Introduction
The study aimed to compare the efficacy and safety of the Exoseal-Cordis vascular closure device (VCD) with manual compression for achieving hemostasis after endovascular procedures. The device is an active percutaneous mechanical device for arterial occlusion that employs a bioabsorbable polyglycolic acid plug placed around the introducer sheath to quickly achieve hemostasis and enable early mobilization.
The study sample consisted of 20 patients who underwent diagnostic or therapeutic endovascular surgery procedures between December 2014 and July 2015 at two hospitals in Maringa, Brazil. Patients were randomized into one of two groups: those treated with the Exoseal-Cordis VCD and those treated with manual compression alone. The device is contraindicated in highly calcified arteries, arteries with diameters of less than 5 mm, and patients with an allergy to polyglycolic acid.
Results
There was no significant difference in skin-artery depth between the groups. The duration of compression in the VCD group was 2 minutes, while in the MC group it was 21.2 ± 11 minutes (p = 0.0005). The delay before returning to mobility of the punctured lower limb was 2.35 ± 0.75 hours in the VCD group and 6 hours in the MC group (p = 0.0005). There were no complications reported.
The study concludes that hemostasis by manual compression is equally effective as the use of a VCD, but the duration of compression and delay before resumption of activity are shorter in patients treated with the device. The results support already-published data demonstrating the benefits of using a VCD, including shorter duration of compression and earlier mobilization. However, the debate over the financial impact of using a VCD remains ongoing, with some studies suggesting that the cost of the device would outweigh the benefits in certain situations.
Manual:
Download: Technical evaluation of Exoseal-Cordis vascular closure device
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