901-97 Stroke and Long-term Anticoagulant Therapy in 3404 Post-Myocardial Infarction Patients

In a randomized, double-blind, placebo controlled trial (ASPECT) we studied 3404 post-myocardial infarction patients who suffered a stroke during long-term anticoagulant therapy. The duration of treatment ranged from 1 day to six years. Three years following randomization, 2% of the patients on anticoagulant therapy had a stroke compared to 4% in placebo.The incidence of stroke analyzed on “intention-to-treat” was 0.7 per 100 patient-years in the anticoagulant group and 1.2 per 100 patient-years in placebo, a hazard ratio (HR) of 0.60 with a 95% confidence interval (Cl) of 0.40 to 0.90, a 40% reduction in the risk of stroke in the anticoagulated group. A total of 19 intracranial bleeding was observed. The risk of hemorrhages was 8 times greater for anticoagulated patients compared to placebo. Eight of the 17 bleedings were fatal in the anticoagulant group and no fatal hemorrhages occurred in placebo. A total of 15 cerebral infarctions occurred in the anticoagulated group and 43 in placebo. Of the 14 hemorrhagic strokes, 6 were within INR 3.0–4.0 and 8 with an INR>4.0, Of the 7 non-hemorrhagic strokes, 2 were at INR<2, 3 within INR 3.0–4.0, 1 at INR>4.0, and no measurement was available in one patient. The total number of patients who died or were severely disabled as a result of cerebral stroke amounted to 13 in the anticoagulated group, compared to 18 in placebo.ConclusionThe results of the ASPECT trial indicated that long-term anticoagulant therapy substantially reduced the risk of stroke in post-myocardial infarction patients. The increased risk of bleeding complications associated with anticoagulant therapy was offset by a marked reduction in ischemic events

Ocular and adnexal anomalies in craniofacial microsomia: a systematic review

Ocular anomalies may occur in craniofacial microsomia (CFM). The aim of this systematic review was to review the literature on ocular anomalies and their incidence, in order to estimate the need for ophthalmological screening in CFM patients. Online databases were searched, and data on the number of patients, type and incidence of ocular anomalies, and visual acuity were extracted. Four subgroups of ocular and adnexal anomalies were identified, to provide an overview of the different anomalies. Twenty-five papers analysing 1419 patients in total were included. Ocular anomalies were documented in 6.7–100% of patients. The most reported type I ocular anomalies were eyelid coloboma, lipodermoids, and orbital dystopia. The most reported type II ocular anomalies were epibulbar dermoid, microphthalmia, and anophthalmia. Ptosis

Controlled safety study of a hemoglobin-based oxygen carrier, DCLHb, in acute ischemic stroke

BACKGROUND AND PURPOSE: Diaspirin cross-linked hemoglobin (DCLHb) is a purified, cell-free human hemoglobin solution. In animal stroke models its use led to a significant reduction in the extent of brain injury. The primary objective of this study was to evaluate the safety of DCLHb in patients with acute ischemic stroke. METHODS: DCLHb or saline was administered to 85 patients with acute ischemic stroke in the anterior circulation, within 18 hours of onset of symptoms, in a multicenter, randomized, single-blind, dose-finding, controlled safety trial, consisting of 3 parts: 12 doses of 25, 50, and 100 mg/kg DCLHb over 72 hours. RESULTS: DCLHb caused a rapid rise in mean arterial blood pressure. The pressor effect was not accompanied by complications or excessive need for antihypertensive treatment. Two patients in the 100 mg/kg group had adverse events that were possibly drug related: one suffered fatal brain and pulmonary edema, the other transient renal and pancreatic insufficiency. Multivariate logistic regression analysis showed that a severe stroke at baseline and treatment with DCLHb (OR, 4.0; CI, 1.4 to 12.0) were independent predictors of a worse outcome (Rankin Scale score of 3 to 6) at 3 months. CONCLUSIONS: Outcome scale scores were worse in the DCLHb group, and more serious adverse events and deaths occurred in DCLHb-treated patients than in control patients. We recommend that additional safety studies be performed, preferably with a second generation, genetically engineered hemoglobin

Microstructural brain injury in post-concussion syndrome after minor head injury

Introduction: After minor head injury (MHI), post-concussive symptoms commonly occur. The purpose of this study was to correlate the severity of post-concussive symptoms in MHI patients with MRI measures of microstructural brain injury, namely mean diffusivity (MD) and fractional anisotropy (FA), as well as the presence of microhaemorrhages. Methods: Twenty MHI patients and 12 healthy controls were scanned at 3 T using diffusion tensor imaging (DTI) and high-resolution gradient recalled echo (HRGRE) T2*-weighted sequences. One patient was excluded from the analysis because of bilateral subdural haematomas. DTI data were preprocessed using Tract Based Spatial Statistics. The resulting MD and FA images were correlated with the severity of post-concussive symptoms evaluated with the Rivermead Postconcussion Symptoms Questionnaire. The number and location of microhaemorrhages were assessed on the HRGRE T2*-weighted images. Results: Comparing patients with controls, there were no differences in MD. FA was decreased in the right temporal subcortical white matter. MD was increased in association with the severity of post-concussive symptoms in the inferior fronto-occipital fasciculus (IFO), the inferior longitudinal fasciculus and the superior longitudinal fasciculus. FA was reduced in association with the severity of post-concussive symptoms in the uncinate fasciculus, the IFO, the internal capsule and the corpus callosum, as well as in the parietal and frontal subcortical white matter. Microhaemorrhages were observed in one patient only. Conclusions: The severity of post-concussive symptoms after MHI was significantly correlated with a reduction of white matter integrity, providing evidence of microstructural brain injury as a neuropathological substrate of the post-concussion syndrome

Patterns in the Use of Heart Failure Telemonitoring:Post Hoc Analysis of the e-Vita Heart Failure Trial

Background: Research on the use of home telemonitoring data and adherence to it can provide new insights into telemonitoring for the daily management of patients with heart failure (HF). Objective: We described the use of a telemonitoring platform—including remote patient monitoring of blood pressure, pulse, and weight—and the use of the electronic personal health record. Patient characteristics were assessed in both adherent and nonadherent patients to weight transmissions. Methods: We used the data of the e-Vita HF study, a 3-arm parallel randomized trial performed in stable patients with HF managed in outpatient clinics in the Netherlands. In this study, data were analyzed from the participants in the intervention arm (ie, e-Vita HF platform). Adherence to weight transmissions was defined as transmitting weight ≥3 times per week for at least 42 weeks during a year. Results: Data from 150 patients (mean age 67, SD 11 years; n=37, 25% female; n=123, 82% self-assessed New York Heart Association class I-II) were analyzed. One-year adherence to weight transmissions was 74% (n=111). Patients adherent to weight transmissions were less often hospitalized for HF in the 6 months before enrollment in the study compared to those who were nonadherent (n=9, 8% vs n=9, 23%; P=.02). The percentage of patients visiting the personal health record dropped steadily over time (n=140, 93% vs n=59, 39% at one year). With univariable analyses, there was no significant correlation between patient characteristics and adherence to weight transmissions. Conclusions: Adherence to remote patient monitoring was high among stable patients with HF and best for weighing; however, adherence decreased over time. Clinical and demographic variables seem not related to adherence to transmitting weight.</p

Patterns in the Use of Heart Failure Telemonitoring: Post Hoc Analysis of the e-Vita Heart Failure Trial

BACKGROUND: Research on the use of home telemonitoring data and adherence to it can provide new insights into telemonitoring for the daily management of patients with heart failure (HF). OBJECTIVE: We described the use of a telemonitoring platform-including remote patient monitoring of blood pressure, pulse, and weight-and the use of the electronic personal health record. Patient characteristics were assessed in both adherent and nonadherent patients to weight transmissions. METHODS: We used the data of the e-Vita HF study, a 3-arm parallel randomized trial performed in stable patients with HF managed in outpatient clinics in the Netherlands. In this study, data were analyzed from the participants in the intervention arm (ie, e-Vita HF platform). Adherence to weight transmissions was defined as transmitting weight ≥3 times per week for at least 42 weeks during a year. RESULTS: Data from 150 patients (mean age 67, SD 11 years; n=37, 25% female; n=123, 82% self-assessed New York Heart Association class I-II) were analyzed. One-year adherence to weight transmissions was 74% (n=111). Patients adherent to weight transmissions were less often hospitalized for HF in the 6 months before enrollment in the study compared to those who were nonadherent (n=9, 8% vs n=9, 23%; P=.02). The percentage of patients visiting the personal health record dropped steadily over time (n=140, 93% vs n=59, 39% at one year). With univariable analyses, there was no significant correlation between patient characteristics and adherence to weight transmissions. CONCLUSIONS: Adherence to remote patient monitoring was high among stable patients with HF and best for weighing; however, adherence decreased over time. Clinical and demographic variables seem not related to adherence to transmitting weight. TRIAL REGISTRATION: ClinicalTrials.gov NCT01755988; https://clinicaltrials.gov/ct2/show/NCT01755988