The impact of baseline right heart size and function on heart failure hospitalization and mortality: 2-year results of the TRILUMINATE Trial
Notice bibliographique
Résumé
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.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,003 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».