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Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design

AIMS: Atrial fibrillation (AF) worsens the prognosis of patients with heart failure (HF). Successful treatments are still very scarce for those with permanent AF and preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. In this study, the long‐term benefits and safety profile of heart rate...

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Autores principales: Rodríguez Muñoz, Daniel, Crespo‐Leiro, María Generosa, Fernández Lozano, Ignacio, Zamorano Gómez, José Luis, Peinado Peinado, Rafael, Manzano Espinosa, Luis, de Juan Bagudá, Javier, Marco del Castillo, Álvaro, Arribas Ynsaurriaga, Fernando, Salguero Bodes, Rafael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10682904/
https://www.ncbi.nlm.nih.gov/pubmed/37731197
http://dx.doi.org/10.1002/ehf2.14488
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author Rodríguez Muñoz, Daniel
Crespo‐Leiro, María Generosa
Fernández Lozano, Ignacio
Zamorano Gómez, José Luis
Peinado Peinado, Rafael
Manzano Espinosa, Luis
de Juan Bagudá, Javier
Marco del Castillo, Álvaro
Arribas Ynsaurriaga, Fernando
Salguero Bodes, Rafael
author_facet Rodríguez Muñoz, Daniel
Crespo‐Leiro, María Generosa
Fernández Lozano, Ignacio
Zamorano Gómez, José Luis
Peinado Peinado, Rafael
Manzano Espinosa, Luis
de Juan Bagudá, Javier
Marco del Castillo, Álvaro
Arribas Ynsaurriaga, Fernando
Salguero Bodes, Rafael
author_sort Rodríguez Muñoz, Daniel
collection PubMed
description AIMS: Atrial fibrillation (AF) worsens the prognosis of patients with heart failure (HF). Successful treatments are still very scarce for those with permanent AF and preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. In this study, the long‐term benefits and safety profile of heart rate regularization through left‐bundle branch pacing (LBBP) and atrioventricular node ablation (AVNA) will be explored in comparison with pharmacological rate‐control strategy. METHODS AND RESULTS: The PACE‐FIB trial is a multicentre, prospective, open‐label, randomized (1:1) clinical study that will take place between March 2022 and February 2027. A total of 334 patients with HFpEF/HFmrEF and permanent AF will receive either LBBP followed by AVNA (intervention arm) or optimal pharmacological treatment for heart rate control according to European guideline recommendations (control arm). All patients will be followed up for a minimum of 36 months. The primary outcome measure will be the composite of all‐cause mortality, HF hospitalization, and worsening HF at 36 months. Other secondary efficacy and safety outcome measures such as echocardiographic parameters, functional status, and treatment‐related adverse events, among others, will be analysed too. CONCLUSION: LBBP is a promising stimulation mode that may foster the clinical benefit of heart rate regularization through AV node ablation compared with pharmacological rate control. This is the first randomized trial specifically addressing the long‐term efficacy and safety of this pace‐and‐ablate strategy in patients with HFpEF/HFmrEF and permanent AF.
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spelling pubmed-106829042023-11-30 Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design Rodríguez Muñoz, Daniel Crespo‐Leiro, María Generosa Fernández Lozano, Ignacio Zamorano Gómez, José Luis Peinado Peinado, Rafael Manzano Espinosa, Luis de Juan Bagudá, Javier Marco del Castillo, Álvaro Arribas Ynsaurriaga, Fernando Salguero Bodes, Rafael ESC Heart Fail Study Designs AIMS: Atrial fibrillation (AF) worsens the prognosis of patients with heart failure (HF). Successful treatments are still very scarce for those with permanent AF and preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction. In this study, the long‐term benefits and safety profile of heart rate regularization through left‐bundle branch pacing (LBBP) and atrioventricular node ablation (AVNA) will be explored in comparison with pharmacological rate‐control strategy. METHODS AND RESULTS: The PACE‐FIB trial is a multicentre, prospective, open‐label, randomized (1:1) clinical study that will take place between March 2022 and February 2027. A total of 334 patients with HFpEF/HFmrEF and permanent AF will receive either LBBP followed by AVNA (intervention arm) or optimal pharmacological treatment for heart rate control according to European guideline recommendations (control arm). All patients will be followed up for a minimum of 36 months. The primary outcome measure will be the composite of all‐cause mortality, HF hospitalization, and worsening HF at 36 months. Other secondary efficacy and safety outcome measures such as echocardiographic parameters, functional status, and treatment‐related adverse events, among others, will be analysed too. CONCLUSION: LBBP is a promising stimulation mode that may foster the clinical benefit of heart rate regularization through AV node ablation compared with pharmacological rate control. This is the first randomized trial specifically addressing the long‐term efficacy and safety of this pace‐and‐ablate strategy in patients with HFpEF/HFmrEF and permanent AF. John Wiley and Sons Inc. 2023-09-20 /pmc/articles/PMC10682904/ /pubmed/37731197 http://dx.doi.org/10.1002/ehf2.14488 Text en © 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. 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 Study Designs
Rodríguez Muñoz, Daniel
Crespo‐Leiro, María Generosa
Fernández Lozano, Ignacio
Zamorano Gómez, José Luis
Peinado Peinado, Rafael
Manzano Espinosa, Luis
de Juan Bagudá, Javier
Marco del Castillo, Álvaro
Arribas Ynsaurriaga, Fernando
Salguero Bodes, Rafael
Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title_full Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title_fullStr Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title_full_unstemmed Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title_short Conduction system pacing and atrioventricular node ablation in heart failure: The PACE‐FIB study design
title_sort conduction system pacing and atrioventricular node ablation in heart failure: the pace‐fib study design
topic Study Designs
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10682904/
https://www.ncbi.nlm.nih.gov/pubmed/37731197
http://dx.doi.org/10.1002/ehf2.14488
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