The purpose of the Long term Evaluation of Cardiac Arrhythmias after Transcatheter Aortic Valve Implantation (LOCATE) Registry is to perform long-term ambulatory monitoring of patients with severe aortic stenosis who undergo trans-catheter aortic valve implantation (TAVI) and develop new onset conduction system abnormalities post-procedure that do not require urgent permanent pacemaker (PPM) implantation. The primary objectives of this study are to assess the incidence of late onset heart block necessitating PPM implantation and to evaluate the incidence of new onset atrial fibrillation (AF) following TAVI. This study aims to provide valuable insights into the long-term cardiac health of TAVI patients and inform the development of improved treatment strategies for aortic stenosis patients with conduction system abnormalities.
New left bundle branch block (QRS >120ms)
New first degree AV block (PR>200ms) or worsening of pre-existing first-degree AV block by >30ms
New right bundle branch block (QRS>120ms)
Intra-procedural 2:1 or higher-grade AV block with spontaneous improvement within 24 hours
Patients with high grade or complete AV block post TAVI needing urgent pacemakers
Patient with existing cardiac implantable electronic devices (CIEDs)
Patients having a particular medical condition that dictates that they cannot tolerate subcutaneous, chronically-inserted device
Patient is currently pregnant as evidenced by urine positive Beta-HCG. (Urine Beta human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) as standard of care for arrhyhtmia monitoring after TAVI procedure will have the ILR monitored monthly by the electrophysiology team. All alerts will be reviewed and discussed with the implanting physician for further management. Patients will be followed for up to 12 months.
Cohort
Prospective
TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)
DeviceNo intervention will be done as part of this prospective registry. Implantation of Boston Scientific Loop Recorder (LUX-Dx) will be performed regardless of this research and outside this research protocol per standard of care
Incidence of brady arrhythmias
Incidence of significant brady arrhythmias (2:1 or higher-grade Atrioventricular block (AV) block) requiring pacemaker implantation post TAVI in patients with evidence of conduction system injury following TAVI
Predictors of development of late onset heart block needing pacing
Evaluate predictors of development of late onset (\>30 days) heart block needing pacing
New onset Atrial Fibrillation
Assess the incidence of new onset atrial fibrillation post TAVI
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