Abstract
BACKGROUND: Cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is common. Transcatheter tricuspid valve replacement (TTVR) is feasible with CIEDs in the right ventricle; however, data in this population are limited. OBJECTIVES: This study retrospectively analyzed patients undergoing compassionate-use transjugular TTVR with the LuX-Valve Plus for symptomatic TR with CIEDs from January 2022 to August 2024 at 17 international centers. METHODS: The primary endpoint was procedural TR reduction. Secondary endpoints included TR reduction, survival at 30 days, NYHA functional class changes, and CIED function at follow-up. Non-CIED group was used for comparison. RESULTS: Of 99 patients, 36 (36.4%) had CIEDs. Baseline characteristics were similar, though the CIED group had a higher EuroSCORE (European System for Cardiac Operative Risk Evaluation) II score and more comorbidities. Procedural success (CIED vs non-CIED: 91.7% vs 95.2%; P = 0.781), 30-day mortality (5.6% vs 4.8%; P > 0.999), TR reduction (≤1+: 83.8% vs 84.9%; P > 0.999), and NYHA functional class I/II (80.8% vs 83.7%; P = 0.89) were comparable. The CIED cohort exhibited a higher numerical incidence of conversion to surgery (8.3% vs 1.6%) and tricuspid reintervention (11.5% vs 3.3%) within 6 months; however, these differences did not reach statistical significance (P = 0.267 and P = 0.160, respectively). Of the 22 patients with postoperative interrogation (median of 3.3 months), 9.1% of CIED patients exhibited worsening device parameters, with no need for lead replacement or extraction. CONCLUSIONS: Transjugular TTVR is safe and effective for managing TR and heart failure in patients with CIEDs. Due to the small sample size, these findings highlight the need for larger, prospective studies to validate these outcomes.