Currently, mitral valve regurgitation (MR) is one of the leading heart valve diseases with as much as 19% of men and women having at least mild MR and 1.9 % having at least moderate MR Singh et al. (1999). DEMCON Medical Systems is working on a novel TC method to repair Mitral valve regurgitation in early stages as a preventive measure against progressive MR. The envisioned device is to achieve this through the placement of artificial chordae tendineae or neochordae. This thesis presents the next iteration step within this project. A design was created which was capable of placing neochordae in a simplified procedure, in an ex vivo environment. The design was translated into a prototype, which was used to evaluate the design via two tests.

Test one consisted of a timed intervention. Eleven participants were asked to place neochordae on a plastic heart model in four rounds. The procedure was completed from the start untill locking of the neochordae length 41/44 times. Mean procedure time dropped over the rounds with 590.7, 404.5, 303.7, 280.2 [s] for rounds 1, 2, 3, 4 respectively. Standard deviation reduction over the rounds on the placed neochordae length was less than the reduction in procedure time. Mean ± standard deviations were 88.7 ± 7.4, 87.6 ± 7.0, 85.6 ± 2.0, 88.4, ± 12 [mm] for rounds 1,2,3,4 respectively.

In test two, the design was presented and the procedure demonstrated to a panel of four cardiac experts from the Maastricht University Medical Centre (MUMC), including a thorax surgeon, two cardiologists, and an interventional cardiologist. They were asked to evaluate the device’s safety and theorize on the clinical effectiveness of the design. They concluded that the tines on the ventricular and leaflet fixation components were potential safety risks, due to potentially damaging pre-existing chordae tendineae and papillary muscles during placement. Furthermore, they critiqued the general shape of the implant. Participants expressed a need to place multiple neochordae. Additionally, they expressed a preference for the straight-line technique the implemented folding leaflet technique.

Through these results, it was concluded that the designed procedure is feasible to execute in an ex vivo environment. The procedure order, has the potential to serve as inspiration and backbone for future developments. The translatability of the designed components onto the next iteration has to be critically reviewed. First, several components have to be further evaluated on their mechanical performance as well as overall performance in a more clinically representative test environment. Additionally, the feedback provided at the MUMC is in stark contrast to the continuous guidance from the thorax surgeon at the MST. The fundamentality and severity of their critique should be taken as a warning and prompt further investigation towards patient safety criteria and research into the optimal implant shape. Future research into these crucial aspects could hinder the strict adaptation of the current component designs. Overall this iteration and its evaluation have generated a lot of new insights regarding the placement of neochordae.