Early Experience with a Novel Transcatheter Tricuspid Heart Valve Prosthesis

Objectives: Patients presenting with isolated TR are often highly symptomatic but ineligible for conventional valve surgery. Thus, minimal invasive tricuspid treatment techniques might play an important role in the future treatment of the disease. Here, we want to present our center’s early experience with the first dedicated transcatheter tricuspid valve prostheses.

Methods: The Tricento heart valve is a bicavally anchored transcatheter prosthesis. It consists of a covered nitinol stent with a lateral bicuspid porcine valve. The design aims to eliminate systolic backflow to the venae cavae to limit end organ dysfunction caused by increased CVP and to increase effective right ventricular stroke volume. The device is implanted via transfemoral venous access and is fully resheathable and retrievable until final release. We treated a 62-year-old male (A) and a 63-year-old female (B) patients with the device. Both suffered from frequent right heart decompensations, dyspnea (New York Heart Association [NYHA] III/IV), holosystolic liver vein backflow, ascites, and kidney dysfunction. Highly impaired RV function, severe pulmonary hypertension, and left heart disease were excluded. Notably, both patients underwent heart transplantation over a decade ago. Pathomechanisms were primary tricuspid regurgitation caused by flail septal leaflet in patient A and annular dilatation with massive central malcoaptation in patient B. After Heart Team discussion both patients were considered ineligible for conventional surgery or edge-to-edge repair.

Results: The implantations of the custom-tailored prostheses were eventless. No residual regurgitation to the caval veins could be seen in the final angiograms. CVP dropped significantly, while PA pressure increased moderately. Both patients were extubated immediately after the procedure within the hybrid OR. Patient A was discharged from intensive care unit on postoperative day 1, and left hospital on postoperative day 14 after recovery from contrast-induced nephropathy. Follow-up is available for 6 months with no further decompensations and improvement of NYHA functional status to grades I to II. Patient B underwent the procedure just 9 days ago and is still hospitalized due to postoperative pneumonia. Thus, clinical benefit is not judgeable yet.

Conclusion: Tricuspid valve replacement with the Tricento device seems to be technically feasible as all five so far worldwide performed cases were eventless. Further studies with larger cohorts are required to assess both safety and efficacy of the procedure.