Document Detail


Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.
MedLine Citation:
PMID:  18398227     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. METHODS: The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. RESULTS: Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression group, there was 2 access-site hematomas and 1 pseudoaneurysm treated with thrombin injection (p = 1.0). CONCLUSION: Among diagnostic patients with good sheath placement and favorable femoral anatomy, the FISH device is superior in achieving time to hemostasis and ambulation compared to manual compression. At 30 days, there is no apparent difference in serious or minor adverse vascular events with the use of the FISH device.
Authors:
Anthony A Bavry; Russell E Raymond; Deepak L Bhatt; Charles E Chambers; Andrew J DeNardo; James B Hermiller; Paul R Myers; Douglas E Pitts; John A Scott; Scott J Savader; Steven Steinhubl
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of invasive cardiology     Volume:  20     ISSN:  1557-2501     ISO Abbreviation:  J Invasive Cardiol     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-04-09     Completed Date:  2008-06-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8917477     Medline TA:  J Invasive Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  152-6     Citation Subset:  IM    
Affiliation:
Department of Interventional Cardiology, Cleveland Clinic, 9500 Euclid Avenue, NO. 605, Cleveland, OH 44114, USA. bavrya@ccf.org
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aged, 80 and over
Blood Loss, Surgical / prevention & control*
Equipment Safety
Female
Heart Catheterization / adverse effects*,  methods*
Hemostasis, Surgical* / instrumentation,  methods
Hemostatic Techniques / instrumentation*
Humans
Male
Middle Aged
Comments/Corrections
Comment In:
J Invasive Cardiol. 2008 Apr;20(4):157-8   [PMID:  18398228 ]

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


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