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Predictors of complications and learning curve using the Angio‐Seal TM closure device following interventional and diagnostic catheterization
Author(s) -
Warren Benjamin S.,
Warren Stafford G.,
Miller Scott D.
Publication year - 1999
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/(sici)1522-726x(199910)48:2<162::aid-ccd8>3.0.co;2-2
Subject(s) - medicine , clopidogrel , abciximab , vascular closure device , ticlopidine , hematoma , surgery , arteriotomy , ecchymosis , pseudoaneurysm , femoral artery , complication , radiology , aspirin , myocardial infarction , percutaneous coronary intervention , artery
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. © 1999 Wiley‐Liss, Inc.