What is the clinical evidence from this study?

Study design: Observational. Population: Severe symptomatic tricuspid regurgitation with pre-existing cardiac implantable electronic devices (n=65). Intervention: TricValve implantation. Primary outcome: Procedural safety, including lead-related events and the need for lead extraction or repositioning during intervention.

What does this research mean for the field?

TricValve implantation in patients with pre-existing cardiac implantable electronic devices is feasible and safe, with manageable lead-related complications in 6.2% of patients and no requirement for routine prophylactic lead extraction. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

September 17, 2026European Journal of Cardio-Thoracic SurgeryOpen Access

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

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Why the study?

Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?

Population

65 patients with severe symptomatic tricuspid regurgitation and pre-implanted cardiac implantable electronic…

Design

Cohort

Follow-up

159 days (IQR 60-358 days)

Key result

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.

Authors

KOKira Osipenko ICIuliana Coti PWPaul Werner

Discussion

Member takes

Overview

Supports feasibility of TricValve in CIED patients without routine extraction; hypothesis-generating, requiring prospective validation.

Key Points

To evaluate the procedural feasibility and safety of TricValve bicaval valve system implantation in patients with pre-existing cardiac implantable electronic devices, specifically assessing lead-related complications.
Multicentre retrospective study across 23 international centres evaluating N=65 patients with pre-existing cardiac implantable electronic devices who underwent TricValve implantation between May 2023 and November 2024.
Pre-procedural computed tomography and echocardiography were reviewed to assess device interaction and lead positioning, with clinical outcomes evaluated over a median follow-up of 159 days (IQR 60–358 days).
Technical success was achieved in 100% (65/65) of patients, with zero procedural deaths, zero valve malfunctions, and no need for periprocedural lead extraction or repositioning.
Lead-related complications occurred in 4 patients (6.2%), and post-implantation imaging confirmed stable lead positioning across all remaining cases.

Study Design

Type

Observational (n=65)

Multicenter

Yes

Structured PICO

Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?

Population

65 patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices who underwent TricValve implantation, followed for a median of 159 days.

Exposure

TricValve bicaval valve system implantation

Outcome

Procedural safety, including lead-related events and the need for lead extraction or repositioning during interventionsafety

TricValve implantation in patients with pre-existing CIEDs is feasible and safe, suggesting routine prophylactic lead extraction is not necessary.

Cite This Study

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.

synapsesocial.com/papers/6aaba4611561938ee54ba361 https://doi.org/10.1093/ejcts/ezag224

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September 17, 2026European Journal of Cardio-Thoracic SurgeryOpen Access

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

View Full Paper

Ask AI

Bookmark

Why the study?

Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?

Population

65 patients with severe symptomatic tricuspid regurgitation and pre-implanted cardiac implantable electronic…

Design

Cohort

Follow-up

159 days (IQR 60-358 days)

Key result

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.

Authors

KOKira Osipenko ICIuliana Coti PWPaul Werner

Discussion

Member takes

Overview

Supports feasibility of TricValve in CIED patients without routine extraction; hypothesis-generating, requiring prospective validation.

Key Points

To evaluate the procedural feasibility and safety of TricValve bicaval valve system implantation in patients with pre-existing cardiac implantable electronic devices, specifically assessing lead-related complications.
Multicentre retrospective study across 23 international centres evaluating N=65 patients with pre-existing cardiac implantable electronic devices who underwent TricValve implantation between May 2023 and November 2024.
Pre-procedural computed tomography and echocardiography were reviewed to assess device interaction and lead positioning, with clinical outcomes evaluated over a median follow-up of 159 days (IQR 60–358 days).
Technical success was achieved in 100% (65/65) of patients, with zero procedural deaths, zero valve malfunctions, and no need for periprocedural lead extraction or repositioning.
Lead-related complications occurred in 4 patients (6.2%), and post-implantation imaging confirmed stable lead positioning across all remaining cases.

Study Design

Type

Observational (n=65)

Multicenter

Yes

Structured PICO

Is TricValve implantation safe and feasible in patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices?

Population

65 patients with severe symptomatic tricuspid regurgitation and pre-existing cardiac implantable electronic devices who underwent TricValve implantation, followed for a median of 159 days.

Exposure

TricValve bicaval valve system implantation

Outcome

Procedural safety, including lead-related events and the need for lead extraction or repositioning during interventionsafety

TricValve implantation in patients with pre-existing CIEDs is feasible and safe, suggesting routine prophylactic lead extraction is not necessary.

Cite This Study

synapsesocial.com/papers/6aaba4611561938ee54ba361 https://doi.org/10.1093/ejcts/ezag224

Also Consider

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