Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: a report from TRANSLATE-ACS.

Background: Data regarding sex-based outcomes after percutaneous coronary intervention (PCI) for myocardial infarction are mixed. We sought to examine whether sex differences in outcomes exist in contemporary practice.

Methods And Results: We examined acute myocardial infarction patients undergoing PCI between April 2010 and October 2012 at 210 US hospitals participating in the Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) observational study.

TransRadial Education and Therapeutics (TREAT): shifting the balance of safety and efficacy of antithrombotic agents in percutaneous coronary intervention: a report from the Cardiac Safety Research Consortium.

Percutaneous coronary intervention (PCI) is an integral part of the treatment of coronary artery disease. The most common complication of PCI, bleeding, typically occurs at the vascular access site and is associated with short-term and long-term morbidity and mortality. Periprocedural bleeding also represents the primary safety concern of concomitant antithrombotic therapies essential for PCI success.

Long-term outcomes after transmyocardial revascularization.

Background: Two independent reports documented substantially higher operative mortality associated with transmyocardial revascularization (TMR) when used in isolation than that reported in the premarket clinical trials. To clarify the state of the art, this article assesses temporal trends in the use of TMR, short-term and long-term outcomes, and outcomes stratified by procedure type (TMR only and TMR + coronary artery bypass graft [CABG]) and by the 2 specific TMR devices.

Methods: The study population included all patients undergoing TMR in isolation or in combination with CABG at 435 cardiothoracic hospitals in the United States participating in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) from January 2000 through November 2006 (n = 15,386).

Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): an evaluation of hemostasis strategies.

Background: Previous research found at least one vascular closure device (VCD) to be associated with excess vascular complications, compared to manual compression (MC) controls, following cardiac catheterization. Since that time, several more VCDs have been approved by the Food and Drug Administration (FDA). This research evaluates the safety profiles of current frequently used VCDs and other hemostasis strategies.

Aneurysm-related mortality rates in the US AneuRx clinical trial.

Background: The AneuRx (Medtronic) stent graft was approved by the FDA in September 1999. The purpose of this study was to ascertain the aneurysm-related mortality rate of a subgroup of the patient cohort from Medtronic's investigational premarket study.

Study Design: There were 931 study subjects, from 19 medical centers, who were followed for an average of 3.

Gender differences in correlates of troponin assay in diagnosis of myocardial infarction.

Cardiac troponins are the most sensitive and specific biomarker for myocardial infarction (MI) diagnosis. If there is a gender bias in MI diagnosis, it could be reduced by more consistently applying objective diagnostic criteria to improve women's outcomes. This study set out to assess the accuracy and correlates of the cardiac troponin I (cTnI) assay in the diagnosis of non-ST-segment elevation MI, to determine how the assay accuracy and correlates vary by gender, and to explore the interaction between factors that may influence cTnI accuracy and affect gender differences in diagnosis.

Risk of local adverse events by gender following cardiac catheterization.

Purpose: To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization.

Methods: The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size.

Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II.

Objectives: To assess the relative risks of serious local adverse events following cardiac catheterization by type of hemostasis device (versus manual compression controls) and gender.

Background: Reports to the FDA (U.S.

Risk of local adverse events following cardiac catheterization by hemostasis device use and gender.

Hemostasis devices are primarily used to stop bleeding from the femoral artery catheterization site after cardiac diagnostic or interventional procedures. Studies assessing the effectiveness of hemostatic devices compared to manual compression have produced mixed results regarding the relative risk of serious adverse events, such as hemorrhage. This study assessed the relative risk of serious complications following the use of the two main types of hemostasis devices (as compared with manual compression), and assessed the relative rates of these complications by gender.

The public health impact of the MiniMed Continuous Glucose Monitoring System (CGMS)-an assessment of the literature.

The Medtronic MiniMed (Northridge, CA) Continuous Glucose Monitoring System (CGMS) was approved by the U. S. Food and Drug Administration in 1999, for the continuous tracking of glucose concentration.

Relative risks of reported serious injury and death associated with hemostasis devices by gender.

Purpose: To assess relative risks by gender of reported serious injuries and deaths associated with the use of hemostasis devices, stratified by year of report, type of injury, and type of device.

Methods: Reports from the Food and Drug Administration's Medical Device Reporting system and National Center for Health Statistics data on use of cardiac catheterization were used to estimate relative risks of reported serious injuries and deaths by gender.

Results: Estimated risks of reported serious injuries and deaths associated with hemostasis devices were two to three times greater in females than in males for hemorrhage and hematoma (p < 0.