Optically-guided instrument for transapical beating-heart delivery of artificial mitral chordae tendineae.

Objective: We sought to develop an instrument that would enable the delivery of artificial chordae tendineae (ACT) using optical visualization of the leaflet inside the beating heart. Methods: A delivery instrument was developed together with an ACT anchor system. The instrument incorporates an optically clear silicone grasping surface in which are embedded a camera and LED for direct leaflet visualization during localization, grasping, and chordal delivery. ACTs, comprised of T-shaped anchors and an expanded polytetrafluoroethylene chordae, were fabricated to enable testing in a porcine model. Ex vivo experiments were used to measure the anchor tear-out force from the mitral leaflets. In vivo experiments were performed in which the mitral leaflets were accessed transapically using only optical guidance and ACTs were deployed in the posterior and anterior leaflets (P2 and A2 segments). Results: In 5 porcine ex vivo experiments, the mean force required to tear the anchors from the leaflets was 3.8 +/- 1.2 N. In 5 porcine in vivo nonsurvival procedures, 14 ACTs were successfully placed in the leaflets (9 in P2 and 5 in A2). ACT implantation took an average of 3.22 +/- 0.83 minutes from entry to exit through the apex. Conclusions: Optical visualization of the mitral leaflet during chordal placement is feasible and provides direct feedback to the operator throughout the deployment sequence. This enables visual confirmation of the targeted leaflet location, distance from the free edge, and successful deployment of the chordal anchor. Further studies are needed to refine and assess the device for clinical use.