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 nature of groin complications when the Vasoseal (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone balloon angioplasty (53%), coronary stenting (20%), and diagnostic angiography (27%). Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late external bleeding (2%), purulent discharge (1.5%), a minor ooze of blood (7%), hematomas >6 cm (6%), and hematomas < or = 6 cm (7%). One or more complications occurred with 64 of 204 (30.5%) uses. Multivariate analysis identified diagnostic angiography to be associated 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 with increased risk. This complication rate is similar to other reported series except for a higher rate of vascular surgery. The high incidence of anticoagulation in our study patients (94%) may explain this difference. We recommend caution and adherence to the recommended technique when the device is used in anticoagulated patients.