Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study (JCEP March 2026)-Article: Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study

Article: Tricuspid Right Ventricular Lead Entrapment in Transcatheter Tricuspid Interventions: The Tri-LEAD Study

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The Tri-LEAD study evaluated whether transcatheter tricuspid edge-to-edge repair (T-TEER) adversely affects preexisting transvenous right ventricular (RV) pacemaker or implantable cardioverter-defibrillator (ICD) leads, which may interact with or become “entrapped” by tricuspid valve repair devices. This retrospective, multicenter international registry included 146 patients treated with T-TEER between 2015 and 2023 across 10 high-volume centers in Europe and the United States. Patients were elderly (mean age 78 years; 54% male) and most had RV pacemaker leads (77%), while 23% had RV ICD leads. The primary endpoint was RV lead dysfunction over 2 years, defined by clinically relevant changes in lead parameters (threshold increase ≥1 V or impedance change ≥200 Ω), lead dislodgement or fracture, cardiac injury/perforation, pericardial effusion, or need for unplanned surgical/percutaneous intervention related to lead problems.<br /><br />Over a median 557-day follow-up, T-TEER substantially reduced tricuspid regurgitation severity (post-procedure, 44% achieved grade 1 and 40% grade 2). Regarding lead safety, 6.8% had significant impedance changes and 1.4% had significant threshold changes, but there were no cases of lead fracture, dislodgement, cardiac perforation/injury, or pacemaker-related reinterventions. A comparative analysis against 116 control patients with severe tricuspid regurgitation managed without intervention showed no increased risk of the composite safety endpoint with T-TEER (adjusted subdistribution hazard ratio 1.39; 95% CI 0.64–3.02). Longitudinal mixed-model analyses demonstrated minimal, clinically insignificant changes in sensing, impedance, and threshold over time, similar to controls.<br /><br />The study concludes that T-TEER does not meaningfully compromise RV lead performance in the short to midterm, supporting its use in patients with severe tricuspid regurgitation who already have pacemaker or ICD leads in place. Limitations include retrospective design and lack of systematic imaging to precisely characterize clip–lead interactions.

Keywords

Tri-LEAD study

transcatheter tricuspid edge-to-edge repair

T-TEER

tricuspid regurgitation

right ventricular pacemaker lead

implantable cardioverter-defibrillator lead

lead dysfunction

lead entrapment

multicenter registry

lead impedance and threshold changes