Key result
Transvalvular CIED leads show no impact on T-TEER procedural success or residual TR reduction.
Why the study?
Patients with transvalvular CIED leads are under-represented in pivotal tricuspid transcatheter edge-to-edge repair (T-TEER) trials due to concerns over leaflet grasping, tricuspid regurgitation reduction, and lead damage. Whether a transvalvular lead genuinely modifies the safety or effectiveness of T-TEER had never been quantified.
Does the presence of a transvalvular CIED lead compromise procedural success, residual tricuspid regurgitation reduction, or periprocedural safety in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER)?
Meta-Analysis (n=5,453)
Yes
Does the presence of a transvalvular CIED lead compromise procedural success, residual tricuspid regurgitation reduction, or periprocedural safety in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER)?
In patients selected by Heart Teams for T-TEER, the presence of a transvalvular CIED lead does not compromise procedural success, acute TR reduction, or periprocedural safety, and clinically apparent lead injury is essentially non-existent, indicating that lead carriage alone should not disqualify patients from T-TEER.
Answers are grounded in this paper and cite their sources.
May support T-TEER eligibility despite transvalvular leads; extends observational data but leaves randomized confirmation open.
Background Transvalvular leads from cardiac implantable electronic devices (CIED) are present in roughly one in four patients referred for tricuspid transcatheter edge-to-edge repair (T-TEER). Leads are believed to impede leaflet grasping, limit tricuspid regurgitation (TR) reduction and risk lead damage, and lead carriers are under-represented in pivotal trials. Whether a lead genuinely modifies the safety or effectiveness of T-TEER has never been quantified. Methods We searched Europe PMC, PubMed/MEDLINE, OpenAlex, ClinicalTrials.gov, reference lists and conference proceedings (January 2000 to 2 August 2026) for studies reporting T-TEER outcomes separately by transvalvular lead status. Two reviewers independently screened, extracted data and appraised risk of bias (ROBINS-I, Newcastle–Ottawa); certainty was rated with GRADE. Random-effects models (restricted maximum likelihood) yielded risk ratios (RR) and a pooled adjusted hazard ratio (aHR). Because Hartung–Knapp intervals can be anticonservative with few studies and zero between-study variance, we report the wider of the Hartung–Knapp and Wald intervals. Results Nine comparative studies (5,453 patients; 1,394 with and 4,059 without a lead) and two single-arm cohorts were included. Pooled lead prevalence was 22.3% (95% CI 18.0–26.9). Lead carriage was not associated with any difference in procedural or device success (RR 1.00, 0.96–1.04; k = 5), residual TR ≤ 2 + at discharge (RR 0.99, 0.95–1.04; k = 6) or at follow-up (RR 0.95, 0.88–1.03), NYHA class I/II (RR 0.96, 0.90–1.02), early mortality (RR 0.83, 0.19–3.65), major adverse events (RR 0.77, 0.49–1.21) or major bleeding (RR 0.90, 0.30–2.73); I² was 0% throughout. Among lead carriers, 82.4% (76.4–87.7) achieved residual TR ≤ 2+. No lead dislodgement, dysfunction, entrapment or revision occurred in 1,360 patients across five cohorts (0.00%, 0.00–0.05). The pooled adjusted hazard of death or heart-failure hospitalisation was numerically higher but non-significant (aHR 1.28, 0.95–1.72; p = 0.070; k = 3). Certainty was low for residual TR, NYHA class and lead integrity, and very low elsewhere. Conclusions A transvalvular CIED lead does not measurably compromise the technical success, acute effectiveness or periprocedural safety of T-TEER, and lead injury appears essentially non-existent. The modest, non-significant excess of late clinical events most plausibly reflects residual confounding rather than a procedural penalty. Lead carriage should not by itself disqualify a patient from T-TEER. Registration This review was conducted according to a protocol finalised before data extraction. Registration details are given in the Declarations.
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Gohri et al. (2026) conducted a meta-analysis in Symptomatic moderate-to-severe or greater tricuspid regurgitation undergoing tricuspid transcatheter edge-to-edge repair (T-TEER) (n=5,453). Transvalvular cardiac implantable electronic device (CIED) lead carriage during T-TEER vs. T-TEER in patients without a transvalvular CIED lead was evaluated on Co-primary: Procedural or device success; and residual tricuspid regurgitation (TR) ≤2+ at discharge or 30 days (RR 1.00, 95% CI 0.96-1.04). Transvalvular CIED lead carriage was not associated with any difference in T-TEER procedural/device success (RR 1.00, 95% CI 0.96-1.04) or residual TR ≤2+ at discharge (RR 0.99, 95% CI 0.95-1.04).
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