Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model

Jose L Navia; Samir Kapadia; Haytham Elgharably; Gabriel Maluenda; Krzysztof Bartuś; Cristian Baeza; Rajesh K Nair; Josep Rodés-Cabau; Cesare Beghi; Rodolfo C Quijano

doi:10.1016/j.jacbts.2017.08.003

Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model

JACC Basic Transl Sci. 2018 Jan 24;3(1):67-79. doi: 10.1016/j.jacbts.2017.08.003. eCollection 2018 Feb.

Authors

Affiliations

¹ Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
² Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
³ Hospital San Borja Arriaran, Santiago, Chile.
⁴ Jagiellonian University, Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Krakow, Poland.
⁵ Department of Cardiology, Waikato Hospital, Hamilton, New Zealand.
⁶ Quebec Heart Institute and Lung Institute, Laval University, Quebec City, Quebec, Canada.
⁷ Ospedale di Circolo Polo Universitario, Varese, Italy.
⁸ NaviGate Cardiac Structures, Inc., Lake Forest, California.

Abstract

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. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.

Keywords: ICE, intracardiac echocardiography; NaviGate bioprosthesis; PVL, paravalvular leak; RA, right atrium; RHF, right heart failure; RV, right ventricle/ventricular; RVOT, right ventricle outflow; TA, tricuspid annulus; TR, tricuspid regurgitation; TV, tricuspid valve; preclinical model; transcatheter replacement; tricuspid valve.