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

BACKGROUND

Tricuspid transcatheter edge-to-edge repair (T-TEER) is an important treatment option for symptomatic severe tricuspid valve regurgitation. Interaction with a preexisting right ventricular (RV) pacing lead can result in clinically significant RV lead dysfunction over time.

OBJECTIVES

The goal of this study was to evaluate the 2-year safety and function of preexisting RV leads after T-TEER.

METHODS

The Tri-LEAD (Tricuspid Right Ventricular lead entrapment in transcatheter tricuspid interventions) study was a retrospective multicenter international registry of 146 patients who underwent T-TEER with an RV lead in situ from 2015 to 2023. Primary outcome was RV lead dysfunction after T-TEER at 2 years (defined as change in RV lead function, dislodgement, or fracture) and need for intervention due to RV lead dysfunction or cardiac complication.

RESULTS

Mean patient age was 78.1 ± 8.6 years, and 54% were male. Over a median follow-up of 557 days (Q1-Q3: 278-966 days), 10 patients (6.8%) had an impedance change >200 Ω and 2 patients (1.4%) had a threshold change ≥1 V, with no observed cases of RV lead fracture, dislodgement, cardiac structure perforation, or pacemaker-related re-interventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted SHR: 1.39; 95% CI: 0.64 to 3.02; P = 0.41). Over time, changes in RV lead sensing (-0.53 mV/year; 95% CI: -1.15 to 0.08; P = 0.094), impedance (-2.4 Ω/year; 95% CI: -15.4 to 10.6; P = 0.72), and threshold (-0.011 V/year; 95% CI: -0.052 to 0.031; P = 0.62) were minimal and not clinically significant.

CONCLUSIONS

T-TEER has no detrimental impact on the performance of transvenous RV leads in the short term or midterm.