Effectiveness of Hypnosis for the Prevention of Anxiety During Coronary Angiography (HYPCOR study): a prospective randomized study.

BACKGROUND: Coronary angiography is the gold standard for the diagnosis of coronary artery disease. This intervention is nevertheless a source of anxiety for the patient both by its discomfort and by the consequences linked to the discovery of potential diseases. OBJECTIVES: The aim of this study was to determine the effectiveness of hypnosis in reducing anxiety in patients undergoing coronary angiography. METHODS: One hundred sixty-nine patients with planned coronary angiography and no history of coronary angiography were randomized to a hypnosis or control group. Patients in the hypnosis group underwent a hypnosis session with self-hypnosis posthypnotic suggestions, while those in the control group had a conversational interview with the hypnotherapist. The primary endpoint was pre-exam anxiety level assessed by the Spielberger State-Trait Anxiety Inventory (STAI-Y A). RESULTS: Performing a hypnosis session did not result in a significant decrease in anxiety before the intervention. Age, high trait anxiety, high state anxiety the day before, and belief that hypnosis works in general were associated with increased anxiety before the procedure. No adverse events were reported after hypnosis. There was no statistically significant difference between the 2 groups for the occurrence of complications of the intervention. CONCLUSION: In this study, performing a hypnosis session before coronary angiography did not reduce the state of anxiety measured just before the intervention. In all cases, the hypnotic experience appears to be positive for the patient, encouraging further research efforts. TRIAL REGISTRATION: The research protocol has been registered on the ClinicalTrials.gov registry (NCT02818101; 29/06/2016) and with the ANSM (IDRCB 2016-A00205-46; 02/02/2016).

Comparison of SARS-CoV-2 Variants of Concern Alpha (B.1.1.7) vs. Beta (B.1.351) in Critically Ill Patients: A Multicenter Cohort Study.

Objectives: The clinical outcomes of the Beta (B.1.351) variant of concern (VOC) of the SARS-CoV-2 virus remain poorly understood. In early 2021, northeastern France experienced an outbreak of Beta that was not observed elsewhere. This outbreak slightly preceded and then overlapped with a second outbreak of the better understood VOC Alpha (B.1.1.7) in the region. This situation allowed us to contemporaneously compare Alpha and Beta in terms of the characteristics, management, and outcomes of critically ill patients. Methods: A multicenter prospective cohort study was conducted on all consecutive adult patients who had laboratory confirmed SARS CoV-2 infection, underwent variant screening, and were admitted to one of four intensive care units (ICU) for acute respiratory failure between January 9th and May 15th, 2021. Primary outcome was 60-day mortality. Differences between Alpha and Beta in terms of other outcomes, patient variables, management, and vaccination characteristics were also explored by univariate analysis. The factors that associated with 60-day death in Alpha- and Beta-infected patients were examined with logistic regression analysis. Results: In total, 333 patients (median age, 63 years; 68% male) were enrolled. Of these, 174 and 159 had Alpha and Beta, respectively. The two groups did not differ significantly in terms of 60-day mortality (19 vs. 23%), 28-day mortality (17 vs. 20%), need for mechanical ventilation (60 vs. 61%), mechanical ventilation duration (14 vs. 15 days), other management variables, patient demographic variables, comorbidities, or clinical variables on ICU admission. The vast majority of patients were unvaccinated (94%). The remaining 18 patients had received a partial vaccine course and 2 were fully vaccinated. The vaccinated patients were equally likely to have Alpha and Beta. Conclusions: Beta did not differ from Alpha in terms of patient characteristics, management, or outcomes in critically ill patients. Trial Registration: ClinicalTrials.gov, identifier: NCT04906850.

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

INTRODUCTION: Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care. METHODS AND ANALYSIS: We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics. ETHICS AND DISSEMINATION: This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39.

Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial.

PURPOSE: Subluxation techniques are superior to divide-and-conquer in procedure duration, pain, and ultrasound quantity, but their safety in endothelial cell loss (ECL) is unclear. This randomized single-blind noninferiority clinical trial aimed to determine whether subluxation supracapsular phacoemulsification techniques are inferior to a reference endocapsular technique (divide-and-conquer) regarding postoperative corneal ECL. METHODS: Patients (aged18 years or older) with greater than +0.2 logarithm of the minimum angle of resolution best spectacle-corrected visual acuity and normal to severe density cataract were randomized to subluxation or divide-and-conquer phacoemulsification in 2015 to 2016. Follow-up with ophthalmic tests was conducted on day 4 and months 1, 3, and 12. The primary study outcome was ECL at all time points. Secondary study end points were operative variables, including effective phaco time and procedure duration. A clinically relevant noninferiority ECL limit was established on the basis of the literature. RESULTS: In total, 292 patients (mean age, 73 yrs; 59% female) were randomized and underwent subluxation (n = 148) or divide-and-conquer (n = 144). Day 4 and month 1, 3, and 12 data were available for 243, 270, 275, and 198 patients, respectively. The unexpectedly high dropout at 12 months meant that the 12-month ECL data could only be assessed qualitatively. Surgery was successful in all patients. Subluxation was noninferior to divide-and-conquer in ECL. Effective phaco times were similar, but subluxation associated with shorter procedure duration. CONCLUSIONS: The subluxation technique was noninferior to divide-and-conquer regarding postoperative ECL, at least in the first 3 months, and associated with reduced intervention time. Subluxation techniques may be suitable alternatives to endocapsular techniques.Clinical Trial Registration-URL: ClinicalTrials.gov. Unique identifier: NCT02535819.

Efficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial.

BACKGROUND: People with special needs have high unmet oral healthcare needs, partly because dentists find it difficult to access their oral cavity. The Oral Accessibility Spatula aims to improve oral accessibility. This prospective multicenter interventional open-label non-randomized patient-self-controlled trial assessed the ability of the spatula to improve the oral accessibility of special-needs patients during dental examinations. METHODS: The cohort was a convenience sample of minor and adult patients with special needs due to physical, intellectual, and/or behavioral disorders who underwent dental check-up/treatment in five French tertiary hospitals/private clinics in 2016-2018 and evinced some (Venham-Score = 2-4) but not complete (Venham-Score = 5) resistance to oral examination. After inclusion, patients underwent oral examination without the spatula and then immediately thereafter oral examination with the spatula. Primary outcome was Oral Accessibility Score (0-12 points; higher scores indicate visualization and probing of the tooth sectors). Secondary outcomes were patient toleration (change in Venham-Score relative to first examination), safety, and Examiner Satisfaction Score (0-10; low scores indicate unsatisfactory examination). RESULTS: The 201 patients were mostly non-elderly adults (18-64 years, 65%) but also included children (21%), adolescents (11%), and aged patients (3%). One-quarter, half, and one-quarter had Venham-Score = 2, 3, and 4 at inclusion, respectively. The spatula significantly improved Oral Accessibility Score (4.8 to 10.8), Venham-Score (3.1 to 2.6), and Examiner Satisfaction Score (3.4 to 7.2) (all p<0.001). There were no severe spatula-related adverse events. CONCLUSION: The spatula significantly improved oral access, was safe and well-tolerated by the patients, and markedly improved oral examination quality.

Mechanical Modeling of a Keratoconic Cornea.

PURPOSE: We created a laboratory model of a cornea that was subjected to various pressures and thermal and mechanical factors to better understand the genesis of keratoconus deformation. METHODS: A steel base allowed for fixation of circular multilaminated patches of araldite (10 cm in diameter, 5 mm thick) in which the corneal anatomy was modeled. The model was plunged into a steam room (374°F/3 bars of pressure for 1 h) to ensure thermal homogeneity and was subjected to pressure using compressed air. Three models were assessed: a fault-free model with no lesion (model 1), and 2 models with a defect. The first of the defective models (model 2) had an external crack-type lesion (1 cm long; 1 mm deep). The second defective model (model 3) had one quarter thinned down using abrasive sandpaper (thickness reduced by 30%-40%). RESULTS: For model 1, which represented a healthy cornea, homogeneous modification was noted when examined under polarized light. In model 2, no excessive deformation was noticed, but there were stress lines at the edge of the lesion. Model 3 had a deformity, similar to keratoconic deformation. CONCLUSIONS: Our findings suggest that the disease progresses under environmental stresses, but only when there is an initial defect, and especially when there is a thinning down defect. This thinning down defect may be induced by continual eye rubbing.

Visual outcomes following Descemet stripping automated endothelial keratoplasty for corneal endothelial dysfunction.

OBJECTIVE: To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK). METHODS: A total of 40 eyes of 36 patients with corneal endothelial dysfunction underwent DSAEK. All were followed up for 1 year. Visual acuity (VA; logMAR), mean endothelial cell density (MCD; via noncontact specular microscopy), and topography assessment were performed at baseline (preoperatively). Visual acuity and topography measurement were repeated at postoperative year 1. Subjective assessment of visual quality was evaluated using the National Eye Institute Visual Function Questionnaire (NEI-VFQ). RESULTS: Preoperative best-corrected VA (BCVA) was 1.29 ± 0.53 logMAR with mean optical correction of -0.33 ± 1.74 D. Postoperative BCVA, assessed after a mean of 10.8 ± 2.1 months, showed mean line gain of 7.11 ± 4.8 logMAR, with optical correction of +1.17 ± 1.54 D. Mean 6-month postoperative pachymetry was 598.2 ± 72.3 µm. Three patients experienced premature graft detachment, requiring repositioning via injection of a sterile air bubble. No other adverse events were observed. Significant improvement (p<.05 for all) in general, near, and far vision, ocular pain, difficulty in carrying out daily tasks, dependency, social life, and mental health were reflected by NEI-VFQ scores at 10.4 ± 2.1 months postoperatively versus preoperatively. No significant correlation was noted between postoperative VA line gain and NEI-VFQ-25 questionnaire score (p>0.05). CONCLUSIONS: Descemet stripping automated endothelial keratoplasty treatment may restore corneal clarity, improve VA, and increase vision-related quality of life in patients with advanced endothelial dysfunction. Further large-scale study is needed to corroborate these findings.

Taurolidine/Citrate Lock Therapy for Primary Prevention of Catheter-Related Infections in Cancer Patients: Results of a Prospective, Randomized, Phase IV Trial (ATAPAC).

BACKGROUND: Totally implantable venous access port (TIVAP)-related infections (RIs) remain a serious health problem in cancer patients receiving an intravenous (i.v.) therapy. PATIENTS AND METHODS: The ATAPAC study was a prospective, randomized, monocentric, phase IV trial evaluating the efficacy of taurolidine lock solution versus standard saline solution for primary TIVAP-RI prevention in nonhematological cancer patients receiving i.v. chemotherapy. The primary endpoint was the TIVAP-RI incidence rate. From December 2014 to September 2015, 163 patients were enrolled in the study (taurolidine: n = 86 vs. CONTROL: n = 77). Four patients in the control group (5%) had a Staphylococcus epidermidis TIVAP-RI, and 1 patient (1%) in the taurolidine group had a Staphylococcus aureus infection. The TIVAP-RI incidence rate was 0.4 and 0.1‰ catheter-days, respectively (p = 0.21). The infection-free TIVAP survival was not statistically significant (p = 0.09). TIVAP-RI required a total of 22 hospitalization days in the taurolidine group versus 106 days in the control arm with associated costs of EUR 4,849 and EUR 36,020, respectively. Taurolidine-related toxicity was transitory and classified as grade I. CONCLUSIONS: The ATAPAC trial did not show a significant risk-infection reduction by TauroLock™. A larger, prospective, randomized trial is needed to assess TauroLock efficacy for primary TIVAP-RI prevention in low-risk cancer patients.

Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness After Cataract Surgery.

PURPOSE: To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery. METHODS: One hundred sixty eyes underwent phacoemulsification-based cataract surgery performed by an experienced surgeon (n = 110; senior group) or a surgically less experienced ophthalmic assistant (n = 50; junior group), using the divide-and-conquer or tilt-and-tumble technique for cataractous lens extraction. The primary endpoint was postoperative corneal edema 2 hours after surgery, determined by pachymetry-based CCT. RESULTS: Mean age of patients was 71.5 ± 9.1 years. Mean CCT at postoperative hour 2 was 622.8 ± 69.3 µm: an increase of 14.3% ± 10.8 from 545.3 ± 33.7 µm preoperatively (P = 0.0028). Mean CCT at postoperative hour 2 and postoperative corneal edema were significantly higher for the junior group than the senior group, with mean respective increases of 105.8 ± 81.4 µm (19.3% ± 14.2%) and 66.4 ± 3.7 µm (12.3% ± 8.3%), P = 0.0001. After adjustment for confounding factors, surgical experience was the only factor significantly associated with corneal edema: ß = 39.58; SD = 11.05; P = 0.0005. Other intergroup differences observed included significantly longer mean operating and mean ultrasound times in the junior group than in the senior group. A final corneal suture was used more frequently in the senior than in the junior group, at rates of 32.7% and 2.0%, respectively, P < 0.0001. CONCLUSIONS: Greater surgical experience was found to be associated with reduced early postoperative corneal edema, shorter operative time, and shorter ultrasound time. This suggests that beyond mastering the initial learning curve of phacoemulsification, surgical experience enables faster and safer surgery.

Immunoglobulin M oligoclonal bands: biomarker of targetable inflammation in primary progressive multiple sclerosis.

OBJECTIVE: To identify a biomarker distinguishing patients who, despite a primary progressive multiple sclerosis (PPMS) clinical course, may nonetheless benefit from immune therapy. METHODS: The presence or absence of both immunoglobulin (Ig) G and IgM oligoclonal bands (OCB) was blindly examined in paired cerebrospinal fluid (CSF) and serum samples from a large PPMS patient cohort, and related to clinical and imaging evidence of focal inflammatory disease activity. RESULTS: Using both cross-sectional samples and serial sampling in a subgroup of patients followed prospectively as part of the placebo-controlled OLYMPUS study of rituximab in PPMS, we found that the presence of CSF-restricted IgM OCB (but not of IgG OCB) is associated with an active inflammatory disease phenotype in PPMS patients. This finding was confirmed in an independent, multicenter validation cohort. INTERPRETATION: The presence of CSF IgM OCB may be a biomarker for a subset of PPMS patients with more active inflammatory disease, who may benefit from immune-directed treatments.

Secretory products of multiple sclerosis B cells are cytotoxic to oligodendroglia in vitro.

B cells are important in the pathogenesis of multiple sclerosis (MS) and some of the effects are not dependent on maturation of B cells into immunoglobulin (Ig) producing plasmablasts and plasma cells. B cells present antigen, activate T cells, and are involved in immunoregulation and cytokine secretion. To determine if B cells from MS patients secrete products that have deleterious effects on glial cells not mediated by Ig, and to compare effects with secretory products of normal controls (NC), we isolated B cells from 7 patients with relapsing remitting MS (RRMS) and 4 NC. B cells were cultured alone or after stimulation with CD40 ligand (CD40L), CD40L+cross-linking of the B cell antigen receptor (xBCR) and CD40L+xBCR+stimulation of toll like receptor 9 (TLR9). Supernatants were harvested and incubated with mixed central nervous system (CNS) neonatal rat glial cells. Supernatants from unstimulated NC B cells induced on average death of 7% (range 0-24%) of differentiated oligodendrocytes (OL); in contrast, supernatants from unstimulated B cells from RRMS patients induced death of 57% (range 35-74%) of OL. Supernatants of stimulated B cells from NC did not increase the minimal OL death whereas stimulation of B cells from RRMS had variable results compared to unstimulated B cells. Supernatants from both NC and RRMS induced microglial enlargement and loss of normal resting bipolar morphology. OL death did not correlate with levels of tumor necrosis alpha (TNF-α), lymphotoxin alpha (LT-α), interleukin 6 (IL-6), IL-10, transforming growth factor beta 1 (TGF-ß1) or any combination or ratio of these cytokines. Analysis of 26 supernatants from NC and RRMS patients failed to detect IgM. There were very low levels of IgG in 8 of the 26 supernatants, and no correlation between of OL death and presence or absence of IgG. Sera used in both the B cell and glial cell cultures were heated, which inactivates complement. The effects of B cell supernatants on OL could be direct and/or indirect involving either microglia and/or astrocytes. The identity of the toxic factor(s) is as yet unknown. Thus we have demonstrated that B cells from patients with RRMS but not NC secrete one or more factors toxic to OL. It is possible that such factors produced by peripheral blood B cells when within the CNS could contribute to demyelination in MS patients.