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.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  NCT02482844; Pre-results.
authors: Clermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.|Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors: Grégoire
authors: G
authors: Massoullié
authors: Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
authors: Pierre
authors: P
authors: Bordachar
authors: Cardiology Department, CH Annecy Genèvois, Pringy, France.
authors: Didier
authors: D
authors: Irles
authors: Institut Mutualiste Montsouris, Paris, France.
authors: Christophe
authors: C
authors: Caussin
authors: North Hospital, Saint-Etienne, France.
authors: Antoine
authors: A
authors: Da Costa
authors: Arrhythmia Unit, Cardiology Department, University Hospital, Grenoble, France.
authors: Pascal
authors: P
authors: Defaye
authors: Clermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.|Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors: Frédéric
authors: F
authors: Jean
authors: Ramsay Générale de Santé, Hôpital Privé de Clairval, Marseille, France.
authors: Alexis
authors: A
authors: Mechulan
authors: Federation of Cardiology, University Hospital Rangueil, Toulouse cedex, France.
authors: Pierre
authors: P
authors: Mondoly
authors: Clermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.|Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors: Géraud
authors: G
authors: Souteyrand
authors: CHU Clermont-Ferrand, Biostatistics unit (Clinical Research and Innovation Direction), Clermont-Ferrand, France.
authors: Bruno
authors: B
authors: Pereira
authors: Hôpital Cardiologique du Haut-Lévêque, CHU Bordeaux, Université Bordeaux, IHU LIRYC, Bordeaux, France.
authors: Sylvain
authors: S
authors: Ploux
authors: Clermont Université, Université d'Auvergne, Cardio Vascular Interventional Therapy and Imaging (CaVITI), Image Science for Interventional Techniques (ISIT), UMR6284, Clermont-Ferrand, France.|Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
authors: Romain
authors: R
authors: Eschalier
mesh_terms: D000328:Adult; D000465:Algorithms; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery*; D002037:Bundle-Branch Block / Q000175:diagnosis* / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects; D000075224:Cardiac Conduction System Disease; D000066491:Clinical Decision-Making / Q000379:methods*; D004562:Electrocardiography; D055724:Electrophysiological Phenomena; D006321:Heart / Q000503:physiopathology; D006350:Heart Valve Prosthesis; D006801:Humans; D008991:Monitoring, Physiologic; D010138:Pacemaker, Artificial; D011183:Postoperative Complications / Q000175:diagnosis* / Q000209:etiology; D011379:Prognosis; D012107:Research Design; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*; D016896:Treatment Outcome
keywords: Left bundle branch block; Transcatheter aortic valve implantation; cardiac electrophysiology; remote monitoring.