Predictors of complications and learning curve using the Angio-SealTM closure device following interventional and diagnostic catheterization
✍ Scribed by Benjamin S. Warren; Stafford G. Warren; Scott D. Miller
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 74 KB
- Volume
- 48
- Category
- Article
- ISSN
- 1522-1946
No coin nor oath required. For personal study only.
✦ Synopsis
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 G 6 cm (0.8%), hematoma I 6 cm (2.4%), and ecchymosis G 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) F 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,