Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.

Objectives: This study sought to examine the association between baseline beta-blocker (BB) dose and outcomes in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial.

Background: Beta-blockers reduce morbidity and mortality in chronic heart failure (HF) patients with reduced ejection fraction, but it is unclear whether titrating to higher BB doses improves outcomes in this setting.

Methods: The HF-ACTION trial was a randomized, multicenter trial enrolling 2,331 ambulatory HF patients with systolic dysfunction (New York Heart Association functional class II to IV, left ventricular ejection fraction <0.

Opportunities and challenges in linking information across databases in pediatric cardiovascular medicine.

Multicenter databases are increasingly utilized in pediatric cardiovascular research. In this review, we discuss the rational for using these types of data sources, provide several examples of how large datasets have been utilized in clinical research, and describe different mechanisms for linking databases to enable studies not possible with individual datasets alone.

Biomarkers in cardiovascular clinical trials: past, present, future.

Background: Cardiovascular (CV) clinical trials are instrumental in understanding treatment effects and offer insights into the natural progression of CV disease. Biomarkers are a critical component of patient selection, end point definition, and safety monitoring, and clinical trials provide a platform for the discovery and validation of new biomarkers that may augment the understanding of disease mechanisms, risk stratification, and/or clinical decision-making.

Content: We review the roles that biomarkers have played in CV clinical trials and roles that CV clinical trials have played and will continue to play in the discovery and validation of biomarkers and their implementation in clinical practice.

Center variation in hospital costs for patients undergoing congenital heart surgery.

Background: Congenital heart disease consumes significant health care resources; however, there are limited data regarding factors affecting resource utilization. The purpose of this study was to evaluate variation between centers in total hospital costs for 4 congenital heart operations of varying complexity and associated factors.

Methods And Results: The Premier Database was used to evaluate total cost in children undergoing isolated atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, tetralogy of Fallot (TOF) repair, or arterial switch operation (ASO) from 2001 to 2007.

Storage age of transfused platelets and outcomes after cardiac surgery.

Background: The relationship between duration of platelet (PLT) storage, currently limited to 5days, and surgical outcomes has not been established. We tested the hypothesis that PLT storage age was associated with adverse outcomes.

Study Design And Methods: A retrospective cohort of aortocoronary bypass (CABG) surgery patients from January 1996 to January 2005 receiving one or more PLT transfusions was selected for study.

Use of guidelines-recommended management and outcomes among women and men with low-level troponin elevation: insights from CRUSADE.

Background: Troponin elevation above the upper limit of normal (ULN) is diagnostic of myocardial infarction, but interpretation of "gray-zone" troponin elevations (1 to 1.5x ULN) remains uncertain. Using the CRUSADE database, we explored relationships between sex and treatment and outcomes among patients with troponin 1 to 1.

The Treatment for Adolescents With Depression Study (TADS): outcomes over 1 year of naturalistic follow-up.

Objective: The Treatment for Adolescents With Depression Study (TADS) evaluates the effectiveness of fluoxetine, cognitive-behavioral therapy (CBT), and their combination in adolescents with major depressive disorder. The authors report effectiveness outcomes across a 1-year naturalistic follow-up period.

Method: The randomized, controlled trial was conducted in 13 academic and community sites in the United States.

A financial analysis of operative facial fracture management.

Background: The financial impact of operative facial fracture management has not been systematically investigated. This study aims to provide a descriptive financial analysis of patients undergoing operative facial fracture management at a single academic medical center and the financial impact on the health system.

Methods: The records of 202 patients who underwent operative facial fracture management over a 3-year period (2003 to 2005) were analyzed.

Temporal trends in the use of early cardiac catheterization in patients with non-ST-segment elevation acute coronary syndromes (results from CRUSADE).

We evaluated temporal trends in the use of early (<48 hours) catheterization in patients with non-ST-segment elevation acute coronary syndromes with respect to baseline risk features since publication of the American College of Cardiology/American Heart Association guidelines, which include a class IA recommendation for an early invasive strategy for high-risk patients with non-ST-segment elevation acute coronary syndromes. Overall, we found that early catheterization use increased from 53% to 61% during the 3 years after the guidelines were released, but the increased use of early catheterization was highest (11%) in the group that was at lowest risk of predicted mortality, and it was lowest (6%) in the group at highest risk of predicted mortality who would potentially receive the most benefit from an aggressive treatment approach. In conclusion, despite the overall increase in the use of early catheterization, the gap between the use of an early invasive strategy in the highest and lowest risk patients remains large and tends to increase over time.

Clinical correlates of long-term mortality after percutaneous interventions of saphenous vein grafts.

Background: Increasing number of patients undergo percutaneous intervention of saphenous vein grafts (SVGs). However, the clinical factors associated with long-term mortality after SVG interventions are currently less known. Accordingly, the goal of present study was to evaluate clinical correlates of long-term mortality and to develop a simple bedside tool for risk stratification in patients undergoing SVG interventions.

Clinical outcomes with drug-eluting stents following atheroablation therapies.

Background: Prior studies of atheroablation (directional atherectomy, rotational atherectomy and laser angioplasty) have demonstrated either no advantage or worse outcomes relative to conventional balloon angioplasty. Because these techniques are still required in a minority of patients, we hypothesized that the use of drug-eluting stents (DES) would minimize the rate of major adverse cardiac events (MACE) after atheroablation.

Methods: From 2,252 percutaneous coronary intervention procedures, 212 patients were extracted using case control matching and were analyzed to compare the rate of MACE across four groups (DES with atheroablation, bare-metal stent (BMS) with atheroablation, DES without atheroablation, bare-metal stent without atheroablation).

Discovery of proteins related to coronary artery disease using industrial-scale proteomics analysis of pooled plasma.

Background: Relating a disease state to an entire population of proteins provides an opportunity to gain new insights into a disease.

Methods: Male populations of 53 patients with angiographic coronary artery disease and 53 control subjects without coronary disease from the Duke Databank for Cardiovascular Disease were established and matched for age and race as well as extremes of risk factors. Major plasma protein abnormalities were excluded.

Acute heart failure associated with high admission blood pressure--a distinct vascular disorder?

Background: Although blood pressure (BP) is elevated in patients with acute heart failure (AHF), first admission BP has not been meticulously recorded before treatment in previous studies.

Methods: During three consecutive months, all AHF admissions (335 patients) to a city hospital which provides the sole inpatient medical service for approximately 500,000 people were registered. First BP was recorded before treatment at the first patient encounter in the ambulance or the emergency room.

Acute clopidogrel use and outcomes in patients with non-ST-segment elevation acute coronary syndromes undergoing coronary artery bypass surgery.

Objectives: We sought to characterize patterns of clopidogrel use before coronary artery bypass grafting (CABG) and examine the drug's impact on risks for postoperative transfusions among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS).

Background: Adherence in community practice to American College of Cardiology/American Heart Association guidelines for clopidogrel use among NSTE ACS patients has not been previously characterized.

Methods: We evaluated 2,858 NSTE ACS patients undergoing CABG at 264 hospitals participating in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) Initiative.

Enterococcal prosthetic valve infective endocarditis: report of 45 episodes from the International Collaboration on Endocarditis-merged database.

Enterococcal prosthetic valve infective endocarditis (PVE) is an incompletely understood disease. In the present study, patients with enterococcal PVE were compared to patients with enterococcal native valve endocarditis (NVE) and other types of PVE to determine differences in basic clinical characteristics and outcomes using a large multicenter, international database of patients with definite endocarditis. Forty-five of 159 (29%) cases of definite enterococcal endocarditis were PVE.

Elevated body mass index and intermediate-term clinical outcomes after acute coronary syndromes.

Purpose: Obesity is a coronary disease risk factor, but its independent effect on clinical outcomes following acute coronary syndromes has not been quantified. We evaluated the relationship between elevated body mass index (BMI) and 30-day, 90-day, and 1-year clinical outcomes postacute coronary syndromes.

Subjects And Methods: Using 15 071 patients (normal weight [BMI = 18.

The Child and Adolescent Psychiatry Trials Network (CAPTN).

Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact.

Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical clinical trials model widely used in other areas of medicine.

Results: CAPTN, a collaborative effort of the Duke Clinical Research Institute and the American Academy of Child and Adolescent Psychiatry, will conduct large, simple "practical" trials that provide generalizable answers to important clinical questions without bias.

Novel approaches to clinical trials: device-related infections.

The explosive growth in the use of cardiac devices and the continued large number of thoracic operations produce a significant number of costly infectious complications. These infections represent a leading cause of death and disability after device implantation or surgery. Unfortunately, few objective data are available to validate the clinical epidemiology of surgical and device-related infections, and although the number of randomized trials is increasing, too few have tested strategies for prophylaxis or treatment, particularly in the cardiac arena.