Tri-LEAD: T-TEER Safe at 2 Years in Patients With Implanted Cardiac Devices

Tricuspid transcatheter edge-to-edge repair (T-TEER) did not compromise transvenous right ventricular (RV) lead performance in either the short- or mid-term, according to results of the Tri-LEAD study published Dec. 22 in JACC: Clinical Electrophysiology.

The retrospective, multicenter study focused on two-year RV lead dysfunction (change in RV lead function, dislodgement or fracture) and need for intervention due to RV lead dysfunction or cardiac complication in 146 patients (mean age, 78 years; 46% women) across 10 international centers with severe tricuspid regurgitation (TR) who underwent T-TEER with an RV lead in situ from 2015 to 2023.

Results over a median follow-up of 557 days found that 10 patients (6.8%) had an impedance change >200 Ω and two patients (1.4%) had a threshold change ≥1 V. There were no observed cases of RV lead fracture, dislodgement, cardiac structure perforation or pacemaker-related reinterventions. T-TEER was not associated with an increased risk of the composite safety endpoint (adjusted subdistribution hazard ratio, 1.39; p=0.41).

Additionally, changes in RV lead sensing (–0.53 mV/year; p=0.094), impedance (–2.4 Ω/year; p=0.72) and threshold (–0.011 V/year; p=0.62) remained minimal and clinically insignificant.

JACC Central Illustration: Summary of the main findings of the Tri-LEAD study.

"Although we observed changes in 8.3% of cases in threshold or impedance at the 2-year follow-up, these changes did not result in any clinically significant RV lead dysfunction or cardiac complication," write study authors Tatyana Storozhenko, MD, PhD, et al. "This finding indicates that T-TEER could be considered a viable and secure therapeutic option in patients with severe TR who have an implanted RV pacemaker or ICD in situ." Larger, prospective studies are warranted.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Tricuspid Valve Insufficiency, Tricuspid Valve, Electric Impedance, Defibrillators, Electrophysiology


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