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 preexisting cardiac implantable electronic devices (CIEDs) remains uncertain due to potential lead-related complications. This study aims to evaluate the feasibility and safety of TricValve implantation in patients with preexisting 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 analysed to assess device interaction, lead positioning, and complications. The primary end-point was procedural safety, including lead-related events and the need for lead extraction or repositioning during intervention. Secondary end-points included echocardiographic outcomes, CIED/non-CIED-related complications, and survival during follow-up of 159 days (interquartile range [IQR] 60-358 days).
Results: TricValve implantation was technically successful in all patients (100%). Periprocedurally, 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 preexisting 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.
Related
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- Trajectory changes in psychosocial adaptation levels of patients after implantation of cardiac implantable electronic devices and development of the intervention programme: a mixed-methods research protocol
- Resolution of Lancisi's sign following bicaval TricValve implantation for torrential tricuspid regurgitation: a case report defining a novel bedside marker of haemodynamic recovery.
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BibTeX
@article{osipenko2026tricvalve,
title = {{TricValve System Implantation in Patients With Cardiac Implantable Electronic Devices: A Multicentre Observational Study}},
author = {Kira Osipenko and Iuliana Coti and Paul Werner and Amila Kahrovic and Luis Nombela Franco and Ignacio J Amat Santos and Amir A Mahabadi and Christian Frerker and Federico De Marco and Jan Althoff and Antonio Mangieri and Javier Martín Moreiras and Nikola Pavlović and Joachim Schofer and Ulrich Schäfer and Eike Tigges and Christoph Wilde and Jörg Hausleiter and Omar Abdul-Jawad Altisent and Maurizio Taramasso and Luis Fernando Pajín Valbuena and Joško Bulum and Santiago Ordoñez and Martin Swaans and João Silva Marques and Boris Dickmann and Birgit Zirngast and Daniel Zimpfer and Martin Andreas},
journal = {European Journal of Cardio-Thoracic Surgery},
year = {2026},
month = sep,
doi = {10.1093/ejcts/ezag224},
url = {https://doi.org/10.1093/ejcts/ezag224},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - TricValve System Implantation in Patients With Cardiac Implantable Electronic Devices: A Multicentre Observational Study
AU - Kira Osipenko
AU - Iuliana Coti
AU - Paul Werner
AU - Amila Kahrovic
AU - Luis Nombela Franco
AU - Ignacio J Amat Santos
AU - Amir A Mahabadi
AU - Christian Frerker
AU - Federico De Marco
AU - Jan Althoff
AU - Antonio Mangieri
AU - Javier Martín Moreiras
AU - Nikola Pavlović
AU - Joachim Schofer
AU - Ulrich Schäfer
AU - Eike Tigges
AU - Christoph Wilde
AU - Jörg Hausleiter
AU - Omar Abdul-Jawad Altisent
AU - Maurizio Taramasso
AU - Luis Fernando Pajín Valbuena
AU - Joško Bulum
AU - Santiago Ordoñez
AU - Martin Swaans
AU - João Silva Marques
AU - Boris Dickmann
AU - Birgit Zirngast
AU - Daniel Zimpfer
AU - Martin Andreas
PY - 2026
DA - 2026/09/15
JO - European Journal of Cardio-Thoracic Surgery
DO - 10.1093/ejcts/ezag224
UR - https://doi.org/10.1093/ejcts/ezag224
AB - 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 preexisting cardiac implantable electronic devices (CIEDs) remains uncertain due to potential lead-related complications. This study aims to evaluate the feasibility and safety of TricValve implantation in patients with preexisting 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 analysed to assess device interaction, lead positioning, and complications. The primary end-point was procedural safety, including lead-related events and the need for lead extraction or repositioning during intervention. Secondary end-points included echocardiographic outcomes, CIED/non-CIED-related complications, and survival during follow-up of 159 days (interquartile range [IQR] 60-358 days). Results: TricValve implantation was technically successful in all patients (100%). Periprocedurally, 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 preexisting 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.
SN - 1010-7940
SN - 1873-734X
ER -