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Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide
BACKGROUND: Despite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI w...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319663/ https://www.ncbi.nlm.nih.gov/pubmed/30652151 http://dx.doi.org/10.1186/s42155-018-0026-0 |
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author | Hoffmann, Pavel Al-Ani, Ahmed von Lueder, Thomas Hoffmann, Jenny Majak, Peter Hagen, Ove Loose, Helga Kløw, Nils Einar Opdahl, Anders |
author_facet | Hoffmann, Pavel Al-Ani, Ahmed von Lueder, Thomas Hoffmann, Jenny Majak, Peter Hagen, Ove Loose, Helga Kløw, Nils Einar Opdahl, Anders |
author_sort | Hoffmann, Pavel |
collection | PubMed |
description | BACKGROUND: Despite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI with two different principles, pre-suture with ProGlide and collagen plug closure with Manta. RESULTS: Seventy-six patients treated with ProGlide and 75 with Manta were analysed. The endpoints were 1: access site vascular complications and 2: non-planned vascular or endovascular surgery at the puncture site. Complications occurred in 2 (2.7%) ProGlide and in 8 (10.7%) Manta cases, p = 0.047. During the learning phase there were no significant differences. In the established phase there was one event (2%) in the ProGlide group, compared to 6 endpoints (12.0%), p = 0.047, in the Manta group. Unplanned surgery or intervention was seen in two (2.7%) ProGlide and in 7 (9.3%) Manta patients, p = ns. There were no significant differences during the learning phase. In established use, endpoints occurred more frequently in patients treated with the Manta device (12%), than in patients treated with the ProGlide (2%), p = 0.047. CONCLUSION: The ProGlide presuture closure device was associated with significantly lower rates of vascular complications and lower rates of surgery and interventions compared to the collagen plug Manta system. TRIAL REGISTRATION: The data were collected from Internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål. |
format | Online Article Text |
id | pubmed-6319663 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-63196632019-01-14 Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide Hoffmann, Pavel Al-Ani, Ahmed von Lueder, Thomas Hoffmann, Jenny Majak, Peter Hagen, Ove Loose, Helga Kløw, Nils Einar Opdahl, Anders CVIR Endovasc Original Article BACKGROUND: Despite decreasing sheath diameter, access site bleeding and vascular complications are still a major concern in transfemoral aortic valve implantation (TAVI), and may increase morbidity and even increase mortality. The aim was to compare safety of arterial closure in transfemoral TAVI with two different principles, pre-suture with ProGlide and collagen plug closure with Manta. RESULTS: Seventy-six patients treated with ProGlide and 75 with Manta were analysed. The endpoints were 1: access site vascular complications and 2: non-planned vascular or endovascular surgery at the puncture site. Complications occurred in 2 (2.7%) ProGlide and in 8 (10.7%) Manta cases, p = 0.047. During the learning phase there were no significant differences. In the established phase there was one event (2%) in the ProGlide group, compared to 6 endpoints (12.0%), p = 0.047, in the Manta group. Unplanned surgery or intervention was seen in two (2.7%) ProGlide and in 7 (9.3%) Manta patients, p = ns. There were no significant differences during the learning phase. In established use, endpoints occurred more frequently in patients treated with the Manta device (12%), than in patients treated with the ProGlide (2%), p = 0.047. CONCLUSION: The ProGlide presuture closure device was associated with significantly lower rates of vascular complications and lower rates of surgery and interventions compared to the collagen plug Manta system. TRIAL REGISTRATION: The data were collected from Internal quality control registry on treatment of patients with valvular heart disease with or without coronary artery disease, No 2014/17280, Oslo University Hospital, Ullevål. Springer International Publishing 2018-09-21 /pmc/articles/PMC6319663/ /pubmed/30652151 http://dx.doi.org/10.1186/s42155-018-0026-0 Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Article Hoffmann, Pavel Al-Ani, Ahmed von Lueder, Thomas Hoffmann, Jenny Majak, Peter Hagen, Ove Loose, Helga Kløw, Nils Einar Opdahl, Anders Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title | Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title_full | Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title_fullStr | Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title_full_unstemmed | Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title_short | Access site complications after transfemoral aortic valve implantation - a comparison of Manta and ProGlide |
title_sort | access site complications after transfemoral aortic valve implantation - a comparison of manta and proglide |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6319663/ https://www.ncbi.nlm.nih.gov/pubmed/30652151 http://dx.doi.org/10.1186/s42155-018-0026-0 |
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