Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model
Author + information
- Jose L. Navia, MDa,∗ (naviaj{at}ccf.org),
- Samir Kapadia, MDb,
- Haytham Elgharably, MDa,
- Gabriel Maluenda, MDc,
- Krzysztof Bartuś, MDd,
- Cristian Baeza, MDc,
- Rajesh K. Nair, MDe,
- Josep Rodés-Cabau, MDf,
- Cesare Beghi, MDg and
- Rodolfo C. Quijano, MD, PhDh
- aDepartment of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio
- bDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
- cHospital San Borja Arriaran, Santiago, Chile
- dJagiellonian University, Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Krakow, Poland
- eDepartment of Cardiology, Waikato Hospital, Hamilton, New Zealand
- fQuebec Heart Institute and Lung Institute, Laval University, Quebec City, Quebec, Canada
- gOspedale di Circolo Polo Universitario, Varese, Italy
- hNaviGate Cardiac Structures, Inc., Lake Forest, California
- ↵∗Address for correspondence:
Dr. José L. Navia, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Avenue/Desk J4-1, Cleveland, Ohio 44143.
Visual Abstract
Highlights
• Surgery for isolated tricuspid regurgitation carries a high mortality risk, especially in the setting of right ventricular dysfunction and reoperation.
• Transcatheter valve therapy is as promising alternative for treatment of isolated tricuspid valve disease associated with right heart failure.
• The NaviGate bioprosthesis is a novel self-expanding valved stent designed to treat functional tricuspid regurgitation.
• The preclinical evaluation shows that transcatheter tricuspid valve implantation using the NaviGate device is safe, is feasible through 2 different approaches, and results in a secure and stable engagement of the native annulus, with excellent hemodynamic and valve performance.
Summary
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.
Footnotes
The Cleveland Clinic has an ownership position on patents licensed to the company; and holds stock in NaviGate Cardiac Structures, Inc. Dr. Navia is the inventor on patents related to this device; and has served as a consultant to and holds stock in NaviGate Cardiac Structures, Inc. Dr. Kapadia has served on the advisory board of Navigate; and has stock options in NaviGate Cardiac Structures, Inc. Dr. Quijano is an inventor on patents related to this device; and holds stock in NaviGate Cardiac Structures, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Basic to Translational Science author instructions page.
- Received August 15, 2017.
- Accepted August 25, 2017.
- 2018 The Authors
