Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial

Background: Patients with tricuspid regurgitation (TR) frequently have transvalvular cardiac implantable electronic device (CIEDs). Objectives: The aim of this study was to determine the safety and efficacy of tricuspid transcatheter edge-to-edge repair in patients with transvalvular CIED leads. Methods: The TRILUMINATE (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System) Pivotal Trial (NCT03904147) is an international randomized, controlled trial in symptomatic subjects with severe TR. Subjects with CIED leads were screened by an eligibility committee prior to inclusion into the randomized or single-arm cohorts. Safety events were adjudicated by an independent review committee. All echocardiograms were analyzed by an independent core laboratory. Results: A total of 98 subjects (of 469) with attempted TriClip procedures had transvalvular CIED leads. CIED+ subjects were older (80.2 ± 8.6 years vs 78.2 ± 7.6 years; P = 0.02), with a higher prevalence of renal disease (46.9% vs 31.5%; P = 0.004) and lower health status (Kansas City Cardiomyopathy Questionnaire overall summary score 51.9 ± 21.0 vs 55.0 ± 23.1) at baseline compared with CIED− subjects. Slightly fewer clips were implanted in CIED+ subjects (mean 1.9) than in CIED− subjects (mean 2.2) (P = 0.0018). Procedural times were significantly shorter in CIED+ subjects (132.9 ± 63.3 minutes vs 155.9 ± 71.9 minutes; P = 0.0043) although greater in those with lead-induced TR (149.5 ± 87.5 minutes). Major adverse events (1.0% vs 1.1%) and major bleeding (3.1% vs 3.0%) were infrequent in CIED+ and CIED− subjects. At 30 days, TR reduction to moderate or less was similar in CIED+ and CIED− subjects (88% vs 87%) and was sustained out to 1 year in the majority of subjects (81% vs 84%). Compared with baseline, Kansas City Cardiomyopathy Questionnaire overall summary score significantly improved through 1 year in CIED+ subjects (18.7 ± 22.6; P < 0.0001) and CIED− subjects (16.8 ± 22.6; P < 0.0001). Heart failure symptoms were reduced in both groups at 30 days, with 85% of CIED+ subjects and 87% of CIED− subjects in NYHA functional class I or II. There were no differences in mortality, heart failure hospitalization, and need for tricuspid valve surgery or intervention between groups. No lead revisions, removals, or replacements were reported through follow-up. Conclusions: Tricuspid transcatheter edge-to-edge repair with the TriClip system was safe and effective in selected CIED+ subjects and did not affect CIED function. CIED+ subjects experienced similar TR reduction and quality-of-life improvements as CIED− subjects. Future work should define the treatable scope of patients with transvalvular CIED leads.