Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model.

Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model.

Transcatheter mitral valve replacement with the NaviGate stent in a preclinical model.

Aims: The aim of this study was to test the feasibility of transcatheter mitral valve implantation of the NaviGate device in acute and chronic preclinical models.

Methods And Results: We evaluated NaviGate valved stent implantation in the mitral position in an acute swine model (n=24, ≤5 days) through three different approaches - transatrial, transapical, and transseptal - and in a chronic swine model (n=12, >10 days) through a transatrial approach. The NaviGate implantation procedures were successful in 83% of the acute model studies (n=20) and 83% of the chronic model studies (n=10).