Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II.
OBJECTIVE
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.
Tavris
Dale R
DR
Food and Drug Administration, Center for Devices and Radiological Health, Division of Postmarket Surveillance, Rockville, Maryland, USA.
Dey
Syamal
S
Albrecht-Gallauresi
Beverly
B
Brindis
Ralph G
RG
Shaw
Richard
R
Weintraub
William
W
Mitchel
Kristi
K
D006328:Cardiac Catheterization / Q000009:adverse effects*; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000209:etiology; D004867:Equipment Design; D005260:Female; D006406:Hematoma / Q000453:epidemiology / Q000209:etiology; D006470:Hemorrhage / Q000453:epidemiology / Q000209:etiology; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D016017:Odds Ratio; D012042:Registries; D018570:Risk Assessment