Transcatheter tricuspid valve replacement using the LuX-Valve Plus system - 1-year compassionate use outcomes

Sep 29, 2026

Uploaded by jay

Transcatheter tricuspid valve replacement (TTVR) was assessed in consecutive patients treated under an international compassionate use programme using the LuX-Valve Plus system from 2019 to 2024. One-year endpoints included TVARC clinical success, tricuspid regurgitation (TR) reduction, survival, heart-failure hospitalization–free survival, NYHA class and right-ventricular (RV) failure symptoms, RV reverse remodelling, and adverse events. In 39/41 with 1-year follow-up, clinical success was 76.9% with durable TR reduction and improved functional status.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

AccessFree to download

Background

Rationale and study aim

Methods

Patient cohort and endpoints

Statistical analysis

Results

Baseline characteristics

One-year outcomes and survival

Echocardiographic and functional changes

Adverse events and safety

RESEARCH LETTER doi:10.1002/ejhf.70010 Online publish-ahead-of-print 18 August 2025 Transcatheter tricuspid valve replacement using the LuX-Valve Plus system: 1-year compassionate use outcomes Transcatheter tricuspid valve replacement (TTVR) has emerged as an important treatment tool for patients with severe tricuspid regurgitation (TR) and heart failure.1 Currently, one TTVR device is Food and Drug Administration and CE mark approved and several others are at different stages of development. For the transjugular LuX-Valve Plus TTVR system, evidence is consistently growing. Besides compassionate use 30-day outcome data,2 the TRAVEL study recently reported effective TR reduction (≤2+ in 95.5% of patients) in an Asian patient population, while being associated with low procedural complication rates (permanent pacemaker requirement in 1.6%, severe bleeding in 14.3%) and good 1-year survival (89.7%).3 Since 1-year real-world data outside of China are lacking, the present study aimed at investigating 1-year outcomes following compassionate use LuX-Valve Plus TTVR. The study included consecutive patients from 16 international centres who underwent LuX-Valve Plus TTVR from 20 19 until 2024 in a compassionate use programme. Accordingly, no pre-specified in-or exclusion criteria were available and the individual screening process was left to the discretion of each individual centre. Procedural details of TTVR using the LuX-Valve Plus system have previously been described.4 One-year endpoints included clinical success according to the Tricuspid Valve Academic Research Consortium (TVARC),5 TR reduction, 1-year survival and survival free from heart failure hospitalization (HFH), changes in New York Heart Association (NYHA) functional class and symptoms of right ventricular (RV) failure, RV reverse remodelling (RVRR) as well TTVR-related adverse events. Numbers arepresented as mean ± standard deviation or median with interquartile range (IQR). Two ................................................................. .............................................................. .............................................................................. dependent samples were compared using the Wilcoxon test. A two-sided p-value of <0.05 yielded statistical significance. All analyses were performed using R (version 4.0.4) and SPSS (version 25, IBM, Armonk, NY, USA). The analysis was approved by each centre’s local ethics committee and adheres to the principles outlined in the Declaration of Helsinki. The study included a total of 74 patients (mean age 75.9 ± 7.4 years; 56.8% women). TR was severe, massive and torrential in 13.7%, 21.9% and 64.4%, respectively. Patients were highly symptomatic (NYHA class ≥III 84.3%, peripheral oedema 81. 1%, ascites 40.3%, pleural effusion 35.6%) and presented with advanced surgical risk (TRI-SCORE 5.9 ± 2.4 points). Renal function was impaired as represented by an estimated glomerular filtration rate of 52.4 ± 25.2 ml/min. The median N-terminal pro-B-type natriuretic peptide value was 1985 (IQR 1023–3668) pg/ml. The most common comorbidities within the study cohort were atrial fibrillation (90.4%), arterial hypertension (62.2%) and coronary artery disease (32.9%). TTVR reduced TR to ≤ 1+ and ≤2+ in 90.5% and 94.6% of patients, respectively. Residual TR was paravalvular in all cases. Intraprocedural success according to TVARC was achieved in 68 patients (91. 1%) with a mean procedural time of 131 ± 40 min. The postprocedural tricuspid valve inflow gradient was 2.0 ± 1.2 mmHg. Overall, 42.5% of patients were discharged with prescription of directoral anticoagulants and 53.5% with vitamin K antagonists. Antiplatelet therapy included acetylsalicylic acid in 5.7% of patients. One-year follow-up was available in 39 out of 41 eligible patients (alive and TTVR performed > 1 year ago) (Figure 1). Clinical success at 1-year follow-up was 76.9% with durable TR reduction to ≤ 1+ in 78.4% and ≤2+ in

FAQs

What treatment and patient population were evaluated in this study?

The study evaluated LuX-Valve Plus transcatheter tricuspid valve replacement in 74 consecutive patients treated in a compassionate use programme across 16 international centres from 2019 to 2024.

Which outcomes were used to assess 1-year effectiveness?

Effectiveness at one year included TVARC clinical success, TR reduction, survival, survival free from heart-failure hospitalization, NYHA functional class changes, RV reverse remodelling, and TTVR-related adverse events.

How did patients do at 1-year follow-up in terms of survival and TR reduction?

Among patients with available follow-up, one-year survival was 77.7% and survival free from heart-failure hospitalization was 66.8%. Clinical success was 76.9%, with durable TR reduction to ≤1+ in 78.4% and ≤2+ in 86.5% of patients.

Sep 29, 2026

Uploaded by jay