First-in-Human Experience of Transcatheter Mitral Valve Repair With the PASCAL Ace Implant System

Abstract

The PASCAL transcatheter mitral valve repair (TMVr) system (Edwards Lifesciences, Irvine, CA) enables repair of a regurgitant mitral valve through leaflet approximation around an anatomic spacer. The clasps can be deployed independently for sequential leaflet capture and are separated by a spacer that fills the regurgitant orifice, and are enclosed by contoured paddles that reduce leaflet stress. Uniquely, the device can be elongated, enabling easy retrieval from the left ventricle with minimal risk of chordal entanglement. The PASCAL Ace implant is a smaller variant of the original PASCAL implant (Figure 1) that features narrower paddles (6 mm vs 10 mm) with increased curvature of the paddles around a smaller central spacer, which enables capture of more leaflet and a larger neo-coaptation area relative to device size. Therefore, despite being an overall smaller device than the original PASCAL implant, the grasp on the mitral valve leaflets may encase more leaflet surface area around the curved spacer, distributing tension across the captured leaflet tissue and minimizing leaflet trauma. These design features may be particularly useful in patients with smaller mitral valve areas, with commissural mitral regurgitation (MR) jets, and in those with excess, redundant leaflet tissue, such as degenerative myxomatous or Barlow-type mitral valves. The echocardiographic appearance is similar to the original PASCAL implant in terms of reflectivity, though with a slimmer profile. We describe the first-in-human experience of the PASCAL Ace implant system in two patients with differing anatomical constraints for percutaneous mitral valve repair.