LuX-Valve Shows Promise for High-Risk Tricuspid Regurgitation

Transcatheter therapies for severe tricuspid regurgitation (TR) are rapidly evolving as alternatives to high-risk surgical interventions and ineffective medical management. While transcatheter edge-to-edge repair (TEER) with devices like the TriClip and transcatheter tricuspid valve replacement (TTVR) with EVOQUE have shown early promise and received FDA approval, limitations remain, particularly for patients with large coaptation gaps, non-central regurgitant jets, lead-induced tricuspid regurgitation (TR), and annular size. The LuX-Valve system, distinguished by its unique design and anchoring mechanism, aims to address some of these anatomical challenges.

In a prospective, multicenter, single-arm study (TRAVEL study), Pan evaluated the safety and performance of the first-generation LuX-Valve in 126 symptomatic patients with severe tricuspid regurgitation (TR) at prohibitive surgical risk—mean Society of Thoracic Surgeons score 9.2% +/- 4.4%. The LuX-Valve is a transatrial orthotopic bioprosthetic valve system designed specifically for the tricuspid anatomy, with a unique anchoring mechanism that relies on septal anchoring and passive leaflet graspers rather than radial force or leaflet capture. The first-generation device studied in TRAVEL is surgically implanted through an atrial approach. The newer 2^nd generation iteration, the LuX-Valve Plus, is a fully percutaneous transjugular system.

Procedural success, defined as successful valve implantation with no more than moderate residual TR and absence of major procedural complications, was achieved in 98% of cases. The 30-day all-cause mortality rate was 2.4%, and the 1-year mortality rate was 10.3%. No intraprocedural deaths occurred, and conversion to surgery was required in one patient related to right ventricular perforation. Notably, the permanent pacemaker implantation rate was low at 1.6%, which is considerably lower than that reported with some other TTVR devices. Surgical access-related bleeding was the most common adverse event (13%), but the newer percutaneous system will mitigate this.

At 1 year, sustained clinical benefit was observed. NYHA functional class improved significantly, with 91% of surviving patients in class I or II compared to 18.2% at baseline. The median 6-minute walk distance increased from 190 to 300 meters (P<0.001). Echocardiographic follow-up showed mild or no TR in 85.3%, moderate TR in 4.6%, and severe TR in only 0.9% of patients with available imaging data.

These findings demonstrate that the LuX-Valve is a feasible, safe, and clinically effective treatment option in a high-risk TR population. Its minimal ventricular footprint and septal anchoring may offer advantages in preserving basal right ventricular function and reducing conduction system interference. While these results are encouraging, they are derived from a single-arm cohort without a comparator. Ongoing studies, including the percutaneous transjugular LuX-Valve Plus in the TRINITY trial, will help define the long-term role of this novel system in the expanding TTVR landscape.