Ultrasound Elastography Detects Age-Related Changes in Adult False Vocal Folds.

PURPOSE: To investigate the feasibility of ultrasound elastography for assessing the symmetry in stiffness values and movements of both false vocal folds (FVFs). METHODS: After Institutional Review Board's approval and written informed consent obtained, we measured ultrasound strain and shear wave velocity (SWV) of the bilateral FVF in vocal fold abduction and adduction in 30 participants using a linear array transducer (4-10 MHz). Twenty-eight participants met inclusion criteria as healthy subjects for analysis. Mean strain of FVF produced by FVF movement from abduction to adduction was analyzed using 2D speckle-tracking software offline. A SWV ratio ([SWVadduction - SWabduction ]/SWabduction ) was developed to test the contractibility of FVF. Statistical analysis included one-way ANOVA to test the difference in mean strain, SWV (adduction and abduction), and SWV ratio among the three age groups; linear regression to analyze correlations of stiffness and movement between the right and left FVF; and intraclass correlation coefficient (ICC) to examine intra- and interobserver reliability in performing shear wave elastography (SWE) of FVF. RESULTS: The 28 healthy participants were divided into 3 age groups (10 of young 20-44 years; 9 of mid-age 45-64 years; and 9 of senior ≥65 years). The SWV in FVF abduction was higher and the SWV ratio was lower in seniors compared to young participants (P < .05). Good to excellent correlation of mean strain and SWV between both FVFs (R2 > 0.89). The reliability of performing SWE of FVF was moderate to excellent. CONCLUSION: Ultrasound elastography is feasible to assess the stiffness, dynamic movement, and symmetry of adult FVF, and healthy seniors may exhibit increased FVF stiffness.

Development of open-source software for free-hand 3D vascular ultrasound: Dialysis fistula application.

BACKGROUND: The arteriovenous fistula (AVF) is the preferred vascular access for End Stage Renal Disease, having superior patency and lower infection risks than prosthetic graft and catheter access. When AVF dysfunction or delayed maturation does occur, the gold standard for diagnosis is the fistula angiogram (a.k.a. fistulogram). 3D ultrasound is available for obstetrical and other specialized uses, but it is cost prohibitive and has a field of view that is too small to cover the region of interest for the dialysis fistula application. We sought to develop a point of care 3D solution using freehand 2D ultrasound data acquisition. METHODS: We developed open-source software for 3D image reconstruction and projection of an angiogram-like image of the vascular access using a 2D freehand ultrasound scanner. We evaluated this software by comparing the ultrasound "sono-angiogram" images to fistulogram images in five subjects, using visual inspection and by applying the Percent of Exact Match (PEM) as a statistic test. RESULTS: The sono-angiograms showed identifiable characteristics that matched the fistulogram results in all five subjects. The PEM ranged between 42.8% and 77.0%, with Doppler and grayscale ultrasound data, showing complementary advantages and disadvantages when used for sono-angiogram image construction. Motion from freehand ultrasound acquisition was a significant source of mismatch. 3D image generation is a potential advantage with ultrasound data. CONCLUSIONS: While further work is needed to improve the accuracy with free hand scanning, fistulogram-like "sono-angiograms" can be generated using point of care 2D ultrasound. Methods such as these may be able to assist in point-of-care diagnosis in the future. The software is open-source, and importantly, the ultrasound data used are non-proprietary and available from any standard ultrasound machine. The simplicity and accessibility of this approach warrant further study.

Semiautomated Software to Improve Stability and Reduce Operator-Induced Variation in Vascular Ultrasound Speckle Tracking.

OBJECTIVES: Ultrasound is useful in predicting arteriovenous fistula (AVF) maturation, which is essential for hemodialysis in end-stage renal disease patients. We developed ultrasound software that measures circumferential vessel wall strain (distensibility) using conventional ultrasound Digital Imaging and Communications in Medicine (DICOM) data. We evaluated user-induced variability in measurement of arterial wall distensibility and upon finding considerable variation we developed and tested 2 methods for semiautomated measurement. METHODS: Ultrasound scanning of arteries of 10 subjects scheduled for AVF surgery were performed. The top and bottom of the vessel wall were tracked using the Kanade-Lucas-Tomasi (KLT) feature-tracking algorithm over the stack of images in the DICOM cine loops. The wall distensibility was calculated from the change of vessel diameter over time. Two semiautomated methods were used for comparison. RESULTS: The location of points selected by users for the cine loops varied significantly, with a maximum spread of up to 120 pixels (7.8 mm) for the top and up to 140 pixels (9.1 mm) for the bottom of the vessel wall. This variation in users' point selection contributed to the variation in distensibility measurements (ranging from 5.63 to 41.04%). Both semiautomated methods substantially reduced variation and were highly correlated with the median distensibility values obtained by the 10 users. CONCLUSIONS: Minimizing user-induced variation by standardizing point selection will increase reproducibility and reliability of distensibility measurements. Our recent semiautomated software may help expand use in clinical studies to better understand the role of vascular wall compliance in predicting the maturation of fistulas.

Ultrasound Measurement of Vascular Distensibility Based on Edge Detection and Speckle Tracking Using Ultrasound DICOM Data.

This study presents an edge detection and speckle tracking (EDST) based algorithm to calculate distensibility as percentage of change of vessel diameter during cardiac cycles. Canny edge detector, Vandermonde matrix representation, Kanade Lucas Tomasi algorithm with pyramidal segmentation, and penalized least squares technique identifies the vessel lumen edge, track the vessel diameter, detrend the signal and find peaks and valleys when the vessel is fully distended or contracted. An upper extremity artery from 10 patients underwent an ultrasound examination as part of preoperative evaluation before arteriovenous fistula surgery. Three studies were performed to evaluate EDST with automatic peak and valley selection versus manual speckle selection of expert users using manual peak and valley selection. Results demonstrate the effectiveness of the proposed methodology, to obtain comparable results as those obtained by expert-users, and considerably reducing the variability associated with external factors such as excessive motion, fluctuations in stroke volume, beat-to-beat blood pressure changes, breathing cycles, and arm-transducer pressure.

Ultrasound speckle tracking to detect vascular distensibility changes from angioplasty and branch ligation in a radio-cephalic fistula: Use of novel open source software.

We used novel open source software, based on an ultrasound speckle tracking algorithm, to examine the distensibility of the vessel wall of the inflow artery, anastomosis, and outflow vein before and after two procedures. An 83-year-old white man with a poorly maturing radio-cephalic fistula received an angioplasty at the anastomosis followed by branch ligation 28 days later. Duplex Doppler measurements corroborated the blood flow related changes anticipated from the interventions. The experimental distensibility results showed that it is technically feasible to measure subtle vessel wall motion changes with high resolution (sub-millimeter) using standard Digital Imaging and Communications in Medicine (DICOM) ultrasound data, which are readily available on conventional ultrasound scanners. While this methodology was originally developed using high resolution radiofrequency from ultrasound data, the goal of this study was to use DICOM data, which makes this technology accessible to a wide range of users.

Detecting High-Resolution Intramural Vascular Wall Strain Signals Using DICOM Data.

Maintaining dialysis vascular access is a source of considerable morbidity in patients with end-stage renal disease (ESRD). High-resolution radiofrequency (RF) ultrasound vascular strain imaging has been applied experimentally in the vascular access setting to assist in diagnosis and management. Unfortunately, high-resolution RF data are not routinely accessible to clinicians. In contrast, the standard DICOM formatted B-mode ultrasound data are widely accessible. However, B-mode, representing the envelope of the RF signal, is of much lower resolution. If strain imaging could use open-source B-mode data, these imaging techniques could be more broadly investigated. We conducted experiments to detect wall strain signals with submillimeter tracking resolutions ranging from 0.2 mm (3 pixels) to 0.65 mm (10 pixels) using DICOM B-mode data. We compared this submillimeter tracking to the overall vascular distensibility as the reference measurements to see if high-strain resolution strain could be detected using open-source B-Mode data. We measured the best-fit coefficient of determination between signals, expressed as the percentage of strain waveforms that exhibited a correlation with a p value of 0.05 or less. The lowest percentage was 86.7%, and most were 90% and higher. This indicates high-resolution strain signals can be detected within the vessel wall using B-mode DICOM data.

Sono-angiography for dialysis vascular access based on the freehand 2D ultrasound scanning.

INTRODUCTION: Dialysis vascular access, preferably an autogenous arteriovenous fistula, remains an end stage renal disease (ESRD) patient's lifeline providing a means of connecting the patient to the dialysis machine. Once an access is created, the current gold standard of care for maintenance of vascular access is angiography and angioplasty to treat stenosis. While point of care 2D ultrasound has been used to detect access problems, we sought to reproduce angiographic results comparable to the gold standard angiogram (fistulogram) using ultrasound data acquired from a conventional 2D ultrasound scanner. METHODS: A 2D ultrasound probe was used to acquire a series of cross sectional images of the vascular access including arteriovenous anastomosis of a subject with a radio-cephalic fistula. These 2D B-mode images were used for 3D vessel reconstruction by binary thresholding to categorize vascular versus non-vascular structures followed by standard image segmentation to select the structure representative of dialysis vascular access and morphologic filtering. Image processing was done using open source Python Software. RESULTS: The open source software was able to: (1) view the gold standard fistulogram images, (2) reconstruct 2D planar images of the fistula from ultrasound data as viewed from the top, analogous to computerized tomography images, and (3) construct a 2D representation of vascular access similar to the angiogram. CONCLUSION: We present a simple approach to obtain an angiogram-like representation of the vascular access from readily available, non-proprietary 2D ultrasound data in the point of care setting. While the sono-angiogram is not intended to replace angiography, it may be useful in providing 3D imaging at the point of care in the dialysis unit, outpatient clinic, or for pre-operative planning for interventional procedures. Future work will focus on improving the robustness and quality of the imaging data while preserving the straightforward freehand approach used for ultrasound data acquisition.

Angioplasty Induced Changes in Dialysis Vascular Access Compliance.

Dialysis vascular access remains vitally important to maintain life and functional capacity with end stage renal disease. Angioplasty is an integral part of maintaining dialysis access function and patency. To understand the effect of angioplasty balloon dilation on vascular wall mechanics, we conducted a clinical study to evaluate the elastic modulus of the anastomosis in five subjects with anastomosis stenoses, before and after six angioplasty procedures, using B-mode ultrasound DICOM data. A novel and open source vascular ultrasound high-resolution speckle tracking software tool was used. The median lumen diameter increased from 3.4 to 5.5 mm after angioplasty. Meanwhile, the median elastic modulus of the 18 measurements at the anastomosis increased by 52.2%, from 2.24 × 103 to 3.41 × 103 mmHg. The results support our hypothesis that the structural changes induced in the vessel wall by balloon dilation lead to reduced vascular compliance and a higher elastic modulus of the vessel wall.

Quantifying lung ultrasound comets with a convolutional neural network: Initial clinical results.

Lung ultrasound comets are "comet-tail" artifacts appearing in lung ultrasound images. They are particularly useful in detecting several lung pathologies and may indicate the amount of extravascular lung water. However, the comets are not always well defined and large variations in the counting results exist between observers. This study uses a convolutional neural network to quantify these lung ultrasound comets on a 4864-image clinical lung ultrasound dataset labeled by the authors. The neural network counted the number of comets correctly on 43.4% of the images and has an intraclass correlation (ICC) of 0.791 with respect to human counting on the test set. The ICC level indicates a higher correlation level than previously reported ICC between human observers. The neural network was then deployed and applied to a clinical 6272-image dataset. The correlation between the automated comet counts and the clinical parameters was examined. The comet counts correlate positively with the diastolic blood pressure (p = 0.047, r = 0.448), negatively with ejection fraction (p = 0.061, r = -0.513), and negatively with BMI (p = 0.009, r = -0.566). The neural network can be alternatively formulated as a diagnostic test for comet-positive images with 80.8% accuracy. The results could potentially be improved with a larger dataset and a refined approach to the neural networks used.

A pilot study to measure vascular compliance changes during fistula maturation using open-source software.

PURPOSE:: Autogenous arteriovenous fistulas are the preferred access for hemodialysis. Yet when created, fistulas often fail to mature, requiring surgical or radiologic interventions before their use. This pilot study measures the vascular wall elasticity and flow gradient using an open-source ultrasound software program designed to aid in assessing fistula maturation. METHODS:: A total of seven end-stage renal disease patients were enrolled for our study after providing informed consent. Ultrasound scanning was performed for the inflow artery, post-arterial anastomotic segment, and outflow vein at initial and follow-up evaluation. Conventional digital imaging and communications in medicine data were collected from the ultrasound machine. The vessel diameter and distensibility of artery, post-arterial anastomotic segment, and vein were computed from the digital imaging and communications in medicine data using an open-source ultrasound software program. RESULTS:: The vessel diameter of artery and vein increased from 4.6 ± 1.1 mm to 6.0 ± 1.1 mm and from 5.8 ± 0.7 mm to 7.5 ± 0.9 mm from 1 to 6 weeks post-operation, respectively. Conversely, the vessel diameter of post-arterial anastomotic segment decreased from 4.2 ± 1.0 mm to 3.5 ± 0.9 mm from 1 to 6 weeks post-operation. The distensibility of artery and post-arterial anastomotic segment increased from 3.4% ± 0% to 5.9% ± 1.1% and 3.7% ± 1.2% to 4.9% ± 1.4%, respectively, while the distensibility of vein decreased from 5.0% ± 1.3% to 2.6% ± 0.4% from 1 to 6 weeks post-operation. CONCLUSION:: This study demonstrates that the change in vessel diameter and distensibility related to the healthy remodeling as the vein dilates during maturation.

Ultrasound Strain Imaging to Assess the Biceps Brachii Muscle in Chronic Poststroke Spasticity.

OBJECTIVES: The aim of the study was to assess the feasibility of ultrasound strain imaging in characterizing the biceps brachii muscle in chronic poststroke spasticity. METHODS: We prospectively analyzed strain imaging data from bilateral biceps brachii muscles in 8 healthy volunteers and 7 patients with poststroke chronic spasticity. Axial deformations of the biceps brachii muscle and overlying subcutaneous tissue were produced by external compression using a sandbag (1.0 kg) attached to a transducer. The lengthening and shortening of the biceps brachii muscle and subcutaneous tissue were produced by manual passive elbow extension (from 90° to 0°) and flexion (from 0° to 90°), respectively. We used offline 2-dimensional speckle tracking to estimate axial and longitudinal strain ratios (biceps brachii strain/subcutaneous tissue strain), and the longitudinal tissue velocity of the biceps brachii muscle. Statistical analyses included analysis of variance for testing differences in strain imaging parameters among healthy, nonspastic, and spastic biceps brachii muscles, the Bonferroni correction for further testing differences in US strain imaging among paired groups (healthy versus spastic, nonspastic versus spastic, and healthy versus nonspastic), and the Pearson correlation coefficient for assessing the intraobserver reliability of performing strain imaging in stroke survivors. RESULTS: The differences in strain imaging parameters between healthy and spastic and between nonspastic and spastic biceps brachii muscles were significant at both 90° elbow flexion and maximal elbow extension (P < .01). There was no significant difference in axial strain ratios at 90° of elbow flexion or longitudinal tissue velocities between healthy and nonspastic muscles (P > .05). The intraobserver reliability of performing strain imaging in stroke survivors was good (r = 0.85; P < .01). CONCLUSIONS: Ultrasound strain imaging seems to be feasible for characterizing the biceps brachii muscle in chronic poststroke spasticity.

An Open-Source Ultrasound Software for Diagnosis of Fistula Maturation.

Vascular access is essential for hemodialysis patients. The mature native arteriovenous fistula has been the preferred vascular access for hemodialysis, because it has greater longevity than synthetic grafts. However, once surgically created, fistulas often fail to develop (mature) into viable points of vascular access, requiring surgical or radiologic interventions before their use. Because maturation depends on vascular mechanics (e.g., distensibility and wall shear), we developed open-source ultrasound software to investigate these metrics clinically. We demonstrated in a single patient the ability of the software for consistent measurements from various locations within a cardiac cycle and between different cardiac cycles. We further assessed the ability of the software to identify changes in distensibility of a patient's fistula from 1 to 6 weeks postoperation. The routine frame rates of clinical machines demonstrated high fidelity tracking within cardiac cycles (coefficient of variation [CV] = 2.4% ± 0.011) and between cardiac cycles (CV = 2.4% ± 0.004). The distensibility of the patient's fistula from 1 to 6 weeks postoperation increased from 4% to 7% in the arterial inflow and from 3% to 4% in the postarterial anastomotic segment (PAAS). In contrast, the distensibility of the outflow vein decreased from 4% to 2%. These results corroborate that in addition to diameter changes, the mechanical properties of the vascular segments changed during fistula maturation. This demonstrates that our software-based approach may allow ultrasound-based mechanical measurements to become more accessible for wider clinical research.

Design and Testing of a Single-Element Ultrasound Viscoelastography System for Point-of-Care Edema Quantification.

Management of fluid overload in patients with end-stage renal disease represents a unique challenge to clinical practice because of the lack of accurate and objective measurement methods. Currently, peripheral edema is subjectively assessed by palpation of the patient's extremities, ostensibly a qualitative indication of tissue viscoelastic properties. New robust quantitative estimates of tissue fluid content would allow clinicians to better guide treatment, minimizing reactive treatment decision making. Ultrasound viscoelastography (UVE) can be used to estimate strain in viscoelastic tissue, deriving material properties that can help guide treatment. We are developing and testing a simple, low-cost UVE system using a single-element imaging transducer that is simpler and less computationally demanding than array-based systems. This benchtop validation study tested the feasibility of using the UVE system by measuring the mechanical properties of a tissue-mimicking material under large strains. We generated depth-dependent creep curves and viscoelastic parameter maps of time constants and elastic moduli for the Kelvin model of viscoelasticity. During testing, the UVE system performed well, with mean UVE-measured strain matching standard mechanical testing with maximum absolute errors ≤4%. Motion tracking revealed high correlation and signal-to-noise ratios, indicating that the system is reliable.

Comparison of Ultrasound Corticomedullary Strain with Doppler Parameters in Assessment of Renal Allograft Interstitial Fibrosis/Tubular Atrophy.

To compare the capability of ultrasound strain and Doppler parameters in the assessment of renal allograft interstitial fibrosis/tubular atrophy (IF/TA), we prospectively measured ultrasound corticomedullary strain (strain) and intra-renal artery Doppler end-diastolic velocity (EDV), peak systolic velocity (PSV) and resistive index (RI) in 45 renal transplant recipients before their kidney biopsies. We used 2-D speckle tracking to estimate strain, the deformation ratio of renal cortex to medulla produced by external compression using the ultrasound transducer. We also measured Doppler EDV, PSV and RI at the renal allograft inter-lobar artery. Using the Banff scoring system for renal allograft IF/TA, 45 patients were divided into the following groups: group 1 with ≤5% (n = 12) cortical IF/TA; group 2 with 6%-25% (n = 12); group 3 with 26%-50% (n = 11); and group 4 with >50% (n = 10). We performed receiver operating characteristic curve analysis to test the accuracy of these ultrasound parameters and duration of transplantation in determining >26% cortical IF/TA. In our results, strain was statistically significant in all paired groups (all p < 0.005) and inversely correlated with the grade of cortical IF/TA (p < 0.001). However, the difference in PSV and EDV was significant only between high-grade (>26%, including 26%-50% and >50%) and low-grade (≤25%, including <5% and 6%-25%) cortical IF/TA (p < 0.001). RI did not significantly differ in any paired group (all p > 0.05). The areas under the receiver operating characteristic curve for strain, EDV, PSV, RI and duration of transplantation in determining >26% cortical IF/TA were 0.99, 0.94, 0.88, 0.52 and 0.92, respectively. Our results suggest that corticomedullary strain seems to be superior to Doppler parameters and duration of transplantation in assessment of renal allograft cortical IF/TA.

Quantitative lung ultrasound comet measurement: method and initial clinical results.

BACKGROUND/AIMS: Recently, ultrasound signals termed 'lung water comets' associated with pulmonary edema have been correlated with adverse clinical events in dialysis patients. These comets fluctuate substantially during the ultrasound exam highlighting the need for objective quantitative measurement methods. METHODS: We developed an image-processing algorithm for the detection and quantification of lung comets. Quantification measures included comet number (comet count) and the fraction of the ultrasound beams with comet findings (comet fraction). We used this algorithm in a pilot study in 20 stable dialysis outpatients to identify associations between ultrasound comets and clinical parameters including blood pressure (BP), percent blood volume reduction on dialysis (%BV), ejection fraction (EF), and ultrafiltration on dialysis (UF). RESULTS: Positive findings included associations with lung comet measurements with pre-dialysis Diastolic BP (r = 0.534, p = 0.015), subject age (r = -0.446, p = 0.049), and a combination of EF and end dialysis %BV reduction (r = -0.585, p = 0.028). Comet fraction and comet count were closely correlated due to the inherent relationship between these two metrics (r = 0.973, p < 0.001). Negative findings included ultrasound comets that did not change from beginning to end of dialysis (p = 0.756), and were not significantly correlated with single dialysis treatment UF (p = 0.522), subject body weight (p = 0.208), or BMI (p = 0.358). CONCLUSIONS: Ultrasound signal processing methods may help quantify lung ultrasound comets. Additional findings include algorithmic lung comet measurement that did not change significantly during single dialysis sessions in these stable outpatients, but were associated with cardiovascular and fluid status parameters.

Corticomedullary strain ratio: a quantitative marker for assessment of renal allograft cortical fibrosis.

OBJECTIVES: To quantitatively assess the correlation between the corticomedullary strain ratio and cortical fibrosis in renal transplants. METHODS: Using quasistatic ultrasound elasticity imaging, we prospectively assessed the corticomedullary strain ratio in renal allografts of 33 patients who underwent renal transplant sonography and biopsy. Based on Banff score criteria for renal cortical fibrosis, 33 allografts were divided into 2 groups: group 1 (n = 19), with mild (<25%) fibrosis; and group 2 (n = 14), with moderate (>26%) fibrosis. We used 2-dimensional speckle-tracking software to perform offline analysis of cortical and medullary strain induced by external compression by the ultrasound transducer. We then calculated the corticomedullary strain ratio (cortical normalized strain/medullary normalized strain; normalized strain = developed strain/applied strain [deformation from the abdominal wall to the pelvic muscles]). An unpaired 2-tailed t test was used to determine differences in normalized strain and the strain ratio between the groups. Receiver operating characteristic curve analysis was performed to determine the best strain ratio cutoff value for identifying moderate fibrosis. RESULTS: Normalized strain differed between the cortex and medulla (mean ± SD: group 1, 4.58 ± 2.02 versus 2.58 ± 1.38; P = .002; group 2, 1.71 ± 0.42 versus 2.60 ± 0.87; P = .0011). The strain ratio in group 1 was higher than in group 2 (2.06 ± 1.33 versus 0.70 ± 0.20; P = .0007). The area under the receiver operating characteristic curve was 0.964. The sensitivity and specificity of a strain ratio cutoff value of 0.975 for determining moderate fibrosis were 92.9% and 94.7%, respectively. CONCLUSIONS: Strain values vary in different compartments of the kidney. The corticomedullary strain ratio on ultrasound elasticity imaging decreases with increasing renal cortical fibrosis, which makes it potentially useful as a noninvasive quantitative marker for monitoring the progression of fibrosis in renal transplants.

Quantification of ultrasound correlation-based flow velocity mapping and edge velocity gradient measurement.

This study investigated the use of ultrasound speckle decorrelation- and correlation-based lateral speckle-tracking methods for transverse and longitudinal blood velocity profile measurement, respectively. By studying the blood velocity gradient at the vessel wall, vascular wall shear stress, which is important in vascular physiology as well as the pathophysiologic mechanisms of vascular diseases, can be obtained. Decorrelation-based blood velocity profile measurement transverse to the flow direction is a novel approach, which provides advantages for vascular wall shear stress measurement over longitudinal blood velocity measurement methods. Blood flow velocity profiles are obtained from measurements of frame-to-frame decorrelation. In this research, both decorrelation and lateral speckle-tracking flow estimation methods were compared with Poiseuille theory over physiologic flows ranging from 50 to 1000 mm/s. The decorrelation flow velocity measurement method demonstrated more accurate prediction of the flow velocity gradient at the wall edge than the correlation-based lateral speckle-tracking method. The novelty of this study is that speckle decorrelation-based flow velocity measurements determine the blood velocity across a vessel. In addition, speckle decorrelation-based flow velocity measurements have higher axial spatial resolution than Doppler ultrasound measurements to enable more accurate measurement of blood velocity near a vessel wall and determine the physiologically important wall shear.

Performance of Biopsy Needle With Therapeutic Injection System to Prevent Bleeding Complications.

Renal disease is epidemic in the United States with approximately 8 × 106 people having chronic kidney disease. Renal biopsies are widely used to provide essential diagnostic information to physicians. However, the risk of bleeding complications possibly leading to life-threatening situations results in the contra-indication of biopsy in certain patient populations. Safer renal biopsies will allow more accurate diagnosis and better management of this epidemic health problem. We report the preclinical testing of a novel biopsy device called the therapeutic injection system (TIS). The device introduces a third stage to the standard two-stage side-cut percutaneous biopsy process. The third stage is designed to reduce bleeding complications by injecting a hemostatic plug at the time of biopsy. Laboratory evaluation and preliminary in vivo animal testing using an anticoagulated porcine model of the TIS and Bard Monopty® (Bard Medical, Covington, GA) control device were performed. The hemostatic material Gelfoam® (Pfizer, Brussels, Belgium) was selected as the active material comprising the hemostatic plugs. The performance of two composite plugs, one composed of polyvinyl alcohol (PVA) combined in 2:1 and 12:1 ratios with the hemostatic material, and one plug composed of 100[Formula: see text] hemostatic material were tested. Stroke sequence and hemostatic plug deployment were verified by sequential firing of the TIS biopsy needle into clear gelatin and ex vivo bovine kidney specimens. In vivo trials with porcine specimens revealed a significant reduction in blood loss (8.1 [Formula: see text] 3.9 ml, control versus 1.9 [Formula: see text] 1.6 ml, 12:1 PVA/hemostatic, TIS, [Formula: see text] = 0.01, [Formula: see text] = 6). The 100[Formula: see text] hemostatic plug showed a substantial and immediate reduction in blood loss (9.2 ml, control versus 0.0 ml, TIS, [Formula: see text] = 1). The prototype device was shown to work repeatedly and reliably in laboratory trials. Initial results show promise in this approach to control post biopsy bleeding. This solution maintains the simplicity and directness of the percutaneous approach, while not significantly changing the standard percutaneous biopsy procedure.

Renal transplant elasticity ultrasound imaging: correlation between normalized strain and renal cortical fibrosis.

After transplantation, over a widely variable time course, the cortex of the transplanted kidney becomes stiffer as interstitial fibrosis develops and renal function declines. Elasticity ultrasound imaging (EUI) has been used to assess biomechanical properties of tissue that change in hardness as a result of pathologic damage. We prospectively assessed the hardness of the renal cortex in renal transplant allograft patients using a normalized ultrasound strain procedure measuring quasi-static deformation, which was correlated with the grade of renal cortical fibrosis. To determine cortical strain, we used 2-D speckle-tracking software (EchoInsight, Epsilon Imaging, Ann Arbor, MI, USA) to perform offline analysis of stored ultrasound loops capturing deformation of renal cortex and its adjacent soft tissue produced by pressure applied using the scanning transducer. Normalized strain is defined as the mean developed strain in the renal cortex divided by the overall mean strain measured in the soft tissues from the abdominal wall to pelvic muscles. Using the Banff scoring criteria for renal cortical fibrosis as the gold standard, we classified 20 renal transplant allograft biopsy tissue samples into two groups: group 1 (n = 10) with mild (<25%) renal cortical fibrosis and group 2 (n = 10) with moderate (26%-50%) renal cortical fibrosis. An unpaired two-tailed t-test was used to determine the statistical difference in strains between patients with mild and those with moderate renal cortical fibrosis. Receiver operating characteristic curve analysis was performed to assess the accuracy of developed strain and normalized strain in predicting moderate renal cortical fibrosis. The reference strain did not significantly differ between the two groups (p = 0.10). However, the developed renal cortical strain in group 1 with mild fibrosis was higher than that in group 2 with moderate fibrosis (p = 0.025). The normalized strain in group 1 was also higher than that in group 2 (p = 0.0014). The areas under receiver operating characteristic curves for developed strain and normalized strain were 0.78 and 0.95, respectively. The optimal cutoff for distinguishing moderate renal cortical fibrosis was -0.08 for developed strain (sensitivity = 0.50, specificity = 1.0) and 2.5 for normalized strain (sensitivity = 0.80, specificity = 1.0). In summary, renal cortex strain is strongly correlated with grade of renal cortical fibrosis. Normalized strain is superior to developed strain in distinguishing moderate from mild renal cortical fibrosis. We conclude that free-hand real-time strain EUI may be useful in assessing the progression of cortical fibrosis in renal transplant allografts. Further prospective study using this method is warranted.

In vivo vascular wall shear rate and circumferential strain of renal disease patients.

This study measures the vascular wall shear rate at the vessel edge using decorrelation based ultrasound speckle tracking. Results for nine healthy and eight renal disease subjects are presented. Additionally, the vascular wall shear rate and circumferential strain during physiologic pressure, pressure equalization and hyperemia are compared for five healthy and three renal disease subjects. The mean and maximum wall shear rates were measured during the cardiac cycle at the top and bottom wall edges. The healthy subjects had significantly higher mean and maximum vascular wall shear rate than the renal disease subjects. The key findings of this research were that the mean vascular wall shear rates and circumferential strain changes between physiologic pressure and hyperemia that was significantly different between healthy and renal disease subjects.