COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy"

Contains fulltext : 252137.pdf (Publisher’s version ) (Open Access)BACKGROUND: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. STUDY OBJECTIVES: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. STUDY DESIGN: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. SUMMARY: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. NCT TRIAL NUMBER: NCT04676880

Fully three-dimensional sound speed-corrected multi-wavelength photoacoustic breast tomography

Photoacoustic tomography is a contrast agent-free imaging technique capable of visualizing blood vessels and tumor-associated vascularization in breast tissue. While sophisticated breast imaging systems have been recently developed, there is yet much to be gained in imaging depth, image quality and tissue characterization capability before clinical translation is possible. In response, we have developed a hybrid photoacoustic and ultrasound-transmission tomographic system PAM3. The photoacoustic component has for the first time three-dimensional multi-wavelength imaging capability, and implements substantial technical advancements in critical hardware and software sub-systems. The ultrasound component enables for the first time, a three-dimensional sound speed map of the breast to be incorporated in photoacoustic reconstruction to correct for inhomogeneities, enabling accurate target recovery. The results demonstrate the deepest photoacoustic breast imaging to date namely 48 mm, with a more uniform field of view than hitherto, and an isotropic spatial resolution that rivals that of Magnetic Resonance Imaging. The in vivo performance achieved, and the diagnostic value of interrogating angiogenesis-driven optical contrast as well as tumor mass sound speed contrast, gives confidence in the system's clinical potential.Comment: 33 pages Main Body, 9 pages Supplementary Materia

DR haplotype diversity of the cynomolgus macaque as defined by its transcriptome

The DR region of particular primate species may display allelic polymorphism and gene copy number variation (region configuration polymorphism). The sum of these distinct types of polymorphism is defined as complexity. To date, however, the DR region of cynomolgus macaques (Macaca fascicularis) has been poorly defined. Transcriptome analysis of a pedigreed colony, comprising animals from Indonesia and Indochina, revealed a total of 15 Mafa-DRA and 57 DRB alleles, specifying 28 different region configurations. The DRA alleles can be divided into two distinct lineages. One lineage is polymorphic, but the majority of the amino acid replacements map to the leader peptide. The second lineage is at best oligomorphic, and segregates with one specific Mafa-DRB allele. The number of Mafa-DRB genes ranges from two to five per haplotype. Due to the presence of pseudogenes, however, each haplotype encodes only one to three bona fide DRB transcripts. Depending on the region configuration in which the Mafa-DRB gene is embedded, identical alleles may display differential transcription levels. Region configurations appear to have been generated by recombination-like events. When genes or gene segments are relocated, it seems plausible that they may be placed in the context of distinct transcription control elements. As such, DRB region-related transcription level differences may add an extra layer of polymorphism to this section of the adaptive immune system

Composition, potential emissions and agricultural value of pig slurry from Spanish commercial farms

[EN] Pig slurry is a valuable fertilizer for crop production but at the same time its management may pose environmental risks. Slurry samples were collected from 77 commercial farms of four animal categories (gestating and lactating sows, nursery piglets and growing pigs) and analyzed for macronutrients, micronutrients, heavy metals and volatile fatty acids. Emissions of ammonia (NH3) and biochemical methane potential (BMP) were quantified. Slurry electrical conductivity, pH, dry matter content and ash content were also determined. Data analysis included an analysis of correlations among variables, the development of predictionmodels for gaseousemissions and the analysis of nutritional content of slurries for crop production. Descriptive information is provided in this work and shows a wide range of variability in all studied variables. Animal category affected some physicochemical parameters, probably as a consequence of different slurry management and use of cleaning water. Slurries from gestating sows and growing pigs tended to be more concentrated in nutrients, whereas the slurry from lactating sows and nursery piglets tended to be more diluted. Relevant relationships were found among slurry characteristics expressed in fresh basis and gas emissions. Predictivemodels using on-farmmeasurable parameterswere obtained forNH3 (R2 = 0.51) andCH4 (R2 = 0.76), which suggests that BMP may be estimated in commercial farms from easily determined slurry characteristics. Finally, slurry nutrient composition was highly variable. Therefore, complete analyses of slurries should be performed for an effective and environmental friendly land application.This project was funded by the Spanish Ministry of Science and Innovation (AGL2011-30023) and the Valencian Government (ACOMP/2013/118). We thank the BABEL Project, Building Academic Bonds between Europe and Latin America. Erasmus Mundus Programme Action 2 for PhD fellowships. 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Aspects of imaging in the assessment and follow up of benign prostatic hyperplasia

For assessing patients suffering from benign prostatic hyperplasia and monitoring subsequent treatment, symptom questionnaires, uroflowmetry, prostate volume measurements, postvoiding residual urine volume measurements and pressure-flow studies may be used. This review highlights aspects of imaging in the assessment of benign prostatic hyperplasia, including volume determinations of prostate and postvoiding residual urine, texture imaging and biopsy guidance. Future developments are also briefly discusse

Equipment control in a sterile environment using the Gyromouse and a new interface, the user interface (UI) wand

Providing the surgeon/interventionist with controlling devices that avoid the need for interference of an assistant could enable more direct control and reduce errors due to miscommunication or misinterpretation. Therefore the need for an input device controlling equipment from the sterile environment is high. We evaluated the usability of two hand-held interfaces; an acceleration-sensitive Gyromouse and the User Interface Wand (UI Wand), a new prototype pointing device. The evaluation consisted of a quantitative evaluation in a laboratory setting and a qualitative evaluation using a simulated clinical setting. A quantitative tapping task was performed on a computer screen using target objects of different sizes and positioned at different distances, resulting in a set of indices of difficulties (ID's) based on Fitts' Law. The qualitative task was performed in the simulated clinical setting where images and patient data were viewed and manipulated, and a printer and two loudspeakers controlled. In the quantitative evaluation, the Gyromouse showed to be 25+/-3% (mean+/-SD, n = 11, p 2.5 bits and equally fast for ID's <2.5 bits. In the qualitative evaluation 10 of 11 subjects preferred the UI Wand over the Gyromouse and the UI Wand was considered to enable the quickest control. Both input devices are able to control equipment from the sterile environment. With the Gyromouse, the cursor often has to be searched for after activating, because the cursor remains where it is left and shifts because of drift. Despite being slower and the need for large targets, the UI Wand is preferred due to the absolute pointing characteristic; the cursor is where you are pointing at and, therefore, it is always clear where the cursor i

A practical clinical method for contour determination in ultrasonographic prostate images

This paper describes a practical method for automated determination of the contour of the prostate in ultrasonographic images. In this method, we use specific edge detection techniques, based on nonlinear Laplace filtering. Possible edges are located at zero-crossings of the second derivative of the image. The strength of the edge is reflected by the value of the gradient of the image at that location. Combining the information about location and strength, an edge intensity image is constructed from the initial ultrasonographic image. In our method, edge enhancement techniques are performed on the edge intensity image. Edges that actually represent a boundary are selected and linked: interpolation techniques are used to fill the gaps between detected boundary edges. The method for contour determination in ultrasonographic images is used for accurate volume measurements in an everyday clinical environment. Its computer implementation is fast, accurate (mean difference within 6% of exact volume) and easy to us