Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial

BACKGROUND The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring.OBJECTIVES This study sought to determine the efficacy and safety of the guidewire during transcatheter aort...

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Autores: Regueiro, A, Alperi, A, Vilalta, V, Asmarats, L, Baz, JA, Nombela-Franco, L, Calabuig, A, Muñoz-García, A, Sabaté, M, Moris, C, Picard-Deland, M, Pelletier-Beaumont, E, Rodés-Cabau, J
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p17432
Acceso en línea:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17432
Access Level:acceso abierto
Palabra clave:aortic stenosis
hemodynamic assessment
left ventricular pacing
transcatheter aortic valve replacement
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spelling Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI TrialRegueiro, AAlperi, AVilalta, VAsmarats, LBaz, JANombela-Franco, LCalabuig, AMuñoz-García, ASabaté, MMoris, CPicard-Deland, MPelletier-Beaumont, ERodés-Cabau, Jaortic stenosishemodynamic assessmentleft ventricular pacingtranscatheter aortic valve replacementBACKGROUND The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring.OBJECTIVES This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures.METHODS This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire.RESULTS A total of 121 patients (mean age: 82.2 +/- 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary effi-cacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 +/- 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported.CONCLUSIONS The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment.ELSEVIER SCIENCE INC2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17432JACC-Cardiovascular InterventionsISSN: 19368798ISSNe: 18767605reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p174322026-06-14T12:41:47Z
dc.title.none.fl_str_mv Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
title Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
spellingShingle Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
Regueiro, A
aortic stenosis
hemodynamic assessment
left ventricular pacing
transcatheter aortic valve replacement
title_short Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
title_full Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
title_fullStr Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
title_full_unstemmed Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
title_sort Safety and Efficacy of TAVR With a Pressure Sensor and Pacing Guidewire SAFE-TAVI Trial
dc.creator.none.fl_str_mv Regueiro, A
Alperi, A
Vilalta, V
Asmarats, L
Baz, JA
Nombela-Franco, L
Calabuig, A
Muñoz-García, A
Sabaté, M
Moris, C
Picard-Deland, M
Pelletier-Beaumont, E
Rodés-Cabau, J
author Regueiro, A
author_facet Regueiro, A
Alperi, A
Vilalta, V
Asmarats, L
Baz, JA
Nombela-Franco, L
Calabuig, A
Muñoz-García, A
Sabaté, M
Moris, C
Picard-Deland, M
Pelletier-Beaumont, E
Rodés-Cabau, J
author_role author
author2 Alperi, A
Vilalta, V
Asmarats, L
Baz, JA
Nombela-Franco, L
Calabuig, A
Muñoz-García, A
Sabaté, M
Moris, C
Picard-Deland, M
Pelletier-Beaumont, E
Rodés-Cabau, J
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv aortic stenosis
hemodynamic assessment
left ventricular pacing
transcatheter aortic valve replacement
topic aortic stenosis
hemodynamic assessment
left ventricular pacing
transcatheter aortic valve replacement
description BACKGROUND The SavvyWire (OpSens Inc) is a 0.035-inch preshaped guidewire with dedicated pacing properties and a distal pressure sensor allowing for continuous hemodynamic pressure monitoring.OBJECTIVES This study sought to determine the efficacy and safety of the guidewire during transcatheter aortic valve replacement (TAVR) procedures.METHODS This prospective, multicenter clinical study included patients with severe aortic stenosis undergoing TAVR in 8 European centers. The primary efficacy endpoint was defined as effective left ventricular rapid pacing runs with the guidewire translating into a significant systemic pressure drop (below 60 mm Hg). The safety outcome included the absence of major procedural complications related to the guidewire.RESULTS A total of 121 patients (mean age: 82.2 +/- 5.9 years, 50% women) were included in the study, and 119 (98.3%) patients were finally treated with the study device. A balloon-expandable valve was implanted in 45 (37.8%) patients. Predilatation and postdilatation were performed in 89 (74.8%) and 14 (11.8%) patients, respectively. The primary effi-cacy endpoint was achieved in 116 (98.3%) patients, and the mean aortic systolic arterial pressure achieved during rapid pacing was 46.6 +/- 11.3 mm Hg. Hemodynamic assessment with the use of the OptoMonitor 3 (OpSens Inc) without additional catheter exchange was achieved in 117 (99.2%) patients. The safety endpoint was achieved in 117 (99.2%) patients. No procedural mortality, stroke, or ventricular perforation was reported.CONCLUSIONS The use of the guidewire during TAVR procedures appeared to be efficacious and safe. This device could help minimize interventions during the procedure and improve the clinical decision making after transcatheter heart valve deployment.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17432
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=17432
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv ELSEVIER SCIENCE INC
publisher.none.fl_str_mv ELSEVIER SCIENCE INC
dc.source.none.fl_str_mv JACC-Cardiovascular Interventions
ISSN: 19368798
ISSNe: 18767605
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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