Document Detail


Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures.
MedLine Citation:
PMID:  17200896     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.
Authors:
Lakshmi A Ratnam; Jowad Raja; Graham J Munneke; Robert A Morgan; Anna-Maria Belli
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article    
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  30     ISSN:  0174-1551     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:    2007 Mar-Apr
Date Detail:
Created Date:  2007-01-22     Completed Date:  2007-07-20     Revised Date:  2007-11-30    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  182-8     Citation Subset:  IM    
Affiliation:
Department of Radiology, St. George's Hospital, Blackshaw Road, London, SW17 0QT, UK.
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MeSH Terms
Descriptor/Qualifier:
Arterial Occlusive Diseases / surgery
Equipment Design
Equipment Safety
Female
Femoral Artery / surgery*
Hemostasis, Surgical / instrumentation*
Humans
London
Male
Peripheral Vascular Diseases / surgery
Prospective Studies
Punctures / adverse effects,  instrumentation*
Risk Factors
Sex Factors
Thinness
Treatment Outcome
Comments/Corrections
Comment In:
Cardiovasc Intervent Radiol. 2007 Jul-Aug;30(4):812   [PMID:  17573549 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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