageal high-resolution manometry and 24-hour pH-impedance monitoring within the first year after lung transplantation were retrospectively included. A univariable analysis was performed to evaluate the parameters associated with GER disease and BOS occurrence. The Cox regression model was used to identify the prognostic factors of death or retransplantation. RESULTS: Thirteen percent of patients exhibited major esophageal motility disorders and 20% pathological GER. GER occurrence was associated with younger age, cystic fibrosis, and hypotensive esophagogastric junction. Within a median follow-up of 62 months, 10 patients (11%) developed BOS, and no predictive factors were identified. At the end of the follow-up, 10 patients died and 1 underwent retransplantation. The 5-year cumulative survival rate without retransplantation was lower in patients with major esophageal motility disorders compared with that in those without (75% vs 90%, P = 0.01) and in patients who developed BOS compared with that in those without (66% vs 91%; P = 0.005). However, in multivariable analysis, major esophageal motility disorders and BOS were no longer significant predictors of survival without retransplantation. DISCUSSION: Major esophageal motility disorders and BOS were associated with allograft survival in lung transplantation in the univariable analysis. Although the causes of this association remain to be determined, this observation confirms that esophageal motor dysfunction should be evaluated in the context of lung transplantation.