Accuracy assessment of catheter guidance technology in electrophysiology procedures: a comparison of a new 3D-based fluoroscopy navigation system to current electroanatomic mapping systems.

BACKGROUND: With increasing complexity in electrophysiology (EP) procedures, the use of electroanatomic mapping systems (EAMS) as a supplement to fluoroscopy has become common practice. This is the first study that evaluates spatial and point localization accuracy for 2 current EAMS, CARTO3(®) (Biosense Webster, Diamond Bar, CA, USA) and EnSite Velocity(®) (St. Jude Medical Inc., St. Paul, MN, USA), and for a novel overlay guidance (OG) software (Siemens AG, Forchheim, Germany) in a phantom experiment. METHODS AND RESULTS: A C-arm CT scan was performed on an acrylic phantom containing holes and location markers. Spatial accuracy was assessed for each system using distance measurements involving known markers inside the phantom and properly placed catheters. Anatomical maps of the phantom were acquired by each EAMS, whereas the 3D-based OG software superimposed an overlay image of the phantom, segmented from the C-arm CT data set, onto biplane fluoroscopy. Registration processes and landmark measurements quantitatively assessed the spatial accuracy of each technology with respect to the ground truth phantom. Point localization performance was 0.49 ± 0.25 mm in OG, 0.46 ± 0.17 mm in CARTO3(®) and 0.79 ± 0.83 mm in EnSite(®) . The registration offset between virtual visualization and reality was 1.10 ± 0.52 mm in OG, 1.62 ± 0.77 mm in CARTO3(®) and 2.02 ± 1.21 mm in EnSite(®) . The offset to phantom C-arm CT landmark measurements was 0.30 ± 0.26 mm in OG, 0.24 ± 0.21 mm in CARTO3(®) and 1.32 ± 0.98 mm in EnSite(®) . CONCLUSIONS: Each of the evaluated EP guidance systems showed a high level of accuracy; the observed offsets between the virtual 3D visualization and the real phantom were below a clinically relevant threshold of 3 mm.

Management of vaginal mesh exposure: A systematic review.

Objectives: To identify various predisposing factors, the clinical presentation, and the management of vaginal mesh-related complications, with special emphasis on mesh exposure and the indications for and results of vaginal mesh removal. Methods: A systematic literature review was performed using a search strategy based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. PubMed was queried for studies regarding aetiology, risk factors, and management of vaginal mesh exposure from 1 January 2008 to June 2018. Full-text articles were obtained for eligible abstracts. Relevant articles were included, and the cited references were used to identify relevant articles not previously included. Results: A total of 102 abstracts were identified from the PubMed search criteria. An additional 45 studies were identified based on review of the cited references. After applying eligibility criteria and excluding impertinent articles, 58 studies were included in the final analysis. Conclusion: Numerous studies have found at least some degree of symptomatic improvement regardless of the amount of mesh removed. Focal areas of exposure or pain can be successfully managed with partial mesh removal with low rates of complications. With partial mesh removal, many patients will ultimately require subsequent mesh removal procedures. For this reason, complete mesh excision is an alternative for patients with diffuse vaginal pain, large mesh exposure, and extrusion of mesh into adjacent viscera. However, when considering complete mesh removal, it is important to counsel patients regarding possible complications of removal and the increased risk of recurrent stress urinary incontinence and pelvic organ prolapse postoperatively. Abbreviations: MUS: midurethral sling; OR: odds ratio; POP: pelvic organ prolapse; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-analyses; SUI: stress urinary incontinence; TOT: transobturator; TVT: tension-free vaginal tape.

Neural Mechanisms Contributing to Dysphagia in Mouse Models.

Investigative research into curative treatments for dysphagia is hindered by our incomplete understanding of the neural mechanisms of swallowing in health and disease. Development of translational research models is essential to bridge this knowledge gap by fostering innovative methodology. Toward this goal, our laboratory has developed a translational research assessment tool to investigate the neural mechanistic control of swallowing in unrestrained, self-feeding mice. Here we describe our initial development of synchronous brainstem neural recordings with a videofluoroscopic swallow study assay in healthy mice across the life span. Refinement of this combined methodology is currently underway. Ultimately, we envision that this assessment tool will permit systematic analysis of therapeutic interventions for dysphagia in preclinical trials with numerous mouse models of human conditions that cause dysphagia, such as amyotrophic lateral sclerosis, Parkinson's disease, stroke, and advanced aging.

Improved targeting accuracy of lung tumor biopsies with scanning-beam digital x-ray tomosynthesis image guidance.

PURPOSE: Electromagnetic navigation bronchoscopy (ENB) provides improved targeting accuracy during transbronchial biopsies of suspicious nodules. The greatest weakness of ENB-based guidance is the registration divergence that exists between the planning CT, acquired days or weeks before the intervention, and the patient on the table on the day of the intervention. Augmenting ENB guidance with real-time tomosynthesis imaging during the intervention could mitigate the divergence and further improve the yield of ENB-guided transbronchial biopsies. The real-time tomosynthesis prototype, the scanning-beam digital x-ray (SBDX) system, does not currently display images reconstructed by the iterative algorithm that was developed for this lung imaging application. A protocol using fiducial markers was therefore implemented to permit evaluation of potential improvements that would be provided by the SBDX system in a clinical setting. METHODS: Ten 7 mm lesions (5 per side) were injected into the periphery of each of four preserved pig lungs. The lungs were then placed in a vacuum chamber that permitted simulation of realistic motion and deformation due to breathing. Standard clinical CT scans of the pig lung phantoms were acquired and reconstructed with isotropic resolution of 0.625 mm. Standard ENB-guided biopsy procedures including target identification, path planning, CT-to-lung registration and navigation to the lesion were carried out, and a fiducial marker was placed at the location at which a biopsy would have been acquired. The channel-to-target distance provided by the ENB system prior to fiducial placement was noted. The lung phantoms were then imaged using the SBDX system, and using high-resolution conebeam CT. The distance between the fiducial marker tip and the lesion was measured in SBDX images and in the gold-standard conebeam-CT images. The channel-to-target divergence predicted by the ENB system and measured in the SBDX images was compared to the gold standard to determine if improved targeting accuracy could be achieved using SBDX image guidance. RESULTS: As expected, the ENB system showed poorer targeting accuracy for small peripheral nodules. Only 20 nodules of the 40 injected could be adequately reached using ENB guidance alone. The SBDX system was capable of visualizing these small lesions, and measured fiducial-to-target distances on SBDX agreed well with measurements in gold-standard conebeam-CT images (p = 0.0001). The correlation between gold-standard conebeam-CT distances and predicted fiducial-to-target distances provided by the ENB system was poor (p = 0.72), primarily due to inaccurate ENB CT-to-body registration and movement due to breathing. CONCLUSIONS: The SBDX system permits visualization of small lung nodules, as well as accurate measurement of channel-to-target distances. Combined use of ENB with SBDX real-time image guidance could improve accuracy and yield of biopsies, particularly of those lesions located in the periphery of the lung.

Decellularized extracellular matrix microparticles as a vehicle for cellular delivery in a model of anastomosis healing.

Extracellular matrix (ECM) materials from animal and human sources have become important materials for soft tissue repair. Microparticles of ECM materials have increased surface area and exposed binding sites compared to sheet materials. Decellularized porcine peritoneum was mechanically dissociated into 200 µm microparticles, seeded with fibroblasts and cultured in a low gravity rotating bioreactor. The cells avidly attached and maintained excellent viability on the microparticles. When the seeded microparticles were placed in a collagen gel, the cells quickly migrated off the microparticles and through the gel. Cells from seeded microparticles migrated to and across an in vitro anastomosis model, increasing the tensile strength of the model. Cell seeded microparticles of ECM material have potential for paracrine and cellular delivery therapies when delivered in a gel carrier. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 1728-1735, 2016.

Improving the Utility of Laryngeal Adductor Reflex Testing: A Translational Tale of Mice and Men.

OBJECTIVES: Evaluation of the laryngeal adductor reflex (LAR) entails delivering air through an endoscope positioned 1 to 2 mm from the arytenoid mucosa to elicit bilateral vocal fold (VF) closure. This short working distance limits visualization to only the ipsilateral arytenoid and results in quantification of a single LAR metric: threshold pressure that evokes the LAR. Our goal was to evolve the LAR procedure to optimize its utility in clinical practice and translational research. STUDY DESIGN: Prospective translational experiment. SETTING: Academic institution. SUBJECTS: Young healthy human adults (n = 13) and 3 groups of mice: healthy, primary aging mice (n = 5), a transgenic mouse model of amyotrophic lateral sclerosis (ALS; n = 4), and young healthy controls (n = 10). METHODS: The VFs were visualized bilaterally during supramaximal air stimulation through an endoscope. Responses were analyzed to quantify 4 novel metrics: VF adduction phase duration, complete glottic closure duration, VF abduction phase duration, and total LAR duration. RESULTS: The 4 LAR metrics are remarkably similar between healthy young humans and mice. Compared to control mice, aging mice have shorter glottic closure durations, whereas ALS-affected mice have shorter VF abduction phase durations. CONCLUSIONS: We have established a new LAR protocol that permits quantification of novel LAR metrics that are translatable between mice and humans. Using this protocol, we showed that VF adduction is impaired in primary aging mice, whereas VF abduction is impaired in ALS-affected mice. These preliminary findings highlight the enhanced diagnostic potential of LAR testing.

Adapting human videofluoroscopic swallow study methods to detect and characterize dysphagia in murine disease models.

This study adapted human videofluoroscopic swallowing study (VFSS) methods for use with murine disease models for the purpose of facilitating translational dysphagia research. Successful outcomes are dependent upon three critical components: test chambers that permit self-feeding while standing unrestrained in a confined space, recipes that mask the aversive taste/odor of commercially-available oral contrast agents, and a step-by-step test protocol that permits quantification of swallow physiology. Elimination of one or more of these components will have a detrimental impact on the study results. Moreover, the energy level capability of the fluoroscopy system will determine which swallow parameters can be investigated. Most research centers have high energy fluoroscopes designed for use with people and larger animals, which results in exceptionally poor image quality when testing mice and other small rodents. Despite this limitation, we have identified seven VFSS parameters that are consistently quantifiable in mice when using a high energy fluoroscope in combination with the new murine VFSS protocol. We recently obtained a low energy fluoroscopy system with exceptionally high imaging resolution and magnification capabilities that was designed for use with mice and other small rodents. Preliminary work using this new system, in combination with the new murine VFSS protocol, has identified 13 swallow parameters that are consistently quantifiable in mice, which is nearly double the number obtained using conventional (i.e., high energy) fluoroscopes. Identification of additional swallow parameters is expected as we optimize the capabilities of this new system. Results thus far demonstrate the utility of using a low energy fluoroscopy system to detect and quantify subtle changes in swallow physiology that may otherwise be overlooked when using high energy fluoroscopes to investigate murine disease models.

Validation of computational fluid dynamics-based analysis to evaluate hemodynamic significance of access stenosis.

PURPOSE: Stenosis in a vascular access circuit is the predominant cause of access dysfunction. Hemodynamic significance of a stenosis identified by angiography in an access circuit is uncertain. This study utilizes computational fluid dynamics (CFD) to model flow through arteriovenous fistula to predict the functional significance of stenosis in vascular access circuits. METHODS: Three-dimensional models of fistulas were created with a range of clinically relevant stenoses using SolidWorks. Stenoses diameters ranged from 1.0 to 3.0 mm and lengths from 5 to 60 mm within a fistula diameter of 7 mm. CFD analyses were performed using a blood model over a range of blood pressures. Eight patient-specific stenoses were also modeled and analyzed with CFD and the resulting blood flow calculations were validated by comparison with brachial artery flow measured by duplex ultrasound. RESULTS: Predicted flow rates were derived from CFD analysis of a range of stenoses. These stenoses were modeled by CFD and correlated with the ultrasound measured flow rate through the fistula of eight patients. The calculated flow rate using CFD correlated within 20% of ultrasound measured flow for five of eight patients. The mean difference was 17.2% (ranged from 1.3% to 30.1%). CONCLUSIONS: CFD analysis-generated flow rate tables provide valuable information to assess the functional significance of stenosis detected during imaging studies. The CFD study can help in determining the clinical relevance of a stenosis in access dysfunction and guide the need for intervention.