Key result
Transvalvular CIED leads show no association with T-TEER procedural success or residual TR.
Why the study?
Transvalvular CIED leads are present in about one in four patients referred for T-TEER and are thought to impede grasping, limit TR reduction, and risk lead injury, prompting a synthesis of the comparative evidence.
Does the presence of a transvalvular CIED lead affect procedural or device success and residual tricuspid regurgitation reduction in patients undergoing tricuspid transcatheter edge-to-edge repair?
Meta-Analysis (n=5,453)
Yes
Does the presence of a transvalvular CIED lead affect procedural or device success and residual tricuspid regurgitation reduction in patients undergoing tricuspid transcatheter edge-to-edge repair?
In patients selected by Heart Teams for tricuspid transcatheter edge-to-edge repair, the presence of a transvalvular CIED lead was not associated with worse procedural success, TR reduction, periprocedural safety, or clinically apparent lead injury, though late outcomes remain uncertain.
Supports T-TEER in selected patients with transvalvular CIED leads; leaves open effects on late outcomes.
Transvalvular leads from cardiac implantable electronic devices (CIED) are present in about one in four patients referred for tricuspid transcatheter edge-to-edge repair (T-TEER) and are thought to impede grasping, limit tricuspid regurgitation (TR) reduction and risk lead injury. We synthesised the comparative evidence. 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 by lead status. Two reviewers independently screened records, extracted outcomes with lead phenotype, exposure definition and selection criteria, and appraised risk of bias (ROBINS-I); certainty was graded (GRADE). Random-effects models yielded risk ratios (RR); adjusted late clinical outcomes were summarised study by study, with exploratory pooling across heterogeneous endpoints. Nine comparative studies (5,453 patients; 1,394 with and 4,059 without a lead) and two single-arm cohorts were included. All cohorts comprised patients judged suitable for T-TEER by a Heart Team or eligibility committee; five excluded or minimised lead-causative TR by design. Lead presence was not associated with a significant difference in procedural or device success (RR 1.00, 95% CI 0.96–1.04; k = 5), residual TR ≤ 2 + at discharge (RR 0.99, 0.95–1.04; k = 6) or 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, with upper confidence limits of 45–98%. No lead revisions or clinically apparent lead malfunctions were reported in 1,360 patients across five cohorts (0.00%, 0.00–0.05%); device interrogation was not systematic. Adjusted late outcomes, defined differently in each study, showed a non-significant trend towards more events (EuroTR death or heart-failure hospitalisation HR 1.31, 0.99–1.74; exploratory pooled HR 1.28, 0.95–1.72). Certainty was low or very low. Among patients selected by experienced Heart Teams as suitable for T-TEER, a transvalvular CIED lead was not associated with worse procedural success, TR reduction or periprocedural safety, and no clinically apparent lead injury was reported. These are associations in selected patients, not evidence of equivalence or causation; the exposure was heterogeneous, lead-causative TR was often excluded, and late outcomes remain uncertain. 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 presence during T-TEER vs. T-TEER without a transvalvular CIED lead was evaluated on Procedural or device success (co-primary with residual TR ≤2+ at discharge or 30 days) (RR 1.00, 95% CI 0.96–1.04). Transvalvular CIED lead presence was not associated with a difference in T-TEER procedural success (RR 1.00, 95% CI 0.96–1.04) or discharge residual TR ≤2+ (RR 0.99, 95% CI 0.95–1.04).
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