Novel Ring for Tricuspid Annuloplasty: A Feasibility Study in Animal Model

Abstract

Abstract Background Tricuspid regurgitation (TR) is the most common disease of the tricuspid valve, and tricuspid valvuloplasty is the main treatment method. Currently, most tricuspid annuloplasty rings are incomplete and rigid and can easily cause myocardial tear and prosthesis dehiscence. Therefore, we developed a novel tricuspid annuloplasty ring and evaluated its effectiveness. Methods In this study, eight adult pigs were selected, and implanted the novel rings (N = 4) and the commercial Edwards MC3 rings (N = 4) respectively, through median thoracotomy. The perioperative echocardiographic data were recorded, and a 6-month follow-up was completed to evaluate the effectiveness and safety of the novel rings. Results The average weight of the pigs was 70.06 kg. A total of five pigs successfully underwent tricuspid valvuloplasty and completed follow-up. The diameter of the native tricuspid annulus ranged from 25 to 29 mm. Three pigs experienced the decline of tricuspid regurgitation grade after surgery. The average tricuspid transvalvular gradients at one month and six months after the operation were 4.28 mmHg and 4.26 mmHg, respectively. No serious complications related to surgery, such as bleeding, infective endocarditis, or pericardial effusion, were found during the follow-up period. Autopsy confirmed that the tricuspid valves had good morphology and function, and the valve leaflets were completely closed. No deformation of the tricuspid annuloplasty rings was observed. Conclusions The novel tricuspid valvuloplasty ring was confirmed to be feasible in this animal model. During the six-month follow-up, the rings showed good effects without significant complications.