Pain and discomfort in closure of femoral access coronary angiography. the CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study

Abstract

Background: Pain and discomfort in relation to vascular closure are the predominant patient complaints after coronary angiography (CAG). No large-scale randomized studies have evaluated pain and discomfort after CAG with access site closure by manual compression versus a vascular closure device (VCD). Aim: To compare pain and discomfort after femoral artery closure by manual compression versus FemoSeal® VCD. Methods: The study is a sub study to the CLOSE-UP study, a randomized, single centre comparison of FemoSeal® VCD versus manual compression after CAG. Pain and discomfort score was assessed immediately after the closure procedure, at time for mobilization, at discharge and after 14 days. Results: 1014 patients were included and 1001 patients entered analysis. In-hospital follow-up was obtained for all patients and 14-day follow-up was completed for 96% of patients. The closure procedure lasted 1 (11) min in the FemoSeal®VCD group and 8 (610) min in the manual compression group. Pain and discomfort score at the procedure was significantly higher in the FemoSeal®VCD group. No differences in pain and discomfort were detected after leaving the catheterization laboratory. Conclusion: Closure of femoral access after CAG by the FemoSeal®VCD was associated with significantly more pain and discomfort compared with closure by manual compression. No difference in pain and discomfort was found at follow-up. © 2013 The European Society of Cardiology.