The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Robot-Assisted Treatment of Epigastric Hernias With a Suprapubic Approach

Background: Robot-assisted ventral hernia repair has shown itself to be feasible and safe in abdominal wall surgery. Presently, the ports are placed laterally to meet the distance from the fascial defect. The aim of our study is to report our experience of epigastric hernia treatment with trocar insertion in the suprapubic region. Materials and Methods: On a prospectively collected dataset on robot-assisted surgery, patients treated for epigastric hernias with suprapubic approach were identified. Demographic and clinical data were collected and analyzed. Results: Twelve patients were selected. Median age was 58.5 years [interquartile range (IQR): 47.8 to 67.3 y]; 4 patients were male (33.3%) and the median body mass index was 23.9 kg/m2 (IQR: 22.3 to 26.2 kg/m2). All patients were referred to surgery because of pain. The median measure of the hernia defect was 30 mm (IQR: 13.75 to 31.0 mm); median larger mesh diameter was 13.5 cm (IQR: 9.5 to 15.0 cm); and median operative time was 136.5 minutes (IQR: 120.0 to 186.5 min). No intraoperative complication or conversion to open surgery occurred. Postoperatively, 2 patients presented a seroma and median length of hospital stay was 2.0 days (IQR: 1.75 to 3 d). No case of hernia recurrence was recorded at a mean follow-up of 11.2 months (range: 4 to 29 mo). Conclusions: In the robot-assisted treatment of hernias of the epigastric region, a suprapubic port placement can be considered instead of a lateral one to have a better field overview, especially in subxiphoid hernias. Further studies are needed to assess the benefits and limitations of such technique

Robot-assisted Treatment of Epigastric Hernias With a Suprapubic Approach

Background: Robot-assisted ventral hernia repair has shown itself to be feasible and safe in abdominal wall surgery. Presently, the ports are placed laterally to meet the distance from the fascial defect. The aim of our study is to report our experience of epigastric hernia treatment with trocar insertion in the suprapubic region. Materials and Methods: On a prospectively collected dataset on robot-assisted surgery, patients treated for epigastric hernias with suprapubic approach were identified. Demographic and clinical data were collected and analyzed. Results: Twelve patients were selected. Median age was 58.5 years [interquartile range (IQR): 47.8 to 67.3 y]; 4 patients were male (33.3%) and the median body mass index was 23.9 kg/m2 (IQR: 22.3 to 26.2 kg/m2). All patients were referred to surgery because of pain. The median measure of the hernia defect was 30 mm (IQR: 13.75 to 31.0 mm); median larger mesh diameter was 13.5 cm (IQR: 9.5 to 15.0 cm); and median operative time was 136.5 minutes (IQR: 120.0 to 186.5 min). No intraoperative complication or conversion to open surgery occurred. Postoperatively, 2 patients presented a seroma and median length of hospital stay was 2.0 days (IQR: 1.75 to 3 d). No case of hernia recurrence was recorded at a mean follow-up of 11.2 months (range: 4 to 29 mo). Conclusions: In the robot-assisted treatment of hernias of the epigastric region, a suprapubic port placement can be considered instead of a lateral one to have a better field overview, especially in subxiphoid hernias. Further studies are needed to assess the benefits and limitations of such technique

Six Sigma can significantly reduce costs of poor quality of the surgical instruments sterilization process and improve surgeon and operating room personnel satisfaction

Abstract Operating room (OR) management is a complex multidimensional activity combining clinical and managerial aspects. This longitudinal observational study aimed to assess the impact of Six-Sigma methodology to optimize surgical instrument sterilization processes. The project was conducted at the operating theatre of our tertiary regional hospital during the period from July 2021 to December 2022. The project was based on the surgical instrument supply chain analysis. We applied the Six Sigma lean methodology by conducting workshops and practical exercises and by improving the surgical instrument process chain, as well as checking stakeholders’ satisfaction. The primary outcome was the analysis of Sigma improvement. Through this supply chain passed 314,552 instruments in 2022 and 22 OR processes were regularly assessed. The initial Sigma value was 4.79 ± 1.02σ, and the final one was 5.04 ± 0.85σ (SMD 0.60, 95%CI 0.16–1.04, p = 0.010). The observed improvement was estimated in approximately $19,729 of cost savings. Regarding personnel satisfaction, 150 questionnaires were answered, and the overall score improved from 6.6 ± 2.2 pts to 7.0 ± 1.9 pts (p = 0.013). In our experience the application of the Lean Six Sigma methodology to the process of handling the surgical instruments from/to the OR was cost-effective, significantly decreased the costs of poor quality and increased internal stakeholder satisfaction

SERS Detection of Amyloid Oligomers on Metallorganic-Decorated Plasmonic Beads

Protein misfolded proteins are among the most toxic endogenous species of macromolecules. These chemical entities are responsible for neurodegenerative disorders such as Alzheimer’s, Parkinson’s, Creutzfeldt–Jakob’s and different non-neurophatic amyloidosis. Notably, these oligomers show a combination of marked heterogeneity and low abundance in body fluids, which have prevented a reliable detection by immunological methods so far. Herein we exploit the selectivity of proteins to react with metallic ions and the sensitivity of surface-enhanced Raman spectroscopy (SERS) toward small electronic changes in coordination compounds to design and engineer a reliable optical sensor for protein misfolded oligomers. Our strategy relies on the functionalization of Au nanoparticle-decorated polystyrene beads with an effective metallorganic Raman chemoreceptor, composed by Al³⁺ ions coordinated to 4-mercaptobenzoic acid (MBA) with high Raman cross-section, that selectively binds aberrant protein oligomers. The mechanical deformations of the MBA phenyl ring upon complexation with the oligomeric species are registered in its SERS spectrum and can be quantitatively correlated with the concentration of the target biomolecule. The SERS platform used here appears promising for future implementation of diagnostic tools of aberrant species associated with protein deposition diseases, including those with a strong social and economic impact, such as Alzheimer’s and Parkinson’s diseases

Development of a model for laparoscopic cholecystectomy video assisted training. A randomized study

<div><p>Abstract Purpose: To identify the surgical trainee benefits through the use of video assisted training (VAT). Methods: Twelve cases of uncomplicated laparoscopic cholecystectomy (LC) were selected. Edited video segments focused on essential intra-operative anatomical structure identification and critical surgical steps. Evaluation of these videos was constructed on a scoring system based on pre and post-teach tests. Results: The mean value of the pre-teach score was 33.2 ± 18.0 points and in the post-teach test the mean value was 66.7 ± 9.7 points. A statistically significant difference was seen when comparing pre and post-teach results (p<.00001). Conclusion: The widespread and the systematic use of video assisted learning may be a useful and economic tool in adjunct to the surgical training techniques practiced until now throughout the surgical community.</p></div

European paediatric surgeons' association survey on the management of primary spontaneous pneumothorax in children

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