Clipping Versus Coiling for Ruptured MCA Aneurysms Associated with Intracerebral Hematoma Requiring Surgical Evacuation.

BACKGROUND: Ruptured middle cerebral artery aneurysm (MCAa) can lead to intracerebral hematoma, and surgical evacuation can be performed in these cases. MCAa can be treated by clipping or before by endovascular therapy (EVT). Our objective was to compare the impact on the functional outcome of MCAa in patients with intracerebral hematoma requiring evacuation. METHODS: This is a multicenter, retrospective, cohort study with nine French neurosurgical units from January 1, 2013, to December 31, 2020. All participants were adult patients who required evacuation of an intracerebral hematoma. We looked for risk factors for poor outcomes by comparing the baseline characteristics and treatments performed by using the 6-month modified Rankin scale score. Poor outcomes were defined by an modified Rankin scale score of 3-6. RESULTS: A total of 162 patients were included. A total of 129 (79.6%) patients were treated by microsurgery, and 33 (20.4%) patients were treated by EVT. In multivariate analysis, factors associated with poor outcomes included hematoma volume, realization of a decompressive craniectomy, occurrence of procedure-related symptomatic cerebral ischemia, occurrence of delayed cerebral ischemia, and EVT. In the propensity score matching analysis (n = 33 per group), poor outcomes were observed in 30% of the patients in the clipping group versus 76% in the EVT group (P < 0.001). These differences may have been related to a longer delay between hospital admission and hematoma evacuation in the EVT group. CONCLUSIONS: In the specific subgroup of ruptured MCAa with intracerebral hematoma that requires surgical evacuation, clipping with concomitant hematoma evacuation could provide better functional outcomes than EVT followed by surgical evacuation.

Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials.

BACKGROUND: The majority of central venous catheters (CVC) removed in the ICU are not colonized, including when a catheter-related infection (CRI) is suspected. We developed and validated a predictive score to reduce unnecessary CVC removal. METHODS: We conducted a retrospective cohort study from five multicenter randomized controlled trials with systematic catheter-tip culture of consecutive CVCs. Colonization was defined as growth of ≥103 colony-forming units per mL. Risk factors for colonization were identified in the training cohort (CATHEDIA and 3SITES trials; 3899 CVCs of which 575 (15%) were colonized) through multivariable analyses. After internal validation in 500 bootstrapped samples, the CVC-OUT score was computed by attaching points to the robust (> 50% of the bootstraps) risk factors. External validation was performed in the testing cohort (CLEAN, DRESSING2 and ELVIS trials; 6848 CVCs, of which 588 (9%) were colonized). RESULTS: In the training cohort, obesity (1 point), diabetes (1 point), type of CVC (dialysis catheter, 1 point), anatomical insertion site (jugular, 4 points; femoral 5 points), rank of the catheter (second or subsequent, 1 point) and catheterization duration (≥ 5 days, 2 points) were significantly and independently associated with colonization . Area under the ROC curve (AUC) for the CVC-OUT score was 0.69, 95% confidence interval (CI) [0.67-0.72]. In the testing cohort, AUC for the CVC-OUT score was 0.60, 95% CI [0.58-0.62]. Among 1,469 CVCs removed for suspected CRI in the overall population, 1200 (82%) were not colonized. The negative predictive value (NPV) of a CVC-OUT score < 6 points was 94%, 95% CI [93%-95%]. CONCLUSION: The CVC-OUT score had a moderate ability to discriminate catheter-tip colonization, but the high NPV may contribute to reduce unnecessary CVCs removal. Preference of the subclavian site is the strongest and only modifiable risk factor that reduces the likelihood of catheter-tip colonization and consequently the risk of CRI. CLINICAL TRIALS REGISTRATION: NCT00277888, NCT01479153, NCT01629550, NCT01189682, NCT00875069.

Proton Pump Inhibitor Use and Associated Infectious Complications in the PICU: Propensity Score Matching Analysis.

OBJECTIVES: We aimed to evaluate the association between proton pump inhibitor (PPI) exposure and nosocomial infection (NI) during PICU stay. DESIGN: Propensity score matched analysis of a single-center retrospective cohort from January 1, 2017, to December 31, 2018. SETTING: Tertiary medical and surgical PICU in France. PATIENTS: Patients younger than 18 years old, admitted to the PICU with a stay greater than 48 hours. INTERVENTION: Patients were retrospectively allocated into two groups and compared depending on whether they received a PPI or not. MEASUREMENTS AND MAIN RESULTS: Seven-hundred fifty-four patients were included of which 231 received a PPI (31%). PPIs were mostly used for stress ulcer prophylaxis (174/231; 75%), but upper gastrointestinal bleed risk factors were rarely present (18%). In the unadjusted analyses, the rate of NI was 8% in the PPI exposed group versus 2% in the nonexposed group. After propensity score matching ( n = 184 per group), we failed to identify an association between PPI exposure and greater odds of NI (adjusted odds ratio 2.9 [95% CI, 0.9-9.3]; p = 0.082). However, these data have not excluded the possibility that there is up to nine-fold greater odds of NI. CONCLUSIONS: This study highlights the prevalent use of PPIs in the PICU, and the potential association between PPIs and nine-fold greater odds of NI is not excluded.

Surgical management of lumbar spinal stenosis in patients over 80: is there an increased risk?

Management of lumbar spinal stenosis (LSS) represents the first cause of spinal surgery for the elderly and will increase with the aging population. Although the surgery improves quality of life, the procedure involves anaesthetic and operative risks. The aim of this study was to assess whether the postoperative complication rate was higher for elderly patients and to find confounding factors. We conducted a retrospective study including all LSS surgeries between 2012 and 2020 at the University Hospital of Caen. We compared two populations opposing patients aged over 80 with others. The primary endpoint was the occurrence of a severe complication (SC). Minor complications were the secondary endpoint. Comorbidities, history of lumbar spine surgery and surgical characteristics were recorded. Nine hundred ninety-six patients undergoing surgery for degenerative LSS were identified. Patients over 80 were significantly affected by additional comorbidities: hypertension, heart diseases, higher age-adjusted comorbidity Charlson score, ASA score and use of anticoagulants. Knee-chest position was preferred for younger patients. Older patients underwent a more extensive decompression and had more incidental durotomies. Of the patients, 5.2% presented SC. Age over 80 did not appear to be a significant risk factor for SC, but minor complications increased. Multivariate analysis showed that heart diseases, history of laminectomy, AA-CCI and accidental durotomies were independent risk factors for SC. Surgical management for lumbar spinal stenosis is not associated to a higher rate of severe complications for patients over 80 years of age. However, preoperative risk factors should be investigated to warn the elderly patients that the complication risk is increased although an optimal preparation is the way to avoid them.

Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study.

OBJECTIVE: Postoperative pulmonary complications (PPC) remain a main issue after cardiac surgery. The objective was to report the incidence and identify risk factors of PPC after cardiac surgery. DESIGN: An international multicenter prospective study (42 international centers in 9 countries). PARTICIPANTS: A total of 707 adult patients who underwent cardiac surgery under cardiopulmonary bypass. INTERVENTIONS: None MEASUREMENTS AND MAIN RESULTS: During a study period of 2 weeks, the investigators included all patients in their respective centers and screened for PPCs. PPC was defined as the occurrence of at least 1 pulmonary complication among the following: atelectasis, pleural effusion, respiratory failure, respiratory infection, pneumothorax, bronchospasm, or aspiration pneumonitis. Among 676 analyzed patients, 373 patients presented with a PPC (55%). The presence of PPC was significantly associated with a longer intensive care length of stay and hospital length of stay. One hundred ninety (64%) patients were not intraoperatively ventilated during cardiopulmonary bypass. Ventilation settings were similar regarding tidal volume, respiratory rate, inspired oxygen. In the regression model, age, the Euroscore II, chronic obstructive pulmonary disease, preoxygenation modality, intraoperative positive end-expiratory pressure, the absence of pre- cardiopulmonary bypass ventilation, the absence of lung recruitment, and the neuromuscular blockade were associated with PPC occurrence. CONCLUSION: Both individual risk factors and ventilatory settings were shown to explain the high level of PPCs. These findings require further investigations to assess a bundle strategy for optimal ventilation strategy to decrease PPC incidence.

Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen: A randomized double-blind trial.

AIM: To assess the safety and efficacy of the short-acting glucagon-like peptide-1 receptor agonist exenatide on a population of patients with type 2 diabetes (T2D) mostly treated with continuous subcutaneous insulin injection (CSII). MATERIALS AND METHODS: A phase 2/3, multicentre, randomized, parallel-group, double-blind, placebo-controlled, 6-month trial was conducted. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10 µg BID) or matched placebo. RESULTS: A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n = 28) and placebo (n = 18). CSII treatment was used by 75% and 89% of patients of the exenatide and placebo groups, respectively. At 6 months, the change in HbA1c was -0.62% ± 0.94% and 0.08% ± 0.81% in the exenatide and placebo groups, respectively (difference, -0.70%; 95% CI [-1.24%; -0.15%], P = .014); body weight and body mass index decreased in the exenatide group (-2.55 ± 3.25 kg and -1.00 ± 1.31 kg/m2 ) and increased in the placebo group (1.29 ± 2.82 kg and 0.46 ± 1.16 kg/m2 ) (observed difference, -3.85 and -1.45, respectively, both P < .001); the postdinner capillary blood glucose value was lower in the exenatide group compared with the placebo group (162.4 ± 80.5 vs. 259.1 ± 94.4 mg/dL, respectively; observed difference, -96.7, P < .01). Hypoglycaemic risk, quality of life and overall safety were not different between the groups, apart from the expected occurrence of digestive effects in the exenatide group. CONCLUSIONS: Although we failed to reach our planned sample size, the addition of exenatide treatment 10 µg BID SC in T2D patients with uncontrolled HbA1c despite an intensified insulin regimen, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance.

Decreased number of deaths related to severe traumatic brain injury in intensive care unit during the first lockdown in Normandy: at least one positive side effect of the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has led to severe containment measures to protect the population in France. The first lockdown modified daily living and could have led to a decrease in the frequency of severe traumatic brain injury (TBI). In the present study, we compared the frequency and severity of severe TBI before and during the first containment in Normandy. METHODS: We included all patients admitted in the intensive care unit (ICU) for severe TBI in the two tertiary neurosurgical trauma centres of Normandy during the first lockdown. The year before the containment served as control. The primary outcome was the number of patients admitted per week in ICU. We compared the demographic characteristics, TBI mechanisms, CT scan, surgical procedure, and mortality rate. RESULTS: The incidence of admissions for severe TBI in Normandy decreased by 33% during the containment. The aetiology of TBI significantly changed during the containment: there were less traffic road accidents and more TBI related to alcohol consumption. Patients with severe TBI during the containment had a better prognosis according to the impact score (p=0.04). We observed a significant decrease in the rate of short-term mortality related to severe TBI during the period of lockdown (p=0.02). CONCLUSIONS: Containment related to the COVID-19 pandemic has resulted in a modification of the mechanisms of severe TBI in Normandy, which was associated with a decline in the rate of short-term death in intensive unit care.

Severe acute respiratory syndrome coronavirus-2-related and imputable deaths in children: results from the French pediatric national registry.

BACKGROUND: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for an important mortality rate worldwide. We aimed to evaluate the actual imputability of SARS-CoV-2 on the mortality rate associated with SARS-CoV-2-related illnesses in the pediatric intensive care unit (PICU). Secondary objectives were to identify risk factors for death. METHODS: This national multicenter comparative study comprised all patients under 18 years old with positive SARS-CoV-2 polymerase chain reactions (PCRs) [acute corona virus disease 2019 (COVID-19) or incidental SARS-CoV-2 infection] and/or pediatric inflammatory multisystem syndrome (PIMS) recorded in the French PICU registry (PICURe) between September 1, 2021, and August 31, 2022. Included patients were classified and compared according to their living status at the end of their PICU stay. Deceased patients were evaluated by four experts in the field of pediatric infectiology and/or pediatric intensive care. The imputability of SARS-CoV-2 as the cause of death was classified into four categories: certain, very probable, possible, or unlikely, and was defined by any of the first three categories. RESULTS: There were 948 patients included of which 43 died (4.5%). From this, 26 deaths (67%) could be attributed to SARS-CoV-2 infection, with an overall mortality rate of 2.8%. The imputability of death to SARS-CoV-2 was considered certain in only one case (0.1%). Deceased patients suffered more often from comorbidities, especially heart disease, neurological disorders, hematological disease, cancer, and obesity. None of the deceased patients were admitted for pediatric inflammatory multisystem syndrome (PIMS). Mortality risk factors were male gender, cardiac comorbidities, cancer, and acute respiratory distress syndrome. CONCLUSIONS: SARS-CoV-2 mortality in the French pediatric population was low. Even though the imputability of SARS-CoV-2 on mortality was considered in almost two-thirds of cases, this imputability was considered certain in only one case.

Gripwise Versus Jamar: The Challenge of a New Dynamometer Assessing Handgrip Strength.

BACKGROUND: Sarcopenia diagnosis is partly based on handgrip strength (HGS) assessment. The gold-standard dynamometer for this measurement is the Jamar. The electronic Gripwise is a smaller and lighter one, and its measurements are correlated with the Jamar's in laboratory tests. Our study aimed to confirm this correlation in aged patients. METHODS: This monocenter cross-sectional study was performed in patients of 65 years and older admitted at the University Hospital. Participants were assessed either in a seated or bedridden position, randomly allocated to begin the measurements with the Jamar or the Gripwise. RESULTS: Among 649 aged inpatients assessed for eligibility, 348 were included (mean age: 79 ±â€…9; 52% females). The intraclass correlation coefficient was 0.93 (95% confidence interval [CI] 0.92-0.94, p < .001) for the maximum value measured with both devices and 0.94 (95% CI 0.93-0.95, p < .001) for the mean values. However, there was a significant difference in detecting low values (<16 kg in women, <27 kg in men), found in 48% of patients with Jamar, and 71% with Gripwise (p < .001). Thus, we determined alternate cutoffs for diagnosing HGS low values with the Gripwise (<12 kg in women, <22 kg in men), further validated in a supplementary validation population (n = 70). The diagnostic performances of these alternative cutoffs were high (93% sensitivity and 87% specificity in women; 94% sensitivity and 96% specificity in men). CONCLUSIONS: The correlation of the Gripwise with the Jamar was confirmed in aged inpatients. However, lower values recorded with the Gripwise require alternate cutoffs for a relevant low HGS diagnosis.

Microsurgery and Endovascular Therapy for Distal Anterior Cerebral Artery Aneurysm: A Multicenter Retrospective Cohort Study.

BACKGROUND: Distal anterior cerebral aneurysm (DACA) represents 4% of intracranial aneurysms. Two treatment modalities are available: microsurgery and endovascular therapy (EVT). OBJECTIVE: To compare the results between microsurgery and EVT in a modern French cohort. METHODS: A multicenter retrospective cohort study of 3 French neurosurgical units was carried out from January 1, 2015, to December 31, 2020. All participants were adult patients who required treatment for a ruptured or unruptured DACA aneurysm. RESULTS: A total of 69 patients were included; 16 patients (23.2%) were treated by microsurgery and 53 (76.8%) were treated by EVT. Thirty-one patients (44.9%) had ruptured aneurysms. The complication rate was low, with 1 death and 1 symptomatic ischemia. There was no difference in complications between microsurgery and EVT (P = 0.22). The number of retreatments was higher in EVT (15% vs. 0%) but not significantly (P = 0.18). CONCLUSIONS: In the specific subgroup of DACA, both treatment modalities are effective in ruptured and unruptured aneurysms, with a low rate of complications. Retreatment may be more frequent in EVT but it does not lead to more complications.

Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials.

BACKGROUND: The anatomic site for central venous catheter insertion influences the risk of central venous catheter-related intravascular complications. We developed and validated a predictive score of required catheter dwell time to identify critically ill patients at higher risk of intravascular complications. METHODS: We retrospectively conducted a cohort study from three multicenter randomized controlled trials enrolling consecutive patients requiring central venous catheterization. The primary outcome was the required catheter dwell time, defined as the period between the first catheter insertion and removal of the last catheter for absence of utility. Predictors were identified in the training cohort (3SITES trial; 2336 patients) through multivariable analyses based on the subdistribution hazard function accounting for death as a competing event. Internal validation was performed in the training cohort by 500 bootstraps to derive the CVC-IN score from robust risk factors. External validation of the CVC-IN score were performed in the testing cohort (CLEAN, and DRESSING2; 2371 patients). RESULTS: The analysis was restricted to patients requiring mechanical ventilation to comply with model assumptions. Immunosuppression (2 points), high creatinine > 100 micromol/L (2 points), use of vasopressor (1 point), obesity (1 point) and older age (40-59, 1 point; ≥ 60, 2 points) were independently associated with the required catheter dwell time. At day 28, area under the ROC curve for the CVC-IN score was 0.69, 95% confidence interval (CI) [0.66-0.72] in the training cohort and 0.64, 95% CI [0.61-0.66] in the testing cohort. Patients with a CVC-IN score ≥ 4 in the overall cohort had a median required catheter dwell time of 24 days (versus 11 days for CVC-IN score < 4 points). The positive predictive value of a CVC-IN score ≥ 4 was 76.9% for > 7 days required catheter dwell time in the testing cohort. CONCLUSION: The CVC-IN score, which can be used for the first catheter, had a modest ability to discriminate required catheter dwell time. Nevertheless, preference of the subclavian site may contribute to limit the risk of intravascular complications, in particular among ventilated patients with high CVC-IN score. Trials Registration NCT01479153, NCT01629550, NCT01189682.

Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort.

INTRODUCTION: Natalizumab, a therapy for relapsing-remitting multiple sclerosis (RRMS), is associated with a risk of progressive multifocal leukoencephalopathy (PML). Over the last several years, practitioners have used off-label extended interval dosing (EID) of natalizumab to reduce PML risk, despite the absence of a large-scale efficacy evaluation. METHODS: We conducted a retrospective, multicenter cohort study among adults with RRMS receiving stable standard interval dosing (SID), defined as a ≥ 12-month consecutive period of ≥ 11 natalizumab infusions/year in France. We compared the 12-month risk difference of remaining relapse-free (primary endpoint) between patients who switched to EID (≤ 9 natalizumab infusions) and those who remained on SID, with a noninferiority margin of - 11%. We used propensity score methods such as inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM). Secondary endpoints were annualized relapse rate, disease progression, and safety. RESULTS: Baseline characteristics were similar between patients receiving EID (n = 147) and SID (n = 156). The proportion of relapse-free patients 12 months postbaseline was 142/147 in the EID (96.6%) and 144/156 in the SID group (92.3%); risk difference (95% CI) 4.3% (- 1.3 to 9.8%); p < 0.001 for non-inferiority. There were no significant differences between relapse rates (0.043 vs. 0.083 per year, respectively; p = 0.14) or Expanded Disability Status Scale mean scores (2.43 vs. 2.72, respectively; p = 0.18); anti-JC virus index values were similar (p = 0.23); and no instances of PML were reported. The comparisons using IPTW (n = 306) and PSM (n = 204) were consistent. CONCLUSION: These results support the pertinence of using an EID strategy for RRMS patients treated with natalizumab. CLINICAL TRIALS: gov identifier (NCT04580381).

Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial.

BACKGROUND: Postoperative atrial fibrillation (PoAF) after cardiac surgery has a high incidence of 30%, but its management is controversial. Two strategies are recommended without evidence of a superiority of one against the other: rate control with beta-blocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with fast onset and short half-life. One retrospective, single-center study compared landiolol to amiodarone for PoAF after cardiac surgery with a better hemodynamic stability and a higher rate of reduction to sinus rhythm with landiolol, justifying the need for a multicenter randomized controlled trial. Our aim is to compare landiolol to amiodarone in the setting of PoAF after cardiac surgery with the hypothesis of a higher rate of reduction to sinus rhythm with landiolol during the 48 h after the first episode of POAF. METHODS: The FAAC trial is a multicenter single-blind two parallel-arm randomized study, which planned to include 350 patients with a first episode of PoAF following cardiac surgery. The duration of the study is 2 years. The patients are randomized in two arms: a landiolol group and an amiodarone group. Randomization (Ennov Clinical®) is performed by the anesthesiologist in charge of the patient if PoAF is persistent for at least 30 min after correction of hypovolemia, dyskalemia, and absence of pericardial effusion on a transthoracic echocardiography done at bedside. Our hypothesis is an increase of the percentage of patients in sinus rhythm from 70 to 85% with landiolol in less than 48 h after onset of PoAF (alpha risk = 5%, power = 90%, bilateral test). DISCUSSION: The FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223739. Registered on January 10, 2020.

Association between Following the ESCMID Guidelines for the Management of Candidemia and Mortality: A Retrospective Cohort Study.

OBJECTIVES: The objective of this study was to evaluate the association between ESCMID adherence and 30-day mortality in candidemia. METHODS: We performed a retrospective cohort study in two French tertiary-care hospitals. All patients with at least one positive blood culture (BC) for Candida spp. between January 2013 and December 2019 were included. An adherent case was defined as a candidemia case for which the treatment fulfilled a bundle of defined criteria based on the latest ESCMID recommendations. We explored factors associated with adherence to ESCMID recommendations in an unadjusted model, and we used a propensity score method to address potential channeling biases with regard to 30-day mortality. RESULTS: During the study period, 165 cases of candidemia were included. Among the ESCMID criteria, funduscopic examination was not performed in 45% and neither was echocardiography in 31%, while the ESCMID criteria were fully implemented in 44 cases (27%). In the propensity score analysis, the all-cause 30-day mortality rate was significantly lower among adherent cases (3.4/36.6, 9%) than among nonadherent cases (42.4/119.5, 36%) (OR = 5.3 95% CI [1.6-17.1]). CONCLUSIONS: In our study, adherence to the bundle of criteria for candidemia management was associated with increased survival, supporting additional efforts to implement these recommendations.

Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes.

INTRODUCTION: The use of predictive low-glucose suspend (PLGS) sensor-augmented pumps has been shown to lead to a significant reduction in hypoglycemic episodes in patients with type 1 diabetes (T1D), but their effects on hyperglycemia exposure are heterogeneous. The aim of this study was to determine the settings of the Medtronic 640G system to obtain the optimal balance between occurrence of both hypoglycemia and hyperglycemia. METHODS: The hypo- and hyperglycemia area under the curve (AUC), as well as system settings [hypoglycemic threshold, mean insulin total daily dose (TDD), mean basal insulin percentage, and mean daily duration of PLGS] were collected between 2 and 12 times during 1 year in patients from four university hospital centers. Univariate/multivariate analyses and receiver operating characteristics (ROC) curves were performed to determine factors associated with hyper- and hypoglycemia AUC. RESULTS: A total of 864 observations were analyzed from 110 patients with T1D. Two preselected settings predictive of low hyperglycemia AUC were a basal insulin percentage < 52.0% [sensitivity (Se) = 0.66 and specificity (Sp) = 0.53] and a PLGS duration > 157.5 min/day (Se = 0.47 and Sp = 0.73). The preselected setting predictive of a low hypoglycemia AUC was a PLGS duration ≤ 174.4 min (Se = 0.83 and Sp = 0.51). Between-visit variation of PLGS and TDD was positively correlated (r = 0.61; p < 0.0001). CONCLUSION: The most important Medtronic 640G setting was the mean daily PLGS duration, where a value between 157.5 and 174.4 min/day was associated with the best reduction in both hypo- and hyperglycemia AUC. In this study, we showed that PLGS duration could be indirectly modified through total daily insulin dose adaptation. TRIAL REGISTRATION: This study is registered in clinicaltrials.gov (NCT03047486).

Complications of peripherally inserted central catheters in adult hospitalized patients and outpatients in the KTFIXPICC study: A randomized controlled trial evaluating a fixation device KT FIX Plussystem.

BACKGROUND: Poor securement potentiates Peripherally inserted central catheters (PICC) complications. A dressing device (KT FIX Plus) offers stronger skin attachment, which may reduce the risk of dressing disruption. We aimed to evaluate this device. METHODS: We conducted a single-center parallel-group open-label randomized controlled trial. Hospitalized and outpatient consecutive adults requiring PICCs were randomized to KT FIX Plus or standard of care (SOC). The primary endpoint was the composite of PICC-associated complications until removal, including occlusion, migration, accidental withdrawal, infection, thrombosis, and hematoma. RESULTS: No statistically significant difference was observed in terms of complications: 67 (35%) in the KT FIX Plus group vs 36 (37%) in the SOC group (log-rank P = 0.76). In multivariate Cox analysis, independent risk factors for PICC-associated complications were obesity (adjusted hazard ratio (aHR), 1.08, P < .001) and diabetes (aHR, 1.85, P = .039), adjusting for chronic renal failure, number of lumens, catheter/vein diameter ratio and duration of home-based care. Multiple lumen catheters increased the risk of accidental withdrawal and migration (HR, 2.4, P = .008). CONCLUSIONS: In our study, the use of KT FIX Plus did not reduce the risk of complications adjusting for other risk factors such as obesity and diabetes. The number of catheter lumens is one of the modifiable factors to reduce complications. Further studies are required to find the best securement and dressing system.

Is laparoscopic bariatric surgery as safe and effective before and after age 60? Results from a propensity-score analysis.

BACKGROUND: Patients over 60 years old undergoing bariatric surgery is still increasing. OBJECTIVES: First, to assess the impact of age (>60 years) on the 90-day morbidity and mortality of both laparoscopic Roux-en-Y gastric bypass (LRYGB) and sleeve gastrectomy (LSG), and second, to determine the effectiveness of surgical weight loss and resolution of obesity-related comorbidities for patients 60 years of age and older over a 2-year period. SETTING: Bicentric study from University Hospital of Caen and Memorial Hospital of Saint Lô, France. METHODS: This is a retrospective review of a prospectively maintained database of patients with morbid obesity undergoing laparoscopic bariatric surgery from October 2005 to April 2019. Patients 60 years of age and older were defined as cases (elderly group [EG], n = 137), and patients younger than 60 years of age were defined as controls (young group [YG], n = 1544). The primary endpoint of the study was the prevalence of severe postoperative complications within 90 days of surgery determined by a propensity-score-matching (PSM) analysis. RESULTS: The PSM population included 133 patients in the EG who were matched 1:2 with 266 patients in the YG. There was no mortality in either group. Although not significant (with an absolute difference of 4.5% between the EG and the YG), the odds of severe postoperative complications were 2.5 times higher in the EG than in the YG (7.5% versus 3.0%, P = .053). At 90 days postoperatively, the prevalences of overall morbidity (31.6% versus 22.9%, P = .044), leakage (5.3% versus 1.1%, P = .026), and reoperation (5.3% versus 1.1%, P = .026) were significantly higher in the EG than in the YG. CONCLUSION: This propensity-matched study suggests that laparoscopic bariatric surgery is probably an effective treatment in obese elderly patients (EPs) in terms of weight loss and resolution of comorbidities. However, the EP should be warned of the increased risk of severe postoperative complications within 90 days, including leakage and reoperation rates, especially after RYGB.

Microsurgical Clipping of Middle Cerebral Artery Aneurysms: Complications and Risk Factors for Complications.

OBJECTIVE: Middle cerebral artery aneurysms (MCAAs) have been considered good candidates for microsurgery. Our objective was to evaluate the risk of complications and the risk factors for complications with microsurgical treatment of MCAAs to better define the indications for microsurgery. METHODS: We conducted a retrospective cohort study from 3 tertiary neurosurgical units from January 2013 to May 2020. We evaluated the frequency of complications and searched for the risk factors for complications after microsurgery. Complications were defined as a composite criterion with the presence of one of the following: procedural-related death, symptomatic cerebral ischemia, impossible exclusion, incomplete exclusion, or rebleeding of the treated aneurysm and symptomatic surgical site hematoma. RESULTS: A total of 292 MCAAs were treated, with 29 complications (9.9%), including symptomatic cerebral ischemia (4.8%), aneurysm rebleeding (0.3%), surgical site hematoma (1.0%), impossible exclusion (0.3%), and incomplete exclusion (4.1%). Severe complications, defined as death or a modified Rankin scale score of ≥4 at 3 months, were infrequent, occurring in 7 of the 292 patients (2.4%). On multivariate analysis, the risk factors were a ruptured aneurysm, a larger maximum aneurysm size, a larger neck size, and arterial branches passing <1 mm from the aneurysm neck or dome. CONCLUSIONS: Microsurgical management of MCAAs can be performed with very low morbidity rates. In some cases, at least for factors that do not result in significant difficulty for endovascular therapy, such as the presence of an en passage artery or ruptured aneurysm, endovascular therapy can be considered to be as safe and effective as clipping.

Dolutegravir Monotherapy as Maintenance Strategy: A Meta-Analysis of Individual Participant Data From Randomized Controlled Trials.

Background: Dolutegravir monotherapy (DTG-m) results in virological failure (VF) in some people with human immunodeficiency virus (PWH). We sought to identify the independent factors associated with the risk of VF and to explore the effect size heterogeneity between subgroups of PWH enrolled in DTG-m trials. Methods: We searched for randomized clinical trials (RCTs) evaluating DTG-m versus combined antiretroviral therapy (cART) among PWH virologically controlled for at least 6 months on cART. We performed an individual participant data meta-analysis of VF risk factors and quantified their explained heterogeneity in random-effect models. Definition of VF was a confirmed plasma human immunodeficiency virus (HIV)-1 ribonucleic acid (RNA) >50 copies/mL by week 48. Results: Among 416 PWH from 4 RCTs, DTG-m significantly increased the risk of VF (16 of 227 [7%] versus 0 of 189 for cART; risk difference 7%; 95% confidence interval [CI], 1%-2%; P = .02; I2 = 51%). Among 272 participants exposed to DTG-m, VF were more likely in participants with the following: first cART initiated ≥90 days from HIV acute infection (adjusted hazard ratio [aHR], 5.16; 95% 95% CI, 1.60-16.65), CD4 T cells nadir <350/mm3 (aHR, 12.10; 95% CI, 3.92-37.40), HIV RNA signal at baseline (aHR, 4.84; 95% CI, 3.68-6.38), and HIV-deoxyribonucleic acid (DNA) copy number at baseline ≥2.7 log/106 peripheral blood mononuclear cells (aHR, 3.81; 95% CI, 1.99-7.30). Among these independent risk factors, the largest effect size heterogeneity was found between HIV DNA subgroups (I2 = 80.2%; P for interaction = .02). Conclusions: Our study supports the importance of a large viral reservoir size for explaining DTG-m simplification strategy failure. Further studies are needed to link size and genetic diversity of the HIV-1 reservoir.