International longitudinal registry of patients with atrial fibrillation and treated with rivaroxaban: RIVaroxaban Evaluation in Real life setting (RIVER)

Background Real-world data on non-vitamin K oral anticoagulants (NOACs) are essential in determining whether evidence from randomised controlled clinical trials translate into meaningful clinical benefits for patients in everyday practice. RIVER (RIVaroxaban Evaluation in Real life setting) is an ongoing international, prospective registry of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) and at least one investigator-determined risk factor for stroke who received rivaroxaban as an initial treatment for the prevention of thromboembolic stroke. The aim of this paper is to describe the design of the RIVER registry and baseline characteristics of patients with newly diagnosed NVAF who received rivaroxaban as an initial treatment. Methods and results Between January 2014 and June 2017, RIVER investigators recruited 5072 patients at 309 centres in 17 countries. The aim was to enroll consecutive patients at sites where rivaroxaban was already routinely prescribed for stroke prevention. Each patient is being followed up prospectively for a minimum of 2-years. The registry will capture data on the rate and nature of all thromboembolic events (stroke / systemic embolism), bleeding complications, all-cause mortality and other major cardiovascular events as they occur. Data quality is assured through a combination of remote electronic monitoring and onsite monitoring (including source data verification in 10% of cases). Patients were mostly enrolled by cardiologists (n = 3776, 74.6%), by internal medicine specialists 14.2% (n = 718) and by primary care/general practice physicians 8.2% (n = 417). The mean (SD) age of the population was 69.5 (11.0) years, 44.3% were women. Mean (SD) CHADS2 score was 1.9 (1.2) and CHA2DS2-VASc scores was 3.2 (1.6). Almost all patients (98.5%) were prescribed with once daily dose of rivaroxaban, most commonly 20 mg (76.5%) and 15 mg (20.0%) as their initial treatment; 17.9% of patients received concomitant antiplatelet therapy. Most patients enrolled in RIVER met the recommended threshold for AC therapy (86.6% for 2012 ESC Guidelines, and 79.8% of patients according to 2016 ESC Guidelines). Conclusions The RIVER prospective registry will expand our knowledge of how rivaroxaban is prescribed in everyday practice and whether evidence from clinical trials can be translated to the broader cross-section of patients in the real world

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease

BACKGROUND: The cholesteryl ester transfer protein inhibitor evacetrapib substantially raises the high-density lipoprotein (HDL) cholesterol level, reduces the low-density lipoprotein (LDL) cholesterol level, and enhances cellular cholesterol efflux capacity. We sought to determine the effect of evacetrapib on major adverse cardiovascular outcomes in patients with high-risk vascular disease. METHODS: In a multicenter, randomized, double-blind, placebo-controlled phase 3 trial, we enrolled 12,092 patients who had at least one of the following conditions: an acute coronary syndrome within the previous 30 to 365 days, cerebrovascular atherosclerotic disease, peripheral vascular arterial disease, or diabetes mellitus with coronary artery disease. Patients were randomly assigned to receive either evacetrapib at a dose of 130 mg or matching placebo, administered daily, in addition to standard medical therapy. The primary efficacy end point was the first occurrence of any component of the composite of death from cardiovascular causes, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina. RESULTS: At 3 months, a 31.1% decrease in the mean LDL cholesterol level was observed with evacetrapib versus a 6.0% increase with placebo, and a 133.2% increase in the mean HDL cholesterol level was seen with evacetrapib versus a 1.6% increase with placebo. After 1363 of the planned 1670 primary end-point events had occurred, the data and safety monitoring board recommended that the trial be terminated early because of a lack of efficacy. After a median of 26 months of evacetrapib or placebo, a primary end-point event occurred in 12.9% of the patients in the evacetrapib group and in 12.8% of those in the placebo group (hazard ratio, 1.01; 95% confidence interval, 0.91 to 1.11; P=0.91). CONCLUSIONS: Although the cholesteryl ester transfer protein inhibitor evacetrapib had favorable effects on established lipid biomarkers, treatment with evacetrapib did not result in a lower rate of cardiovascular events than placebo among patients with high-risk vascular disease. (Funded by Eli Lilly; ACCELERATE ClinicalTrials.gov number, NCT01687998 .)

Painful ophthalmoplegia manifesting with third nerve palsy in childhood [Çocukluk ça?ında üçüncü sinir felci i?le seyreden a?rılı oftalmopleji]

The causes of painful ophthalmoplegia that manifests with third nerve palsy in childhood include postinfectious third nerve palsy, compressive lesions, vascular anomalies and ophthalmoplegic migraine. Ophthalmoplegic migraine is a rare pathology in the literature and is characterized by recurrent attacks of headache and ophthalmoplegia that usually begins during childhood. Ophtalmoplegia occurs due to paresis or paralysis of cranial nerves 3, 4 or 6. Attacks may last a few hours to weeks and usually are recovered with appropriate therapy, but some cases may demonstrate permanent defects. In this paper, we discuss the case of an 11-year-old patient, who was admitted to our outpatient clinic with the complaints of right ptosis, mydriasis and severe headache. Ophthalmologic examination revealed oculomotor nerve palsy, the patient was diagnosed as having ophthalmoplegic migraine and medical treatment was started. Her complaints have regressed with medication for migraine and recovered completely in 8 weeks. In this case report, painful ophthalmoplegia during childhood and its possible causes are discussed

Application and our clinical results of low vision aids [Az Görenlere Yardim Cihazi Uygulamalari ve Klinik Sonuçlarimiz]

Objective: To evaluate the results of low vision aids (LVAs) in low vision patients with various reasons. Material and Methods: Forty-eight patients with low vision in whom visual acuity could not be improved with standart optical corrections were evaluated at neuroophthalmology section of our clinic between January 2010-January 2011. Best corrected visual acuity was measured with Snellen chart for distance, and with Jaeger for near. Patients were examined with high spheric lenses and Eschenbach LVAs for distance and near. Results: Low vision aids were applied to twenty-five cases for near, to six cases for distance, and to three cases for both near and distance. The success rate was 73.7% (twenty-eight out of thirty-eight patients) for near examination and 56.25% (nine out of sixteen patients) for distance. Conclusion: Low vision aids are effective optic systems in low vision patients. LVAs should be tried in all patients with low visual acuity to improve quality of life

The effect of intravitreal bevacizumab and ranibizumab on macular edema of the contralateral eye: A comparative study of two anti-VEGFs

Purpose: To compare the effects of bevacizumab and ranibizumab on the visual function and macular thickness in the contralateral (untreated) eye of patients with bilateral diabetic macular edema (DME). Materials and Methods: Thirty-nine patients with bilateral DME, who had been treated with both bevacizumab and ranibizumab in the same eye, were considered retrospectively for this study. Recorded outcome measurements included the best-corrected visual acuity (BCVA) assessment with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and the central subfield macular thickness (CSMT) measurement of the contralateral, uninjected eye before and at 4 weeks after the injections. Results: The median BCVA of the uninjected eye was 50 ETDRS letters and the median CSMT was 459 ?m preceding the bevacizumab injection whereas at the control appointment, 4 weeks after the injection, the median BCVA had increased to 52 letters (P = 0.098), and the median CSMT had decreased to 390 ?m (P = 0.036). The mean interval between the bevacizumab and ranibizumab treatments was 4.79 1.52 months. The measurements of the untreated eye after the ranibizumab treatment showed that the median BCVA decreased from 55 to 52 letters, and the median CSMT increased from 361 ?m to 418 ?m (P = 0.148 and P = 0.109, respectively). Conclusions: In contrast to ranibizumab, the intravitreal administration of bevacizumab resulted in a statistically significant decrease in macular thickness in the untreated eye in patients with bilateral DME. © 2016 Oman Ophthalmic Society | Published by Wolters Kluwer Medknow

Clinical imaging of a case with optic disc melanocytoma [Optik disk melanositomlu bir olguda klinik görüntüleme]

Melanocytoma is usually a stable and benign lesion that may be localized deep in the optic disc. Histological examination reveals uniformly distributed round or oval polyhedral nevus cells containing giant melanosomes(macromelanosom). Although visual acuity is not disturbed in most cases, some visual deterioration or rarely malign transformation has also been reported. These patients should be examined once a year and the follow up examination should include fundus photography, and if indicated visual field examination and retinal nerve fiber thickness measurement. In this study, we discuss a 45 years old female patient presenting with the complaint of difficulty in near vision, whose biomicroscopic examination revaled a dark pigmented lesion on the right optic disc

Anatomic and functional results of macular hole surgery with silicone oil tamponade

Purpose: To review the anatomical and visual outcomes in patients who underwent macular hole surgery with silicone oil tamponade. Materials and Methods: A retrospective review of 21 patients who had undergone macular holes surgery with silicone oil tamponade was conducted The primary outcome variables include best-corrected visual acuity (BCVA) in Early Treatment of Diabetic Retinopathy Study (ETDRS) letters and optical coherence tomography changes in eyes with a macular hole after the surgery. Results: The median age of 21 patients was 58.32 years. Thirteen patients had Stage 3 macular holes and eight patients had Stage 4 macular holes. Anatomical closure rate was achieved in 90.4% (19/21) of all patients. The median preoperative BCVA was 31.2 ETDRS letters (range: 13-52 letters), which increased to 42.9 ETDRS letters (range: 27-74 letters), six weeks following the removal of the silicone oil. Conclusion: Our study with 21 patients indicates that the use of silicone oil tamponade in macular hole surgery showed satisfactory anatomical and functional outcomes. As an alternative to gas tamponade, silicone oil can be used for primary macular hole surgery in patients that are unable to position themselves in a face-down posture after surgery

Spontaneous closure of macular hole induced by accidental Nd: YAG laser injury

The natural history of Neodymium:yttrium aluminum garnet (Nd:YAG) laser-induced macular holes remains uncertain because this type of injury is uncommon. A 47 years old male physicist with the diagnosis of macular hole induced by accidental Nd:YAG laser injury was followed-up. The size of the macular hole decreased and vitreous hemorrhage resolved spontaneously. Accidental exposure to high-energy Nd:YAG laser may lead to concussive retinal damage and create a macular hole. Laser-induced macular holes can resolve spontaneously. The presence of an epiretinal membrane and the size of the macular hole are the common ocular signs that seem to affect the natural course of laser-induced macular holes