A Remote Consult Retinal Artery Occlusion Diagnostic Protocol.

PURPOSE: To report a novel protocol for diagnosis of retinal artery occlusions at the point of care using OCT and a remote consult model. DESIGN: Retrospective case series and evaluation of a diagnostic test or technology. PARTICIPANTS: Adult patients who presented with painless monocular vision loss and were diagnosed with a nonarteritic retinal artery occlusion. METHODS: OCT machines were placed in the stroke center or emergency department at 3 hospitals within our health system. Patients who presented with painless monocular vision loss were evaluated by the stroke neurology service and an OCT was acquired. The images were interpreted remotely by the retina service. An in-house ophthalmology consult was not required to make the final treatment decision. Eligible patients were treated with intra-arterial tissue plasminogen activator (IA-tPA). Patients were followed by ophthalmology during their admission when an in-house consultation service was available or otherwise evaluated immediately after discharge. MAIN OUTCOME MEASURES: Visual acuity (VA) before and after treatment with IA-tPA; time from last known well (LKW) to treatment; and time from presentation to treatment. RESULTS: In the first 18 months since the protocol went live, 59 patients were evaluated. Twenty-five patients (42%) had a confirmed retinal artery occlusion based on OCT and follow-up examination. Ten patients were eligible for treatment, and 9 patients received treatment with IA-tPA. There was a statistically significant improvement in mean VA from logarithm of the minimum angle of resolution (logMAR) 2.14 to logMAR 0.7 within 24 hours after treatment (P = 0.0001) and logMAR 1.04 after 4 weeks (P = 0.01). Clinically significant improvement was noted in 66% of patients within 24 hours and maintained through 1 month in 56% of all treated patients. The mean time to treatment from LKW was 543 minutes and from presentation at the stroke center was 146 minutes. CONCLUSIONS: We report the successful implementation of a remote consult protocol using point-of-care automated OCT. This novel paradigm demonstrates the potential utility of remote consult services for the diagnosis of time-sensitive ophthalmic emergencies. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Ophthalmic drop waste due to self-imposed use cessation dates.

Self-imposed use cessation dates for multi-use eye drop bottles lead to significant drug waste and increased costs. We quantified the residual medication in eye drop bottles across three clinics in an academic ambulatory setting.

Sociodemographic and Temporal Differences in Menthol Cigarette Use Among US Adults Who Smoke, 1999-2018.

Introduction: Monitoring menthol cigarette use allows for identification of potential health disparities. We examined sociodemographic and temporal differences in menthol cigarette use among US adults who smoke. Methods: We analyzed data from the 1999-2018 National Health and Nutrition Examination Survey for adults aged 20 years or older who smoke (N = 11,431) using binary logistic regression. Results: Among US adults who smoke, 28.8% used menthol cigarettes. After adjusting for age, sex, race and ethnicity, education, income-to-poverty ratio, and health status, the prevalence of menthol use among adults who smoke increased on average by 3.8% (95% CI, 2.7%-4.9%) annually. Non-Hispanic Black adults had the highest average prevalence of menthol cigarette use, 73.0% (95% CI, 70.9%-75.2%), and Mexican American adults had higher average annual increase in menthol cigarette use, 7.1% (95% CI, 4.0%-10.3%). Adults with fair or poor health status had a 4.3% annual increase in menthol cigarette use (95% CI, 2.5%-6.1%). The adjusted prevalence ratios of menthol cigarette use were 1.61 (95% CI, 1.39-1.83) for adults aged 20-29 years compared with those aged 65 years or older, 1.41 (95% CI, 1.32-1.49) for female adults compared with male adults, and 1.17 (95% CI, 1.07-1.27) for high school graduates or higher compared with those with no high school diploma. Conclusion: Non-Hispanic Black adults who smoke had the highest prevalence of menthol cigarette use among all racial and ethnic groups; the prevalence of menthol cigarette use among adults who smoke increased especially among Mexican American adults, younger adults, and adults who reported fair to poor health status.

RAF inhibitors that evade paradoxical MAPK pathway activation.

Oncogenic activation of BRAF fuels cancer growth by constitutively promoting RAS-independent mitogen-activated protein kinase (MAPK) pathway signalling. Accordingly, RAF inhibitors have brought substantially improved personalized treatment of metastatic melanoma. However, these targeted agents have also revealed an unexpected consequence: stimulated growth of certain cancers. Structurally diverse ATP-competitive RAF inhibitors can either inhibit or paradoxically activate the MAPK pathway, depending whether activation is by BRAF mutation or by an upstream event, such as RAS mutation or receptor tyrosine kinase activation. Here we have identified next-generation RAF inhibitors (dubbed 'paradox breakers') that suppress mutant BRAF cells without activating the MAPK pathway in cells bearing upstream activation. In cells that express the same HRAS mutation prevalent in squamous tumours from patients treated with RAF inhibitors, the first-generation RAF inhibitor vemurafenib stimulated in vitro and in vivo growth and induced expression of MAPK pathway response genes; by contrast the paradox breakers PLX7904 and PLX8394 had no effect. Paradox breakers also overcame several known mechanisms of resistance to first-generation RAF inhibitors. Dissociating MAPK pathway inhibition from paradoxical activation might yield both improved safety and more durable efficacy than first-generation RAF inhibitors, a concept currently undergoing human clinical evaluation with PLX8394.

Reasons for Electronic Cigarette Use Among Middle and High School Students - National Youth Tobacco Survey, United States, 2016.

Electronic cigarettes (e-cigarettes) were the most commonly used tobacco product among U.S. middle school and high school students in 2016 (1). CDC and the Food and Drug Administration (FDA) analyzed data from the 2016 National Youth Tobacco Survey (NYTS) to assess self-reported reasons for e-cigarette use among U.S. middle school (grades 6-8) and high school (grades 9-12) student e-cigarette users. Among students who reported ever using e-cigarettes in 2016, the most commonly selected reasons for use were 1) use by "friend or family member" (39.0%); 2) availability of "flavors such as mint, candy, fruit, or chocolate" (31.0%); and 3) the belief that "they are less harmful than other forms of tobacco such as cigarettes" (17.1%). The least commonly selected reasons were 1) "they are easier to get than other tobacco products, such as cigarettes" (4.8%); 2) "they cost less than other tobacco products such as cigarettes" (3.2%); and 3) "famous people on TV or in movies use them" (1.5%). Availability of flavors as a reason for use was more commonly selected by high school users (32.3%) than by middle school users (26.8%). Efforts to prevent middle school and high school students from initiating the use of any tobacco product, including e-cigarettes, are important to reduce tobacco product use among U.S. youths (2).

Exposure to Secondhand Smoke Among Nonsmokers - United States, 1988-2014.

Exposure to secondhand smoke from burning tobacco products can cause sudden infant death syndrome, respiratory infections, ear infections, and asthma attacks in infants and children, and coronary heart disease, stroke, and lung cancer in adult nonsmokers (1). There is no risk-free level of secondhand smoke exposure (2). CDC analyzed questionnaire and laboratory data from the National Health and Nutrition Examination Survey (NHANES) to assess patterns of secondhand smoke exposure among U.S. nonsmokers. The prevalence of secondhand smoke exposure among U.S. nonsmokers declined substantially during 1988-2014, from 87.5% to 25.2%. However, no change in exposure occurred between 2011-2012 and 2013-2014, and an estimated one in four nonsmokers, or approximately 58 million persons, were still exposed to secondhand smoke during 2013-2014. Moreover, marked disparities persisted across population groups. Exposure prevalence was highest among nonsmokers aged 3-11 years (37.9%), non-Hispanic blacks (50.3%), and those who were living in poverty (47.9%), in rental housing (38.6%), or with someone who smoked inside the home (73.0%), or among persons who had less than a high school education (30.7%). Comprehensive smoke-free laws and policies for workplaces and public places and smoke-free rules for homes and vehicles can further reduce secondhand smoke exposure among all nonsmokers.

Use of subconjunctival injections of 5-fluorouracil to rescue and prolong intraocular pressure reduction for a failing Ahmed glaucoma implant.

PURPOSE: 5-Fluorouracil (5-FU) has been well described for a failing trabeculectomy bleb, but not for aqueous shunts. We sought to determine whether subconjunctival 5-FU prolongs the intraocular pressure (IOP) efficacy of Ahmed shunts. METHODS: We included all patients with Ahmed FP-7 implantation by one surgeon at Yale University. Patients with <3 months follow-up were excluded. Injections were done on a case-by-case basis, usually for IOP > 21 on >2 medications. Five-milligram (0.1 cc) injections were made over the plate. The control group consisted of Ahmed FP-7 patients without injections. The main outcome measure was IOP. Secondary outcome was success (IOP <21 mmHg, 20% decrease from preoperative IOP, and no reoperation). RESULTS: The average age of controls was 72.5 ± 16.6 years, and 63.7 ± 18.8 with 5-FU (p = 0.02). Forty-four patients received 5-FU and 45 did not. Mean preoperative IOP in controls was 31.5 ± 11 mmHg on 3.1 ± 1 medications, and 31.9 ± 9.0 mmHg (p = 0.86) on 3.3 ± 0.9 medications with 5-FU (p = 0.18). At a mean 137 days after surgery, mean pre-injection IOP was 25.3 ± 7.7 mmHg on 2.0 ± 1.3 medications. Five years following implantation, control IOPs averaged 12.9 ± 7.1 mmHg (53% decrease from preoperative IOP, p < 0.001) on 1.4 ± 1.1 medications versus 17.2 ± 4.9 mmHg (46% decrease from preoperative, 32% decrease from pre-5FU IOP, p < 0.001) on 2.7 ± 0.8 medications with 5-FU. The IOP at 5 years was statistically similar in both groups (p = 0.23). Five-year success rates trended higher with 5-FU (77 vs. 67%, p = 0.38). CONCLUSIONS: Subconjunctival injection of 5-FU sustained a significant long-term decline in intraocular pressures in eyes with failing Ahmed shunts. Outcomes between eyes receiving injections and controls were statistically similar.

Novel Pharmacologic Candidates for Treatment of Primary Open-Angle Glaucoma.

Primary open-angle glaucoma (OAG) affects approximately 45 million people worldwide and more than 2.5 million people aged 40 years or older in the United States. Pharmacologic treatment for glaucoma is directed towards lowering intraocular pressure (IOP) to slow disease progression and delay visual field loss. Current medical treatment options for the lowering of IOP include the following classes of topical medications: beta-adrenergic antagonists, alpha-adrenergic agonists, cholinergic agonists, carbonic anhydrase inhibitors, and prostaglandin analogs. Issues with existing drugs include failure to achieve target IOP with monotherapy, drug-related side effects, and low patient compliance with multiple daily administration of eye drops. In recent years, the scientific and medical community has seen encouraging development of novel classes of drugs for primary OAG, the majority of which lower IOP by targeting the trabecular meshwork outflow pathway to increase aqueous humor outflow. Among the most promising new pharmacologic candidates are rho kinase inhibitors including ripasudil (K-115), netarsudil (AR-13324), and AMA0076; adenosine receptor agonists including trabodenoson (INO-8875); and modified prostaglandin analogs including latanoprostene bunod (LBN, BOL-303259-X) and ONO-9054. This study aims to systematically review and summarize the most recent developments in clinical trials for new pharmacologic options for the treatment of primary open-angle glaucoma.

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.

PURPOSE: To compare 2 frequently used aqueous shunts for the treatment of glaucoma. DESIGN: International, multicenter, randomized trial. PARTICIPANTS: Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. METHODS: Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. RESULTS: A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. CONCLUSIONS: Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.

Clinical efficacy of a RAF inhibitor needs broad target blockade in BRAF-mutant melanoma.

B-RAF is the most frequently mutated protein kinase in human cancers. The finding that oncogenic mutations in BRAF are common in melanoma, followed by the demonstration that these tumours are dependent on the RAF/MEK/ERK pathway, offered hope that inhibition of B-RAF kinase activity could benefit melanoma patients. Herein, we describe the structure-guided discovery of PLX4032 (RG7204), a potent inhibitor of oncogenic B-RAF kinase activity. Preclinical experiments demonstrated that PLX4032 selectively blocked the RAF/MEK/ERK pathway in BRAF mutant cells and caused regression of BRAF mutant xenografts. Toxicology studies confirmed a wide safety margin consistent with the high degree of selectivity, enabling Phase 1 clinical trials using a crystalline formulation of PLX4032 (ref. 5). In a subset of melanoma patients, pathway inhibition was monitored in paired biopsy specimens collected before treatment initiation and following two weeks of treatment. This analysis revealed substantial inhibition of ERK phosphorylation, yet clinical evaluation did not show tumour regressions. At higher drug exposures afforded by a new amorphous drug formulation, greater than 80% inhibition of ERK phosphorylation in the tumours of patients correlated with clinical response. Indeed, the Phase 1 clinical data revealed a remarkably high 81% response rate in metastatic melanoma patients treated at an oral dose of 960 mg twice daily. These data demonstrate that BRAF-mutant melanomas are highly dependent on B-RAF kinase activity.

The Relationship between Medicare Payment and Service Volume for Retina Procedures from 2005 through 2009.

PURPOSE: To calculate the relationship between Medicare payment and service volume for the 3 highest-volume retina procedures: intravitreal injection (Current Procedural Terminology [CPT] code 67028), laser treatment for retinal edema (CPT code 67210), and laser treatment for proliferative retinopathy (CPT code 67228). DESIGN: Retrospective, longitudinal database study. PARTICIPANTS: One hundred percent dataset of all retina procedures performed on Medicare Part B beneficiaries within the United States from 2005 through 2009. METHODS: Fixed-effects regression model using Medicare Part B carrier data for all 50 states and the District of Columbia, controlling for time-invariant carrier-specific characteristics, national trends in service volume, Medicare beneficiary population, number of ophthalmologists, and income per capita. MAIN OUTCOME MEASURES: Medicare payment-service volume elasticities, defined as the percent change in service volume per 1% change in Medicare payment, for intravitreal injection, laser treatment for retinal edema, and laser treatment for proliferative retinopathy. RESULTS: For all 3 retina procedures, the regression coefficients representing the Medicare payment-service volume elasticity were nonsignificant: intravitreal injection elasticity, -0.75 (95% confidence interval [CI], -1.62 to 0.13; P = 0.09); laser treatment for retinal edema elasticity, 0.14 (95% CI, -0.38 to 0.65; P = 0.59); and laser treatment for proliferative retinopathy elasticity, 0.05 (95% CI, -0.26 to 0.35; P = 0.77). CONCLUSIONS: This study found no evidence suggesting that there is an association between Medicare payment and service volume for the 3 highest-volume retina procedures from 2005 through 2009.

A Quantitative Analysis of the Relationship between Medicare Payment and Service Volume for Glaucoma Procedures from 2005 through 2009.

PURPOSE: To calculate the association between Medicare payment and service volume for 6 commonly performed glaucoma procedures. DESIGN: Retrospective, longitudinal database study. SUBJECTS: A 100% dataset of all glaucoma procedures performed on Medicare Part B beneficiaries within the United States from 2005 to 2009. METHODS: Fixed-effects regression model using Medicare Part B carrier data for all 50 states and the District of Columbia, controlling for time-invariant carrier-specific characteristics, national trends in glaucoma service volume, Medicare beneficiary population, number of ophthalmologists, and income per capita. MAIN OUTCOME MEASURES: Payment-volume elasticities, defined as the percent change in service volume per 1% change in Medicare payment, for laser trabeculoplasty (Current Procedural Terminology [CPT] code 65855), trabeculectomy without previous surgery (CPT code 66170), trabeculectomy with previous surgery (CPT code 66172), aqueous shunt to reservoir (CPT code 66180), laser iridotomy (CPT code 66761), and scleral reinforcement with graft (CPT code 67255). RESULTS: The payment-volume elasticity was nonsignificant for 4 of 6 procedures studied: laser trabeculoplasty (elasticity, -0.27; 95% confidence interval [CI], -1.31 to 0.77; P = 0.61), trabeculectomy without previous surgery (elasticity, -0.42; 95% CI, -0.85 to 0.01; P = 0.053), trabeculectomy with previous surgery (elasticity, -0.28; 95% CI, -0.83 to 0.28; P = 0.32), and aqueous shunt to reservoir (elasticity, -0.47; 95% CI, -3.32 to 2.37; P = 0.74). Two procedures yielded significant associations between Medicare payment and service volume. For laser iridotomy, the payment-volume elasticity was -1.06 (95% CI, -1.39 to -0.72; P < 0.001): for every 1% decrease in CPT code 66761 payment, laser iridotomy service volume increased by 1.06%. For scleral reinforcement with graft, the payment-volume elasticity was -2.92 (95% CI, -5.72 to -0.12; P = 0.041): for every 1% decrease in CPT code 67255 payment, scleral reinforcement with graft service volume increased by 2.92%. CONCLUSIONS: This study calculated the association between Medicare payment and service volume for 6 commonly performed glaucoma procedures and found varying magnitudes of payment-volume elasticities, suggesting that the volume response to changes in Medicare payments, if present, is not uniform across all Medicare procedures.

Healthcare burden of venous thromboembolism in childhood chronic renal diseases.

BACKGROUND: Chronic renal diseases (CRD) are associated with approximately 5% of pediatric venous thromboembolism (VTE) cases, but the epidemiology of VTE in CRD is ill-defined. METHODS: Children (<18 years) with CRD were identified from MarketScan® Research databases. The VTE status of subjects with CRD who qualified for this study was ascertained during the 6 months following the initial diagnosis of CRD. Demographics, healthcare utilization, mortality, and co-morbid conditions were assessed. RESULTS: A total of 22,877 children with predefined CRD ICD-9-CM codes were identified between April 1, 2003 and June 30, 2012, among whom 0.55% had VTE. Our analysis revealed that in-hospital mortality was more likely in children with VTE than in those without VTE (11.9 vs. 0.9%, respectively; p < 0.0001). The usage of healthcare facilities, based on the number of inpatient admissions, length of stay, outpatient visits, and pharmaceutical claims, was also significantly higher in patients with VTE than in those without (p < 0.0001). Total mean healthcare expenditures for the 6-month follow-up period were 13-fold greater in the VTE group than in the group without VTE ($338,338 ± $544,045 vs. $25,171 ± $90,792; p < 0.0001). In a multivariate model, infection, hemodialysis, and trauma/surgery significantly increased the likelihood of VTE. CONCLUSIONS: Venous thromboembolism is rare in children with CRD, but it is associated with higher mortality and healthcare utilization when present. Among the children with CRD enrolled in our study, the likelihood of VTE was increased among those with co-morbid, non-renal chronic conditions.

Providing prescheduled appointments as a strategy for improving follow-up compliance after community-based glaucoma screening: results from an urban underserved population.

To determine if receiving a prescheduled appointment is associated with an increased likelihood of complying with follow-up eye care among individuals identified as at risk for glaucoma during community-based glaucoma screening in an urban underserved population. This study sampled 362 individuals aged ≥30 years without known glaucoma from low-income, predominantly black/Hispanic neighborhoods in New Haven, Connecticut presenting to one of twelve community-based glaucoma screening events from May 2010 to October 2012. A quasi-experimental design systematically assigned 63 individuals identified as at risk for glaucoma into either intervention or control group with a 1:2 ratio. Individuals in the control group (n = 41) received counseling on glaucoma and a recommendation for obtaining a follow-up appointment at the eye department of a local community health center, which offers affordable health services with income-adjusted fee discounts to uninsured, low-income patients. Those in the intervention group (n = 22) received the same counseling and a prescheduled appointment at the community health center. The overall rate of follow-up compliance within 3 months of screening was 30 % (41 % in the intervention group; 24 % in the control group). Multivariate logistic regression analysis adjusting for sex, age, ethnicity, health insurance status, car access, living situation, and smoking status found that follow-up compliance was significantly associated with intervention (adjusted odds ratio 4.8; 95 % confidence interval 1.1-20.9). Providing prescheduled appointments can improve follow-up compliance after community-based glaucoma screening. This finding may be potentially applicable to community-based health screening for other preventable diseases.

Risk of venous thromboembolism among hospitalizations of adults with selected autoimmune diseases.

Previous research has suggested autoimmune diseases are risk factors for developing venous thromboembolism (VTE). We assessed whether having diagnoses of selected autoimmune diseases associated with antiphospholipid antibodies--autoimmune hemolytic anemia (AIHA), immune thrombocytopenic purpura (ITP), rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE)--were associated with having a VTE diagnosis among US adult hospitalizations. A cross-sectional study was conducted using the 2010 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality. VTE and autoimmune diseases were identified using International Classification of Diseases, Ninth Revision, Clinical Modification coded diagnoses information. The percentages of hospitalizations with a VTE diagnosis among all non-maternal adult hospitalizations without any of the four autoimmune diseases of interest and among those with AIHA, ITP, RA, and SLE diagnoses were 2.28, 4.46, 3.35, 2.65 and 2.77%, respectively. The adjusted odds ratios (OR) for having a diagnosis of VTE among non-maternal adult hospitalizations with diagnoses of AIHA, ITP, RA, and SLE were 1.25 [95% confidence interval (CI) 1.05-1.49], 1.20 (95% CI 1.07-1.34), 1.17 (95% CI 1.13-1.21), and 1.23 (95% CI 1.15-1.32), respectively, when compared to those without the corresponding conditions. The adjusted OR for a diagnosis of VTE associated with a diagnosis of any of the four autoimmune diseases was 1.20 (95% CI 1.16-1.24). The presence of a diagnosis of AIHA, ITP, RA, and SLE was associated with an increased likelihood of having a VTE diagnosis among the group of all non-maternal adult hospitalizations.

HIPAA for physicians in the information age.

The increased prominence of electronic health records, email, mobile devices, and social media has transformed the health care environment by providing both physicians and patients with opportunities for rapid communication and knowledge exchange. However, these technological advances require increased attention to patient privacy under the Health Insurance Portability and Accountability Act (HIPAA). Instant access to large amounts of electronic protected health information (PHI) merits the highest standard of network security and HIPAA training for all staff members. Physicians are responsible for protecting PHI stored on portable devices. Personal, residential, and public wireless connections are not certified with HIPAA-compliant Business Associate Agreements and are unsuitablefor PHI. A professional and privacy-oriented approach to electronic communication, online activity, and social media is imperative to maintaining public trust in physician integrity. As new technologies are integrated into health care practice, the assurance of privacy will encourage patients to continue to seek medical care.

The Ahmed versus Baerveldt study: three-year treatment outcomes.

OBJECTIVE: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. DESIGN: International, multicenter, randomized trial. PARTICIPANTS: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. METHODS: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. RESULTS: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P< 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. CONCLUSIONS: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications.

Clustering patterns of comorbidities associated with in-hospital death in hospitalizations of US adults with venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) is a significant source of mortality, morbidity, disability, and impaired health-related quality of life in the world. OBJECTIVE: We aimed to evaluate the clustering patterns and associations of 29 comorbidities with in-hospital death among adult hospitalizations with a diagnosis of VTE in the United States by analyzing data from the 2009 Nationwide Inpatient Sample. METHODS: This cross-sectional study included 153,124 adult hospitalizations with a diagnosis of VTE. Adjusted rate ratios and 95% confidence intervals (CI) for in-hospital death were generated by using multivariable log-linear regression models to measure independent associations between comorbidities and in-hospital death. RESULTS: We estimated that 44,200 in-hospital deaths occurred in 2009 among 773,273 US adult hospitalizations with a diagnosis of VTE. Subgroups of hospitalizations with comorbidities of "congestive heart failure," "chronic pulmonary disease," "coagulopathy," "liver disease," "lymphoma," "fluid and electrolyte disorders," "metastatic cancer," "peripheral vascular disorders," "pulmonary circulation disorders," "renal failure," "solid tumor without metastasis," or "weight loss" were positively and independently associated with 1.07 (95% CI: 1.02-1.12 ) to 2.06 (95% CI: 1.97-2.16) times increased likelihoods of in-hospital death, when compared to those without the corresponding comorbidities. The clustering patterns of these comorbidities by 4 disease categories (i.e., "cancer," "cardiovascular/respiratory/blood," "gastrointestinal/urologic," and "nutritional/bodyweight") were associated with 2.74 to 10.28 times increased likelihoods of in-hospital death, as compared to hospitalizations without any of these comorbidities. The overall increase in the cumulative number of comorbidities corresponded to significantly elevated risks (P-trend<0.01) for in-hospital death among hospitalizations with a diagnosis of VTE. CONCLUSION: The presence of multiple comorbidities is ubiquitous among hospitalizations of adults with VTE and among in-hospital deaths with VTE in the United States. The findings of our study further suggest that, among hospitalizations of adults with VTE, the presence of certain comorbidities or clustering of these comorbidities significantly elevates the risk of in-hospital death.

Clinicopathologic correlation of disc and peripapillary region using SD-OCT.

PURPOSE: To describe a technique for evaluating peripapillary and optic nerve head (ONH) anatomy using spectral domain optical coherence tomography (SD-OCT) raster scanning in humans and compare quantifiable parameters between diagnosis categories. METHODS: Ninety-five eyes of 51 consecutive patients were evaluated in this retrospective cross-sectional pilot study. Cirrus 5-line raster SD-OCTs with a resolution of 5 to 15 µm obtained through the ONH were included. A single observer manually measured neural canal opening (NCO), prelaminar canal depth (PLCD), peripapillary choroidal thickness (PPCT), and canal nerve fiber layer (CNFL) in normals, ocular hypertension, primary open-angle glaucoma (POAG), low-pressure glaucoma (LPG), secondary glaucoma, and early atrophic age-related macular degeneration. Clinical information, including central corneal thickness (CCT), was obtained via medical record review. Mean anatomical values within diagnosis categories were compared using one-way analysis of variance and multivariate analysis. Bivariate analysis was used to investigate relationships between continuous variables, and significant (p < 0.05) relationships were incorporated into the final statistical model. RESULTS: Horizontal NCO was significantly greater in eyes with LPG than that in normals (p = 0.021). The PPCT was thinner in age-related macular degeneration (p = 0.001) and glaucoma (p = 0.004) compared with that in controls (normals). Mean CNFL was thinner in POAG (p < 0.001) and LPG (p = 0.053) compared with that in normals. Vertical NCO was inversely correlated to CCT (p = 0.013). Multivariate analysis indicated a positive correlation between PLCD and PPCT (p = 0.008) and an inverse correlation between CNFL and PLCD (p < 0.001). Controlling for PPCT, PLCD and CCT were inversely correlated (p < 0.001). CONCLUSIONS: The SD-OCT raster scanning may be used to quantify ONH anatomy in humans. The NCO differences between POAG and LPG may indicate a distinct structural vulnerability in LPG. In addition, CNFL, PPCT, and PLCD may be important parameters to consider in glaucoma. The PLCD correlates with PPCT and should be considered in new models of glaucoma pathogenesis.