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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 (n = 50) who had received percutaneous vascular closing...

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Autores principales: Thomas, Christoph, Steger, Volker, Heller, Stefan, Heuschmid, Martin, Ketelsen, Dominik, Claussen, Claus D., Brechtel, Klaus
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3557636/
https://www.ncbi.nlm.nih.gov/pubmed/23401769
http://dx.doi.org/10.1155/2013/875484
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author Thomas, Christoph
Steger, Volker
Heller, Stefan
Heuschmid, Martin
Ketelsen, Dominik
Claussen, Claus D.
Brechtel, Klaus
author_facet Thomas, Christoph
Steger, Volker
Heller, Stefan
Heuschmid, Martin
Ketelsen, Dominik
Claussen, Claus D.
Brechtel, Klaus
author_sort Thomas, Christoph
collection PubMed
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 (n = 50) 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.
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spelling pubmed-35576362013-02-11 Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites Thomas, Christoph Steger, Volker Heller, Stefan Heuschmid, Martin Ketelsen, Dominik Claussen, Claus D. Brechtel, Klaus Radiol Res Pract Clinical Study 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 (n = 50) 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. Hindawi Publishing Corporation 2013 2013-01-14 /pmc/articles/PMC3557636/ /pubmed/23401769 http://dx.doi.org/10.1155/2013/875484 Text en Copyright © 2013 Christoph Thomas et al. https://creativecommons.org/licenses/by/3.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Study
Thomas, Christoph
Steger, Volker
Heller, Stefan
Heuschmid, Martin
Ketelsen, Dominik
Claussen, Claus D.
Brechtel, Klaus
Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites
title 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_short 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
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3557636/
https://www.ncbi.nlm.nih.gov/pubmed/23401769
http://dx.doi.org/10.1155/2013/875484
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