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Catheter-associated urinary tract infections (CAUTIs) are one of the most common nosocomial infections and can lead to numerous medical complications from the mild catheter encrustation and bladder stones to the severe septicaemia, endotoxic shock, and pyelonephritis. Catheters are one of the most commonly used medical devices in the world and can be characterised as either indwelling (ID) or intermittent catheters (IC). The primary challenges in the use of IDs are biofilm formation and encrustation. ICs are increasingly seen as a solution to the complications caused by IDs as ICs pose no risk of biofilm formation due to their short time in the body and a lower risk of bladder stone formation. Research on IDs has focused on the use of antimicrobial and antibiofilm compounds, while research on ICs has focused on preventing bacteria entering the urinary tract or coming into contact with the catheter. There is an urgent need for in vitro urinary tract models to facilitate faster research and development for CAUTI prevention. There are currently three urinary tract models that test IDs; however, there is only a single very limited model for testing ICs. There is currently no standardised urinary tract model to test the efficacies of ICs.

Vascular access for the infusion of medications and solutions requires timely assessment, planning, insertion, and assessment. Traditional vascular access is reactive, painful, and ineffective, often resulting in the exhaustion of peripheral veins prior to consideration of other access options. Evidence suggests clinical pathways improve outcomes by reducing variations and establishing processes to assess and coordinate care, minimizing fragmentation and cost. Implementation of a vascular access clinical pathway leads to the intentional selection of the best vascular access device for the patient specific to the individual diagnosis, treatment plan, current medical condition, and the patient's vessel health (1). The Vessel Health and Preservation (VHP) programme incorporates evidence-based practices focused on timely, intentional proactive device selection implemented within 24 hours of admission into any acute facility. VHP is an all-inclusive clinical pathway, guiding clinicians from device selection through patient discharge, including daily assessment. Initiation of the VHP programme within a facility provides a systematic pathway to improve vascular access selection and patient care, allowing for the reduction of variations and roadblocks in care while increasing positive patient outcomes and satisfaction. Patient safety and preservation of vessel health is the ultimate goal.

This is the first book that comprehensively and systematically describes the new technology of hydrophilic interaction liquid chromatography (HILIC). Hydrophilic interaction chromatography is a separation technique suitable for polar and hydrophilic compounds and orthogonal to reversed phase liquid chromatography. From small organic molecules to pr

Direct puncture and cannulation of peripheral arteries is frequently performed in critical care and in emergency settings, mainly for hemodynamic monitoring and blood sampling. While there is abundant literature on peripheral arterial cannulation in children and adults, there is still scope for clinical improvements which may impact on patient safety. Although the radial artery is the most frequently utilized access site today, due to its superficial proximity, ease of access, and low risk of adverse events, other sites are sometimes chosen. The authors propose the Safe Insertion of Arterial Catheters (SIA) protocol, an ultrasound-guided insertion bundle applying a systematic approach to arterial cannulation, with a focus on improving insertion practices, reducing procedural complications, increasing the patient safety profile, and improving device performance.

Background: To evaluate novice and expert clinicians’ procedural confidence utilizing a blended learning mixed fidelity simulation model when applying a standardized ultrasound-guided central venous catheterization curriculum. Methods: Simulation-based education and ultrasound-guided central venous catheter insertion aims to provide facility-wide efficiencies and improves patient safety through interdisciplinary collaboration. The objective of this quality improvement research was to evaluate both novice (<50) and expert (>50) clinicians’ confidence across 100 ultrasound-guided central venous catheter insertion courses were performed at a mixture of teaching and non-teaching hospitals across 26 states within the United States between April 2015 and April 2016. A total of 1238 attendees completed a pre- and post-survey after attending a mixed method clinical simulation course. Attendees completed a 4-h online didactic education module followed by 4 h of hands-on clinical simulation stations (compliance/sterile technique, needling techniques, vascular ultrasound assessment, and experiential complication management). Results: The use of a standardized evidence-based ultrasound-guided central venous catheter curriculum improved confidence and application to required clinical tasks and knowledge across all interdisciplinary specialties, regardless of level of experience. Both physician and non-physician groups resulted in statistically significant results in both procedural compliance ( p < 0.001) and ultrasound skills ( p < 0.001). Conclusion: The use of a standardized clinical simulation curriculum enhanced all aspects of ultrasound-guided central venous catheter insertion skills, knowledge, and improved confidence for all clinician types. Self-reported complications were reported at significantly higher rates than previously published evidence, demonstrating the need for ongoing procedural competencies. While there are growing benefits for the role of simulation-based programs, further evaluation is needed to explore its effectiveness in changing the quality of clinical outcomes within the healthcare setting.

INTRODUCTION: Peripheral arterial catheter insertion is a common procedure for critically ill patients requiring frequent blood gas sampling and continuous blood pressure monitoring. There are clear advantages of ultrasound-guided arterial cannulation, which have shown to be more effective in reducing complications, time to successful cannulation, number of attempts, and overall first-time success rates. Evidence suggests that using palpation alone has a first-time success rate of less than 70% yet is still a widely performed technique. A systematic evaluation may be required to reduce variations in arterial catheterization practices. DESIGN: The arterial insertion method is a systematic evaluation to aid in arterial catheter insertion with ultrasound guidance, intended to improve the procedural approach. The process of arterial insertion method ensures appropriate choice of zone selection to optimize catheter longevity and performance in patients requiring arterial access. Moving the insertion site proximally 4 cm from the red zone into the green zone may reduce mechanical complications and preserve catheter performance and dwell time. CONCLUSION: The standardization of ultrasound guidance in arterial catheterization promotes vessel health and patient safety through device and site optimization. The arterial insertion method systematic evaluation may be utilized to reduce variation in practice and promote the use of ultrasound as a standard for the insertion of radial arterial catheters.

Electrospun hydroxyapatite (HA)/biopolymer fibrous composites have attracted much interest in the field of hard-tissue engineering. Unfortunately, poor mechanical property is a continuing problem and limits their usefulness in many applications. In this study, we attempted to improve the mechanical strength, modulus, and toughness of the HA/poly( l -lactic acid) (PLLA) electrospun scaffold by aligning the needle-shaped HA particles within the PLLA nanofibers. Three types of HA particles with different aspect ratios and sizes were incorporated into PLLA nanofibrous scaffolds with a random or aligned fibrous assembly. It was the first time that the needle-shaped HA particles with high aspect ratios were perfectly oriented along the long axes of the nanofibers. All HA particles significantly enhanced the tensile modulus, strength, and toughness of the corresponding scaffold, but to different extents. The dramatic reinforcement effects for different morphologies were rationalized using the Halpin–Tsai and shear-lag models for composites.

BACKGROUND AND OBJECTIVES: Current treatments for overweight adults include reduced-calorie diet, exercise, behavior modification, and selective use of medications. Many achieve suboptimal results with these measures and progress to obesity. Whether the intragastric balloon (IGB), a reversible device approved for treatment of obesity, is a safe and effective option in overweight adults is less well studied. We conducted a study to prospectively analyze the safety and effectiveness of IGB in overweight adults, to compare the results to a simultaneously studied cohort of obese patients, and to share procedural tips for safe IGB placement and removal. METHODS: One hundred thirty-nine patients were evaluated in this prospective, nonrandomized study. Twenty-six overweight [body mass index (BMI), 26-30)] and 113 obese (BMI > 30) patients underwent outpatient, endoscopic IGB placement under intravenous sedation. The IGB was filled with a 550-900 mL (average, 640 mL) solution of saline, radiological contrast, and methylene blue, with an approximate final proportion of 65:2:1. The patients were followed up at 1-2 weeks and then monthly for 6 months. At 6 months, they underwent IGB removal via an esophageal overtube to optimize safety, and then they were observed for 6 more months. RESULTS: IGB time was 190 ± 36 d in the overweight patients and 192 ± 43 d in the obese patients. Symptoms of IGB intolerance included nausea and pain, which were transiently present in 50-95% of patients for several days, and necessitated early IGB removal in 6% of patients. There were no procedure-related complications and no IGB-related esophagitis, erosion, perforation, or obstruction. The percentage of excess weight loss (EWL%) was 96 ± 54% in the overweight group and 41 ± 26% in the obese group (P < 0.001). CONCLUSION: In overweight adults failing standard treatments, IGB placement for 6 months had an acceptable safety profile and excellent weight loss.

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study ( ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.

BACKGROUND: Chlorhexidine (CHX) is a widely utilized disinfectant that can cause IgE-mediated urticaria/anaphylaxis. The cross-reactivity of patients with IgE-mediated CHX allergy with other disinfectants, which share structural similarities with CHX like polyhexanide (polyhexamethylene biguanide; PHMB), alexidine (ALX), or octenidine (OCT), is unknown. METHODS: Forty-four patients with anaphylaxis or urticaria upon CHX exposure and positive skin prick test (SPT) and/or positive CHX ImmunoCAP test (Phadia TFS, Uppsala, Sweden) were recruited. IgE to the biguanide and/or hexamethylene structure was investigated with PHMB ImmunoCAP (n = 32) and by basophil activation tests (BAT) with CHX and ALX (n = 37). Inhibition tests of CHX and PHMB ImmunoCAPs by CHX, ALX, PHMB, and OCT were performed. RESULTS: IgE reactivity to PHMB as surrogate marker for biguanide/hexamethylene reactivity was detected in 5/32 sera. Seven of 37 patients showed a positive BAT with ALX, but only under optimized conditions. Binding to CHX ImmunoCAP was inhibited by ALX in 1/32 sera, and binding to PHMB was blocked by ALX (1/5) and by OCT in another (1/5). In SPT, 9/10 patients were positive for CHX and 3 of them with ALX (only at highest concentration at 5 mg/mL). A further patient reacted primarily with OCT and showed IgE cross-reactivity with CHX, ALX, and PHMB. CONCLUSION: The IgE response to CHX seems polyclonal. The chloroguanide ending of CHX is the main epitope for the IgE and is suitable as screening assay to detect CHX reactivity. IgE-reactivities with the biguanide or hexamethylene components of other disinfectants (ALX, PHMB) can be detected by SPT, PHMB ImmunoCAP, and ALX-BAT in 15%-33% of CHX-allergic patients.

Radial arterial catheters (RAC) are used extensively across critical care settings (Anesthesia, Intensive Care, Emergency Medicine) for continuous hemodynamic monitoring, allowing for immediate adjustments in vasopressor therapies and blood collection. Radial catheter failures are an ongoing significant issue for critical care clinicians with reported incidences at almost 25%. Common complications include loss of function, lack of blood return, poor quality waveforms and dislodgement, posing potential patient risks, and sudden loss of intra-arterial monitoring frequently requires prompt replacement. Contemporary research and technological improvements have highlighted several concepts to enhance the approach of RAC insertion and management while reducing immediate and late complications. The authors have prioritized the following 10 "best practice" aspects that may improve overall device function and reliability.

A fibrous precursor for bone repair composites was made by coating poly(L-lactide) (PLLA) fibers with hydroxyapatite (HA) using a biomimetic method. To enhance the bonding between the HA coating and the PLLA fiber, PLLA fibers were etched with either sodium hydroxide or sodium hypochlorite to generate carboxyl groups on fiber surfaces. The experiments were designed to determine the influence of etching on the fiber surface morphology and chemistry as well as the subsequent HA coating on the etched fiber surfaces. It was found that the etching pretreatment increased the roughness as well as the hydrophilicity of fibers, indicating that hydrolysis of PLLA chains had taken place on fiber surfaces. The etching pretreatment also promoted HA coating formation by introducing thicker coating on the surface of fibers with a longer etching time, a higher etching concentration, or with NaOCl as the etching agent. A mechanism of surface hydrolysis and oxidation of PLLA was proposed.

Infection is the leading complication associated with intravascular devices, and these infections develop when a catheter becomes colonized by microorganisms. To combat this issue, medical device manufacturers seek to provide healthcare facilities with antimicrobial medical devices to prevent or reduce the colonization. In order to adequately evaluate these devices, an in vivo model is required to accurately assess the performance of the antimicrobial devices in a clinical setting. The model presented herein was designed to provide a simulation of the subcutaneous tunnel environment to evaluate the ability of an antimicrobial peripherally inserted central catheter (PICC), coated with chlorhexidine based technology, to reduce microbial migration and colonization compared to an uncoated PICC. Three samples of control, uncoated PICCs and three samples of coated PICCs were surgically tunneled into the backs of female New Zealand White rabbits. The insertion sites were then challenged with Staphylococcus aureus at the time of implantation. Animals were evaluated out to thirty days and sacrificed. Complete en bloc dissection and evaluation of the catheter and surrounding tissue demonstrated that the chlorhexidine coated catheter was able to significantly reduce microbial colonization and prevent microbial migration as compared to the standard, un-treated catheter.

The study examines the role of foreign direct investment (FDI) on economic growth and trade balances of 10 emerging economies in Europe before they joined the European Union. This article uses the Granger causality test to investigate the link between FDI inflows and economic growth for the countries under study. The findings show that gross domestic product growth has a unilateral Granger-cause on FDI inflows for 9 of 10 emerging European economies. However, the results did not show FDI inflows Granger-causing the changes in economic growth of any of the 10 countries. Furthermore, FDI inflows had no or negative effects on trade balances of the majority of the emerging European nations. The policy implications of this study are that host governments in emerging economies must carefully evaluate spillover effects of FDI inflows on their economies before offering significant incentive packages to lure multinational enterprises into their countries.

BACKGROUND/PURPOSE: The MANTA is a dedicated plug-based large-bore vascular closure device (VCD) providing safe hemostasis in most patients, but data on the clinical impact and mechanisms of MANTA related complications are limited. This study sought to determine the frequency, impact and predictors of MANTA-related access complications. METHODS/MATERIALS: This patient-level meta-analysis included data from 2 medical device approval studies and 1 post-approval registry. The primary endpoint was the composite of major and minor access complications. Technical success was defined as hemostasis with MANTA closure device without need for vascular surgery or stenting. RESULTS: Eight hundred ninety-one patients (mean age 80) underwent transcatheter aortic valve replacement (n = 814), endovascular aortic repair (n = 71), balloon aortic valvuloplasty (n = 4) or mechanical circulatory support (n = 2). Technical success was 96.4% and median time to hemostasis was 31 (interquartile range: 17-76) seconds. The primary endpoint occurred 9.1% and bailout vascular surgery or stenting was necessary in 32 patients (3.6%). Female gender (OR: 2.63, CI: 1.46-4.73, p = 0.001), left femoral access (OR: 2.18, CI: 1.17-4.06, p = 0.015) and unfavorable arteriotomy phenotype (combination of a small femoral artery diameter with a deep arteriotomy; OR 2.27: 1.26-4.10, p = 0.006) independently predicted access complications. Access complications most often consisted of vessel dissection, stenosis or occlusion and predominantly occurred in patients with an unfavorable arteriotomy phenotype. CONCLUSIONS: Large-bore arteriotomy closure with MANTA VCD provided fast and safe hemostasis with an acceptable complication rate. Refined procedure planning and risk-stratification may further improve MANTA VCD performance.

The main purpose of this study is to use the Sharpe Ratio to test the efficient market hypothesis for different market capitalization and investment styles of mutual funds. The results of the study for the entire period of 1994‐2007 as well as the two subperiods (1994‐1999 and 2000‐2007) indicate that small cap funds have provided the highest risk‐adjusted return for the entire period whereas growth funds have exhibited lower returns. The findings, therefore, suggest that the mutual funds market is not always efficient, which makes it possible for an investor or a mutual fund manager to earn excess return on a risk‐adjusted basis.

Residency programs are charged with teaching, assessing, and documenting resident competency for a multitude of skills. Documentation of competency requires demonstrating specific milestones mandated by the Accreditation Council for Graduate Medical Education. Our department designed an innovative, competition-based approach to objectively assess the skill level of postgraduate year 1 residents in performing basic anesthesia-related tasks after 1 month of anesthesiology training. We launched an "Olympic" event to assess requisite skills in an environment of friendly competition. A simulation format was chosen to allow standardized objective assessment of the resident's skill level at an early stage of training, with possible identification of and intervention for skills needing improvement. Our experience may serve as a template for other programs and specialties developing processes for assessing and documenting improvement in skill and competency over the course of residency training.

PURPOSE:: This study compared an antimicrobial and anti-thrombogenic peripherally inserted central catheter treated with a chlorhexidine-based technology, a peripherally inserted central catheter with bulk distributed fluoro-oligomers, and a poly 2-methoxyethyl acrylate-based peripherally inserted central catheter to an untreated peripherally inserted central catheter (control) in an ovine model at 14 and 30 days post-implant. METHODS:: One of four types of peripherally inserted central catheters was surgically implanted into the left jugular vein of each of 18 sheep for 14 or 30 days. Blood analysis consisted of complete blood counts, serum chemistries, and coagulation (fibrinogen, prothrombin time, and partial thromboplastin time) profiles. Sheep were sacrificed to examine the vein and thorax. Histological analysis was performed on serial catheter sections using standard microscopy on hematoxylin and eosin-stained tissues. RESULTS:: All catheters developed fibroblastic sleeves at both 14 and 30 days. The chlorhexidine-peripherally inserted central catheter showed a 64% lower mean fibroblastic sleeve weight and a 66% shorter mean fibroblastic sleeve length compared to the untreated control at 14 days. By 30 days, compared to untreated control, the chlorhexidine-peripherally inserted central catheter showed 81% lower mean fibroblastic sleeve weight with 75% shorter mean fibroblastic sleeve length, the fluoro-oligomer-peripherally inserted central catheter showed 54% lower mean sheath weight with 40% shorter mean fibroblastic sleeve length, and the poly 2-methoxyethyl acrylate-peripherally inserted central catheter had 41% lower mean fibroblastic sleeve weight with 57% lower fibroblastic sleeve length. CONCLUSION:: Among the three anti-thrombogenic peripherally inserted central catheter technologies, the chlorhexidine-peripherally inserted central catheter had the smallest fibroblastic sleeves, followed by the fluoro-oligomer-peripherally inserted central catheter, poly 2-methoxyethyl acrylate-peripherally inserted central catheter, and control peripherally inserted central catheter.

Poly(L-lactic acid) (PLLA) micro-fibers have been coated with hydroxyapatite (HA) using a quick biomimetic method to form a precursor for bone repair composites. To increase the coating content within a coating time as short as 1-2.5 h, PLLA fibers have been treated by soaking in NaOH or NaOCl solutions at mild conditions. Although different surface hydrolysis and coating methods have been used to prepare bioceramic/polymer composites, it is for the first time that the influences of the surface treatment and HA coating process on the mechanical properties of the polymer and HA/polymer composite fibers were investigated systemically.

Composites using high-modulus polylactic acid (PLA) fibers coated with calcium phosphate (CaP) were prepared using a cyclic precipitation technique. Scanning electron microscopy revealed that small nuclei of CaP formed after the first soaking cycle, while large quantities of CaP particles were observed after the sixth cycle. The amount of CaP deposited on the PLA yarn increased with deposition time in Ca(2+) and PO(4) (3-) solutions and number of cycles, and decreased with stirring rate during washing cycles. It was observed that around 35 wt % of CaP was deposited on the yarn surface after six cycles of cyclic-soaking. Based on the results, a heterogeneous nucleation and growth mechanism was proposed for the CaP deposition on the surface of hydrolyzed polyester. Composites comprising the coated fibers in a poly(caprolactone) matrix exhibited flexural moduli within the range of that of the cortical bone.