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TRAVEL II study is a prospective, multi-center and single-arm clinical trial, which primarily aims to evaluate the acute and long-term safety and efficacy of LuX-Valve Plus in patients with severe tricuspid regurgitation (TR). TRAVEL II clinical trial has enrolled 96 patients from 15 centers in China. The average age of the patients was 71.35 years old with an average STS score of 9.09%. 37.5% of the patients had prior left heart valve surgery, and 15.63% of them had pacemaker/ICD implanted before. Patients were combined with multi other comorbidities, which formed a poor baseline and increased the risks of surgical treatment or difficulties of other interventional therapies.

The safety results showed that the incidence of composite events is 8.33%. Incidence of myocardial infarction, stroke, use of ECMO or IABP, acute liver failure, long-term mechanical ventilation (>72 hours), cardiovascular injury requiring surgical intervention (heart perforation, vascular injury), and life-threatening severe bleeding were all 0%. All-cause mortality was only 2.08%. Incidence of acute renal failure, severe paravalvular leakage, and conversion to surgical tricuspid valve replacement or tricuspid valvuloplasty were 1.04%, 2.08%, and 3.13% respectively. Incidence of new onset degree III AVB requiring permanent pacemaker implantation was only 1.04%.

The safety results showed that the incidence of composite events is 8.33%. Incidence of myocardial infarction, stroke, use of ECMO or IABP, acute liver failure, long-term mechanical ventilation (>72 hours), cardiovascular injury requiring surgical intervention (heart perforation, vascular injury), and life-threatening severe bleeding were all 0%. All-cause mortality was only 2.08%. Incidence of acute renal failure, severe paravalvular leakage, and conversion to surgical tricuspid valve replacement or tricuspid valvuloplasty were 1.04%, 2.08%, and 3.13% respectively. Incidence of new onset degree III AVB requiring permanent pacemaker implantation was only 1.04%.

In terms of NYHA cardiac function improvement, 84.43% of patients improved from pre-procedure NYHA class III/IV to class I/II at 30 days, and 91.86% improved to NYHA class I/II at 6 months. In terms of quality of life (QoL), patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 15 points at 30 days, and increased by 20 points at 6 months. The results indicate that the cardiac function and QoL of patients improved continuously.

Prof. Granada concluded that LuX-Valve Plus system is a versatile TTVR device that does not depend on radial force for anchoring. Its innovative design (ventricular septal anchor & leaflet-grasping clips) provides redundant mechanisms for anchoring and stability. The multicenter, TRAVEL II study showed that LuX-Valve Plus system was safe and effective in achieving short delivery times, low 30-day composite event rates, significant TR reduction and improvement in functional and QoL metrics at 6 months.

Prof. Fanglin Lu concluded that, LuX-Valve Plus intended to shorten the learning curve and decrease the difficulties of TR interventional treatment.

This compassionate use study was conducted among 15 sites internationally in recent years, and was widely spread in Europe, U.S. and Asia-Pacific region. It enrolled elderly patients from global population with high/extremely high surgical risk and severe TR or above. Since the patients in compassionate use were in poor conditions, the baseline was very challenging. The average age of the patients was 78 years old. 75% of patients have annulus diameter ≥55mm. 97.4% of patients have TR ≥3. 

In-hospital and 30-day outcomes indicated outstanding treatment result. First, in-hospital TR grade reduced instantly. 92.2% of patients recovered to ≤2+. The incidence of new pacemaker implantation was only 3.9%. Then, 30-day outcomes showed TR grade reduced significantly, 95% of patients recovered to ≤2+. NYHA cardiac function improved continuously, 85.4% of patients improved to post-operative class I/II. Moreover, the echocardiographic findings showed the right heart/ventricle benefits as well.

Prof. Kent So introduced that not all anatomies are suitable for T-TEER treatment or surgical operation because of the special anatomical structure of tricuspid valve and pathological changes accompanied. Therefore, TTVR has become the new clinical treatment option, which has a high likelihood of complete elimination of TR. LuX-Valve Plus is such kind of TTVR device which delivered via transjugular vein, can cover a wide range of tricuspid annulus dimensions with low pacemaker rate. 

The HK early experience indicated that procedure success rate was 100%, and the procedural and 30-day outcomes showed that the incidences of all-cause mortality, cardiovascular mortality, malposition/migration, emergency surgery/reintervention, vascular access complication, cerebrovascular accident and myocardial infarction were all 0%. The echocardiographic assessment at 30 days showed that 100% of the patients had their TR grade improved to none/trace. The safety and efficacy of LuX-Valve Plus were preliminarily validated one more time.

Experience with LuX-Valve Plus in Patient after TEER were Shared by Prof. Simon Lam at New York Valves 2024

Prof. Simon Lam (林祥智教授，Queen Mary Hospital, Hong Kong, China) shared a complex case. An elderly male patient, who occurred recurrent tricuspid regurgitation after TEER, would be planned to re-do MV TEER followed by TTVR with LuX-Valve Plus.

During this case, LuX-Valve Plus was implanted in the same procedure with MV TEER and without the extraction of the previous T-TEER clips. It indicated that LuX-Valve Plus was compatible in patients with MV and TV TEER device, and showed efficacious results. It further indicated that LuX-Valve Plus was not only compatible with mitral valve procedure, but also compatible with other TV TEER clips implanted.