A EUROPEAN post-market registry study has demonstrated that tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip system is safe and effective for patients with severe tricuspid regurgitation (TR) and endocardial leads, achieving significant symptom relief and TR reduction without lead-related complications.
Tricuspid regurgitation, a common valvular heart disease, often coexists with endocardial leads from pacemakers or defibrillators, which can exacerbate valve dysfunction. While T-TEER has emerged as a minimally invasive treatment for TR, its efficacy and safety in patients with existing leads remained uncertain. This analysis from the bRIGHT EU Post-Approval Study (PAS) addresses this gap, focusing on outcomes for high-risk patients with lead-associated TR in real-world clinical settings.
The prospective study included 511 patients across 26 European centres, of whom 110 (21.5%) had endocardial leads. Among these, 80.7% had TR at least partially attributed to lead interference. At 30-day follow-up, 71% of lead patients achieved TR reduction to moderate or less (p<0.0001). Functional status improved dramatically, with New York Heart Association (NYHA) Class I/II patients increasing from 17% at baseline to 75% post-procedure. Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), showed a mean 20-point improvement (p<0.0001). Major adverse event rates were comparable between lead and non-lead groups (2.5% overall), with no lead malfunctions reported. Procedural success was achieved in 99% of cases, independent of baseline TR severity or lead position.
These findings support T-TEER as a viable option for TR patients with endocardial leads, addressing both valve dysfunction and lead-related complications. For clinical practice, TriClip offers a safe alternative to surgery for high-risk patients, particularly those ineligible for lead extraction. Future research should explore long-term durability beyond 30 days and assess outcomes in larger, diverse cohorts. Additionally, studies comparing T-TEER with lead revision strategies could optimise treatment pathways for this growing patient population.
Reference
Goebel B et al. Outcomes of tricuspid transcatheter edge-to-edge repair in subjects with endocardial leads. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2025;21(5):e253-61.
