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Patients with severe tricuspid valve regurgitation (TVR) are associated with high rates of morbidity and mortality. In recent years, catheter-based heart valve replacement has emerged as a promising treatment option for the patients suffering from aortic valve problems; however, commercial TVR device is still unavailable for the reason of the complicated anatomical variation of tricuspid valve. Recently, a new tricuspid valve prosthesis has been invented by Jenscare Biotechnology CO., Ltd(Ningbo, China). This bovine pericardium TV prosthesis is designed as D-shape and it contains a self-expandable nitinol stent covered by a layer of polyethylene terephthalate (PET). Its positioning calls for a special delivery system. To evaluate its feasibility and safety, initial in vivo animal experiment has been performed.
9 healthy adult goats (30-40kg) were prepared for in vivo experimental implementation of this tricuspid valve prosthesis. Echography was used for valve sizing before each examination. After cutting a small incision at the 3rd or 4th anterolateral intercostals , the prosthesis was delivered through right atrium guided by echography. Once accurately positioned, the D-shaped repositionable prosthesis was released by a special anchoring device. Aspirin and Plavix were given for anticoagulation postoperatively. Blood samples were taken for analysis. Echography was performed immediately after each operation and also during their recovery stages.
All the devices were successfully implanted at the tricuspid valve position of the 9 goats. One of the goats was sacrificed immediately after the procedure and another two were excuted in 30days and 90days, respectively. The other 6 goats survived more than six months. By using echocardiography, mild to moderate perivalvular leakage was found in two goats, while no transvalvular gradient was observed in all surviving ones.
Even though the animal experiment result has demonstrated that this new catheter-based TV device is feasible for TVR treatment, the evaluation of long-term therapeutic effects and safety of the implantation procedures remains to be done in the future.
STRUCTURAL: Valvular Disease: Other