A retrospective study was conducted to determine the frequency and nature of groin complications when the Angio-Seal device was used on 252 occasions by one operator immediately following interventional (66%) and diagnostic (34%) procedures. Sixty-nine percent of the 238 successfully deployed cases received ticlopidine or clopidogrel, 16% received abciximab, and 15% received heparin postprocedure. Complications included vascular surgery for collagen plug perforation into the femoral artery (0.8%), failure to deploy (5.6%), pseudoaneurysm (0.4%), brisk, visible bleeding (9%), persistent ooze (14%), hematoma > 6 cm (0.8%), hematoma </= 6 cm (2.4%), and ecchymosis > 1 cm(2) (10%). Multivariate analysis identified diagnostic cases (6 Fr sheaths) to be associated with a reduced risk of complications [odds ratio (OR) 0.1] while interventional procedures (8 Fr sheaths), postprocedure heparin, and body mass index (BMI) < 28 (OR 10.1, 3.2, and 2.8, respectively) were associated with increased risk. Gender, age, ticlopidine, clopidogrel, and abciximab were not independent predictors of complications. A learning curve for device deployment was observed in the first 50 cases (14% nondeployment vs. 3.5% for the subsequent 202 procedures, P = 0.009) and failure to deploy was independent of sheath size used. Angio-Seal can be used with reasonable safety and efficacy immediately after diagnostic and interventional procedures. Cathet. Cardiovasc. Intervent. 48:162-166, 1999.
Copyright 1999 Wiley-Liss, Inc.