Valvular & structural heart disease
Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial
Authors' conclusion
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. (TRILUMINATE Pivotal Trial; NCT03904147).
Study context
- Population
- Symptomatic subjects with severe tricuspid regurgitation (TR) with transvalvular CIED leads undergoing attempted TriClip proceduressubjects (of 469) with attempted TriClip procedures had transvalvular CIED leads
- Participants
- 98 subjects
- Comparison
- CIED+ vs CIED- subjects
- CIED+n = 98
Methodological detailssingle-arm cohorts, independent review committee adjudication, independent core laboratory
- Single-arm cohorts
- Independent review committee adjudication
- Independent core laboratory
Primary result
As reported in the abstract
P = 0.02
Further findings
Renal disease · baseline
P = 0.004
TR reduction to moderate or less · 30 days; 1 year
30 days
1 year
NYHA functional class I or II · 30 days
Procedural time · shorter in CIED+
P = 0.0043
| Outcome | CIED+ | CIED- | P value |
|---|---|---|---|
| Kansas City Cardiomyopathy Questionnaire overall summary score · baselineMean | 51.9 (SD 21.0) | 55.0 (SD 23.1) | |
| Clips implantedFewer in CIED+ · mean | 1.9 | 2.2 | P = 0.0018 |
| Change in Kansas City Cardiomyopathy Questionnaire overall summary score vs baseline · 1 year | 18.7 (SD 22.6) | 16.8 (SD 22.6) | |
| P | P < 0.0001 | P < 0.0001 |
- Procedural time — lead-induced TR
- 149.5 ± 87.5 minutes
Mortality, heart failure hospitalization, and need for tricuspid valve surgery or intervention
- No differences between groups
Safety
Major adverse events
Major bleeding
Lead revisions, removals, or replacements · through follow-up
- No lead revisions, removals, or replacements were reported
Original publication
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