Bilateral Simultaneous Magnetic Resonance-Guided Focused Ultrasound Pallidotomy for Life-Threatening Status Dystonicus.

BACKGROUND: Invasive treatments like radiofrequency stereotactic lesioning or deep brain stimulation of the globus pallidus internus can resolve drug-resistant status dystonicus (SD). However, these open procedures are not always feasible in patients with SD. OBJECTIVE: The aim was to report the safety and efficacy of simultaneous asleep bilateral transcranial magnetic resonance-guided focused ultrasound (MRgFUS) pallidotomy for life-threatening SD. METHODS: We performed bilateral simultaneous MRgFUS pallidotomy under general anesthesia in 2 young patients with pantothenate kinase-associated neurodegeneration and GNAO1 encephalopathy. Both patients had medically refractory SD and severe comorbidities contraindicating open surgery. RESULTS: SD resolved at 4 and 12 days after MRgFUS, respectively. Adverse events (intraoperative hypothermia and postoperative facial paralysis) were mild and transient. CONCLUSION: Bilateral simultaneous MRgFUS pallidotomy under general anesthesia is safe and may be a valid alternative therapeutic option for fragile patients. Further studies are needed to assess long-term efficacy of the procedure. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Integrated short peripheral intravenous cannulas and risk of catheter failure: A systematic review and meta-analysis.

BACKGROUND: Short peripheral catheters (SPCs) are used to provide intravenous therapies in hospitalized patients. Recently, the category of SPC has become more complex, with the introduction in clinical practice of "integrated" SPCs (ISPCs), renewed regarding the material (polyurethane rather than polytetrafluoroethylene) and design (large wing; pre-assembled extension; preassembled needle-free connector (NFC)). METHODS: This systematic review and meta-analysis aimed to analyze randomized controlled trials (RCTs) and quasi-randomized studies in hospitalized patients, analyzing the risk of overall catheter failure as well as the risk of each type of complication (occlusion, infiltration, thrombophlebitis, and dislodgement) for ISPCs compared to non-integrated SPCs. These systematic review and meta-analysis were registered on PROSPERO (CRD42022322970). DATA SOURCES: We searched PUBMED®, EMBASE®, and the Cochrane Controlled Clinical Trials register from April to November 2022. RESULTS: INCLUDED STUDIES: The research identified 1260 articles. After the abstract review, 13 studies were included for full manuscript review and, after that, six papers (4727 patients) were included in the meta-analysis. DESCRIPTION OF THE EFFECT: We found a significantly reduced risk of catheter failure (pooling all complications) for ISPCs compared to SPCs (p = 0.002 RR 0.65; 95% CI 0.63-0.9). A significant reduction in the risks of occlusion (p = 0.007 RR 0.72; 95% CI 0.56-0.92) was observed. As regards the risk of infiltration, thrombophlebitis, and dislodgement, the analysis showed a trend in favor of ISPCs, though not statistically significant (respectively p = 0.2 RR 0.84; 95% CI 0.64-1.1; p = 0.25 RR 0.91; 95% CI 0.78-1.07; p = 0.06 RR 0.72; 95% CI 0.52-1.01). CONCLUSIONS: ISPCs significantly reduce the risks of catheter failure (overall complications) and occlusion. More RCTs are needed to understand if the preassembled ISPC is better than the composted closed system (non-integrated SPC + extension line + NFC).

Three Logistic Predictive Models for the Prediction of Mortality and Major Pulmonary Complications after Cardiac Surgery.

Background and Objectives: Pulmonary complications are a leading cause of morbidity after cardiac surgery. The aim of this study was to develop models to predict postoperative lung dysfunction and mortality. Materials and Methods: This was a single-center, observational, retrospective study. We retrospectively analyzed the data of 11,285 adult patients who underwent all types of cardiac surgery from 2003 to 2015. We developed logistic predictive models for in-hospital mortality, postoperative pulmonary complications occurring in the intensive care unit, and postoperative non-invasive mechanical ventilation when clinically indicated. Results: In the "preoperative model" predictors for mortality were advanced age (p < 0.001), New York Heart Association (NYHA) class (p < 0.001) and emergent surgery (p = 0.036); predictors for non-invasive mechanical ventilation were advanced age (p < 0.001), low ejection fraction (p = 0.023), higher body mass index (p < 0.001) and preoperative renal failure (p = 0.043); predictors for postoperative pulmonary complications were preoperative chronic obstructive pulmonary disease (p = 0.007), preoperative kidney injury (p < 0.001) and NYHA class (p = 0.033). In the "surgery model" predictors for mortality were intraoperative inotropes (p = 0.003) and intraoperative intra-aortic balloon pump (p < 0.001), which also predicted the incidence of postoperative pulmonary complications. There were no specific variables in the surgery model predicting the use of non-invasive mechanical ventilation. In the "intensive care unit model", predictors for mortality were postoperative kidney injury (p < 0.001), tracheostomy (p < 0.001), inotropes (p = 0.029) and PaO2/FiO2 ratio at discharge (p = 0.028); predictors for non-invasive mechanical ventilation were kidney injury (p < 0.001), inotropes (p < 0.001), blood transfusions (p < 0.001) and PaO2/FiO2 ratio at the discharge (p < 0.001). Conclusions: In this retrospective study, we identified the preoperative, intraoperative and postoperative characteristics associated with mortality and complications following cardiac surgery.

Anesthesia-induced Takotsubo cardiomyopathy in trigeminal neuralgia: illustrative case.

BACKGROUND: Takotsubo syndrome (TS) represents a form of nonischemic cardiomyopathy characterized by sudden and temporary weakening of the myocardium. Many data suggest a primary role for sympathetic overstimulation in its pathogenesis. Nevertheless, these correlates are less easily identified during anesthesia. OBSERVATIONS: A 50-year-old female patient with a 4-year history of drug-resistant left trigeminal neuralgia. She was scheduled for surgical microvascular decompression. In the operating room, after induction of general anesthesia and oral intubation, the electrocardiogram revealed a significant ST segment elevation along with a sudden decrease in systolic blood pressure and heart rate. Administration of atropine caused a conversion into ventricular tachycardia. The advanced cardiac life support protocols were applied with prompt defibrillation and rapid recovery at sinus rhythm. A transthoracic echocardiogram revealed apical akinesia with ballooning of the left ventricle with a reduction of systolic function. An emergency coronary arteriography was performed, showing normal epicardial coronary vessels. After 4 days, echocardiography revealed normalization of the left ventricular function with improvement of the ejection fraction. LESSONS: In patients affected by trigeminal neuralgia, chronic pain can lead to a state of adrenergic hyperactivation, which can promote TS during the induction of general anesthesia, probably through the trigeminocardiac reflex.

Postoperative apnea after pyloromyotomy for infantile hypertrophic pyloric stenosis.

Objective: Infantile hypertrophic pyloric stenosis (IHPS), which causes gastric outlet obstruction and hypochloremic hypokalemic metabolic alkalosis, could pose a risk of postoperative apnea in patients. The aim of this study is to evaluate the incidence of postoperative apnea in babies admitted to a tertiary-level pediatric surgical center in Milano, Italy with diagnosis of IHPS in 2010-2019. The secondary objective is to evaluate the risk factors for postoperative apnea. Methods: This is a single-center, retrospective, observational cohort study. All patients admitted to our institution with diagnosis of IHPS during the study period were enrolled. Demographic and surgical variables, along with blood gas parameters, were obtained from the population. Postoperative apnea was defined as a respiratory pause longer than 15 s or a respiratory pause lasting less than 15 s, but associated with either bradycardia (heart rate <120 per minute), desaturation (SatO2 <90%), cyanosis, or hypotonia. Occurrence was obtained from nursing charts and was recorded as a no/yes dichotomous variable. Results: Of 122 patients, 12 (9.84%) experienced apnea and 110 (90.16%) did not. Using univariate analysis, we found that only postoperative hemoglobin was significantly different between the groups (p=0.03). No significant multivariable model was better than this univariate model for prediction of apnea. Conclusions: Postoperative anemia, possibly due to hemodilution, increased the risk of postoperative apnea. It could be hypothesized that anemia can be added as another apnea-contributing factor in a population at risk due to metabolic changes.

The Role of Bypass Surgery for the Management of Complex Intracranial Aneurysms in the Anterior Circulation in the Flow-Diverter Era: A Single-Center Series.

Despite the increasing popularity of flow diverters (FDs) as an endovascular option for intracranial aneurysms, the treatment of complex aneurysms still represents a challenge. Combined strategies using a flow-preservation bypass could be considered in selected cases. In this study, we retrospectively reviewed our series of patients with complex intracranial aneurysms submitted to bypass. From January 2015 to May 2022, 23 patients were selected. We identified 11 cases (47.8%) of MCA, 6 cases (26.1%) of ACA and 6 cases (26.1%) of ICA aneurysms. The mean maximal diameter was 22.73 ± 12.16 mm, 8 were considered as giant, 9 were fusiform, 8 presented intraluminal thrombosis, 10 presented wall calcification, and 18 involved major branches or perforating arteries. Twenty-five bypass procedures were performed in 23 patients (two EC-IC bypasses with radial artery graft, seventeen single- or double-barrel STA-MCA bypasses and six IC-IC bypasses in anterior cerebral arteries). The long-term bypass patency rate was 94.5%, and the total aneurysm exclusion was 95.6%, with a mean follow-up of 28 months. Median KPS values at last follow-up was 90, and a favorable outcome (KPS ≥ 70 and mRS ≤ 2) was obtained in 87% of the cases. The use of bypass techniques represents, in selected cases, a valid therapeutic option in the management of complex anterior circulation aneurysms when a simpler direct approach, including the use of FD, is considered not feasible.

Association of COVID-19 Vaccinations With Intensive Care Unit Admissions and Outcome of Critically Ill Patients With COVID-19 Pneumonia in Lombardy, Italy.

Importance: Data on the association of COVID-19 vaccination with intensive care unit (ICU) admission and outcomes of patients with SARS-CoV-2-related pneumonia are scarce. Objective: To evaluate whether COVID-19 vaccination is associated with preventing ICU admission for COVID-19 pneumonia and to compare baseline characteristics and outcomes of vaccinated and unvaccinated patients admitted to an ICU. Design, Setting, and Participants: This retrospective cohort study on regional data sets reports: (1) daily number of administered vaccines and (2) data of all consecutive patients admitted to an ICU in Lombardy, Italy, from August 1 to December 15, 2021 (Delta variant predominant). Vaccinated patients received either mRNA vaccines (BNT162b2 or mRNA-1273) or adenoviral vector vaccines (ChAdOx1-S or Ad26.COV2). Incident rate ratios (IRRs) were computed from August 1, 2021, to January 31, 2022; ICU and baseline characteristics and outcomes of vaccinated and unvaccinated patients admitted to an ICU were analyzed from August 1 to December 15, 2021. Exposures: COVID-19 vaccination status (no vaccination, mRNA vaccine, adenoviral vector vaccine). Main Outcomes and Measures: The incidence IRR of ICU admission was evaluated, comparing vaccinated people with unvaccinated, adjusted for age and sex. The baseline characteristics at ICU admission of vaccinated and unvaccinated patients were investigated. The association between vaccination status at ICU admission and mortality at ICU and hospital discharge were also studied, adjusting for possible confounders. Results: Among the 10 107 674 inhabitants of Lombardy, Italy, at the time of this study, the median [IQR] age was 48 [28-64] years and 5 154 914 (51.0%) were female. Of the 7 863 417 individuals who were vaccinated (median [IQR] age: 53 [33-68] years; 4 010 343 [51.4%] female), 6 251 417 (79.5%) received an mRNA vaccine, 550 439 (7.0%) received an adenoviral vector vaccine, and 1 061 561 (13.5%) received a mix of vaccines and 4 497 875 (57.2%) were boosted. Compared with unvaccinated people, IRR of individuals who received an mRNA vaccine within 120 days from the last dose was 0.03 (95% CI, 0.03-0.04; P < .001), whereas IRR of individuals who received an adenoviral vector vaccine after 120 days was 0.21 (95% CI, 0.19-0.24; P < .001). There were 553 patients admitted to an ICU for COVID-19 pneumonia during the study period: 139 patients (25.1%) were vaccinated and 414 (74.9%) were unvaccinated. Compared with unvaccinated patients, vaccinated patients were older (median [IQR]: 72 [66-76] vs 60 [51-69] years; P < .001), primarily male individuals (110 patients [79.1%] vs 252 patients [60.9%]; P < .001), with more comorbidities (median [IQR]: 2 [1-3] vs 0 [0-1] comorbidities; P < .001) and had higher ratio of arterial partial pressure of oxygen (Pao2) and fraction of inspiratory oxygen (FiO2) at ICU admission (median [IQR]: 138 [100-180] vs 120 [90-158] mm Hg; P = .007). Factors associated with ICU and hospital mortality were higher age, premorbid heart disease, lower Pao2/FiO2 at ICU admission, and female sex (this factor only for ICU mortality). ICU and hospital mortality were similar between vaccinated and unvaccinated patients. Conclusions and Relevance: In this cohort study, mRNA and adenoviral vector vaccines were associated with significantly lower risk of ICU admission for COVID-19 pneumonia. ICU and hospital mortality were not associated with vaccinated status. These findings suggest a substantial reduction of the risk of developing COVID-19-related severe acute respiratory failure requiring ICU admission among vaccinated people.

Lung Ultrasound Patterns in Multisystem Inflammatory Syndrome in Children (MIS-C)-Characteristics and Prognostic Value.

Objective and design: Following COVID-19 infection, children can develop an hyperinflammatory state termed Multisystem Inflammatory Syndrome in Children (MIS-C). Lung Ultrasound (LUS) features of COVID-19 in children have been described, but data describing the LUS findings of MIS-C are limited. The aim of this retrospective observational study conducted between 1 March and 31 December 2020, at a tertiary pediatric hospital in Milano, is to describe LUS patterns in patients with MIS-C and to verify correlation with illness severity. The secondary objective is to evaluate concordance of LUS with Chest X-ray (CXR). Methodology: Clinical and laboratory data were collected for all patients (age 0−18 years) admitted with MIS-C, as well as LUS and CXR patterns at admission. PICU admission, needed for respiratory support and inotrope administration, hospital, and PICU length of stay, were considered as outcomes and evaluated in the different LUS patterns. An agreement between LUS and CXR evaluation was assessed with Cohen' k. Results: 24 children, who had a LUS examination upon admission, were enrolled. LUS pattern of subpleural consolidations < or > 1 cm with or without pleural effusion were associated with worse Left Ventricular Ejection Fraction at admission and need for inotropes. Subpleural consolidations < 1 cm were also associated with PICU length of stay. Agreement of CXR with LUS for consolidations and effusion was slight. Conclusion: LUS pattern of subpleural consolidations and consolidations with or without pleural effusion are predictors of disease severity; under this aspect, LUS can be used at admission to stratify risk of severe disease.

Towards an Established Intraoperative Oncological Favorable Tool: Results of Fluorescein-Guided Resection from a Monocentric, Prospective Series of 93 Primary Glioblastoma Patients.

It is commonly reported that maximizing surgical resection of contrast-enhancing regions in patients with glioblastoma improves overall survival. Efforts to achieve an improved rate of resection have included several tools: among those, the recent widespread of fluorophores. Sodium fluorescein is an unspecific, vascular dye which tends to accumulate in areas with an altered blood-brain barrier. In this retrospective analysis of patients prospectively enrolled in the FLUOCERTUM study, we aimed to assess the role of fluorescein-guided surgery on surgical radicality, survival, and morbidity. A retrospective review based on 93 consecutively and prospectively enrolled IDH wild-type glioblastoma patients (2016-2022) was performed; fluorescence characteristics, rate of resection, clinical outcome, and survival were analyzed. No side effect related to fluorescein occurred; all of the tumors presented a strong yellow-green enhancement and fluorescein was judged fundamental in distinguishing tumors from viable tissue in all cases. Gross total resection was achieved in 77 cases out of 93 patients (82.8%). After a mean follow-up time of 17.4 months (3-78 months), the median progression-free survival was 12 months, with a PFS-6 and PFS-12 of 94.2% and 50%, respectively, whereas median overall survival was estimated to be 16 months; survival at 6, 12, and 24 months was 91.8%, 72.3%, and 30.1%, respectively. Based on these results, we can assert that the fluorescein-guided technique is a safe and valuable method for patients harboring a newly diagnosed, untreated glioblastoma.

Effectiveness and safety of intravenous dexmedetomidine sedation for ophthalmic surgery under regional anesthesia.

PURPOSE: To assess the effectiveness and safety of intravenous (IV) dexmedetomidine for sedation in ophthalmic surgery. METHODS: Prospective, observational, uncontrolled, single-center study. Patients were sedated with a continuous dexmedetomidine IV infusion started 15 min before regional anesthesia administration and maintained up to the end of surgery. Effectiveness of dexmedetomidine was assessed by the Modified Observer's Assessment of Alertness and Sedation (MOAA/S) targeted at 5. Safety was assessed by the incidence of patients' movements/snoring and by the incidence of respiratory and haemodynamic complications. An eleven-point numerical rating scale (NRS) was used to assess the level of satisfaction of both the surgeon and the patient. RESULTS: 123 patients (73 males, mean age: 63 ± 13) were included; 81 (81/123; 65.8%) patients reached the requested MOAA/S score of 5. Any intraoperative movement - mostly voluntary - occurred in 34 (34/123; 27.6%) cases with no need for a switch to general anaesthesia; no ocular complications related to the intraoperative movements occurred. Intraoperative snoring occurred in 30 (30/123; 24.4%) patients and it did not affect the surgical manoeuvres. Respiratory drive depression requiring manual or mechanical ventilation never occurred. Bradycardia occurred in 14 (14/123; 11.3%), cases but only 4 (4/123; 3.2%) patients required atropine administration, which was always effective. Intraoperative analgesia was consistently obtained and both the surgeons and the patients reported a high NRS satisfaction score. CONCLUSION: Dexmedetomidine provided adequate sedation in patients undergoing ocular surgery under local anaesthesia and showed a good effectiveness and safety profile. Upper airway obstruction, apnoea and snoring can occur.

Retrospective survey from vascular access team Lombardy net in COVID-19 era.

BACKGROUND: Venous Access Devices (VADs) are the most used devices in COVID-19 patients. OBJECTIVE: Identify VADs implanted, catheter related thrombosis (CRT), catheter-related bloodstream infection (CRBSI), and accidental remove of VADs in both COVID-19 positive and COVID-19 free patients. Successive analysis was conducted comparing COVID-19 positive patients with COVID-19 free with inverse probability propensity score weights using simple regression to account for these two confounders (peripheral tip as central/peripheral and hospitalization as no/yes). METHODS: This multicenter, retrospective cohort study collected data from seven hospitals in Lombardy during the pandemic period from February 21st to May 31st 2020. RESULTS: A total of 2206 VADs were evaluated, 1107 (50.2%) of which were inserted in COVID-19 patients. In COVID-19 cohort the first choice was Long Peripheral Cannula in 388 patients (35.1%) followed by Midline Catheter in 385 (34.8%). The number of "central tip" VADs inserted in COVID-free inpatients and COVID-19 positive were similar (307 vs 334). We recorded 42 (1.9%) CRT; 32 (79.2%) were observed in COVID-19 patients. A total of 19 CRBSI were diagnosed; 15 (78.95%) were observed in COVID-19. Accidental removals were the more represented complication with 123 cases, 85 (69.1%) of them were in COVID-19. COVID-19 significantly predicted occurrence of CRT (OR = 2.00(1.85-5.03); p < 0.001), CRSB (OR = 3.82(1.82-8.97); p < 0.001), and Accidental Removal (OR = 2.39(1.80-3.20); p < 0.001) in our propensity score weighted models. CONCLUSIONS: CRT, CRBSI, and accidental removal are significantly more frequent in COVID-19 patients. Accidental removals are the principal complication, for this reason, the use of subcutaneously anchored securement is recommended for a shorter period than usual.

Double layer stent for the treatment of leaks and fistula after upper gastrointestinal oncologic surgery: a retrospective study.

Anastomotic dehiscence is one of the most morbidity related and deadly complication after foregut oncologic surgery. The aim of the study is to evaluate the effectiveness of double layer stents (Niti-S™ Beta™ Esophageal Stent) in the management of dehiscences after upper gastrointestinal oncologic surgery. We retrospectively studied consecutive patients who underwent Niti-S™ Beta™ esophageal stent placement from June 2014 to September 2019 for the treatment of anastomotic leaks/fistula following esophagectomy or gastrectomy for cancer. Univariate two-sided logistic regression analysis was used to evaluate possible predictors of successful anastomotic leak/fistula closure. A total of 37 patients were studied and 75 stents were positioned in these patients during the endoscopic procedures. Effective leak/fistula closure was obtained in 23/37 (62.2%). No technical endoscopic failure or complications ensued during the placing of the devices. Regarding delayed complications, migration was observed in 17/75 (22.7%) procedures and stent leaking in 29/75 (38.6%). Three variables significantly favoured stent treatment failure, namely previous neoadjuvant therapy (OR 9.3, P = 0.01), fistula (instead of leak) (OR 6.5, P = 0.01), and stent leak (OR 17.0, P = 0.01). Placement of Beta Niti-S esophageal stent is a safe and effective method that could be considered for the management of leaks and fistula after upper gastrointestinal cancer. Crucial points in the management of post-surgical leaks with this technique are the prompt recognition of leaks and fistula, the prompt endoscopic/radiologic drain of collection and the choice of adequate size of the stent.

Risk of adverse events in gastrointestinal endoscopy: Zero-inflated Poisson regression mixture model for count data and multinomial logit model for the type of event.

BACKGROUND AND AIMS: We analyze the possible predictive variables for Adverse Events (AEs) during sedation for gastrointestinal (GI) endoscopy. METHODS: We consider 23,788 GI endoscopies under sedation on adults between 2012 and 2019. A Zero-Inflated Poisson Regression Mixture (ZIPRM) model for count data with concomitant variables is applied, accounting for unobserved heterogeneity and evaluating the risks of multi-drug sedation. A multinomial logit model is also estimated to evaluate cardiovascular, respiratory, hemorrhagic, other AEs and stopping the procedure risk factors. RESULTS: In 7.55% of cases, one or more AEs occurred, most frequently cardiovascular (3.26%) or respiratory (2.77%). Our ZIPRM model identifies one population for non-zero counts. The AE-group reveals that age >75 years yields 46% more AEs than age <66 years; Body Mass Index (BMI) ≥27 27% more AEs than BMI <21; emergency 11% more AEs than routine. Any one-point increment in the American Society of Anesthesiologists (ASA) score and the Mallampati score determines respectively a 42% and a 16% increment in AEs; every hour prolonging endoscopy increases AEs by 41%. Regarding sedation with propofol alone (the sedative of choice), adding opioids to propofol increases AEs by 43% and adding benzodiazepines by 51%. Cardiovascular AEs are increased by age, ASA score, smoke, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Respiratory AEs are increased by BMI, ASA and Mallampati scores, emergency, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Hemorrhagic AEs are increased by age, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. The risk of suspension of the endoscopic procedure before accomplishment is increased by female gender, ASA and Mallampati scores, and in-hospital, and it is reduced by emergency and procedure duration. CONCLUSIONS: Age, BMI, ASA score, Mallampati score, in-hospital, procedure duration, other sedatives with propofol increase the risk for AEs during sedation for GI endoscopy.

Micronvasive behaviour of single small hepatocellular carcinoma: which treatment?

BACKGROUND: Microinvasion (MI), defined as infiltration of the portal or hepatic vein or bile duct and intrahepatic metastasis are accurate indicators of a poor prognosis for mall hepatocellular carcinomas (HCC). A previous study showed that intraoperative ultrasound (IOUS) definition of MI-HCC had a high concordance with histological findings. Aim of this study is to evaluate overall survival and recurrence patterns of patients with MI-HCC submitted to hepatic resection (HR) or laparoscopic ablation therapies (LAT). METHODS: A total of 171 consecutive patients (78 h; 93 LAT) with single, small HCC (< 3 cm) with a MI pattern at IOUS examination were compared analyzing overall survival and recurrence patterns using univariate and multivariate analysis and weighting by propensity score. RESULTS: Overall recurrences were similar in the 2 groups (HR: 51 patients (65%); LAT: 66 patients (71%)). The rate of local tumor progression in the HR group was very low (5 pts; 6%) in comparison to LAT group (22 pts; 24%; p = 0.002). The overall survival curves of HR are significantly better than that of the LAT group (p = 0.0039). On the propensity score Cox model, overall mortality was predicted by the surgical treatment with a Hazard ratio 1.68 (1.08-2.623) (p = 0.022). CONCLUSIONS: If technically feasible and in patients fit for surgery, HR with an adequate tumor margin should be preferred to LAT in patients with MI-HCC at IOUS evaluation, to eradicate MI features near the main nodule, which are relatively frequent even in small HCC (< 3 cm).

Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design.

OBJECTIVE: Meropenem is a ß-lactam, carbapenem antibacterial agent with antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms and is important in the empirical treatment of serious infections in Intensive Care Unit (ICU) patients. Multi-drug resistant gram-negative organisms, coupled with scarcity of new antibiotic classes, forced healthcare community to optimize the therapeutic potential of available antibiotics. Our aim is to investigate the effect of continuous infusion of meropenem against bolus administration, as indicated by a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens in a population of ICU patients. DESIGN: Double blind, double dummy, multicenter randomized controlled trial (1:1 allocation ratio). SETTING: Tertiary and University hospitals. INTERVENTIONS: 600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with meropenem, will be randomized to receive a continuous infusion of meropenem 3 g/24 h or an equal dose divided into three daily boluses (i.e. 1g q8h). MEASUREMENTS: The primary endpoint will be a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens. Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint. We expect a primary outcome reduction from 52 to 40% in the continuous infusion group. CONCLUSIONS: The trial will provide evidence for choosing intermittent or continuous infusion of meropenem for critically ill patients with multi-drug resistant gram-negative infections.

Studying Enhanced Recovery After Surgery (ERAS®) Core Items in Colorectal Surgery: A Causal Model with Latent Variables.

BACKGROUND: Previous Enhanced Recovery After Surgery (ERAS®) studies have not always taken into account that ERAS interventions depend on baseline covariates and that several confounding variables affect the composite outcomes. METHOD: A causal latent variable model is proposed to analyze data obtained prospectively concerning 1261 patients undergoing elective colorectal surgery within the ERAS protocol. Primary outcomes (composite of any complication, surgical site infection, medical complications, early ready for discharge (TRD), early actual discharge) and secondary outcomes (composite of late bowel function recovery, IV fluid resumption, nasogastric tube replacement, postoperative nausea and vomiting, re-intervention, re-admission, death) are considered along with their multiple dimensions. RESULTS: Concerning the primary outcomes, our results evidence three subpopulations of patients: one with probable good outcome, one with possibly prolonged TRD and discharge without complications, and the other one with probable complications and prolonged TRD and discharge. Epidural anesthesia, waiving surgical drainage, and early ambulation, IV fluid stop and urinary catheter removal act favorably, while preoperative hospital stay and blood transfusion act negatively. Concerning the secondary outcomes our results evidence two subpopulations of patients: one with high probability of good outcome and one with high probability of complications. Epidural anesthesia, waiving surgical drainage, early ambulation and IV fluid stop act favorably, while blood transfusion acts negatively also with respect to these secondary outcomes. CONCLUSION: The multivariate causal latent class two-parameter logistic model, a modern statistical method overcoming drawbacks of traditional models to estimate the average causal effects on the treated, allows us to disentangle subpopulations of patients and to evaluate ERAS interventions.

Noninvasive Ventilatory Support of Patients with COVID-19 outside the Intensive Care Units (WARd-COVID).

Rationale: Treatment with noninvasive ventilation (NIV) in coronavirus disease (COVID-19) is frequent. Shortage of intensive care unit (ICU) beds led clinicians to deliver NIV also outside ICUs. Data about the use of NIV in COVID-19 is limited.Objectives: To describe the prevalence and clinical characteristics of patients with COVID-19 treated with NIV outside the ICUs. To investigate the factors associated with NIV failure (need for intubation or death).Methods: In this prospective, single-day observational study, we enrolled adult patients with COVID-19 who were treated with NIV outside the ICU from 31 hospitals in Lombardy, Italy.Results: We collected data on demographic and clinical characteristics, ventilatory management, and patient outcomes. Of 8,753 patients with COVID-19 present in the hospitals on the study day, 909 (10%) were receiving NIV outside the ICU. A majority of patients (778/909; 85%) patients were treated with continuous positive airway pressure (CPAP), which was delivered by helmet in 617 (68%) patients. NIV failed in 300 patients (37.6%), whereas 498 (62.4%) patients were discharged alive without intubation. Overall mortality was 25%. NIV failure occurred in 152/284 (53%) patients with an arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio <150 mm Hg. Higher C-reactive protein and lower PaO2/FiO2 and platelet counts were independently associated with increased risk of NIV failure.Conclusions: The use of NIV outside the ICUs was common in COVID-19, with a predominant use of helmet CPAP, with a rate of success >60% and close to 75% in full-treatment patients. C-reactive protein, PaO2/FiO2, and platelet counts were independently associated with increased risk of NIV failure.Clinical trial registered with ClinicalTrials.gov (NCT04382235).

Guidelines Adaptation to the COVID-19 Outbreak for the Management of Hepatocellular Carcinoma.

Background: COVID-19 pandemic rendered the surgical approach as well as the surgical indication very complex due to the outstanding consumption of public health system' resources, especially in the intensive care subdivision. A multidisciplinary team-based strategy is necessary to adapt guidelines and medical practices to the actual situation. The aim of this study is to evaluate the changes in the therapeutic algorithm in a small group of patients with hepatocellular carcinoma (HCC) enlisted for surgery during the COVID-19 outbreak. Materials and Methods: A multidisciplinary strategy has been adopted to allocate HCC patients to a treatment that permitted to reduce the risk of complications and the hospital stay, thus preventing contamination by the virus. Nasopharyngeal swab and a chest radiograph were performed in all patients within 48 hours before the surgical procedure: in the suspected cases with negative COVID tests, we prudently postponed surgery and repeated the diagnostic tests after 15 days. Results: During the emergency state, 11 HCC patients were treated (8 laparoscopic ablations and 3 hepatic resections). We reported only 1 postoperative complication (hemothorax) and 1 death during the follow-up for COVID pneumonia. Comparing our performances with those in the same time frame in the past 4 years, we treated a similar number of HCC patients, obtaining a decrease in operative timing (P = .0409) and hospital stay (P = .0412) (Fig. 2b) with similar rates of immediate postoperative complications, without ICU admissions. Conclusions: An adapted algorithm for the treatment of HCC to COVID outbreak permitted to manage safely these patients by identifying those most at risk of evolution of the neoplastic disease.