First-in-Human Implantations of the NaviGate Bioprosthesis in a Severely Dilated Tricuspid Annulus and in a Failed Tricuspid Annuloplasty Ring
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Based on an old misconception that the tricuspid valve is not important for cardiac performance, functional tricuspid regurgitation (TR) has been historically ignored. As a consequence, an increasing number of patients present in the current era with severe TR associated with right heart failure that is refractory to medical treatment. Traditional or redotricuspid valve surgery in that setting has been shown to have high mortality (up to 35% at 30 days).1–3 Thereby, transcatheter valve implantation technology seems as an attractive alternative. Herein, we report the first-in-human successful implantation of the NaviGate valved-stent (NaviGate Cardiac Structures, Inc, NCSI, Lake Forest, CA) in 2 patients with severe TR and prohibitive risk for conventional surgery, for which they received Food and Drug Administration and institutional review board approvals for compassionate use (Figure 1).
A 64-year-old woman presented after multiple admissions for refractory right heart failure with severe functional TR secondary to annular dilatation, severe right ventricular (RV) dysfunction, severe pulmonary hypertension (systolic pressure, 75 mm Hg), and moderate ischemic mitral regurgitation (Figure 2A). Other comorbidities included chronic kidney dysfunction, chest radiation for breast cancer, atrial fibrillation, obstructive lung disease, and coronary bypass surgery with patent grafts. The patient was deemed high risk for conventional open-heart surgery by the Multidisciplinary Heart Team and was found a candidate for compassionate use of a first-in-human NaviGate valved-stent implantation. Preoperative sizing included a focused 4-dimensional computed tomography that was used to develop a 3-dimensional printing model of the …