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Implementation and use of a crisis hotline during the treatment as usual and universal screening phases of a suicide intervention study

Fri, 03/04/2016 - 12:28pm

BACKGROUND: Although research suggests that crisis hotlines are an effective means of mitigating suicide risk, lack of empirical evidence may limit the use of this method as a research safety protocol. PURPOSE: This study describes the use of a crisis hotline to provide clinical backup for research assessments. METHODS: Data were analyzed from participants in the Emergency Department Safety and Follow-up Evaluation (ED-SAFE) study (n=874). Socio-demographics, call completion data, and data available on suicide attempts occurring in relation to the crisis counseling call were analyzed. Pearson chi-squared statistic for differences in proportions were conducted to compare characteristics of patients receiving versus not receiving crisis counseling. P<0.05 was considered statistically significant. RESULTS: Overall, there were 163 counseling calls (6% of total assessment calls) from 135 (16%) of the enrolled subjects who were transferred to the crisis line because of suicide risk identified during the research assessment. For those transferred to the crisis line, the median age was 40 years (interquartile range 27-48) with 67% female, 80% white, and 11% Hispanic. CONCLUSIONS: Increasing demand for suicide interventions in diverse healthcare settings warrants consideration of crisis hotlines as a safety protocol mechanism. Our findings provide background on how a crisis hotline was implemented as a safety measure, as well as the type of patients who may utilize this safety protocol.

The Impact of Sertraline Co-Administration on the Pharmacokinetics of Olanzapine: A Population Pharmacokinetic Analysis of the STOP-PD

Fri, 03/04/2016 - 12:28pm

BACKGROUND AND OBJECTIVE: Clinical evidence and expert opinion support using a combination of an antipsychotic and an antidepressant when treating major depression with psychotic features. We characterized the impact of sertraline co-administration on olanzapine clearance in psychotic depression using population pharmacokinetic methods.

METHODS: The Study of Pharmacotherapy for Psychotic Depression (STOP-PD) randomized 259 participants to olanzapine plus placebo or olanzapine plus sertraline. Olanzapine was started at 2.5-5 mg/day and sertraline at 25-50 mg/day. Doses were increased to a maximum of 20 mg/day for olanzapine and 200 mg/day for sertraline. Up to four olanzapine concentration samples were collected during the 12-week trial and 12-week continuation phase. We used NONMEM (Version VII) for population pharmacokinetic analysis, assessing effects of the covariates sex, African American origin, smoking, age, and sertraline co-administration.

RESULTS: Population pharmacokinetic analysis comprised 336 samples from 175 individuals. The structural model published by Bigos et al. was sufficient to describe the olanzapine data adequately: a one-compartment model with first-order absorption and elimination, using an additive residual error structure with the absorption rate constant fixed to 0.5. Sertraline co-administration significantly increased olanzapine apparent clearance (p < 0.005) by 25-35 % depending on the patient characteristics included. Male sex was associated with a significantly increased clearance. Age and race did not have a significant impact on clearance.

CONCLUSIONS: Contrary to expectations from the knowledge of cytochrome P450 interactions, sertraline increased olanzapine apparent clearance. Plausible explanations include patients treated with sertraline having poorer adherence to olanzapine, or the impact of sertraline inhibition of transporters resulting in increased intracellular concentrations and thus access to metabolizing enzymes.

Comparative Effectiveness of Statin Therapy in Chronic Kidney Disease and Acute Myocardial Infarction: A Retrospective Cohort Study

Fri, 03/04/2016 - 12:27pm

BACKGROUND: Whether there is a kidney function threshold to statin effectiveness in patients with acute myocardial infarction is poorly understood. Our study sought to help fill this gap in clinical knowledge.

METHODS: We undertook a new-user cohort study of the effectiveness of statin therapy by level of estimated glomerular filtration rate (eGFR) in adults who were hospitalized for myocardial infarction between 2000 and 2008. Data came from the Cardiovascular Research Network. The primary clinical outcomes were 1-year all-cause mortality and cardiovascular hospitalizations, with adverse outcomes of myopathy and development of diabetes mellitus. We calculated incidence rates, the number needed to treat, and used Cox proportional hazards regression with propensity score matching and adjustment to control for confounding, with testing for variation of effect by level of kidney function.

RESULTS: Compared with statin non-initiators (n = 5583), statin initiators (n = 5597) had a lower propensity score-adjusted risk for death (hazard ratio 0.79; 95% confidence interval [CI], 0.71-0.88) and cardiovascular hospitalizations (hazard ratio 0.90; 95% CI, 0.82-1.00). We found little evidence of variation in effect by level of eGFR (P = .86 for death; P = .77 for cardiovascular hospitalization). Adverse outcomes were similar for statin initiators and statin non-initiators. The number needed to treat to prevent 1 additional death over 1 year of follow-up ranged from 15 (95% CI, 11-28) for eGFR < 30 mL/min/1.73 m(2) requiring statin treatment over 2 years to prevent 1 additional death, to 67 (95% CI, 49-118) for patients with eGFR > 90 mL/min/1.73 m(2).

CONCLUSIONS: Our findings suggest that there is potential for important public health gains by increasing the routine use of statin therapy for patients with lower levels of kidney function.

Confirmatory factor analysis of the Autonomy over Tobacco Scale (AUTOS) in adults

Fri, 03/04/2016 - 12:27pm

INTRODUCTION: The Autonomy over Tobacco Scale (AUTOS), a 12-item self-administered questionnaire, was designed to measure autonomy in three correlated lower-order symptom domains: withdrawal, psychological dependence, and cue-induced craving. The factor structure of the AUTOS remains an open question; confirmatory analyses in adolescents supported the hierarchical structure, while exploratory analyses in adolescents and adults yield single-factor solutions. Here we seek to determine whether the hypothesized hierarchical structure is valid in adult smokers.

METHODS: The AUTOS was administered to two independent convenience samples of adult current smokers: a calibration sample recruited in the US for online studies, and a confirmation sample drawn from the prospective Nicotine Dependence in Teens study in Montreal. We tested competing hierarchical and single-factor models using the robust weighted least-squares (WLSMV) estimation method.

RESULTS: A single-factor model that allowed correlated error variances between theoretically related items fit well in the calibration sample (n = 434), chi(2)SB(52) = 165.71; chi(2)/df = 3.19; SRMR = 0.03; CFI = 0.96; NNFI = 0.95; RMSEA = 0.07 (95% CI: 0.06, 0.08). Reliability of the single factor was high (omegaB = 0.92) and construct validity was adequate. In the confirmation sample (n = 335), a similar model fit well: chi(2)SB(53) = 126.94; chi(2)/df = 2.44; SRMR = 0.04; CFI = 0.95; NNFI = 0.93; RMSEA = 0.07 (95% CI: 0.05, 0.08). Reliability of the single factor was again high (omegaB = 0.92) and construct validity was adequate.

CONCLUSION: The AUTOS is unidimensional in adult smokers.

The Association Between Midlife Physical Activity and Depressive Symptoms in Late Life: Age Gene/Environment Susceptibility-Reykjavik Study

Fri, 03/04/2016 - 12:27pm

BACKGROUND: There is little evidence on the long-term association between physical activity (PA) and depressive symptoms in old age. We examined the association of midlife PA and depressive symptoms in late life.

METHODS: A large community-based population residing in Reykjavik, Iceland, participated in a longitudinal study with an average of 25 years of follow up. Midlife PA was categorized as active and inactive groups (n = 4,140, Active = 1,292, Inactive = 2,848, mean age 52+/-7 years). The main outcome had six or higher depressive symptoms assessed by the 15-item Geriatric Depression scale. Participants who had a history of depression (n = 226), and were diagnosed with dementia (n = 393), and had incomplete cognitive data (n = 595) and incomplete analytical data (n = 422) were excluded. Level of weekly PA was ascertained by a questionnaire at midlife. Depressive symptoms were assessed on average 25 (+/-4) years later.

RESULTS: After controlling for demographic and health-related risk factors, those who were active at midlife were less likely to have high level of depressive symptomatology (6 or higher Geriatric Depression scale scores, odds ratio = 0.58, 95% confidence interval: 0.41-0.83, p < .005) compared with those who were inactive in midlife. After full adjustment of three domains of late-life cognitive function the results remained significant (odds ratio = 0.61, 95% confidence interval: 0.43-0.86, p = .005).

CONCLUSION: Our study shows that midlife PA is associated with lower depressive symptoms 25 years later. Participating in regular PA in midlife may improve mental health in late life.

MicroRNA Cargo of Extracellular Vesicles from Alcohol-exposed Monocytes Signals Naive Monocytes to Differentiate into M2 Macrophages

Fri, 03/04/2016 - 12:27pm

Membrane-coated extracellular vesicles (EVs) released by cells can serve as vehicles for delivery of biological materials and signals. Recently, we demonstrated that alcohol-treated hepatocytes cross-talk with immune cells via exosomes containing microRNA (miRNAs). Here, we hypothesized that alcohol-exposed monocytes can communicate with naive monocytes via EVs. We observed increased numbers of EVs, mostly exosomes, secreted by primary human monocytes and THP-1 monocytic cells in the presence of alcohol in a concentration- and time-dependent manner. EVs derived from alcohol-treated monocytes stimulated naive monocytes to polarize into M2 macrophages as indicated by increased surface expression of CD68 (macrophage marker), M2 markers (CD206 (mannose receptor) and CD163 (scavenger receptor)), secretion of IL-10, and TGFbeta and increased phagocytic activity. miRNA profiling of the EVs derived from alcohol-treated THP-1 monocytes revealed high expression of the M2-polarizing miRNA, miR-27a. Treatment of naive monocytes with control EVs overexpressing miR-27a reproduced the effect of EVs from alcohol-treated monocytes on naive monocytes and induced M2 polarization, suggesting that the effect of alcohol EVs was mediated by miR-27a. We found that miR-27a modulated the process of phagocytosis by targeting CD206 expression on monocytes. Importantly, analysis of circulating EVs from plasma of alcoholic hepatitis patients revealed increased numbers of EVs that contained high levels of miR-27a as compared with healthy controls. Our results demonstrate the following: first, alcohol increases EV production in monocytes; second, alcohol-exposed monocytes communicate with naive monocytes via EVs; and third, miR-27a cargo in monocyte-derived EVs can program naive monocytes to polarize into M2 macrophages.

Importance of Nucleic Acid Recognition in Inflammation and Autoimmunity

Fri, 03/04/2016 - 12:26pm

An important concept in immunology is the classification of immune responses as either innate or adaptive, based on whether the antigen receptors are encoded in the germline or generated somatically by gene rearrangement. The innate immune system is an ancient mode of immunity, and by being a first layer in our defense against infectious agents, it is essential for our ability to develop rapid and sustained responses to pathogens. We discuss the importance of nucleic acid recognition by the innate immune system to mounting an appropriate immune response to pathogens and also how inflammation driven by uncontrolled recognition of self-nucleic acids can lead to autoimmune diseases. We also summarize current efforts to either harness the immune system using agonists of nucleic acid-specific innate sensors or, on the contrary, by using inhibitors in autoimmune situations.

Prenatal Triptan Exposure and Internalising and Externalising Behaviour Problems in 3-Year-Old Children: Results from the Norwegian Mother and Child Cohort Study

Fri, 03/04/2016 - 12:26pm

BACKGROUND: Triptans are commonly prescribed for migraine, a pain condition that is highly prevalent in women of childbearing age. No prior studies have investigated associations between exposure to triptans during fetal life and risk of externalising and internalising behaviours in children.

METHODS: This study was set in the Norwegian Mother and Child Cohort study, a prospective birth cohort. A total of 41 173 live, singleton births without major malformations present at 36-month post-partum follow-up were included in this study; 396 used a triptan during pregnancy, 798 used a triptan prior to pregnancy only, 3291 reported migraine without triptan use, and 36 688 reported no history of migraine or triptan use. Marginal structural models were used to analyse the association between timing of triptan exposure and neurodevelopmental outcome.

RESULTS: Children exposed to triptans during pregnancy had a 1.39-fold increased risk of externalising behaviours compared with those whose mothers used triptans prior to pregnancy only (95% CI 0.97, 1.97), a 1.36-fold increased risk compared with the unmedicated migraine group (95% CI 1.02, 1.81), and a 1.41-fold increased risk compared with the population comparison group (95% CI 1.08, 1.85). The greatest risk was associated with first trimester exposure (RR 1.77, 95% CI 0.98, 3.14). Risk differences were small, ranging from 3-6%.

CONCLUSIONS: This study found an increased risk of clinically relevant externalising behaviours in children with prenatal exposure to triptans, and this risk was highest for first trimester exposure. Absolute risks were small, and the results may be due to confounding by underlying migraine severity.

Impact of Plasmodium falciparum Coinfection on Longitudinal Epstein-Barr Virus Kinetics in Kenyan Children

Fri, 03/04/2016 - 12:26pm

Endemic Burkitt lymphoma is associated with Epstein-Barr virus (EBV) and Plasmodium falciparum coinfection, although how P. falciparum exposure affects the dynamics of EBV infection is unclear. We have used a modeling approach to study EBV infection kinetics in a longitudinal cohort of children living in regions of high and low malaria transmission in Kenya. Residence in an area of high malaria transmission was associated with a higher rate of EBV expansion during primary EBV infection in infants and during subsequent episodes of EBV DNA detection, as well as with longer episodes of EBV DNA detection and shorter intervals between subsequent episodes of EBV DNA detection. In addition, we found that concurrent P. falciparum parasitemia also increases the likelihood of the first and subsequent peaks of EBV in peripheral blood. This suggests that P. falciparum infection is associated with increased EBV growth and contributes to endemic Burkitt lymphoma pathogenesis.

Primary care physicians' willingness to disclose oncology errors involving multiple providers to patients

Fri, 03/04/2016 - 12:26pm

BACKGROUND: Full disclosure of harmful errors to patients, including a statement of regret, an explanation, acceptance of responsibility and commitment to prevent recurrences is the current standard for physicians in the USA.

OBJECTIVE: To examine the extent to which primary care physicians' perceptions of event-level, physician-level and organisation-level factors influence intent to disclose a medical error in challenging situations.

DESIGN: Cross-sectional survey containing two hypothetical vignettes: (1) delayed diagnosis of breast cancer, and (2) care coordination breakdown causing a delayed response to patient symptoms. In both cases, multiple physicians shared responsibility for the error, and both involved oncology diagnoses.

SETTING: The study was conducted in the context of the HMO Cancer Research Network Cancer Communication Research Center.

PARTICIPANTS: Primary care physicians from three integrated healthcare delivery systems located in Washington, Massachusetts and Georgia; responses from 297 participants were included in these analyses.

MAIN MEASURES: The dependent variable intent to disclose included intent to provide an apology, an explanation, information about the cause and plans for preventing recurrences. Independent variables included event-level factors (responsibility for the event, perceived seriousness of the event, predictions about a lawsuit); physician-level factors (value of patient-centred communication, communication self-efficacy and feelings about practice); organisation-level factors included perceived support for communication and time constraints.

KEY RESULTS: A majority of respondents would not fully disclose in either situation. The strongest predictors of disclosure were perceived personal responsibility, perceived seriousness of the event and perceived value of patient-centred communication. These variables were consistently associated with intent to disclose.

CONCLUSION: To make meaningful progress towards improving disclosure; physicians, risk managers, organisational leaders, professional organisations and accreditation bodies need to understand the factors which influence disclosure. Such an understanding is required to inform institutional policies and provider training.

Receipt of Prescription Opioids in a National Sample of Pregnant Veterans Receiving Veterans Health Administration Care

Fri, 03/04/2016 - 12:25pm

BACKGROUND: A growing number of reproductive-age women veterans are returning from Operations Enduring Freedom, Iraqi Freedom, and New Dawn (OEF/OIF/OND). In 2010, 42% of women veterans receiving Veterans Health Administration (VHA) services were aged 18 to 45. Prescription opioid use has increased among all veterans over the past decade; however, exposure among pregnant veterans has not been examined.

METHODS: We identified 2,331 women who delivered babies within the VHA system between 2001 and 2010. Delivery, opioid prescribing history, and demographic and health-related variables were obtained from a national database of veterans receiving VHA services. Receipt of an opioid prescription was defined as any filled VHA prescription for opioids in the 280-day pregnancy window before delivery. We developed a multivariable logistic regression model adjusted for sociodemographic, service-related, psychiatric diagnosis, and physical health variables to examine the odds of filling an opioid prescription during the pregnancy window.

FINDINGS: Ten percent of pregnant veterans received VHA prescription opioids during their pregnancy window. Significant factors associated with opioid prescriptions included presence of any psychiatric diagnosis (adjusted odds ratio [aOR], 1.67; 95% CI, 1.24-2.26), diagnosis of back problems (aOR, 2.94; 95% CI, 1.92-4.49), or other nontraumatic joint disorders (aOR, 2.20; 95% CI, 1.36-3.58).

CONCLUSIONS: This study suggests that a substantial proportion of women veterans received VHA prescriptions for opioids during pregnancy. Providers should be aware of the potential risks of prescription opioid use during pregnancy, assess for potential undertreatment of psychiatric diagnoses, and consider alternate pain management strategies when possible.

Probability-based particle detection that enables threshold-free and robust in vivo single-molecule tracking

Fri, 03/04/2016 - 12:25pm

Single-molecule detection in fluorescence nanoscopy has become a powerful tool in cell biology but can present vexing issues in image analysis, such as limited signal, unspecific background, empirically set thresholds, image filtering, and false-positive detection limiting overall detection efficiency. Here we present a framework in which expert knowledge and parameter tweaking are replaced with a probability-based hypothesis test. Our method delivers robust and threshold-free signal detection with a defined error estimate and improved detection of weaker signals. The probability value has consequences for downstream data analysis, such as weighing a series of detections and corresponding probabilities, Bayesian propagation of probability, or defining metrics in tracking applications. We show that the method outperforms all current approaches, yielding a detection efficiency of > 70% and a false-positive detection rate of < 5% under conditions down to 17 photons/pixel background and 180 photons/molecule signal, which is beneficial for any kind of photon-limited application. Examples include limited brightness and photostability, phototoxicity in live-cell single-molecule imaging, and use of new labels for nanoscopy. We present simulations, experimental data, and tracking of low-signal mRNAs in yeast cells.

A Qualitative Study of Vulnerable Patient Views of Type 2 Diabetes Consumer Reports

Fri, 03/04/2016 - 12:25pm

BACKGROUND: The Patient Protection and Affordable Care Act (ACA) mandates the release of publicly available consumer reports to highlight differences in quality of care and reduce healthcare disparities. However, little is known about patient perceptions of the value of such reports.

OBJECTIVE: This study aims to identify whether vulnerable populations with type 2 diabetes perceive consumer reports as helpful in making decisions about diabetes care.

METHODS: We conducted a brief demographic survey and qualitative study of 18 focus groups: six each of African American, Hispanic, and non-Hispanic White consumers diagnosed with type 2 diabetes (n = 92). We analysed focus group transcripts to identify recurring themes, which were summarized and compared across population groups.

RESULTS: Participants expressed minimal interest in currently available consumer reports. They instead listed personal referrals and interpersonal interactions among the most important factors when choosing a physician. Further, in place of information to aid in physician selection, participants articulated strong desires for more basic, straightforward disease-specific information that would promote diabetes self-management.

CONCLUSIONS: This study's results call into question the value of consumer reports as defined by the ACA. Participants reported little interest in comparative provider performance data. Instead, they were more interested in information to assist in diabetes self-management. This suggests that consumer reports may not be as important a tool to improve outcomes and reduce health disparities as policy makers imagine them to be.

Impact of Leukoaraiosis Burden on Hemispheric Lateralization of the National Institutes of Health Stroke Scale Deficit in Acute Ischemic Stroke

Fri, 03/04/2016 - 12:24pm

BACKGROUND AND PURPOSE: The National Institutes of Health Stroke Scale (NIHSS) awards higher deficit scores for infarcts in the dominant hemisphere when compared with otherwise similar infarcts in the nondominant hemisphere. This has been shown to adversely affect stroke recognition, therapeutic decisions, and outcome. However, factors modifying the association between infarct side and deficit severity are incompletely understood. Thus, we sought to determine whether age and age-related leukoaraiosis alter the relation between NIHSS deficit score and the side and volume of infarction. METHODS: We studied 238 patients with supratentorial, nonlacunar ischemic infarcts prospectively included in our stroke registry between January 2013 and January 2014. NIHSS deficit severity was assessed at the time of presentation. Infarct volumes were assessed by manual planimetry on diffusion-weighted imaging. Leukoaraiosis burden was graded on fluid-attenuated inversion recovery images according to the Fazekas scale and dichotomized to none-to-mild (0-2) versus severe (3-6). Multivariable linear regression with backward elimination was used to identify independent predictors of the admission NIHSS. RESULTS: Left-hemispheric infarction (P < 0.001), severe leukoaraiosis (P=0.001), their interaction term (P=0.005), infarct volume (P < 0.001), and sex (P=0.013) were independently associated with the NIHSS deficit. Analysis of the individual NIHSS components showed that severe leukoaraiosis was associated with an increase of the lateralizing components of the NIHSS in patients with right-hemispheric infarction (P<0.05). CONCLUSIONS: Severe leukoaraiosis substantially attenuates the classic hemispheric lateralization of the NIHSS deficit by relating to greater NIHSS scores of components that are typically assigned to left hemisphere function.

Prenatal triptan exposure and parent-reported early childhood neurodevelopmental outcomes: an application of propensity score calibration to adjust for unmeasured confounding by migraine severity

Fri, 03/04/2016 - 12:24pm

PURPOSE: Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children.

METHODS: Using data from the Norwegian Mother and Child Cohort Study, we used propensity score matching to examine associations between prenatal triptan exposure and psychomotor function, communication, and temperament. We used an external validation study to perform propensity calibration to adjust effect estimates for confounders unmeasured in the main study (migraine severity, type, and maternal attitudes towards medication use).

RESULTS: We identified 4204 women who reported migraine headache at baseline, of which 375 (8.9%) reported using a triptan greater than or equal to once during pregnancy. Children with prenatal triptan exposure had 1.37-fold greater unadjusted odds of fine motor problems (95% confidence interval (CI): 1.06-1.77), which decreased after propensity score matching (odds ratio (OR): 1.29, 95%CI 0.97-1.73) and was further attenuated after calibration (OR: 1.25, 95%CI 0.89-1.74). We observed no increased risk for gross motor or communication problems, and no differences in temperament. Adjustment for migraine severity using propensity score calibration had a moderate impact on effect estimates, with percent changes ranging from 2.4% to 50%.

CONCLUSIONS: Prenatal triptan exposure was not associated with psychomotor function, communication problems, or temperament in 3-year-old children. Adjustment for migraine severity reduced effect estimates and should be considered in future studies of the safety of triptans during pregnancy.

Trauma-Informed Care in the Massachusetts Child Trauma Project

Fri, 03/04/2016 - 12:24pm

Child maltreatment is a serious public health concern, and its detrimental effects can be compounded by traumatic experiences associated with the child welfare (CW) system. Trauma-informed care (TIC) is a promising strategy for addressing traumatized children's needs, but research on the impact of TIC in CW is limited. This study examines initial findings of the Massachusetts Child Trauma Project, a statewide TIC initiative in the CW system and mental health network. After 1 year of implementation, Trauma-Informed Leadership Teams in CW offices emerged as key structures for TIC systems integration, and mental health providers' participation in evidence-based treatment (EBT) learning collaboratives was linked to improvements in trauma-informed individual and agency practices. After approximately 6 months of EBT treatment, children had fewer posttraumatic symptoms and behavior problems compared to baseline. Barriers to TIC that emerged included scarce resources for trauma-related work in the CW agency and few mental providers providing EBTs to young children. Future research might explore variations in TIC across service system components as well as the potential for differential effects across EBT models disseminated through TIC.

Results of repeated percutaneous interventions on failing arteriovenous fistulas and grafts and factors affecting outcomes

Fri, 03/04/2016 - 12:24pm

OBJECTIVE: Repeated percutaneous interventions on failing arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) for hemodialysis are common, but the outcomes are largely unknown. We sought to determine the results of the second percutaneous intervention on failing AVGs and AVFs and to identify factors associated with loss of patency.

METHODS: For the purpose of this study, the second percutaneous intervention was identified as the index procedure. We reviewed the second percutaneous interventions on failing AVFs and AVGs at a single institution between 2007 and 2013. Patient comorbidities, graft or fistula configuration, lesion characteristics, and procedural characteristics of the intervention performed were analyzed with respect to technical success, primary patency, primary assisted patency, and secondary patency. Patency was defined per Society for Vascular Surgery recommended reporting standards and was determined from the time of the index procedure. Cox proportional hazards multivariable modeling was performed to identify independent determinants of loss of patency.

RESULTS: Among 91 patients, 96 second-time percutaneous interventions were performed on 52 AVFs and 44 AVGs. Patients included 56% men and 44% women with a mean age of 64 +/- 17 years. The lesions intervened on were primarily located along the accessed portion of the outflow in AVFs and within the length of the graft and at the venous anastomosis in AVGs. Transluminal angioplasty alone was performed in 82 procedures (85%), and uncovered or covered stents were placed in 15 procedures (16%). Pharmacomechanical thrombectomy was performed in 32 patients (34%) and was more commonly performed in AVGs compared with AVFs (53% vs 17%; P = .0002). Technical success was achieved in 90 procedures (97%; n = 92). One-year primary patency, assisted primary patency, and secondary patency rates were 35%, 86%, and 86%, respectively. One-year primary patency did not differ between AVFs and AVGs, but secondary patency was lower for AVG in comparison to AVF (P = .04). On multivariable analysis, only the need for pharmacomechanical thrombectomy significantly predicted failure of primary patency (hazard ratio, 2.6; 95% confidence interval, 1.6-4.3). The presence of an AVG rather than an AVF independently predicted failure of secondary patency (hazard ratio, 2.9; 95% confidence interval, 1.0-8.2).

CONCLUSIONS: The second percutaneous interventions on AVFs and AVGs are associated with excellent technical success but poor primary patency. The need for pharmacomechanical thrombectomy predicts the need for additional percutaneous intervention to maintain patency. With additional interventions, acceptable secondary patency out to 5 years can be achieved, although AVGs have inferior secondary patency to AVFs. To develop optimal practice management algorithms, the effectiveness of repeated percutaneous interventions for failing AVGs and AVFs vs creation of a new access should be further investigated.

Intracranial hemorrhage with target specific oral anticoagulants in patients with atrial fibrillation: An updated meta-analysis of randomized controlled trials

Fri, 03/04/2016 - 12:23pm

Although individual trials with Target Specific Oral Anticoagulants (TSOACs) have shown decreased rates of intracranial hemorrhage (ICH), there is limited data regarding the absolute and relative benefit of TSOACs in prevention of ICH. We performed a meta analysis to evaluate the absolute risk of ICH with TSOACs in patients with atrial fibrillation (AF), using data from the most recent clinical trials.

A comparative evaluation of risk-adjustment models for benchmarking amputation-free survival after lower extremity bypass

Fri, 03/04/2016 - 12:23pm

BACKGROUND: Providing patients and payers with publicly reported risk-adjusted quality metrics for the purpose of benchmarking physicians and institutions has become a national priority. Several prediction models have been developed to estimate outcomes after lower extremity revascularization for critical limb ischemia, but the optimal model to use in contemporary practice has not been defined. We sought to identify the highest-performing risk-adjustment model for amputation-free survival (AFS) at 1 year after lower extremity bypass (LEB).

METHODS: We used the national Society for Vascular Surgery Vascular Quality Initiative (VQI) database (2003-2012) to assess the performance of three previously validated risk-adjustment models for AFS. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular (FINNVASC) registry, and the modified Project of Ex-vivo vein graft Engineering via Transfection III (PREVENT III [mPIII]) risk scores were applied to the VQI cohort. A novel model for 1-year AFS was also derived using the VQI data set and externally validated using the PIII data set. The relative discrimination (Harrell c-index) and calibration (Hosmer-May goodness-of-fit test) of each model were compared.

RESULTS: Among 7754 patients in the VQI who underwent LEB for critical limb ischemia, the AFS was 74% at 1 year. Each of the previously published models for AFS demonstrated similar discriminative performance: c-indices for BASIL, FINNVASC, mPIII were 0.66, 0.60, and 0.64, respectively. The novel VQI-derived model had improved discriminative ability with a c-index of 0.71 and appropriate generalizability on external validation with a c-index of 0.68. The model was well calibrated in both the VQI and PIII data sets (goodness of fit P = not significant).

CONCLUSIONS: Currently available prediction models for AFS after LEB perform modestly when applied to national contemporary VQI data. Moreover, the performance of each model was inferior to that of the novel VQI-derived model. Because the importance of risk-adjusted outcome reporting continues to increase, national registries such as VQI should begin using this novel model for benchmarking quality of care.