Rapid hemostasis of arterial puncture sites with collagen in patients undergoing diagnostic and interventional cardiac catheterization

Abstract

Despite the continuous reduction of sheath sizes in diagnostic and interventional cardiac catheterizations and the discontinuation of coumadin use after coronary stent implantation, a challenging role remains for hemostatic devices in the sealing femoral puncture sites. Since the introduction of the vascular hemostatic device (VHD) in 1991 and the hemostatic puncture closing device (HPCD) in 1992, numerous studies investigating these devices have been published. The deployment success rates reported in 2,292 patients for VHD is 97%, ranging from 88 to 100%. For HPCD, the mean deployment success rate resulting from 622 published patients leads to an identical result of 97%, ranging between 91 and 100%. For time to hemostasis, data have been analyzed according to the four different clinical situations, depending on level of anticoagulation (none or full) and the time of sheath removal (immediate or delayed). In randomized studies, when compared with the manual control groups, both devices revealed a statistically significant reduction in time to hemostasis: 12 to 16 minutes less for diagnostic catheterization and 14 to 30 minutes less for PTCA. As for minor local complications, no clinically relevant differences seem to exist. None of these devices has been proven to reduce major local complications. Prospective trials addressing early mobilization after percutaneous transluminal coronary angioplasty and the cost effectiveness of arterial closure devices in defined subgroups are warranted.