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Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study

INTRODUCTION: Percutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction dist...

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Autores principales: Massoullié, Grégoire, Bordachar, Pierre, Irles, Didier, Caussin, Christophe, Da Costa, Antoine, Defaye, Pascal, Jean, Frédéric, Mechulan, Alexis, Mondoly, Pierre, Souteyrand, Géraud, Pereira, Bruno, Ploux, Sylvain, Eschalier, Romain
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5093384/
https://www.ncbi.nlm.nih.gov/pubmed/27797979
http://dx.doi.org/10.1136/bmjopen-2015-010485
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author Massoullié, Grégoire
Bordachar, Pierre
Irles, Didier
Caussin, Christophe
Da Costa, Antoine
Defaye, Pascal
Jean, Frédéric
Mechulan, Alexis
Mondoly, Pierre
Souteyrand, Géraud
Pereira, Bruno
Ploux, Sylvain
Eschalier, Romain
author_facet Massoullié, Grégoire
Bordachar, Pierre
Irles, Didier
Caussin, Christophe
Da Costa, Antoine
Defaye, Pascal
Jean, Frédéric
Mechulan, Alexis
Mondoly, Pierre
Souteyrand, Géraud
Pereira, Bruno
Ploux, Sylvain
Eschalier, Romain
author_sort Massoullié, Grégoire
collection PubMed
description INTRODUCTION: Percutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction disturbances responsible for a poorer prognosis. The management of this complication remains controversial. METHOD AND ANALYSIS: The screening of LBBB after TAVI persisting for more than 24 hours will be conducted by surface ECG. Stratification will be performed by post-TAVI intracardiac electrophysiological study. Patients at high risk of conduction disturbances (≥70 ms His–ventricle interval (HV) or presence of infra-Hisian block) will be implanted with a pacemaker enabling the recording of disturbance episodes. Those at lower risk (HV <70 ms) will be implanted with a loop recorder device with remote monitoring of cardiovascular implantable electronic devices (CIEDs). Clinical, ECG and implanted device follow-up will also be performed at 3, 6 and 12 months. The primary objective is to assess the efficacy and safety of a decisional algorithm based on electrophysiological study and remote monitoring of CIEDs in the prediction of high-grade conduction disturbances in patients with LBBB after TAVI. The primary end point is to compare the incidence (rate and time to onset) of high-grade conduction disturbances in patients with LBBB after TAVI between the two groups at 12 months. Given the proportion of high-grade conduction disturbances (20–40%), a sample of 200 subjects will allow a margin of error of 6–7%. The LBBB–TAVI Study has been in an active recruiting phase since September 2015 (21 patients already included). ETHICS AND DISSEMINATION: Local ethics committee authorisation was obtained in May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02482844; Pre-results.
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spelling pubmed-50933842016-11-14 Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study Massoullié, Grégoire Bordachar, Pierre Irles, Didier Caussin, Christophe Da Costa, Antoine Defaye, Pascal Jean, Frédéric Mechulan, Alexis Mondoly, Pierre Souteyrand, Géraud Pereira, Bruno Ploux, Sylvain Eschalier, Romain BMJ Open Cardiovascular Medicine INTRODUCTION: Percutaneous aortic valve replacement (transcatheter aortic valve implantation (TAVI)) notably increases the likelihood of the appearance of a complete left bundle branch block (LBBB) by direct lesion of the LBB of His. This block can lead to high-grade atrioventricular conduction disturbances responsible for a poorer prognosis. The management of this complication remains controversial. METHOD AND ANALYSIS: The screening of LBBB after TAVI persisting for more than 24 hours will be conducted by surface ECG. Stratification will be performed by post-TAVI intracardiac electrophysiological study. Patients at high risk of conduction disturbances (≥70 ms His–ventricle interval (HV) or presence of infra-Hisian block) will be implanted with a pacemaker enabling the recording of disturbance episodes. Those at lower risk (HV <70 ms) will be implanted with a loop recorder device with remote monitoring of cardiovascular implantable electronic devices (CIEDs). Clinical, ECG and implanted device follow-up will also be performed at 3, 6 and 12 months. The primary objective is to assess the efficacy and safety of a decisional algorithm based on electrophysiological study and remote monitoring of CIEDs in the prediction of high-grade conduction disturbances in patients with LBBB after TAVI. The primary end point is to compare the incidence (rate and time to onset) of high-grade conduction disturbances in patients with LBBB after TAVI between the two groups at 12 months. Given the proportion of high-grade conduction disturbances (20–40%), a sample of 200 subjects will allow a margin of error of 6–7%. The LBBB–TAVI Study has been in an active recruiting phase since September 2015 (21 patients already included). ETHICS AND DISSEMINATION: Local ethics committee authorisation was obtained in May 2015. We will publish findings from this study in a peer-reviewed scientific journal and present results at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02482844; Pre-results. BMJ Publishing Group 2016-10-26 /pmc/articles/PMC5093384/ /pubmed/27797979 http://dx.doi.org/10.1136/bmjopen-2015-010485 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Cardiovascular Medicine
Massoullié, Grégoire
Bordachar, Pierre
Irles, Didier
Caussin, Christophe
Da Costa, Antoine
Defaye, Pascal
Jean, Frédéric
Mechulan, Alexis
Mondoly, Pierre
Souteyrand, Géraud
Pereira, Bruno
Ploux, Sylvain
Eschalier, Romain
Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title_full Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title_fullStr Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title_full_unstemmed Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title_short Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB–TAVI Study
title_sort prognosis assessment of persistent left bundle branch block after tavi by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre lbbb–tavi study
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5093384/
https://www.ncbi.nlm.nih.gov/pubmed/27797979
http://dx.doi.org/10.1136/bmjopen-2015-010485
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