GROIN COMPLICATIONS ASSOCIATED WITH COLLAGEN PLUG CLOSURE OF FEMORAL ARTERIAL PUNCTURE SITES IN ANTICOAGULATED PATIENTS

A retrospective study was conducted to determine the frequency and nat ure of groin complications when the Vasoseal(TM) (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone ba lloon angioplasty (53%), coronary stenting (20%), and diagnostic angio graphy (27%), Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late e xternal bleeding (2%), purulent discharge (1.5%), a minor ooze of bloo d (7%), hematomas >6 cm (6%), and hematomas less than or equal to 6 cm (7%), One or more complications occurred with 64 of 204 (30.5%) uses, Multivariate analysis identified diagnostic angiography to be associa ted with a reduced risk of complications [odds ratio (OR) 0.25], while stent procedure (OR 2.7) and female gender (OR 2.5) were associated w ith increased risk, This complication rate is similar to other reporte d series except for a higher rate of vascular surgery, The high incide nce of anticoagulation in our study patients (94%) may explain this di fference. We recommend caution and adherence to the recommended techni que when the device is used in anticoagulated patients. (C) 1998 Wiley -Liss, Inc.