TY - JOUR
T1 - Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement
T2 - The MARE Study
AU - Rodés-Cabau, Josep
AU - Urena, Marina
AU - Nombela-Franco, Luis
AU - Amat-Santos, Ignacio
AU - Kleiman, Neal
AU - Munoz-Garcia, Antonio
AU - Atienza, Felipe
AU - Serra, Vicenç
AU - Deyell, Marc W.
AU - Veiga-Fernandez, Gabriela
AU - Masson, Jean Bernard
AU - Canadas-Godoy, Victoria
AU - Himbert, Dominique
AU - Castrodeza, Javier
AU - Elizaga, Jaime
AU - Francisco Pascual, Jaume
AU - Webb, John G.
AU - de la Torre, Jose Maria
AU - Asmarats, Lluis
AU - Pelletier-Beaumont, Emilie
AU - Philippon, François
N1 - Funding Information:
Dr. Asmarats is supported by a grant from the Fundacion Alfonso Martin Escudero (Madrid, Spain). Dr. Rodés-Cabau holds the Canadian Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions; and has received research institutional grants from Medtronic and Edwards Lifesciences. Dr. Nombela-Franco has served as a proctor for Abbott; and has received speaker honoraria from Edwards Lifesciences. Dr. Amat-Santos has been a proctor for Boston Scientific. Dr. Atienza has served on advisory boards for Medtronic. Dr. Deyell has received research funding from Biosense Webster; and speaking honoraria from Abbott Medical. Dr. Himbert has been a consultant and proctor for Edwards Lifesciences. Dr. Webb has been a consultant for Edwards Lifesciences. Dr. de la Torre has served on advisory boards for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/8/13
Y1 - 2018/8/13
N2 - Objectives: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Background: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. Methods: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. Results: A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. Conclusions: A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)
AB - Objectives: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). Background: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. Methods: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. Results: A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. Conclusions: A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307)
KW - atrial fibrillation
KW - bradyarrhythmias
KW - left bundle branch block
KW - pacemaker implantation
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jcin.2018.04.016
DO - 10.1016/j.jcin.2018.04.016
M3 - Article
C2 - 30031719
AN - SCOPUS:85053817050
SN - 1936-8798
VL - 11
SP - 1495
EP - 1505
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 15
ER -