Evaluation of CIED-related tricuspid regurgitation in single-chamber leadless pacing vs. conventional pacing: a single-center randomized clinical trial

Abstract

Conventional transvenous pacemaker leads can interfere with TV leaflets, tendinous cords, and papillary muscles, leading to notable TR. Leadless pacemakers are designed to be implanted without transvenous leads, thus are thought to cause less mechanical disruption to the TV apparatus. However, existing data on the impact of leadless pacemaker implantation on TR is limited and inconsistent. Objectives To determine whether leadless pacemakers, compared to conventional transvenous pacemakers, reduce CIED-related TR at 12 months post-implantation. Methods A randomized clinical trial is designed to compare CIED-related TR evolution between patients receiving a leadless pacemaker versus a conventional pacemaker at HUJT. TR progression, defined as a worsening of at least one severity grade post-implantation, will be analyzed as the main outcome at 12 months post-implantation. Secondary outcomes will include the assessment of RV function and procedure-related complications. A total of 172 participants will be enrolled in the study through consecutive nonprobabilistic sampling, with an equal distribution between the two groups. Participants will be randomly allocated to either the leadless pacemaker group or the conventional pacemaker group. Patients aged 18 years or older with indications for single-chamber pacing will be included, excluding those with pre-existing significant TR, severe RV or LV impairment, or comorbidities that preclude device implantation. Results Leadless pacemaker implantation is expected to result in less TV interference compared to conventional pacemakers, which may lead in a reduced incidence of TR. No significant increase in complications is anticipated