A Percutaneous Catheter Solution as a Spacer for Regurgitant Heart Valve Disease

Spacers, such as FORMA (Edwards Lifescience) or Mitraspacer, are used to treat mitral regurgitation or tricuspid regurgitations. However, they require external therapeutic liquid filler injection into the spacer device. This should be leak-tight over the time of implantation, which is a major limitation in device design. Here, we propose a self-expandable spacer with a nitinol inner mesh and expanded poly (tetrafluoroethylene) (ePTFE) coating that also functions as a spacer. We designed nitinol 3D mesh templates, coated with a commercially available low and high durometer ePTFE membrane. Finally, we implanted the spacer into a swine pulmonary artery and right atrium (superior vena cava) as an intervention technique. Twenty-four swine were used, except in two cases suspected of procedural infection. The results were analyzed in the remaining 22 cases and all devices were easily delivered and had good function in self-expansion and implantation. After eight weeks, all individuals were examined for gross and pathological analysis to determine the biological safety of the device. There was no evidence of damage or other abnormalities and increased postoperative endothelialization outside of ePTFE coatings. In conclusion, this study suggests using a self-expandable spacer to complement the medical limitations of the existing filling-type spacer devices.