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Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement
BACKGROUND: No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self‐expanding valves. METHODS AND RESULTS: This study included a real‐world, multicenter registry invo...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649510/ https://www.ncbi.nlm.nih.gov/pubmed/34546114 http://dx.doi.org/10.1161/JAHA.120.020682 |
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author | Bernardi, Fernando L. M. Rodés‐Cabau, Josep Tirado‐Conte, Gabriela Amat Santos, Ignacio J. Plachtzik, Claudia Cura, Fernando Sztejfman, Matias Mangione, Fernanda M. Tumeleiro, Rogério Esteves, Vinicius Borges Cardozo Pessoa de Melo, Eduardo França Alcocer Chauvet, Alejandro Fuchs, Felipe Sarmento‐Leite, Rogerio de Campos Martins, Estêvão Carvalho Nombela‐Franco, Luis Delgado‐Arana, José Raul Bocksch, Wolfgang Lamelas, Pablo Giuliani, Carlos Campanha‐Borges, Diego Carter Mangione, Jose A. de Brito, Fábio Sandoli Abizaid, Alexandre C. Ribeiro, Henrique B. |
author_facet | Bernardi, Fernando L. M. Rodés‐Cabau, Josep Tirado‐Conte, Gabriela Amat Santos, Ignacio J. Plachtzik, Claudia Cura, Fernando Sztejfman, Matias Mangione, Fernanda M. Tumeleiro, Rogério Esteves, Vinicius Borges Cardozo Pessoa de Melo, Eduardo França Alcocer Chauvet, Alejandro Fuchs, Felipe Sarmento‐Leite, Rogerio de Campos Martins, Estêvão Carvalho Nombela‐Franco, Luis Delgado‐Arana, José Raul Bocksch, Wolfgang Lamelas, Pablo Giuliani, Carlos Campanha‐Borges, Diego Carter Mangione, Jose A. de Brito, Fábio Sandoli Abizaid, Alexandre C. Ribeiro, Henrique B. |
author_sort | Bernardi, Fernando L. M. |
collection | PubMed |
description | BACKGROUND: No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self‐expanding valves. METHODS AND RESULTS: This study included a real‐world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1‐year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1‐year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). CONCLUSIONS: Repositioning a self‐expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1‐year mortality, regardless of the type of valve implanted. |
format | Online Article Text |
id | pubmed-8649510 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-86495102021-12-20 Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement Bernardi, Fernando L. M. Rodés‐Cabau, Josep Tirado‐Conte, Gabriela Amat Santos, Ignacio J. Plachtzik, Claudia Cura, Fernando Sztejfman, Matias Mangione, Fernanda M. Tumeleiro, Rogério Esteves, Vinicius Borges Cardozo Pessoa de Melo, Eduardo França Alcocer Chauvet, Alejandro Fuchs, Felipe Sarmento‐Leite, Rogerio de Campos Martins, Estêvão Carvalho Nombela‐Franco, Luis Delgado‐Arana, José Raul Bocksch, Wolfgang Lamelas, Pablo Giuliani, Carlos Campanha‐Borges, Diego Carter Mangione, Jose A. de Brito, Fábio Sandoli Abizaid, Alexandre C. Ribeiro, Henrique B. J Am Heart Assoc Original Research BACKGROUND: No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self‐expanding valves. METHODS AND RESULTS: This study included a real‐world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1‐year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1‐year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). CONCLUSIONS: Repositioning a self‐expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1‐year mortality, regardless of the type of valve implanted. John Wiley and Sons Inc. 2021-09-03 /pmc/articles/PMC8649510/ /pubmed/34546114 http://dx.doi.org/10.1161/JAHA.120.020682 Text en © 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Research Bernardi, Fernando L. M. Rodés‐Cabau, Josep Tirado‐Conte, Gabriela Amat Santos, Ignacio J. Plachtzik, Claudia Cura, Fernando Sztejfman, Matias Mangione, Fernanda M. Tumeleiro, Rogério Esteves, Vinicius Borges Cardozo Pessoa de Melo, Eduardo França Alcocer Chauvet, Alejandro Fuchs, Felipe Sarmento‐Leite, Rogerio de Campos Martins, Estêvão Carvalho Nombela‐Franco, Luis Delgado‐Arana, José Raul Bocksch, Wolfgang Lamelas, Pablo Giuliani, Carlos Campanha‐Borges, Diego Carter Mangione, Jose A. de Brito, Fábio Sandoli Abizaid, Alexandre C. Ribeiro, Henrique B. Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title | Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title_full | Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title_fullStr | Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title_full_unstemmed | Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title_short | Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
title_sort | incidence, predictor, and clinical outcomes of multiple resheathing with self‐expanding valves during transcatheter aortic valve replacement |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649510/ https://www.ncbi.nlm.nih.gov/pubmed/34546114 http://dx.doi.org/10.1161/JAHA.120.020682 |
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