Vascular hemostasis bandage compared to standard manual compression after cardiac catheterization in children.

BACKGROUND Femoral venous and arterial approaches are the commonly used to obtain vascular access for pediatric cardiac catheterization. Hemostasis after catheter removal is usually obtained by manual compression. However, this technique is time consuming and at times painful. Although several closure devices are available for adults, they are not widely applicable in children. OBJECTIVES To evaluate the safety and efficacy of a microporous polysaccharide hemospheres hemostasis (MPH) bandage compared to manual compression. METHODS Prospective randomized study, involving 112 children after cardiac catheterization. One group received the MPH bandage, another manual compression. Compression time was predetermined by the size of sheath plus one minute. Success was defined as no bleeding or hematoma formation. If bleeding continued, compression was continued as needed and time to hemostasis recorded. Informed consent was obtained prior to randomization. Group comparisons were performed with a Student's t, Pearson's Chi Square, and Fisher's exact test as appropriate. RESULTS Fewer children required a compression time of >15 min (P = 0.006) and more had a shorter time to hemostasis (P = 0.003) in the MPH group for venous access control. Time to hemostasis was also shorter in the MPH (P = 0.048) in arterial access cases, but the number of children requiring a compression time >15 min was the same. Complications including hematoma formation in each group were similar. CONCLUSIONS The MPH bandage allows a shorter time to achieve hemostasis compared to manual compression. This improves turnaround time and laboratory efficiency.