Effects of a 3D segmental prosthetic system for tricuspid valve annulus remodelling on the right coronary artery: a human cadaveric coronary angiography study.

OBJECTIVES: A prosthetic system to repair secondary tricuspid valve regurgitation was developed. The conceptual engineering of the current device is based on 3D segmental remodelling of the tricuspid valve annulus in lieu of reductive annuloplasty. This study was designed to investigate the operational safety of the current prosthetic system with regard to the anatomical integrity of the right coronary artery (RCA) in fresh cadaveric human hearts.

METHODS: During the study period, from January to April 2016, the current prosthetic system was implanted on the tricuspid valve annulus in fresh cadaveric human hearts that met the study's inclusion criteria. The prepared specimens were investigated via selective coronary angiography of the RCA in the catheterization laboratory. The RCA angiographic anatomies were categorized as normal, distorted, kinked or occluded.

RESULTS: Sixteen specimens underwent implantation of the current prosthetic system. The mean age of the cadaveric human hearts was 43.24 ± 15.79 years, with vehicle accident being the primary cause of death (59%). A dominant RCA was noticed in 62.5% of the specimens. None of the specimens displayed any injury, distortion, kinking or occlusion in the RCA due to the implantation of the prostheses.

CONCLUSIONS: In light of the results of the present study, undertaken on fresh cadaveric human heart specimens, the current segmental prosthetic system for 3D remodelling of the tricuspid valve annulus seems to be safe vis-à-vis the anatomical integrity of the RCA. Further in vivo studies are needed to investigate the functional features of the current prosthetic system with a view to addressing the complex pathophysiology of secondary tricuspid valve regurgitation.