Early sheath removal after coronary artery interventions with use of a suture-mediated closure device: Clinical outcome and results of Doppler US evaluation

PURPOSE: To evaluate the safety and efficacy of a suture-mediated closure d evice by comparing clinical outcomes of its use to those of manual compress ion and by using Doppler ultrasound (US) examination. MATERIALS AND METHODS: One hundred patients were randomized to treatment wi th either suture-mediated closure (n = 50) or manual compression (n = 50) a fter percutaneous transluminal coronary angioplasty (PTCA), The 50 patients randomized to receive suture-based treatment were allowed to get out of be d 4 hours after the procedure, whereas bed rest was required for 1 day in t he patients treated with manual compression. All patients underwent clinica l and US examination before getting out of bed and before discharge from th e hospital. RESULTS: Forty-seven of 50 patients randomized to undergo suture-mediated c losure were ambulatory the day of intervention, in 6.2 hours +/- 4.7 (mean +/- SE) after undergoing PTCA, The results of the US examination for these patients demonstrated the absence of bleeding complications after getting o ut of bed. All patients treated with use of manual compression were ambulat ory the following day, 18.3 hours +/- 2.2 after undergoing PTCA. There was no difference in the occurrence of vascular complications between the two g roups. CONCLUSION: Suture-based closure is a safe and effective method of achievin g immediate hemostasis and shorter bed rest without increasing the risk of bleeding complications in PTCA procedures.