Short-Term Safety and Efficacy of Femoral Vascular Closure after Percutaneous Coronary Intervention with Combination of the Boomerang™ Device and Intravenous Protamine Sulfate

Background: The Cardiva Boomerang (TM) is a device used to perform femoral vascular closure. It facilitates passive hemostasis at the arteriotomy site, leaving no residual foreign body. Methods: We performed a controlled, randomized study of 60 patients undergoing percutaneous coronary intervention. Patients were randomized into two groups (30 per group) to undergo vascular closure with the Boomerang (TM) or the Perclose (TM) suture-based device after the intravenous administration of protamine sulfate. We compared overall success rates, patient-reported pain, length of time to achieve hemostasis and mobilization of the patient, and the frequency of complications in the two groups. Results: Overall success rates using the Boomerang (TM) and perclose (TM) devices were similarly high, at 93% and 97%, respectively. The Boomerang (TM) was significantly quicker to deploy than the Perclose (TM), device deployment time, median (Q1-Q3), [2.00 (1.33-2.75) vs. 3.84 (2.75-4.38) mins, p < 0.001)]. The pain score was significantly lower in the Boomerang (TM) group (1.1 +/- 1.7 vs. 6.4 +/- 2.9, p < 0.001). The time the device remained in the artery and manual compression time were significantly longer with the Boomerang (TM) (p < 0.001), as well as the time taken to achieve hemostasis and time to ambulation. There were no major complications in either group and no significant differences between the groups in the frequency of minor complications. Conclusions: We conclude that when used in combination with intravenous protamine sulfate, the Boomerang (TM) device is as safe and effective as the Perclose (TM) device for femoral vascular closure, but quicker to deploy and less painful to patients.