Abstract Objective To update the “Testosterone Therapy in Men With Androgen Deficiency Syndromes” guideline published in 2010. Participants The participants include an Endocrine Society–appointed task force of 10 medical content experts and a clinical practice guideline methodologist. Evidence This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus Process One group meeting, several conference calls, and e-mail communications facilitated consensus development. Endocrine Society committees and members and the cosponsoring organization were invited to review and comment on preliminary drafts of the guideline. Conclusions We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone–binding globulin, we recommend obtaining a free T concentration using either equilibrium dialysis or estimating it using an accurate formula. In men determined to have androgen deficiency, we recommend additional diagnostic evaluation to ascertain the cause of androgen deficiency. We recommend T therapy for men with symptomatic T deficiency to induce and maintain secondary sex characteristics and correct symptoms of hypogonadism after discussing the potential benefits and risks of therapy and of monitoring therapy and involving the patient in decision making. We recommend against starting T therapy in patients who are planning fertility in the near term or have any of the following conditions: breast or prostate cancer, a palpable prostate nodule or induration, prostate-specific antigen level > 4 ng/mL, prostate-specific antigen > 3 ng/mL in men at increased risk of prostate cancer (e.g., African Americans and men with a first-degree relative with diagnosed prostate cancer) without further urological evaluation, elevated hematocrit, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, uncontrolled heart failure, myocardial infarction or stroke within the last 6 months, or thrombophilia. We suggest that when clinicians institute T therapy, they aim at achieving T concentrations in the mid-normal range during treatment with any of the approved formulations, taking into consideration patient preference, pharmacokinetics, formulation-specific adverse effects, treatment burden, and cost. Clinicians should monitor men receiving T therapy using a standardized plan that includes: evaluating symptoms, adverse effects, and compliance; measuring serum T and hematocrit concentrations; and evaluating prostate cancer risk during the first year after initiating T therapy.
Hemodynamic characteristics of stable and unstable vertebrobasilar dolichoectatic and fusiform aneurysms
Background and purpose Vertebrobasilar dolichoectatic and fusiform aneurysms (VBDAs) are known to have a poor natural history, with high rates of growth, rupture, and stroke. The purpose of this study was to identify hemodynamic characteristics that differ between VBDAs associated with growth, rupture, and stroke. Materials and methods VBDAs with CT angiography or MR angiography followed longitudinally without treatment were studied. Unstable aneurysms were defined as those that grew or ruptured during follow-up. Aneurysms associated with stroke were defined as those associated with posterior circulation infarct at follow-up. Baseline data, including demographics, comorbidities, and aneurysm morphology and size were collected. Image based computational fluid dynamics models were created and run under pulsatile flow conditions. Relevant hemodynamic and geometric variables were calculated and compared between groups (stable vs unstable and no stroke vs stroke) using the Wilcoxon test. Results A total of 37 VBDAs were included (24 stable, 13 unstable; 30 no stroke, 7 stroke). Unstable aneurysms had lower shear rates (P=0.05), blood flow velocity (P=0.03), and lower vorticity (P=0.049) than stable aneurysms. In addition, unstable aneurysms had higher mean oscillatory shear indices (P=0.001). There were no differences in the hemodynamic characteristics of aneurysms in the stroke group compared with the non-stroke group. Conclusion This small study suggests there may be hemodynamic differences between unstable and stable VBDAs. Unstable VBDAs appear to be under lower flow conditions with lower velocity, vorticity, and shear rates, and have more oscillatory flow. There was no difference in the hemodynamic characteristics of aneurysms in the stroke and no stroke group.
Goals: The goal of this study is to examine the causes, type of adverse events (AE), and effects of elective intubation in outcomes associated with esophageal food impaction (EFI). Background: EFI is a gastrointestinal emergency requiring immediate medical attention. Study: Retrospective review of all EFI cases presenting at 3 large tertiary centers from October 1, 2011 to October 31, 2014 and all cases registered in the Clinical Outcome Research Initiative (CORI) database from January 1, 2000 to December 31, 2012. Statistical analysis compared health care utilization, AEs, and outcomes in patients with or without elective intubation. Results: A total of 214 cases presenting with EFI at our 3 referral hospitals and 4950 cases in the CORI database met inclusion criteria. Prevalence of structural disorders was similar in the Mayo Clinic and CORI datasets: 24.3% and 27.7% had strictures, and 3.8% and 2.5% had a tumor, respectively. AEs in the nonintubation group were 14.7% compared with 33.3% in the elective intubation group (P=0.003); however, 71.0% of these events were associated with EFI itself and not therapeutic procedure. Esophageal AEs were common (15.0%), followed by pulmonary and cardiovascular events with 3.0% and 1.4%, respectively. Severity of the AEs was influenced by the impaction-to-endoscopy time. Conclusions: Prevalence of structural esophageal disorders was similar to previous smaller studies. Elective intubation was associated with increased AEs; however, this is felt to be because of the nature of EFI itself and not by therapeutic endoscopy. Prolonged impaction-to-endoscopy time was associated with severe AEs.
Temporal trends of in‐hospital complications associated with catheter ablation of atrial fibrillation in the United States: An update from Nationwide Inpatient Sample database (2011–2014)
AbstractBackgroundCatheter ablation is widely accepted intervention for atrial fibrillation (AF) refractory to antiarrhythmic drugs, but limited data are available regarding contemporary trends in major complications and in‐hospital mortality due to the procedure. This study was aimed at exploring the temporal trends of in‐hospital mortality, major complications, and impact of hospital volume on frequency of AF ablation–related outcomes.MethodsThe Nationwide Inpatient Sample database was utilized to identify the AF patients treated with catheter ablation. In‐hospital death and common complications including vascular access complications, cardiac perforation and/or tamponade, pneumothorax, stroke, and transient ischemic attack, were identified using International Classification of Disease (ICD‐9‐CM) codes.ResultIn‐hospital mortality rate of 0.15% and overall complication rate of 5.46% were noted among AF ablation recipients (n = 50,969). Significant increase in complications during study period (relative increase 56.37%, P‐trend < 0.001) was observed. Cardiac (2.65%), vascular (1.33%), and neurological (1.05%) complications were most common. On multivariate analysis (odds ratio [OR]; 95% confidence interval [95% CI]; P value), significant predictors of complications were female sex (OR = 1.40; CI = 1.17–1.68; P value < 0.001), high burden of comorbidity as indicated by Charlson Comorbidity Index ≥2 (OR = 2.84; CI = 2.29–3.52; P value < 0.001), and low hospital volume (< 50 procedures).ConclusionOur study noted a decline in AF ablation–related hospitalizations and complications associated with the procedure. These findings largely reflect shifting trends of outpatient performance of the procedure and increasing safety profile due to improved institutional expertise and catheter techniques.
Contained right atrial rupture: an unusual presentation of a rare primary cardiac tumour
Nonalcoholic fatty liver disease (NAFLD) is a burgeoning health problem worldwide and an important risk factor for both hepatic and cardiometabolic mortality. The rapidly increasing prevalence of this disease and of its aggressive form nonalcoholic steatohepatitis (NASH) will require novel therapeutic approaches based on a profound understanding of its pathogenesis to halt disease progression to advanced fibrosis or cirrhosis and cancer. The pathogenesis of NAFLD involves a complex interaction among environmental factors (i.e., Western diet), obesity, changes in microbiota, and predisposing genetic variants resulting in a disturbed lipid homeostasis and an excessive accumulation of triglycerides and other lipid species in hepatocytes. Insulin resistance is a central mechanism that leads to lipotoxicity, endoplasmic reticulum stress, disturbed autophagy, and, ultimately, hepatocyte injury and death that triggers hepatic inflammation, hepatic stellate cell activation, and progressive fibrogenesis, thus driving disease progression. In the present review, we summarize the currently available data on the pathogenesis of NAFLD, emphasizing the most recent advances. A better understanding of NAFLD/NASH pathogenesis is crucial for the design of new and efficient therapeutic interventions.
Risk of Suicidal Behavior With Use of Efavirenz: Results from the Strategic Timing of Antiretroviral Treatment Trial