A Novel Transcatheter Tricuspid Valve Device Development and Preliminary Validation

Abstract

BACKGROUND: The current interventional therapy for tricuspid regurgitation (TR) is not suitable for various severe forms of TR. We aimed to develop a novel transcatheter tricuspid valve device (TTVD) suitable for different TR situations and to verify its safety and efficacy by in vitro and in vivo animal experiments.

METHODS: The transcatheter tricuspid valve is comprised of a double-layered self-expanding nickel-titanium alloy stent, which can be delivered to the correct location via the right atrium or jugular vein. The operability, safety, and applicabilityof TTVD were verified by in vitro and in vivo animal model experiments.

RESULTS: The outer stent of the interventional valve is designed to match the shape of the tricuspid annuloplasty ring or the tricuspid dilated annulus. The interventional valve was successfully deployed and anchored in vitro. In animal survival experiments, postoperative transthoracic echocardiography showed that the TTVD released under direct vision had satisfactory opening and closing of the leaflets without perivalvular leakage. Digital subtraction angiography showed that the TTVD was successfully released via the right jugular vein in the pig models of TR and TR after implantation of a tricuspid annuloplasty ring.

CONCLUSION: This study developed a novel TTVD. Animal experiments showed that the TTVD is suitable for various forms of TR.