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 involv...
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2021
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oai:doaj.org-article:2b830aadc64c4c25a7b1829b1388f2422021-11-23T11:36:35ZIncidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement10.1161/JAHA.120.0206822047-9980https://doaj.org/article/2b830aadc64c4c25a7b1829b1388f2422021-09-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.120.020682https://doaj.org/toc/2047-9980Background 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.Fernando L. M. BernardiJosep Rodés‐CabauGabriela Tirado‐ConteIgnacio J. Amat SantosClaudia PlachtzikFernando CuraMatias SztejfmanFernanda M. MangioneRogério TumeleiroVinicius Borges Cardozo EstevesEduardo França Pessoa de MeloAlejandro Alcocer ChauvetFelipe FuchsRogerio Sarmento‐LeiteEstêvão Carvalho de Campos MartinsLuis Nombela‐FrancoJosé Raul Delgado‐AranaWolfgang BockschPablo LamelasCarlos GiulianiDiego Carter Campanha‐BorgesJose A. MangioneFábio Sandoli de BritoAlexandre C. AbizaidHenrique B. RibeiroWileyarticleaortic valve stenosisresheathingself‐expanding valvetranscatheter aortic valve replacementDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 18 (2021) |
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DOAJ |
| collection |
DOAJ |
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EN |
| topic |
aortic valve stenosis resheathing self‐expanding valve transcatheter aortic valve replacement Diseases of the circulatory (Cardiovascular) system RC666-701 |
| spellingShingle |
aortic valve stenosis resheathing self‐expanding valve transcatheter aortic valve replacement Diseases of the circulatory (Cardiovascular) system RC666-701 Fernando L. M. Bernardi Josep Rodés‐Cabau Gabriela Tirado‐Conte Ignacio J. Amat Santos Claudia Plachtzik Fernando Cura Matias Sztejfman Fernanda M. Mangione Rogério Tumeleiro Vinicius Borges Cardozo Esteves Eduardo França Pessoa de Melo Alejandro Alcocer Chauvet Felipe Fuchs Rogerio Sarmento‐Leite Estêvão Carvalho de Campos Martins Luis Nombela‐Franco José Raul Delgado‐Arana Wolfgang Bocksch Pablo Lamelas Carlos Giuliani Diego Carter Campanha‐Borges Jose A. Mangione Fábio Sandoli de Brito Alexandre C. Abizaid Henrique B. Ribeiro Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self‐Expanding Valves During Transcatheter Aortic Valve Replacement |
| 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 |
article |
| author |
Fernando L. M. Bernardi Josep Rodés‐Cabau Gabriela Tirado‐Conte Ignacio J. Amat Santos Claudia Plachtzik Fernando Cura Matias Sztejfman Fernanda M. Mangione Rogério Tumeleiro Vinicius Borges Cardozo Esteves Eduardo França Pessoa de Melo Alejandro Alcocer Chauvet Felipe Fuchs Rogerio Sarmento‐Leite Estêvão Carvalho de Campos Martins Luis Nombela‐Franco José Raul Delgado‐Arana Wolfgang Bocksch Pablo Lamelas Carlos Giuliani Diego Carter Campanha‐Borges Jose A. Mangione Fábio Sandoli de Brito Alexandre C. Abizaid Henrique B. Ribeiro |
| author_facet |
Fernando L. M. Bernardi Josep Rodés‐Cabau Gabriela Tirado‐Conte Ignacio J. Amat Santos Claudia Plachtzik Fernando Cura Matias Sztejfman Fernanda M. Mangione Rogério Tumeleiro Vinicius Borges Cardozo Esteves Eduardo França Pessoa de Melo Alejandro Alcocer Chauvet Felipe Fuchs Rogerio Sarmento‐Leite Estêvão Carvalho de Campos Martins Luis Nombela‐Franco José Raul Delgado‐Arana Wolfgang Bocksch Pablo Lamelas Carlos Giuliani Diego Carter Campanha‐Borges Jose A. Mangione Fábio Sandoli de Brito Alexandre C. Abizaid Henrique B. Ribeiro |
| author_sort |
Fernando L. M. Bernardi |
| title |
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_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_sort |
incidence, predictor, and clinical outcomes of multiple resheathing with self‐expanding valves during transcatheter aortic valve replacement |
| publisher |
Wiley |
| publishDate |
2021 |
| url |
https://doaj.org/article/2b830aadc64c4c25a7b1829b1388f242 |
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