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Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience
AIMS: The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. METHODS AND RESULTS: 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter ao...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4803290/ https://www.ncbi.nlm.nih.gov/pubmed/27003573 http://dx.doi.org/10.1371/journal.pone.0151247 |
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author | Wöhrle, Jochen Gonska, Birgid Rodewald, Christoph Seeger, Julia Scharnbeck, Dominik Rottbauer, Wolfgang |
author_facet | Wöhrle, Jochen Gonska, Birgid Rodewald, Christoph Seeger, Julia Scharnbeck, Dominik Rottbauer, Wolfgang |
author_sort | Wöhrle, Jochen |
collection | PubMed |
description | AIMS: The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. METHODS AND RESULTS: 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. CONCLUSIONS: In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02162069 |
format | Online Article Text |
id | pubmed-4803290 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-48032902016-03-25 Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience Wöhrle, Jochen Gonska, Birgid Rodewald, Christoph Seeger, Julia Scharnbeck, Dominik Rottbauer, Wolfgang PLoS One Research Article AIMS: The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. METHODS AND RESULTS: 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. CONCLUSIONS: In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. TRIAL REGISTRATION: ClinicalTrials.gov NCT02162069 Public Library of Science 2016-03-22 /pmc/articles/PMC4803290/ /pubmed/27003573 http://dx.doi.org/10.1371/journal.pone.0151247 Text en © 2016 Wöhrle et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Wöhrle, Jochen Gonska, Birgid Rodewald, Christoph Seeger, Julia Scharnbeck, Dominik Rottbauer, Wolfgang Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title | Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title_full | Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title_fullStr | Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title_full_unstemmed | Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title_short | Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience |
title_sort | transfemoral aortic valve implantation with the new edwards sapien 3 valve for treatment of severe aortic stenosis—impact of valve size in a single center experience |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4803290/ https://www.ncbi.nlm.nih.gov/pubmed/27003573 http://dx.doi.org/10.1371/journal.pone.0151247 |
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