Hospital-based health technology assessment of innovative medical devices: insights from a nationwide survey in France.

Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization.

Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use.

Functionalized Lipid Droplets and Microfluidics Approach to Study Immune Cell Polarity In Vitro.

The study of lymphocyte polarization upon antigen encounter typically relies on the random pairing between the cells of interest and a stimulating particle (micro bead) that mimics only some of the properties of the antigen-presenting cells. Here, we show how to build and use a microfluidic chip that allows to multiplex and synchronize the encounter between a lymphocyte and an antigen-presenting object: a functionalized oil-in-water droplet. We also explain how to fabricate and functionalize lipid droplets, an antigen-presenting tool that is, at the same time, deformable, fluid, and spherical.

Polarity in immune cells.

Immune cells are responsible for pathogen detection and elimination, as well as for signaling to other cells the presence of potential danger. In order to mount an efficient immune response, they need to move and search for a pathogen, interact with other cells, and diversify the population by asymmetric cell division. All these actions are regulated by cell polarity: cell polarity controls cell motility, which is crucial for scanning peripheral tissues to detect pathogens, and recruiting immune cells to sites of infection; immune cells, in particular lymphocytes, communicate with each other by a direct contact called immunological synapse, which entails a global polarization of the cell and plays a role in activating lymphocyte response; finally, immune cells divide asymmetrically from a precursor, generating a diversity of phenotypes and cell types among daughter cells, such as memory and effector cells.

Microtubules restrict F-actin polymerization to the immune synapse via GEF-H1 to maintain polarity in lymphocytes.

Immune synapse formation is a key step for lymphocyte activation. In B lymphocytes, the immune synapse controls the production of high-affinity antibodies, thereby defining the efficiency of humoral immune responses. While the key roles played by both the actin and microtubule cytoskeletons in the formation and function of the immune synapse have become increasingly clear, how the different events involved in synapse formation are coordinated in space and time by actin-microtubule interactions is not understood.

Quality of economic evaluations of drug-coated balloons and drug-eluting stents in peripheral artery disease: a systematic review.

Objective: We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings.

Methods: A systematic review was performed using four electronic databases to identify health economic evaluation studies reporting on the use of DCBs and DESs in PAD.

Pinching the cortex of live cells reveals thickness instabilities caused by myosin II motors.

The cell cortex is a contractile actin meshwork, which determines cell shape and is essential for cell mechanics, migration, and division. Because its thickness is below optical resolution, there is a tendency to consider the cortex as a thin uniform two-dimensional layer. Using two mutually attracted magnetic beads, one inside the cell and the other in the extracellular medium, we pinch the cortex of dendritic cells and provide an accurate and time-resolved measure of its thickness.

Traction Force Microscopy to Study B Lymphocyte Activation.

Traction force microscopy (TFM) enables the measurement of forces produced by a cell on a substrate. This technique infers traction force measurements from an experimentally observed displacement field produced by a cell pulling on an elastic substrate. Here, we adapted TFM to investigate the spatial and temporal structure of the force field exerted by B cells when activated by antigen engagement of the B cell receptor.

Quality of economic evaluations of ventricular assist devices: A systematic review.

Objective: Because of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies.

Evaluation of 3D printing costs in surgery: a systematic review.

Objectives: The use of three-dimensional (3D) printing in surgery is expanding and there is a focus on comprehensively evaluating the clinical impact of this technology. However, although additional costs are one of the main limitations to its use, little is known about its economic impact. The purpose of this systematic review is to identify the costs associated with its use and highlight the first quantitative data available.

The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review.

Background: Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.

Materials And Methods: A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database.

Diacylglycerol kinase ζ promotes actin cytoskeleton remodeling and mechanical forces at the B cell immune synapse.

Diacylglycerol kinases (DGKs) limit antigen receptor signaling in immune cells by consuming the second messenger diacylglycerol (DAG) to generate phosphatidic acid (PA). Here, we showed that DGKζ promotes lymphocyte function-associated antigen 1 (LFA-1)-mediated adhesion and F-actin generation at the immune synapse of B cells with antigen-presenting cells (APCs), mostly in a PA-dependent manner. Measurement of single-cell mechanical force generation indicated that DGKζ-deficient B cells exerted lower forces at the immune synapse than did wild-type B cells.

Differential nanoscale organisation of LFA-1 modulates T-cell migration.

Effector T-cells rely on integrins to drive adhesion and migration to facilitate their immune function. The heterodimeric transmembrane integrin LFA-1 (αLβ2 integrin) regulates adhesion and migration of effector T-cells through linkage of the extracellular matrix with the intracellular actin treadmill machinery. Here, we quantified the velocity and direction of F-actin flow in migrating T-cells alongside single-molecule localisation of transmembrane and intracellular LFA-1.

Benefits of 3D printing applications in jaw reconstruction: A systematic review and meta-analysis.

Background: Three-dimensional (3D) printing has changed surgical practice over the past few years, especially in maxillofacial surgery. However, little is known about its real clinical impact. The objectives of our study were to identify clinical outcomes that have been evaluated in the literature regarding 3D printing applications in jaw reconstruction, and to quantify the impact of this technology on operating times.

Actomyosin-driven force patterning controls endocytosis at the immune synapse.

An important channel of cell-to-cell communication is direct contact. The immune synapse is a paradigmatic example of such type of interaction: it forms upon engagement of antigen receptors in lymphocytes by antigen-presenting cells and allows the local exchange of molecules and information. Although mechanics has been shown to play an important role in this process, how forces organize and impact on synapse function is unknown.

Actin filaments regulate microtubule growth at the centrosome.

The centrosome is the main microtubule-organizing centre. It also organizes a local network of actin filaments. However, the precise function of the actin network at the centrosome is not well understood.

Level of Evidence in Economic Evaluations of Left Atrial Appendage Closure Devices: A Systematic Review.

Objectives: The objective of the present work was to assess the level of evidence in economic evaluations of percutaneous left atrial appendage closure devices, and to test the complementarity of three different tools for assessing the quality of economic evaluations.

Methods: We conducted a systematic review of articles in English or French listed in MEDLINE, Embase, Cochrane, the Cost-Effectiveness Analysis registry and the National Health Service Economic Evaluation Database. We included only economic evaluations concerning left atrial appendage closure devices.

Single-use flexible bronchoscopes compared with reusable bronchoscopes: Positive organizational impact but a costly solution.

Rationale, Aims, And Objectives: There is at present no standard methodology to analyse the organizational impacts (OIs) of medical devices (MDs), and the field is still in its infancy. The aim of the present study was to assess, at a hospital level, the organizational and economic impacts of the introduction of a new MD, specifically the single-use flexible bronchoscope (FB).

Methods: Both the organizational and economic impacts of the single-use FB were evaluated in comparison with the reusable FB currently used as standard practice in our institution.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

Objectives: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items.

Study Design And Setting: A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE.

HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?

Background: The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis.

Advantages and disadvantages of 3-dimensional printing in surgery: A systematic review.

Background: Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and disadvantages of 3D printing applied in surgery.

Methods: We conducted a systematic review of articles on 3D printing applications in surgery published between 2005 and 2015 and identified using a PubMed and EMBASE search.

Combining multi-criteria decision analysis and mini-health technology assessment: A funding decision-support tool for medical devices in a university hospital setting.

Background: At the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a notable example is the Matrix4value model.

A Systematic Review of the Level of Evidence in Economic Evaluations of Medical Devices: The Example of Vertebroplasty and Kyphoplasty.

Context: Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty.

Objective: To assess the level of evidence provided by the available economic evaluations for vertebroplasty and kyphoplasty.