TricValve system implantation in patients with cardiac implantable electronic devices: A multicentre observational study

Abstract Objectives Tricuspid regurgitation (TR) is associated with high morbidity and mortality. The TricValve bicaval valve system has emerged as a transcatheter option for patients with severe symptomatic TR who are not candidates for surgery or orthotopic interventions. However, its safety in patients with pre-existing cardiac implantable electronic devices (CIED) remains uncertain due to potential lead-related complications. This study aims to evaluate the feasibility and safety of TricValve implantation in patients with pre-existing CIED, with particular focus on lead-related complications and the need for lead extraction or repositioning. Methods We conducted a multicentre retrospective study including 65 patients with pre-implanted CIED who underwent TricValve implantation between May 2023 and November 2024 at 23 international centres. Pre-procedural computed tomography and echocardiography were analyzed to assess device interaction, lead positioning, and complications. The primary endpoint was procedural safety, including lead-related events and the need for lead extraction or repositioning during intervention. Secondary endpoints included echocardiographic outcomes, CIED/non-CIED-related complications and survival during follow-up of 159 days (IQR 60–358 days). Results TricValve implantation was technically successful in all patients (100%). Periprocedural no lead extraction or repositioning was required. Lead-related complications occurred in 4 patients (6.2%). No procedural deaths or TricValve malfunctions were observed. Post-implantation imaging confirmed stable lead positioning in all remaining cases. Conclusions TricValve implantation in patients with pre-existing CIED appears feasible. Lead-related complications during early follow-up were rare, manageable, and did not compromise device function or procedural success. Our data do not support routine prophylactic lead extraction before TricValve implantation.