Data on the association of previous cardiac surgery (PCS) with outcomes following tricuspid valve transcatheter edge-to-edge repair (T-TEER) are limited. This study aimed to evaluate the impact of PCS on outcomes after T-TEER. This analysis included patients from the EuroTR registry (European Registry of Transcatheter Repair for Tricuspid Regurgitation; NCT0630726) who underwent T-TEER for clinically relevant tricuspid regurgitation (TR) between 2016 and 2024 and had available information on cardiac surgical history. Study endpoints were procedural TR reduction, improvement in NYHA functional class, all-cause mortality, and the composite of death or heart failure hospitalization (HFH) at 2 years. Among 2929 patients, 27.2
BACKGROUND:Peptide receptor radionuclide and targeted therapy are both approved treatment options for patients with metastatic gastroenteropancreatic neuroendocrine tumours (GEP NETs), but clinical evidence for preferred sequencing is scarce. The COMPETE trial evaluated the efficacy and harms of peptide receptor radionuclide therapy ([177Lu]Lu-edotreotide) versus targeted molecular therapy (everolimus) in patients with advanced, progressive, somatostatin receptor-positive GEP NETs. METHODS:This phase 3, open-label, superiority trial included patients aged 18 years or older with treatment-naive or previously treated unresectable or metastatic (or both) grade 1-2 GEP NETs. Patients were enrolled from 49 specialist neuroendocrine tumour treatment centres across 14 countries in Africa, Europe, North America, and Oceania and randomised (2:1) to intravenous [177Lu]Lu-edotreotide (7·5 ± 0·7 GBq every 3 months, maximum four cycles) or oral everolimus (10 mg/day) for up to 30 months. Random assignment was via a central, web-based randomisation system (block size of 6) and stratified by primary tumour origin and previous therapy. The primary endpoint was progression-free survival, assessed via blinded independent central review in all randomly assigned patients at 30 months. Harms were assessed in all enrolled patients who received at least one dose of a study drug. This study was registered with ClinicalTrials.gov (NCT03049189) and is no longer recruiting. FINDINGS:Between April 13, 2017, and June 20, 2022, 324 patients were enrolled and 309 patients (including 168 [54%] male patients and 141 [46%] female patients) were randomly assigned to treatment: 207 to the [177Lu]Lu-edotreotide group and 102 to the everolimus group. The median follow-up for progression-free survival was 27·5 months (IQR 19·6-30·4) for the [177Lu]Lu-edotreotide group and 21·2 months (8·9-29·4) for the everolimus group. Median progression-free survival was significantly longer with [177Lu]Lu-edotreotide versus everolimus (23·9 months [95% CI 18·7-30·0] vs 14·1 months [9·2-20·9]; stratified hazard ratio 0·67 [95% CI 0·48-0·95]; p=0·022). Treatment-related adverse events occurred in 178 (82%) of 217 patients in the [177Lu]Lu-edotreotide group and 96 (97%) of 99 patients in the everolimus group. 40 (18%) patients in the [177Lu]Lu-edotreotide group and 40 (40%) in the everolimus group had at least one treatment-related grade 3-4 adverse event. The most common treatment-related adverse events in the [177Lu]Lu-edotreotide group were diarrhoea and nausea (both 79 [36%] patients) and asthenia (66 [33%] patients), whereas those in the everolimus group were diarrhoea (45 [45%] patients), asthenia (36 [36%] patients), and anaemia (27 [27%] patients). No treatment-related deaths occurred in either study group. INTERPRETATION:[177Lu]Lu-edotreotide led to statistically significant and clinically meaningful improvements in progression-free survival. Efficacy and harms results support the use of [177Lu]Lu-edotreotide in early lines of therapy in patients with advanced, progressive GEP NETs. FUNDING:ITM Solucin.
BACKGROUND:N-terminal pro-B-type natriuretic peptide (NT-proBNP) is an established marker of myocardial stress, yet its prognostic role in tricuspid valve transcatheter edge-to-edge repair (T-TEER) for tricuspid regurgitation (TR) remains unclear. OBJECTIVES:The aim of this study was to evaluate the prognostic value of baseline NT-proBNP and its early postprocedural trajectory after T-TEER. METHODS:Patients undergoing T-TEER with available baseline NT-proBNP measurements in the EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation) registry were analyzed. NT-proBNP was evaluated continuously and by tertiles, with longitudinal changes assessed when serial measurements were available. Endpoints were the 2-year composite of all-cause mortality or first heart failure hospitalization, changes in NT-proBNP, symptomatic alleviation, and residual TR. RESULTS:In total, 2,282 patients (median age 80 years [Q1-Q3: 76-83 years], 54% women, 86% in NYHA functional class III or IV) with baseline NT-proBNP values (tertile 1, ≤1,674 pg/mL; tertile 2, 1,674-3,743 pg/mL; and tertile 3, >3,743 pg/mL) were included. Higher tertiles were associated with greater comorbidity burden, more advanced biventricular remodeling, and more severe TR. Baseline NT-proBNP was independently associated with the primary endpoint (adjusted HR: 1.62; 95% CI: 1.29-2.04). Residual TR ≤2+ at discharge occurred in 86.3%, 82.9%, and 81.4% across tertiles (P = 0.040), and higher NT-proBNP was associated with a lower likelihood of symptomatic alleviation (adjusted OR per log10 increase: 0.63; 95% CI: 0.48-0.84; P < 0.001). Both baseline NT-proBNP and higher than expected 30-day levels relative to baseline were independently associated with higher subsequent risk for the primary endpoint. CONCLUSIONS:Baseline NT-proBNP was independently associated with 2-year mortality or heart failure hospitalization after T-TEER. Early postprocedural NT-proBNP trajectories provided incremental prognostic information and may identify patients at increased risk.
BACKGROUND:Risk stratification for tricuspid valve transcatheter edge-to-edge repair (T-TEER) is paramount in the decision-making process to appropriately select patients with severe tricuspid regurgitation. OBJECTIVES:The aim of this study was to develop and validate an artificial intelligence-driven risk score, the EuroTR (European Registry of Transcatheter Repair for Tricuspid Regurgitation) score, to predict 1-year mortality in patients undergoing T-TEER. METHODS:The EuroTR score was developed using data from the EuroTR registry, comprising 1,225 patients in the derivation cohort and 601 patients in the validation cohort. On the basis of 18 clinical, laboratory, echocardiographic, and hemodynamic parameters, an extreme gradient boosting algorithm was trained and independently validated against established risk models. RESULTS:Among the entire study cohort (N = 1,826), the overall 1-year survival rate was 82.1% (95% CI: 80.1%-84.2%), with no significant differences between the derivation and validation cohorts. The EuroTR score successfully stratified patients into low-risk and high-risk groups for 1-year mortality after T-TEER (HR: 4.26; 95% CI: 2.71-6.67; P < 0.001), and it significantly outperformed established risk scores such as the EuroScore and the TRI-SCORE in the validation cohort. Beyond mortality prediction (Harrell's C index [validation cohort] = 0.741; 95% CI: 0.699-0.783), increasing EuroTR score values were associated with a higher likelihood of a clinically relevant combined endpoint of 1-year mortality, need for heart failure hospitalization, or persistent dyspnea corresponding to NYHA functional class ≥III. The likelihood of poor outcomes increased from 30.6% in patients with the lowest EuroTR scores (EuroTR risk rank <5%) to 85.5% in the highest risk group (EuroTR risk rank ≥95%). The EuroTR score's performance was confirmed in several subgroups (atrial vs nonatrial tricuspid regurgitation, TRILUMINATE-eligible vs TRILUMINATE-noneligible patients, and patients with vs without cardiac implantable electronic device leads). CONCLUSIONS:The EuroTR score offers an easy-to-use, externally validated, accurate risk stratification tool for patients undergoing T-TEER. It supports personalized treatment strategies and the design of future clinical trials, helping optimize patient selection and enhance shared decision-making within multidisciplinary heart teams.
