Document Detail

The experience with the Epiclose-T vascular access closure device: a human study.
MedLine Citation:
PMID:  18258532     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The Epiclose-T, a novel closure device for arterial access sites, is designed as a double-balloon device that applies direct pressure on the arteriotomy site, allowing natural coagulation and leaving no artificial material behind. We assessed prospectively the initial safety and efficacy of the Epiclose-T after diagnostic cardiac catheterization, and evaluated patient comfort. METHODS: In our randomized, controlled, prospective study, the study group consisted of 32 patients (17 male, mean age 52.8+/-11.0 years) treated with Epiclose-T device. The control group included 39 patients (20 male, mean age 55.5+/-11.0 years) treated with manual compression. RESULTS: Hemostasis was achieved successfully in 90.6% of the study group. For the 30-day follow-up, there were no statistically significant differences between the groups in the rate of major and minor complications. No bleeding requiring transfusion was seen in both groups. However, the number of major complications, including large hematoma (0 vs. 1 patient-2.6%) and pseudoaneursym (0 vs. 1 patient-2.6%), occurred more often in the control group. The number of small hematomas was 3 (7.7%) in the compression group and 2 (6.9%) in the Epiclose-T group. In the failure group (3 patients), body-mass-index was somewhat lower than that of the success group (median--26 (25-33) kg/m2 vs. 27 (24-32) kg/m2, p=0.07). Most patients were satisfied by the Epiclose-T closure device and grade it as excellent or good. CONCLUSION: Hemostasis can be easily and safely achieved by Epiclose-T device with no significant minor and major complications with patients' total satisfaction.
Hürkan Kurşaklioğlu; Atila Iyisoy; Cem Barçin; Turgay Celik; Ronn Nitzan; Sedat Köse; Basri Amasyali; Ersoy Işik
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Anadolu kardiyoloji dergisi : AKD = the Anatolian journal of cardiology     Volume:  8     ISSN:  1308-0032     ISO Abbreviation:  Anadolu Kardiyol Derg     Publication Date:  2008 Feb 
Date Detail:
Created Date:  2008-02-08     Completed Date:  2008-03-07     Revised Date:  2008-06-19    
Medline Journal Info:
Nlm Unique ID:  101095069     Medline TA:  Anadolu Kardiyol Derg     Country:  Turkey    
Other Details:
Languages:  eng     Pagination:  38-42     Citation Subset:  IM    
Department of Cardiology, Gülhane Military Medical Academy, Ankara, Turkey.
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MeSH Terms
Equipment Design
Femoral Artery / surgery
Heart Catheterization / instrumentation*
Hemostatic Techniques / instrumentation*
Middle Aged
Postoperative Complications
Prospective Studies
Treatment Outcome
Comment In:
Anadolu Kardiyol Derg. 2008 Apr;8(2):174; author reply 174   [PMID:  18400645 ]

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

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