Objectives This study was designed to assess the risk of significant bleeding complications in patients receiving antiplatelet or anticoagulation medications at the time of implantable ...cardioverter-defibrillator (ICD) device implantation. Background Periprocedural management of antiplatelet or anticoagulation therapy at the time of device implantation remains controversial. Methods We performed a retrospective chart review of bleeding complications in all patients undergoing ICD or pacemaker implantation from August 2004 to August 2007. Aspirin or clopidogrel use was defined as taken within 5 days of the procedure. A significant bleeding complication was defined as need for pocket exploration or blood transfusion; hematoma requiring pressure dressing or change in anticoagulation therapy; or prolonged hospitalization. Results Of the 1,388 device implantations, 71 had bleeding complications (5.1%). Compared with controls not taking antiplatelet agents (n = 255), the combination of aspirin and clopidogrel (n = 139) significantly increased bleeding risk (7.2% vs. 1.6%; p = 0.004). In patients taking aspirin alone (n = 536), bleeding risk was marginally higher than it was for patients taking no antiplatelet agents (3.9% vs. 1.6%, p = 0.078). The use of periprocedural heparin (n = 154) markedly increased risk of bleeding when compared with holding warfarin until the international normalized ratio (INR) was normal (n = 258; 14.3% vs. 4.3%; p < 0.001) and compared with patients receiving no anticoagulation therapy (14.3% vs.1.6%; p < 0.0001). There was no statistical difference in bleeding risk between patients continued on warfarin with an INR ≥1.5 (n = 46) and patients who had warfarin withheld until the INR was normal (n = 258; 6.5% vs. 4.3%; p = 0.50). Conclusions Dual antiplatelet therapy and periprocedural heparin significantly increase the risk of bleeding complications at the time of pacemaker or ICD implantation.
To identify clinical characteristics associated with the presence of epiretinal membrane (ERM) in patients with uveitis.
Case-control study.
Five hundred ninety-eight subjects seen in a single ...tertiary referral clinic between January 1, 2008, and December 31, 2011, who were diagnosed with uveitis.
Spectral-domain optical coherence tomography (SD OCT) images of all subjects were reviewed to assess for ERM. A multivariate logistic regression analysis was performed to compare characteristics of subjects with ERM (cases) with characteristics of subjects without ERM (controls). A second multivariate analysis assessed the relationship between ERM and visual acuity. Fundus photographs were reviewed to compare SD OCT ascertainment of ERM with photographic ascertainment.
Presence or absence of ERM on OCT imaging.
Of 598 uveitic participants, 246 (41%) were found to have ERM in at least 1 eye on SD OCT imaging. The prevalence of ERM by Standardization of Uveitis Nomenclature anatomic subtype was 28.1% for anterior uveitis, 57.0% for intermediate uveitis, and 43.4% for posterior uveitis and panuveitis. Multivariate analysis showed that the following clinical factors were associated significantly with ERM: older age (3% increased risk per year of age; 95% confidence interval CI, 1.02-1.05), intermediate uveitis (odds ratio OR, 3.41; 95% CI, 1.67-6.96), posterior uveitis and panuveitis (OR, 1.81; 95% CI, 1.09-3.01), male sex (OR, 1.59; 95% CI, 1.05-2.42), and history of cataract surgery (OR, 1.78; 95% CI, 1.13-2.79). When adjusted for covariates, eyes with ERM had a mean logarithm of the minimum angle of resolution visual acuity of 0.58 (20/76) versus 0.48 (20/60) in non-ERM eyes (P = 0.039). Of OCT-defined ERMs in this cohort, 38% were not detectable on fundus photographs.
Epiretinal membrane is a common complication of uveitis that is associated with patient age, intermediate uveitis, posterior uveitis, panuveitis, male sex, and previous cataract surgery. It can contribute independently to vision loss in uveitic eyes. In uveitis, OCT is more sensitive than fundus photography for identification of ERM.
Objective To assess the utility of hepcidin, a potent regulator of host defense and inflammation, in the diagnosis of late-onset sepsis in very low birth weight infants. Study design We compared the ...diagnostic performance of hepcidin with C-reactive protein from the serum concentrations in acute and convalescent blood specimens obtained from 44 infants suspected of late-onset sepsis. The predictive accuracies were assessed from the areas under receiver operating characteristic curves and the cutoffs that differentiated infants with and without sepsis were identified using classification and regression tree analysis. Results Seventeen of the enrolled infants in this study were bacteremic and/or received antibiotics for neonatal sepsis for ≥5 days (infants with sepsis). The concentrations of hepcidin were increased 4-fold in infants with compared with infants without sepsis ( P < .0001) and returned to similar levels following therapy. The areas under receiver operating characteristic curves of hepcidin was 0.93 compared with 0.83 for C-reactive protein, P = .06. Hepcidin concentration >92.2 ng/mL correctly classified 91% of all infants (positive predictive value: 100%, negative predictive value: 87%, specificity: 100%, and sensitivity: 76%). Conclusion Serum hepcidin concentration may be a useful adjunct test, in addition to blood culture and other markers of infection, in the evaluation of late-onset sepsis in very low birth weight infants.
Patients With Prior Myocardial Infarction, Stroke, or Symptomatic Peripheral Arterial Disease in the CHARISMA Trial Deepak L. Bhatt, MD, FACC, Marcus D. Flather, MD, Werner Hacke, MD, Peter B. ...Berger, MD, FACC, Henry R. Black, MD, William E. Boden, MD, FACC, Patrice Cacoub, MD, Eric A. Cohen, MD, Mark A. Creager, MD, FACC, J. Donald Easton, MD, Christian W. Hamm, MD, FACC, Graeme J. Hankey, MD, S. Claiborne Johnston, PhD, MD, Koon-Hou Mak, MD, FACC, Jean-Louis Mas, MD, Gilles Montalescot, MD, PhD, Thomas A. Pearson, MD, FACC, P. Gabriel Steg, MD, FACC, Steven R. Steinhubl, MD, FACC, Michael A. Weber, MD, FACC, Liz Fabry-Ribaudo, MSN, RN, Tingfei Hu, MS, Eric J. Topol, MD, FACC, Keith A. A. Fox, MBChB, for the CHARISMA Investigators Dual antiplatelet therapy with clopidogrel plus aspirin has already been validated in the settings of acute coronary syndromes and coronary stenting. We identified 9,478 patients in the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial who were enrolled with documented prior myocardial infarction (MI), ischemic stroke, or symptomatic peripheral arterial disease. The median duration of follow-up was 27.6 months. The rate of cardiovascular death, MI, or stroke was significantly lower in the clopidogrel plus aspirin arm than in the placebo plus aspirin arm: 7.3% versus 8.8% (hazard ratio 0.83, 95% confidence interval 0.72 to 0.96, p = 0.01); this benefit persisted after multivariate modeling and was not dependent on the time from the ischemic event.
We investigate whether ocular and person-based characteristics were associated with dark adaptation (DA).
Cross-sectional, single-center, observational study.
One hundred sixteen participants older ...than 50 years of age with a range of age-related macular degeneration (AMD) severity.
Participants underwent best-corrected visual acuity (BCVA) testing, ophthalmoscopic examination, and multimodal imaging. Presence of reticular pseudodrusen (RPD) was assessed by masked grading of fundus images and was confirmed with optical coherence tomography. Eyes also were graded for AMD features (drusen, pigmentary changes, late AMD) to generate person-based AMD severity groups. One eye was designated the study eye for DA testing. Nonparametric statistical testing was performed on all comparisons.
The primary outcome of this study was the rod intercept time (RIT), which is defined as the time for a participant's visual sensitivity to recover to a stimulus intensity of 5×10(-3) cd/m(2) (a decrease of 3 log units), or until a maximum test duration of 40 minutes was reached.
A total of 116 study eyes from 116 participants (mean age, 75.4±9.4 years; 58% female) were analyzed. Increased RIT was associated significantly with increasing AMD severity, increasing age (r = 0.34; P = 0.0002), decreasing BCVA (r = -0.54; P < 0.0001), pseudophakia (P = 0.03), and decreasing subfoveal choroidal thickness (r = -0.27; P = 0.003). Study eyes with RPD (15/116 13%) had a significantly greater mean RIT compared with eyes without RPD in any AMD severity group (P < 0.02 for all comparisons), with 80% reaching the DA test ceiling.
Impairments in DA increased with age, worse visual acuity, presence of RPD, AMD severity, and decreased subfoveal choroidal thickness. Analysis of covariance found the multivariate model that best fit the data included age, AMD group, and presence of RPD (R(2) = 0.56), with the presence of RPD conferring the largest parameter estimate.
Management of oral anticoagulation in patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation remains controversial. Prior studies demonstrate that ...continuation of warfarin may be safer when compared with strategies requiring interruption and/or heparin bridging. Limited data from randomized trials exist.
We conducted a randomized trial to determine whether warfarin continuation is superior to warfarin interruption during PPM or ICD implantation.
Patients on oral anticoagulation referred for PPM or ICD implantation were randomized to warfarin continuation versus interruption. Patients randomized to warfarin interruption were further stratified into two groups based on their risk for thromboembolic events in the absence of warfarin. Moderate-risk patients were randomized to warfarin continuation versus warfarin interruption. High-risk patients were randomized to warfarin continuation versus warfarin interruption with heparin bridging. The primary combined outcome included thromboembolic events, anticoagulant-related complications, or any significant bleeding necessitating additional intervention or discontinuation of anticoagulation.
We studied 100 patients (average age 70.8 years, 21% female, mean body mass index 28.4) who underwent 64 ICD and 36 PPM implantations. Fifty patients were assigned to continue warfarin. The randomized groups were well matched. Among patients randomized to warfarin interruption, there were two pocket hematomas, one pericardial effusion, one transient ischemic attack, and one patient who developed heparin-induced thrombocytopenia. No events were noted among patients continuing warfarin (P = .056).
While the results were not statistically significant, there was a trend toward reduced complications in patients randomized to warfarin continuation. This strategy should be considered in patients undergoing PPM or ICD implantation.
The measurement of late gadolinium-enhanced magnetic resonance imaging (LGE-MRI) intensity in arbitrary units limits the objectivity of thresholds for focal scar detection and interpatient ...comparisons of scar burden.
To develop and validate a normalized measure, the image intensity ratio (IIR), for the assessment of left atrial (LA) scar on LGE-MRI.
Electrocardiogram- and respiratory-gated 1.5 Tesla LGE-MRI was performed in 75 patients (75% men; 62 ± 8 years) before atrial fibrillation ablation. The local IIR was defined as LA myocardial signal intensity for each of the 20 sectors on contiguous axial image planes divided by the mean LA blood pool image intensity. Intracardiac point-by-point sampled electroanatomic map points were coregistered with the corresponding image sectors.
The average bipolar voltage for all 8153 electroanatomic map points was 0.9 ± 1.1 mV. In a mixed effects model accounting for within patient clustering, and adjusting for age, LA volume, mass, body mass index, sex, CHA2DS2-VASc score, atrial fibrillation type, history of previous ablations, and contrast delay time, each unit increase in local IIR was associated with 91.3% decrease in bipolar LA voltage (P < .001). Local IIR thresholds of >0.97 and >1.61 corresponded to bipolar voltage <0.5 and <0.1 mV, respectively.
Normalization of LGE-MRI intensity by the mean blood pool intensity results in a metric that is closely associated with intracardiac voltage as a surrogate of atrial fibrosis.
Summary Background The annual number of hospital admissions and in-hospital deaths due to severe acute lower respiratory infections (ALRI) in young children worldwide is unknown. We aimed to estimate ...the incidence of admissions and deaths for such infections in children younger than 5 years in 2010. Methods We estimated the incidence of admissions for severe and very severe ALRI in children younger than 5 years, stratified by age and region, with data from a systematic review of studies published between Jan 1, 1990, and March 31, 2012, and from 28 unpublished population-based studies. We applied these incidence estimates to population estimates for 2010, to calculate the global and regional burden in children admitted with severe ALRI in that year. We estimated in-hospital mortality due to severe and very severe ALRI by combining incidence estimates with case fatality ratios from hospital-based studies. Findings We identified 89 eligible studies and estimated that in 2010, 11·9 million (95% CI 10·3–13·9 million) episodes of severe and 3·0 million (2·1–4·2 million) episodes of very severe ALRI resulted in hospital admissions in young children worldwide. Incidence was higher in boys than in girls, the sex disparity being greatest in South Asian studies. On the basis of data from 37 hospital studies reporting case fatality ratios for severe ALRI, we estimated that roughly 265 000 (95% CI 160 000–450 000) in-hospital deaths took place in young children, with 99% of these deaths in developing countries. Therefore, the data suggest that although 62% of children with severe ALRI are treated in hospitals, 81% of deaths happen outside hospitals. Interpretation Severe ALRI is a substantial burden on health services worldwide and a major cause of hospital referral and admission in young children. Improved hospital access and reduced inequities, such as those related to sex and rural status, could substantially decrease mortality related to such infection. Community-based management of severe disease could be an important complementary strategy to reduce pneumonia mortality and health inequities. Funding WHO.
Intravenous enoxaparin did not reduce significantly the primary end point (p = 0.06) compared with unfractionated heparin (UFH) in the randomized Acute Myocardial Infarction Treated with primary ...angioplasty and intravenous enoxaparin Or unfractionated heparin to Lower ischemic and bleeding events at short- and Long-term follow-up (ATOLL) trial. We present the results of the prespecified per-protocol analysis excluding patients who did not receive the treatment allocated by randomization or received both enoxaparin and UFH. We evaluated all-cause mortality, complication of myocardial infarction, procedural failure, or major bleeding (primary end point) and all-cause mortality, recurrent acute coronary syndrome, or urgent revascularization (main secondary end point). Baseline and procedural characteristics were well balanced between the 2 treatment groups. Of 910 randomized patients, 795 patients (87.4%) were treated according to the protocol with consistent anticoagulation using intravenous enoxaparin (n = 400) or UFH (n = 395). Enoxaparin reduced significantly the rates of the primary end point (relative risk RR 0.76, 95% confidence interval CI 0.62 to 0.94, p = 0.012) and the main secondary end point (RR 0.37, 95% CI 0.22 to 0.63, p <0.0001). There was less major bleeding with enoxaparin (RR 0.46, 95% CI 0.21 to 1.01, p = 0.050) contributing to the significant improvement of the net clinical benefit (RR 0.46, 95% CI 0.3 to 0.74, p = 0.0002). All-cause mortality was also reduced with enoxaparin (RR 0.36, 95% CI 0.18 to 0.74, p = 0.003). In conclusion, in the per-protocol analysis of the ATOLL trial, pertinent to >87% of the study population, enoxaparin was superior to UFH in reducing ischemic end points and mortality.
To determine the rate of inappropriate admissions to emergency departments (EDs) and to identify determinants of these admissions.
Prospective multicenter study.
Burgundy (France), EDs and medical ...nursing homes (MNHs).
1000 Burgundy MNH residents admitted to EDs, from April 17 to June 20, 2013.
For each subject, a questionnaire was completed. Data included age, gender, type of health professional who referred the resident to the ED (THP), whether or not a medical dispatcher organized the transfer to the ED, transport mode, reason for admission to the ED, level of independence according to the Groupes Iso-Ressource score (GIRS), and diagnosis made in the ED. The French version of the Appropriateness Evaluation Protocol grid was applied to each admission to the ED, and in some situations, the expert committee ruled on the appropriateness of the admission to the ED. MNH characteristics were also recorded. Two groups were constituted according to the appropriateness or not of admission to the ED.
Mean age of the 1000 residents was 87. There were 706 women. Two-thirds were referred to the EDs by a physician, mainly a general practitioner. In 91.7%, the transfer to the ED was organized by a medical dispatcher, and 8.8% were transported by medicalized transport. More than 95% had a GIRS ≤4. Among the admissions to EDs, 18.1% were inappropriate. Female gender (P = .017), nonmedicalized transport (P = .002), public MNH (P = .044), and nonaccess to a geriatric opinion in an emergency (P = .043) were determinants of inappropriate admission to EDs.
In this first study on admissions to EDs of MNH residents using French data, we found a lower rate of admissions to the ED than that reported in the literature. Female gender, nonmedicalized transport, public MNH, and nonaccess to a geriatric opinion in an emergency were associated with inappropriate admission to EDs.
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