Clinical Outcomes of Non-Atrial Fibrillation Bradyarrhythmias Treated With a Ventricular Demand Leadless Pacemaker Compared With an Atrioventricular Synchronous Transvenous Pacemaker ― A Propensity Score-Matched Analysis ―

Abstract

Background: Implanting a ventricular demand leadless pacemaker (VVI-LPM) for patients with non-atrial fibrillation (AF) bradyarrhythmias such as sick sinus syndrome (SSS) or high-grade (i.e., second- or third-degree) atrioventricular (AV) block is not recommended unless they have limited vascular access or a high infection risk; nevertheless, an unexpectedly high number of VVI-LPM implantations have been performed. This study investigated the clinical outcomes of these unusual uses. Methods and Results: This study retrospectively analyzed 193 patients who were newly implanted with a VVI-LPM or an atrioventricular synchronous transvenous pacemaker (DDD-TPM) for non-AF bradyarrhythmias at a high-volume center in Japan from September 2017 to September 2020. Propensity score-matching produced 2 comparable cohorts treated with a VVI-LPM or DDD-TPM (n=58 each). Each group had 20 (34%) patients with SSS and 38 (66%) patients with high-grade AV block. During a median follow up of 733 (interquartile range 395−997) days, there were no significant differences between the VVI-LPM and DDD-TPM groups regarding late device-related adverse events (0% vs. 4%, log-rank P=0.155), but the VVI-LPM group had a significantly increased readmission rate for heart failure (HF) (29% vs. 2%, log-rank P=0.001) and a tendency to have higher all-cause mortality (28% vs. 4%, log-rank P=0.059). Conclusions: The implantation of a VVI-LPM for non-AF bradyarrhythmias increased the incidence of HF-related rehospitalization at the mid-term follow up compared to the use of a DDD-TPM.