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.
Tavris
Dale R
DR
Food and Drug Administration, Center for Devices and Radiological Health, Division of Postmarket Surveilance, USA. drt@cdrh.fda.gov
Gallauresi
Beverly Albrecht
BA
Lin
Ba
B
Rich
Suzanne E
SE
Shaw
Richard E
RE
Weintraub
William S
WS
Brindis
Ralph G
RG
Hewitt
Kathleen
K
D000704:Analysis of Variance; D006328:Cardiac Catheterization / Q000009:adverse effects*; D016022:Case-Control Studies; D003094:Collagen; D003327:Coronary Disease / Q000503:physiopathology / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006487:Hemostasis / Q000502:physiology; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D012307:Risk Factors; D012737:Sex Factors; D013536:Suture Techniques / Q000295:instrumentation
D003094:Collagen