Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation
Bibliographic record
Abstract
BACKGROUND: Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal) is the first randomized controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER). OBJECTIVES: Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year. METHODS: The TRILUMINATE Pivotal trial is an international randomized controlled trial of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFHs), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. RESULTS: Between August 21, 2019, and June 29, 2022, 572 subjects were randomized, including the primary cohort (n = 350) and subsequent enrollment (n = 222). Subjects were older (78.1 ± 7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio = 1.84; P < 0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (P = 0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year; P = 0.40). A significant treatment effect was observed for change in quality of life with 52.3% of device subjects achieving a ≥15-point KCCQ score improvement (compared with 23.5% of control subjects; P < 0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%; P < 0.0001), KCCQ change at 1 year (13.0 ± 1.4 points vs -0.5 ± 1.4 points; P < 0.0001), and 6-minute walk distance change at 1 year (1.7 ± 7.5 m vs -27.4 ± 7.4 m; P < 0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs performance goal: 90%; P < 0.0001). CONCLUSIONS: TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance and health status. Rates of all-cause mortality or tricuspid valve surgery and HFH through 1 year were not reduced by T-TEER.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".