EFFICACY AND SAFETY OF A HEMOSTATIC PUNCTURE CLOSURE DEVICE WITH EARLY AMBULATION AFTER CORONARY ANGIOGRAPHY

A collagen hemostatic puncture closure device has been developed as an alternative to traditional manual pressure techniques for achieving e ffective femoral arterial hemostasis after coronary angiography, The p urpose of the current study was to determine if patients receiving thi s device can ambulate safely at 1 hour compared with patients receivin g traditional manual pressure and bed rest after sheath removal for di agnostic cardiac catheterization, Patients (n = 304) were randomized t o either the device group (n = 202) with ambulation at 1 hour after sh eath removal or to the manual pressure control group (n = 102) with am bulation at 4 to 6 hours after sheath removal. The device group achiev ed earlier time to hemostasis (0.9 +/- 3 vs 17.0 +/- 8 minutes, p = 0. 0001) and faster time to outpatient discharge (5.0 +/- 4 vs 7.7 +/- 4 hours, p = 0.0001) compared with the control group, There were bleedin g or vascular complications in 19 patients (9%) in the device group an d in 6 patients (6%) in the manual pressure group (p = 0.397). In pati ents undergoing diagnostic coronary angiography, this device, compared with traditional techniques for achieving hemostasis after sheath rem oval, allows for faster time to effective hemostasis with resultant ea rlier discharge from the hospital. (C) 1998 by Excerpta Medica, Inc.