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 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.