Abstract
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.
Highlights
A spacer device has been used to block spaces or lesions in the heart, such as the regurgitant orifice in the conventional way of a catheter-based cardiac interventional treatment (e.g., FORMA by Edward Lifesciences, CA, USA [1,2,3,4,5], Percu-ProTM System [6] and Mitra-SpacerTM by Cardiosolutions Inc., Stoughton, MA, USA [7])
A total of 24 types of spacer devices were produced, except for two cases suspected of procedural infection
This study proposes an ePTFE coated spacer device as a novel alternative in existing catheter-based cardiac interventional treatments
Summary
A spacer device has been used to block spaces or lesions in the heart, such as the regurgitant orifice in the conventional way of a catheter-based cardiac interventional treatment (e.g., FORMA by Edward Lifesciences, CA, USA [1,2,3,4,5], Percu-ProTM System [6] and Mitra-SpacerTM by Cardiosolutions Inc., Stoughton, MA, USA [7]). The spacer is placed in the regurgitant orifice and creates a new surface for leaflet coaptation, which aims to assist coaptation of dilated valve leaflets. These spacers are designed to expand into suitable spatial fit, shape, and size inside of the heart for the purpose of the operator. Saline, or other biocompatible fillers are injected from outside the body via a separate pathway (“lumen”) into the spacer device. The fillers’ physical properties affect the size, shape, and function of the device [8,9]. There is always a potential for filler leakage inside the body, so biocompatibility between the body and the fillers should be a priority for clinicians
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