Key result
TricValve implantation in CIED patients is feasible with a ~6% lead-related complication rate.
Why the study?
Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?
Observational (n=65)
Yes
Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?
TricValve implantation in patients with pre-existing CIEDs is feasible and safe, suggesting routine prophylactic lead extraction is not necessary.
Answers are grounded in this paper and cite their sources.
Supports feasibility of TricValve in CIED patients without routine extraction; hypothesis-generating, requiring prospective validation.
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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Osipenko et al. (2026) conducted an observational in Severe symptomatic tricuspid regurgitation with pre-existing cardiac implantable electronic devices (n=65). TricValve implantation was evaluated on Procedural safety, including lead-related events and the need for lead extraction or repositioning during intervention. TricValve implantation in patients with pre-existing cardiac implantable electronic devices was feasible, with lead-related complications occurring in 6.2% of patients and no procedural deaths.
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