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

K. Osipenko Iuliana Coti Paul Werner Amila Kahrovic Luis Nombela Franco I. A. Amat Santos A. Mahabadi C. Frerker F. de Marco J. Althoff A. Mangieri J. M. Moreiras Nikola Pavlović Joachim Schofer Ulrich Schäfer Eike Tigges Christoph Wilde J. Hausleiter O. Altisent M. Taramasso Luis Fernando Pajín Valbuena J. Bulum Santiago Ordoñez M. Swaans J. S. Marques Boris Dickmann Birgit Zirngast Daniel Zimpfer Martin Andreas

Sep 2026 · European Journal of Cardio-Thoracic Surgery · 0 citations

Medicine

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.

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