French University Hospital Research Articles

Impact of Mogamulizumab in Real-Life Advanced Cutaneous T-Cell Lymphomas: A Multicentric Retrospective Cohort Study.

Simple SummaryMogamulizumab is a recent monoclonal antibody prescribed in the second line to treat advanced mycosis fungoides and Sézary syndromes. We collected data from all patients who used mogamulizumab in six French university hospitals until 1 September 2021. Our primary objective was to determine the median progression free survival (PFS). Secondary objectives were to consider tolerance regarding side effect occurrence and severity. Twenty-one patients were included, with a median time of follow-up of 11.6 months, and progression-free survival was estimated at 22 months. Twenty patients presented adverse events, of which 10 were severe. The median time between the introduction of mogamulizumab and the first adverse event was 21 days. Our study suggests that mogamulizumab is a significant treatment option to extend PFS in patients with advanced refractory cutaneous T-cell lymphomas (CTCL). The long-term safety of mogamulizumab was determined to be acceptable since we reported few grade III–IV adverse events (AEs) compared to other systemic treatments.Background: Advanced mycosis fungoides (MF) and Sézary syndrome (SS) are rare, aggressive cutaneous T-cell lymphomas that may be difficult to treat. Mogamulizumab is a recent monoclonal antibody targeting the CCR4 receptor expressed on the surface of Sézary cells. It can be prescribed in MF/SS stages III to IV in the second line after systemic therapy or in stages IB-II after two unsuccessful systemic therapies. We lack data on long-term efficiency and potential side effects in real-life conditions. Our study aims to determine efficacy considering the median PFS of advanced CTCL with mogamulizumab. Secondary objectives were to consider tolerance and estimate delay until side effects appeared. Methods: Data on patients with advanced cutaneous T-cell lymphomas were collected since French Authorization, in six French university hospitals. Patients were followed until they stopped mogamulizumab because of relapse or toxicity. For those still treated by mogamulizumab, the end point was 1 September 2021. We excluded 3 patients as they had already been included in the MAVORIC study and data was not available. Results: The median time of follow-up was 11.6 months. Of the 21 patients included, we reported four full-response patients, eight in partial response, one in stability, three in progression, and five were deceased. One patient had visceral progression, and seven had new lymphadenopathy. Progression-free survival was estimated at 22 months. Twenty patients presented adverse events, of which 10 were severe, i.e., grade III-IV. The median time between the introduction of mogamulizumab and the first adverse event was 21 days. Conclusions: Our study suggests that mogamulizumab can give patients with advanced refractory CTCL a consequent PFS, estimated at 22 months. The long-term safety of mogamulizumab was determined to be acceptable since we reported few grade III–IV AEs, comparable with other studies. No other study using real-life data has been performed to investigate the AEs of mogamulizumab.

Economic evaluation of pre-operative shower with antiseptic soap to prevent surgical site infections

A pre-operative shower is recommended before surgery to prevent surgical site infections (SSIs). We modelled the occurrence of SSIs and the potential savings for patients undergoing an antimicrobial soap (AS) shower prior to surgery at a French University Hospital level. AS shower prevented 209 SSIs, generating a potential saving of €632,210 per year. Results grouped by type of surgery showed annual savings of €26,537, €20,520 and €14,377 for orthopaedic, gynaecologic and obstetric, and digestive surgery, respectively. Despite the lack of published data surrounding the efficacy of AS in preventing SSIs, we demonstrated the potential savings and benefits of generalizing AS before surgical interventions.

Are patients living far from hospital at higher risk of late adjuvant chemotherapy for colon cancer?

Late adjuvant chemotherapy (aCT) administration after colectomy (>56 d) is known to be associated with impaired prognosis. We aim to identify risk factors associated with late aCT, especially the travel time between patients' home and hospital. We performed a retrospective monocentre cohort study. Patients included had a colectomy for a stage III or high risk stage II colon cancer between 2009 and 2015 performed at a French university hospital. Risk factors for late aCT were identified using a fractional polynomial logistic regression. Ninety-four patients were included. The risk of late aCT was associated with travel time length, emergent colectomy, the need for scheduled care before aCT, and length of time between colectomy and postoperative multidisciplinary meeting advising aCT. Our study suggests that, in patients with colon cancer, factors unrelated to disease severity and complexity could be associated with a higher risk of late aCT.

Characteristics, expectations, experiences of care, and satisfaction of patients receiving chiropractic care in a French University Hospital in Toulouse (France) over one year: a case study

BackgroundIn October 2017, a partnership was established between the University Hospital of Toulouse and the French Chiropractic College, “Institut Franco-Européen de Chiropraxie” (IFEC). Before 2017, chiropractors did not practice in hospitals in France. Chiropractic students and chiropractors are now integrated in an interdisciplinary medical team at University Hospital.Our study aimed to describe the characteristics of patients who received chiropractic care at the University Hospital of Toulouse, their expectations, experiences of care, and satisfaction.MethodA prospective case study was conducted. Patients referred for chiropractic care in the French University Hospital of Toulouse from January to December 2020 were eligible to participate. Participants provided the following data: demographics, previous chiropractic care treatments, pain location, intensity (NRS) and duration, disability (NDI, ODI), health-related quality of life (SF-12) and depressive symptomatology (PHQ-9). We conducted semi-structured interviews to explore their expectations, barriers and facilitators impacting their experience of care, and satisfaction.ResultsSeventeen participants were recruited and seven were interviewed. All participants had chronic pain with a median pain intensity of 05/10 (IQR 04–06) on the NRS scale. Nine of 17 participants presented with multiple pain locations. Thirteen of seventeen participants presented with low back pain and eight with neck pain. The median SF-12 health-related quality of life score was 50/100 (IQR 28.5–60.5) for physical health, and 52/100 (IQR 43–62) for mental health. The PHQ-9 median score of depressive symptomatology was 7.7/27 (IQR 2.0–12.5).Overall, participants were satisfied with their care and the collaboration between chiropractors and physicians. Participants expected a caring communication with the chiropractic team. Their experience was facilitated by their trust in their physician. Patients perceived the turnover of chiropractic students as a barrier to their satisfaction.ConclusionOur participants presented with chronic musculoskeletal pain and depressive symptoms. Our study identified facilitators and barriers for patient expectation and satisfaction with chiropractic care in a hospital setting. This study provides the first data describing the collaboration between chiropractors and physicians in France in the management of musculoskeletal disorders. These findings will inform the quality improvement of our partnership, student’s training and the development of future hospital-based collaborations integrating chiropractic care in a multidisciplinary team in France.

Evaluation of a new transition organization for young adults with endocrine or metabolic diseases

To evaluate the effect of a new care organization on multiple outcomes of transition success and its cost-effectiveness in patients with any endocrine or metabolic disease diagnosed during childhood and transferred to adult care. Non-randomized controlled trial in a French university hospital. Patients transferred to adult care during the control period (04/2014-08/2016) and the intervention period (09/2016-06/2018) were included. The intervention is based on case management involving liaising with pediatric services, personalizing care pathways, and liaising with structures outside hospital (general practitioner, educational and social sector). The primary endpoint was the percentage of patients lost to follow-up at 24 months post transfer. Other outcomes were collected from medical files, consultation software, and questionnaires. A cost analysis was performed. Two hundred two patients were included (101 per period), the most represented pathologies were congenital and non-congenital hypopituitarism (respectively n = 34 (17%) and n = 45 (22%)) and thyroid diseases (n = 21, 10%). Patients were aged 22.5 in median at 24 months post transfer where 12 were lost to follow-up in the control group vs 9 with the intervention (P = 0.49). The percentage of honored consultation among those planned during 24 months was higher with intervention (P = 0.0065). Patient satisfaction, physician trust, and transfer delay did not differ between the groups. The incremental cost-effectiveness ratio was €179 per patient not lost to follow-up. At 24 months post transfer, the rate of lost to follow-up did not differ significantly, but indicators of a steadier follow-up were increased and the intervention appeared to be cost-effective.

366. Psychological impact on healthcare workers in the departments of obstetrics and gynecology in france during and after the first covid-19 lockdown: a prospective observational study

Introduction and aims of the study: The previous Asian epidemics have had a pregnant mental impact on healthcare workers. After the physical morbidity of the Covid-19outbreak, it is the mental and psychological impact that reachesthe global population. We aimed to assess the level of stress and anxiety inall healthcare workers in the departments of obstetrics and gynecology in France during and after the first Covid-19 lockdown in 2020. Methods:Two web-based cross-sectional surveys wereproposed to all staff of obstetrics and gynecologic department of 18 French university hospitals in spring 2020: The HAD scale (Hospital Anxiety and Depression scale), the PSS-10 questionnaire (Perceived Stress Scale), a 10-cm continuous Visual Analogue Scale (stress-VAS) and the Short Form 12 Questionnaire (SF-12) were used to assess the level of stress, anxiety, depression and quality of life during and after the first national lockdown.

A very low prevalence of SARS-CoV-2 infection but a high prevalence of other respiratory virus infections in children admitted to paediatric emergency departments.

AimTo investigate the prevalence of infections by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) and other respiratory viruses among children admitted to paediatric emergency departments (PEDs).MethodsFrom April to July 2020, a prospective, multicentre cohort study was conducted in the PEDs of eight French university hospitals. Regardless of the reason for admission, a nasopharyngeal swab sample from each child was screened using reverse transcription polymerase chain reaction tests for SARS‐CoV‐2 and other respiratory viruses. We determined the prevalence of SARS‐CoV‐2 and other respiratory viruses and identified risk factors associated with a positive test.ResultsOf the 924 included children (median [interquartile range] age: 4 years [1–9]; boys: 55%), 908 (98.3%) were tested for SARS‐CoV‐2. Only three samples were positive (0.3%; 95% confidence interval: 0.1–1) and none of these children had symptoms of coronavirus disease 2019. Of the 836 samples (90%) tested for other viruses, 129 (15.4%) were positive (primarily rhinovirus). Respiratory viruses were significantly more common in young children and in children with respiratory tract symptoms and fever.ConclusionThe prevalence of SARS‐CoV‐2 among children admitted to emergency departments was low. In contrast, and despite social distancing and other protective measures, the prevalence of other respiratory viruses detection was high.

A retrospective comparison of COVID-19 and seasonal influenza mortality and outcomes in the ICUs of a French university hospital.

SARS-Cov-2 (COVID-19) has become a major worldwide health concern since its appearance in China at the end of 2019. To evaluate the intrinsic mortality and burden of COVID-19 and seasonal influenza pneumonia in ICUs in the city of Lyon, France. A retrospective study. Six ICUs in a single institution in Lyon, France. Consecutive patients admitted to an ICU with SARS-CoV-2 pneumonia from 27 February to 4 April 2020 (COVID-19 group) and seasonal influenza pneumonia from 1 November 2015 to 30 April 2019 (influenza group). A total of 350 patients were included in the COVID-19 group (18 refused to consent) and 325 in the influenza group (one refused to consent). Diagnosis was confirmed by RT-PCR. Follow-up was completed on 1 April 2021. Differences in 90-day adjusted-mortality between the COVID-19 and influenza groups were evaluated using a multivariable Cox proportional hazards model. COVID-19 patients were younger, mostly men and had a higher median BMI, and comorbidities, including immunosuppressive condition or respiratory history were less frequent. In univariate analysis, no significant differences were observed between the two groups regarding in-ICU mortality, 30, 60 and 90-day mortality. After Cox modelling adjusted on age, sex, BMI, cancer, sepsis-related organ failure assessment (SOFA) score, simplified acute physiology score SAPS II score, chronic obstructive pulmonary disease and myocardial infarction, the probability of death associated with COVID-19 was significantly higher in comparison to seasonal influenza [hazard ratio 1.57, 95% CI (1.14 to 2.17); P = 0.006]. The clinical course and morbidity profile of both groups was markedly different; COVID-19 patients had less severe illness at admission (SAPS II score, 37 [28 to 48] vs. 48 [39 to 61], P < 0.001 and SOFA score, 4 [2 to 8] vs. 8 [5 to 11], P < 0.001), but the disease was more severe considering ICU length of stay, duration of mechanical ventilation, PEEP level and prone positioning requirement. After ICU admission, COVID-19 was associated with an increased risk of death compared with seasonal influenza. Patient characteristics, clinical course and morbidity profile of these diseases is markedly different.

Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study.

The aim of this study was to assess the safety and efficacy of the TightRail™ sheath for pacemaker/defibrillator transvenous lead extraction (TLE). Multicenter observational study including patients who underwent a TLE with the TightRail™ sheath in five French university hospitals from September 2014 to January 2020. Two hundred and twenty-fivepatients (76% males, 71 ± 12 years) underwent a TLE procedure with the TightRail™. A total of 438 leads were extracted using the TightRail™, and the mean age of the extracted leads was 128 ± 85 months; of these, 344 (79%) were pacing leads and 94 (21%) were implantable cardioverter defibrillator leads. The overall clinical success of the extraction procedures was 93%. Overall, 410 of the 438 leads (95%) were extracted (complete or incomplete removal). After multilevel mixed-effects logistic regression model, we found that lead age(odds ratio[OR], 95% confidence interval [CI]for a 1 year increase: 1.11 [1.07-1.15], p < .001) and number of leads extracted (OR, 95% CI: 2.09 [1.50-2.96], p < .001) were the two independent factors associated with complete lead removal failure. Finally, there were 7(3%) cases of major complications but no per-procedural death. This is the first large-scale survey assessing the efficacy and safety profile of the Tightrail™ mechanical sheath. The clinical success rate was 93%, and the lead removal failure was dependent on the age and number of leads. We show a satisfactory safety profile in this cohort of patients from primarily low-volume centers with older leads.

Stratification of sigmoid volvulus early recurrence risk using a combination of CT features

PurposeThe purpose of this study was to identify computed tomography (CT) features associated with early recurrence of sigmoid volvulus (SV) after a first uncomplicated episode and to develop a score for early SV recurrence risk stratification. Materials and methodsA total of 95 patients (59 men, 36 women; mean age, 72 ± 15 [SD] years; age range: 57–87 years) who underwent abdominal CT examination for a first uncomplicated SV episode from January 1st 2006 to July 31st 2020 in two French University Hospitals were retrospectively included. A SV recurrence occurring within six months was defined as early SV recurrence. CT findings associated with SV were searched for using univariable analysis. CT features associated with early recurrence were computed into a multivariable logistic regression model that was further used to build a score to stratify SV recurrence risk. Kaplan-Meier curves were built to evaluate recurrence-free survival. ResultsEarly SV recurrence occurred in 53 patients (56%). At multivariable analysis, left lateral section volume < 150 cm3 and maximal colon distension > 10 cm were associated with early SV recurrence (Odds ratio [OR] = 4.62; 95% CI: 1.77–13.33; P = 0.002 and OR = 4.43 95% CI: 1.63–13.63; P = 0.005) respectively), and an early SV recurrence score with 1 point attributed to each of these two variables was built. Early SV recurrence was observed in 26%, 54% and 89% of patients with score of 0, 1 and 2, respectively (P < 0.001). ConclusionA simple CT score allows stratification of early SV recurrence after a first episode and helps to select patient who would not benefit from prophylactic colonic surgery because of a low SV recurrence risk.

P306 Efficacy and tolerance of sodium picosulfate preparation in bowel Magnetic Resonance Imaging in Crohn’s disease

Abstract Background Polyethylene glycol (PEG) is one of the most commonly used bowel preparation for magnetic resonance imaging (MRI) in Crohn’s Disease (CD). Sodium picosulfate (Pico) is a low volume bowel preparation known for its efficacy and higher tolerability for colonoscopy. No study has to date evaluated tolerance and efficacy of Pico preparations for MRI in CD. Aim: To assess for the first time the efficacy and tolerance of Pico preparation compared to PEG preparation for bowel MRI in CD. Methods The study took place in a French university hospital. To assess the efficacy of low volume preparations compared to PEG, we selected consecutive bowel MRI from January to June, 2017 prepared with PEG formulas, and consecutive MRI from January, 2020 to June, 2020 prepared with low-volume Pico formula.The sample size was calculated to assess the non-inferiority of Pico preparation vs PEG. The efficacy endpoint was the quality of bowel distention on a, 5 points scale and by visual analog scale (VAS) by two independent readers. To study Pico preparation tolerability, we performed a prospective survey in CD patients undergoing MRI from October, 2020 to August, 2021. Patients completed a self-administered validated questionnaire on tolerability and a VAS. Results In the efficacy study,84 MRIs were analysed (42 in each PEG and Pico group). There was no significant difference between PEG and Pico preparation regarding jejunum and ileum distention on the, 5 points quality scale. Moreover, we did not find significant difference between PEG and Pico regarding overall quality in the VAS (8.1 ±, 1.4 in PEG group, vs, 8.7 ±, 1.2 in Pico group, by reader, 1 (p=, 0.125);, 6.35 ±, 1 in PEG group, 6.5 ±, 1 in Pico group by reader, 2 (p=0.298)) with a moderate but significant correlation rate between the two readers (r=, 0.45; p&amp;lt;0.001). There was no significant difference regarding ileal diameter between the two preparations with a moderate correlation rate between the two readers (r=0.41; p&amp;lt;0.01). In the prospective study, 38 patients participated in the survey. The bowel preparation intake was completefor, 94.7% of the patients. The mean tolerance was, 6.84/10. Overall, 81.6% of patients were willing to take the same preparation again. Conclusion The study assessed Pico preparation non-inferiority to PEG preparation for small bowel MRI and confirmed low volume bowel preparations good tolerability profile. This suggests that low-volume preparations could be more widely implemented in clinical practice for small bowel imaging in chronic inflammatory bowel disease and thus improve follow-up acceptance.

PET metabolic tumor volume as a new prognostic factor in childhood rhabdomyosarcoma.

Childhood RMS is a rare malignant disease in which evaluation of tumour spread at diagnosis is essential for therapeutic management. F-18 FDG-PET imaging is currently used for initial RMS disease staging. This multicentre retrospective study in six French university hospitals was designed to analyse the prognostic accuracy of MTV at diagnosis for patients with RMS between 1 January 2007 and 31 October 2017, for overall (OS) and progression-free survival (PFS). MTV was defined as the sum of the primitive tumour and the largest metastasis, where relevant, with a 40% threshold of the primary tumour SUVmax. Additional aims were to define the prognostic value of SUVmax, SUVpeak, and bone lysis at diagnosis. Participants were 101 patients with a median age of 7.4 years (IQR [4.0-12.5], 62 boys), with localized disease (35 cases), regional nodal spread (43 cases), or distant metastases (23). 44 patients had alveolar subtypes. In a univariate analysis, a MTV greater than 200 cm3 was associated with OS (HR = 3.47 [1.79;6.74], p<0.001) and PFS (HR = 3.03 [1.51;6.07], p = 0.002). SUVmax, SUVpeak, and bone lysis also influenced OS (respectively p = 0.005, p = 0.004 and p = 0.007) and PFS (p = 0.029, p = 0.019 and p = 0.015). In a multivariate analysis, a MTV greater than 200 cm3 was associated with OS (HR = 2.642 [1.272;5.486], p = 0.009) and PFS (HR = 2.707 [1.322;5.547], p = 0.006) after adjustment for confounding factors, including SUVmax, SUVpeak, and bone lysis. A metabolic tumor volume greater than 200 cm3, SUVmax, SUVpeak, and bone lysis in the pre-treatment assessment were unfavourable for outcome.

Real-World Treatment Patterns and Clinical Outcomes for Standard of Care Regimens in Patients with Deficient MMR or MSI-High Metastatic Colorectal and Non-Colorectal Cancer: A Retrospective Chart Review Study in France.

There is limited evidence on the effectiveness of standard of care (SOC) treatments in previously treated patients with deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) metastatic cancer. Immune checkpoints inhibitors (ICIs) have emerged as key treatments for dMMR/MSI-H tumors. However, clinical outcomes data with SOC regimens are still limited. Study objectives were to evaluate real-world treatment patterns and clinical outcomes in patients with dMMR/MSI-H metastatic colorectal cancer (mCRC) and non-CRC receiving SOC regimens. Given the resulting small cohort of patients with metastatic non-CRC, only summary results are provided. Two French university hospitals participated in a retrospective chart review study in which adult patients with dMMR/MSI-H mCRC and non-CRC were enrolled. Treatment patterns, overall survival (OS) from the start of third-line (3L, for mCRC) or second-line (2L, for non-CRC) treatment, and the best overall response rate (BORR) were reported. Thirty-six patients with dMMR/MSI-H mCRC were included. Almost all patients received combination treatments both in first-line (1L, 100%) and 2L (97%). For 3L and later, combination treatment was preferred over monotherapy but decreased in usage (75% at 3L and 57% at fourth-line, 4L). The BORR was 5.7% and median OS for patients with dMMR/MSI-H mCRC receiving 3L therapy was 9.0months (95% confidence interval, CI 4.0-14.1); it decreased to 4.1months (95% CI 4.0-9.0) when survival data of patients receiving ICIs at fourth or later lines were censored at progression date of prior treatment line. Real-world clinical outcomes observed for patients with dMMR/MSI-H mCRC receiving 3L treatment(s) are suboptimal, suggesting a high unmet need that could be addressed with ICIs.

Diagnostic Value of 18F-FDG PET/CT vs. Chest-Abdomen-Pelvis CT Scan in Management of Patients with Fever of Unknown Origin, Inflammation of Unknown Origin or Episodic Fever of Unknown Origin: A Comparative Multicentre Prospective Study.

Fluorodesoxyglucose Positron Emission Tomography (PET/CT) has never been compared to Chest-Abdomen-Pelvis CT (CAPCT) in patients with a fever of unknown origin (FUO), inflammation of unknown origin (IUO) and episodic fever of unknown origin (EFUO) through a prospective and multicentre study. In this study, we investigated the diagnostic value of PET/CT compared to CAPCT in these patients. The trial was performed between 1 May 2008 through 28 February 2013 with 7 French University Hospital centres. Patients who fulfilled the FUO, IUO or EFUO criteria were included. Diagnostic orientation (DO), diagnostic contribution (DC) and time for diagnosis of both imaging resources were evaluated. One hundred and three patients were included with 35 FUO, 35 IUO and 33 EFUO patients. PET/CT showed both a higher DO (28.2% vs. 7.8%, p < 0.001) and DC (19.4% vs. 5.8%, p < 0.001) than CAPCT and reduced the time for diagnosis in patients (3.8 vs. 17.6 months, p = 0.02). Arthralgia (OR 4.90, p = 0.0012), DO of PET/CT (OR 4.09, p = 0.016), CRP > 30 mg/L (OR 3.70, p = 0.033), and chills (OR 3.06, p = 0.0248) were associated with the achievement of a diagnosis (Se: 89.1%, Sp: 56.8%). PET/CT both orients and contributes to diagnoses at a higher rate than CAPCT, especially in patients with FUO and IUO, and reduces the time for diagnosis.

Reference values of coagulation assays performed for thrombophilia screening after a first venous thrombosis and their intra-patient associations

IntroductionNo reference values are currently available for coagulation assays performed for thrombophilia screening prescribed according to guidelines, after a first venous thromboembolic (VTE) event, and we have no idea of the intra-patient associations between results. MethodsWe performed a retrospective study of consecutive prescriptions fulfilling guidelines in a French university hospital from 2010 to 2019 (n = 3842) from the Glims® laboratory information system. We collected results of 12 parameters: aPTT, PT, fibrinogen (Fg), one-stage clotting methods for factors VIII, IX, XI and II (FVIII, FIX, FXI, FII), antithrombin (using an amidolytic assay: AT), protein C and S (using clotting assays: PC and PS) and mixing tests of a lupus-anticoagulant sensitive aPTT and of DRVVT. ResultsWe show the results of the 12 parameters from 3603 individual files with less than 6 missing values, then describe these distributions and correlations between results from 2930 files with no missing value. We give the frequency of results described as indicating a risk of first VTE or of VTE recurrence. We propose 2 quantitative scores linking the 12 parameters at the individual level and reflecting their degree of dispersion with respect to their mean, describe the values of these scores and their associations with thrombophilic results. ConclusionsThese normal values should help laboratory workers to validate process results and to assess their degree of originality. Our 2 scores should help to determine the intra-patient plausibility of associations of results. The usefulness of these laboratory scores for predicting clinically-relevant outcomes deserves to be investigated.

Lower Rate of Daily Smokers With Symptomatic COVID-19: A Monocentric Self-Report of Smoking Habit Study.

Background: Identification of prognostic factors in COVID-19 remains a global challenge. The role of smoking is still controversial.Methods: PCR-positive in- and outpatients with symptomatic COVID-19 from a large French University hospital were systematically interviewed for their smoking status, use of e-cigarette, and nicotinic substitutes. The rates of daily smokers in in- and outpatients were compared using the same smoking habit questionnaire to those in the 2019 French general population, after standardisation for sex and age.Results: The inpatient group was composed of 340 patients, median age of 66 years: 203 men (59.7%) and 137 women (40.3%), median age of both 66 years, with a rate of 4.1% daily smokers (CI 95% [2.3–6.9]) (5.4% of men and 2.2% of women). The outpatient group was composed of 139 patients, median age of 44 years: 62 men (44.6%, median age of 43 years) and 77 women (55.4%, median age of 44 years). The daily smoker rate was 6.1% (CI 95% [2.7–11.6], 5.1% of men and 6.8% of women). Amongst inpatients, daily smokers represented 2.2 and 3.4% of the 45 dead patients and of the 29 patients transferred to ICU, respectively. The rate of daily smokers was significantly lower in patients with symptomatic COVID-19, as compared to that in the French general population after standardisation by age and sex, with standardised incidence ratios (SIRs) of 0.24 [0.12–0.48] for outpatients and 0.24 [0.14–0.40] for inpatients.Conclusions: Daily smoker rate in patients with symptomatic COVID-19 is lower as compared to the French general population

Corneal wounds repair emergencies during COVID‐19: 10/0 absorbable polyglactin sutures as a valuable strategy

AbstractPurposeThe aim of this study is to report the use of Vicryl 10‐0 (polyglactin 910) resorbable monofilament in corneal trauma during COVID‐19 pandemic: structural and functional results, and follow‐up adaptation during health crisis.MethodsDuring the COVID‐19 pandemic, nine patients were selected from the overall population of open or closed globe surgical emergencies (n = 37) in a french University Hospital. Selected patients were eligible for corneal sutures with Vicryl 10‐0, thus replacing the traditional 10‐0 nonabsorbable monofilament nylon suture. Postoperative treatment combined anti‐inflammatory drugs, topical antibiotics and lubricating drops. Outpatient visits were performed at D10, M2, M6 then every six month. Interim visits were performed if needed between D10 and M2 by teleconsultation. Patients received complete examination including different imaging. The main outcome was best corrected visual acuity. Secondary outcomes included average corneal astigmatism and the occurrence of complications.ResultsMean distance and near acuity improved from 0.711 ± 0.805 &amp; 0.556 ± 0.305 logMAR preoperatively to 0.056 ± 0.073 &amp; 0.333 ± 0.100 logMAR postoperatively (p = 0.032 and p = 0.043 respectively). Mean astigmatism decreased from 4.91 ± 4.21 diopters preoperatively to 0.99 ± 0.57 after suture resorption (p = 0.020). There were no serious adverse events or repeated surgery.ConclusionsPolyglactin 910 10‐0 could provide a maximum infectious risk reduction; a shorter topical treatment and antibiotic prophylaxis. The absorbable nature of the sutures simplifies logistics by reducing the number of early outpatient visits before M2. It avoids suture removal, especially for the pediatric population. Interim teleconsultation(s) on demand are interesting to evaluate the need for an additional face‐to‐face consultation. Vicryl 10‐0 sutures are ideally suited to the COVID‐19 pandemic logistical constraints, as a safe and effective alternative to nylon 10‐0 for the management of eligible corneal wounds.

Neurogenic bladder and continent cystostomy: Results of a monocentric cohort in a French university hospital

The main objective was to evaluate the complications of continuous urinary shunts in a French university hospital according to surgical technique and functional results especially on continence. The secondary objective was to evaluate the management of complications. A retrospective study was conducted between January 2008 and August 2017. Patients who had a continent cystostomy with or without bladder augmentation were included. Diversions for non-neurological causes were excluded. Cystostomy was performed using the appendix or a Monti's artifice. Data collected included complications and their management, functionality of the diversion and of the bladder reservoir, cystostomy continence, and urethral continence. Nineteen patients were included. The median follow-up time was 46 months. The majority of early postoperative complications were classified as grade II Clavien-Dindo. No postoperative deaths occurred. Late complications most frequently involved cystostomy duct stenosis (n=5), cystostomy incontinence (n=5), and urethral incontinence (n=8). Thirteen patients had revision surgery for late complications. Late complications on continence evolved favorably after revision surgery or medical treatment in all, but one case. Our results are consistent with the literature. Complications and the re-interventions are frequent and should lead to a multidisciplinary information and evaluation of the patient in preoperative care. 3.

Registry of cases of pulmonary hypertension in army hospitals

Background Pulmonary hypertension (PH) is a progressive disorder characterized by abnormally elevated blood pressure of the pulmonary circulation, which results, over time, from extensive vascular remodeling and increased pulmonary vascular resistance. Registries conducted since the National Institutes of Health study have enhanced our understanding of select aspects of pulmonary arterial hypertension (PAH). A network of 17 French university hospitals reported observations from a registry of 674 adults with PAH and described the minimum prevalence and incidence, as well as the clinical and hemodynamic characteristics, of this group. Objective To record all the cases of PH in all Egyptian army hospitals in the period between January 2015 and December 2019. Patients and methods This study was conducted on 150 patients with PH. They were recruited from the outpatient clinic and Department of Chest at specialized hospitals of Kobry Elkobba Armed Forces, as well as Air Force specialized and international medical center of the armed forces. This study was carried out on all patients diagnosed as having PH, as a retrospective and prospective study, starting from January 2015 till December 2019. The patients were subjected to the diagnostic algorithm of PH suggested by the 2015 European Cardiology Society/European Respiratory Society guidelines for the diagnosis and treatment of PH. Results The study was conducted on 150 patients with PH, including group 1 [88 (58.6%) patients], group 2 [16 (10.6%) patients], group 3 [eight (5.3%) patients], group 4 [34 (22.6%) patients], and group 5 [four (2.6%) patients], and there were seven patients of multigroups. The detailed data of different therapies were shown as important numbers. The diuretic therapies were given to 120 patients, 12 patients were on oxygen therapy, calcium channel blockers were only given to the five vasoreactive patients in our study, and 34 patients received oral anticoagulant, whereas specific drugs were given to 93 patients. Conclusion This was a preliminary study establishing patient characteristics in Egypt in the form of a registry. The most frequent PH etiologies were PAH and chronic thromboembolic PH, and patients were substantially younger at diagnosis compared with other international cohorts. Most patients with PAH received targeted therapy and showed significant improvement in disease severity (WHO Function Class). One of the most important limitation was the lack of the of the follow-up and survival data of many patients; however, many patients who were in the follow-up programs made a great survival but not to count on it as a result in the registry.

Impact du nouveau règlement européen 2017/745 relatif aux dispositifs médicaux sur l’activité des pharmacies hospitalières : exemple de la fonction d’approvisionnement pharmaceutique au sein d’un centre hospitalo-universitaire français

The new European regulation (MDR) on medical devices (MD) is expected to have major impacts on the industrial sector, but also consequences on healthcare professionals. Our objective was to evaluate the impact of the MDR on the supply of MDs in hospital pharmacies at the level of a French university hospital. We conducted a prospective follow-up of marketing cessations and supply disruptions directly related to the MDR between November 2019 and September 2020. The data were analyzed accounting for the nature of the suppliers (status/size), the nature of the MDs (route/class), and the proposed alternatives. The economic impact on hospital pharmacies was also estimated. Over this period, 96 MD product designations were declared out of stock or in cessation (total of 402 references), of which half corresponded to class IIa MDs, mainly used for surgical procedures. Of the 14 companies concerned (36% French), the majority were manufacturers, of small/medium-size or intermediate size. Substitutions were proposed for only 15 products (15.6%). The cost of pharmaceutical management of these disruptions/marketing cessations was estimated at 3052€. Even before the official date of its application, the impacts of the MDR on the supply function of hospital pharmacies are already visible. In the short, medium and long term, prospective monitoring of the impacts, positive or negative, would seem to be justified at the level of manufacturers, healthcare professionals and end users of MDs.