The impact of baseline right heart size and function on heart failure hospitalization and mortality: 2-year results of the TRILUMINATE Trial
Bibliographic record
Abstract
Abstract Background Little is known about right heart remodeling outcomes following tricuspid transcatheter edge-to-edge (TEER) repair for the treatment of severe tricuspid regurgitation (TR). Purpose To assess the association between baseline right heart size and function on 2-year outcomes following tricuspid TEER in patients with severe, symptomatic TR from the TRILUMINATE Pivotal randomized controlled trial. Methods Patients were randomized 1:1 to tricuspid TEER + medical therapy (Device) or medical therapy alone (Control). Echocardiograms were analyzed by an independent core laboratory, and an independent clinical events committee adjudicated adverse events. RV dilation was defined as a basal RV end-diastolic dimension indexed to body surface area (RVEDDi) ≥24.5 mm/m2. RV function was defined based on tricuspid annular plane systolic excursion (TAPSE): normal (>1.7 cm), mild-moderate dysfunction (1.3-1.7 cm), and severe dysfunction (<1.3 cm). Severe right atrial (RA) dilatation was defined as RA volume index (RAVi) of >60 mL/m2. Pulmonary artery systolic pressure (PASP) was estimated using the peak TR velocity plus an estimate of RA pressure. Normal RV-pulmonary artery (PA) coupling ratio was defined as TAPSE/PASP>0.4 mm/mmHg. Results A total of 572 patients were randomized (285 to Device, 287 to Control) from 68 centers in the US, Canada and Europe. Baseline RAVi (77.4±41.3 mL/m2), tricuspid valve annulus (4.3±0.8 cm), and basal RVEDDi (27.2±4.6 mm/m2) were consistent with RV remodeling, with TAPSE = 1.7±0.4 cm. Basal RVEDDi was predictive of mortality at 2 years (8.2% for RVEDDi<24.5 mm/m2 vs 21.4% for RVEDD≥24.5 mm/m2, p=0.0004), with no differences between treatment groups. Mortality was not significantly different by stated cutoffs for either the whole group, or between groups for RAVi, RV dysfunction severity by TAPSE, or TAPSE/PASP. The Table shows the annualized HFH for right heart size and function. Among subjects with RV dilation, HFH rate was significantly lower in Device vs Control subjects at 2 years (p=0.0079) and were similar with no RV dilation (p=0.83). Among subjects with severe RV dysfunction, HFH rate was significantly lower in Device vs Control subjects at 2 years (p=0.0008) but were similar in subjects with normal or mild-moderate RV dysfunction (p>0.6 for both). In patients without severe RA dilatation, HFH rate was significantly lower in Device vs Control at 2 years (p=0.0018) and was similar in patients with severe RA dilatation (p=0.35). For patients with TAPSE/PASP>0.4 mm/mmHg, HFH rate was significantly lower in Device vs Control at 2 years (p=0.0024) and was similar with TAPSE/PASP ≤0.4 (p=0.61). Conclusions Compared to medical therapy, annualized 2-year HFH was significantly lower in patients treated with TEER with baseline RV dilatation, severe RV dysfunction, normal RV-PA coupling, and non-severe RA dilatation. Basal RVEDDi was predictive of all-cause mortality at 2 years for both treatment groups.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".