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

Dale R Tavris; Beverly Albrecht Gallauresi; Ba Lin; Suzanne E Rich; Richard E Shaw; William S Weintraub; Ralph G Brindis; Kathleen Hewitt

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

J Invasive Cardiol. 2004 Sep;16(9):459-64.

Authors

Dale R Tavris¹, Beverly Albrecht Gallauresi, Ba Lin, Suzanne E Rich, Richard E Shaw, William S Weintraub, Ralph G Brindis, Kathleen Hewitt

Affiliation

¹ Food and Drug Administration, Center for Devices and Radiological Health, Division of Postmarket Surveilance, USA. drt@cdrh.fda.gov

PMID: 15353824

Abstract

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.

Publication types

Comparative Study
Multicenter Study

MeSH terms

Analysis of Variance
Cardiac Catheterization / adverse effects*
Case-Control Studies
Collagen
Coronary Disease / physiopathology
Coronary Disease / therapy*
Equipment Design
Female
Femoral Artery*
Hemorrhage / etiology
Hemorrhage / prevention & control*
Hemostasis / physiology
Hemostatic Techniques / instrumentation*
Humans
Logistic Models
Male
Multivariate Analysis
Risk Factors
Sex Factors
Suture Techniques / instrumentation

Substances

Collagen