Outcomes of patients with large anatomies undergoing transcatheter tricuspid valve replacement with the LuX-Valve Plus system

BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) is increasingly performed to treat patients with severe or greater symptomatic tricuspid regurgitation (TR) at high risk for surgery. However, patients with large tricuspid annuli are not eligible for most TTVR systems. AIMS: This study aimed to report intraprocedural and 30-day clinical success rates for patients undergoing TTVR with the 55-70 mm LuX-Valve Plus system in the European TRINITY study cohort. METHODS: The co-primary endpoints were intraprocedural and 30-day clinical success, as defined by the Tricuspid Valve Academic Research Consortium criteria. Clinical and echocardiographic outcomes were reported. RESULTS: Enrolled patients (n=114) had a mean age of 77.8±5.8 years and a high Society of Thoracic Surgeons risk score of 9.9±6.0%. Intraprocedural success was 95.6%, with no cases of intraprocedural mortality or stroke. Two patients (1.8%) required cardiac surgery within the first 24 hours. At 30 days, 7 patients (6.1%) required a pacemaker implantation. Thirty-day clinical success was 91.2%, with residual severe TR being the primary reason for failure. In 93.7% of patients, residual TR was moderate or less. The mean Kansas City Cardiomyopathy Questionnaire score improved from 57.3±20.7 points to 71.0±23.5 points (p<0.001), and the proportion of patients with New York Heart Association Class III-IV symptoms reduced from 57.1% at baseline to 20.9% at 30 days (p<0.001). CONCLUSIONS: TTVR with the LuX-Valve Plus system to treat patients with severe or greater symptomatic TR and a large tricuspid annulus was associated with high intraprocedural and 30-day clinical success rates, significant TR reduction and functional improvement, and low permanent pacemaker implantation rates.