Performance Comparison of Augmented Reality Versus Ultrasound Guidance for Puncture: A Phantom Study.

PURPOSE: Augmented reality (AR) is an innovative approach that could assist percutaneous procedures; by directly seeing "through" a phantom, targeting a lesion might be more intuitive than using ultrasound (US). The objective of this study was to compare the performance of experienced interventional radiologists and operators untrained in soft tissue lesion puncture using AR guidance and standard US guidance. MATERIAL AND METHODS: Three trained interventional radiologists with 5-10 years of experience and three untrained operators performed punctures of five targets in an abdominal phantom, with US guidance and AR guidance. Correct targeting, accuracy (defined as the Euclidean distance between the tip and the center of the target), planning time, and puncture time were documented. RESULTS: Accuracy was higher for the trained group than the untrained group using US guidance (1 mm versus 4 mm, p = 0.001), but not when using AR guidance (4 mm vs. 4 mm, p = 0.76). All operators combined, no significant difference was found concerning accuracy between US and AR guidance (2 mm vs. 4 mm, p = 0.09), but planning time and puncture time were significantly shorter using AR (respectively, 15.1 s vs. 74 s, p < 0.001; 16.1 s vs. 59 s; p < 0.001). CONCLUSION: Untrained and trained operators obtained comparable accuracy in percutaneous punctures when using AR guidance whereas US performance was better in the experienced group. All operators together, accuracy was similar between US and AR guidance, but shorter planning time, puncture time were found for AR guidance.

[Medical information of patients with implants: Findings and prospects]. / Information médicale du patient porteur d'implants : constats et perspectives.

OBJECTIVES: The main objective of this study was to assess the level of knowledge and information received by patients regarding their implants and to discuss the role of community pharmacists. METHODS: A prospective survey was conducted in 3 pharmacies among patients presenting for various reasons. Firstly, on the same day, all patients visiting the pharmacy were asked if they had an implant. Secondly, patients with implants were offered a short survey consisting of 16 questions concerning the implant and the information received. RESULTS AND DISCUSSION: The survey was conducted with 178 patients, among whom 11.4% had implants. The majority of them reported having osteoarticular, dental, or ophthalmic implants. Women were 67.1% of the cohort. None of the 178 patients with implants in the survey had complete information about their implant and its follow-up, which would enable optimal care and effective reporting in case of potential complications. CONCLUSION: The majority of patients visiting the pharmacy had received limited or inadequate information about their implants. Community pharmacists, as local healthcare providers, in collaboration with hospitals, could play a crucial role in patient education. During the initial dispensing of postoperative treatments, pharmacists could inform and advise patients to enhance their patient journey.

Evolution of the Chronic Venous Leg Ulcer Microenvironment and Its Impact on Medical Devices and Wound Care Therapies.

Studies have reported that the constituents of the wound microenvironment are likely to have critical roles in the degradation and fate of the polymeric matrix and the compounds dissolved in the wound dressing matrix. Thus, chronic wound assessment and the design of effective medical devices and drug products for wound care partly rely on an in-depth understanding of the wound microenvironment. The main aim of this review is to identify and discuss the different stages of chronic wound progression, focusing on the changes in the biochemical composition of the wound microenvironment, with particular attention given to venous leg ulcers (VLUs), as they are one of the most prevalent chronic wound aetiologies. The pathophysiology of venous ulcers is detailed, followed by a thorough review of what is known about the VLU microenvironment and its changes as a function of the evolution of the VLU. Simulating conditions for VLU are then discussed with the view of highlighting potentially relevant simulating media as a function of VLU evolution for a better assessment of biological safety, in particular medical devices intended to be in contact with these wounds.

Impact of lock solutions on the mechanical performance of polyurethane central venous catheters: A comparative study.

The impact of ethanol locks on the mechanical performances of central venous catheters was compared to that of aqueous-based locks. Several mechanical tests were performed to evaluate catheter behavior: kinking radius measurements, burst pressure, and tensile tests. Different polyurethanes were studied to assess the impact of radio-opaque charge and polymer chemical composition on catheter behavior. The results were correlated to swelling measurements and calorimetric measurements. In particular, ethanol locks have a higher impact on long contact time than aqueous-based locks: stresses and strains at break were lower, and kinking radii were higher. However, for all catheters, the mechanical performances remain much higher than the normative requirements.

Patient information pathway in orthopedic surgery: Roles of ERAS and pharmacists.

INTRODUCTION: Enhanced Rehabilitation After Surgery (ERAS) pathways significantly improve the care of patients in orthopedic surgery. However, patient knowledge and memorization of the information provided are currently poorly documented. HYPOTHESIS: The information provided by a postoperative pharmacist could have a positive impact on patient care, in particular by improving knowledge about their prosthesis. MATERIAL AND METHOD: This prospective feasibility study included a cohort of 80 patients operated on for a hip or knee prosthesis and who received postoperative pharmacist interviews (POPI). These POPIs informed the patient about the prosthesis, the complications, positions to avoid, as well as the postoperative follow-up. The objective was to measure the patient's knowledge before and after the POPI. Qualitative and quantitative analyses, by indication and patient pathway, were performed. RESULTS: The patient's knowledge before POPI was 70% correct. After POPI this rate rose to 91%. DISCUSSION: Patients' knowledge was weak and heterogeneous, especially regarding the implanted prosthesis. The POPI led to significant improvement and standardization of knowledge which should contribute to the prevention of iatrogenic harm (positions to avoid, infection prevention, compliance with analgesics and anticoagulants). CONCLUSION: A POPI with a pharmacist improves overall patient management during hip or knee arthroplasty. LEVEL OF EVIDENCE: III; non-randomized prospective feasibility study.

Surface and mechanical properties of polyurethane central venous catheters after repeated contact with chemotherapy excipient solutions.

This article investigates the impact of the interactions between polyurethane central venous catheters and solutions containing excipients used in cisplatin and paclitaxel formulations. Changes to the properties of catheters and the leaching of catheter additives into the infused solutions were studied while these solutions were infused cyclically for several months. Chemotherapy treatment was mimicked in vitro in compliance with hospital practices. The treatment cycle was repeated 10 times, using solutions containing only the excipients. After 10 treatment cycles, no physical or chemical degradation of the catheter was observed. Mechanical performances were stable, but surface modifications occurred, causing the surface to become more hydrophobic. A loss in polyurethane antioxidant amount was observed in part due to a leaching phenomenon.

Development of a Hospital Compounded, Taste-Masked, Temozolomide Oral Suspension and 5-Year Real-Life Experience in Treating Paediatric Patients.

The development of oral pediatric forms by pharmaceutical companies is still insufficient. In fact, many drugs used in paediatric oncology, such as temozolomide, are not labeled and adapted for paediatric use. Temozolomide (TMZ) is an alkylating agent used as the standard of care for many adult and pediatric brain tumours, such as neuroblastoma, glioblastoma and medulloblastoma. The present study was carried out to propose a suitable and palatable formulation of the oral liquid preparation of TMZ. The suspension is composed of TMZ suspended in SyrSpend SF pH 4, as well as TMZ crystallization stabilizing agents and sweetening agents. To reach this formulation, several taste-masking agents were evaluated. Here, we describe the method of preparation of the formation as well as the monocentric population treated with the formulation over a 5-year period. A 20 mg/mL TMZ suspension was developed. TMZ suspension is stable for 6 weeks, stored between 2 and 8 degrees, protected from light, and compatible with nasogastric tubes. Thirty-eight patients participated in the palatability study and choose cola flavour, and 104 patients were treated in Gustave Roussy with the developed suspension; no unexpected event was reported. To conclude, we propose here a new TMZ liquid formulation which is stable for at least 6 weeks and well-tolerated with extensive feedback.

Intrinsic stability of the antiviral drug umifenovir by stress testing and DFT studies.

Umifenovir is an antiviral drug approved in China and Russia for the treatment of influenza. The available dosage form consists of capsules marketed under the brand name Arbidol®. Due to its broad spectrum, umifenovir may also be used in other viral contexts, alone or combined with other antiviral drugs. Although knowledge of umifenovir intrinsic stability may be useful for any potential development of other pharmaceutical forms for other routes of administration and for quality risk management, no data regarding this matter is available to date. In this study, the exploration of the molecule's behaviour under hydrolytic, oxidative and photolytic conditions was carried out experimentally and supported by density functional theory (DFT) studies. It comes out that umifenovir is sensitive to these stress conditions giving rise to 6 structurally characterized degradation products. The one-electron oxidation process produced on the sulphur atom is probably the main cause of umifenovir degradation with reference to the structures of the degradation products formed and the DFT data.

Bacteriological and mechanical impact of the Sterrad sterilization method on personalized 3D printed guides for mandibular reconstruction.

Surgical cutting guides are increasingly used for maxillofacial reconstruction. They are usually provided by laboratories. In recent years, surgical teams have published studies on the possibility of manufacturing their own cutting guides thanks to 3D printers. The object of this study is to analyze the impact of the sterilization on the surface of those personalized models and to assess the effectiveness of sterilization. Using the data from high-resolution CT scan of patient, 3D models were generated through computerized assisted design and fabricated with a 3D printer using Acrylonitrile Butadiene Styrene (ABS). For the sterilization, a Sterrad method was used. In order to evaluate the effectiveness of sterilization, 3D models were artificially contaminated with several bacterial reference strains, sterilized and finally cultured. The surfaces and mechanical modifications were analyzed before and after sterilization with infrared spectrometry, surface contact angle, extensometer, scanning electron microscopy and atomic force microscopy. Ten models of different shapes and 24 samples were fabricated, sterilized and analyzed. The 3D models were designed in 48 h, printed in an average of 122 min and underwent a 47 min cycle of sterilization. All experimentally contaminated 3D models were negative in culture, with at least, a six log reduction of the initial inoculum. The hydrophobicity and roughness of the surface suffered few changes. The reproducibility of this procedure was proved by identical results in the three sterilization rounds. Using Sterrad process for the sterilization of ABS printed material doesn't represent a bacterial risk for the patient. It is a feasible and safe innovative reconstructive method that can save time particularly for oncological cases.

Pemetrexed degradation by photocatalytic process: Kinetics, identification of transformation products and estimation of toxicity.

This study employed a UV-A/visible/TiO2 system to investigate the degradation of pemetrexed, an antifolate agent used in chemotherapy. The laboratory-scale method employed a photostability chamber that could be used to study multiple samples. Reversed-phase HPLC coupled with high-resolution ESI-LTQ-Orbitrap mass spectrometry was used to determine the transformation products (TPs) of PEME. Based on the identified TPs and existing chemical knowledge, the mechanism of degradation of the target compound was proposed. Concentrations were monitored as a function of time, and the degradation kinetics were compared. The structures of seven TPs, four of which have not been described to date, were proposed. Most of the TPs stemmed from OH radical additions to the dihydropyrrole moiety and oxidative decarboxylation of the glutamate residue. Based on the elucidated structures, a computational toxicity assessment was performed, showing that the TPs with higher log D values than the parent compound are more toxic than the PEME itself. To support these findings, the toxicities of irradiated samples on Vibrio fischeri were monitored over time. The experimental results corresponded well with the results of previous computational studies.

Restructuration kinetics of amphiphilic intraocular lenses during aging.

Photooxidation and hydrolysis are the two primary aging factors of intraocular lenses. Opacifications, dislocations, glistening and yellowing of the implanted acrylic lenses, which are due to chain scissions and depolymerization, are the consequences of aging from the clinical perspective. The purpose of this study was to examine the consequence of the aging of intraocular lenses on chemical and surface properties. Acrylic lenses made of poly acrylic-co-polystyrene polymer were artificially aged by photooxidation and hydrolysis from 2 to 20 years. Degradation products were observed by Reverse-phase High-Performance Liquid Chromatography RP-HPLC and thermogravimetric analysis (TGA). The surface, which was analyzed by atomic force microscopy (AFM) and fibronectin adhesion kinetics, was chosen as an indicator of intraocular biocompatibility. Low-molecular-weight degradation products (LMWP) result from chain scission under both hydrolysis and photooxidation. The osmotic effects of water enable degradation products to migrate through the polymer. A portion of the degradation products exudate in the surrounding center, whereas a portion link with lateral chains of the polymer. At the same time, the surface roughness evolves to externalize the most hydrophilic chains. As a result, the fibronectin adhesion level decrease with time, which indicates the existence of a biocompatible kinetic for implanted intraocular lenses.

Permeability of expander breast implants: In vitro and in vivo analyses.

INTRODUCTION: The biocompatibility of the polysiloxane breast implant has been studied moderately. The aging of these implants due to lipid penetration and the release of polymerization impurities, such as Platine or octamethylcyclotetrasiloxane (named D4), has already been documented. Since these studies, manufacturing procedures have been improved; thus, the security of breast implants has also improved. Although polymerization and the choice of monomer influence the shell properties, few studies have compared these together in breast implants. Our study compares the permeability and mechanical resistance of 3 breast expander shells after in vivo and in vitro aging. RESULTS: In vitro, all tested shells quickly sorbed linear molecules, such as fatty acids, and released siloxane impurities. The penetration of a molecule with steric hindrance, such as cholesterol, is slower. Allergan shells have the highest rates of molecule sorption and siloxane release. In vivo, after implantation, Allergan shells lost their initial mechanical properties over time. This observation was not found for mentor shells. For all brands, many biological molecules penetrate the shells, among which cholesterol and fatty acids are always present. DISCUSSION: The aging of polysiloxane shells depends on the sorption of many biological molecules and the release of siloxane impurities. The siloxanes are impurities and / or degradation products that are due to aging. Moreover, according to our results, the shells act as matrices that separate molecules according to their chemical and physical properties. CONCLUSION: Not all polysiloxane expander shells have the same properties during aging. The manufacturing procedures and the choice of siloxane monomers are the two most probative factors that explain the observed differences.

Computerized pediatric oncology prescriptions review by pharmacist: A descriptive analysis and associated risk factors.

BACKGROUND: Systematic prescription analyses by clinical pharmacists result in pharmacist interventions (PIs) to reduce prescription errors and improve medication safety. PIs are particularly critical in oncology, because antineoplastic drugs are highly toxic with low therapeutic indexes especially in a pediatric population. The aim of this study is to describe PIs in a pediatric oncology department and to identify potential risk factors associated with prescription errors. PROCEDURE: We conducted a 20-month observational study in a pediatric oncology department concerning electronic prescription of injectable chemotherapies was conducted. PIs were analyzed for drug-related problems (DRPs), type of intervention, population characteristics, involved drugs, and the potential risk factors. RESULTS: Clinical pharmacists made 90 PIs for 10,214 antineoplastic prescriptions for a rate of 88 PIs per 10,000 prescriptions. The majority of DRPs were dosage errors (61.8%), imputable to measurements (weight and/or height) in 47.4% or unreported dose reduction. The most common patient ages were in the range 1-10 years and the most common time for medical double checks was 2-9 pm. There were statistically more prescription errors in standardized protocols (P < 0.001). CONCLUSIONS: Not surprisingly, PIs were predominantly to correct dose errors, half of which related to height and weight measurements that were not updated. No significant risk factors for errors were identified for errors except in the standardized status of prescription, which appears to be linked in part to our software that did not automatically reflect dose reduction from one course to the next. Medical double-checking followed by a clinical pharmacist's double check were effective in order to prevent prescription errors.

Biocompatibility assessment of cyclic olefin copolymers: Impact of two additives on cytotoxicity, oxidative stress, inflammatory reactions, and hemocompatibility.

This work reports the biocompatibility evaluation of cyclic olefin copolymers (COC) as candidates for implantable medical devices. The focus was to establish the influence of two major additives (antioxidant and lubricant) on the overall biocompatibility. The cytotoxicity was evaluated according to ISO 10993-5 guidelines using L929 fibroblasts, HUVEC, and THP-1-derived macrophages. Oxidative stress (ROS, GSH/GSSG, and SOD analysis) and pro-inflammatory cytokines (Il-6 and TNF-α secretion) were quantified using THP-1 cells in direct contact with films. Hemocompatibility was assessed through haemolysis testing, dynamic blood coagulation, platelet adhesion, and activation (membranous P-selectin expression). Results show that the different types of COC have successfully passed the in vitro biocompatibility tests. The presence of antioxidant induces however a slight decrease in ROS production in correlation with a high SOD activity and a modification in blood coagulation profile probably linked to antioxidant recrystallization phenomenon on the surface of COC. The lubricant presence reduced haemolysis, fibrinogen adhesion, and platelet activation. Surface nanotopography of COC highlights different types of needles and globules according to the present additive. Those primary results indicate that COC are promising biomaterial. However, additives influenced some biological parameters pointing out the necessity of a global approach of risk analysis for biocompatibility evaluation. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 3333-3349, 2017.

RP-HPLC detection and dosage method for acrylic monomers and degradation products released from implanted medical devices.

Acrylic copolymers are useful in medical therapeutics. As in dental implants or intraocular lenses, acrylics are present in many medical devices or drug adjuvants. Industrial using of acrylics is still important in painting or textile manufacturing. Scientific research background has proved that acrylic suffer for depolymerized and cross-linking mechanisms under heating and photo-oxidative conditions. Those aging processes could lead to release of unreacted monomers and degradation products. We developed a new RP-HPLC method with good resolution, recovery, linearity, detection and quantification limits that is efficient for acrylic monomers quantification in in vitro and in vivo saline solution matrices. This method allows the detection of copolymer and medical devices degradation products too. Both the limit of quantification and the limit of detection for monomers and degradation products are above cytotoxic concentrations for human epithelial cells. Those biological results confirm the interest of the method for dosage of unreacted acrylics after polymerization and for the research of degradation products in body fluids as aqueous humor.

Interaction of intraocular lenses with fibronectin and human lens epithelial cells: Effect of chemical composition and aging.

The aim of this study is to investigate in vitro interactions between hydrophobic acrylate intraocular lenses (IOLs) and their biological environment. The influence of lens chemical composition and aging on fibronectin (FN) adsorption and on IOLs cytotoxicity on human lens epithelial cells was examined. Cytotoxicity of acrylate monomers used in IOLs manufacture was also investigated. Four different IOLs were included in the study: Acrysof(®), Tecnis(®), EnVista(®), and iSert(®). Implants were artificially aged in a xenon arc chamber to simulate 2 years of light exposure. Fibronectin adsorption on IOL surface was quantified using ELISA and correlated to surface roughness determined with AFM. Direct contact cytotoxicity was determined with the MTT assay and cell morphology was observed with light microscopy. Results showed that fibronectin adsorption did not differ significantly among IOLs, whatever their chemical composition. Moreover, aging conditions did not impact fibronectin adsorption. All IOLs were biocompatible even after applying 2-year aging conditions, with cell viability higher than 70%. Five acrylate monomers appeared to be toxic in the range of concentrations tested, but no monomer release from the IOLs could be detected during accelerated 2-year incubation with saline solution. This study did not reveal an influence of chemical composition and aging on protein adsorption and on biocompatibility.

Brain and plasma riluzole pharmacokinetics: effect of minocycline combination.

PURPOSE: amyotrophic lateral sclerosis is a fatal neurodegenerative disease characterized by the loss of motorneurons. The only drug approved is riluzole. Minocycline is an antibiotic with numerous neuroprotective properties. riluzole and minocycline were given to an animal model of ALS and had beneficial effect on the disease. The combination was then tested in humans in phase II and phase III studies with less beneficial effects and a faster decline of the disease in the group treated with minocycline. In a previous study, we showed that riluzole is transported out of the brain by the P-glycoprotein at the blood-brain barrier level. METHODS: in this work, we studied in CF1 mice, the plasmatic and cerebral pharmacokinetics of riluzole combined or not with minocycline. RESULTS: our results showed that the kinetics of riluzole are not linear with dose, but that cerebral AUC0-infinity increase proportionally with plasmatic AUC0-infinity. At the dose of 10 mg/kg, the cerebral AUC0-infinity /plasmatic AUC0-infinity ratio was 4.6 in mdr1a (-/-) mice and 2.4 in mdr1a (+/+) mice. The combination of minocycline (170 mg/kg) and riluzole (10 mg/kg) induced a 2 fold increase in the cerebral AUC0-infinity of riluzole and induced a neuromuscular toxicity in mice. This effect of minocycline was not found at low concentration (10 mg/kg of minocycline). CONCLUSIONS: if our results are confirmed in humans, riluzole cerebral concentrations could be predicted by plasmatic concentrations. Furthermore, the combination of high doses of minocycline with riluzole could induce neurological toxicity that lead to deceiving results in ALS clinical studies.