DEPARTMENT MEDICAL AND RESEARCH CENTER, TEHRAN, IRAN
Background: Reports to the FDA of local vascular complications associated with the use of hemostasis devices following cardiac catheterizations and resulting in serious injuries have raised concerns about the safety of these devices. A review of the medical literature also has posed cause for concern. We performed this study to assess the efficacy and risks of local adverse events in hemostasis following cardiac catheterization with N-Acetylglucosamine facilitated manual compression versus manual compression alone.
Methods: N-Acetylglucosamine was used for hemostasis in 205 patients who underwent diagnostic cardiac catheterization performed via femoral access at a single site. Another 205 patients underwent diagnostic cardiac catheterization and received routine manual compression and served as the control group. Ambulation was permitted 12 hours after manual compression and 6 hours after using N-Acetylglucosamine. Poisson regression analysis using four different outcomes was used to assess the risk associated with the type of hemostasis, while controlling for confounding variables.
Results: Overall, the unadjusted incidence of any vascular complication was 4.8% for the manual compression and 5.4% for the N-Acetylglucosamine group. No serious adverse events were seen in this study.
Conclusions: N-Acetylglucosamine does not appear to pose a greater risk for local vascular complications following cardiac catheterization than the manual compression method. This method permitted early ambulation and was as safe as manual compression.