Tricuspid regurgitation (TR) is a condition associated with poor quality of life, frequent hospitalizations due to heart failure, and increased mortality, even under optimal medical treatment.
Currently, surgery is the recommended treatment according to clinical guidelines. However, several studies have been showing very promising results regarding transcatheter tricuspid valve replacement (TTVR), showing it is safe and effective, reducing symptoms, improving quality of life, reducing hospitalizations, and increasing six-minute walk test distance.
This was an analysis the TRAVEL study, including 126 patients with severe TR, poor surgical candidates and under optimal medical management, receiving the Lux-Valve.
Primary endpoint was all-cause mortality and heart failure-related hospitalization at one-year follow-up.
Mean patient age was 65.8 with 9% STS score, and 80% were women. All patients were in functional class III-IV. Atrial fibrillation was present in 72%, coronary artery disease in 6%, stroke or TIA in 5%, COPD in 11%, and kidney function deterioration in 15%. Additionally, 68% had undergone left-sided valve treatment (surgical or percutaneous), 3% had a history of PCI or CABG, and 15% had a permanent pacemaker, CRT, or ICD. Mean NT-proBNP level was 770.
The most common cause of TR was secondary (86.5%), followed by primary (6.3%), mixed (4%), and pacemaker-lead related (3.2%).
Echocardiographic analysis showed severe TR in 51%, massive in 35%, and torrential in remaining patients. TAPSE was 17 mm, effective regurgitant orifice area was 11 mm², pulmonary artery systolic pressure was 39 mmHg, right ventricular diastolic diameter was 37 mm, and left ventricular ejection fraction was 60%.
On CT imaging, the maximum and minimum tricuspid annulus diameters were 50 and 41 mm, respectively.
Procedural success rate was 97.6%.
At 30 days, mortality was 2.4%, with new dialysis required in 3.2%, endocarditis in 0.8%, liver failure in 1.6%, access-related bleeding in 12%, and reintervention in 4%.
At 12 months, the primary outcome was seen in 14.3% of patients, with 10.3% all-cause mortality and 4% heart failure-related hospitalizations. All patients improved their functional class and six-minute walk test results. A sustained reduction in TR was observed (95% with mild or less TR), along with reverse remodeling of the right ventricle.
Conclusion
At one-year follow-up, the TRAVEL study showed sustained TR reduction in TTVR patients treated with the Lux-Valve, together with reverse remodeling of the right heart and improved functional class. Furthermore, the procedure was proved successful and showed benefits in survival.
Original Title: Transcatheter Tricuspid Valve Replacement With the Novel System 1-Year Outcomes From the TRAVEL Study.
Reference: Xiangbin Pan, et al. JACC: CARDIOVASCULAR INTERVENTIONS, Article in Presshttps://doi.org/10.1016/j.jcin.2024.12.030.
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