Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites

Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients () who had received percutaneous vascular closing with...

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Main Authors: Christoph Thomas, Volker Steger, Stefan Heller, Martin Heuschmid, Dominik Ketelsen, Claus D. Claussen, Klaus Brechtel
Format: Article
Language:English
Published: Hindawi Limited 2013-01-01
Series:Radiology Research and Practice
Online Access:http://dx.doi.org/10.1155/2013/875484
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spelling doaj-7a2f34c00f2c4ff0a11a39d4a81a09592020-11-24T22:15:08ZengHindawi LimitedRadiology Research and Practice2090-19412090-195X2013-01-01201310.1155/2013/875484875484Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access SitesChristoph Thomas0Volker Steger1Stefan Heller2Martin Heuschmid3Dominik Ketelsen4Claus D. Claussen5Klaus Brechtel6Diagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDepartment of Thoracic, Cardiac and Vascular Surgery, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDiagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDiagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDiagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDiagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyDiagnostic and Interventional Radiology, Department of Radiology, University of Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, GermanyPurpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients () who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion) and continued (freedom from groin surgery in further course) technical success and major (deviations from expected outcome requiring surgery) and minor (other deviations from expected outcome) complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests) and operator experience (paired samples t-test). Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based) and 90.0%, 84.0%, 16.0%, and 16.0% (patient based), respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.http://dx.doi.org/10.1155/2013/875484
collection DOAJ
language English
format Article
sources DOAJ
author Christoph Thomas
Volker Steger
Stefan Heller
Martin Heuschmid
Dominik Ketelsen
Claus D. Claussen
Klaus Brechtel
spellingShingle Christoph Thomas
Volker Steger
Stefan Heller
Martin Heuschmid
Dominik Ketelsen
Claus D. Claussen
Klaus Brechtel
Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
Radiology Research and Practice
author_facet Christoph Thomas
Volker Steger
Stefan Heller
Martin Heuschmid
Dominik Ketelsen
Claus D. Claussen
Klaus Brechtel
author_sort Christoph Thomas
title Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title_short Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title_full Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title_fullStr Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title_full_unstemmed Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title_sort safety and efficacy of the prostar xl vascular closing device for percutaneous closure of large arterial access sites
publisher Hindawi Limited
series Radiology Research and Practice
issn 2090-1941
2090-195X
publishDate 2013-01-01
description Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients () who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion) and continued (freedom from groin surgery in further course) technical success and major (deviations from expected outcome requiring surgery) and minor (other deviations from expected outcome) complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests) and operator experience (paired samples t-test). Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based) and 90.0%, 84.0%, 16.0%, and 16.0% (patient based), respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.
url http://dx.doi.org/10.1155/2013/875484
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