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Diane N Sayah,1– 3 Itika Garg,1,2 Raviv Katz,1,2 Ying Zhu,1,4 Ying Cui,1,5 Rebecca Zeng,1,2 Rachel Tandias,1,2 Jade Y Moon,1,2 Filippos Vingopoulos,1,2 Hannah E Wescott,1,2 Grace Baldwin,1,2 Kira Wang,1,2 Tobias Elze,1,2 Cassie Ann Ludwig,1,2 Demetrios G Vavvas,1,2 Joan W Miller,1,2 Deeba Husain,1,2 Leo A Kim,1,2 Nimesh A Patel,1,2 John B Miller1,2 1Harvard Retinal Imaging Lab, Boston, MA, USA; 2Retina Service, Department of Ophthalmology, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA; 3College of Optometry, University of Houston, Houston, TX, USA; 4Eye Center of Xiangya Hospital, Central South University, Changsha, Hunan, People’s Republic of China; 5Guangdong Eye Institute, Department of Ophthalmology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, People’s Republic of ChinaCorrespondence: John B Miller, Retina Service, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, 243 Charles St, Boston, MA, 02114, USA, Tel +1 617 573-3750, Fax + 1 617 573-3698, Email John_Miller@meei.harvard.eduPurpose: Visual prognosis and treatment burden for macular neovascularization (MNV) can differ between myopic macular degeneration (MMD) and age-related macular degeneration (AMD). We describe and compare MNV associated with MMD and AMD using swept-source (SS)-OCTA.Patients and Methods: Adult patients with documented MNV associated with MMD or AMD were consecutively recruited. Qualitative and quantitative features were assessed from 6x6mm angiograms, including the MNV area and vessel density (VD). Descriptive statistics and linear regression analyses were carried out.Results: Out of 75 enrolled eyes with diagnosed MNV (30 MMD-MNV and 45 AMD-MNV; mean age 55± 19 and 75± 8 years, respectively), 44 eyes had discernible MNV (11 MMD-MNV and 33 AMD-MNV) on SS-OCTA at the time of the study and were included in the analysis. The MMD-MNV group exhibited a three-fold smaller sized MNV (p=0.001), lower greatest linear dimension (p=0.009) and greatest vascular caliber (p< 0.001) compared to AMD-MNVs, and had a higher prevalence of tree-in-bud pattern. Eyes with AMD showed a higher prevalence of type 1 MNVs with medusa pattern. There was no difference in the location of the MNV, shape’s regularity, margins, presence of core vessel, capillary fringe, peripheral loops, or perilesional dark halo (p> 0.05) between both conditions. After adjustment, decreased MNV area and increased VD were associated with the tree-in-bud pattern, whereas the diagnosis did not significantly influence those parameters.Conclusion: While larger studies are warranted, this study is the first to describe and compare MMD-MNV and AMD-MNV using SS-OCTA, providing relevant clinical insight on MNV secondary to MMD and AMD. These findings also further validate OCTA as a powerful tool to detect and characterize MNV non-invasively.Keywords: macular neovascularization, age-related macular degeneration, high myopia, swept source, OCT angiography

Yifan Lu,1,2,&ast; Ying Cui,1,3,&ast; Ying Zhu,1,4,&ast; Edward S Lu,1 Rebecca Zeng,1 Itika Garg,1 Raviv Katz,1 Rongrong Le,1,5 Jay C Wang,1 Demetrios G Vavvas,1,2 Deeba Husain,1,2 Joan W Miller,1,2 David Wu,1,2 John B Miller1,2 1Harvard Retinal Imaging Lab, Massachusetts Eye and Ear, Boston, MA, USA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; 3Guangdong Eye Institute, Department of Ophthalmology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, People’s Republic of China; 4Eye Center of Xiangya Hospital, Central South University, Changsha, Hunan, People’s Republic of China; 5Wenzhou Medical University Affiliated Eye Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: John B Miller, Retina Service, Mass, Eye and Ear Infirmary, Harvard Medical School, 243 Charles St, Boston, MA, 02114, USA, Tel +1 (617) 573-3750, Fax +1 (617) 573-3698, Email john_miller@meei.harvard.eduPurpose: Retinal artery occlusion (RAO) is an ophthalmic emergency that can lead to poor visual outcomes and is associated with an increased risk of stroke and cardiovascular events. Wide-field swept-source OCT-A (WF SS-OCTA) can provide quick and non-invasive angiographic information with a wide field of view. Here, we looked for associations between OCT-A vascular imaging metrics and vision in RAO patients.Methods: Patients with diagnoses of central (CRAO) or branched retinal artery occlusion (BRAO) were included. 6mm × 6mm Angio and 15mm × 15mm AngioPlex Montage OCT-A images were obtained for both eyes in each patient using Zeiss Plex Elite 9000 WF SS-OCTA device. Each 6mm × 6mm image was divided into nine Early Treatment Diabetic Retinopathy Study (ETDRS) subfields. Non-perfusion area (NPA) was manually measured using 15mm × 15mm images. A linear regression model was utilized to identify correlation between imaging metrics and vision. P-values less than 0.05 were considered as statistically significant.Results: Twenty-five subjects were included. For RAO eyes, there was a statistically significant inverse correlation between retinal thickness as well as superficial capillary plexus (SCP) vessel density (VD) and vision. An inverse correlation was found between deep capillary plexus (DCP) VD and vision without statistical significance. There was a positive correlation between choroidal thickness as well as choroidal volume and vision without statistical significance. No significant correlation was found between the metrics and vision in contralateral eyes. For NPA and vision, no significant correlation was identified.Conclusion: This is the first study to investigate the utility of WF SS-OCTA in RAO and to demonstrate correlations between retinal vascular imaging metrics and visual outcomes. The results of this study provide a basis to understand the structural changes involved in vision in RAO and may guide management of RAO and prevention of cerebral stroke and cardiovascular accidents.Keywords: WF SS-OCTA, RAO, BRAO, CRAO, ETDRS, ARI network

Filippos Vingopoulos,1,2 Megan Kasetty,1 Itika Garg,1,2 Rebecca F Silverman,1 Raviv Katz,1,2 Ryan A Vasan,3 Alice C Lorch,3 Zhonghui K Luo,3 John B Miller1,2 1Harvard Retinal Imaging Lab, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA; 2Retina Service, Massachusetts Eye and Ear, Harvard Medical School, Boston, MA, USA; 3Comprehensive Ophthalmology and Cataract Service, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USACorrespondence: John B Miller, Harvard Retinal Imaging Lab, Massachusetts Eye and Ear, Harvard Medical School, 243 Charles St, Boston, MA, USA, Tel +1 617 573-3750, Fax +1 617 573-3698, Email john_miller@meei.harvard.eduBackground: To characterize contrast sensitivity function (CSF) in cataractous and pseudophakic eyes compared to healthy control eyes using a novel quantitative CSF test with active learning algorithms.Methods: This is a prospective observational study at an academic medical center. CSF was measured in eyes with visually significant cataract, at least 2+ nuclear sclerosis (NS) and visual acuity (VA) ≥ 20/50, in pseudophakic eyes and in healthy controls with no more than 1+ NS and no visual complaints, using the Manifold Contrast Vision Meter. Outcomes included Area under the Log CSF (AULCSF) and CS thresholds at 1, 1.5, 3, 6, 12, and 18 cycles per degree (cpd). A subgroup analysis as performed on cataract eyes with VA ≥ 20/25.Results: A total of 167 eyes were included, 58 eyes in the cataract group, 77 controls, and 32 pseudophakic eyes with respective median AULCSF of 1.053 (0.352) vs 1.228 (0.318) vs 1.256 (0.360). In our multivariate regression model, cataract was associated with significantly reduced AULCSF (P= 0.04, β= − 0.11) and contrast threshold at 6 cpd (P= 0.01, β= − 0.16) compared to controls. Contrast threshold at 6 cpd was significantly reduced even in the subgroup of cataractous eyes with VA ≥ 20/25 (P=0.02, β=− 0.16).Conclusion: The novel qCSF test detected disproportionate significant contrast deficits at 6 cpd in cataract eyes; this remained significant even in the cataractous eyes with VA ≥ 20/25. CSF testing may enhance cataract evaluation and surgical decision-making, particularly in patients with subjective visual complaints despite good VA.Keywords: cataract, contrast sensitivity function, Contrast sensitivity, qCSF method

Chloe Y Li,1,&ast; Itika Garg,1,2,&ast; Deepthi Bannai,3 Megan Kasetty,1 Raviv Katz,1,2 Iniya Adhan,3 Konstantinos AA Douglas,1 Jay C Wang,1 Leo A Kim,2 Matcheri Keshavan,3 Paulo Lizano,3,&ast; John B Miller1,2,&ast; 1Harvard Retinal Imaging Laboratory, Massachusetts Eye and Ear, Boston, MA, USA; 2Retina Service, Massachusetts Eye and Ear, Boston, MA, USA; 3Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, MA, USA&ast;These authors contributed equally to this workCorrespondence: John B Miller, Harvard Medical School, Department of Ophthalmology, Massachusetts Eye and Ear, 243 Charles St, Boston, MA, 02114, USA, Tel +1 617-573-3529, Email john_miller@meei.harvard.edu Paulo Lizano, Harvard Medical School, Department of Psychiatry, Beth Israel Deaconess Medical Center, 75 Fenwood Road, Room 612, Boston, MA, 02115, USA, Tel +1 617-754-1227, Email plizano@bidmc.harvard.eduPurpose: While structural changes within the retina of psychosis patients have been established, no detailed studies of choroidal microvasculature in these patients have been performed. Given evidence of microvascular disruption in psychosis patients, this study sought to determine whether there exists evidence of microvascular disruption in the choroids in these patients.Methods: Fifty-six subjects (20 controls and 36 psychosis patients) were recruited from April 2018 to February 2020. Five were excluded due to imaging artifact or missing demographic information. Swept-source optical coherence tomography angiography (SS-OCTA) images were obtained. Choroid vascular enface images (12 mm × 9mm) were exported every 2.6 μm from Bruch’s membrane to the choroid–scleral interface from Topcon to ImageJ. The images were binarized using Otsu’s method, signal from the optic disk and retinal vasculature was removed, and average choroid vascular density (CVD) was calculated as the average of percent area occupied by choroidal vasculature across images in the stack. Choroid vascular volume (CVV) was calculated as the CVD multiplied by maximum CT and image area. During image analysis, study staff were blinded to the phenotype of the study subjects.Results: Compared with same-sex controls, male psychiatric patients had significantly lower CVD. Compared with same-sex controls, female psychiatric patients had significantly lower maximum CT with correspondingly decreased CVV, after adjusting for age. When all psychiatric patients were compared with all healthy controls, no significant differences in CT, CVD, or CVV were noted.Conclusion: These results suggest that the pathogenesis of psychotic illness affects choroidal microvasculature in a sex-specific manner.Keywords: choroid vascular density, swept source optical coherence tomography angiography, psychosis, schizophrenia, bipolar disorder

Itika Garg,1,2 Raviv Katz,1 Yifan Lu,1,2 John B Miller1,2 1Harvard Retinal Imaging Lab, Boston, MA, USA; 2Retina Service, Massachusetts Eye and Ear Infirmary, Boston, MA, USACorrespondence: John B Miller, Tel +1 617 573-3750, Fax +1 617 573-3698, Email john_miller@meei.harvard.eduPurpose: The COVID-19 pandemic has had a widespread impact on the health sector worldwide, both in the clinical and research subsector. This has necessitated for the invention of protocols compliant with social distancing policies to efficiently tackle the current needs. Our aim is to describe a novel remote imaging technique, which helped us continue our research with widefield swept-source optical coherence tomography angiography (WF SS-OCTA).Patients and Methods: As a part of this cross-sectional observational study from August 2020 to September 2020 at Massachusetts Eye and Ear (MEE), we used our institute approved remote desktop, outside of MEE, to gain full access to the on-site WF SS-OCTA device in the imaging room for the purpose of remote imaging. With only the patient being in the imaging room, effective communication was established via video conferencing on an encrypted tablet computer device for the entire procedure.Results: We imaged four patients with various retinal pathologies, aged 32– 69 years. All images obtained were of high quality and signal strength (median score 9/10 for both) and all patients reported a highly satisfactory, comfortable, and safe experience amidst the COVID-19 pandemic.Conclusion: This novel method is better for remote imaging compared to the previously described techniques as it is time and cost effective, requires limited resources without compromising the image quality or patient satisfaction and adheres to the various guidelines for infection control, most importantly social distancing. As a paradigm shift, this can also be employed in future for setups with limited staff like busy emergency departments or a rural setup with limited access or difficult commute, in the “new-normal” era.Keywords: COVID-19, COVID, teleophthalmology, remote imaging, teleimaging, telemedicine, optical coherence tomography angiography, retinal imaging, optical coherence tomography

Neal S Patel,1,&ast; Jade Y Moon,1,&ast; Raviv Katz,1 Karen M Wai,1 Lucia Sobrin,2 Demetrios G Vavvas,2 John B Miller1,2 1Harvard Retinal Imaging Lab, Mass Eye and Ear, Boston, MA, USA; 2Retina Service, Mass Eye and Ear, Boston, MA, USA&ast;These authors contributed equally to this workCorrespondence: John B MillerRetina Service, Mass Eye and Ear, Department of Ophthalmology, Harvard Medical School, Harvard Retinal Imaging Lab, 243 Charles St, Boston, MA, 02114, USATel +617 573-3750Fax +617 573-3698Email john_miller@meei.harvard.eduPurpose: Since the start of the COVID-19 pandemic, numerous authors have published data demonstrating retinal changes found in patients with COVID-19. However, others have debated the significance of these findings and the effects of COVID-19 on the retina remain uncertain. This study aims to better understand retinal findings in patients with COVID-19.Patients and Methods: A retrospective review of patients with a history of a positive COVID-19 polymerase chain reaction test was performed between March 1st, 2020 and October 31st, 2020. Patients were included if they presented within 90 days of their first positive COVID-19 test and underwent color fundus photography and/or OCT of the macula. All images were reviewed by two independent graders who assessed the presence of retinal heme, cotton wool spots, vascular sheathing, and disc edema, as well as hyper-reflective changes, intra-retinal fluid, and sub-retinal fluid on OCT.Results: A total of 119 eyes from 61 patients were included. Among 83 eyes which underwent OCT of the macula, inner retinal hyper-reflective changes were seen in 16.9% (n=14), outer retinal hyper-reflective changes in 18.1% (n=15), intra-retinal fluid in 28.9% (n=24), and sub-retinal fluid in 14.5% (n=12). Among 48 eyes which underwent color fundus photography, retinal hemorrhage was seen in 27.1% (n=13), optic disc edema in 2.1% (n=1), and cotton wool spots in none of the eyes. Sub-analysis of 70 eyes from 41 patients with no alternative retinal pathology to potentially explain the above findings revealed none of the above exam findings on OCT of the macula (n=35), fundus photography (n=28), or documented exam (n=66).Conclusion: While a number of patients seen after COVID-19 infection demonstrated retinal findings, all could be explained by pre-existing retinal conditions. In a sub-group of eyes without pre-existing retinal disease, we did not identify any retinal findings that could be associated with COVID-19.Keywords: COVID-19, SARS-CoV-2, retina, optical coherence tomography, fundus photography

Jade Y Moon,1,2,* John B Miller,1,2,* Raviv Katz,2 Thong Ta,1 Colleen Szypko,1 Itika Garg,1,2 Alice C Lorch,1 Matthew F Gardiner,1 Grayson W Armstrong1 1Department of Ophthalmology, Harvard Medical School, Boston, MA, USA; 2Harvard Retinal Imaging Lab, Massachusetts Eye and Ear, Boston, MA, USA*These authors contributed equally to this workCorrespondence: Grayson W ArmstrongMassachusetts Eye and Ear, 243 Charles Street, Boston, MA 02114, USATel +1 704-957-5576Fax +1 617-573-3416Email grayson_armstrong@meei.harvard.eduPurpose: During the COVID-19 pandemic, there is growing concern that patients are forgoing necessary care. Emergency departments (ED) represent an important site of eye care. We analyzed patterns of ED visits at an eye-specific ED since the declaration of the public health crisis.Materials and Methods: In this retrospective, cross-sectional single center study, medical records of 6744 patients who presented to the Massachusetts Eye and Ear ED between March 1st and April 30th in 2018, 2019, and 2020 were studied. The primary outcome measures were total volume of ED visits, proportion of urgent ED visits, and proportion of surgical visits.Results: Overall, the median number of daily visits to the ED decreased by 18 visits per day since the declaration of public health guidelines (interquartile range, 9– 24, p < 0.001). This accounted for a 32% decrease in the total volume of ED visits in 2020 compared to prior years during the study period (p < 0.001). There was a 9% increase in the proportion of primary diagnoses considered urgent (p = 0.002). The proportion of visits requiring urgent surgery increased by 39% (p = 0.004).Conclusion: The total number of eye-specific ED visits dropped compared to prior years while the proportion of urgent visits increased. Patients were likely more reluctant to seek eye care, deferring less urgent evaluation.Keywords: COVID-19, urgent ophthalmic diagnoses, epidemiology, eye-specific emergency department, medical services

Yifan Lu,1,2,* Jay C Wang,1–3,* Rebecca Zeng,2 Raviv Katz,2 Demetrios G Vavvas,2,3 Joan W Miller,2,3 John B Miller1–3 1Department of Ophthalmology, Harvard Medical School, Boston, Ma, USA; 2Harvard Retinal Imaging Laboratory, Massachusetts Eye and Ear, Boston, Ma, USA; 3Retina Service, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA*These authors contributed equally to this workCorrespondence: John B MillerRetina Service, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, 243 Charles St, Boston, MA 02114, USATel +1 617 573 3750Fax +1 617 573 3698Email john_miller@meei.harvard.eduPurpose: Optical coherence tomography angiography (OCT-A) has emerged as a novel tool for the non-invasive imaging and evaluation of the retinal microvasculature. There is little existing literature that compares OCT-A microvasculature metrics across different OCT-A devices in chorioretinal diseases. Herein, we examined these metrics on three available OCT-A platforms.Patients and methods: All subjects were scanned on each of three OCT-A devices: Optovue Avanti Angiovue, Topcon DRI-OCT Triton Swept-Source OCT, and Zeiss Cirrus 5000-HD-OCT Angioplex. Two investigators independently measured foveal avascular zone (FAZ) area. Superficial capillary plexus (SCP) and deep capillary plexus (DCP) vessel densities (VD) were calculated from binarized images with ImageJ software. Image quality across devices was qualitatively compared. Interclass correlation coefficient (ICC), Bland-Altman analysis, repeated measures ANOVA, and post-hoc tests were performed for statistical analysis.Results: Thirteen eyes of seven patients with chorioretinal diagnoses were reviewed. ICC for FAZ measurement was 0.95. There was no significant difference in FAZ area across the three devices (p= 0.792). There was a significant difference in the SCP VD between the OCT-A devices (Triton 0.344 ± 0.013, Angiovue 0.323 ± 0.013, Angioplex 0.367 ± 0.014, p < 0.05). Significantly greater DCP VD was observed with Angioplex (0.385 ± 0.010) in comparison to both Triton (0.331 ± 0.009) and Angiovue (0.341 ± 0.020). A comparison of image quality revealed that Angiovue gives the highest quality, followed by Angioplex and Triton.Conclusion: Core macular microvasculature metrics are now readily accessible on a variety of available OCT-A devices. While the FAZ can be reliably measured across all three devices in this study, there were significant differences for the vessel density in both the SCP and DCP. As a result, clinicians should be careful when comparing microvasculature metrics across different devices when using patient data in multicenter research investigations and clinical trials.Keywords: OCTA, Angiovue, Angioplex, Triton, Zeiss, Optovue

Tamer Abdin,1 Gideon Zamir,2 Alon Pikarsky,2 Ran Katz,1 Ezekiel H Landau,1 Ofer N Gofrit1 1Department of Urology, 2Department of General Surgery, Hadassah Hebrew University Hospital, Jerusalem, Israel Aim: To report on a simple and rapid method of urinary diversion. This method was applied successfully in different clinical scenarios when primary reconstruction of the ureters was not possible. Materials and methods: The disconnected ureter is catheterized by a feeding tube. The tube is secured with sutures and brought out to the lateral abdominal wall as cutaneous tube ureterostomy (CTU). Results: This method was applied in three different clinical scenarios: a 40-year-old man who sustained multiple high-velocity gunshots to the pelvis with combined rectal and bladder trigone injuries and massive bleeding from a comminuted pubic fracture. Damage control included colostomy and bilateral CTUs. A 26-year-old woman had transection of the right lower ureter during abdominal hysterectomy. Diagnosis was delayed for 3 weeks when the patient developed sepsis. The right kidney was diverted with a CTU. A 37-year-old male suffered from bladder perforation and hemorrhagic shock. Emergency cystectomy was done and urinary diversion was accomplished with bilateral CTUs. In all cases, effective drainage of the urinary system was achieved with normalization of kidney function. Conclusion: When local or systemic conditions preclude definitive repair and damage control surgery is needed, CTU provides fast and effective urinary diversion. Keywords: Ureter, trauma, tube cutenuous ureterostomy

Ofer N Gofrit,1 Amos Shapiro,1 Ran Katz,1 Mordechai Duvdevani,1 Vladimir Yutkin,1 Ezekiel H Landau,1 Kevin C Zorn,2 Guy Hidas,1 Dov Pode1 1Department of Urology, Hadassah Hebrew University Hospital, Jerusalem, Israel; 2Department of Surgery, Section of Urology, Montreal, Canada Background: Partial cystectomy provides oncological results comparable with those of radical cystectomy in selected patients with invasive bladder cancer without the morbidity associated with radical cystectomy and urinary diversion. We describe a novel technique of partial cystectomy that allows accurate identification of tumor margins while minimizing damage to the rest of the bladder. Methods: During the study period, 30 patients underwent partial cystectomy for invasive high-grade cancer. In 19 patients, the traditional method of tumor identification was used, ie, identifying the tumor by palpation and cystotomy. In eleven patients, after mobilization of the bladder, flexible cystoscopy was done and the light of the cystoscope was pointed toward one edge of the planned resected ellipse around the tumor, thus avoiding cystotomy. Results: Patients who underwent partial cystectomy using the novel method were similar in all characteristics to patients operated on using the traditional technique except for tumor diameter which was significantly larger in patients operated on using the novel method (4.3±1.5 cm versus 3.11±1.18 cm, P=0.032). Complications were rare in both types of surgery. The 5-year local recurrence-free survival was marginally superior using the novel method (0.8 versus 0.426, P=0.088). Overall, disease-specific and disease-free survival rates were similar. Conclusion: The use of a flexible cystoscope during partial cystectomy is a simple, low-cost maneuver that assists in planning the bladder incision and minimizes injury to the remaining bladder by avoiding the midline cystotomy. Initial oncological results show a trend toward a lower rate of local recurrence compared with the standard method. Keywords: bladder cancer, partial cystectomy, cystoscopic-assisted partial cystectomy

Cardiovascular risk remains high in kidney transplant recipients (KTRs) despite improved kidney function after transplant. Urinary markers of kidney fibrosis and injury may help to reveal mechanisms of this risk. In a case-cohort study among stable KTRs who participated in the FAVORIT trial, we measured four urinary proteins known to correlate with kidney tubulointerstitial fibrosis on biopsy (urine alpha 1 microglobulin [α1m], monocyte chemoattractant protein-1 [MCP-1], procollagen type I [PINP] and type III [PIIINP] N-terminal amino peptide) and evaluated associations with cardiovascular disease (CVD) events (n = 300) and death (n = 371). In adjusted models, higher urine α1m (hazard ratio [HR] per doubling of biomarker 1.40 [95% confidence interval [CI] 1.21, 1.62]), MCP-1 (HR 1.18 [1.03, 1.36]), and PINP (HR 1.13 [95% CI 1.03, 1.23]) were associated with CVD events. These three markers were also associated with death (HR per doubling α1m 1.51 [95% CI 1.32, 1.72]; MCP-1 1.31 [95% CI 1.13, 1.51]; PINP 1.11 [95% CI 1.03, 1.20]). Higher concentrations of urine α1m, MCP-1, and PINP may identify KTRs at higher risk for CVD events and death. These markers may identify a systemic process of fibrosis involving both the kidney and cardiovascular system, and give new insights into mechanisms linking the kidney with CVD.

ObjectiveEpratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double-blind, placebo-controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE).MethodsPatients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti-double-stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG-2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5-60 mg/day). BILAG-2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12-week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG-based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG-2004 score, no worsening in the BILAG-2004 score, SLEDAI-2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders.ResultsIn the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793 patients and 791 patients, respectively, were randomized, 786 (99.1%) and 788 (99.6%), respectively, received study medication, and 528 (66.6%) and 533 (67.4%), respectively, completed the study. There was no statistically significant difference in the primary end point between the groups, with the week 48 BICLA response rates being similar between the epratuzumab groups and the placebo group (response rates ranging from 33.5% to 39.8%). No new safety signals were identified.ConclusionIn patients with moderate or severely active SLE, treatment with epratuzumab + standard therapy did not result in improvements in response rates over that observed in the placebo + standard therapy group.

AimsThe metabolic syndrome (MetS) is a clustering of low levels of HDL cholesterol, hyperglycaemia, high waist circumference, hypertension and elevated triglycerides, and is associated with cardiovascular disease. Calcified atherosclerotic plaque in the thoracic aorta (TAC), measured by non-contrast cardiac computed tomography (CT) scans, is a marker for atherosclerosis and relates to mortality. We sought to evaluate the independent association of MetS and TAC on cardiac CT scans.MethodsWe examined the relation of the MetS, and each of its components, to the prevalence of TAC, measured from 2000 to 2002 in 6778 white, Chinese, African-American and Hispanic participants in the Multi-Ethnic Study of Atherosclerosis (MESA).ResultsAdjusting for age, gender, race, smoking, LDL cholesterol and lipid-lowering medications, relative risks and 95% confidence intervals (CI) for a TAC score > 0 were: 1.19 (95% CI 1.11 to 1.28) for participants with MetS, 1.34 (95% CI 1.21 to 1.49) for those with diabetes and MetS, and 1.33 (95% CI 1.11, 1.58) for those with diabetes and no MetS compared with participants who were free of the MetS and diabetes. Associations were found for most of the components of the MetS with TAC.ConclusionsWe conclude that in adults without known heart disease, the MetS, most of its components and diabetes are associated with a higher prevalence of calcified atherosclerotic plaque in the thoracic arteries in a multi-ethnic population of men and women.

© 2015 International Society of Nephrology Urinary uromodulin (uUMOD) is the most common secreted tubular protein in healthy adults. However, the relationship between uUMOD and clinical outcomes is still unclear. Here we measured uUMOD in 192 participants

When the faculty members for study abroad programs invite student affairs professionals to accompany them abroad, they combine skills and talents to ensure that students' holistic needs are met. The authors were partnered in an Italian Studies summer program in 2001 and 2002,in which the student affairs professional was available to help the faculty members address student concerns and proffer guest lecturing. The authors concluded that this partnership is imperative for future study abroad programs.

Some suggest race-specific cutpoints for kidney measures to define and stage chronic kidney disease (CKD), but evidence for race-specific clinical impact is limited. To address this issue, we compared hazard ratios of estimated glomerular filtration rates

Women have high rates of peripheral artery disease (PAD) despite fewer cardiovascular disease (CVD) risk factors, compared to men. We sought to determine the gender-specific prevalence of low ankle brachial index (ABI) and the relationship to C-reactive pr

Background: Previous studies suggest that the å4 and å2 alleles of apolipoprotein E (APOE) may be associated with decreased and increased risks of CKD, respectively, but there are limited data in older adults. We evaluated the associations of apolipoprotei

OBJECTIVE - Insulin resistance is a risk factor for cardiovascular and noncardiovascular diseases. Impaired kidney function is linked with insulin resistance and may affect relationships of insulin resistance with health outcomes. RESEARCH DESIGN AND METHODS - We performed a cohort study of 3,138 Cardiovascular Health Study participants (age ≥65 years) without diabetes. Insulin sensitivity index (ISI) was calculated from fasting and 2-h postload insulin and glucose concentrations. Associations of ISI and fasting insulin concentration with all-causemortality were tested using Cox proportional hazards models, adjusting for demographic variables, prevalent cardiovascular disease, lifestyle variables, waist circumference, and LDL cholesterol. Subsequent models were additionally adjusted for or stratified by glomerular filtration rate estimated using serum cystatin C (eGFR). RESULTS - A total of 1,810 participants died during the 14.7-year median follow-up. Compared with the highest quartile of ISI, the lowest quartile (most insulin resistant) was associated with 21% (95% CI 6-41) and 11%(-3 to 29) higher risks of death without and with adjustment for eGFR, respectively. Compared with the lowest quartile of fasting insulin concentration, the highest quartile was associated with 22% (4-43) and 4% (-12 to 22) higher risks of death without and with adjustment for eGFR, respectively. Similar attenuation by eGFR was observed when blood pressure, triglycerides, HDL cholesterol, and C-reactive protein were included in models. CONCLUSIONS - Insulin resistance measured as ISI or fasting insulin concentration is associated with increased risk of death among older adults, adjusting for conventional confounding characteristics. Impaired kidney function may mediate or confound this relationship. © 2012 by the American Diabetes Association.

OBJECTIVES We sought to evaluate cystatin-C, a novel measure of renal function, as a predictor of mortality in elderly persons with heart failure (HF) and to compare it with creatinine. BACKGROUND Renal function is an important prognostic factor in patients with HF, but creatinine levels, which partly reflect muscle mass, may be insensitive for detecting renal insufficiency. METHODS A total of 279 Cardiovascular Health Study participants with prevalent HF and measures of serum cystatin-C and creatinine were followed for mortality outcomes over a median of 6.5 years. RESULTS Median creatinine and cystatin-C levels were 1.05 mg/dl and 1.26 mg/l. Each standard deviation increase in cystatin-C (0.35 mg/l) was associated with a 31% greater adjusted mortality risk (95% confidence interval [CI] 20% to 43%, p < 0.001), whereas each standard deviation increase in creatinine (0.39 mg/dl) was associated with a 17% greater adjusted mortality risk (95% CI 1% to 36%, p = 0.04). When both measures were combined in a single adjusted model, cystatin-C remained associated with elevated mortality risk (hazard ratio 1.60, 95% CI 1.32 to 1.94), whereas creatinine levels appeared associated with lower risk (hazard ratio 0.73, 95% CI 0.57 to 0.95). CONCLUSIONS Cystatin-C is a stronger predictor of mortality than creatinine in elderly persons with HF. If confirmed in future studies, this new marker of renal function could improve risk stratification in patients with HF. (C) 2005 by the American College of Cardiology Foundation

BACKGROUND: Bowel dilation and bowel wall thickness are common prenatal ultrasound measurements for fetuses with gastroschisis. Data regarding antenatal sonographic bowel findings and postnatal outcomes are conflicting. Our objective was to evaluate the impact of in utero bowel measurements on perinatal outcomes in gastroschisis pregnancies. METHODS: Retrospective cohort study of 116 pregnancies complicated by gastroschisis between 2011 and 2020. We reviewed ultrasounds documenting fetal bowel measurements. To evaluate the association of these measurements with antepartum and delivery outcomes, we ran logistic and linear models using generalized estimating equations. RESULTS: Eleven perinatal outcomes reached statistical significance, although with minimal clinical impact given small magnitude of effect. Intra-abdominal bowel dilation was associated with a 0.5 week decrease in delivery gestational age (GA) (95% CI –0.07, –0.03) and a 6.93 g increase in birth weight (95% CI 1.54, 28.73). Intra-abdominal bowel wall thickness was associated with later GA of non-stress test (NST) start of 0.22 weeks (95% CI 0.07, 0.37), increased delivery GA of 0.08 weeks (95% CI 0.02, 0.15), 0.006 decrease in umbilical artery (UA) pH (95% CI –0.009, –0.003), 0.26 increase in UA base deficit (95% CI 0.09, 0.43), and decreased odds of cesarean delivery (OR = 0.83, 95% CI 0.70, 0.99). Extra-abdominal bowel wall thickness was associated with a 0.1 increase in UA base deficit (95% CI 0.02, 0.19) and a 0.05 increase in 5-min APGAR score (95% CI 0.01, 0.09). Stomach cross-section was associated with a 0.01 week decrease in delivery GA (95% CI –0.02, –0.001) and increased odds of receiving betamethasone (OR = 1.02, 95% CI 1.01, 1.04). CONCLUSIONS: In utero bowel characteristics reached statistical significance for several outcomes, but with minimal meaningful clinical differences in outcomes. [ABSTRACT FROM AUTHOR]

Understanding what relates to the behaviours associated with derailment (i.e. failure or burnout in managerial positions) may prevent costly outcomes of derailment for the manager, co-workers and the organization. The outcomes of derailment are especially pertinent with those working in college and university administration as many, including faculty, other staff and students, depend on these administrators. Data collected about 173 middle- and top-level college and university administrators from 88 different colleges and universities across the USA revealed that self- and observer-ratings (peers and direct reports) of willingness to improve negatively related to boss ratings of derailment. Specifically, the more administrators were willing to improve (and the more others believed those administrators were willing to improve), the less likely it was that bosses believed those administrators displayed the characteristics and behaviours associated with derailment. We conclude with a discussion of our findings including guidance for college and university administrators. (Contains 2 tables.)