Usefulness of collagen plugging with VasoSeal (R) after PTCA as compared to manual compression with identical sheath dwell times (Reprinted from Catheterization and Cardiovascular Diagnosis, vol 43, pg 421-427, 1998)

This study investigated the usefulness of collagen plugging with VasoSeaL(R ) (Datascope Corporation, Montvale, New Jersey) in patients after PTCA comp ared to a control group having identical sheath dwell times and therefore c omparable Levels of anticoagulation. A total of 150 patients were enrolled in this prospective and randomized study. Sheaths were pulled at exactly 5 hours after arterial puncture. Time to hemostasis and local complications w ere determined. There were no statistical differences in baseline character istics. The mean time to hemostasis in the collagen group was significantly shorter (3 +/- 3 minutes) than that of the control group (17.4 +/- 7 minut es). At 24 hours, 23% of the collagen group patients had a small, 1% a medi um and 4% a large hematoma. In the control group, 32% had a small and 4% a medium-sized hematoma, but no patient a large hematoma. After collagen, one patient developed a pseudoaneurysm needing vascular surgery. In the contro l group, no major complications occurred. Compared to patients with manual compression at an identical sheath dwell t ime and an identical level of anticoagulation, there was a significant redu ction in time to hemostasis but no statistical difference regarding local c omplications. Although the incidence of medium or large hematoma was low, t he trend towards a decreased risk of smaller hematomas seemed to be counter balanced by an increased risk of larger hematomas.