Transcatheter Tricuspid Valve Replacement With the Novel System
Bibliographic record
Abstract
BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) is emerging as a promising surgical alternative for high-risk patients with tricuspid regurgitation (TR). Nonetheless, the feasibility of more dedicated devices and the need for additional clinical evidence warrant further exploration. OBJECTIVES: The purpose of this study was to report the 1-year outcomes of the TRAVEL (Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve) study with the LuX-Valve system for patients with severe TR. METHODS: A total of 126 patients with symptomatic severe TR were prospectively enrolled in the single-arm, multicenter TRAVEL study from June 2020 to August 2021. All patients underwent TTVR via the transatrial approach using the LuX-Valve system. The primary endpoint was all-cause mortality and hospitalization for heart failure at 1-year follow-up. Clinical and echocardiographic outcomes were reported. RESULTS: At baseline, all enrolled patients (mean age 65.8 ± 7.5 years, 79.4% women) were at high surgical risk (mean Society of Thoracic Surgeons score 9.2% ± 4.4%), with severe or greater TR and NYHA functional class ≥ III. In 1-year follow-up, all-cause mortality was 10.3%, and 4.0% of patients were hospitalized for heart failure. TR was reduced to mild or less in 95.2% (P < 0.001), with decreases in right atrial systolic volume (-38.3 ± 21.7 mL; P < 0.001) and mid right ventricular end-systolic diameter (-6.4 ± 2.3 mm; P < 0.001). NYHA functional class I or II was achieved in 79.8% (P < 0.001), and 6-minute walking distance increased by 71.3 ± 42.8 m (P < 0.001). CONCLUSIONS: The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart reverse remodeling and improved functional status. Favorable procedural success and survival benefits were also demonstrated. (the TRAVEL Trial: Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve; NCT04436653).
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.026 |
| 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) | 0.000 | 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 teacher head, 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".