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. METHODS: Of 1089 sites that submitted data to the CathPCI Registry from 2005 through the second quarter of 2009, a total of 1,819,611 percutaneous coronary intervention (PCI) procedures performed via femoral access site were analyzed. Assessed outcomes included bleeding, femoral artery occlusion, embolization, artery dissection, pseudoaneurysm, and arteriovenous fistula. Seven types of hemostasis strategy were evaluated for rate of "any bleeding or vascular complication" compared to MC controls, using hierarchical multiple logistic regression analysis, controlling for demographic factors, type of hemostasis, several indices of co-morbidity, and other potential confounding variables. Rates for different types of hemostasis strategy were plotted over time, using linear regression analysis. RESULTS: Four of the VCDs and hemostasis patches demonstrated significantly lower bleeding or vascular complication rates than MC controls: Angio-Seal (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.65-0.70); Perclose (OR, 0.54; CI, 0.51-0.57); StarClose (OR, 0.77; CI, 0.72-0.82); Boomerang Closure Wire (OR, 0.63; CI, 0.53-0.75); and hemostasis patches (OR, 0.70; CI, 0.67-0.74). All types of hemostasis strategy, including MC, exhibited reduced complication rates over time. All trends were statistically significant except one. CONCLUSIONS: This large, nationally representative observational study demonstrated better safety profiles for most of the frequently used VCDs, compared to MC controls.

Pharmacotherapy and pregnancy: highlights from the Third International Conference for Individualized Pharmacotherapy in Pregnancy.

To address provider struggles to provide evidence-based, rational drug therapy to pregnant women, this third Conference was convened to highlight the current progress and research in the field. Speakers from academic centers, industry, and governmental institutions spoke about: the Food and Drug Administration's role in pregnancy pharmacology and the new labeling initiative; drug registries in pregnancy; the pharmacist's role in medication use in pregnancy; therapeutic areas such as preterm labor, gestational diabetes, nausea and vomiting in pregnancy, and hypertension; breast-feeding and medications; ethical challenges for consent in pregnancy drug studies; the potential for cord blood banks; and concerns about the fetus when studying drugs in pregnancy. The Conference highlighted several areas of collaboration within the current Obstetrics Pharmacology Research Units Network and hoped to educate providers, researchers, and agencies with the common goal to improve the ability to safely and effectively use individualized pharmacotherapy in pregnancy.

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. RESULTS: Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men. CONCLUSIONS: High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization.

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. Food and Drug Administration) of local vascular complications associated with the use of hemostasis devices following cardiac catheterization and resulting in serious injuries, raised concerns about the safety of these devices. Review of the medical literature also posed cause for concern. METHODS: Data were obtained from the American College of Cardiology-National Cardiovascular Data Registry, modified to suit the needs of this research. It included information from 59 institutions and 13,878 cardiac catheterizations performed during the last quarter of 2003. Multiple logistic regression, using 10 different outcomes, was used to assess the risk associated with type of device and gender, while controlling for demographic and physiologic variables, type of procedure, and several indices of comorbidity. RESULTS: Serious adverse events were reported in 3.37% of patients, the most common being bleeding with hematoma (2.00%). The adjusted odds ratio for women (compared to men) was 1.73 for any vascular complication. Only one hemostasis device, VasoSeal, demonstrated a high risk of any vascular complication compared to manual compression controls (OR = 2.38 [1.47-3.85; p = 0.0004]). This risk was mainly associated with diagnostic cardiac catheterization (OR = 3.36). CONCLUSIONS: VasoSeal appears to pose a greater risk for serious local vascular complications following cardiac catheterization than either manual compression controls or other hemostasis devices. Women have almost twice the risk of men for most local complications.

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.

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 < 0.0001), but there was no significant difference in risks by gender for infection. CONCLUSIONS: Cardiac catheterization is sometimes associated with serious injuries and deaths. Among patients who receive hemostasis devices, the risk of these events are disproportionately greater in women.