Tricuspid annuloplasty ring prototype testing

Abstract

Background

Current surgical technique to fix the tricuspid valve regurgitation carry a high percentage (up to 37%) of recurrence of severe tricuspid valve regurgitation in mid-term follow up. There is a need for anatomically and physiologically correct Tricuspid annulus device. Our ring is developed in the way that mimics the normal anatomy & physiology of Tricuspid annulus. The aim of this study is to test three prototypes and choose the proper prototype that is tested and suitable to conform well to the normal shape of the tricuspid annulus with no distortion of the movement during the different phases of the cardiac cycle.

Methods

We used an acute open heart model in sheep as an animal model to test three prototypes. We used adult sheep (6 males and 6 females), body weight 60–70 Kg, age: 1–3 years old. We followed the protocol of open heart model in animals.

Results

Post Prototype implantation, Tricuspid valve leaflet coaptation was verified with no induced tricuspid regurgitation. On the other hand, there was no ring distortion or ring material fracture.

All the three prototypes conformed well to the normal shape of the tricuspid annulus with no distortion of the movement during the different phases of the cardiac cycle (both in systole and diastole).

Conclusions

All the three tested prototypes seemed to be effective and reproducible.